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6 trends shaping the future of clinical trials in 2023 and beyond, context: why is the clinical research industry changing so quickly.

The clinical research industry has seen steady improvements over the past several decades, but technological advances and unprecedented global issues such as the COVID-19 pandemic have spurred the transformation of this industry at a breakneck speed.[ 1 ]

In the past three years alone, the face of the clinical trial arena has changed completely in response to new challenges, bringing a host of new possibilities and opportunities.

In this article, we look at these altering factors and discuss the trends shaping the future of clinical trials in 2023 and beyond.

Exhibit A: Common issues causing challenges for clinical researchers

Despite the changes, there are still several significant challenges that continue to plague clinical research. Furthermore, their consequences cannot be ignored as they can lead to study complications either by exceeding timelines or going over budget.

Common challenges that hinder clinical trials, regardless of location or medical condition, include the following:

• Unequal representation of minorities in clinical trial participants

When the study sample does not represent the actual patient population, it questions the validity of trial results and whether they are accurate enough for the general population. [ 2 ]

The reason for this disproportionate sampling is complex, and you can read more about it in this article, Three Clinical Trial Recruitment Challenges and Strategies to Overcome Them .

• Inability to meet enrollment numbers

Despite the advances, 85% of clinical trials still struggle to enroll enough participants. [ 3 ]

And such poor enrollment severely delays a research study, costing sponsors and CROs. If an adequate number of participants are not enrolled, developing novel, life-saving drugs can become a much longer process than initially expected.

• Poor patient retention

Even after enrollment numbers have been met, there is always a chance that patients are unwilling to participate for the length of the clinical trial. While participant drop-outs are normal, if the attrition rate is too high, it can affect the accuracy of results or, delay the trial further.

For more information on this challenge, check out this discussion Exploring the Significance of Clinical Trial Patient Retention and Strategies for Improvement .

• Predominance of manual data entry

Despite the technology available, adoption can be slow and many still rely on staff to manually enter data in study records. [ 4 ]

This approach not only slows down trial operations but is also prone to human error and becomes increasingly difficult to track when trials are multicenter or international.

• Difficulties navigating regulatory guidelines and standards

With new solutions and strategies come new ethical concerns regarding patient safety, privacy, and medical autonomy worldwide. [ 5 ]

To safeguard patients, regulatory boards and government oversight organizations continuously update and modify their policies to address these and other foreseeable issues in the future of clinical trials. However, staying up-to-date and accommodating them in study documentation and protocols is becoming more and more challenging.

Exhibit B: The alluring benefits of tech adoption and new trial models

While the challenges may be present, strategies that use some form of technological solution have shown effectiveness in diminishing and overcoming barriers. [ 6 ]

But this is just one aspect. Technologies can help sponsors immensely by streamlining operations, managing data and accessibility, improving trial quality, facilitating auditing and regulatory compliance, enhancing oversight, reducing the workload on study staff, and so much more. With such compelling benefits, technologies are an investment that is simply too good to pass.

Besides the tangible benefits, many of these digital solutions are becoming industry standards, and companies adopt them to stay competitive.

Exhibit C: The COVID-19 pandemic added fuel to the fire

Pre-2020, many technological initiatives were beginning to be partially adopted in clinical research to assist conventional methodologies, not replace them.

However, with the sudden spread of COVID-19 and the ensuing contact restrictions and lockdowns, sponsors were forced to make drastic changes to keep trials on track. [ 7 ]

Among these was the immediate phasing out of in-person and localized protocols in favor of tech initiatives that adhered to social distancing mandates and overcame travel restrictions, such as decentralized clinical trials, mHealth, and telemedicine.

Technology proved to be an invaluable asset during this time, not only because it allowed research to continue but because it also facilitated patients.

Then, as restrictions were lifted post-pandemic, clinical study sites continued to use these solutions they had invested heavily in to find that they were still better than conventional methods, thus sealing the presence of technologies in the future of clinical trials.

6 Major trends shaping the future of clinical trials

Now that we understand what prompted these trends and why it is increasingly important for sponsors and clinical researchers to get on board to remain competitive, efficient, and productive in the effort to get novel treatments to patients safely and swiftly, let’s examine 6 major trends reshaping the clinical research industry this year and into the foreseeable future.

1. Patient-centric trials

Patient-centricity in clinical research keeps the patient in mind, prioritizing their experience in all operations to reduce any personal burden they may feel while participating in a clinical trial.

This approach is especially important because it improves the rapport between patients and researchers and tackles major challenges like low enrollment rates. When the recruitment process is optimized for patients, it is more convenient and easier for patients to join. Therefore they are more enticed to enroll.

Furthermore, if patients have good experiences, they will speak more highly of your trial and can encourage positive sentiments about clinical research. [ 8 ]

As for designing patient-centric clinical trials, there are several practices sponsors and CROs can incorporate during their trials, including the following:

• Introducing flexibility in schedule through remote visits
• Simplifying protocols so that they are clearer and easier to follow
• Maintaining effective communication with patients
• Creating engaging clinical trial content
• Introducing mechanisms to collect patient feedback and incorporating it
• Providing participants reimbursements to lessen the financial burden of participating
• Consulting with patient advocacy groups to design clinical trials that address the needs of actual patients besides answering research questions

These are just some of the ways sponsors can develop patient-centric trials. For more information about patient-centricity and its future in clinical trials, refer to this article: Putting Patients First: A Guide to Patient Centricity in Clinical Trials .

Challenges to overcome

In the quest for patient-centricity, the validity of the clinical trial must not be compromised. Researchers still need to set up robust protocols to ensure the trial is scientifically accurate, and in some cases, patient comfort may need to be balanced with other factors. [ 8 ]

Certain medical conditions and interventions will require difficult procedures, tests, or complex protocols, but that is just the nature of clinical research. However, there is always room for balance, and when faced with complex trial protocols, researchers can make patient-centric adjustments in other areas to maintain a positive patient experience.

2. Decentralized clinical trial models

Decentralization in clinical research is not new and has been in the works for decades, albeit not at a fast pace. While the benefits were well understood, it wasn’t until the 2020 COVID-19 pandemic that the concept of remote clinical trial was launched to the forefront.[ 9 ]

While sponsors and CROs were forced to adopt decentralized trials (DCTs) and hybrid trials during the pandemic, this type of clinical trial has continued to be effective as it overcomes geographical barriers as participants interact with healthcare proxies at local healthcare facilities or even at-home visits which increases the reach of a clinical trial and has the potential to bring in a more diverse population of trial participants.

Furthermore, decentralization techniques also reduce administrative burdens via digital solutions that streamline operations, centralize data, reduce staffing requirements, and support management responsibilities.

However, decentralized clinical trials are not always feasible as the degree of decentralization depends heavily on the medical condition, novel intervention being investigated, and diagnostic tests being used.

Therefore, trials requiring close personal care, specialized equipment for tests and procedures, or involving a drug that cannot be safely delivered from patients cannot be fully decentralized.[ 9 ]

Finally, decentralization requires all clinical trial staff to be comfortable using the new systems. Overcoming this learning curve requires substantial investment in training to ensure this model works efficiently.

3. Rapidly increasing adoption and integration of MedTech, eClinical, and mHealth systems

Technology has always had a significant impact on shaping the future of clinical trials through the development of software and systems that digitalize certain aspects of clinical trial operations. [ 10 ]

Known as mHealth, these digital solutions refer to the mobile, wireless health technology that removes many barriers separating researchers and participants. Some of the most popular technologies over the past few years include: [ 10 ]

• ePRO and eCOA
• Wearable, online monitoring devices
• Telehealth, such as remote study visits via phone or video calls
• EDC for quickly aggregating data from various sources

These solutions enable decentralized operations and streamline numerous operations for consistency and coherence, such as remote data collection.

Along with increased adoption, there is an ongoing move toward automatic integration via API, further reducing manual tasks through comprehensive, single-platform mHealth software that combines the functionality into an all-in-one single sign-in system, such as IQVIA’s Orchestrated Clinical Trials , Veeva Clinical Suite , and Medidata Clinical Cloud .

Given concerns about the patient data these systems have access to and the risk of tampering and hacking, there are growing concerns about data privacy, resulting in stricter regulatory guidelines and standards, which can be challenging to comply with.

Additionally, as the complexity of digital solutions increases, so does the need for technologically-competent staff. Hiring and training such personnel takes resources; not all clinical sites can take that burden.

Moreover, an “all-in-one” solution does not mean every mHealth system is right for every clinical trial. Sponsors must take the time to research to ensure they are investing in the one that fulfills their organization’s specific requirements, such as the ability to integrate with existing systems and workflow; otherwise, they will cause further delays.

Many companies even offer “mix-and-match” options that let sponsors pay only for the solutions they need instead of the entire system.

4. Accessibility: Fostering awareness and increasing diversity in clinical trials

The future of clinical trials relies heavily on accessibility because it overcomes many geographical, social, and financial barriers preventing underrepresented groups, such as minorities and underserved populations, from participating in clinical trials.

Not only does it make it simpler for them to take part, but it also improves the diversity of study samples, making them more representative of patient populations and, therefore, easier to translate results to the general public. [ 2 ]

Furthermore, accessibility improves awareness and raises health literacy about clinical research participation, encouraging people to find more information and enroll. This is especially important among some communities who have a justified negative perception of medical research because of the long, unfortunate history of a lack of access to medical research.

Sponsors and CROs don’t have to look far for accessibility solutions as online platforms such as Power are available. These sites provide the latest information on clinical trials and allow sponsors to speak directly to their target patient population.

Additionally, many other online resources provide accessibility plans, such as the FDA industry-wide guidance , the NIH strategic plan for 2021 - 2025 for addressing health disparities, and diversity strategy guides .

Approaching under-represented communities should not feel like an afterthought. Outreach material needs to be honest, transparent, and culturally sensitive consistently.[ 11 ]

Furthermore, eligibility criteria need to be reassessed to ensure that they are not the barrier stopping willing people from such groups from participating.

However, it is critical to find a balance as inclusion and exclusion criteria are necessary to provide statistical power to clinical trial results. Finding a balance is key.

5. Artificial intelligence (AI) and machine learning (ML)

AI and machine learning are already being leveraged in clinical research to help reduce costs and streamline almost every stage of clinical trial operations, from matching potential participants to clinical to managing patient data. [ 12 ]

These AI and ML systems take advantage of the vast data stores across multiple healthcare sources, pulling and organizing structured and unstructured information for rapid access and analysis.

Furthermore, this tech is augmented with user-friendly interfaces that give all clinical research stakeholders: such as sponsors and researchers, the ability to see real-time information for faster, better decision-making throughout the lifetime of a clinical trial.

Some of the most innovative uses of these AI models include:[ 13 ]

• Digital twins of subjects to create artificial control groups that simulate how subjects would respond if they were not given the novel intervention
• Deep learning scans that ingest health records and pathology reports to compare against eligibility criteria greatly decrease the time spent pre-screening potential participants.
• Designing and executing more efficient automated processes and computational tools in trials that are less error-prone and generate better outcomes.

Even though AI professionals have found their place in the clinical research world, there is still a lack of expertise that does not meet the ever-rising demand.

Additionally, there is still a considerable reluctance to adopt AI and ML models in the healthcare and clinical research industry. One major reason is the difficulty in understanding these complicated models. Therefore, investment is necessary to train clinical trial personnel in AI practices and languages.

Finally, there are growing privacy concerns arising from the patient data such models can access and how to control it to prevent misuse.

6. Big data: Increased use of real-world data and real-world evidence

While these are two separate concepts, big data and real-world data (RWD) share a link and will continue to play an important role in the future of clinical trials. [ 14 ]

Big data refers to the massive troves of data available nowadays. On the other hand, RWD, and subsequently real-world evidence (RWD) that comes from studying RWD, is collected from:[ 15 ]

• Real health records from patient populations
• phase IV clinical trials, post-marketing surveys, and surveillance studies
• observational and longitudinal studies

While the sources vary, both provide large quantities of data analyzed to reveal important health outcomes. These outcomes are fed back into drug development efforts that open the door to creating new trial models.[ 16 ]

This positive feedback loop also enables sponsors and CROs to design clinical trials that focus on evidence-based medicine practices and address patients' most pertinent concerns in their treatments.

One of the most significant challenges hindering the use of big data, RWD, and RWE are regulatory considerations that still need to be sorted through and developed into a solid framework that sponsors and CROs can use to design their clinical trials.

Furthermore, compared to other clinical trial models, such as traditional randomized controlled trials (RCTs), RWE studies lack control over covariates, making them less statistically powerful in some cases. Finding ways to manage these covariants and account for them in study outcomes is necessary to ensure their accuracy.

As the landscape of clinical research continues to evolve with advancements in technology, the future of clinical trials fills with exciting possibilities.

While many challenges still plague the industry, such as enrollment problems and diversity concerns, numerous solutions and strategies are on the horizon that show promise in alleviating these concerns for better, faster drug development.

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As the global COVID-19 pandemic enters its third year, the life sciences innovation system is setting new records in the level of investment, activity, and scientific progress, in addition to the number and range of new medicines reaching patients around the world. Beyond the ground-breaking contributions to COVID-19 in the form of vaccines and therapeutics, this sector has also succeeded in adapting and re-focusing to a remarkable extent, overcoming the many operational and organizational challenges facing those who are leading biopharmaceutical innovation.

This report - Global Trends in R&D: Overview through 2021 – assesses the trends in new drug approvals and launches, overall pipeline activity in terms of actively researched medicines, and the number of initiated clinical trials. It also profiles the state of R&D funding and the activity of companies of different types, and the results of research are compared to the input effort in a Clinical Development Productivity Index. The notable acceleration and adaptability of the innovation ecosystem is examined in terms of several accelerators of the innovation cycle, including dramatic reductions in so-called white space within clinical development timelines that have been achieved for COVID-19 vaccines and other medicines and suggests the kinds of optimization to expect in the future.

Key Findings

New drug approvals and launches.

• A record 84 novel active substances (NASs) were initially launched globally in 2021, double the number of five years ago. This brings the total number of launches over the past 20 years to a total of 883.
• The U.S. remains the country with the earliest and highest number of launches and among the 72 NASs launched in 2021, a record 44 (over 60%) were characterized by the FDA as first-in-class, and more than half (40) carried an orphan drug designation indicating their use for patients with rare diseases.

R&D PIPELINE

• The total number of products that are in active development in human trials globally exceeds 6,000, up 68% over the 2016 level, as life sciences companies continue to invest and advance innovative therapeutics and vaccines across a wide range of disease areas, despite the disruptions caused by the COVID-19 pandemic.
• Precision medicine increasingly dominates in oncology where targeted therapies account for almost all of research, and over 40% of the pipeline is for rare cancers where next-generation biotherapeutics — including cell and gene therapies – are increasingly being deployed.

