Cell and Gene Therapy Pipeline 2H 2025

IPD Analytics has released its latest pipeline report, “Cell and Gene Therapy Pipeline – 2H 2025.” In the report, we analyze 17 cell and gene therapies with potential for approval within the next year and with estimated costs per treatment between $500K and $4M. The expected financial impact of these therapies increases the importance of planning for payers and health-systems.

Overall, the areas with the most potential approvals include central nervous system (CNS) conditions, with 6 potential approvals, and endocrinology and metabolic conditions, with 4 potential approvals. While clinical holds and manufacturing issues may push back potential approvals, IPD anticipates several approvals per year going forward. Orphan gene therapies are approximately 2–3.5 times more likely to receive FDA approval once reaching Phase 1 trials than other drugs; additionally, 8 of the CGTs in our report are currently undergoing or are intended for review via the accelerated approval pathway. The following table summarizes the pipeline CGTs with potential approvals through mid-2026.