USA—IQVIA’s latest report on the biopharmaceutical industry shows that it has rebounded from the COVID-19 pandemic and is returning to pre-pandemic levels of investment, pipeline activity, and launch of novel medicines.
The pandemic has accelerated process and technology innovations, which are now being integrated across the global pipeline, enabling ongoing productivity gains.
Despite the ongoing pandemic, clinical trial activity has remained resilient, with a restoration of pre-pandemic growth rates in 2022 after experiencing two years of heightened investment during the pandemic.
The report also examines changes in the Productivity Index driven by shifting pipeline complexity and probability of success. This suggests that the industry is evolving and adapting to new challenges and opportunities.
The research and development pipeline has remained flat in 2022, with a continued focus on oncology and share gain in rare, next-generation, Chinese, and evidence-based practices (EBP) segments.
The report also reveals that there has been an increase in the number of first-in-class launches in 2022, indicating the availability of novel science for patients.
For instance, in 2022, a total of 64 novel active substances (NASs) were launched globally, representing a decline from the more than 80 launched in each of the prior two years but returning to pre-COVID-19 levels.
According to the IQVIA report, the research and development pipeline remained flat in 2022 with 6,147 products in active development from Phase I to regulatory submission.
This represents a growth of 2% over the last two years and 49% since 2017. The slowing growth since the pandemic began is attributed to delays in development activity caused by disruptions from COVID-19 and new variants since 2020.
Oncology remains the primary focus of the pipeline, comprising 38% or 2,331 products, and growing at 10.5% CAGR over the last five years.
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.
Clinical development productivity, which is a composite metric of success rates, clinical trial complexity, and trial duration, rebounded in 2022, reversing a 10-year downward trend.
While trial complexity returned to the previous trend after an outlier high in 2021, overall success rates improved slightly.
Life sciences attracts increased venture capital investment
The life sciences industry has seen a surge in venture capital investment and deal activity in recent years, driven by growing interest in innovative technologies and breakthrough therapies, according to the report.
Despite a slight dip in deal value from 2021, 2022 still saw over US$42 billion invested in more than 2,000 life sciences deals, well above pre-pandemic levels.
Investment in later-stage deals has been particularly strong, with a 10% compound annual growth rate (CAGR) increase since 2017.
This trend suggests that investors are increasingly interested in mature companies with proven technologies and a clear path to commercialization, rather than early-stage startups with higher risk profiles.
While the total number of deals peaked in 2021 at 2,588, a 21% increase over the previous year, the number of deals declined by 22% in 2022 to 2,009 deals.
However, this is still slightly above the 1,994 deals seen in 2019. The decline in deal activity could be due to a variety of factors, including market saturation, increasing competition for deals, and ongoing uncertainty caused by the pandemic.
The life sciences industry continues to attract significant interest from venture capitalists due to its potential for high returns and significant impact on global health.
Breakthrough therapies and technologies, such as gene editing and precision medicine, are driving innovation and creating new opportunities for investment.
As the industry evolves and adapts to new challenges and opportunities, it is likely that venture capital investment in life sciences will continue to grow.
Insufficient diversity in clinical trials despite sponsor focus
Despite increasing sponsor focus on diversity in clinical trials and diversity data reporting, 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 inclusiveness drop most notable in the past five years.
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.
Despite the ongoing pandemic, clinical trial activity has remained remarkably resilient. While non-COVID trial activity declined by 1% over 2021, it has seen a restoration of pre-pandemic growth rates with an 8% increase over 2019.
Trial complexity dropped sharply in 2022 after unusually high levels in 2021, which were driven by larger numbers of study subjects.
The report also suggests that the biopharmaceutical industry is recovering from the pandemic and is continuing to innovate and evolve.
Companies are prioritizing novel therapies and using innovative development methods to optimize new therapy development and delivery to patients.
Finally, the report highlights that 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.
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