PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930126
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930126
Gene Therapy Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034
Growth Factors of gene therapy Market
The global gene therapy market is experiencing strong momentum due to rapid advancements in genetic science and the increasing prevalence of rare and inherited disorders. According to Fortune Business Insights, the gene therapy market was valued at USD 4.29 billion in 2025. The market is projected to grow from USD 5.20 billion in 2026 to USD 11.33 billion by 2034, registering a CAGR of 10.20% during the forecast period. In 2025, North America dominated the market with a share of 24.60%, supported by strong research funding and early regulatory approvals.
Gene therapy involves modifying or replacing defective genes to treat or prevent diseases. These therapies are increasingly used for congenital genetic disorders such as spinal muscular atrophy, hemophilia, B-thalassemia, and inherited retinal diseases, as well as acquired conditions such as leukemia. The rising global burden of genetic and rare diseases is significantly driving demand for curative therapies, thereby supporting market growth.
Market Dynamics
Market Drivers
The rising burden of genetic disorders worldwide is a key driver of the gene therapy market. The growing awareness of gene-based treatments that address the root cause of diseases has increased clinical adoption. According to the World Federation of Hemophilia, 218,804 hemophilia patients were reported globally in 2023, highlighting the unmet need for long-term therapeutic solutions. Increasing research activities and funding for rare disease treatment further accelerate market expansion.
Market Restraints
The high cost of gene therapies remains a major restraint limiting patient access. These therapies often involve complex manufacturing processes and one-time treatment models, resulting in extremely high prices. For instance, in December 2022, CSL received U.S. FDA approval for the first gene therapy for hemophilia B, priced at USD 3.5 million per treatment. Such pricing creates financial challenges for patients, healthcare providers, and payers, slowing widespread adoption.
Market Opportunities
Advancements in gene delivery systems present significant growth opportunities. Innovations aimed at improving vector efficiency, tissue specificity, and scalability are transforming therapy development. In May 2025, Dyno Therapeutics launched new adeno-associated virus (AAV) capsid vectors targeting the eye, musculoskeletal system, and central nervous system. These developments are expected to improve therapeutic outcomes and support market expansion during the forecast period.
Market Challenges
A key challenge in the gene therapy market is maintaining long-term clinical efficacy. While early treatment responses are often strong, durability concerns remain due to immune responses and declining transgene expression. This necessitates extended clinical follow-up and increases development costs. Regulatory scrutiny regarding durability has also delayed approvals, impacting market growth.
Market Trends
A prominent trend in the gene therapy market is the focus on improving manufacturing scalability. With the growing number of clinical candidates, companies are investing in advanced bioprocessing technologies and automated manufacturing systems. In October 2024, the Cell and Gene Therapy Catapult received USD 1.5 million in funding to reduce AAV production costs and improve scalability, reflecting industry-wide efforts to enhance supply capabilities.
Segmentation Analysis
By Product
The market is segmented into Zolgensma, Luxturna, Roctavian, and others.
The Zolgensma segment dominated the market in 2024, with a value of USD 1.24 billion in 2025, driven by its proven durability and effectiveness in treating spinal muscular atrophy.
The Roctavian segment is projected to grow at a CAGR of 38.72% over the forecast period.
By Vector Type
Viral vectors dominated the market, accounting for 98.46% share in 2026, due to high transduction efficiency and long-lasting gene expression. The non-viral vector segment is expected to grow at a CAGR of 57.65%.
By Indication
The genetic disorders segment held the largest share in 2024 and is expected to account for 31.4% of the market in 2025, driven by increasing demand for personalized therapies. The ophthalmology segment is projected to grow at a CAGR of 19.35%.
By End User
The hospitals & clinics segment dominated the market with a 55.99% share in 2025, supported by their role in clinical trials and treatment administration.
Regional Outlook
North America led the market with a value of USD 1.05 billion in 2025 and USD 1.12 billion in 2026, driven by strong R&D activity and FDA approvals.
Europe reached USD 2.32 billion in 2025, supported by favorable regulatory frameworks.
Asia Pacific recorded USD 0.53 billion in 2026, with India and China valued at USD 0.04 billion and USD 0.19 billion, respectively.
