2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory approval.


“This is just the beginning, we’re gonna see a huge number of cell and gene therapies,” said Robert M Califf, the commissioner of food and drugs at the US Food and Drug Administration (FDA), commenting on last year’s record number of approvals. In 2023 no less than seven therapies got the green light from the US FDA, including five gene therapies for rare genetic diseases, and one was approved in the European Union.

And as the industry group Alliance of Regenerative Medicine (ARM) points out in its recent Cell & Gene State of the Industry report, more pioneering therapies are set to receive approval this year. The organization predicts as many as 17 possible US and EU green lights in 2024 with seven therapies already pending regulatory decisions. “We’re optimistic that we’ll see a lot of these pulled through to the finish line,” said Tim Hunt, CEO of ARM.

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While the elevated cost of these therapies remains a bone of contention, with the price tag of the latest FDA-approved therapies, Casgevy and Lyfgenia for sickle cell disease (SCD), reaching beyond USD 2 million per patient, ARM argues that they are actually cost-effective. A report from the Institute for Clinical and Economic Review (ICER) has found that gene therapies such as the hemophilia A and B therapies Roctavian and Hemgenix could eliminate the need for expensive prophylactic treatment and potentially offset treatment costs.