CLINICAL TRIAL ACTIVITY

• Overall clinical trial activity has been sustained through the pandemic as the industry has adapted to the disruption and developed new approaches to enable research to continue. In 2021, 5,500 new planned clinical trial starts were reported, up 14% over 2020 and 19% higher than 2019.
• The aggregate number of study participants in intended new trials exceeded 2 million in 2021 for the first time, double the level seen prior to the trials for both COVID-19 and several very large Ebola virus vaccine trials.

CLINICAL DEVELOPMENT PRODUCTIVITY

• The composite success rate across all development phases and therapy areas declined to 5.0% in 2021, which can be attributed to an appetite for increased scientific risk in clinical development programs as the bar for efficacy and safety rises, as well as increased pauses in product development due to the pandemic.
• Across disease areas, probability of success varies considerably, and 2021’s composite success rate fell below the 10-year trend in all areas except for vaccines and cardiovascular.

R&D FUNDING

• Venture capital deal activity and investment flows in the U.S. accelerated in the past two years as interest in life sciences intensified with more than 2,000 deals and $47 billion of deal value occurring in 2021. In addition, the 15 largest pharmaceutical companies invested a record $133 billion in 2021 in R&D expenditure, an increase of 44% since 2016.
• Life sciences deal transactions – including licensing, collaborative R&D arrangements, and acquisitions – remained at just under 5,000 deals in total in 2021, including over 500 related to COVID-19.

EMERGING BIOPHARMACEUTICAL COMPANIES’ CONTRIBUTION TO INNOVATION

• Emerging biopharma companies (EBPs) – those with an estimated expenditure on R&D of less than $200 million and less than $500 million in revenue annually – are responsible for a record 65% of the molecules in the R&D pipeline, up from less than 50% in 2016 and one-third in 2001.
• EBPs originated – that is, filed the original product patent – for half of the NASs launched in the U.S. in 2021.

ACCELERATORS OF INNOVATION CYCLES

• In addition to actions taken directly in support of COVID-19 vaccine and therapeutic development, intensified efforts are being taken by all stakeholders to accelerate innovation cycles and bring scientific breakthroughs to patients faster. The median time from first patent filing to launch in the U.S. has fallen to its lowest level and in the past two years included 21 drugs that were launched less than five years into their patent terms.
• Most new drugs (72%) received some form of expedited review by FDA including one in four receiving an accelerated approval or an Emergency Use Authorization.

Other Findings

• The record number of NAS launches in 2021 included eight COVID-19 vaccines or therapeutics and excluding those launches each of the past two years still exceed any year in history for new launches.
• Oncology, neurology and infectious diseases have all had a rising share of new launches in the past five years with 197 of the 330 launches (60%), compared to 110 of 221 (49%) from 2012 to 2016.
• The total 169 oncology launches in the past decade include some of the most groundbreaking new treatments in immuno-oncology as well as next- generation biotherapeutics, and many treatments for rare cancers.
• The research and development pipeline plateaued in 2021 with 6,085 products in active development from Phase I to regulatory submission, growing less than 1% from 2020.
• This slowing growth in 2021 is likely due to slowing activity from prolonged uncertainty as a result of impacts of new variants on activity during the ongoing pandemic.
• Oncology remains the focus of the pipeline, comprising 37% or 2,226 products.
• Currently, more than 3,200 companies and more than 200 academic or research groups around the world are involved in the R&D pipeline.
• The U.S. share of the global R&D pipeline has remained relatively stable, at above 40% over the past 15 years.
• Europe’s share has declined from 31% to 25% over the past 15 years, while the absolute number of active programs grew by 32% — from 1,492 to 1,966.
• The composite success rate for the pipeline fell to a 10-year low in 2021, driven by drops in Phase I, II and III success, while slightly offset by an increase in regulatory submission success rates, though still not a return to pre-pandemic levels.
• Phase III success rates saw the greatest drop in 2021, declining to 48%, which is 19% below the 10-year pre-pandemic average.
• Some of this increase in attrition may be due to increasingly risky or aspirational research — both in the mechanism of action with increasing next-generation and first-in-class pipeline penetration.
• COVID-19 vaccine pivotal trial timelines were reduced by 70%, with an estimated 26 months of whitespace and operational time savings compared to earlier vaccine trials.
• These time savings were enabled by regulatory and government investment, which de-risked critical decision-making, innovation, and resourcing.
• Whitespace efficiencies were driven by urgency, execution-partner alignment, and leader engagement, leading to at least two months of savings from accelerated contracting and trial planning alone.

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Mapping trends in health research and medical innovation

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The health industry is developing at great speed. CASISD researchers and their collaborators conducted a bibliometric analysis on global patterns of growth in research and technology transfer in ‘big health’, hinting at future trends and prospects. Project leader, Jiaofeng Pan, shares his insights and the key findings.

Jiaofeng Pan, president of the Institutes of Science and Development at the Chinese Academy of Sciences (CASISD) in Beijing. Credit: CASISD

‘Big health’ is a comprehensive concept to encapsulate the changing world, evolving social needs, and the spectrum of new disease threats. Health-related industries have become a hotspot and focus for global development. Many countries and regions have released policies and initiatives to accelerate innovation and the application of big health technologies.

We systematically analysed progress, prospects, changes in industry as well as trends in promising areas of big health research and technology transfer. We have also conducted a comparative analysis of China’s competitiveness in this arena to provide a reference to help academia and industry identify future directions for research.

What are the key findings?

By analysing scientific publications, patents, clinical trials and funding across five major areas of technology, and 20 sub-themes, and combining this data with in-depth interviews and expert assessment, we see that health-related research is now booming. The five major themes are: disease prevention and health promotion, disease screening and diagnosis, disease treatment, disease management, and public health.

In particular, chemotherapy, surgical treatment and infectious disease control were some of the most promising technological themes with substantial research outputs. Chemotherapy, preventive vaccines and biotherapy are also seeing relatively high industrial transfer rate, while anti-tumour and anti-inflammatory drugs are R&D hotspots in China, and globally. We also found that a large proportion of funding goes to development of chemotherapy and biotherapeutic drugs to treat cancer and infectious diseases.

Big data and artificial intelligence are driving the continual upgrades in health-related industries, and the focus of medicine is shifting from disease treatment to disease prevention, while diagnosis is becoming more precise, portable and intelligent. Public health services will be further improved.

How does China perform in ‘big health’?

China published 549,526 academic papers in the field of big health between 2017 and 2021, accounting for 16.7% of the global total. In complementary and alternative therapy, China is leading the world with 41.3% of global publications. In terms of research impact, China is higher than the global average, with the best performance in public health, followed by disease prevention and health promotion, and disease management. When it comes to the number of publications involving international cooperation, China excelled in chemotherapy and infectious disease control, both of which accounted for more than 95% of its total publications.

China, the United States, Japan, Germany and South Korea took the top five places in patent applications and licenses in all five technology areas, with China ranking top in disease prevention and health promotion, public health and disease management. This reflects the nation’s strength in transferring research results in these fields. However, compared with the United States and other developed countries, China lagged relatively behind in terms of average citations per paper in most research areas, which means it needs to further improve the quality and efficiency of its basic research.

How can we advance the transfer of big health technologies?

Industry and the research community need to work together more closely. We need to further reduce barriers between basic research, clinical application, translational medicine and industrial transfer to drive innovation, and we should encourage more effective collaboration between industry, universities, research institutes and hospitals to accelerate the transfer of basic medical research and clinical results.

What opportunities do you see for the big health industry?

In the post-pandemic era, the big health industry is facing unprecedented opportunities. By evaluating the number of publications, the growth rate and the number of top 1% papers, we see that chemotherapy, surgical treatment, infectious disease control, nutritional health, mental health, healthy environment, preventive vaccines, diagnostic markers and health education will be the most promising topics in the future.

We also predict that new technologies such as biotechnology, nanotechnology, information technology, and advanced manufacturing technology will give a strong impetus for innovation in the field of big health.

For full report in English: https://www.nature.com/collections/casisd2023

For full report in Chinese: http://www.naturechina.com/pdf?file=/public/upload/pdf/2022/11/05/636663b2cd5b9.pdf

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Clinical Trials Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Report Covers Global Clinical Trials Market Growth Analysis and is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Design (Treatment Studies and Observational Studies), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America).

Clinical Trial Market Size

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Clinical Trial Market Analysis

The Clinical Trials Market size is estimated at USD 50.66 billion in 2024, and is expected to reach USD 67.5 billion by 2029, growing at a CAGR of 5.91% during the forecast period (2024-2029).

The COVID-19 pandemic tremendously impacted the market for clinical trials, as there has been a rising focus on developing new therapeutics or vaccines to treat the disease. Also, COVID-19 brought a shift in terms of the way clinical trials are performed. There has been an increased interest in virtual/decentralized trials in the clinical trial space, and those have been featured on conference agendas and in articles for a long time. Moreover, COVID-19 forced some of the trials to move to a virtual model to keep the trials on track during the pandemic. Additionally, as of November 8, 2022, a total of 8,397 studies have been registered for COVID-19 on the ClinicalTrials.gov website, among which 2,932 studies were registered for Europe alone, followed by 2,290 studies in North America. Thus, such an increase in the number of clinical trials registered to find an effective treatment for the disease is anticipated to drive market growth. Therefore, COVID-19 is predicted to have a significant impact on the market studied.

The major factors propelling the market's growth include the high demand for clinical trials in emerging markets, increased research and development (R&D) spending in the pharmaceutical industry, an increasing prevalence of diseases; and the focus on rare diseases and multiple orphan drugs in the pipeline. For instance, Novartis AG, one of the major players in the studied market, invested USD 9,540 million in the year 2021, which increased from USD 8,980 million in 2020. In addition, another market player, Pfizer Inc., invested USD 13,829 million in 2021 on R&D as compared to USD 9,393 in FY 2020. Thus, the increased research and development expenses by the major players in the market are expected to drive the growth of the market.

Factors such as growing burden of diseases need more advanced and effective medicines for treatment and thus contributes to the growth of the market. For instance, as per IDF Atlas 2021 edition, in 2021, there were 536.6 million people aged 20-79 years living with diabetes around the world and this number is expected to reach 783.7 million by 2045. Such high burden of diseases also propel the growth of the market.

Additionally, the initiatives taken by the government in different regions also conbtribute to the growth of the market. For instance, in January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched an initiative to transform how clinical trials are initiated, designed, and ran, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim of ACT EU is to further develop Europe as a focal point for clinical research, to further promote the development of high-quality, safe, and effective medicines, and to better integrate clinical research into the European health system. Such, initiatives by governments across the globe are contributing to market growth.

Therefore, owing to the factors mentioned above, the studied market is anticipated to grow over the forecast period. However, the lack of a skilled workforce in clinical research and stringent regulations for patient enrolment are factors that are expected to hinder the market growth during the analysis period.

Clinical Trial Market Trends

Phase iii by phase segment is expected to grow over the forecast period.

Phase III clinical trials evaluate the comparative effect of the new medication over the previous medications available or conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials. This usually involves up to 3,000 participants with the condition that the new medication is meant to treat and may last for many years. Also, the number of Phase III clinical trials remains comparatively higher than Phase II and Phase I trials, owing to their greater complexity and need for a larger patient pool. Factors such as increasing research activities, the growing burden of diseases, and many investigative drugs in Phase III are propelling the growth of the market segment.

The high number of clinical trials in Phase III is driving the growth of the market segment. For instance, according to the data from clinicaltrials.gov, as of November 8, 2022, 9,137 clinical trials were in Phase III for cancer, 5,069 for cardiology, and 5,217 for respiratory studies. Thus, such a high number of clinical trials registered under phase III of clinical trials is expected to contribute to the segment's growth.

Additionally, the Phase III trials conducted by market players are also contributing to the growth of the market segment. For instance, in May 2022, Lipidor AB reported that half of the patients have been enrolled in the Phase III study of AKP02 skin spray for mild to moderate psoriasis. Also, in August 2022, Wockhardt Ltd initiated a global Phase III clinical study of its new antibiotic candidate WCK 5222. It is entirely a new class of antibiotic known as "β-lactam ENHANCER', and is targeted for the treatment of hospitalized adults with complicated urinary tract infections, including acute pyelonephritis. Such a high number of studies in Phase III depicts the growth of the segment.

Thus, the factors mentioned above are expected to propel the segment's growth over the forecast period.

North America is Expected to Dominate the Market Over The Forecast Period

The North American region is expected to contribute significantly to the market growth during the study period owing to factors such as high R&D expenditure of the pharmaceutical industry, presence of well-established players, robust regulatory framework, and rising prevalence of diseases, coupled with the significant contribution of the United States.

The American Cancer Society estimated that in the United States, around 1,918,0303 new cases are estimated to register in 2022. Thus, the high burden of cancer is expected to boost the demand for the development of drugs and devices for disease diagnosis and treatment, thereby driving the market growth.

Additionally, the support from the government of the countries in the region is also contributing to the growth of the market. For instance, in June 2022, the Government of Canada launched the Clinical Trials Fund (CTF), supported by a Budget 2021 investment of USD 250 million over three years for the Canadian Institutes of Health Research (CIHR). With this funding, the government aims to improve health outcomes for Canadians while ensuring Canada is well-positioned to respond to future pandemics and other health priorities. The CTF will strengthen the clinical trials infrastructure in Canada and support the training of new clinical researchers.

Furthermore, the major market players in the region are active in the innovation of new drugs and devices, which is another factor predicted to contribute to the market growth in the region. For instance, in September 2021, Janssen started the Phase III trial for the investigational respiratory syncytial virus (RSV) vaccine among older adults. The study will evaluate the efficacy, safety and immunogenicity of Janssen's investigational adult vaccine against lower respiratory tract disease (LRTD) throughout North America and some other countries of different regions. Such trials are expected to propel the growth of the market in the region.

Such continuous developments are expected to fuel the clinical trials market in the North American region.

Clinical Trial Industry Overview

The clinical trials market is moderately competitive. Strategic partnerships between pharmaceutical companies and CROs are expected to impact the market's growth significantly. Also, the quick adoption of advanced technology for improved healthcare contributes to the growth of the market. Some of the key players are Clinipace, Eli Lilly and Company, Laboratory Corporation of America, ICON PLC, and Novo Nordisk AS.

Clinical Trial Market Leaders

Laboratory Corporation of America

Eli Lilly and Company

Novo Nordisk AS

*Disclaimer: Major Players sorted in no particular order

Clinical Trial Market News

• July 2022: An early-stage clinical trial investigating an investigational vaccine to stave off Nipah virus infection was started by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH) of the United States.
• May 2022: The International AIDS Vaccine Initiative (IAVI) and Moderna Inc. started a Phase I clinical trial of an mRNA vaccine antigen in Rwanda and South Africa.