Competitive Landscape
The market is semi-consolidated, led by Novartis AG, F. Hoffmann-La Roche Ltd., and BioMarin Pharmaceutical Inc. These companies benefit from strong product portfolios, global reach, and active R&D pipelines. Other key players include CSL, Vertex Pharmaceuticals, Krystal Biotech, and Rocket Pharmaceuticals.
Conclusion
The global gene therapy market is set for sustained growth from USD 4.29 billion in 2025 to USD 11.33 billion by 2034, driven by rising genetic disease prevalence, technological advancements, and increasing regulatory approvals. Despite challenges related to cost and long-term efficacy, continued innovation in delivery systems and manufacturing scalability is expected to support long-term market expansion.
Segmentation By Product
- Zolgensma
- Luxturna
- Roctavian
- Others
By Vector Product
- Viral Vectors
- Non-Viral Vectors
By Indication
- Genetic Disorders
- Ophthalmology
- Hematology
- Others
By End User
- Hospitals & Clinics
- Specialty Clinics
- Others
By Geography
- North America (By Product, Vector Type, Indication, End User, and Country)
- U.S.
- Canada
- Europe (By Product, Vector Type, Indication, End User, and Country/Sub-region)
- Germany
- U.K.
- France
- Spain
- Italy
- Scandinavia
- Rest of Europe
- Asia Pacific (By Product, Vector Type, Indication, End User, and Country/Sub-region)
- China
- Japan
- India
- Australia
- Southeast Asia
- Rest of Asia Pacific
- Latin America (By Product, Vector Type, Indication, End User, and Country/Sub-region)
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa (By Product, Vector Type, Indication, End User, and Country/Sub-region)
- GCC
- South Africa
- Rest of the Middle East & Africa
Table of Content
1. Introduction
- 1.1. Research Scope
- 1.2. Market Segmentation
- 1.3. Research Methodology
- 1.4. Definitions and Assumptions
2. Executive Summary
3. Market Dynamics
- 3.1. Market Drivers
- 3.2. Market Restraints
- 3.3. Market Opportunities
- 3.4. Market Trends
4. Key Insights
- 4.1. Development of Gene Therapy for New Disease Indications
- 4.2. Regulatory Scenarios, By Key Countries/Regions
- 4.3. Technological Advancements in Gene Therapy Market
- 4.4. New Product Launches, By Key Players
- 4.5. Pipeline Analysis, By Key Companies
- 4.6. Key Industry Developments (Mergers, Acquisitions, Partnerships, Launches, and Others)
- 4.7. Pricing & Reimbursement Landscape in the Gene Therapy Market
- 4.8. Manufacturing & Supply Chain Insights
- 4.9. Investment & Funding Trends in the Market
- 4.10. Patient Access to the Therapy & Ethical Considerations
5. Global Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 5.1. Market Analysis, Insights and Forecast - By Product
- 5.1.1. Zolgensma
- 5.1.2. Luxturna
- 5.1.3. Roctavian
- 5.1.4. Others
- 5.2. Market Analysis, Insights and Forecast - By Vector Type
- 5.2.1. Viral Vectors
- 5.2.2. Non-Viral Vectors
- 5.3. Market Analysis, Insights and Forecast - By Indication
- 5.3.1. Genetic Disorders
- 5.3.2. Ophthalmology
- 5.3.3. Hematology
- 5.3.4. Others
- 5.4. Market Analysis, Insights and Forecast - By End User
- 5.4.1. Hospitals & Clinics
- 5.4.2. Specialty Clinics
- 5.4.3. Others
- 5.5. Market Analysis, Insights and Forecast - Region
- 5.5.1. North America
- 5.5.2. Europe
- 5.5.3. Asia Pacific
- 5.5.4. Latin America
- 5.5.5. Middle East & Africa
6. North America Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 6.1. Market Analysis, Insights and Forecast - By Product
- 6.1.1. Zolgensma
- 6.1.2. Luxturna
- 6.1.3. Roctavian
- 6.1.4. Others
- 6.2. Market Analysis, Insights and Forecast - By Vector Type
- 6.2.1. Viral Vectors
- 6.2.2. Non-Viral Vectors
- 6.3. Market Analysis, Insights and Forecast - By Indication
- 6.3.1. Genetic Disorders
- 6.3.2. Ophthalmology
- 6.3.3. Hematology
- 6.3.4. Others
- 6.4. Market Analysis, Insights and Forecast - By End User
- 6.4.1. Hospitals & Clinics
- 6.4.2. Specialty Clinics
- 6.4.3. Others
- 6.5. Market Analysis, Insights and Forecast - By Country
- 6.5.1. U.S.
