艾昆纬-2023年全球研发趋势（英）-2023-74页_2mb

Global Trends in R&D 2023: Key Summary

• Introduction and Overview: The biopharmaceutical industry resumed pre-pandemic R&D investment, pipeline activity, and drug launches after record-breaking levels during the COVID-19 pandemic. Process innovations from the pandemic are being integrated, enabling ongoing productivity gains. The report analyzes trends in drug approvals, pipeline development, clinical trials, and productivity, highlighting shifts in therapeutic focus and geographical investments.

• R&D Funding: Global funding for biopharma increased, with U.S. investments dropping 39% from 2021 but remaining 25% above 2019 levels. Deal activity shifted towards Chinese and Korean companies, and emerging biopharma firms originated and launched more drugs. Large pharma collectively spent $138B on R&D, the highest ever, with a slight decrease in R&D as a percentage of revenue.

• R&D Pipeline: The pipeline remained flat in 2022, with a continued focus on oncology (38% of products) and rare diseases. First-in-class therapies and next-generation biotherapeutics (e.g., gene editing, CAR T-cell treatments) are increasing, with more international companies contributing. Emerging biopharma now drives two-thirds of pipeline molecules.

• Clinical Trial Activity: Clinical trial resilience was evident despite pandemic disruptions, with non-COVID-19 starts decreasing slightly but returning to pre-pandemic growth. Oncology had the most trial activity, and mRNA vaccine trials expanded beyond COVID-19. Diversity in patient representation declined, particularly for Black/African American and Hispanic participants.

• New Drug Approvals and Launches: The number of novel active substances (NASs) launched globally fell to 64 in 2022, below pandemic peaks but back to pre-pandemic levels. First-in-class and specialty drugs rose, with emerging biopharma increasingly independent in product development and market entry.

• Clinical Development Productivity: Productivity improved in 2022 due to reduced trial complexity, with composite success rates at 6.3%. Phase II and III success rates rose, but trial durations increased modestly. New enablers like expedited review pathways and AI/ML are accelerating drug development.

• Productivity Enablers: Innovations include first-in-class therapies, novel trial designs (e.g., basket/master protocols), and decentralized trials, shown to reduce timeline waste despite higher complexity. Regulatory changes and AI/ML are enhancing efficiency and targeting high-need areas like oncology and rare diseases.