Clinical Trial Market Report - Table of Contents

1. INTRODUCTION

1.1 Study Assumptions and Market Definition

1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

4.1 Market Overview

4.2 Market Drivers

4.2.1 Demand for Clinical Trials in the Emerging Markets

4.2.2 High R&D Expenditure of the Pharmaceutical Industry

4.2.3 Rising Prevalence of Diseases

4.3 Market Restraints

4.3.1 Lack of Skilled Workforce in Clinical Research

4.3.2 Stringent Regulations for Patient Enrollment

4.4 Porter's Five Forces Analysis

4.4.1 Threat of New Entrants

4.4.2 Bargaining Power of Buyers/Consumers

4.4.3 Bargaining Power of Suppliers

4.4.4 Threat of Substitute Products

4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD million)

5.1 By Phase

5.1.1 Phase I

5.1.2 Phase II

5.1.3 Phase III

5.1.4 Phase IV

5.2 By Design

5.2.1 Treatment Studies

5.2.1.1 Randomized Control Trial

5.2.1.2 Adaptive Clinical Trial

5.2.1.3 Non-randomized Control Trial

5.2.2 Observational Studies

5.2.2.1 Cohort Study

5.2.2.2 Case Control Study

5.2.2.3 Cross Sectional Study

5.2.2.4 Ecological Study

5.3 Geography

5.3.1 North America

5.3.1.1 United States

5.3.1.2 Canada

5.3.1.3 Mexico

5.3.2 Europe

5.3.2.1 Germany

5.3.2.2 United Kingdom

5.3.2.3 France

5.3.2.4 Italy

5.3.2.5 Spain

5.3.2.6 Rest of Europe

5.3.3 Asia-Pacific

5.3.3.1 China

5.3.3.2 Japan

5.3.3.3 India

5.3.3.4 Australia

5.3.3.5 South Korea

5.3.3.6 Rest of Asia-Pacific

5.3.4 Middle East and Africa

5.3.4.1 GCC

5.3.4.2 South Africa

5.3.4.3 Rest of Middle East and Africa

5.3.5 South America

5.3.5.1 Brazil

5.3.5.2 Argentina

5.3.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

6.1 Company Profiles

6.1.1 Clinipace

6.1.2 Laboratory Corporation of America

6.1.3 Eli Lilly and Company

6.1.4 ICON PLC

6.1.5 Novo Nordisk AS

6.1.6 PAREXEL International Corporation

6.1.7 Pfizer Inc.

6.1.8 Pharmaceutical Product Development LLC

6.1.9 IQVIA

6.1.10 F. Hoffmann-La Roche Ltd

6.1.11 Sanofi SA

6.1.12 Syneos Health

6.1.13 ClinDatrix Inc

6.1.14 Charles River Laboratory

• *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

Clinical Trial Industry Segmentation

As per the scope of the report, clinical trials are experiments that are conducted under clinical research and follow a regulated protocol. These experiments are primarily performed to obtain data regarding the safety and efficacy of newly developed drugs. Clinical trial data is mandatory for drug approval and for it to be introduced in the market. This process is expensive and time-consuming and requires expertise at all stages. The Clinical Trials Market is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Design (Treatment Studies and Observational Studies), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers values (in USD million) for the above segments.

Clinical Trial Market Research FAQs

How big is the clinical trials market.

The Clinical Trials Market size is expected to reach USD 50.66 billion in 2024 and grow at a CAGR of 5.91% to reach USD 67.50 billion by 2029.

What is the current Clinical Trials Market size?

In 2024, the Clinical Trials Market size is expected to reach USD 50.66 billion.

Who are the key players in Clinical Trials Market?

Clinipace, Laboratory Corporation of America, ICON PLC, Eli Lilly and Company and Novo Nordisk AS are the major companies operating in the Clinical Trials Market.

Which is the fastest growing region in Clinical Trials Market?

North America is estimated to grow at the highest CAGR over the forecast period (2024-2029).

Which region has the biggest share in Clinical Trials Market?

In 2024, the Asia Pacific accounts for the largest market share in Clinical Trials Market.

What years does this Clinical Trials Market cover, and what was the market size in 2023?

In 2023, the Clinical Trials Market size was estimated at USD 47.83 billion. The report covers the Clinical Trials Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Clinical Trials Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Why is North America anticipated to witness a rapid growth rate in the Clinical Trials Market?

North America is anticipated to witness a rapid growth rate in the Clinical Trials Market due to a) High R&D expenditure of the pharmaceutical industry b) Presence of well-established players c) Robust regulatory framework d) Rising prevalence of diseases.

Which is the major segment in the Clinical Trials Market by phase?

The major segment in the Clinical Trials Market by phase is Phase III. This is mainly due to the high number of clinical trials conducted in this phase compared to others.

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Clinical Research Industry Report

This comprehensive report offers a deep dive into the clinical trials industry, providing a detailed analysis of key market drivers and market segments. Mordor Intelligence offers customization based on your specific interests, including: 1. Service - Laboratory, Analytical Testing, Bioanalytical Testing 2. Therapeutic Area - Oncology, Neurology, CNS, Autoimmune/Inflammation 3. Application - MABs, CGT 4. End-User - Hospitals, Laboratories, and Clinics

Clinical Research Market Report Snapshots

• Clinical Research Market Size
• Clinical Research Market Share
• Clinical Research Market Trends
• Clinical Research Companies

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• Health, Pharma & Medtech ›

Pharmaceutical Products & Market

Clinical trials – statistics & facts

How much do pharma companies spend on r&d, the complexities of clinical studies, drug developers seek approval, key insights.

Detailed statistics

Pharmaceuticals: cost of drug development in the U.S. since 1975

Total global pharmaceutical R&D spending 2014-2028

Number of drugs in the R&D pipeline worldwide 2001-2023

Editor’s Picks Current statistics on this topic

Current statistics on this topic.

Pharmaceuticals

Total number of registered clinical studies worldwide 2000-2024

CRO market size worldwide forecast 2028

Biotechnology

Top companies by COVID-19 treatment vaccines in development June 2022

Related topics

Recommended.

• Global pharmaceutical industry
• Pharmaceutical industry in the U.S.
• Top pharmaceutical drugs
• Coronavirus (COVID-19) vaccines and treatments
• Pharmaceutical research and development (R&D)

Recommended statistics

R&d overview.

• Premium Statistic Total global pharmaceutical R&D spending 2014-2028
• Premium Statistic Industry sectors - expenditure on research and development 2021
• Premium Statistic Top pharmaceutical R&D projects based on net present value August 2023
• Basic Statistic Research and development expenditure: U.S. pharmaceutical industry 1995-2022
• Premium Statistic Research and development in European pharmaceutical industry by country 2021
• Premium Statistic Total clinical research funding by National Institutes for Health 2013-2024

Total global pharmaceutical R&D spending 2014-2028

Total global spending on pharmaceutical research and development from 2014 to 2028 (in billion U.S. dollars)

Industry sectors - expenditure on research and development 2021

Percentage of spending on research and development of total revenue in 2021, by industrial sector

Top pharmaceutical R&D projects based on net present value August 2023

Selected top pharmaceutical R&D projects based on net present value (NPV) as of August 2023 (in billion U.S. dollars)

Research and development expenditure: U.S. pharmaceutical industry 1995-2022

Research and development expenditure of total U.S. pharmaceutical industry from 1995 to 2022 (in billion U.S. dollars)

Research and development in European pharmaceutical industry by country 2021

Pharmaceutical research and development spending in selected European countries in 2021 (in million euros)

Total clinical research funding by National Institutes for Health 2013-2024

Total clinical research funding by the National Institutes for Health (NIH) from FY 2013 to FY 2024 (in million U.S. dollars)

Top R&D companies

• Basic Statistic Global top pharmaceutical companies based on R&D spending 2026
• Basic Statistic Top 50 global pharmaceutical and biotech companies by R&D intensity in 2022
• Basic Statistic Top pharmaceutical companies in R&D spending growth 2022
• Premium Statistic Leading global contract research organizations based on revenue 2022
• Basic Statistic Roche: participation of patients in clinical trials 2009-2017

Global top pharmaceutical companies based on R&D spending 2026

Global top 10 pharmaceutical companies based on projected R&D spending in 2026 (in billion U.S. dollars)

Top 50 global pharmaceutical and biotech companies by R&D intensity in 2022

World's top 50 pharmaceutical and biotechnology companies based on R&D intensity in 2022

Top pharmaceutical companies in R&D spending growth 2022

World's top 50 pharmaceutical and biotechnology companies based on R&D spending growth in 2022

Leading global contract research organizations based on revenue 2022

Leading global contract research organizations (CROs) based on 2022 revenue (in million U.S. dollars)

Roche: participation of patients in clinical trials 2009-2017

Number of patients who took part in clinical trials for pharmaceutical company Roche from 2009 to 2017*

Clinical studies

• Basic Statistic Increase in clinical trials' complexity 2001-2015
• Premium Statistic Clinical trial success rates by therapeutic area 2020
• Basic Statistic Number of registered clinical studies by location worldwide 2024
• Basic Statistic Percent of registered clinical studies worldwide by location 2024
• Basic Statistic Share of recruiting clinical studies worldwide by location 2024
• Premium Statistic Total number of registered clinical studies worldwide 2000-2024
• Basic Statistic Total number of registered clinical studies with posted results worldwide 2008-2024

Increase in clinical trials' complexity 2001-2015

Increase in clinical trials' complexity between 2001-2005 and 2011-2015

Clinical trial success rates by therapeutic area 2020

Clinical trial success rates by therapeutic area as of 2020*

Number of registered clinical studies by location worldwide 2024

Number of registered clinical studies worldwide by location as of April 2024

Percent of registered clinical studies worldwide by location 2024

Percentage of registered clinical studies worldwide by location as of April 2024

Share of recruiting clinical studies worldwide by location 2024

Percentage of registered recruiting clinical studies worldwide by location as of April 2024

Total number of registered clinical studies worldwide since 2000 (as of April 2024)

Total number of registered clinical studies with posted results worldwide 2008-2024

Total number of registered clinical studies with posted results worldwide since 2008 (as of April 2024)

Participation

• Basic Statistic Top clinical trial participant countries worldwide 2015-19, by share
• Basic Statistic Clinical trial participants U.S. vs. rest of world by therapy area 2015-2019
• Basic Statistic Clinical trial participants gender share worldwide 2015-19, by geographic location
• Basic Statistic Clinical trial participants ethnicity share worldwide 2015-19, by geographic location

Top clinical trial participant countries worldwide 2015-19, by share

Top 20 clinical trial participant countries worldwide in 2015-2019, by share of participants

Clinical trial participants U.S. vs. rest of world by therapy area 2015-2019

Number of clinical trial participants in the U.S. and rest of the world in 2015-2019, by therapeutic area (in 1,000s)

Clinical trial participants gender share worldwide 2015-19, by geographic location

Gender share of clinical trial participants worldwide in 2015-2019, by geographic location

Clinical trial participants ethnicity share worldwide 2015-19, by geographic location

Ethnicity share of clinical trial participants worldwide in 2015-2019, by geographic location

Costs and market

• Basic Statistic Pharmaceuticals: cost of drug development in the U.S. since 1975
• Premium Statistic R&D expenditure of new therapeutic drugs 2009-2018
• Basic Statistic Estimated clinical trial cost per patient by therapeutic class 2015-2017
• Basic Statistic Estimated clinical trial cost per drug by therapeutic class 2015-2017
• Premium Statistic CRO market size worldwide forecast 2028
• Premium Statistic Global pharma CRO market size 2015-2024, by pre-clinical, clinical and discovery
• Premium Statistic Size of total U.S. clinical trial supplies market 2016-2025

Cost of developing a drug in the U.S. from the 1970s until today (in million U.S. dollars)*

R&D expenditure of new therapeutic drugs 2009-2018

Mean and median R&D expenditure on new drugs by therapeutic area between 2009 and 2018* (in million U.S. dollars)

Estimated clinical trial cost per patient by therapeutic class 2015-2017

Estimated clinical trial cost per patient by therapeutic area in 2015-2017* (in U.S. dollars)

Estimated clinical trial cost per drug by therapeutic class 2015-2017

Estimated clinical trial cost per drug by therapeutic area in 2015-2017* (in million U.S. dollars)

Global contract research organization (CRO) market in 2023 and 2028 (in billion U.S. dollars)

Global pharma CRO market size 2015-2024, by pre-clinical, clinical and discovery

Global pharmaceutical CRO market size from 2015 to 2024, by pre-clinical, clinical and discovery (in billion U.S. dollars)

Size of total U.S. clinical trial supplies market 2016-2025

Size of the total U.S. clinical trial supplies market from 2016 to 2025 (in million U.S. dollars)

Approvals, launches, setbacks

• Premium Statistic Pharmaceutical industry - number of new substances 1998-2022
• Premium Statistic Number of novel drugs approved annually by CDER 2008-2023
• Basic Statistic Key measurements of U.S. CDER drug approvals in 2023
• Basic Statistic FDA first premarket approvals for medtech products granted 2005-2022
• Premium Statistic Projection of top 2024 pharma and biotech launches by revenue 2028
• Basic Statistic Number of unsuccessful Alzheimer’s drugs in development in the U.S. 1998-2017

Pharmaceutical industry - number of new substances 1998-2022

Number of new chemical or biological entities developed between 1998 and 2022, by region of origin

Number of novel drugs approved annually by CDER 2008-2023

Total number of novel drugs approved by CDER from 2008 to 2023

Key measurements of U.S. CDER drug approvals in 2023

Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2023 that met select key measurements

FDA first premarket approvals for medtech products granted 2005-2022

Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022

Projection of top 2024 pharma and biotech launches by revenue 2028

Leading biotech and pharma product launches in 2024 and revenue forecasts for 2028 (in billion U.S. dollars)

Number of unsuccessful Alzheimer’s drugs in development in the U.S. 1998-2017

Number of unsuccessful Alzheimer’s drugs in development in the U.S. from 1998 to 2017

• Premium Statistic Top companies by COVID-19 treatment vaccines in development June 2022
• Basic Statistic Number of COVID-19 drugs in development worldwide by phase June 2022
• Basic Statistic Number of COVID-19 treatment vaccine trials worldwide by phase June 2022
• Basic Statistic Number of COVID-19 treatment vaccine trials worldwide by type June 2022

Leading companies by number of COVID-19 drugs and vaccines in development as of June 3, 2022

Number of COVID-19 drugs in development worldwide by phase June 2022

Number of coronavirus (COVID-19) drugs and vaccines in development worldwide as of June 3, 2022, by phase

Number of COVID-19 treatment vaccine trials worldwide by phase June 2022

Number of coronavirus (COVID-19) clinical trials for drugs and vaccines worldwide as of June 3, 2022, by phase

Number of COVID-19 treatment vaccine trials worldwide by type June 2022

Number of coronavirus (COVID-19) clinical trials for drugs and vaccines worldwide as of June 3, 2022, by type*

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Discover the Top 10 Trends in Medical Research (2024)

How ware advancements in medical research technology impacting global healthcare? In this data-driven research on 2164 medical research startups & scaleups, you get insights into technology solutions such as molecular analytics, drug development, biomarker discovery, nanotech & more!

