The next decade in cell and gene therapy

Area of Science:

• Biotechnology
• Pharmaceuticals
• Healthcare Economics

Background:

• The US Food and Drug Administration (FDA) approved the first durable cell and gene therapy (dCGT) 8 years ago.
• Over 32 dCGT product-indication approvals have occurred since then.
• Numerous dCGTs are currently in development and the pipeline.

Purpose of the Study:

• To forecast the future growth of durable cell and gene therapies.
• To estimate the number of new product-indication approvals by 2034.
• To project the associated patient growth and drug revenues.

Main Methods:

• A novel multi-modal Markov chain Monte Carlo (MCMC)-based model was utilized.
• The model analyzed historical approval data and pipeline information.
• Forecasts were generated for patient numbers and revenue.

Main Results:

• An estimated 79 new product-indication approvals are expected by 2034.
• This represents an average annual growth of 29% in treated patients.
• Projected list price drug revenues are estimated at US$28.8 billion by 2034.

Conclusions:

• The durable cell and gene therapy sector is poised for significant expansion.
• The pipeline suggests substantial increases in patient access and market value.
• These projections do not account for potential healthcare cost offsets or broader societal benefits.