United States Gene Therapy Market Set to Revolutionize Healthcare: Key Trends and Growth Insights for 2025 | Major key players - Novartis AG, Amgen, Inc., Spark Therapeutics, Inc.

Market Size and Growth:

The Gene Therapy Market size reached US$ 4.80 Billion in 2024 and is expected to reach US$ 35.91 Billion by 2033, growing at a CAGR of 23.1% during the forecast period 2025-2033.

The Gene Therapy Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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The Gene Therapy Market involves the development, production, and commercialization of treatments that modify or manipulate genes to treat or prevent diseases. It encompasses viral and non-viral delivery methods, targeting genetic disorders, cancers, and rare diseases. Driven by advances in biotechnology, rising prevalence of genetic conditions, and increasing R&D investments, the market is expanding globally with innovative therapeutic solutions.

Recent Key Developments of United States (U.S):

Clinical Trial Success for Huntington's Disease: In September 2025, uniQure announced positive topline results from its Phase I/II study of AMT-130, a gene therapy for Huntington's disease. The high-dose treatment showed a statistically significant 75% slowing of disease progression at 36 months.

FDA Approval of a New Gene-Modified Therapy: In August 2025, the U.S. Food and Drug Administration (FDA) approved ZEVASKYN (prademagene zamikeracel) as the first and only autologous cell-based gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Strategic Acquisition to Enhance Drug Delivery: In September 2025, Biogen announced a definitive agreement to acquire Alcyone Therapeutics for an upfront cash payment of $85 million. The acquisition aims to expand Biogen's drug delivery solutions, particularly with ThecaFlex DRxTM, an implantable device for intrathecal delivery of therapies for neurological disorders.

FDA Approval of New Therapy for Recurrent Papillomatosis: In August 2025, the FDA approved Papzimeos (zopapogene imadenovec-drba) from Precigen, Inc. for the treatment of recurrent respiratory papillomatosis.

Expansion of Clinical Trial for Blindness: In July 2025, Atsena Therapeutics announced that the FDA had agreed to the expansion of its ongoing Phase I/II LIGHTHOUSE clinical trial for its gene therapy aimed at reversing or preventing blindness.

List of the Key Players in the Gene Therapy Market:

Spark Therapeutics, Inc.
Novartis AG
bluebird bio, Inc.
Ferring Pharmaceuticals Inc.
Vertex Pharmaceuticals Incorporated
Sarepta Therapeutics, Inc.
CSL Behring LLC
Alnylam Pharmaceuticals, Inc.
Amgen, Inc.
Orchard Therapeutics group.
Krystal Biotech, Inc.

This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

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Segments Covered in the Gene Therapy Market:

By Approach: Ex-Vivo, In-Vivo.

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

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

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

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Gene Therapy market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Gene Therapy Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Gene Therapy market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Gene Therapy Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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