China leads in clinical trials for cell and gene therapy as Western funding faces challenges

In the field of cell and gene therapy (CGT), China has surged ahead of the US, establishing its dominance in clinical trials over the past few years. Despite claims of a flourishing CGT landscape, a closer examination reveals a consistent initiation rate of trials year after year, with China emerging as a global frontrunner in this specialized area of biotechnology.

Biotech companies, both in the West and in China, have faced a series of challenges ranging from financial obstacles to enrollment issues. Additionally, global political changes have triggered regulatory modifications that have directly impacted CGT firms, causing significant setbacks in research and development efforts. In tandem with these challenges, ongoing safety concerns and manufacturing complexities have clouded the path to progress for CGT companies, complicating the production of novel therapies.

GlobalData’s latest report, The State of the Biopharmaceutical Industry 2025 – Mid-Year Update, projects that the global CGT market will reach an estimated value of $79.3 billion by 2030 with an impressive 40% compound annual growth rate. Oncology remains the leading therapeutic area, closely followed by central nervous system (CNS) disorders and metabolic conditions. The rising number of applications for CGTs indicates a robust demand for innovative drug development across various medical fields, suggesting a promising future for these groundbreaking treatments.

Between 2019 and 2024, China experienced a notable surge in the initiation of CGT trials, marking a significant expansion in its research portfolio. GlobalData’s Pharmaceutical Intelligence Center has tracked the consistency in trial initiations globally since 2019. The sizeable proportion of single-country trials underscores the practicality of executing multi-country studies, a choice likely influenced by the intricate manufacturing processes involved in CGT therapies. Whereas European and American regions have observed a decline in trial numbers, certain parts of Asia, particularly China, have witnessed a substantial rise in CGT research activities.

Vladimir Ivošev, the Senior Director of Business Development at Northway Biotech and a commercial advisor at SyVento BioTech, notes that the steady trajectory of trial initiations in recent times is a definitive trend, illustrating a nuanced landscape within the CGT industry. This trend reveals a cautious yet steady approach towards CGT research and development, simultaneously highlighting the region-specific dynamics that contribute to the consistency of trial initiation patterns globally.

The data from GlobalData reaffirms this trend, underscoring a sharp uptick in CGT studies initiated in China, positioning it as a pioneering force in the field of advanced biotechnological research. As the US and European regions grapple with funding challenges and regulatory shifts, China remains at the forefront of CGT trials, leading the charge in groundbreaking medical research and development.