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Summary of Global Trends in R&D 2025

Core Content

This report outlines key trends in the global biopharma R&D landscape for 2024, focusing on funding, clinical trial activity, drug approvals, and productivity improvements. It highlights the resilience of the sector despite various challenges, including geopolitical and economic uncertainties, and explores the role of emerging biopharma companies (EBPs), technological advancements, and regulatory changes in shaping the industry's trajectory.

Main Points

• R&D Funding:

  • Biopharma funding reached a 10-year high of $102Bn in 2024, up from $71Bn in 2023, with a five-year total of $486Bn, significantly higher than the previous five years.
  • Follow-on funding was the largest contributor, reaching $46Bn in 2024, up from $26Bn in 2023.
  • The median value of M&A deals doubled from $153Mn to $405Mn, with 26 deals in the $1Bn to $5Bn range.
  • The U.S. and Europe remained the primary regions for M&A and licensing deals with Chinese companies, with most deals involving out-licensing or acquisition of Chinese R&D assets.

• Clinical Trial Activity:

  • The total number of clinical trial starts stabilized in 2024 at 5,318, matching the pre-pandemic level of 2019.
  • EBP companies accounted for 63% of trial starts in 2024, up from 56% in 2019, while large pharmaceutical companies contributed only 26%.
  • U.S.-headquartered companies led trial starts, with a 35% share in 2024.
  • Oncology remained the most active therapeutic area, with a significant increase in trial starts and enrollment times, particularly in Phase III.

• New Drug Approvals and Launches:

  • 65 novel active substances (NAS) were launched globally in 2024, a decline from 80 in 2023 but still above pre-pandemic levels.
  • Notable launches included the first new mechanism for schizophrenia, the first MASH therapy, and seven non-oncology hematology drugs, including two gene therapies.
  • The U.S. was the leading country for new launches, but European countries had fewer unavailability issues for new drugs compared to the U.S.

• Clinical Development Productivity:

  • The Clinical Program Productivity Index (CPPI) showed an increase in 2024, driven by higher Phase III success rates.
  • The composite success rate from Phase I to approval rose to 7%, up from 6% in 2023.
  • Small molecule success rates were particularly low, while cell and gene therapies showed improvement.

• Productivity Enablers:

  • AI and machine learning are increasingly used in drug discovery and trial design, with over $10Bn in AI/ML deals in 2024.
  • Novel trial designs such as umbrella, basket, and adaptive protocols accounted for 19% of trials in 2024.
  • Real-world data and evidence generation have improved regulatory submissions, contributing to FDA approvals.

• Geographical Trends:

  • China's share of trial starts increased by 66% between 2019 and 2024, becoming the fourth-largest region.
  • Over 80% of China-based trials were conducted within the country, with a high proportion of single-country trials.
  • Western Europe's share of trial-country utilization dropped by 12%, while North America increased by 7%.

Key Information

• Funding Growth:

  • Total R&D funding for large pharmaceutical companies reached $190Bn in 2024, up from $163Bn in 2023.
  • R&D expenditure as a percentage of sales exceeded 25% for the first time in 2024.

• Deal Activity:

  • The number of R&D deals between pharmaceutical companies fell by 5% in 2024, with a decline in EBP deals.
  • The largest M&A deal of 2024 was the $16.5Bn acquisition of Catalent by Novo Holdings, focused on GLP-1 capacity.

• Therapeutic Focus:

  • Oncology and obesity were major drivers of R&D and clinical trial activity.
  • Novel modalities such as cell and gene therapies, antibody-drug conjugates, and multi-specific antibodies gained prominence.

• Technology and Innovation:

  • AI/ML and other advanced analytics are being increasingly adopted to improve R&D efficiency.
  • RNA-based therapies and radiopharmaceuticals have seen a significant rise in deal activity over the past five years.

• Regulatory and Market Dynamics:

  • The use of real-world data contributed to five FDA approvals in 2024.
  • China's median launch lag decreased to 3.7 years, while the number of China-only NAS launches increased dramatically.

Conclusion

The biopharma industry in 2024 demonstrated resilience and innovation, with increased funding, a return to pre-pandemic clinical trial levels, and notable advancements in novel therapies and technologies. While challenges remain in terms of R&D efficiency and regulatory complexity, the industry is actively adopting new strategies and tools to accelerate drug development and improve success rates. Emerging biopharma companies continue to play a pivotal role in driving innovation and clinical trial activity, with increasing collaboration and investment from larger firms.