- 6.5.2. Canada
7. Europe Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 7.1. Market Analysis, Insights and Forecast - By Product
- 7.1.1. Zolgensma
- 7.1.2. Luxturna
- 7.1.3. Roctavian
- 7.1.4. Others
- 7.2. Market Analysis, Insights and Forecast - By Vector Type
- 7.2.1. Viral Vectors
- 7.2.2. Non-Viral Vectors
- 7.3. Market Analysis, Insights and Forecast - By Indication
- 7.3.1. Genetic Disorders
- 7.3.2. Ophthalmology
- 7.3.3. Hematology
- 7.3.4. Others
- 7.4. Market Analysis, Insights and Forecast - By End User
- 7.4.1. Hospitals & Clinics
- 7.4.2. Specialty Clinics
- 7.4.3. Others
- 7.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 7.5.1. Germany
- 7.5.2. U.K.
- 7.5.3. France
- 7.5.4. Italy
- 7.5.5. Spain
- 7.5.6. Scandinavia
- 7.5.7. Rest of Europe
8. Asia Pacific Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 8.1. Market Analysis, Insights and Forecast - By Product
- 8.1.1. Zolgensma
- 8.1.2. Luxturna
- 8.1.3. Roctavian
- 8.1.4. Others
- 8.2. Market Analysis, Insights and Forecast - By Vector Type
- 8.2.1. Viral Vectors
- 8.2.2. Non-Viral Vectors
- 8.3. Market Analysis, Insights and Forecast - By Indication
- 8.3.1. Genetic Disorders
- 8.3.2. Ophthalmology
- 8.3.3. Hematology
- 8.3.4. Others
- 8.4. Market Analysis, Insights and Forecast - By End User
- 8.4.1. Hospitals & Clinics
- 8.4.2. Specialty Clinics
- 8.4.3. Others
- 8.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 8.5.1. China
- 8.5.2. Japan
- 8.5.3. India
- 8.5.4. Australia
- 8.5.5. Southeast Asia
- 8.5.6. Rest of Asia Pacific
9. Latin America Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 9.1. Market Analysis, Insights and Forecast - By Product
- 9.1.1. Zolgensma
- 9.1.2. Luxturna
- 9.1.3. Roctavian
- 9.1.4. Others
- 9.2. Market Analysis, Insights and Forecast - By Vector Type
- 9.2.1. Viral Vectors
- 9.2.2. Non-Viral Vectors
- 9.3. Market Analysis, Insights and Forecast - By Indication
- 9.3.1. Genetic Disorders
- 9.3.2. Ophthalmology
- 9.3.3. Hematology
- 9.3.4. Others
- 9.4. Market Analysis, Insights and Forecast - By End User
- 9.4.1. Hospitals & Clinics
- 9.4.2. Specialty Clinics
- 9.4.3. Others
- 9.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 9.5.1. Brazil
- 9.5.2. Mexico
- 9.5.3. Rest of Latin America
10. Middle East & Africa Gene Therapy Market Analysis, Insights and Forecast, 2021-2034
- 10.1. Market Analysis, Insights and Forecast - By Product
- 10.1.1. Zolgensma
- 10.1.2. Luxturna
- 10.1.3. Roctavian
- 10.1.4. Others
- 10.2. Market Analysis, Insights and Forecast - By Vector Type
- 10.2.1. Viral Vectors
- 10.2.2. Non-Viral Vectors
- 10.3. Market Analysis, Insights and Forecast - By Indication
- 10.3.1. Genetic Disorders
- 10.3.2. Ophthalmology
- 10.3.3. Hematology
- 10.3.4. Others
- 10.4. Market Analysis, Insights and Forecast - By End User
- 10.4.1. Hospitals & Clinics
- 10.4.2. Specialty Clinics
- 10.4.3. Others
- 10.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 10.5.1. GCC
- 10.5.2. South Africa
- 10.5.3. Rest of the Middle East & Africa
11. Competitive Analysis
- 11.1. Global Market Share Analysis (2025)
- 11.2. Company Profiles (Overview, Products, SWOT Analysis, Recent Developments, Strategies, Financials (Based on Availability))
- 11.2.1. Novartis AG
- 11.2.2. F. Hoffmann-La Roche Ltd
- 11.2.3. BioMarin Pharmaceutical Inc.
