China’s clinical development sector has evolved at remarkable speed over the past decade. Policy reform, investment and a maturing ecosystem have transformed the country into one of the world’s most dynamic hubs for clinical research. As Chinese biopharmaceutical companies expand their capabilities and global reach, new opportunities are emerging for innovation-driven collaboration and growth.
Developed jointly by L.E.K. Consulting and PharmaDJ, this Special Report examines the strategic trends shaping the next phase of China’s clinical trial landscape. Drawing on survey insights from leading pharmaceutical companies and CROs, the analysis identifies three defining forces driving the sector forward: the rise of more innovative and differentiated therapies, the continued globalization of Chinese innovation, and the adoption of AI and smarter clinical trial tools.
The report explores how these forces are transforming the industry’s operating model — from early-stage R&D through to global-scale trials — and what they mean for multinational pharmas, domestic biotechs and service providers seeking to strengthen their positions in an increasingly competitive environment. It also provides a practical lens on how companies can prepare for the next wave of development, balancing innovation, efficiency and collaboration.
China 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 and III trials highlights China’s growing capability to advance innovations from early to late stages, creating rising opportunities for clinical development industry participants. While homogeneous competition persists, companies are driving differentiation through early combination planning, indication expansion and strategic asset prioritization. - Continued globalization of Chinese innovation
Globalization remains a strategic imperative for Chinese biopharmas/biotechs, with rising China-to-global trials and licensing deals reaching record highs. This creates expanding opportunities for MNC pharmas to access differentiated, 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 of AI and smarter clinical trial tools
AI is emerging as a transformative enabler across the drug R&D life cycle. Within clinical development, industry participants show growing interest in adopting AI, with the highest near-term potential in data analysis and management. Pharmas and CROs need to proactively integrate AI into their clinical development capabilities to enhance efficiency and improve trial quality.
Download the full report to understand how China’s evolving clinical trial ecosystem is reshaping global drug development and what it means for your organization’s strategy.
11122025071125