The medical research industry advances human health and combats diseases, yet faces significant challenges from high costs and lengthy drug approval processes to reproducibility. However, the landscape is rapidly evolving. Advanced data analytics and artificial intelligence, as well as cutting-edge lab equipment and personalized medicine, expedite research processes. These trends in medical research enhance accuracy and tailor treatments to individual patients. The integration of these innovations addresses the industry’s pressing concerns and also paves the way for more efficient, precise, inclusive, and patient-centric healthcare.

Top 10 Medical Research Trends in 2024

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Innovation Map outlines the Top 10 Trends in Medical Research & 20 Promising Startups

For this in-depth research on the Top Trends in Medical Research and startups, we analyzed a sample of 2000+ global startups & scaleups. This data-driven research provides innovation intelligence that helps you improve strategic decision-making by giving you an overview of emerging technologies in medical research & development. In the Medical Research Innovation Map below, you get a comprehensive overview of the innovation trends & startups that impact your company.

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Tree Map reveals the Impact of the Top 10 Trends in Medical Research (2024)

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Immersive technology, like VR and AR, enhances medical training and patient experiences, allowing them to interact and collaborate with 3D virtual environments and models. Translational medicine bridges the gap between laboratory findings and patient care while promoting effective communication of discoveries among researchers. Lastly, open medical data is democratizing access to research, fostering transparency, and driving innovation.

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Interested in exploring all 2000+ medical research startups & scaleups?

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Medical research methods and workflows are often slow and tedious due to the need to accurately predict disease progression and tailor treatments. This leads to inefficiencies and suboptimal patient outcomes which are being addressed through innovations by identifying specific biological markers in the human body.

Advanced biomarker discovery enables early and precise indications of disease onset, progression, and response to treatments. By pinpointing these biomarkers, researchers develop more targeted therapies. This enables personalized medicine approaches that ensure patients receive the most effective treatments tailored to their unique genetic and biochemical makeup.

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Such platforms allow researchers to seamlessly share, access, and analyze data in real-time. Moreover, they foster interdisciplinary collaboration, ensuring that breakthroughs are rapidly built upon and redundant efforts are minimized.

Biospiel builds a Medical Social Network

Biospiel is a UK-based startup that provides a cloud-based platform to bridge the gap between medical professionals, students, and researchers worldwide. Through its expansive global network, the platform promotes collaboration, discussion, and sharing of medical cases. Moreover, it ensures both GDPR and HIPAA compliance while prioritizing data security and integrity.

The platform also includes features that allow researchers and medical professionals to share medical decisions and earn virtual currency as a reward for their contributions. Besides, the platform lets medical professionals create groups for subspecialty collaboration, chat with peers, and organize various events. In this way, the medical social network promotes collaboration on scientific articles and enhances medical research.

Rayca Precision advances Precision Oncology

UK-based startup Rayca Precision provides AI and bioinformatics-based solutions for clinical and preclinical research. The startup’s RSA2 platform advances RNA sequencing analytics to deliver accelerated analysis and actionable insights. It dissects raw transcriptomic sequencing data to identify fusion events and predict the 3D folding structure of fusion-derived proteins.

Moreover, the platform simplifies collaboration and communication by facilitating the creation of submission-ready interactive reports. The reports also integrate raw sequencing data and study design sheets to enable researchers to share their findings. In this way, Rayca Precision’s platform enables researchers to identify potential drug targets and bridges the gap between research and clinical practice.

3. Novel Drug Development

Prolonged and unpredictable drug development pipelines, treatment failure in late-stage clinical trials, and high investment costs are among the main barriers to drug development. Innovations in novel drug development are leveraging advanced computational models, high-throughput screening, and AI-driven predictive analytics to tackle these issues.

These techniques enable researchers to better understand drug interactions at the molecular level, predict potential side effects earlier, and optimize drug candidates for efficacy. As a result, the drug development process becomes more streamlined and cost-effective as well as has a higher likelihood of producing successful therapeutics for patients.

Creyon Bio promotes Oligonucleotide-Based Medicines (OBMs)

US-based startup Creyon Bio specializes in oligonucleotide-based medicines by combining insights from biology, genomics, and chemistry with machine learning and AI. Its advanced platform identifies design rules for OBMs, including various modalities like antisense oligonucleotides and RNA editing systems. OBMs interact with targets through Watson-Crick-Franklin hybridization, precisely targeting DNA or RNA molecules.

This approach addresses the genetic and molecular basis of diseases, from preventing toxic RNA production to controlling protein production. Creyon Bio’s platform efficiently explores OBM chemistries to optimize them for various uses. Creyon Bio’s approach aims to bridge the gap between diagnosis and treatment in the medical industry.

NordicRWE enables Data-driven Drug Development

Norwegian startup NordicRWE specializes in data-driven drug development emphasizing applications of real-world evidence (RWE). The startup introduces external control arms for cancer clinical trials, replicating outcomes from these trials. Its solution offers a data-driven approach to drug discovery, combining machine learning with pharmacoepidemiological validation using real-world data (RWD).

The startup’s technology also features interactive dashboard solutions and synthetic data generation. Further, its drug development process uses publicly available datasets to generate testable hypotheses. These features make drug development processes more efficient with highly accurate results.

4. Medical Regulatory Technology

The intricate web of regulatory requirements across different jurisdictions poses a significant challenge, often leading to delays in clinical trials, product approvals, and market access. This is why startups are simplifying the regulatory approval and screening process by introducing automated compliance solutions, real-time monitoring tools, and AI-driven predictive analytics.

These advancements streamline the regulatory submission process, ensure timely updates on changing guidelines, and provide proactive alerts about potential compliance risks. Consequently, researchers and pharmaceutical companies expedite the transition from research to patient access while maintaining rigorous adherence to evolving global regulatory standards.

Essenvia simplifies MedTech Regulatory Submission

Essenvia is a US-based startup that develops a platform to expedite MedTech regulatory submissions. It introduces a streamlined process for FDA 510(k) submissions and EU MDR & IVDR CE certifications, aiding in faster market access for medical devices. The startup also offers an automated solution for FDA eSTAR submissions, simplifying the transition of 510(k) submissions to eSTAR through its eSTAR submission builder.

This platform significantly reduces submission time, saving up to four weeks per submission. For EU MDR/IVDR submissions, it offers a collaborative environment with reusable content and pre-built templates to streamline the submission process. Essenvia’s solutions are tailored to meet the regulatory demands, ensuring seamless integration into the medical research industry’s regulatory framework.

MedBoard provides Regulatory Research and Intelligence

UK-based startup MedBoard offers a platform emphasizing AI-powered research in the MedTech and pharma sectors. Its platform, MedBoard Search , delivers regulatory, clinical, and market information spanning a large number of countries, curated from trusted sources. Additionally, it provides access to global medical information, including updates from market authorities, databases, profiles, and various other medical-related media.

The platform also features advanced filters, AI evidence classification, and organized categorization. MedBoard’s menu covers regulatory, clinical, and PMS areas, offering real-time news, databases, analytics, and profiles. This intelligence combines database insights with human-curated summaries, enhancing regulatory research. Consequently, the platform streamlines and enhances regulatory submissions for medical research.

5. Nano Immunization

A persistent challenge in the delivery of therapeutics is the specific targeting of cells without affecting healthy tissues, especially in the context of immune responses. Nano immunization utilizes nanoscale carriers to deliver vaccines or therapeutic agents directly to the desired immune cells.

These nano-carriers are engineered to mimic pathogens to enhance their uptake by immune cells and subsequently boost the body’s immune response. This precision targeting amplifies the efficacy of treatments and also minimizes potential side effects, paving the way for safer and more potent immunotherapies.

Immunyx Pharma makes Targeted Neutrophil Nanoparticles (TENNs)

Immunyx Pharma is a US-based startup that creates targeted neutrophil nanoparticles for immune modulation. The startup’s neutrophil-targeting platform prioritizes dosing activated neutrophils in chronic diseases. When introduced in vivo, the nanoparticles specifically modulate neutrophils without eliminating them, thus preventing neutropenia.

Neutrophils, being abundant and mobile, require precise targeting, which TENNs achieve with extended bioavailability. Further, the nanoparticles deliver concentrated drugs to neutrophils to ensure minimum toxicity. The technology serves as a versatile platform, applicable to a myriad of diseases, and advances the possibilities of targeted drug delivery.

Trained Therapeutix Discovery advances Nanobiologic Therapeutics

Dutch startup Trained Therapeutix Discovery develops nanobiologic therapeutics targeting bone marrow progenitor cells to regulate trained immunity or inhibit inflammation. Thenanobiologics, made from the body’s own molecular building blocks, are equipped with immunoregulatory compounds. By targeting myeloid cell function, the startup combats diseases like cancer and hyperinflammation in conditions like COVID-19.

The startup’s nanobiologic therapeutic solution identifies innate immune memory, from exposure to certain microbe-associated molecular patterns. This assists in understanding the human defense mechanisms against both external and internal threats. Trained Therapeutix’s approach to nanobiologic therapeutics enables medical researchers to gain a better perspective on immune modulation.

6. Molecular Analytics

Accurately deciphering the vast and intricate molecular interactions within biological systems is a computationally intensive task, limiting the depth of understanding of disease mechanisms. Therefore, molecular analytics solutions employ advanced techniques like single-molecule imaging and high-resolution mass spectrometry.

This emerging medical research trend allows researchers to observe and quantify molecular interactions in real-time, even within living cells. By providing a more granular view of molecular dynamics, such innovations enable a deeper comprehension of disease pathways and facilitate the design of more targeted and effective therapeutic interventions.

Deep Breath Intelligence offers Breath Analytics

Deep Breath Intelligence is a Swiss startup that focuses on healthcare through breath analysis. Its solution combines high-resolution mass spectrometry and advanced machine-learning techniques for breath analysis. The startup’s DBI-EPI breath test estimates blood drug concentrations of valproic acid (VPA) from a simple exhale, aiding in epilepsy treatment decisions. The analysis identifies volatile organic compounds (VOCs) in exhaled breath to provide insights into an individual’s metabolic state.

This non-invasive method offers valuable information about a person’s health and clinical status. The startup’s approach to real-time breath analysis of VOCs, in combination with machine learning, improves precision medicine and non-invasive diagnostics in supporting healthcare providers.

Pixelgen Technologies advances Spatial Proteomics

Swedish startup Pixelgen Technologies specializes in molecular pixelation (MPX) technology that provides a detailed look at cell surface proteins and their spatial relationships. Its Pixelgen Single Cell Spatial Proteomics Kit provides insights into spatial polarization and colocalization of proteins on cell surfaces in 3D.

MPX enables deep phenotyping of immune cells, producing highly resolved cell surface protein maps. Additionally, DNA-tagged monoclonal antibodies ensure high multiplex analysis, transitioning smoothly from analog to digital data readout. The technology improves the understanding of cell biology and accelerates new therapeutics development.

7. Immersive Technologies

Traditional methods of data visualization and interpretation cannot show the complexities of biological systems. This makes it challenging for researchers to fully grasp and communicate intricate findings. Immersive technology, such as virtual and augmented reality (VR and AR) allows researchers to interact with detailed 3D models of biological structures.

AR and VR solutions enable researchers to explore intricate cellular environments and simulate potential therapeutic interventions in a fully immersive setting. This enhanced perspective deepens understanding and fosters collaboration among multidisciplinary teams, driving forward more holistic and informed approaches to medical challenges.

Enosis Therapeutics provides VR-modulated Psychedelic Psychotherapy

Australian startup Enosis Therapeutics advances VR-modulated psychedelic psychotherapy (VRPP) protocols and VR modules to provide tools for therapists, researchers, and patients. The VRPP protocol consists of science-backed VR scenarios that guide patients through their healing journey. Specific modules like GroundingVR , SurrenderVR , and AnchoringVR serve distinct purposes, from calming patients to aiding in the integration of their experiences.

These modules ensure that patients engage deeply with their trips, focus on their intentions, and make tangible connections between insights. The startup’s approach to combining VR with psychedelic psychotherapy enables researchers to understand the effects of VR in solving psychological distress.

CleverPoint Neuro produces a Neurofeedback VR Headset

Polish startup CleverPoint creates hardware to understand brain processes using VR-integrated wearable technology. The startup’s product, CleverPoint , collects and analyzes patient responses to VR content with its neurofeedback function. Its products feature varying specifications, like CleverPoint 6 and CleverPoint 12 , which differ in the number of electrodes. The devices are equipped with built-in microphones, headphones, and a battery that lasts up to 20 hours with an additional battery.

Further, CleverPoint integrates sensors such as a three-axis gyro, accelerometer, magnetometer, and ambient light sensors. By collecting detailed biofeedback, the device aids professionals in analyzing patient reactions to virtual environments. This approach has potential implications for understanding and managing brain processes.

8. Translational Medicine

Laboratory findings struggle to translate into effective clinical applications for patients due to the limited predictability of preclinical models or high attrition rates in clinical trials. Translational medicine bridges this gap through innovations such as advanced biomarker discovery and patient-specific models, moving discoveries from the laboratory to clinical settings.

This approach ensures that laboratory discoveries are rapidly and efficiently converted into diagnostic tools, treatments, and therapies that directly benefit patients. Moreover, these innovations benefit the medical industry by accelerating the journey from scientific insight to tangible health outcomes.

Pasithea Therapeutics specializes in Neuroinflammatory Disorders

US-based startup Pasithea Therapeutics develops therapies targeting neuroinflammatory central nervous system (CNS) disorders. The startup’s primary focus revolves around therapies for conditions like Neurofibromatosis Type 1, which affects the skin and nervous system, causing tumor growth along nerves. Another area of concentration is amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease impacting nerve cells in the brain and spinal cord.

Pasithea Therapeutics also develops therapies to address multiple sclerosis, an autoimmune disease affecting the CNS in young adults, and schizophrenia, a chronic psychiatric condition. The startup’s pipeline of therapies like its PAS Series improves patient outcomes.

MediSix Therapeutics ensures Improved T-cell Function

Singapore-based startup MediSix Therapeutics advances T-cell therapies by harnessing an array of proprietary technologies that bolster T-cell function. The startup employs tools like endonucleases, TALEN, and CRISPR/Cas systems, but mainly utilizes PEBL (protein expression blocker). PEBL confines specific proteins within the cell, inhibiting their external expression.

This approach enhances the anti-cancer activity of immune cells by engineering them to lack certain surface molecules. Further, the technology facilitates the creation of T-cells devoid of graft-versus-host disease capacity, resulting in a significant improvement for allogeneic T-cell therapies. MediSix Therapeutics’ pipeline of research expands T-cell function, especially in T-cell malignancies and other tumors.

