
Gene Therapy Market Size To Worth USD 58.87 Billion Rising At 20% CAGR By 2034 Towards Healthcare
Metric | Details | |
Market Size in 2025 | USD 11.4 Billion | |
Projected Market Size in 2034 | USD 58.87 Billion | |
CAGR (2025 - 2034) | 20 | % |
Leading Region | North America Share by 45% | |
Market Segmentation | By Therapy Type, By Vector Type, By Gene Type, By Disease Indication, By Delivery Method, By End User, By Region |
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Aroma Chemicals Market's Regulatory Landscape: Global Regulations
Country / Region | Regulatory Body | Key Regulations | Focus Areas | Notable Notes |
United States | U.S. Food and Drug Administration (FDA) | Investigational New Drug (IND) Application | Clinical Safety and Efficacy | These agencies are ensuring the safety for consumer use |
European Union | European Medicines Agency (EMA) | Regulation (EC) No 1394/2007 | CeCentralized Marketing Authorization | These agencies streamline the clinical trial application process across member states via a single point of entry. |
China | National Medical Products Administration (NMPA) | "Dual-Track" Regulation | Accelerated Approvals | The agencies are observing and avoiding clinical safety misguidance |
Gene Therapy Market Key Regional Analysis:
How Are Advanced Biotech Firms Driving Market Growth in North America?
North America held the dominant share of the gene therapy market share by 45% in 2024, owing to the presence of advanced biotech firms and greater healthcare infrastructure. Moreover, factors like strong research funding and fast-track regulatory approvals are actively improving financial performance and regional dominance in the current period. Furthermore, the emergence of healthcare startup culture is likely to create significant opportunities in the region for the future period.
What's Driving Asia Pacific's Surge in Gene Therapy Research?
Asia Pacific is expected to expand notably during the forecast period, owing to factors like affordability and adoption of modern healthcare technology. Also, the regional countries such as India, China, and South Korea are seen under the heavy investment for manufacturing of the viral vectors and gene editing tools in recent years . Moreover, the greater governmental push for advanced healthcare infrastructure is likely to drive regional growth in the coming years.
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Gene Therapy Market Segmentation Analysis:
By Therapy Type,
Why Did the In-Vivo Gene Therapy Segment Dominate the Market in 2024?
The In-vivo segment held the largest share of the gene therapy market in 2024, owing to its unique characteristics like fast process and effectiveness. Alos, it delivers treatment directly inside the patient's body, making the process faster and more effective. Unlike ex vivo therapy, which requires cells to be removed, edited, and reinserted, in vivo allows doctors to target tissues or organs through injections or infusions. This approach is more practical for diseases like muscular dystrophy, eye disorders, or liver conditions.
By Vector:
How the Viral Vector Segment Maintains Its Dominance in the Current Industry?
The viral vector segment held the largest share of the market in 2024 due to its being considered the most effective segment for delivering therapeutic genes in the cells. Moreover, having unique properties such as targeting specific tissues and long-lasting effects, the viral vectors have gained immense industry attention in recent years, as per the current market survey.
By Gene Type:
The deficiency genes segment dominated the market with the largest share in 2024 because many rare diseases arise from single-gene defects, such as missing or faulty genes. Correcting or replacing these deficiency genes can often restore normal function, offering a permanent solution instead of lifelong treatments. For example, therapies targeting genes responsible for conditions like muscular dystrophy or cystic fibrosis have shown life-changing results.
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By Disease Indication ,
T he cancer segment held the largest share of the gene therapy market in 2024 , because of the urgent need for better treatments and the flexibility of genetic approaches. Gene therapies are being designed to reprogram immune cells to fight tumors, a breakthrough seen in CAR-T therapies for blood cancers. Unlike traditional chemotherapy or radiation, gene-based cancer treatments can be highly personalized and less toxic.
By Delivery Method:
The intravenous segment dominated the market with a significant share in 2024, because it allows systemic distribution of therapies throughout the body, which is essential for treating conditions affecting multiple organs or tissues. This method is straightforward for doctors to administer and ensures that the therapy reaches target areas like the liver, blood, or muscles. Compared to localized methods, intravenous delivery is more versatile and has been widely tested in clinical trials .
By End User:
The hospital segment dominated the market with a significant share in 2024, owing to the requirement of advanced equipment, trained staff, and specialized facilities, which hospitals can arrange. Furthermore, by handling complications like viral vector infusions and others, the hospital can gain more recommendations than small clinics in the coming years. Also, the presence and tie-ups of health insurance companies, several patients choose hospitals as their primary healthcare option.
Browse More Insights of Towards Healthcare:
The global gene therapy cell culture media market is on a steady growth trajectory, starting at USD 193.45 billion in 2024 and projected to reach USD 214.42 billion by 2025. By 2034, the market is expected to surpass USD 541.42 billion, expanding at a robust CAGR of 10.84%.
