Navigating Government Pricing for Cell & Gene Therapies

The wave of FDA-approved cell and gene therapies (CGT) is transforming treatment options for diseases that once had few solutions. As more CGTs move from clinical trial to commercial approval and availability, navigating the complexities of government pricing becomes a critical hurdle for emerging manufacturers.

Cell and Gene Therapy Pipeline: Navigating Key Trends and Pricing Dynamics

Cell and gene therapy (CGT) is emerging as one of the most dynamic and innovative fields in the pharmaceutical industry. The journey began in 2017 with the groundbreaking approval of Kymriah (tisagenlecleucel), a CAR-T cell therapy for acute lymphoblastic leukemia. Since then, the pace has only quickened. From 2017 to 2022, seven gene therapies were approved, with another five approvals in 2023 alone. Now, there are over 20 such products on the market, with many more expected by year-end, showcasing the remarkable strides and potential of this sector.