9. Open Medical Data

Modern medical researchers struggle with restricted access to data and fragmentation of vital datasets. This impedes comprehensive analysis, cross-referencing, and collaborative research, slowing the pace of discovery. Open medical data tools are addressing this by promoting the transparent sharing of research data across the global scientific community.

By creating standardized, accessible repositories and platforms, researchers pool data, harness diverse datasets for broader analyses, and collaboratively build upon each other’s findings. This open approach accelerates research and also ensures a more inclusive and holistic understanding of medical phenomena, benefiting from the collective expertise of the global scientific community.

Metriport offers an Open-source API for Healthcare Data

US-based startup Metriport provides an API for healthcare data that delivers comprehensive patient medical information swiftly. The startup’s FHIR-native medical API integrates with major clinical data networks like CommonWell Health Alliance and Carequality Interoperability Framework.

The API ensures clinical accuracy, supports HL7 FHIR, C-CDA, and PDF formats, and provides a wide range of patient data, from medical history to risk assessments. Metriport’s open-source approach promotes transparency, reliability, and collaboration in healthcare technology. This, in turn, facilitates seamless access to patient data, enhancing informed treatment decisions.

Sorcero develops an AI Platform for Medical Affairs Teams

Sorcero is a US-based startup that enhances the capabilities of medical affairs teams through its AI-driven Clarity platform. The platform magnifies productivity significantly by offering advanced analytics across the therapeutic landscape. Sorcero’s technology organizes and comprehends language usage in life sciences, ensuring clarity and visibility on the impact of scientific engagement on patient outcomes.

Its products like the Intelligent Systematic Literature Review and Medical Insights Management facilitate evidence generation and insight analysis. The platform allows medical science liaisons to capture critical insights and enrich them with AI. The startup’s solutions increase productivity and also reduce literature monitoring time for global life sciences enterprises.

10. Rare Disease Modeling

In medical research, the study of rare diseases is highly challenging due to the nature of the disease and the limited availability of patient samples. This also exacerbates the challenge of conducting large-scale clinical trials to sufficiently validate medical data. Rare disease modeling offers a solution to these constraints by employing advanced in vitro systems. For example, organoids and patient-derived induced pluripotent stem cells (iPSCs) replicate disease conditions.

These models provide a platform to study disease mechanisms, screen potential therapeutics, and predict patient responses in a controlled environment. By simulating the intricacies of rare diseases outside the human body, such innovations are enabling more robust research. It also allows the development of targeted treatments despite the challenges posed by the rarity of the conditions.

Rarebase aids in Small Molecule Screening

US-based startup Rarebase advances drug discovery for rare diseases through its FUNCTION product engine. The startup combines science and high-throughput technology to expedite the discovery process and has screened nearly 4000 drug compounds across 20 000 genes, applying this knowledge to monogenic rare diseases. It screens thousands of small molecule compounds by mapping their impact on gene expression at a genome-scale.

Moreover, Rarebase quantifies drug response across entire genomes and screens entire franchises of root diseases in a single shot through multiplexing. This capability facilitates quicker alignment of a lead compound with diseases likely to benefit from it, advancing research on a broad spectrum of rare diseases.

Organo-ID creates Preclinical Models for Rare Diseases

Turkish startup Organo-ID generates pre-clinical in vitro disease models using advanced organoid technology, focusing on human cancer and liver pathologies. The startup creates endodermal hepatic organoids (eHEPO) from induced pluripotent cells, serving as a realistic in vitro liver model.

Additionally, the company produces patient-derived cancer organoids (PDCOs) that maintain the primary tumor’s characteristics, including its genetic heterogeneity. PDCOs enable real-time modeling and in vitro testing, showcasing how individual patient tumors respond to various treatments. Moreover, Organo-ID’s technology provides medical researchers with a more accurate representation of human organs and diseases.

Discover all Medical Research Trends, Technologies & Startups

Quantum computers process complex biological data at rapid speeds to enable faster diagnosis and treatment optimization. Additionally, bioinformatics harnesses the power of big data to facilitate a deeper understanding of genetic variations and their implications on diseases. Another notable advancement is the use of bioprinting, which offers the potential to create functional organs and tissues, addressing the global shortage of donor organs for transplant and research.

The trends in medical research and top startups outlined in this report only scratch the surface of trends that we identified during our data-driven innovation & startup scouting process. Identifying new opportunities & emerging technologies to implement into your business goes a long way in gaining a competitive advantage.

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Healthcare’s next chapter: What’s ahead for the US healthcare industry

Uncertainty has been the norm in healthcare in 2023, and that’s not likely to change in 2024. A presidential election year looms in the context of pressure on federal government finances from large budget deficits and the impact of higher interest rates on federal debt servicing costs. In addition, the healthcare industry faces uncertainty about the financing of Medicare and Medicaid; regulation, including views about horizontal and vertical integration; and overall industry economics.

In the face of this uncertainty—some might call it opacity—discerning senior management teams can act on a few trends that are clearer. Some of the trends and possible responses germane to strategy and performance of healthcare organizations in 2024 are highlighted below.

What’s ahead for healthcare players: An overview

We outlined in 2022 how the gathering storm fueled by inflation and workforce shortages would put pressure on healthcare over the next few years. Indeed, the pressure on healthcare leaders continues unabated. In response, industry players will have to consider repositioning their businesses as well as gearing up to ensure superior business performance:

• Hospital systems face a 200-basis point gap between reimbursement rates and cost inflation, according to McKinsey analysis. The gap could require performance transformations on the part of health systems, including more outsourcing, ramping up digital and automation efforts, and business rationalization.
• In 2024, employers are facing rising health insurance premiums well above their comfort zone of annual increases of less than 4 percent. 1 Kathryn Mayer, “Aon report: Big increase projected for 2024 employer health care costs,” SHRM, August 29, 2023. As payers see continued increases in medical costs and accelerating prescription drug costs, this pressure will require health plans to renew focus on medical and administrative cost control.
• These cost pressures offer many opportunities for tech-enabled services companies that can show customers near-term return on investment from their products. At the same time, many healthcare services and technology companies without demonstrable return will face severe downside to their businesses.
• Higher interest rates and less liquidity in the financial markets have raised the hurdle rate for private equity (PE) and venture capital firms. In these circumstances, private investors must ensure their portfolio companies deliver bottom-line performance, produce organic growth backed by proven business models, and have the ability to make any inorganic growth accretive based on robust capabilities. Large, well-capitalized healthcare companies will find a favorable valuation environment for acquiring PE portfolio companies as well as for forming strategic partnerships with private investors.

What’s ahead for payers

Payer value creation continues to shift from administering health benefits and providing insurance to managing care and capturing delivery and pharmacy economics. Partnering with and enabling physicians, likely in risk-based arrangements, will continue to gain in importance relative to other models of utilization management.

As pressure from rising medical and prescription costs mount, scaling proven physician partnership models (for example, primary care–centered value-based care) as well as innovating new ones (specialty benefit management and specialty value-based care) will grow in importance. Enhancing health outcomes and members’ care experience, prompted by both the incentives in government programs but also rising demand from employers, will be important priorities.

Finally, a renewed focus on reducing administrative costs will be high on the agenda for payers to ensure sustainable margins, offer a better experience for members and clinicians, and to free up resources to invest in strategic capabilities.

What’s ahead for health systems

Healthcare delivery will continue its restructuring. The definition of at-scale systems has changed in the past few years; today, it takes more than $13 billion to be a top-20 system by revenue, and many have reached their current position through inorganic growth, according to McKinsey analysis. The recent wave of M&A, however, is distinct from its predecessors. It is characterized by cross-geography deals designed to create value by scaling investments in platform capabilities across digital, analytics, shared services, and workforce management.

Beyond scale, sites of care have shifted increasingly from the hospital to ambulatory, home, and virtual care. This trend was playing out before the COVID-19 pandemic and was certainly accelerated by it. But the pivot toward ambulatory sites has been slower than expected, given the impact such a transition has on health system revenue, among other structural issues. Disruptors are vying to meet consumers’ demand for convenient access, but patients can be stuck navigating a complex system of healthcare organizations when their needs become more acute.

In parallel, health systems have struggled to fill their clinical workforce needs. The nursing shortage has become more acute: more than 100,000 nurses left the profession from 2019 to 2022, and health systems could face a shortage of 200,000 to 450,000 nurses by 2025. 2 Gretchen Berlin, Meredith Lapointe, Mhoire Murphy, and Joanna Wexler, “ Assessing the lingering impact of COVID-19 on the nursing workforce ,” McKinsey, May 11, 2022. Anticipated physician shortages are also an issue, though health system employment of physicians has slowed. Regulation (for example, price transparency and the 340B drug pricing program) and rising costs of capital (due to macroeconomic factors as well as ratings trajectories) will continue to create uncertainty.

While health system performance has generally improved over the past year as the industry emerges from the pandemic, a subset of players is really shining. Those that appear to be breaking away are hyperfocused on resilience, taking a multilever approach to growth while continuing to identify and take actions to ensure sustainable margins.

What’s ahead for artificial intelligence in healthcare

Generative artificial intelligence (gen AI) has created considerable excitement in the industry. Gen AI could be catalytic in accelerating the application of digital and automation in healthcare, thereby offering some answers to the twin challenges of affordability and workforce availability. For example, adopting currently available technology (including but not limited to automation, AI, and gen AI) could allow payers to reduce administrative costs by 13 to 25 percent, reduce medical costs by 5 to 11 percent, and increase revenue by 3 to 12 percent.

However, healthcare has lagged behind other industries in adoption of AI. For several reasons, the industry has had a hard time adopting the technology. For example, AI requires time-consuming and often manual preparation of clean and structured data; well-planned, narrow use cases (such as predicting a specific event or outcome); modern infrastructure; and hard-to-hire talent (such as data scientists and data engineers).

Given the need for empathetic and intelligent interactions in a service industry such as healthcare, the recognition, comprehension, and content creation capabilities of gen AI represent a major opportunity. It is particularly appealing in its simplicity: gen AI thrives on unstructured data, which is plentiful in healthcare; it is pretrained; and it is broadly understood by people across the organization. The potential use cases for gen AI cross every domain and function. Gen AI use cases, in addition to existing analytics use cases, could help address real burdens, including reducing preparation time and improving quality of clinical documentation, modernizing outdated or legacy applications, and personalizing patient and member outreach at scale.

Unlocking this value will be a leadership challenge. Senior healthcare executives will need to educate their boards, leadership teams, and employees; attract talent; drive adoption; and pursue change management initiatives such as workflow shifts. Scaling pilots to production-scale solutions with concurrent process changes will be important differentiators in 2024.

What’s ahead in prescription drugs

GLP-1 drugs hold the promise of treating type 2 diabetes (in 11 percent of the US population; 38 percent of the population has prediabetes 3 National Diabetes Statistics Report , Centers for Disease Control and Prevention, accessed November 20, 2023. ) and obesity (42 percent of adults 4 “Adult obesity facts,” Centers for Disease Control and Prevention, accessed November 20, 2023. ), potentially helping to avoid many other ailments, such as heart and chronic kidney disease. The population of patients meeting clinical eligibility criteria for GLP-1s is one of the largest of any new drug class in the past 20 to 30 years.

Although there is much to be excited about, experience shows that taking advantage of medical advances is often elusive in healthcare. GLP-1s must be taken consistently to maintain weight loss; however, initial studies indicate persistency and adherence to therapy is poor (32 percent of members remain persistent at one year and 27 percent during the second year 5 “Real-world analysis of glucagon-like peptide-1 antagonist (GLP-1a) obesity treatment one-year cost-effectiveness and therapy adherence,” Prime Therapeutics and MagellanRx Management, July 11, 2023. ).

Nonetheless, the shift in care and financing models that accompany GLP-1 drugs are likely to be material. The growth of the GLP-1 market has amplified the conversation around preventive care and demonstrated the impact of media awareness and consumer-driven demand in treatment decisions. Its expansion has also fueled the rise of telehealth providers, broadening access points for consumers.

The growth of the GLP-1 market presents cost challenges in the near term because benefits will accrue over time. The annual wholesale acquisition cost per patient ranges from $12,000 to $16,000. The high cost of the therapy raises complex coverage decisions for payers and plan sponsors, made even harder by the potential spending waste from therapy discontinuation.

GLP-1 drugs are not the only broad population drugs emerging or in the late-stage pipeline; others include treatments for Alzheimer’s and non-alcoholic fatty liver disease. New drugs have the potential to not only improve patients’ health but also heighten the need for better therapy and cost management. The resulting business model changes across the healthcare value chain are likely to be meaningful.

We hear from many healthcare leaders that this is an unnerving time given the relentless pressure and uncertain outlook they face. They also tell us that this is an exciting time that presents opportunities for innovation to improve members’ and patients’ health and lives, to reimagine current organizations, and build new capabilities and businesses. We would suggest healthcare leaders address known trends and avoid trying to predict future trends, given the considerable uncertainty ahead. Building resilient and agile organizations capable of rapidly adapting to new challenges as they emerge will be important to succeed in this environment.

Shubham Singhal is the global leader of McKinsey’s Social, Healthcare, and Public Entities (SHaPE) Practice in McKinsey’s Detroit office, and Drew Ungerman is the global leader of McKinsey’s Healthcare Practice and the McKinsey Health Institute in the Dallas office.

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2024 payers outlook: Opportunities abound

2024 healthcare services outlook: Challenges and opportunities

2024 health systems outlook: A host of challenges ahead

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Expert Medical Research Recruiting

The medical industry has seen enormous growth and change over the past two decades and market research has grown and evolved accordingly. Predicted continued growth means that recruiting research respondents will continue to be a critical part of obtaining quality medical market research insights. From this demand, a highly specialized niche has emerged.

Successful medical market research recruiting requires in-depth knowledge of the medical industry, sensitivity to security, privacy and knowledge of privacy laws, along with a willingness to employ multiple approaches to secure quality respondents.

Medical studies cover a wide range of topics from pharmaceutical testing to medical device trials. Studies seek to understand changing attitudes around healthcare, changes in access to medical professionals, usability testing, patient input studies and more. To effectively recruit for so many different research needs, teams of market research experts need to establish trust and rapport with potential respondents that includes both consumers and medical professionals. Extensive databases are just the beginning for what is needed to identify and effectively recruit the right respondent for medical research project success.

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Chapter 1: a growing industry, chapter 2: medical market research, chapter 3: medical market research recruiting overview, chapter 4: challenges for medical market research recruiting, chapter 5: best practices for medical research recruiting.

Chapter 6: Finding an Expert Medical Recruiting Partner 

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The Medical Industry is Growing

The medical industry is booming across a wide range of verticals. While big pharmaceutical companies have become more dependent on  mergers and acquisitions to fuel R&D needs , the landscape for  growth in the global medical devices market  is projected to reach $612.7 billion by 2025.

