A record 48 Regenerative Medicine Advanced Therapy (RMAT) designations were awarded in 2025, according to new analysis from GlobalData. Combined with the 43 designations awarded in 2024, almost half of all RMAT designations have now been granted within the past two years. 

The RMAT designation is intended to accelerate the development and review of regenerative medicine therapies for serious or life-threatening conditions where early clinical evidence suggests the potential to address an unmet medical need. 

GlobalData attributes the increase to the continued expansion of the cell and gene therapy pipeline, with more than 2,300 therapies currently in clinical development worldwide. As more programmes generate promising early data, increasing numbers are becoming eligible for expedited regulatory pathways. 

Although the RMAT programme is focused on advanced therapies such as cell and gene therapies rather than regenerative aesthetic treatments, the findings underline the pace at which regenerative medicine is advancing and the growing regulatory focus on biologically based therapies.