Gene Therapy Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Vectors (Non-Viral Vectors and Viral Vectors), Indication (Neurological Diseases, Cancer, Duchenne Muscular Dystrophy, Hepatological Diseases, and Other Indications), Delivery Mode (In-Vivo and Ex-Vivo), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
The gene therapy market size is expected to grow from US$ 5.11 billion in 2023 to US$ 25.69 billion by 2031; it is projected to register a CAGR of 14.3% during 2023-2031.
Gene therapy is a pioneering treatment method that uses genes to treat diseases. Gene therapy offers a promising approach to treat and cure diseases by introducing genetic material into a patient's cells to replace or correct abnormal genes. Gene therapy can be classified into in-vivo and ex-vivo gene therapy. This innovative treatment method has gained significant attention and investment in recent years, leading to advancements in gene therapy techniques and technologies. The gene therapy market growth is attributed to the increasing burden of genetic diseases and the rising number of FDA approvals of gene therapies. However, the high cost of gene therapy products hinders the growth of the gene therapy market.
Researchers are working on making gene therapy available in clinics. A wide range of product portfolios are in the pipeline at various universities and institutes, and revenue generation is expected to increase during the forecast period. Following the FDA's approval of the first gene therapy, the number of clinical trials for gene therapy surged dramatically from 2017 to 2018. About 1,986 products, including CAR T-cell treatments and other genetically engineered cell therapies, are currently under development, according to the American Society of Gene & Cell Therapy. Over the projection period, the robust pipeline is anticipated to offer new opportunities for the growth of the gene therapy market.
Vectors-Based Insights
Based on vectors, the gene therapy market is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant gene therapy market share in 2023. It is anticipated to record a higher CAGR in the market during the forecast period. Viral vectors have the ability to competently deliver genetic material into target cells. They are derived from viruses that naturally can infect cells and transfer their genetic material. This makes them highly effective in delivering therapeutic genes into the cells of patients. In addition, viral vectors offer a high level of specificity and selectivity. They can be engineered to target particular types of cells or tissues, allowing for targeted delivery of therapeutic genes. This is particularly important in gene therapy, as it reduces the risk of off-target effects and enhances the effectiveness of the treatment. Moreover, viral vectors have been extensively studied and optimized over the years, leading to the development of safer and more efficient vector systems. Advances in vector design and manufacturing technologies have improved the safety profile and scalability of viral vectors, making them more suitable for clinical applications.
According to the analysis from clinicaltrials.gov, ~58% of gene therapies under development are using viral vectors. The most commonly employed viral vector for gene therapy is adeno-associated virus, owing to its ability to deliver genes to non-dividing cells where the gene has a long-term therapeutic impact. Different varieties of adeno-associated viruses target different cells, making them a suitable transporter of genetic material to desired locations inside the body, providing a customized treatment. In addition, viral vectors display low immunogenicity, safety, and long-term transient expression. Overall, the growing demand for safe and effective gene therapies, along with the advantages offered by viral vectors, has contributed to the segment's significant growth, positively influencing the gene therapy market growth.
The US Food and Drug Administration, the World Health Organization, and the Centers for Disease Control and Prevention are among the primary and secondary sources referred to while preparing the gene therapy market report.
Gene therapy is a pioneering treatment method that uses genes to treat diseases. Gene therapy offers a promising approach to treat and cure diseases by introducing genetic material into a patient's cells to replace or correct abnormal genes. Gene therapy can be classified into in-vivo and ex-vivo gene therapy. This innovative treatment method has gained significant attention and investment in recent years, leading to advancements in gene therapy techniques and technologies. The gene therapy market growth is attributed to the increasing burden of genetic diseases and the rising number of FDA approvals of gene therapies. However, the high cost of gene therapy products hinders the growth of the gene therapy market.
Researchers are working on making gene therapy available in clinics. A wide range of product portfolios are in the pipeline at various universities and institutes, and revenue generation is expected to increase during the forecast period. Following the FDA's approval of the first gene therapy, the number of clinical trials for gene therapy surged dramatically from 2017 to 2018. About 1,986 products, including CAR T-cell treatments and other genetically engineered cell therapies, are currently under development, according to the American Society of Gene & Cell Therapy. Over the projection period, the robust pipeline is anticipated to offer new opportunities for the growth of the gene therapy market.
Vectors-Based Insights
Based on vectors, the gene therapy market is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant gene therapy market share in 2023. It is anticipated to record a higher CAGR in the market during the forecast period. Viral vectors have the ability to competently deliver genetic material into target cells. They are derived from viruses that naturally can infect cells and transfer their genetic material. This makes them highly effective in delivering therapeutic genes into the cells of patients. In addition, viral vectors offer a high level of specificity and selectivity. They can be engineered to target particular types of cells or tissues, allowing for targeted delivery of therapeutic genes. This is particularly important in gene therapy, as it reduces the risk of off-target effects and enhances the effectiveness of the treatment. Moreover, viral vectors have been extensively studied and optimized over the years, leading to the development of safer and more efficient vector systems. Advances in vector design and manufacturing technologies have improved the safety profile and scalability of viral vectors, making them more suitable for clinical applications.