Experts predict that healthcare spending will  increase 5.5 percent annually  until 2027. In 2018, Americans spent $3.65 trillion, according to a report from  Axios , averaging over $11,000 per person. With all this money being spent on healthcare, it’s no wonder that medical research marketing is an expanding industry. New companies consistently pop up, and long-sustaining industry leaders remain in the game, making the healthcare field an ever-changing and booming business.

According to Deliotte,  global health care spending will continue to increase  and create opportunity for overall sector growth. Beyond new drugs and medical devices, a rising geriatric population will also drive industry growth.

The Medical Industry Is Changing

A string of global healthcare crises such as AIDS, Zika, COVID-19, obesity and opioid addiction have highlighted a need for disease prevention and wellness outside the traditional healthcare system. Public, non-profit, and commercial enterprises are all involved in this shift. Understanding deeper social components to both disease, chronic conditions, and preventable outbreaks require increased insight about changing social norms, wellness trends and attitudes toward healthcare.

Municipalities and governments also continue to grapple with public policy shifts and the rising cost of healthcare. This, along with the continued growth in the medical device field, will keep the demand for medical market research in growth mode, and quality participant recruiting for medical market research studies in high demand.

Telemedicine

Technology continues to shift how consumers access medical professionals. For example, telemedicine (or telehealth) is able to connect patients to healthcare professionals quicker than ever before.  Telemedicine  allows health care professionals to evaluate, diagnose and treat patients in remote locations using telecommunications technology. It allows patients in remote locations to access medical expertise quickly, efficiently and without travel.

As consumer interest in user-friendly and more accessible healthcare grows, this new care model that is emerging, with the consumer more at the center, has placed more importance on gaining direct consumer feedback.

Telemedicine visits increased at an average compound annual growth rate of 52% per year from 2005 – 2014 ( JAMA ).

By 2025, telemedicine is projected to exceed $64.1 billion in the US, with the global market to surpass $130.5 billion. ( Global Market Insights )

Range of Studies

Medical market research happens across the span of the healthcare industry. There are few areas that are unexplored by research teams to gain insights about how people feel about their experiences. Here are just a few of the categories prevalent in the medical research industry:

• Pharmaceutical Trials
• Research and Development Iterative Feedback Loops
• Longitudinal Studies for Health Outcomes
• Brand Trackers
• Efficacy Projects
• Product Testing / Usability Studies
• Consumer Development
• Patient Experience (Voice of Patient)

Because of this wide range of research, multiple methodologies, both qualitative and quantitative, are needed across the industry to address specific research goals. While pharmaceutical drug trials may require participant recruitment with very specific requirements and a long-term commitment to a study with detailed instructions, a brand tracker may rely on a more generalized participant for a quantitative survey response. Focus groups may be required for one-off product testing, but a research and development study may require multiple feedback sessions from the same group of participants.

Shift in Marketing Target

A major shift in the medical industry in the last few decades has been the increase in direct to consumer marketing for everything from new drugs, to medical devices and even to health plans and private insurance products. In the past, pharmaceutical companies and device manufacturers were marketing directly to medical professionals. Now, the consumer is more often than not the primary target of marketing efforts. While medical professionals may introduce new products to their patients, consumers are driving requests for drugs, regimens or medical devices. Because of this shift in consumer behavior, companies now equally need feedback directly from the end-user as well as from medical professionals.

Beyond evaluating products and services, consumers are increasingly sensitive to brand reputation and customer service. Experts report that  80 percent of customers value the experience provided by a company  just as much as they do its services or products. Marketing within the medical field has become more complex as companies build their brands increasingly in the general public’s eyes. Studies that go beyond product efficacy, but evaluate brand reputation and perception, need to carefully gather information about consumer sentiment for quality insights that can move a brand forward.

Because of this direct to consumer shift, hospitals, drug companies, healthcare device development companies and many other types of businesses in the medical periphery are looking for more feedback from the public. In these instances, the goals may include a large sample of respondents who are reasonably able to attend focus group meetings or personal interviews.

Data Quality

As the need for medical research continues to grow, so does the need for qualified research participants. While researchers look to the data – the numbers from which to gain insight, the quality of the data is inextricably linked to the quality of people participating in the research. Properly sourced and well vetted research participants deliver the best quantitative and qualitative data necessary to produce actionable insights.

Common medical market research studies look for insight about patient experience, product usability, outcomes from treatment protocols, discoveries around product use, or even user experience from web-based services or new technology. Some studies need a large pool of respondents for a portion of the study and then need to access some respondents from that same group for follow-up or deeper conversations or focus groups. Medical research for FDA testing or medical journal papers may require certain sample group sizes.

While an increase in technology is driving a need for a larger sample group for some studies, some medical research projects require participation from a very specific population. When  looking for patients with low incidence conditions , the qualified respondent pool is lean. Even if in a preliminary phase of a study a general respondent is needed, the scope may narrow to an extremely niche group. For example, when looking for general usability of a medical device, a company may want to know if an average consumer can understand how to use the device per the instructions provided and with what degree of efficacy. But as research and development iterations proceed, the research participant pool may need to be slimmed down. At one point, companies may only want to hear from in-home healthcare professionals or specific people caring for someone with a very specific disease or condition. When this respondent field narrows, expert medical recruiters can quickly adapt screeners and manage logistics to deliver the right people to the right study in the right frame of mind.

Sourcing quality respondents for either quantitative or qualitative studies starts with properly maintained respondent databases. Recruiters with medical research experience know how to effectively use their resources to find these very specific participants by quickly expanding their reach beyond their databases and relying on carefully built networks within the medical community. A successful medical respondent recruiting team has networks that include specialists, health system directors, teaching hospitals, in-home medical professionals, leaders of related non-profits, support groups and more. Input from a myriad of professionals around the medical and wellness field reveal additional prospects for projects with very targeted goals.

Knowledge Base

The healthcare field is changing rapidly with new discoveries, drugs, legislation and treatment protocols.  Successful medical research recruiting requires a base of industry knowledge  to keep up with these changes. New abbreviations for medical lingo crop up frequently; medical professionals move from one opportunity to the next. Recruiters are most successful when they regularly read trade journals, medical reports, etc., looking  for ways to reach out to support communities , and maintaining regular contact with medical professionals and caregivers.

Relationship Base

Highly qualified recruiters work for years to  establish rapport with medical professionals , medical office and hospital staff members, support group leaders and members, caregivers and other staff members of healthcare facilities. Filling medical research studies with high-quality respondents requires more than sorting through a database and picking out a few names. A highly detailed database is the starting point from which a recruiter begins to cross reference potential candidates and may require input from medical professionals. Quality medical research recruiters know when to engage these relationships to source the best research participants. These inquiries must protect the privacy of patients while determining their ability and qualifications for a study.

Expert  medical research recruiting requires experience , detailed databases, networking skills and resourcefulness.

The most successful recruiting experts work hard to earn the trust of potential participants and medical professionals alike. Because recruiting for medical research can be incredibly nuanced, hiring a recruiting team with fieldwork experience can save time and money – helping you achieve quality outcomes and stay focused on the research. Consider these issues when evaluating a recruiting team for your next project:

Geographical Challenges

While the results of medical research can have national and even global ramifications, studies may start with very set limitations. Some projects start specifically in a confined locale and then grow into multi-market projects. Others may need one study with very few people but with a significant spread to represent the nation geographically. A research project also may want to pull from within an age group or generation within a specific region. Each of these potential recruiting needs requires having access to both a  national and local database  that is proactively maintained and keeps a record of past study participation.

Ever-Changing Respondent Data

Medical research often involves stringent criteria with many exclusions or combinations of factors. When researchers need respondents that fit narrowly focused criteria, recruiters often start with extensive medical databases. Keeping a database for medical research requires constant recruiting and proactive file maintenance. Beyond typical database care, a medical database requires detailed tracking of conditions, specialties, subspecialties, education level, number of years in practice, past research participation and more. Databases that can be used for efficient medical research recruiting can track detail for both patient and medical professional populations. Great recruiters go beyond databases to cast a wider net to connect with potential respondents, but  starting with a solid database  is essential to help gauge the time needed to move forward with particularly challenging studies.

Keeping Up with HIPAA and Other Security Protocols

HIPAA (Health Insurance Portability and Accountability Act of 1996) safeguards patients’ medical information and health history and provides for data security .  HIPAA rules need to be followed from the beginning of any project from proper screener set up to the storage of recruiting data and database security. Regardless of the number of vendors employed to realize a research project, each is responsible for a faithful execution of HIPPA regulations beyond professional confidentiality and operational security protocols.

Blind Experiment Protocols

Specific needs, such as filling a blinded experiment, require additional skill to maintain the integrity of the study. Withholding certain elements of the research can be an integral part of eliminating experimental biases and should be communicated to all involved with the study and included in the participant recruiting protocol.

Dealing with Respondent Limitations

Another aspect of medical research recruiting that requires tact and skill lies in the handling of limitations. Some patients may have conditions which limit their mobility or require special services to participate in studies. Sensitivity when calling for confirmations is a great practice to eliminate no-shows. Empathetic recruiters know how to anticipate how certain conditions or diseases may create situations where the respondent is genuine in their desire to participate, but the condition creates unpredictability with their ability to manage chronic pain, depression or deal in any other way with changes in their health. Building trust with key respondents is required to show good faith in accommodating issues as they may arise. Showing empathy when recruiting can increase the quality of respondents willing to overcome the challenges of participation even when they are significant. When respondent limitations become a large obstacle for in-person interviews, online research can be an effective solution.

Navigating the Practice

It can be extremely helpful to connect with medical professionals to determine how challenging a goal or objective may be. Extensive relationships with medical professionals and medical offices can help point a recruiter in a previously unseen direction. Beyond knowledge of individual staff members, it is important to understand specific policies at certain institutions or hospital systems. Navigating the hierarchy of teaching hospitals, private practices, group practices or hospitals that may have policies keeping their doctors from participating in outside research is a key part to moving quickly to fill a study.

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While facing challenges from within and outside the medical industry, successful participant recruitment requires a system. However, the system itself cannot account for nuances needed to fill a study with the best participants possible. A recruiting firm well versed in the fieldwork needs of medical research professionals should be able to hold quality conversations around these issues:

A carefully developed database will have a healthy mix of  local and national populations . A database that has been properly maintained will not only cut down on time needed to find qualified participants, but it can be a significant part of the pre-screening process depending on the depth of detail maintained for each respondent. Working from a rich database from the beginning of the project can cut the lag time between the start and finish. While some vendors rely on legacy lists, and past research participants, great recruiting requires an updated list without gaps and a full account of previous research participation.

Digital resources have added a significant number of methods for increasing recruiting prospects.  Social media alone has extended outreach and communication within medical communities and support networks  and has increased the number of ways to identify qualified respondents. Regardless of whether the outreach takes place on social media, through online surveys, over the phone or in person, the methods should be in alignment with patient and client confidentiality. Protocols concerning patient outreach should be clearly communicated to the entire recruiting team with each new method of outreach established.

Connections

Great recruiters know how important it is to visit with professional medical staff and maintain a wide circle of connections within the medical industry. Visiting directly with consumers and patients and becoming active in events that are important to them gains exposure for the industry and builds trust with potential participants. Great recruiters are familiar with causes, awareness campaigns, walks, foundations and other activities important to patients, their caregivers and others in the field. Showing up physically to meet with organizers, educators, family members and others during these activities can make positive connections with patients and their support systems.

Continual learning should be a constant topic around medical research recruiting. Screeners and phone room personnel do not need to maintain deep knowledge across the medical field, but when recruiting for a specific condition, symptom or type of patient, they should be brought up to speed with general information and related medical jargon surrounding the issue before recruiting starts. Taking the time to gain a basic knowledge about the issue surrounding the recruit makes a difference in the immediate rapport building with potential participants and even can help with the initial internal screening of the database pool.

Most doctors, medical professionals and caregivers are strapped for time. In this fast-paced industry, respecting other people’s time is crucial to building and maintaining rapport for medical recruiting. Something as simple as providing clarity about length of time needed for a screener can make an impression of respect for others. Likewise, calling back when expected shows a mindfulness about the time constraints others face in their job environment.

Sensitivity

Patients are also pressed for time; often they are pressed on quality of life issues. Patient participants are offered financial compensation for their time, but that may not always be the biggest motivating factor. They can also be compelled to help others based on the outcome of a trial or study. No matter why they are interested in participating in medical research, they still may be thwarted by health issues. Successful recruiters are sensitive to these challenges and should openly discuss possible physical accommodations to increase participation. In this way, empathy is a strong skill for any medical recruiting professional to develop and maintain.

Communication

Clients are provided with regular updates on recruiting benchmarks in any research recruitment project. Recruiting for medical studies requires a deeper level of communication as the screeners are typically more detailed and nuanced. When a project starts, a great recruiting team can provide feedback to the client from potential participants which can be helpful in steering the study to a better outcome. This quality of communication relies on the screeners and recruiting team being great listeners and asking better questions to yield the highest quality of respondents.

Especially when looking for a very specific research participant, out of the box thinking can be helpful to cast a larger net. Recruiters who are confident in their traditional methods of outreach also are familiar with limitations. Allowing for new ideas and innovative approaches can result in finding a better way to source participants directly, or it may lead to approaching previously unreceptive organizations or hospital systems with a better proposition. Regardless of outcome, allowing for creativity within the confines of patient and client confidentiality is a best practice for medical research recruitment.

Representation

Keeping a big-picture focus on how medical research can improve the lives of patients, doctors and medical professionals alike can help keep a difficult recruiting project on track. The benefits of medical research, whether it leads to a medical breakthrough, improved access to healthcare or improved quality of life for patients, should remain top of mind.  A successful medical research recruiter is in tune with a sense of ambassadorship. Tapping into a passion for improving peoples’ lives can help maintain focus even with a difficult study to fill.

Chapter 6: Finding an Expert Medical Recruiting Partner

Research projects are moving at a faster pace than ever before. Insights departments are being asked to do more with less and get it done quicker without sacrificing quality. A project cannot get into the field until the critical task of recruiting participants is completed. This places quality market research recruitment at a critical juncture of ensuring projects are completed well, on time and within budget. Finding an expert medical recruiting partner with extensive databases, years of experience, sensitivity to issues and knowledge of the medical industry can be a daunting task. Here is a list of questions to ask when vetting potential partners for your next medical research study:

• What medical detail do you already know about those currently in your database?
• Do you have examples of low incidence medical condition recruiting success?
• What methods outside of proprietary databases do you employ to find potential medical research participants?
• How do your recruiters discuss potential disability accommodation with potential recruits?
• How experienced are the recruiters in your phone room with medical terminology?
• Will my project have a  single point of contact ?
• Do you offer a  one-call solution for multi-location projects ?
• What kind of experience does your team have recruiting surgeons, doctors or other specialists in the medical field?
• What kind of daily feedback is given to clients about recruiting progress and quota fulfillment?
• Do you offer a collaborative approach regarding challenges with the screener?
• With what kind of local and national medical groups does your recruiting office maintain relationships?
• How do you proactively build your databases?

