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     157  0 Kommentare Global Biopharma R&D Boasts Increased Funding, Productivity and Product Launches in 2023, says IQVIA Institute Report

    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

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    Global Biopharma R&D Boasts Increased Funding, Productivity and Product Launches in 2023, says IQVIA Institute Report 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 …