The gene therapy market for sickle cell disease is witnessing significant momentum, with revenues forecasted to reach several hundred million dollars over the period from 2025 to 2034.
Meanwhile, the gene therapy clinical trials market is rapidly advancing globally, with anticipated revenue accumulation in the hundreds of millions between 2025 and 2034.
The AAV gene therapy market demonstrated an estimated value of USD 2.75 billion in 2024, projected to rise to USD 3.85 billion in 2025, and is expected to surge to USD 78.56 billion by 2034, reflecting a remarkable CAGR of 40.1%.
The viral vector gene therapy market reached USD 13.14 billion in 2024 and is forecasted to grow to USD 14.62 billion in 2025. By 2034, it is anticipated to achieve USD 38.39 billion, expanding at a CAGR of 11.23%.
In the cell and gene therapy thawing equipment market , the size was recorded at USD 0.96 billion in 2024, set to grow to USD 1.1 billion in 2025, and projected to reach USD 3.56 billion by 2034, with a CAGR of 14.24%.
The cell and gene therapy tools and reagents market is calculated at USD 10.04 billion in 2024, growing to USD 11.12 billion in 2025, and expected to reach USD 27.3 billion by 2034, at a CAGR of 10.76%.
The viral vector-based cell & gene therapy CDMO market was valued at USD 142.77 million in 2024, projected to rise to USD 162 million in 2025, and anticipated to reach USD 497.7 million by 2034, growing at a CAGR of 13.44%.
The cell and gene therapy bioassay services market recorded USD 5.05 billion in 2024, expected to reach USD 5.67 billion in 2025, and projected to expand to USD 16 billion by 2034, with a CAGR of 12.24%.
Finally, the cell and gene therapy manufacturing QC market stood at USD 2.66 billion in 2024, growing to USD 3.11 billion in 2025, and projected to reach USD 12.35 billion by 2034, demonstrating a strong CAGR of 16.89%.
Gene Therapy Market Top Companies
- Amgen Inc. Novartis AG F. Hoffmann-La Roche Gilead Sciences, Inc. bluebird bio, Inc. Bristol-Myers Squibb Company Legend Biotech. BioMarin. uniQure N.V. Merck & Co. Sarepta Therapeutics, Inc. Krystal Biotech, Inc. CRISPR Therapeutics
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What is Going Around the Globe?
- In June 2025, BIRAC, the Biotechnology Industry Research Assistance Council, and Miltenyi Biotec India Pvt. Ltd. signed a strategic Letter of Intent (LoI). A common goal of strengthening domestic capabilities in next-generation therapies is reflected in the partnership, which was established during the present BIO International Convention 2025 in Boston. In March 2025, Bharat Biotech established a vertically integrated facility for cell treatment, gene therapy, and virus manufacture in Hyderabad's Genome Valley. The company asserts that its around $75 million investment is the first of its kind in the country.
Key Companies & Market Share Insights
The key market players can expect profitable growth possibilities as research and development investments are rising at a rapid pace. In addition, the market players are implementing key marketing strategies for the growth and development of the gene therapy market. REGENXBIO Inc. and Ultragenyx Pharmaceutical Inc., for example, deployed new technology for the development of gene therapy treatments in March 2020.
Gene Therapy Market Segmentation:
By Therapy Type
- In Vivo Gene Therapy
- Somatic Cell Gene Therapy Germline Gene Therapy CRISPR-based In Vivo Therapies RNA-based In Vivo Therapies Single-Dose Gene Replacement Therapies Immune Modulating In Vivo Therapies
- Autologous Gene Therapy Allogeneic Gene Therapy CAR-T Cell Therapies Gene-Edited Stem Cell Therapies CRISPR-Cas9 Edited Cell Therapies
By Vector Type
- Viral Vectors
- Adenovirus Adeno-Associated Virus (AAV) Lentivirus Retrovirus Herpes Simplex Virus (HSV)
- Liposomes Naked DNA Electroporation Nanoparticles Physical Methods (e.g., microinjection, gene gun)
By Gene Type
- Deficiency Genes Receptor Genes Antigen Genes Cytokine Genes Tumor Suppressor Genes Other Genes
By Disease Indication
- Cancer Genetic Disorders
- Hemophilia Spinal Muscular Atrophy (SMA) Duchenne Muscular Dystrophy (DMD) β-thalassemia / Sickle Cell Disease
By Delivery Method
- Intravenous (IV) Intrathecal / Intraocular Intramuscular (IM) Subcutaneous Others
By End User
- Hospitals Specialty Clinics Academic & Research Institutes Biotech/Pharmaceutical Companies Others
By Geography
- North America Europe Asia Pacific Latin America Middle East & Africa (MEA)
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