- 11.2.4. CSL
- 11.2.5. Vertex Pharmaceuticals Incorporated
- 11.2.6. Krystal Biotech, Inc.
- 11.2.7. Rocket Pharmaceuticals
- 11.2.8. Dyno Therapeutics, Inc.
List of Tables
- Table 1: Global Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 2: Global Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 3: Global Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 4: Global Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 5: Global Gene Therapy Market Revenue (USD Billion) Forecast, by Region, 2021-2034
- Table 6: North America Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 7: North America Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 8: North America Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 9: North America Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 10: North America Gene Therapy Market Revenue (USD Billion) Forecast, By Country, 2021-2034
- Table 11: Europe Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 12: Europe Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 13: Europe Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 14: Europe Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 15: Europe Gene Therapy Market Revenue (USD Billion) Forecast, By Country/ Sub-region, 2021-2034
- Table 16: Asia Pacific Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 17: Asia Pacific Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 18: Asia Pacific Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 19: Asia Pacific Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 20: Asia Pacific Gene Therapy Market Revenue (USD Billion) Forecast, By Country/ Sub-region, 2021-2034
- Table 21: Latin America Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 22: Latin America Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 23: Latin America Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 24: Latin America Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 25: Latin America Gene Therapy Market Revenue (USD Billion) Forecast, By Country/ Sub-region, 2021-2034
- Table 26: Middle East & Africa Gene Therapy Market Revenue (USD Billion) Forecast, By Product, 2021-2034
- Table 27: Middle East & Africa Gene Therapy Market Revenue (USD Billion) Forecast, By Vector Type, 2021-2034
- Table 28: Middle East & Africa Gene Therapy Market Revenue (USD Billion) Forecast, By Indication, 2021-2034
- Table 29: Middle East & Africa Gene Therapy Market Revenue (USD Billion) Forecast, By End User, 2021-2034
- Table 30: Middle East & Africa Gene Therapy Market Revenue (USD Billion) Forecast, By Country/ Sub-region, 2021-2034
List of Figures
- Figure 1: Global Gene Therapy Market Revenue Breakdown (USD Billion, %) by Region, 2025 & 2034
- Figure 2: Global Gene Therapy Market Value Share (%), By Product, 2025 & 2034
- Figure 3: Global Gene Therapy Market Value Share (%), By Vector Type, 2025 & 2034
- Figure 4: Global Gene Therapy Market Value Share (%), By Indication, 2025 & 2034
- Figure 5: Global Gene Therapy Market Value Share (%), By End User, 2025 & 2034
- Figure 6: Global Gene Therapy Market Value (USD Billion), by Region, 2025 & 2034
- Figure 7: North America Gene Therapy Market Value (USD Billion), By Product, 2025 & 2034
- Figure 8: North America Gene Therapy Market Value Share (%), By Product, 2025
- Figure 9: North America Gene Therapy Market Value (USD Billion), By Vector Type, 2025 & 2034
- Figure 10: North America Gene Therapy Market Value Share (%), By Vector Type, 2025
- Figure 11: North America Gene Therapy Market Value (USD Billion), By Indication, 2025 & 2034
- Figure 12: North America Gene Therapy Market Value Share (%), By Indication, 2025
- Figure 13: North America Gene Therapy Market Value (USD Billion), By End User, 2025 & 2034
- Figure 14: North America Gene Therapy Market Value Share (%), By End User, 2025