According to the analysis from clinicaltrials.gov, ~58% of gene therapies under development are using viral vectors. The most commonly employed viral vector for gene therapy is adeno-associated virus, owing to its ability to deliver genes to non-dividing cells where the gene has a long-term therapeutic impact. Different varieties of adeno-associated viruses target different cells, making them a suitable transporter of genetic material to desired locations inside the body, providing a customized treatment. In addition, viral vectors display low immunogenicity, safety, and long-term transient expression. Overall, the growing demand for safe and effective gene therapies, along with the advantages offered by viral vectors, has contributed to the segment's significant growth, positively influencing the gene therapy market growth.
The US Food and Drug Administration, the World Health Organization, and the Centers for Disease Control and Prevention are among the primary and secondary sources referred to while preparing the gene therapy market report.
1. INTRODUCTION
1.1 Scope of the Study
1.2 Market Definition, Assumptions and Limitations
1.3 Market Segmentation
2. EXECUTIVE SUMMARY
2.1 Key Insights
2.2 Market Attractiveness Analysis
3. RESEARCH METHODOLOGY
4. GENE THERAPY MARKET LANDSCAPE
4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
4.3.1 List of Vendors in the Value Chain
5. GENE THERAPY MARKET - KEY MARKET DYNAMICS
5.1 Key Market Drivers
5.2 Key Market Restraints
5.3 Key Market Opportunities
5.4 Future Trends
5.5 Impact Analysis of Drivers and Restraints
6. GENE THERAPY MARKET - GLOBAL MARKET ANALYSIS
6.1 Gene Therapy - Global Market Overview
6.2 Gene Therapy - Global Market and Forecast to 2031
7. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY VECTOR TYPE, 2021-2031
7.1 Overview
7.2 Viral Vector
7.3 Non-Viral Vector
8. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY METHOD, 2021-2031
8.1 Overview
8.2 Ex-Vivo
8.3 In-Vivo
9. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY APPLICATION, 2021-2031
9.1 Overview
9.2 Neurological Disorders
9.3 Cancer
9.4 Duchenne Muscular Dystrophy
9.5 Hepatological Diseases
9.6 Other Indications
10. GENE THERAPY MARKET - REVENUE ANALYSIS (USD MILLION), 2021-2031 – GEOGRAPHICAL ANALYSIS
10.1 North America
10.1.1 North America Gene Therapy Market Overview
10.1.2 North America Gene Therapy Market Revenue and Forecasts to 2031
10.1.3 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Vector Type
10.1.4 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Method
10.1.5 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Application
10.1.6 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Countries
10.1.6.1 United States Gene Therapy Market
10.1.6.1.1 United States Gene Therapy Market, by Vector Type
10.1.6.1.2 United States Gene Therapy Market, by Method
10.1.6.1.3 United States Gene Therapy Market, by Application
10.1.6.2 Canada Gene Therapy Market
10.1.6.2.1 Canada Gene Therapy Market, by Vector Type
10.1.6.2.2 Canada Gene Therapy Market, by Method
10.1.6.2.3 Canada Gene Therapy Market, by Application
10.1.6.3 Mexico Gene Therapy Market
10.1.6.3.1 Mexico Gene Therapy Market, by Vector Type
10.1.6.3.2 Mexico Gene Therapy Market, by Method
10.1.6.3.3 Mexico Gene Therapy Market, by Application
Note - Similar analysis would be provided for below mentioned regions/countries
10.2 Europe
10.2.1 Germany
10.2.2 France
10.2.3 Italy
10.2.4 Spain
10.2.5 United Kingdom
10.2.6 Rest of Europe
10.3 Asia-Pacific
10.3.1 Australia
10.3.2 China
10.3.3 India
10.3.4 Japan
10.3.5 South Korea
10.3.6 Rest of Asia-Pacific
10.4 Middle East and Africa
10.4.1 South Africa
10.4.2 Saudi Arabia
10.4.3 U.A.E
10.4.4 Rest of Middle East and Africa
10.5 South and Central America
10.5.1 Brazil
10.5.2 Argentina
10.5.3 Rest of South and Central America
11. INDUSTRY LANDSCAPE
11.1 Mergers and Acquisitions
11.2 Agreements, Collaborations, Joint Ventures
11.3 New Product Launches
11.4 Expansions and Other Strategic Developments
12. COMPETITIVE LANDSCAPE
12.1 Heat Map Analysis by Key Players
