• Clinical development productivity rose in 2023, primarily due to an improvement in the composite success rate, a function of phases successfully completed in the year, which rose to 10.8%. This was the highest level since 2018.
• Industry and regulator adoption of innovative and technology-driven enablers contributed to productivity gains. These enablers included the use of predictive biomarkers, novel trial design, and digital and decentralized trial methodologies.
• A total of 69 novel active substances (NASs) were launched globally in 2023 – 6 more than the prior year – including 24 first-in-class launches in the U.S.
• Clinical development programs among larger biopharma companies are moving toward newer modalities, including cell and gene therapy, antibody drug conjugates, and radioligand therapies. This is coupled with an increased focus on neurology, infectious diseases, metabolic diseases (including obesity), and rare diseases.
• R&D funding levels and deal activity recovered in 2023 following a steep decline in 2022 from peak levels in 2020-21.

RESEARCH TRIANGLE PARK, N.C. / Feb 23, 2024 / Business Wire / Global biopharma R&D productivity rebounded in 2023 with higher composite success rates enabled by industry-wide and regulator adoption of data and technology driven innovation, including novel trial design, optimized biomarker use, and digital and decentralized trial methodologies. This rebound occurred while clinical trial starts and funding returned to pre-pandemic levels, according to the new report, “Global Trends in R&D 2024: Activity, Productivity, and Enablers,” released by the IQVIA Institute for Human Data Science.

“The improvement in clinical productivity and composite success was notable across all therapy areas, particularly in Phases I and III and in regulatory review,” said Murray Aitken, executive director of the IQVIA Institute for Human Data Science. “This reflects industry-wide ingenuity and regulatory acceptance of innovative data and technology-driven enablers in trial design and digital trial execution. Clinical trial starts have returned to pre-pandemic levels, signaling a recognizable shift in pipelines and clinical development programs to a focus on innovative modalities in oncology, immunology, neurology and metabolic diseases.”

A few key highlights of the report include:

• Clinical development productivity: Industry-wide clinical development productivity rose primarily through better success rates, which surged from historic lows to the highest levels since 2018. Efforts to manage trial complexity and duration have had more mixed results. Clinical development productivity reached a value of 17.4 in 2023 on the Clinical Development Productivity Index, which provides a composite metric that combines success rates, clinical trial complexity and trial duration on an annual basis. This is compared to the 2010 base level of 20 and shows a continued rebound from a low of 12.8 in 2020, with the majority of this growth driven by an increase in success rates.

• Productivity enablers: Regulatory agencies are generally attempting to make changes which the industry finds positive, including greater simplication, transparency and speed, but the pace of change differs across geographies. Large pharmaceutical companies have shifted country utilization over the last decade by reprioritizing and rationalizing country selection for trials. Innovative program approaches, including use of biomarkers and compressed trial strategies, yield significant time savings and greater productivity. Novel trial designs were used in 18% of trials in 2021-2023, led by oncology where more than 29% of trials use a novel design. Decentralized methodologies peaked but remain a stable feature of trial activity, albeit at a lower level than 2020, which was driven by COVID-19.

• New drug approvals and launches: A total of 69 novel active substances (NASs) were launched globally in 2023 – six more than the prior year – and representing a return to pre-COVID-19 levels. A total of 362 NASs have launched globally in the past five years, including 113 NASs launched in the U.S. but not launched in Europe as of the end of 2023. While the number of NAS launches in China is rising, an increasing number are not available in other countries, reflecting both a rising domestic industry and a mix of reduced barriers and rising incentives for multinational NAS launches.

• Clinical trial activity: Clinical trial starts declined 15% in 2023 from 2022, a third of which was driven by a reduction in COVID-19 trials. This decline also reflected a shift in clinical development programs among large biopharma companies away from immuno-oncology to a focus on hot spots, including cell and gene therapies, antibody-drug conjugates (ADCs), multi-specific antibodies and obesity treatments. Emerging biopharma companies started 416 fewer non-COVID-19 trials in 2023 than at the peak in 2021, while larger companies started 524 fewer. The top four diseases in trial starts – oncology, metabolic/endocrinology, immunology, and neurology – accounted for 79% of those trial starts and declined less than other diseases. There was a notable increase of 68% in obesity clinical trials in 2023 from 2022, nearly double the number from five years ago. This included 124 drugs in active development, of which 46% have oral formulations in development and 40% are GIP/GLP glucagon receptor agonists.

• R&D funding: In 2023, global funding of biopharmaceutical research and development increased to $72Bn, up from $61Bn in 2022. In the same period, M&A activity jumped to $140Bn from $78Bn in 2022, while the median deal value fell for the second year in a row. The leading deals in 2023 included 11 that were over $5Bn and were focused on cancer, neurology and cardiovascular diseases. The largest focus area of deals was antibody-drug conjugates (ADCs), which had six totaling $90Bn.

About the IQVIA Institute for Human Data Science

The IQVIA Institute for Human Data Science contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data.

Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved human outcomes. With access to IQVIA’s institutional knowledge, advanced analytics, technology and unparalleled data, the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science, including government agencies, academic institutions, the life sciences industry, and payers. More information about the IQVIA Institute can be found at www.IQVIAInstitute.org.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 87,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors, and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.