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Global Gene Therapy Market Size, Share, Growth, and Forecast 2026-2035 | USD 74.78 Billion Opportunity Driven by Rare Disease R&D, Viral Vectors, and Regulatory Approvals

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AMGN Amgen Inc. is expanding its presence in genetic medicine through internal development, external innovation, and collaborations, indicating active participation and growth in the gene therapy sector. BIIB Biogen Inc. remains active in neurological and neurodegenerative disorders, with continued work involving spinal muscular atrophy treatments and therapeutic regimen optimization, highlighting its role in gene therapy. GILD Gilead Sciences, Inc. is listed as a leading gene therapy company, indicating its involvement and potential growth in this expanding market. SANG Sangamo Therapeutics, Inc. is mentioned as a leading gene therapy company, suggesting its active role and potential in the growing gene therapy market. NTLA Intellia Therapeutics, Inc. is listed as a leading gene therapy company, indicating its active participation and potential in the expanding gene therapy market. RPTX Rocket Pharmaceuticals, Ltd. is mentioned as a leading gene therapy company, suggesting its active role and potential in the growing gene therapy market. EDIT Editas Medicine, Inc. is listed as a leading gene therapy company, indicating its active participation and potential in the expanding gene therapy market. CRSP CRISPR Therapeutics AG is mentioned as a leading gene therapy company, suggesting its active role and potential in the growing gene therapy market. GNPX Genprex, Inc. is mentioned as a leading gene therapy company, suggesting its active role and potential in the growing gene therapy market. ASTL Astellas Pharma Inc. is mentioned as a leading gene therapy company, suggesting its active role and potential in the growing gene therapy market.

Global Gene Therapy Market Size, Share, Growth, and Forecast 2026-2035 | USD 74.78 Billion Opportunity Driven by Rare Disease R&D, Viral Vectors, and Regulatory Approvals Dublin, Oct. 08, 2026 (GLOBE NEWSWIRE) -- "Gene Therapy Market Size, Share and Growth Analysis Report - Forecast Trends and Outlook (2026-2035)" has been added to ResearchAndMarkets.com's offering.

The global gene therapy market reached USD 9.59 Billion in 2025 and is projected to grow at a CAGR of 22.80% during 2026-2035, reaching USD 74.78 Billion by 2035. Market expansion is supported by the rising prevalence of genetic disorders, rare diseases, and cancer, alongside increased investment in advanced medical research, genetic engineering, and next-generation treatment platforms.

Gene Therapy Market Highlights

Market Growth Drivers

Advances in viral and non-viral vector technologies, gene editing, and genetic engineering are expanding the clinical potential of gene therapy. Pharmaceutical and biotechnology companies are increasing investment in treatments for oncology, neurological conditions, inherited disorders, eye diseases, and other areas with significant unmet medical needs.

Regulatory initiatives are also supporting market growth by providing development pathways for innovative therapies. In April 2026, the FDA accepted Ultragenyx's resubmitted Biologics License Application for UX111, which targets Sanfilippo syndrome Type A. The development reflects continued progress in rare disease gene therapy and may encourage further clinical investment in treatments for underserved patient populations.

In March 2026, MeiraGTx's AAV2-hAQP1 gene therapy for radiation-induced xerostomia received FDA Breakthrough Therapy Designation. This recognition highlights the growing clinical relevance of gene augmentation and supports the advancement of new therapeutic approaches beyond established oncology and inherited disease applications.

Gene Therapy Market Segmentation

The market is analyzed by indication, vector type, and region.

By Indication:

By Vector:

By Region:

Vector and Indication Insights

Viral vectors are expected to retain a leading position in the gene therapy market. Their historical share of more than 74% was supported by high gene transfer efficiency, established clinical performance, and applicability across multiple therapeutic indications. Continued investment in vector design, manufacturing capacity, delivery precision, and safety optimization is expected to strengthen this segment.

Oncological disorders represented over 44% of the market during the historical period. Strong research pipelines, demand for targeted cancer treatments, and the growing use of personalized therapeutic strategies continue to support the oncology segment. Rare diseases and neurological disorders also present substantial opportunities as developers pursue treatments that address the underlying genetic causes of disease.

Regional Market Outlook

North America accounted for approximately 41% of the global market during the historical period. The region benefits from substantial R&D investment, a mature biotechnology industry, established clinical trial infrastructure, supportive regulatory pathways, and early adoption of advanced treatments. The United States remains a major center for gene therapy research, product approvals, commercialization, funding, and strategic partnerships.

Europe and Asia Pacific are also expected to contribute to long-term market development. Expanding research capabilities, investment in biotechnology, improving healthcare infrastructure, and growing interest in treatments for rare and inherited diseases are strengthening opportunities across these regions.

Competitive Landscape

Major participants in the gene therapy market are advancing clinical pipelines, expanding manufacturing capabilities, and pursuing collaborations, licensing agreements, mergers, and acquisitions. Competitive analysis includes patents, clinical trials, funding activity, investment trends, and strategic initiatives.

Novartis AG maintains a significant gene therapy portfolio focused on rare diseases, oncology, and neurological conditions, including treatments for spinal muscular atrophy. Amgen Inc. is expanding its presence in genetic medicine through internal development, external innovation, and collaborations involving companies such as AAVantgarde and Dark Blue Therapeutics.

bluebird bio, Inc. has developed gene therapies for sickle cell disease, thalassemia, and cerebral adrenoleukodystrophy. Biogen Inc. remains active in neurological and neurodegenerative disorders, with continued work involving spinal muscular atrophy treatments and therapeutic regimen optimization.

Other leading gene therapy companies include Sibiono GeneTech Co. Ltd., Gilead Sciences, Inc., Sangamo Therapeutics, Inc., Intellia Therapeutics, Inc., REGENXBIO Inc., Abeona Therapeutics Inc., Orchard Therapeutics plc, Sio Gene Therapies Ltd., Ultragenyx Pharmaceutical Inc., Krystal Biotech, Inc., Rocket Pharmaceuticals, Ltd., MeiraGTx Limited., Solid Biosciences Inc., GenSight Biologics S.A., Editas Medicine, Inc., CRISPR Therapeutics AG, Spark Therapeutics, Inc., Genprex, Inc., Poseida Therapeutics, Inc., Astellas Pharma Inc., Voyager Therapeutics, Inc., Coave Therapeutics, Precision BioSciences, Inc., and others.

Gene Therapy Market Report Coverage

The market report evaluates growth drivers, emerging trends, barriers to commercialization, unmet clinical needs, and opportunities across indications, vector platforms, and regions. It also examines the influence of regulatory decisions, clinical trial progress, funding, partnerships, collaborations, mergers, and acquisitions on the global gene therapy market forecast for 2026-2035.

For more information about this report visit https://www.researchandmarkets.com/r/ujny43

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