Gene Therapy Market to Cross USD 16.5 billion by 2035 | Roots Analysis

The global gene therapy market is anticipated to grow at a CAGR of 19.25% during the forecast period 2024-2035, reaching USD 16.5 billion by 2035.

Jun 27, 2025 - 18:05
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Gene Therapy Market to Cross USD 16.5 billion by 2035 | Roots Analysis

Gene therapies are a class of biologic products designed to alter the genetic material of an individual to treat rare diseases caused by inherited genetic mutations. These therapies are developed to address the underlying genetic cause of a disease, either by introducing a healthy version of the mutated gene or by inactivating the functions of disease-causing genes within the body. Currently, 20 gene therapies are commercially available for the treatment of various genetic disorders, including spinal muscular atrophy and sickle cell disease.

Additionally, more than 370 candidates are currently being evaluated across various phases of clinical trials and around 920 gene therapies are being developed across preclinical and discovery stages of development. Further, it is worth highlighting that these therapies have demonstrated tremendous potential in revolutionizing the treatment of chronic conditions, with promising results in achieving complete disease remission.

As such, the demand for gene therapies is increasing substantially, thereby encouraging gene therapy companies and non-industry players to enhance their R&D capabilities in order to develop and advance a greater number of therapies towards the commercial market. Driven by the growing demand for targeted therapies, the gene therapy market size is poised to experience a noteworthy increase during the forecast period.

Gene Therapy Market Key Players

The gene therapy market report also includes profiles of key players involved in the development of gene therapies: Amgen, Artgen Biotech, BioMarin Pharmaceutical, bluebird bio, CRISPR Therapeutics, CSL Behring, Ferring Pharmaceuticals, Kolon TissueGene, Krystal Biotech, Novartis, Orchard Therapeutics, Pfizer, PTC Therapeutics, Sarepta Therapeutics, Shanghai Sunway Biotech, Sibiono GeneTech, and Spark Therapeutics.

Key Report Takeaways

Presently, 345 developers worldwide, are engaged in manufacturing gene therapies; over to 95% of these players are headquartered in the North America

60% of developers were established between 2011 and 2020, whereas 8% of the developers are startups that are established post 2020

Over 40% of the marketed and clinical stage gene therapies are currently delivered using adeno-associated virus vectors

Close to 30% of the gene therapies are administered via intravenous route of administration

The gene therapy market is anticipated to grow at a CAGR of 19.25%

Competitive Landscape of Gene Therapy Market

The gene therapy market landscape features 345 very large, large, mid-sized and small developers which claim to have the required capabilities for manufacturing gene therapies. It is worth highlighting that close to 60% of the marketed and clinical stage gene therapies are classified as gene augmentation therapies.

Gene Therapy Market Regional Outlook

Based on the key geographical regions, the gene therapy market can be segmented into five major regions, North America, Europe, Asia, Latin America and Rest of the World. Majority of gene therapy developers are headquartered in North America and Europe. Currently, North America captures around 60% of the market share of the global gene therapy market and this trend is unlikely to change in the future. However, in the coming years, the market in Europe is anticipated to grow at a relatively faster pace. This can be attributed to the likely approval and launch of various gene therapies in the European market, owing to the increasing burden of inherited disorders and larger patient enrollment in clinical trials evaluating the safety and efficacy of gene therapies.

Gene Therapy Market Segments

Based on the research, Roots Analysis has segmented the Gene Therapy Market into Therapeutic Area, Type of Vectors, Type of Therapy, Type of Gene Delivery Method, Route of Administration and Geography Regions.

Gene Therapy Market, by Therapeutic Area

Cardiovascular Disorders

Dermatological Disorders

Genetic Disorders

Hematological Disorders

Metabolic Disorders

Muscle Disorders

Oncological Disorders

Ophthalmic Disorders

Other Disorders

Gene Therapy Market, by Type of Vector

Adeno-Associated Virus Vectors

Adenovirus Vectors

Herpes Simplex Virus Vectors

Lentivirus Vectors

Non-Viral Vectors

Retroviral Vectors

Other Vectors

Gene Therapy Market, by Type of Therapy

Gene Augmentation

Gene Editing

Gene Regulation

Oncolytic Immunotherapy

Other Therapies

Gene Therapy Market, by Type of Gene Delivery Method

In vivo

Ex vivo

Gene Therapy Market, by Route of Administration

Intramuscular Route

Intratumoral Route

Intravenous Route

Subretinal Route

Other Routes Of Administration

Gene Therapy Market, by Geographical Region

North America

Europe

Asia

Latin America

Rest of the World

About Roots Analysis

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