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

November 2025 1These 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. Foreword: This report summarizes the key strategic trends of clinical development in China, and canbe 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 markethas expanded rapidly, fueled by favorable policy reforms and sustained R&D investment frompharmas. This evolution haslaid a strong foundation for the next phase of growth, one characterized by deeper innovation, greater global integration ofChinesebiopharmas/biotechsand the increasing adoption of smarter tools such as artificial intelligence (AI). As the industrycontinues to mature, China is poised to emerge as a leading hub globally for innovation-driven clinical development. •This report, produced in collaboration withPharmaDJ, provides a comprehensive overview of the strategic trends shapingChina’s clinical trial ecosystem today. It highlights not only the progress made in innovation, globalization and AI/smarterclinical 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), thisreport serves as a starting point for multinational corporation (MNC)pharmas, Chinesebiopharmasandbiotechs, andCROs to reassess how they can better prepare for the future of drug R&D, by driving greater innovation, efficiency andglobal collaboration. Executive summary: Three strategic trends are shaping the future of China’s clinical trial landscape China has established a strong foundation for clinical trial growth, underpinned by its large patient base, favorable policies and sustained R&Dinvestment frompharmas. Trial volume in China has risen rapidly from roughly one-third of the U.S. and one-half of the European levels in 2019to approximately 0.8×and 1.1×respectively by 2024, positioning China as a major global player in clinical development. As the sector entersits 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:Chinesebiopharmasandbiotechsare increasing investment in first-in-class and best-in-class assets, next-generation modalities, and new technology platforms, gaining stronger global recognition. The surge inPhase II and III trials highlights China’s growing capability to advance innovations from early to late stages, creating risingopportunities forclinical development industry participants. While homogeneous competition persists, companies are driving differentiation through earlycombination planning, indication expansion and strategic asset prioritization. •Continued globalization of Chinese innovation:Globalization remains a strategic imperative for Chinesebiopharmas/biotechs,with risingChina-to-global trials and licensing deals reaching record highs. This creates expanding opportunities for MNCpharmasto accessdifferentiated, early-stage Chinese assets that enhance global portfolios, and for CROs equipped with global-standard quality systems,regulatory expertise and multiregional execution capabilities to play a pivotal role in supporting cross-border clinical development. •Adoption ofAI and smarter clinical trial tools: AI is emerging as a transformative enabler across the drug R&D life cycle. Within clinicaldevelopment, industry participants show growing interest in adopting AI, with the highest near-term potential in data analysis andmanagement.Pharmasand CROs need to proactively integrate AI into their clinical development capabilities to enhance efficiency andimprove trial quality. Agenda •Context of clinical trial development in China•Future strategic trends of clinical trial development in China•Next step questions•Resources and references•About the authors China has a strong foundation for healthcare market growth, based on the key economic andhealthcare indexes comparison of China, the US and European Union countries Key economic and healthcare indexes of China, US andEU China has and will continue to have the largest patient pool with better affordability, though facingseveral challenges such as price pressure and lack of patient awareness Opportunities and challengesof China healthcare market China clinical trial volume has returned to growth after a dip in 2022, with Chinesepharmas’ in-Chinatrials accounting for ~75% oftotal new trial starts In-China trial volume has risen rapidly compared to U.S. and Europe, positioning China as a majorglobal player in clinical development Accelerated i