12.2 Company Positioning and Concentration
13. GENE THERAPY MARKET - KEY COMPANY PROFILES
13.1 Novartis AG
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
Note - Similar information would be provided for below list of companies
13.2 Astellas Pharma Inc
13.3 Bristol-Myers Squibb Company
13.4 Bluebird Bio Inc.
13.5 Sanofi
13.6 F. Hoffmann-La Roche Ltd.
13.7 Daiichi Sankyo
13.8 CSL Behring
13.9 Biogen
13.10 Oxford Biomedica
14. APPENDIX
14.1 Glossary
14.2 About The Insight Partners
14.3 Market Intelligence Cloud
1.1 Scope of the Study
1.2 Market Definition, Assumptions and Limitations
1.3 Market Segmentation
2. EXECUTIVE SUMMARY
2.1 Key Insights
2.2 Market Attractiveness Analysis
3. RESEARCH METHODOLOGY
4. GENE THERAPY MARKET LANDSCAPE
4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
4.3.1 List of Vendors in the Value Chain
5. GENE THERAPY MARKET - KEY MARKET DYNAMICS
5.1 Key Market Drivers
5.2 Key Market Restraints
5.3 Key Market Opportunities
5.4 Future Trends
5.5 Impact Analysis of Drivers and Restraints
6. GENE THERAPY MARKET - GLOBAL MARKET ANALYSIS
6.1 Gene Therapy - Global Market Overview
6.2 Gene Therapy - Global Market and Forecast to 2031
7. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY VECTOR TYPE, 2021-2031
7.1 Overview
7.2 Viral Vector
7.3 Non-Viral Vector
8. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY METHOD, 2021-2031
8.1 Overview
8.2 Ex-Vivo
8.3 In-Vivo
9. GENE THERAPY MARKET – REVENUE ANALYSIS (USD MILLION) – BY APPLICATION, 2021-2031
9.1 Overview
9.2 Neurological Disorders
9.3 Cancer
9.4 Duchenne Muscular Dystrophy
9.5 Hepatological Diseases
9.6 Other Indications
10. GENE THERAPY MARKET - REVENUE ANALYSIS (USD MILLION), 2021-2031 – GEOGRAPHICAL ANALYSIS
10.1 North America
10.1.1 North America Gene Therapy Market Overview
10.1.2 North America Gene Therapy Market Revenue and Forecasts to 2031
10.1.3 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Vector Type
10.1.4 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Method
10.1.5 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Application
10.1.6 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Countries
10.1.6.1 United States Gene Therapy Market
10.1.6.1.1 United States Gene Therapy Market, by Vector Type
10.1.6.1.2 United States Gene Therapy Market, by Method
10.1.6.1.3 United States Gene Therapy Market, by Application
10.1.6.2 Canada Gene Therapy Market
10.1.6.2.1 Canada Gene Therapy Market, by Vector Type
10.1.6.2.2 Canada Gene Therapy Market, by Method
10.1.6.2.3 Canada Gene Therapy Market, by Application
10.1.6.3 Mexico Gene Therapy Market
10.1.6.3.1 Mexico Gene Therapy Market, by Vector Type
10.1.6.3.2 Mexico Gene Therapy Market, by Method
10.1.6.3.3 Mexico Gene Therapy Market, by Application
Note - Similar analysis would be provided for below mentioned regions/countries
10.2 Europe
10.2.1 Germany
10.2.2 France
10.2.3 Italy
10.2.4 Spain
10.2.5 United Kingdom
10.2.6 Rest of Europe
10.3 Asia-Pacific
10.3.1 Australia
10.3.2 China
10.3.3 India
10.3.4 Japan
10.3.5 South Korea
10.3.6 Rest of Asia-Pacific
10.4 Middle East and Africa
10.4.1 South Africa
10.4.2 Saudi Arabia
10.4.3 U.A.E
10.4.4 Rest of Middle East and Africa
10.5 South and Central America
10.5.1 Brazil
10.5.2 Argentina
10.5.3 Rest of South and Central America
11. INDUSTRY LANDSCAPE
11.1 Mergers and Acquisitions
11.2 Agreements, Collaborations, Joint Ventures
11.3 New Product Launches
11.4 Expansions and Other Strategic Developments
12. COMPETITIVE LANDSCAPE
12.1 Heat Map Analysis by Key Players
12.2 Company Positioning and Concentration
13. GENE THERAPY MARKET - KEY COMPANY PROFILES
13.1 Novartis AG
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
Note - Similar information would be provided for below list of companies
13.2 Astellas Pharma Inc
13.3 Bristol-Myers Squibb Company
13.4 Bluebird Bio Inc.
13.5 Sanofi
13.6 F. Hoffmann-La Roche Ltd.
13.7 Daiichi Sankyo
13.8 CSL Behring
13.9 Biogen
13.10 Oxford Biomedica
14. APPENDIX
14.1 Glossary
14.2 About The Insight Partners
14.3 Market Intelligence Cloud