In the end, industry expertise matters greatly but knowing specifically why certain partners excel in the medical marketing research recruiting field can lead to better project success. Knowing how a partner will focus on quick turnaround times, can adapt to methods, and maintain confidentiality can bring confidence in the data emerging from the research.

Recruiting qualified respondents can make or break your medical research study. They provide invaluable insights, and offer important intel, and actionable learnings. The medical industry continues to grow and change every day. New medications are introduced into the market, new discoveries are made about treatment efficacy, new major medical devices require user feedback. These initiatives require research. Keeping pace with the high demands of sourcing quality respondents for today and tomorrow’s medical breakthroughs is a demanding but rewarding job. When your project requires medical research recruiting expertise, and highly responsive communication, call the expert team at Fieldwork.

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Chinese Company Under Congressional Scrutiny Makes Key U.S. Drugs

Lawmakers raising national security concerns and seeking to disconnect a major Chinese firm from U.S. pharmaceutical interests have rattled the biotech industry. The firm is deeply involved in development and manufacturing of crucial therapies for cancer, cystic fibrosis, H.I.V. and other illnesses.

A WuXi Biologics facility in Wuxi, China. WuXi AppTec and an affiliated company, WuXi Biologics, have received millions of dollars in tax incentives to build sprawling research and manufacturing sites in Massachusetts and Delaware. Credit... Imaginechina Limited, via Alamy

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By Christina Jewett

• April 15, 2024

A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity and debilitating illnesses like cystic fibrosis.

WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them.

But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope of work that WuXi does for the U.S. biotech and pharmaceutical industries — and patients. A New York Times review of hundreds of pages of records worldwide shows that WuXi is heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and H.I.V.

The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high . Some biotech executives have pushed back, trying to impress on Congress that a sudden decoupling could take some drugs out of the pipeline for years.

WuXi AppTec and an affiliated company, WuXi Biologics grew rapidly, offering services to major U.S. drugmakers that were seeking to shed costs and had shifted most manufacturing overseas in the last several decades.

WuXi companies developed a reputation for low-cost and reliable work by thousands of chemists who could create new molecules and operate complex equipment to make them in bulk. By one estimate, WuXi has been involved in developing one-fourth of the drugs used in the United States. WuXi AppTec reported earning about $3.6 billion in revenue for its U.S. work.

“They have become a one-stop shop to a biotech,” said Kevin Lustig, founder of Scientist.com, a clearinghouse that matches drug companies seeking research help with contractors like WuXi.

WuXi AppTec and WuXi Biologics have also received millions of dollars in tax incentives to build sprawling research and manufacturing sites in Massachusetts and Delaware that local government officials have welcomed as job and revenue generators. One WuXi site in Philadelphia was working alongside a U.S. biotech firm to give patients a cutting-edge therapy that would turbocharge their immune cells to treat advanced skin cancers.

The tension has grown since February, when four lawmakers asked the Commerce, Defense and Treasury Departments to investigate WuXi AppTec and affiliated companies, calling WuXi a “giant that threatens U.S. intellectual property and national security.”

A House bill called the Biosecure Act linked the company to the People’s Liberation Army, the military arm of the Chinese Communist Party. The bill claims WuXi AppTec sponsored military-civil events and received military-civil fusion funding.

Richard Connell, the chief operating officer of WuXi AppTec in the United States and Europe, said the company participates in community events, which do not “imply any association with or endorsement of a government institution, political party or policy such as military-civil fusion.” He also said shareholders do not have control over the company or access to nonpublic information.

Last month, after a classified briefing with intelligence staff, the Senate homeland security committee advanced a bill by a vote of 11 to 1: It would bar companies from receiving government contracts for work with Wuxi, but would allow the companies to still obtain contracts for unrelated projects. Government contracts with drugmakers are generally limited, though they were worth billions of dollars in revenue to companies that responded to the Covid-19 pandemic.

Mr. Connell defended the company’s record, saying the proposed legislation “relies on misleading allegations and inaccurate assertions against our company.”

WuXi operates in a highly regulated environment by “multiple U.S. federal agencies — none of which has placed our company on any sanctions list or designated it as posing a national security risk,” Mr. Connell said. WuXi Biologics did not respond to requests for comment.

Smaller biotech companies, which tend to rely on government grants and have fewer reserves, are among the most alarmed. Dr. Jonathan Kil, the chief executive of Seattle-based Sound Pharmaceuticals, said WuXi has worked alongside the company for 16 years to develop a treatment for hearing loss and tinnitus, or ringing in the ear. Finding another contractor to make the drug could set the company back two years, he said.

“What I don’t want to see is that we get very anti-Chinese to the point where we’re not thinking correctly,” Dr. Kil said.

It is unclear whether a bill targeting WuXi will advance at all this year. The Senate version has been amended to protect existing contracts and limit supply disruptions. Still, the scrutiny has prompted some drug and biotechnology companies to begin making backup plans.

Peter Kolchinsky, managing partner of RA Capital Management, estimated that half of the 200 biotech companies in his firm’s investment portfolio work with WuXi.

“Everyone is likely considering moving away from Wuxi and China more broadly,” he said in an email. “Even though the current versions of the bill don’t create that imperative clearly, no one wants to be caught flat-footed in China if the pullback from China accelerates.”

The chill toward China extends beyond drugmakers. U.S. companies are receiving billions of dollars in funding under the CHIPS Act, a federal law aimed at bringing semiconductor manufacturing stateside.

For the last several years, U.S. intelligence agencies have been warning about Chinese biotech companies in general and WuXi in particular. The National Counterintelligence and Security Center, the arm of the intelligence community charged with warning companies about national security issues, raised alarms about WuXi’s acquisition of NextCODE, an American genomic data company.

Though WuXi later spun off that company, a U.S. official said the government remains skeptical of WuXi’s corporate structure, noting that some independent entities have overlapping management and that there were other signs of the Chinese government’s continuing control or influence over WuXi.

Aides from the Senate homeland security committee said their core concerns are about the misuse of Americans’ genomic data, an issue that’s been more closely tied to other companies named in the bill.

Aides said the effort to discourage companies from working with WuXi and others was influenced by the U.S. government’s experience with Huawei, a Chinese telecommunications giant. By the time Congress acted on concerns about Huawei’s access to Americans’ private information, taxpayers had to pay billions of dollars to tear Huawei’s telecommunication equipment out of the ground.

Yet WuXi has far deeper involvement in American health care than has been discussed in Congress. Supply chain analytics firms QYOBO and Pharm3r, and some public records, show that WuXi and its affiliates have made the active ingredients for critical drugs.

They include Imbruvica, a leukemia treatment sold by Janssen Biotech and AbbVie that brought in $5.9 billion in worldwide revenue in 2023. WuXi subsidiary factories in Shanghai and Changzhou were listed in government records as makers of the drug’s core ingredient, ibrutinib.

Dr. Mikkael A. Sekeres, chief of hematology at the University of Miami Health System, called that treatment for chronic lymphocytic leukemia “truly revolutionary” for replacing highly toxic drugs and extending patients’ lives.

Janssen Biotech and AbbVie, partners in selling the drug, declined to comment.

WuXi Biologics also manufactures Jemperli, a GSK treatment approved by the Food and Drug Administration last year for some endometrial cancers. In combination with standard therapies, the drug improves survival in patients with advanced disease, said Dr. Amanda Nickles Fader, president of the Society of Gynecologic Oncology.

“This is particularly important because while most cancers are plateauing or decreasing in incidence and mortality, endometrial cancer is one of the only cancers globally” increasing in both, Dr. Fader said.

GSK declined to comment.

The drug that possibly captures WuXi’s most significant impact is Trikafta, manufactured by an affiliate in Shanghai and Changzhou to treat cystic fibrosis, a deadly disease that clogs the lungs with debilitating, thick mucus. The treatment is credited with clearing the lungs and extending by decades the life expectancy of about 40,000 U.S. residents. It also had manufacturers in Italy, Portugal and Spain.

The treatment has been so effective that the Make-A-Wish Foundation stopped uniformly granting wishes to children with cystic fibrosis. Trikafta costs about $320,000 a year per patient and has been a boon for Boston-based Vertex Pharmaceuticals and its shareholders, with worldwide revenue rising to $8.9 billion last year from $5.7 billion in 2021, according to a securities filing .

Trikafta “completely transformed cystic fibrosis and did it very quickly,” said Dr. Meghan McGarry, a University of California San Francisco pulmonologist who treats children with the condition. “People came off oxygen and from being hospitalized all the time to not being hospitalized and being able to get a job, go to school and start a family.”

Vertex declined to comment.

Two industry sources said WuXi plays a role in making Eli Lilly’s popular obesity drugs. Eli Lilly did not respond to requests for comment. WuXi companies also make an infusion for treatment-resistant H.I.V., a drug for advanced ovarian cancer and a therapy for adults with a rare disorder called Pompe disease.

WuXi is known for helping biotech firms from the idea stage to mass production, Dr. Kolchinsky said. For example, a start-up could hypothesize that a molecule that sticks to a certain protein might cure a disease. The company would then hire WuXi chemists to create or find the molecule and test it in petri dishes and animals to see whether the idea works — and whether it’s safe enough for humans.

“Your U.S. company has the idea and raises the money and owns the rights to the drug,” Dr. Kolchinsky said. “But they may count on WuXi or similar contractors for almost every step of the process.”

WuXi operates large bioreactors and manufactures complex peptide, immunotherapy and antibody drugs at sprawling plants in China.

WuXi AppTec said it has about 1,900 U.S. employees. Officials in Delaware gave the company $19 million in tax funds in 2021 to build a research and drug manufacturing site that is expected to employ about 1,000 people when fully operational next year, public records and company reports show.

Mayor Kenneth L. Branner Jr. of Middletown, Del., called it “one of those once-in-a-lifetime opportunities to land a company like this,” according to a news report when the deal was approved.

In 2022, the lieutenant governor of Massachusetts expressed a similar sentiment when workers placed the final steel beam on a WuXi Biologics research and manufacturing plant in Worcester. Government officials had approved roughly $11.5 million in tax breaks to support the project. The company announced this year that it would double the site’s planned manufacturing capacity in response to customer demand.

And in Philadelphia, a WuXi Advanced Therapies site next to Iovance Biotherapeutics was approved by regulators to help process individualized cell therapies for skin cancer patients. Iovance has said it is capable of meeting demand for the therapies independently.

By revenue, WuXi Biologics is one of the top five drug development and manufacturing companies worldwide, according to Statista , a data analytics company. A WuXi AppTec annual report showed that two-thirds of its revenue came from U.S. work.

Stepping away from WuXi could cause a “substantial slowdown” in drug development for a majority of the 105 biotech companies surveyed by BioCentury , a trade publication. Just over half said it would be “extremely difficult” to replace China-based drug manufacturers.

BIO, a trade group for the biotechnology industry, is also surveying its members about the impact of disconnecting from WuXi companies. John F. Crowley, BIO’s president, said the effects would be most difficult for companies that rely on WuXi to manufacture complex drugs at commercial scale. Moving such an operation could take five to seven years.

“We have to be very thoughtful about this so that we first do no harm to patients,” Mr. Crowley said. “And that we don’t slow or unnecessarily interfere with the advancement of biomedical research.”

Julian E. Barnes contributed reporting, and Susan C. Beachy contributed research.

Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy. More about Christina Jewett

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Digital health technologies for remote data acquisition in clinical investigations.

Guidance for Industry, Investigators, and Other Stakeholders December 2023 View the Agency Guidance Snapshot

Summary : A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. This document summarizes recent agency guidance that provides recommendations for sponsors, investigators, and other stakeholders on the use of DHTs for remote data acquisition from participants in clinical investigations that evaluate medical products.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Draft Guidance for Industry and Food and Drug Administration Staff (Draft Guidance) December 2023 View the Agency Guidance Snapshot

Summary : FDA recently issued draft guidance to clarify how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices, such as new or expanded indications for use or postmarket surveillance. The draft guidance also provides expanded recommendations to sponsors considering using real-world evidence to support a regulatory submission for medical devices.

The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Public Health Service Policies on Research Misconduct: Notice of Proposed Rulemaking (NPRM)

October 2023 View the Agency Guidance Snapshot

Summary : This document summarizes the recent Notice of Proposed Rulemaking (NPRM), released by the Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), and the Office of Research Integrity (ORI). The NPRM proposes to revise the Public Health Service (PHS) Policies on Research Misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005. ORI anticipates release of the final rule in the summer of 2024, with implementation to begin a minimum of 4 months afterward. ORI will aim for an effective date of January 1, 2025, to simplify institutional reporting.

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

Guidance for IRBs and Clinical Investigators September 2023 View the Agency Guidance Snapshot

Summary : This document summarizes recent agency guidance that provides recommendations to institutional review boards (IRBs) clinical investigators and licensed physicians regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR part 56.

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

August 2023 View the Agency Guidance Snapshot

Summary : On August 15, 2023, the U.S. Food and Drug Administration (FDA) issued a new guidance document on informed consent (the “Final Guidance”). This guidance finalizes the draft “Informed Consent Information Sheet” from 2014 (the “Draft Guidance”) and supersedes FDA’s guidance from 1998, “A Guide to Informed Consent.” FDA’s issuance of the Final Guidance follows the Agency’s continuing efforts in recent years to modernize and streamline the clinical trial enterprise. The document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.

Psychedelic Drugs: Considerations for Clinical Investigations

Guidance for Industry (Draft Guidance) June 2023 View the Agency Guidance Snapshot

Summary : The U.S. Food and Drug Administration (FDA or Agency) recently issued draft guidance to provide general considerations to sponsors (including sponsor-investigators) developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders).

Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions

(Draft Guidance) June 2023 View the Agency Guidance Snapshot

Summary : This document summarizes recent agency draft guidance regarding the concept of limited IRB review and provides information about how limited review may be conducted. This document also discusses IRB and investigator responsibilities when reviewing and conducting exempt research that requires limited IRB review as a condition of exemption. Note that limited IRB review is a provision that is only included in the 2018 Requirements. If a research study is covered by the pre-2018 Requirements, then limited IRB review is not a consideration.

