2023-05-17-艾昆纬-2023年全球研发趋势（英）_74页_1mb

Summary of Global Trends in R&D 2023

Core Content

This report outlines the trends in global R&D activity in 2022, highlighting the post-pandemic recovery in the biopharmaceutical industry. It covers R&D funding, pipeline activity, clinical trial trends, drug approvals and launches, clinical development productivity, and the enablers driving these changes.

Main Points

R&D Funding

• U.S. Biopharma Investment: R&D investment in U.S. life sciences companies returned to pre-pandemic levels in 2022, with $42.1 billion invested, a 39% decline from 2021 but 25% above 2019.
• Large Pharma R&D Spending: The 15 largest pharmaceutical companies invested a record $138 billion in R&D in 2022, up 43% since 2017 and representing 18.8% of their sales.
• Geographic Shifts: Over the past five years, deal activity has shifted towards companies in China and South Korea, with fewer European-based companies. U.S. companies remain the largest contributors.
• Emerging Biopharma (EBP): EBPs accounted for 67% of new drug launches in 2022 and 69% of those launched by them, indicating growing independence in drug development and commercialization.
• Venture Capital Trends: U.S. venture capital deal activity and investment flows remained high in 2022, with a total deal value of $42.1 billion, though the number of deals dropped from 2021. Angel and seed deals declined sharply.

R&D Pipeline

• Pipeline Size: The global R&D pipeline remained flat in 2022 with 6,147 products in active development, growing at 2% over the last two years and 8.3% CAGR from 2017-2022.
• Therapeutic Focus: Oncology remains the largest segment of the pipeline, with 38% of products (2,331), and a 10.5% CAGR over the last five years.
• Rare Diseases: Over 1,800 molecules target rare disorders, with 40% of these in oncology. Next-generation biotherapeutics account for at least a quarter of rare-oncology products.
• Geographic Distribution: China-headquartered companies now account for 15% of the pipeline, up from 4% a decade ago, while Europe and Japan's shares have fallen to 23% and 6%, respectively.
• EBP Contribution: EBPs are responsible for two-thirds of the molecules in the R&D pipeline, up from 51% in 2017.

Clinical Trial Activity

• Resilience Amid Pandemic: Clinical trial activity remained resilient in 2022, with a 1% decline in non-COVID-19 trial starts compared to 2021, but an 8% increase over 2019.
• Oncology Dominance: Oncology accounted for 40% of all trial starts in 2022, with non-rare oncology representing 44% of all oncology trials, the highest in the past decade.
• Trial Design Trends: Single-arm and open-label trial designs have become more common, especially in approvals for new drugs, used in 43% of launches over the past five years.
• Patient Diversity: Black/African American and Hispanic patient representation in clinical trials has declined over the past decade, with Black/African American inclusion dropping 42% in the last two years.

New Drug Approvals and Launches

• Global Launches: 64 novel active substances (NAS) were launched globally in 2022, a return to pre-pandemic levels after a sharp decline from the over 80 launches in 2020 and 2021.
• First-in-Class Drugs: A growing share of new launches in 2022 were first-in-class, reflecting increased scientific innovation.
• Specialty Medicines: The number of specialty medicine launches continued to grow.
• Expedited Reviews: Most new drugs in 2022 received expedited reviews, with priority and breakthrough designations increasing.

Clinical Development Productivity

• Productivity Index: The Clinical Development Productivity Index showed an increase in 2022, driven by a reduction in trial complexity.
• Success Rates: The composite success rate across all therapy areas fell to 6.3% in 2022, while phase II and III success rates rose by 2–6%.
• Trial Durations: Trial durations have increased slightly over the past decade, but oncology and rare disease trials have been declining in recent years.

Productivity Enablers

• Technology and Data Innovations: These innovations are driving productivity gains, with a focus on reducing complexity, improving timing, and increasing success probabilities.
• Novel Trial Designs: Virtual and decentralized trials are becoming more prevalent, contributing to more complex execution but expected to reduce clinical program duration.
• AI/ML: The use of AI and machine learning is showing increasing potential for impact on clinical development productivity.
• Expedited Reviews: Priority and breakthrough designations are associated with lower trial complexity and faster development timelines.

Key Information

• Global R&D Activity: The industry has largely returned to pre-pandemic levels of investment, pipeline activity, and drug launches.
• Therapeutic Focus: Oncology remains the primary focus of R&D, with a growing emphasis on solid tumors and next-generation biotherapeutics.
• Geographic Shifts: Deal activity has shifted from Europe and Japan to China and South Korea, with U.S. companies still leading in terms of deal volume.
• EBP Growth: Emerging biopharma companies have become more independent and are increasingly responsible for drug development and commercialization.
• Clinical Trial Trends: Trial designs are evolving, with more use of single-arm and open-label trials, and a continued focus on oncology and neurology, especially in mental health.
• Patient Representation: Diversity in clinical trial participants has declined, particularly among Black/African American and Hispanic populations.
• Productivity Drivers: Reduced trial complexity, increased use of virtual trials, and regulatory expedited pathways are contributing to improved productivity in clinical development.

Conclusion

The biopharmaceutical industry is showing signs of recovery and adaptation post-pandemic, with a renewed focus on innovation, efficiency, and patient-centric development. While oncology and neurology remain central to R&D efforts, there is a notable shift towards more accessible and diverse therapeutic areas. The role of emerging biopharma companies is growing, and the integration of new technologies is helping to streamline and accelerate the drug development process.