2025年创新前行全球共进：中国临床试验发展的新篇章研究报告（英文版）

© 2025 L.E.K. Consulting1These materials are intended to supplement a discussion with L.E.K. Consulting. These perspectives will, therefore, only be meaningful to those in attendance. The contents of the materials are confidential and subject to obligations of non-disclosure. Your attention is drawn to the full disclaimer contained in this document.Advancing Innovation and Global Reach: The Next Chapter in China’s Clinical Trial Development PharmaDJ x L.E.K. Clinical Development ReportNovember 2025© 2025 L.E.K. Consulting2Foreword: This report summarizes the key strategic trends of clinical development in China, and can be referenced by pharmaceutical companies and CROs to support their R&D/service strategies• Over the past decade, China’s clinical development landscape has undergone a remarkable transformation. The market has expanded rapidly, fueled by favorable policy reforms and sustained R&D investment from pharmas. This evolution has laid a strong foundation for the next phase of growth, one characterized by deeper innovation, greater global integration of Chinese biopharmas/biotechs and the increasing adoption of smarter tools such as artificial intelligence (AI). As the industry continues to mature, China is poised to emerge as a leading hub globally for innovation-driven clinical development.• This report, produced in collaboration with PharmaDJ, provides a comprehensive overview of the strategic trends shaping China’s clinical trial ecosystem today. It highlights not only the progress made in innovation, globalization and AI/smarter clinical trial tools, but also the opportunities facing both multinational and Chinese companies.• Supported by a comprehensive survey of pharmaceutical companies and contract research organizations (CROs), this report serves as a starting point for multinational corporation (MNC) pharmas, Chinese biopharmas and biotechs, and CROs to reassess how they can better prepare for the future of drug R&D, by driving greater innovation, efficiency and global collaboration.© 2025 L.E.K. Consulting3Executive summary: Three strategic trends are shaping the future of China’s clinical trial landscapeChina has established a strong foundation for clinical trial growth, underpinned by its large patient base, favorable policies and sustained R&D investment from pharmas. Trial volume in China has risen rapidly from roughly one-third of the U.S. and one-half of the European levels in 2019 to approximately 0.8× and 1.1× respectively by 2024, positioning China as a major global player in clinical development. As the sector enters its next phase of growth, three strategic trends are expected to shape the future of China’s clinical trial landscape:• Development of more innovative and differentiated therapies: Chinese biopharmas and biotechs are increasing investment in first-in-class and best-in-class assets, next-generation modalities, and new technology platforms, gaining stronger global recognition. The surge in Phase II an