Decentralized Clinical Trials for Drugs, Biological Products, and Devices

(Draft Guidance) May 2023 View the Agency Guidance Snapshot

Summary : On May 1, 2023, the United States Food and Drug Administration (FDA) released draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders.” This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations

Questions and Answers (Draft Guidance) March 2023 View the Agency Guidance Snapshot

Summary : This document summarizes recent agency draft guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs. The draft guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board

Process for Referrals to Food and Drug Administration and Office for Human Research Protections (Draft Guidance) March 2023 View the Agency Guidance Snapshot

Summary : This document summarizes recent agency draft guidance intended to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to the Food and Drug Administration (FDA) under 21 CFR 50.54, the Office for Human Research Protections (OHRP) under 45 CFR 46.407, or both, for review.

MIT Technology Review

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Taking AI to the next level in manufacturing

Reducing data, talent, and organizational barriers to achieve scale.

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In partnership with Microsoft

Few technological advances have generated as much excitement as AI. In particular, generative AI seems to have taken business discourse to a fever pitch. Many manufacturing leaders express optimism: Research conducted by MIT Technology Review Insights found ambitions for AI development to be stronger in manufacturing than in most other sectors.

Manufacturers rightly view AI as integral to the creation of the hyper-automated intelligent factory. They see AI’s utility in enhancing product and process innovation, reducing cycle time, wringing ever more efficiency from operations and assets, improving maintenance, and strengthening security, while reducing carbon emissions. Some manufacturers that have invested to develop AI capabilities are still striving to achieve their objectives.

This study from MIT Technology Review Insights seeks to understand how manufacturers are generating benefits from AI use cases—particularly in engineering and design and in factory operations. The survey included 300 manufacturers that have begun working with AI. Most of these (64%) are currently researching or experimenting with AI. Some 35% have begun to put AI use cases into production. Many executives that responded to the survey indicate they intend to boost AI spending significantly during the next two years. Those who haven’t started AI in production are moving gradually. To facilitate use-case development and scaling, these manufacturers must address challenges with talents, skills, and data. Following are the study’s key findings:

• Talent, skills, and data are the main constraints on AI scaling. In both engineering and design and factory operations, manufacturers cite a deficit of talent and skills as their toughest challenge in scaling AI use cases. The closer use cases get to production, the harder this deficit bites. Many respondents say inadequate data quality and governance also hamper use-case development. Insufficient access to cloud-based compute power is another oft-cited constraint in engineering and design.
• The biggest players do the most spending, and have the highest expectations. In engineering and design, 58% of executives expect their organizations to increase AI spending by more than 10% during the next two years. And 43% say the same when it comes to factory operations. The largest manufacturers are far more likely to make big increases in investment than those in smaller—but still large—size categories.
• Desired AI gains are specific to manufacturing functions. The most common use cases deployed by manufacturers involve product design, conversational AI, and content creation. Knowledge management and quality control are those most frequently cited at pilot stage. In engineering and design, manufacturers chiefly seek AI gains in speed, efficiency, reduced failures, and security. In the factory, desired above all is better innovation, along with improved safety and a reduced carbon footprint.
• Scaling can stall without the right data foundations. Respondents are clear that AI use-case development is hampered by inadequate data quality (57%), weak data integration (54%), and weak governance (47%). Only about one in five manufacturers surveyed have production assets with data ready for use in existing AI models. That figure dwindles as manufacturers put use cases into production. The bigger the manufacturer, the greater the problem of unsuitable data is.
• Fragmentation must be addressed for AI to scale. Most manufacturers find some modernization of data architecture, infrastructure, and processes is needed to support AI, along with other technology and business priorities. A modernization strategy that improves interoperability of data systems between engineering and design and the factory, and between operational technology (OT) and information technology (IT), is a sound priority.

Artificial intelligence

Large language models can do jaw-dropping things. but nobody knows exactly why..

And that's a problem. Figuring it out is one of the biggest scientific puzzles of our time and a crucial step towards controlling more powerful future models.

• Will Douglas Heaven archive page

Google DeepMind’s new generative model makes Super Mario–like games from scratch

Genie learns how to control games by watching hours and hours of video. It could help train next-gen robots too.

What’s next for generative video

OpenAI's Sora has raised the bar for AI moviemaking. Here are four things to bear in mind as we wrap our heads around what's coming.

The AI Act is done. Here’s what will (and won’t) change

The hard work starts now.

• Melissa Heikkilä archive page

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9 facts about Americans and marijuana

The use and possession of marijuana is illegal under U.S. federal law, but about three-quarters of states have legalized the drug for medical or recreational purposes. The changing legal landscape has coincided with a decades-long rise in public support for legalization, which a majority of Americans now favor.

Here are nine facts about Americans’ views of and experiences with marijuana, based on Pew Research Center surveys and other sources.

As more states legalize marijuana, Pew Research Center looked at Americans’ opinions on legalization and how these views have changed over time.

Data comes from surveys by the Center,  Gallup , and the  2022 National Survey on Drug Use and Health  from the U.S. Substance Abuse and Mental Health Services Administration. Information about the jurisdictions where marijuana is legal at the state level comes from the  National Organization for the Reform of Marijuana Laws .

More information about the Center surveys cited in the analysis, including the questions asked and their methodologies, can be found at the links in the text.

Around nine-in-ten Americans say marijuana should be legal for medical or recreational use,  according to a January 2024 Pew Research Center survey . An overwhelming majority of U.S. adults (88%) say either that marijuana should be legal for medical use only (32%) or that it should be legal for medical  and  recreational use (57%). Just 11% say the drug should not be legal in any form. These views have held relatively steady over the past five years.

Views on marijuana legalization differ widely by age, political party, and race and ethnicity, the January survey shows.

While small shares across demographic groups say marijuana should not be legal at all, those least likely to favor it for both medical and recreational use include:

• Older adults: 31% of adults ages 75 and older support marijuana legalization for medical and recreational purposes, compared with half of those ages 65 to 74, the next youngest age category. By contrast, 71% of adults under 30 support legalization for both uses.
• Republicans and GOP-leaning independents: 42% of Republicans favor legalizing marijuana for both uses, compared with 72% of Democrats and Democratic leaners. Ideological differences exist as well: Within both parties, those who are more conservative are less likely to support legalization.
• Hispanic and Asian Americans: 45% in each group support legalizing the drug for medical and recreational use. Larger shares of Black (65%) and White (59%) adults hold this view.

Support for marijuana legalization has increased dramatically over the last two decades. In addition to asking specifically about medical and recreational use of the drug, both the Center and Gallup have asked Americans about legalizing marijuana use in a general way. Gallup asked this question most recently, in 2023. That year, 70% of adults expressed support for legalization, more than double the share who said they favored it in 2000.

Half of U.S. adults (50.3%) say they have ever used marijuana, according to the 2022 National Survey on Drug Use and Health . That is a smaller share than the 84.1% who say they have ever consumed alcohol and the 64.8% who have ever used tobacco products or vaped nicotine.

While many Americans say they have used marijuana in their lifetime, far fewer are current users, according to the same survey. In 2022, 23.0% of adults said they had used the drug in the past year, while 15.9% said they had used it in the past month.

While many Americans say legalizing recreational marijuana has economic and criminal justice benefits, views on these and other impacts vary, the Center’s January survey shows.

• Economic benefits: About half of adults (52%) say that legalizing recreational marijuana is good for local economies, while 17% say it is bad. Another 29% say it has no impact.

• Criminal justice system fairness: 42% of Americans say legalizing marijuana for recreational use makes the criminal justice system fairer, compared with 18% who say it makes the system less fair. About four-in-ten (38%) say it has no impact.
• Use of other drugs: 27% say this policy decreases the use of other drugs like heroin, fentanyl and cocaine, and 29% say it increases it. But the largest share (42%) say it has no effect on other drug use.
• Community safety: 21% say recreational legalization makes communities safer and 34% say it makes them less safe. Another 44% say it doesn’t impact safety.

Democrats and adults under 50 are more likely than Republicans and those in older age groups to say legalizing marijuana has positive impacts in each of these areas.

Most Americans support easing penalties for people with marijuana convictions, an October 2021 Center survey found . Two-thirds of adults say they favor releasing people from prison who are being held for marijuana-related offenses only, including 41% who strongly favor this. And 61% support removing or expunging marijuana-related offenses from people’s criminal records.

Younger adults, Democrats and Black Americans are especially likely to support these changes. For instance, 74% of Black adults  favor releasing people from prison  who are being held only for marijuana-related offenses, and just as many favor removing or expunging marijuana-related offenses from criminal records.

Twenty-four states and the District of Columbia have legalized small amounts of marijuana for both medical and recreational use as of March 2024,  according to the  National Organization for the Reform of Marijuana Laws  (NORML), an advocacy group that tracks state-level legislation on the issue. Another 14 states have legalized the drug for medical use only.

Of the remaining 12 states, all allow limited access to products such as CBD oil that contain little to no THC – the main psychoactive substance in cannabis. And 26 states overall have at least partially  decriminalized recreational marijuana use , as has the District of Columbia.

In addition to 24 states and D.C.,  the U.S. Virgin Islands ,  Guam  and  the Northern Mariana Islands  have legalized marijuana for medical and recreational use.

More than half of Americans (54%) live in a state where both recreational and medical marijuana are legal, and 74% live in a state where it’s legal either for both purposes or medical use only, according to a February Center analysis of data from the Census Bureau and other outside sources. This analysis looked at state-level legislation in all 50 states and the District of Columbia.

In 2012, Colorado and Washington became the first states to pass legislation legalizing recreational marijuana.

About eight-in-ten Americans (79%) live in a county with at least one cannabis dispensary, according to the February analysis. There are nearly 15,000 marijuana dispensaries nationwide, and 76% are in states (including D.C.) where recreational use is legal. Another 23% are in medical marijuana-only states, and 1% are in states that have made legal allowances for low-percentage THC or CBD-only products.

The states with the largest number of dispensaries include California, Oklahoma, Florida, Colorado and Michigan.

Note: This is an update of a post originally published April 26, 2021, and updated April 13, 2023.  

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Majority of U.S. Catholics Express Favorable View of Pope Francis

Americans rate their federal, state and local governments less positively than a few years ago, about 1 in 4 u.s. teachers say their school went into a gun-related lockdown in the last school year, changing partisan coalitions in a politically divided nation, about half of americans say public k-12 education is going in the wrong direction, most popular.

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ABOUT PEW RESEARCH CENTER  Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of  The Pew Charitable Trusts .

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Zambia visit shows SSW’s global impact

A UNC School of Social Work delegation saw how their research helped a nonprofit create jobs in rural areas.

A small delegation from the UNC School of Social Work visited the growing rural town of Solwezi (population 90,000) in the North-Western Province of Zambia in March. They came to learn about the impact of local women’s savings and credit groups and their financial literacy training.

The trip was coordinated by Gina Chowa and Rain Masa from the school’s center for  Global Social Development Innovations in partnership with longtime collaborator Mathias Zimba, executive director of  Rising Fountains Development Program in Zambia.

“As partners, we work together to identify ideas and practices that will change lives for the better,” Masa said. “Researchers and graduate students at the school can help build the evidence needed to demonstrate to policymakers, officials and the business community what is needed to  improve the lives of rural Zambians .”

Improving lives in six countries

Masa is an associate professor who also serves as GSDI’s research director. He has worked collaboratively on both economic security and HIV treatment projects with Rising Fountains, a Zambian nonprofit dedicated to improving the livelihoods of women and children in rural areas.

Masa emphasized how community involvement localizes these economic programs and increases their chance of success and relevance.

“Economic security is the focal point of our work,” said Masa. “We provide funding and, maybe more importantly, we are available to Mathias and his team for ongoing capacity support as well.”

Paving career paths

During the visit to her native Zambia, Chowa was visibly moved at the end of a day spent at a teen center and a church. The delegation heard from over a dozen enthusiastic groups of about 20 women each and the men who had joined in support of them.

“These people. This is why I do the work I do,” Chowa said.

Following the presentations, the delegation went to see the small business owners in action. These included a man who bought spare parts for just one bicycle and now runs a repair shop with several assistants, craftswomen who purchased a sewing machine and yarn to create and sell clothing, and a woman who uses a mobile phone and SIM cards to help townspeople make financial transactions.

“This is not about politics,” said one Solwezi community leader. “I stand in the middle in support of our people helping better their lives and those of their families.”

At the end of the visit, local residents piled baskets full of sweet melons, gourds and pineapples at the front of a small church as parting gifts.

“The bounty and generosity of spirit of the nearly 150 people of Solwezi whom we visited with earlier this month made a lasting impression,” said Alice Washington, a longtime member of the school’s advisory board.

Read more about the Zambia trip and support the UNC School of Social Work’s global partnerships by making a gift to the  Global Social Development Innovations Fund .

See climate’s impact on algae to zoos in Carolina Digital Repository’s curation of open access articles.

Robert Hawkins named new SSW vice dean

An associate dean at NC State, he will take on his role at the UNC School of Social Work on July 1.

A message from the interim chancellor: Celebrating our students

In a campus email, Lee H. Roberts wrote it's a privilege to interact with students and inspiring to learn about the diverse range of interests they're working on.

Career Treks event highlights public professions

School of Education students networked in Raleigh with representatives from 11 state agencies.

Global studies scholar aspires to diplomacy

After earning a master’s degree, Kat Goodpaster became assistant director of Carolina’s Russian Flagship Program.

Public Service Awards go to 7 people, 2 groups

The Carolina Center for Public Service honored work on health disparities, refugee aid and more.

Trash Force picks up after campus

What started as an extra credit opportunity grew into a club who has fun keeping Carolina clean.

Greensboro junior leapt into two majors

Studying both peace, war and defense and psychology, Elizabeth Cake never gets bored.

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“The music industry’s approach to mental health was disastrous”

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In the new episode of the Music Ally Focus podcast, editor Joe Sparrow is joined by music industry psychologist and therapist Anne Löhr – who gives a snapshot of the state of mental health within the music industry, and her interpretation of how well the industry has supported the mental health of the people in it.

SPOILER: uh-oh, it’s not been great – but it’s getting better. 

“Mental health is a big issue,” in the music industry, Anne says, and, “it has been for a long time.” And the wider music industry’s approach to dealing with mental health, she adds, “was actually disastrous. We all know that mental health issues were either ignored or glorified or normalised […] the sex drugs and rock and roll thing, high misuse of drugs, all these things.”

Do the big players in the industry have a significant duty of care to improve the mental health of everyone that they work with in the music industry? The answer, Anne says, simply, is yes.

One of the key problems has been that the way the industry works has made mental health an individual problem, and not a collective one, she continues: “if you can’t deal with the stressors in your career, it’s your fault and you’re just not made for the business. You are responsible for coping, you’re responsible for getting along, and if you don’t, you’re out. Some musicians are very dependent on being in this business and earning money – so you kind of have to stay in the business… a lot of people do not have a plan B.”

Are things getting better? Yes, slowly, she says: “There are management and booking agencies and artists I work with – I can say that I get a lot of requests for my work. So this is a good sign – people are trying to find help.”

Listen to the whole episode in the embedded player, or wherever you listen to podcasts via this link .

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