Thelansis

Cell and gene therapies are no longer a niche category. With more approvals coming through, payers pushing back harder, and health systems struggling to keep up operationally, CGT commercialisation has entered a very different phase. For investors, manufacturers, and global launch teams, the question is no longer where science is strongest, but where patients can actually access therapy. That comes down to three practical levers: how regulators behave, whether systems can deliver treatment, and how willing payers are to fund it. Why a “Readiness Index” Matters The 2024-25 period marked a clear inflection point. Regulatory agencies in mature markets moved faster, while a growing number of advanced therapy medicinal products (ATMPs) transitioned from trials into commercial planning. At the same time, cracks became visible. Approvals alone stopped being a reliable indicator of access. In several markets, therapies were authorized before hospitals were equipped to deliver them or r...