Breakthrough Innovations Drive Booming U.S. Gene Therapy Market Toward Record Growth in 2025 | Top key players - NOVARTIS AG, Sarepta Therapeutics, Inc., Krystal Biotech.

The US Gene Therapy Market Size reached US$ 2,812.92 million in 2024 and is expected to reach US$ 21,701.51 million by 2033, growing at a CAGR of 23.5 % during the forecast period 2025-2033.

The US Gene Therapy Market, as analyzed by DataM Intelligence, offers a comprehensive industry overview backed by in-depth insights, historical trends, and key statistics. The report dives deep into market dynamics and competitive strategies, profiling major players along with their product portfolios, pricing models, financial performance, growth initiatives, and regional presence.

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The U.S. Gene Therapy Market involves the development and commercialization of treatments that modify or replace defective genes to cure or manage diseases. It focuses on rare genetic disorders, cancers, and chronic conditions. Driven by advanced biotechnologies, regulatory support, and increasing clinical trials, the market represents a cutting-edge frontier in precision and personalized medicine.

Major players in the US Gene Therapy Market

The prominent players in US Gene Therapy market research report are: Alnylam Pharmaceuticals, Inc., NOVARTIS AG, Sarepta Therapeutics, Inc., Krystal Biotech, Inc., CSL, Bluebird Bio, Inc., SPARK THERAPEUTICS, INC., Ferring, Vertex Pharmaceuticals Incorporated, Amgen, Inc., and Orchard Therapeutics Plc, among others.

The companies are primarily focusing on strategies such as new product launches to penetrate the fastest-growing emerging markets across the world.

Key Development

In February 2025, CSL, a global biotechnology leader based in the U.S., announced positive four-year results from the pivotal HOPE-B study, reaffirming the long-term durability and safety of a one-time infusion of HEMGENIX® (etranacogene dezaparvovec-drlb) for adults with hemophilia B. These findings support the therapy's potential as a transformative treatment option for long-term disease management.

In September 2024, uniQure N.V., a frontrunner in gene therapy innovation, received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AMT-191, its investigational gene therapy for Fabry disease a rare, inherited genetic disorder. This designation highlights AMT-191's potential to address significant unmet medical needs for patients suffering from this life-threatening condition.

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Market Segments

By Approach: In-Vivo, Ex Vivo.

By Vector Type: Viral Vectors, Non-Viral Vectors.

By Technique: Gene Addition, Gene Silencing, Gene Editing.

By Application: Rare Diseases, Musculoskeletal Conditions, Blood Disorders, Oncology, Ophthalmology, Others.

The US Gene Therapy industry is experiencing rapid growth, driven by advancements in medical technologies, increased demand for innovative therapies, and a rising focus on patient-centered care. As these sectors evolve, the need for comprehensive market analysis becomes crucial to understand trends, regulatory changes, and emerging opportunities.

Benefits of the Report:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the global market.

➡ Top-down and bottom-up approach for regional analysis

➡ Porter's five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players.

➡ By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Market

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