Evolution and commercialisation of cell and gene therapies

Satyen Sanghavi, Founder & CSO, Regrow Biosciences traces the evolution of cell and gene therapies, highlighting global milestones, industry growth, and reimbursement models.

- 

Emphasising the transformative potential of these therapies, he calls for stronger regulatory and financial backing to ensure wider accessibility

The field of cell and gene therapy has experienced remarkable progress since the early 2000s. A pivotal milestone was the USFDA's approval of Carticel by Genzyme in 1997, marking the first cell therapy approved in the U.S. for the treatment of cartilage defects in the knee. This ground-breaking achievement paved the way for the development of autologous cell therapies targeting multiple medical conditions.

As of 2024, there are over 68 non-genetically modified cell therapies and 32 gene therapies approved for clinical use worldwide, with the US, EU, and Japan playing key roles in regulatory and commercial approvals. The industry has also seen substantial growth in the number of companies dedicated to cell and gene therapy development, with over 100 companies globally actively contributing to this transformative sector. Concurrently, 1,221 clinical trials for cell and gene therapies are ongoing worldwide, spanning in various stages, including 342 in Phase 1/1b, 525 in Phase 2/2b, and 254 in Phase 3, highlighting the sector's robust development pipeline.