United States Gene Therapy Market Report 2032

The U.S. gene therapy market is projected to grow rapidly, with a CAGR of 21.53%, reaching USD 14.29 billion by 2031, up from USD 3.10 billion in 2023. Key growth drivers include rising chronic and genetic disease cases, regulatory approvals, advancements in CRISPR and gene editing, and increased research and investment.

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Key Growth Drivers

• Advancing Technologies: Innovations like CRISPR and Cas nucleases are expanding treatment potential, particularly in areas like cardiovascular disease and congenital conditions.
• Growing Research Activity: Breakthroughs such as a gene therapy enabling hearing in children with congenital deafness highlight the increasing success of research efforts.
• FDA Approvals: New gene therapies are receiving faster approvals—for instance, Beqvez (for hemophilia B) was approved in April 2024, marking continued momentum in regulatory support.

Market Demand Trends

• Chronic & Genetic Diseases: Conditions like cystic fibrosis, sickle cell anemia, and muscular dystrophy are key targets for gene therapy due to limited conventional treatment options.
• Aging Population: With age-related illnesses on the rise, gene therapies offer long-term treatment solutions for cardiovascular, neurodegenerative, and metabolic disorders.
• Cancer Focus: Oncology dominates the market share. Gene therapies are being increasingly used to treat cancers such as glioblastoma and bladder cancer. UC San Diego Health’s July 2024 rollout of a new bladder cancer gene therapy is one example.

Future Market Scenario (2024–2031F)

Significant growth is expected due to:

• Ongoing clinical trials (e.g., glioblastoma treatment at Texas Methodist Hospital).
• Major investments by companies like Gilead Sciences, aiming to quadruple cell therapy output by 2026.
• Rising public and federal support for biotech innovation, including from NIH and BARDA.

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