SHANGHAI — November 3rd, 2026 — China has emerged as a major global clinical development and biopharma innovation hub, with newly initiated clinical trials reaching a record 3,110 in 2025, and on track to set a new high in 2026, according to a new report by L.E.K. Consulting and PharmaDJ.
The findings highlight China’s growing influence in global drug development underpinned by expanding innovative pipelines, advantages in speed and cost efficiency in clinical trial execution, deepening cross-border R&D partnerships and increasing artificial intelligence adoption in clinical trials.
The joint report, “China’s Next Chapter in Clinical Development: Turning Innovation, Global Partnerships and AI Into Impact,” draws on industry research and a survey of 117 market participants in China conducted between August and October.
“China is entering a new chapter in global biopharmaceutical innovation, moving beyond its traditional advantages in clinical trial scale and efficiency to become an increasingly important source of differentiated therapies and scientific innovation,” said Helen Chen, global co-head of healthcare and life sciences and Greater China managing partner at L.E.K. Consulting. “As Chinese-origin assets become more integrated into global R&D pipelines, the opportunity for multinational and Chinese pharmaceutical companies is no longer simply about accessing innovation but also about building deeper, more strategic partnerships that can translate scientific advances into meaningful value for patients worldwide.”
China’s clinical development growth extends beyond trial volume
China recorded 3,110 newly initiated industry-sponsored clinical trials in 2025, up from 1,434 in 2019. Growth has continued into 2026, with over 2,800 trials already initiated by the end of October, putting China on track to set another annual record. Chinese pharmaceutical companies accounted for approximately 80% of new trial starts in 2025, reflecting their increasingly prominent role in the country’s clinical development ecosystem.
The growth is accompanied by an expansion into differentiated therapies, novel targets and next-generation drug modalities. China’s competitive position is also supported by clinical trial cost and speed advantages.
Among survey respondents who provided comparable cost estimates, approximately 75% reported that per-patient clinical trial costs in China were at least 20% lower than in the U.S. and Europe. The report estimates a weighted-average per-patient cost reduction of approximately 45% among respondents reporting lower costs in China.
In addition, more than 70% of respondents assessing trial execution speed perceived trials in China to be faster than in the U.S. and Europe, with many estimating timeline reductions of 10%-29%.
These advantages are creating opportunities for pharmaceutical companies to optimize global clinical development strategies, particularly through earlier-stage research and patient recruitment in China.
Cross-border partnerships evolve from asset licensing toward portfolio co-innovation
China’s growing innovation capabilities are attracting increasing international interest.
Chinese pharma out-licensing deals have surged in recent years, ramping to $100 billion in 2025 and likely doubling in 2026.
Beyond the increase in deal value, the report identifies a shift toward more integrated cross-border partnerships. Multinational pharmaceutical companies are increasingly exploring earlier-stage assets, multi-asset collaborations and agreements incorporating joint research, codevelopment and portfolio-level options.
“The rapid growth in China’s outbound licensing activity reflects a fundamental shift in how global pharmaceutical companies engage with Chinese innovation,” said Grace Wang, a Healthcare and Life Sciences partner at L.E.K. “We are seeing collaboration models evolve beyond traditional single-asset licensing, toward earlier-stage, multi-asset partnerships and codevelopment arrangements. These models create opportunities for multinational companies to access innovative pipelines while enabling Chinese biopharmas to leverage global development capabilities, share investment risks and accelerate their international ambitions.”
These arrangements can provide multinational companies with broader access to Chinese innovation while enabling Chinese biopharmas to secure development funding, access international clinical and regulatory capabilities, and share R&D risks.
The shift suggests that cross-border pharmaceutical business development is evolving beyond individual asset transactions into longer-term innovation partnerships.
Chinese biopharmas prioritize overseas development and global partnerships
International clinical development remains an important priority for Chinese biopharmaceutical companies.
The report finds that Australia and the U.S. are favored destinations for Phase I clinical trials, while the U.S. and Europe are preferred for Phase II and Phase III studies.
Partnership development, licensing opportunities and access to global markets remain important motivations for overseas clinical trials. Multinational clinical research organizations continue to hold an advantage in supporting these international programs. Approximately 77% of surveyed Chinese biopharma respondents expressed a preference for multinational CROs when conducting global trials.
Key considerations include international regulatory expertise, globally consistent quality and compliance standards, and access to overseas clinical trial networks.
AI adoption accelerates, but data security and reliability remain barriers
The report also points to growing AI adoption in China’s clinical development ecosystem.
The share of surveyed companies reporting pilot use of AI in specific areas increased from 20% in 2025 to 39% in 2026, while applications are expanding beyond medical writing and regulatory documentation.
Looking ahead, approximately 59% of respondents assessing future AI investment priorities identified clinical trial protocol design and optimization as a leading investment area over the next two to three years.
Other areas of interest include patient identification, medical writing, trial feasibility assessment and clinical site selection.
Despite growing interest, significant barriers remain. Approximately 60% of respondents identified data security, patient privacy and intellectual property concerns as major obstacles to wider AI adoption. Regulatory uncertainty and concerns about the reliability of AI-generated outputs were also frequently cited.
“China’s clinical development ecosystem is undergoing a significant transformation, driven not only by continued growth in clinical trial activity but also by advances in innovation capabilities, technology and operational efficiency,” said Jialing Dai, PharmaDJ’s president and publisher. “AI is beginning to move beyond experimentation into practical applications across clinical development, from medical writing and regulatory documentation to trial design and patient identification. The next challenge for the industry will be translating these technological advances into measurable improvements in clinical trial efficiency, quality and, ultimately, patient outcomes.”
The findings suggest that broader AI deployment will depend not only on technology availability but also on stronger governance, validated applications and integration into established clinical workflows.
A changing role for China in global drug development
The report concludes that China’s role in global biopharmaceutical development is evolving from a large clinical trial market into a more integrated innovation ecosystem.
For multinational pharmaceutical companies, China’s expanding pipeline of innovative assets presents opportunities for early-stage partnerships, portfolio diversification and more efficient global R&D.
For Chinese biopharmas, international expansion will increasingly depend on differentiated innovation, cross-border development capabilities and access to global partnerships.
For CROs, the changing landscape creates opportunities to support more complex multinational trials, strengthen specialized capabilities and deploy AI-enabled solutions that improve efficiency and quality.
The report identifies four trends expected to shape the sector’s next phase: China’s growing innovation capabilities, the shift toward portfolio co-innovation, continued globalization of Chinese biopharma and the transition of AI from exploration to practical adoption.
The full report, “China’s Next Chapter in Clinical Development: Turning Innovation, Global Partnerships and AI Into Impact,” is available at: