【艾昆纬】英文生物制药创新领域重拾发展动力_96页_3mb
报告摘要
Summary of Global Trends in R&D 2025
Core Content
This report provides an overview of the global trends in biopharmaceutical R&D in 2024, focusing on funding, clinical trial activity, new drug approvals, and the factors influencing clinical development productivity. It highlights the resilience of the R&D sector despite various uncertainties and the increasing role of emerging biopharma companies (EBPs) and novel therapeutic modalities.
Main Points
R&D Funding
- Global R&D funding reached a 10-year high of $102Bn in 2024, up from $71Bn in 2023.
- The five-year total funding from 2020 to 2024 was $486Bn, a sharp contrast to the $282Bn from 2015 to 2019.
- Follow-on funding was the largest contributor, accounting for $46Bn in 2024 or 45% of total biopharma funding.
- IPO values remained low, with $7Bn in 2024 compared to $4Bn in 2023.
- Private and public financing stayed above pre-pandemic levels, at $24Bn and $25Bn, respectively.
R&D Deals
- The total number of R&D deals between pharmaceutical companies dropped by 5% in 2024 compared to 2023.
- EBPs were involved in over half of the 1,016 deals, with the majority involving EBP and large companies.
- Large companies were involved in only 41% of deals in 2024, down from 45% in 2019.
- M&A deal values increased significantly, with the median deal value rising to $405Mn from $153Mn in 2023.
- Deals in the $1Bn–$5Bn range doubled in number and value, contributing $51Bn to total M&A deal value in 2024.
- Oncology accounted for 9 of the 27 deals above $2Bn, while obesity was the focus of the largest deal at $16.5Bn.
Clinical Trial Activity
- Total clinical trial starts in 2024 reached 5,318, similar to the pre-pandemic level in 2019.
- EBPs accounted for 63% of trial starts in 2024, up from 56% in 2019.
- U.S.-headquartered companies led trial starts with a 35% share, while China-headquartered companies accounted for 30%.
- Single-country trials were common, especially for EBPs, with 85% of EBP trials and 63% of larger company trials conducted in one country.
- Oncology continued to be the most active therapeutic area, with median enrollment times exceeding 25 months.
New Drug Approvals and Launches
- 65 novel active substances (NAS) were launched globally in 2024, a decline from 80 in 2023, but still higher than pre-pandemic levels.
- The composite success rate from Phase I to approval increased to 7% in 2024, up from 6% in 2023, driven by improved Phase III success.
- Small molecule success rates were particularly low, at 6% in 2020–2024, while cell and gene therapies saw an increase from 4% to 5%.
- China's median launch lag decreased to 3.7 years, with China-only NAS launches increasing from 9 in 2015–2019 to 76 in 2020–2024.
- The U.S. was the most common first-launch country, with 110 NAS not yet available in Europe, compared to 14 in the reverse direction.
Clinical Development Productivity
- The Clinical Program Productivity Index (CPPI) increased in 2024, driven by higher Phase III success rates.
- Trial complexity remained largely stable, though enrollment duration increased between 2021 and 2023, peaking at 16 months in 2023 before stabilizing in 2024.
- Inter-trial intervals contributed 17 months to the overall development time in 2024, down from 32 months in 2022.
- Western Europe's share of global trial-country utilization fell by 12%, while China's share increased by 66% to 4th place.
Key Information
Productivity Enablers
- Artificial Intelligence (AI) is increasingly used in R&D, with companies focusing on drug discovery and target identification.
- AI/ML deals in 2024 totaled $10Bn, with five deals exceeding $1Bn led by Isomorphic Labs.
- Novel trial designs such as umbrella, basket, master, and adaptive protocols accounted for 19% of trials in 2024.
- Real-world data played a key role in FDA approvals, with five approvals in 2024 based on such evidence.
- Regulatory submission quality improved, as Complete Response Letters decreased and clinical reasons for rejections became less common.
Modalities and Therapeutic Areas
- Oncology remains the most prominent therapeutic area, with 35% of trial starts involving novel mechanisms such as antibody-drug conjugates, cell and gene therapies, and multi-specific antibodies.
- RNA therapies and radiopharmaceuticals have seen a more than doubling in deal activity over the past five years.
- mRNA-based vaccines gained interest post-pandemic due to their development speed and efficiency.
Geographical Trends
- China has become a major player in clinical trials and R&D, with 71 of 73 international M&A or licensing deals in 2024 involving outward deals.
- U.S. and European companies remain the primary acquirers of China-based R&D assets.
- North America retained second place in global trial-country utilization, with a 7% increase in 2024.
Conclusion
The biopharma sector in 2024 showed resilience and growth despite challenges. While R&D funding and clinical trial activity stabilized, new drug approvals slightly declined but remained above pre-pandemic levels. EBPs played a central role in innovation and deal activity, with AI/ML and novel modalities emerging as key enablers of productivity. China's increasing influence in global R&D and its role as a major source of innovation and R&D assets is a notable trend. The shift towards more efficient clinical development and use of advanced analytics is expected to continue shaping the future of biopharma innovation.
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