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Institute Report
Global Trends in R&D 2023
Activity, Productivity, and Enablers
Feb 15, 2023
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Report Summary

As the global healthcare system re-equilibrates post-pandemic, the biopharmaceutical industry has resumed pre-COVID-19 levels of investment, pipeline activity, and launch of novel medicines following record breaking levels of each in 2020 and 2021. Process and technology innovations that were accelerated by extreme circumstances during the pandemic are being integrated across the global pipeline and implemented as operational and organizational changes that are enabling ongoing productivity gains.

This report 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. This set of analyses reveals important shifts in therapeutic and geographic investments and ongoing prioritization of novel mechanisms of action, innovative development methods and accelerated regulatory pathways to optimize new therapy development and delivery to patients. This work also examines changes in the Productivity Index driven by shifting pipeline complexity and probability of success.

Key findings:

  • The past year saw a restoration of pre-pandemic investment flows to life sciences companies in the U.S. after two years of heightened levels during the pandemic.
  • The research and development pipeline remained flat in 2022 with ongoing oncology focus and continued share gain in rare, next-generation, Chinese and EBP segments of the pipeline.
  • Clinical trial activity was remarkably resilient even as the pandemic stretched through 2022, with a 1% decline in non-COVID trial activity over 2021, but a restoration of pre-pandemic growth rates with an 8% increase over 2019.
  • A growing share of new launches in 2022 were first-in-class, reflecting the increasing availability of novel science for patients.
  • Clinical development productivity — a composite metric of success rates, clinical trial complexity and trial duration — rebounded in 2022, reversing a 10-year downward trend. Trial complexity returned to the previous trend after an outlier high in 2021, while overall success rates improved slightly.
  • As technology and data advances take hold across the pharmaceutical development pipeline, productivity is being impacted by a range of trade-off effects on complexity, timing, and probability of success.

Other findings:

  • Venture capital deal activity and investment flows in the U.S. accelerated in the past three years as interest in life sciences intensified, with more than 2,000 deals and $42Bn of deal value occurring in 2022, down from the level in 2021 but still far above pre-pandemic levels.
  • Life sciences venture capital deals continue to grow, with an uptick in investment in later-stage deals which typically draw more dollars and show a 10% CAGR increase since 2017 compared to only 5% CAGR for the five years through 2019.
  • The total number of deals peaked at 2,588 in 2021 — 21% higher than 2020 — but dropped 22% in 2022 to 2,009 deals, only slightly above the 1,994 in 2019.
  • The research and development pipeline remained flat in 2022, with 6,147 products in active development from Phase I to regulatory submission, growing 2% over the last two years and 49% since 2017.
  • This slowing growth since the pandemic began is likely due to delays in development activity as COVID-19 and new variants have caused a series of disruptions to society since 2020.
  • Oncology remains the focus of the pipeline, comprising 38% or 2,331 products and growing at 10.5% CAGR over the last five years.
  • Despite increasing sponsor focus on diversity in clinical trials and diversity data reporting, and recent FDA guidance on diversity data reporting and clinical program diversity planning, Black/African American and Hispanic patient inclusion failed to reach U.S. demographic levels on average across interventional trials, including U.S. sites in the past decade.
  • Black/African American participation has been declining over the past decade, with an inclusiveness drop most notable in the past five years, with a 46% decline in U.S. Census indexed inclusion between 2018 and 2022 — from 81% of US demographics to 43%.
  • Hispanic inclusiveness has varied over the past decade and does not show as distinct a decline as Black/African American inclusion, but also never reached U.S. demographic levels in the past decade. Hispanic patients were enrolled in trials at 53% of U.S. demographic levels in 2022.
  • A total 64 novel active substances (NASs) launched globally in 2022, a decline from the more than 80 launched in each of the prior two years but representing a return to pre-COVID-19 levels.
  • Oncology, neurology, and immunology have had rising shares of new launches in the past five years, with 173 of the 353 launches (49%) compared to 95 of 232 (41%) from 2013 to 2017.
  • Infectious diseases, including COVID-19 as well as anti-bacterial, anti-viral, anti-fungal and anti-parasitic treatments, have included novel treatments for HIV, Ebola, and more recently monkeypox, and are 16% of NAS launches over the last decade, with some year-to-year variability.
  • Clinical development productivity — a composite metric of success rates, clinical trial complexity, and trial duration — rebounded in 2022, reversing a 10-year downward trend. Trial complexity returned to the previous trend after an outlier high in 2021, while overall success rates improved slightly.
  • Trial success rates were consistent with the baseline, indexing up slightly from 2021 but well below the highs of the past 10 years.
  • Trial complexity dropped sharply in 2022 after unusually high levels in 2021, which were driven by larger numbers of study subjects. All other components of the complexity indices declined slightly in 2022.

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