The next decade in cell and gene therapy

In the 8 years since the US Food and Drug Administration (FDA) approved the first durable cell and gene therapy (dCGT), there have been over 32 product-indication approvals, with many more products and indications in the pipeline. Using a novel multi-modal Markov chain Monte Carlo (MCMC)-based model, we estimate that, by 2034, the pipeline will yield ∼79 new product-indication approvals, an annual average of 29% year-over-year growth in treated patients, and US$28.8 billion in list price drug revenues, before any healthcare cost offsets, caregiving impacts, long-term social benefits, or other benefits from treating these additional patients.