- Figure 15: North America Gene Therapy Market Value (USD Billion), By Country, 2025 & 2034
- Figure 16: North America Gene Therapy Market Value Share (%), By Country, 2025
- Figure 17: Europe Gene Therapy Market Value (USD Billion), By Product, 2025 & 2034
- Figure 18: Europe Gene Therapy Market Value Share (%), By Product, 2025
- Figure 19: Europe Gene Therapy Market Value (USD Billion), By Vector Type, 2025 & 2034
- Figure 20: Europe Gene Therapy Market Value Share (%), By Vector Type, 2025
- Figure 21: Europe Gene Therapy Market Value (USD Billion), By Indication, 2025 & 2034
- Figure 22: Europe Gene Therapy Market Value Share (%), By Indication, 2025
- Figure 23: Europe Gene Therapy Market Value (USD Billion), By End User, 2025 & 2034
- Figure 24: Europe Gene Therapy Market Value Share (%), By End User, 2025
- Figure 25: Europe Gene Therapy Market Value (USD Billion), By Country/ Sub-region, 2025 & 2034
- Figure 26: Europe Gene Therapy Market Value Share (%), By Country/ Sub-region, 2025
- Figure 27: Asia Pacific Gene Therapy Market Value (USD Billion), By Product, 2025 & 2034
- Figure 28: Asia Pacific Gene Therapy Market Value Share (%), By Product, 2025
- Figure 29: Asia Pacific Gene Therapy Market Value (USD Billion), By Vector Type, 2025 & 2034
- Figure 30: Asia Pacific Gene Therapy Market Value Share (%), By Vector Type, 2025
- Figure 31: Asia Pacific Gene Therapy Market Value (USD Billion), By Indication, 2025 & 2034
- Figure 32: Asia Pacific Gene Therapy Market Value Share (%), By Indication, 2025
- Figure 33: Asia Pacific Gene Therapy Market Value (USD Billion), By End User, 2025 & 2034
- Figure 34: Asia Pacific Gene Therapy Market Value Share (%), By End User, 2025
- Figure 35: Asia Pacific Gene Therapy Market Value (USD Billion), By Country/ Sub-region, 2025 & 2034
- Figure 36: Asia Pacific Gene Therapy Market Value Share (%), By Country/ Sub-region, 2025
- Figure 37: Latin America Gene Therapy Market Value (USD Billion), By Product, 2025 & 2034
- Figure 38: Latin America Gene Therapy Market Value Share (%), By Product, 2025
- Figure 39: Latin America Gene Therapy Market Value (USD Billion), By Vector Type, 2025 & 2034
- Figure 40: Latin America Gene Therapy Market Value Share (%), By Vector Type, 2025
- Figure 41: Latin America Gene Therapy Market Value (USD Billion), By Indication, 2025 & 2034
- Figure 42: Latin America Gene Therapy Market Value Share (%), By Indication, 2025
- Figure 43: Latin America Gene Therapy Market Value (USD Billion), By End User, 2025 & 2034
- Figure 44: Latin America Gene Therapy Market Value Share (%), By End User, 2025
- Figure 45: Latin America Gene Therapy Market Value (USD Billion), By Country/ Sub-region, 2025 & 2034
- Figure 46: Latin America Gene Therapy Market Value Share (%), By Country/ Sub-region, 2025
- Figure 47: Middle East & Africa Gene Therapy Market Value (USD Billion), By Product, 2025 & 2034
- Figure 48: Middle East & Africa Gene Therapy Market Value Share (%), By Product, 2025
- Figure 49: Middle East & Africa Gene Therapy Market Value (USD Billion), By Vector Type, 2025 & 2034
- Figure 50: Middle East & Africa Gene Therapy Market Value Share (%), By Vector Type, 2025
- Figure 51: Middle East & Africa Gene Therapy Market Value (USD Billion), By Indication, 2025 & 2034
- Figure 52: Middle East & Africa Gene Therapy Market Value Share (%), By Indication, 2025
- Figure 53: Middle East & Africa Gene Therapy Market Value (USD Billion), By End User, 2025 & 2034
- Figure 54: Middle East & Africa Gene Therapy Market Value Share (%), By End User, 2025
- Figure 55: Middle East & Africa Gene Therapy Market Value (USD Billion), By Country/ Sub-region, 2025 & 2034
- Figure 56: Middle East & Africa Gene Therapy Market Value Share (%), By Country/ Sub-region, 2025
- Figure 57: Global Gene Therapy Market Share (%), By Company, 2025
