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

Core Insights - The global CRO industry is experiencing a temporary downturn due to various factors, including the introduction of the U.S. Biodefense Act and a cooling investment climate in the biopharmaceutical market, while the Asia-Pacific market, particularly China, shows promising growth [1][5][10] - The demand for CRO services is expected to rise significantly due to the increasing number of innovative drugs being developed globally, with the CRO market projected to exceed $80 billion by 2024 [2][3] - The Chinese biotech sector is becoming a major player in the global market, with a notable increase in license-out transactions and a diverse range of funding sources for R&D [8][9] Industry Trends - The CRO industry is closely linked to the innovative drug sector, with a significant increase in the number of first-in-class (FIC) drugs approved globally, which benefits CROs [3][4] - Key areas of growth for CRO services include cell and gene therapy, metabolic diseases, and rare diseases, driven by unmet clinical needs and regulatory changes [4][5] - The regulatory landscape is becoming more complex, requiring CROs to adapt their strategies to meet stricter requirements and enhance patient engagement in clinical trials [5][6] Market Dynamics - The Asia-Pacific region is emerging as a key market for clinical trials, with a significant increase in trial numbers and a favorable regulatory environment in China [9][10] - The shift towards mixed outsourcing models is gaining traction, allowing companies to tailor their outsourcing strategies based on specific project needs [12][13] - The integration of AI and data analytics in CRO operations is becoming essential for improving efficiency and meeting the evolving demands of biotech companies [11][12] Strategic Developments - Companies are investing in regulatory consulting and AI capabilities to navigate the changing landscape and enhance their service offerings [7][11] - The hiring of experienced FDA professionals by CROs indicates a strategic move to strengthen their regulatory expertise and improve clinical development processes [6][7] - The focus on end-to-end service solutions is becoming increasingly important as biotech firms seek comprehensive support throughout the drug development lifecycle [11][12]