Dr. Takis Athanasopoulos
With more than 25 years in the cell and gene therapy sector—from academic research to leadership roles in Big Pharma, biotech, and strategic CGT consulting through my London-based firm, Gene & Cell Ltd - I believe 2026 will mark the industry’s transition from promise to proven scalability. We can expect multiple FDA and EMA approvals each year as pipelines expand across thousands of clinical trials, moving beyond rare and ultra-rare diseases into more prevalent conditions such as autoimmune disorders, neurological diseases, and cardiometabolic indications through advancing in-vivo and allogeneic platforms.
Manufacturing innovations in viral and non-viral vectors, point-of-care automation, and closed systems are likely to address many supply bottlenecks, while increasing regulatory alignment may accelerate global access across Europe, China, and the United States. Key challenges remain around large-scale manufacturing, sustainable reimbursement, and reducing cost of goods, but renewed investment and global collaboration are positioning the sector to deliver broader patient impact and durable therapies.
