全球CRO龙头谈市场“冰火两重天” 精鼎医药中国区负责人郑唯玲：如何穿越充满挑战的2025年

Group 1 - The U.S. FDA has announced multiple reforms, including accelerated approvals and the integration of AI, amidst a cooling global biopharmaceutical investment environment, leading to a slowdown in decision-making among pharmaceutical companies and a temporary downturn in the global CRO industry [5][9] - In contrast, the Asia-Pacific market, particularly China, is experiencing growth, with a reported nearly 6% year-on-year decline in revenue for 13 listed CRO companies in China, while net profit surged by 105% [5][6] - The global CRO market is projected to exceed $80 billion by 2024, benefiting from the increasing number of innovative drugs [6][7] Group 2 - The demand for CRO services is expected to grow in key research areas such as cell and gene therapy, metabolic diseases, and rare diseases, driven by unmet clinical needs and regulatory changes [8][9] - The FDA's recent reforms, including the gradual elimination of animal testing and the introduction of AI in drug evaluation, are expected to impact the CRO industry significantly [12][11] - The clinical trial landscape in the Asia-Pacific region has seen a rapid increase, with the proportion of global clinical trials conducted in this region rising from 44% in 2019 to 55% by the end of 2023 [15][16] Group 3 - The CRO industry faces challenges in 2025 due to increased complexity in experimental design and stricter regulatory requirements, particularly in cell and gene therapy [9][11] - The need for innovative trial designs and remote smart clinical trial models is becoming essential, especially for rare diseases and chronic conditions like obesity and type 2 diabetes [11][9] - The demand for end-to-end services from CROs is rising, as biotech companies prioritize efficiency and integrated solutions [17][19] Group 4 - The Asia-Pacific market is becoming a focal point for global pharmaceutical companies, with China emerging as a significant growth engine for innovative drug development [14][15] - The trend of mixed outsourcing models is gaining traction, allowing companies to tailor their outsourcing strategies based on specific project needs [19][18] - The collaboration between CROs and AI companies is expected to enhance clinical data capabilities and address the evolving demands of the industry [18][17]