PUBLISHER: Polaris Market Research | PRODUCT CODE: 1903847
PUBLISHER: Polaris Market Research | PRODUCT CODE: 1903847
The gene therapy market size is expected to reach USD 29.01 billion by 2035, according to a new study by Polaris Market Research. The report "Gene Therapy Market Size, Share, Trends, Industry Analysis Report: By Therapeutic Area, Vector Type (Viral, Non-Viral), Approach, Route of Administration, and Region - Market Forecast 2026-2035" gives a detailed insight into current market dynamics and provides analysis on future market growth.
Gene therapy involves modifying or replacing unhealthy genes within a patient's cells to treat or prevent disease. Rapid advancements in genetic engineering and an increasing understanding of molecular biology are propelling gene therapy from experimental stages to real-world clinical applications. Researchers and biopharmaceutical companies invest heavily in developing safe and effective therapies. Also, regulatory bodies streamline approval processes, which accelerates gene therapy industry expansion.
The demand for gene therapy has surged due to the increasing prevalence of genetic disorders, such as Duchenne muscular dystrophy (DMD), sickle cell disease, hemophilia, and cystic fibrosis. Unlike traditional treatment methods that primarily focus on symptom management, gene therapy targets the underlying genetic cause of these diseases. This targeted approach enhances treatment efficacy. It also offers the potential for long-term or even permanent relief. Significant breakthroughs in gene-editing technologies, such as CRISPR-Cas9 and zinc finger nucleases (ZFNs), have enabled precise and efficient gene modifications.
The rising number of regulatory approvals for gene-based treatments drives the gene therapy market growth. Government agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognized the transformative potential of these therapies. They are expediting the approval process for promising candidates. Therapies such as Zolgensma for spinal muscular atrophy (SMA) and Luxturna for inherited retinal disease have demonstrated remarkable clinical success. This approach is paving the way for broader adoption of gene-based therapies or treatments.
Based on therapeutic area, the oncological disorders segment led the gene therapy market share in 2025. The prevalence of significant physical and psychological impacts of the disease and its treatment contributed to the dominance.
By vector type, the viral segment dominated the revenue share in 2025. The leading position is attributed to its effective and efficient delivering genes to the targeted cells for various cancers, monogenic and infectious diseases.
North America held the largest revenue share in 2025. The regional industry growth is driven by robust research infrastructure and advanced healthcare system. Also, significant funding for clinical trials and a supportive regulatory framework, particularly from the FDA, allows for rapid development and approval of new gene therapies. This factor also boosts the North America gene therapy industry growth.
Abeona Therapeutic, Novartis AG, Spark Therapeutics LLC, Gilead Sciences Inc., Bristol Myers Squibb, Adverum Biotechnologies, Alnylam Pharmaceuticals, American Gene Technologies, Applied Genetic Technologies Corporation, Biogen, and Ultragenyx are among the global market players.
Where is the Gene Therapy Market Headed?
According to our research on gene therapy industry, the market is expected to grow in the coming years due to rising approvals for therapies and technological evolution. Also, venture capital firms and large pharma companies are increasingly investing in vector technologies and delivery mechanisms. Such strategies will boost innovation and capacity expansion in the coming years.
What Does Gene Therapy Report Reveal?
What is the market size and CAGR for the market during 2026-2035?
What are the market drivers, trends, opportunities, and challenges?
Who are the key industry players? What is their relative position in terms of competitive positioning?
What are the leading candidates and technologies?
How do different treatment approaches, such as gene augmentation, oncolytic viral therapy, and immunotherapy, influence the market landscape?
How does the industry differ in terms of therapeutic area, vector type, approach, route of administration, and geography? Which is the leading vector type?
Among North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa, which region shows growth potential?
Polaris Market Research has segmented the market report on the basis of therapeutic area, vector type, approach, route of administration, and region:
By Type Therapeutic Area Outlook (Revenue, USD Billion, 2022-2035)
Autoimmune Disorders
Cardiovascular Diseases
Dermatological Disorders
Hematological Disorders
Metabolic Disorders
Muscle-Related Diseases
Oncological Disorders
Others
By Vector Type Outlook (Revenue, USD Billion, 2022-2035)
Viral
Non-Viral
By Approach Outlook (Revenue, USD Billion, 2022-2035)
Gene Augmentation
Oncolytic Viral Therapy
Immunotherapy
Other Approaches
By Route of Administration Outlook (Revenue, USD Billion, 2022-2035)
Intraarticular
Intracerebellar
Intradermal
Intramuscular
Intratumoral
Intravenous
Intravesical
Intravitreal
Subretinal
Others
By Regional Outlook (Revenue, USD Billion, 2022-2035)
North America
U.S.
Canada
Europe
Germany
France
UK
Italy
Spain
Netherlands
Russia
Rest of Europe
Asia Pacific
China
Japan
India
Malaysia
South Korea
Indonesia
Australia
Rest of Asia Pacific
Middle East & Africa
Saudi Arabia
UAE
Israel
South Africa
Rest of Middle East & Africa
Latin America
Mexico
Brazil
Argentina
Rest of Latin America