IMARC Group has recently released a new research study titled “United States Gene Therapy Market Size, Share, Trends and Forecast by Gene Type, Vector Type, Delivery Method, Application, and Region, 2025-2033”, offers a detailed analysis of the market drivers, segmentation, growth opportunities, trends and competitive landscape to understand the current and future market scenarios.

Market Overview

The United States gene therapy market size was valued at USD 1,312.2 Million in 2024. It is forecasted to reach USD 3,697.8 Million by 2033, exhibiting a CAGR of 12.1% for the period 2025–2033. Key growth drivers include increasing prevalence of genetic disorders, rapid genetic engineering advancements, strategic collaborations, supportive regulatory frameworks, and rising R&D investments. The market evolution is also supported by expanding healthcare infrastructure and improved insurance coverage enabling greater patient access.

Study Assumption Years

●     Base Year: 2024

●     Historical Year/Period: 2019-2024

●     Forecast Year/Period: 2025-2033

United States Gene Therapy Market Key Takeaways

●     Current Market Size: USD 1,312.2 Million (2024)

●     CAGR: 12.1%

●     Forecast Period: 2025-2033

●     The United States has designated over 1,000 orphan drugs including many gene therapies under FDA orphan drug programs.

●     FDA approvals for gene therapies have more than doubled since 2017, with over 20 clearances by 2023.

●     More than 100 gene therapies received the FDA's RMAT designation by 2023, accelerating approvals.

●     Healthcare infrastructure supports over 50 certified centers and 114 gene therapy trials started in 2023.

●     Insurance coverage is increasingly favorable, exemplified by Novartis's coverage of Zolgensma for 97% commercial and 86% Medicaid patients.

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Market Growth Factors

The United States gene therapy market share is experiencing significant growth driven by the increasing prevalence of genetic disorders and chronic diseases. In 2024, approximately 2,001,140 new cases of cancer are expected to be diagnosed in the U.S., with 611,720 related deaths. This rising cancer burden necessitates advanced treatment options like gene therapy, which can target malignant cells precisely and prevent further damage. The expanding geriatric population, projected to grow from 58 million in 2022 to 82 million by 2050—a 47% increase—further escalates the demand for gene therapy solutions, prompting collaborations among pharmaceutical companies and research institutions to accelerate development.

Rapid advancements in genetic engineering and biotechnology such as CRISPR/Cas9 gene-editing tools have made identifying and correcting genetic mutations easier. Significant R&D funding is fueling this progress; for example, in October 2023, the National Institutes of Health awarded Yale School of Medicine nearly USD 40 million to develop a phase 2 CRISPR-based gene therapy targeting rare genetic brain diseases. These technological improvements speed clinical trials and enhance therapeutic developments, thereby propelling market growth.

Strategic collaborations and partnerships are essential drivers in the U.S. gene therapy market. Increasing alliances between biotech firms, pharmaceutical companies, and academic institutes combine resources and expertise to overcome development challenges. A notable example is the January 2023 exclusive agreement between Spark Therapeutics and Neurochase to advance Neurochase's delivery technology for gene therapies targeting rare central nervous system diseases. These alliances strengthen platform capabilities, accelerate innovation, and enhance market competitiveness.