United States Gene Therapy Market Report

Market Overview:

The United States gene therapy market size reached USD 1,312.2 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 3,697.8 Million by 2033, exhibiting a growth rate (CAGR) of 12.1% during 2025-2033. The increasing awareness and acceptance of gene therapy, the potential to address rare diseases, extensive research and development (R&D) activities, and the increasing shift towards personalized medicine represent some of the key factors driving the market.

Gene therapy is a medical approach that aims to treat or cure genetic disorders by introducing functional genes into a patient's cells to replace, modify, or supplement faulty or missing genetic information. The process involves delivering therapeutic genetic material into the patient's body, usually using viral vectors or other methods, to target specific cells and tissues. The therapeutic genes introduced through gene therapy can either directly correct the genetic mutation causing the disorder or provide the cells with instructions to produce functional proteins that the patient's body is unable to generate on its own. This innovative treatment holds promise for a wide range of genetic diseases, including inherited disorders like cystic fibrosis and muscular dystrophy, as well as certain types of cancer and other acquired conditions.

United States Gene Therapy Market Trends:

The development of advanced gene editing technologies, such as CRISPR-Cas9, is significantly enhancing the precision and efficiency of gene therapies which represents one of the key factors driving the growth of the gene therapy market across the United States. These breakthroughs are accelerating research and development (R&D) activities, which are attracting investments, and boosting the growth of the market. The United States is a substantial patient population suffering from various genetic disorders. Gene therapy offers the potential for targeted and personalized treatments, addressing the unmet medical needs of these patients. Regulatory agencies like the U.S. Food and Drug Administration (FDA) are taking proactive steps to streamline the approval process for gene therapies. Expedited pathways and regulatory incentives are encouraging more companies to invest in gene therapy research and clinical trials. The significant potential of gene therapy to revolutionize healthcare is attracting substantial investments from venture capitalists, biotechnology firms, and pharmaceutical companies. The increased funding is accelerating research and development (R&D) activities, which is propelling the market growth. Several gene therapies are showing promising results in clinical trials, which is leading to successful commercialization and FDA approvals. As the public becomes more aware of gene therapy's potential benefits and success stories, there is an increase in acceptance and willingness to consider gene therapies as viable treatment options. Government organizations and non-profit foundations offer grants and funding opportunities to support gene therapy research and development. This financial assistance is facilitating more studies and clinical trials in the field. Gene therapy aligns with the growing trend of personalized medicine, where treatments are tailored to an individual patient’s genetic makeup. This shift in healthcare philosophy is driving interest and investment in gene therapies which is creating a positive outlook for the market across the country.

United States Gene therapy Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the United States gene therapy market report, along with forecasts at the regional and country level for 2025-2033. Our report has categorized the market based on gene type, vector type, delivery method, and application.

Gene Type Insights:

• Antigen
• Cytokine
• Tumor Suppressor
• Suicide Gene
• Deficiency
• Growth Factors
• Receptors
• Others
   

The report has provided a detailed breakup and analysis of the market based on the gene type. This includes antigen, cytokine, tumor suppressor, suicide gene, deficiency, growth factors, receptors, and others. According to the report, xx represented the largest segment.

Vector Type Insights:

• Viral Vector 
  • Adenoviruses
  • Lentiviruses
  • Retroviruses
  • Adeno-Associated Virus
  • Herpes Simplex Virus
  • Poxvirus
  • nia ViruVaccis
  • Others
•  Non-Viral Techniques
  • Naked and Plasmid Vectors
  • Gene Gun
  • Electroporation
  • Lipofection
  • Others
     

A detailed breakup and analysis of the market based on the vector type has also been provided in the report. This includes viral vector (adenoviruses, lentiviruses, retroviruses , adeno-associated virus , herpes simplex virus , poxvirus , vaccinia virus , others ) and non-viral techniques (naked and plasmid vectors, gene gun, electroporation, lipofection, others).

Delivery Method Insights:

• In-Vivo Gene Therapy
• Ex-Vivo Gene Therapy
   

A detailed breakup and analysis of the market based on the delivery method has also been provided in the report. This includes in-vivo gene therapy and ex-vivo gene therapy.

Application Insights:

• Oncological Disorders
• Rare Diseases
• Cardiovascular Diseases
• Neurological Disorders
• Infectious Disease
• Others
   

A detailed breakup and analysis of the market based on the application has also been provided in the report. This includes oncological disorders, rare diseases, cardiovascular diseases, neurological disorders, infectious disease, and others.

Regional Insights:

• Northeast
• Midwest
• South
• West
   

The report has also provided a comprehensive analysis of all the major regional markets, which include Northeast, Midwest, South, and West.

Competitive Landscape:

The report has also provided a comprehensive analysis of the competitive landscape in the United States gene therapy market. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

United States Gene Therapy Market Report Coverage:

Key Questions Answered in This Report:

• How has the United States gene therapy market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the United States gene therapy market?
• What is the breakup of the United States gene therapy market on the basis of gene type?
• What is the breakup of the United States gene therapy market on the basis of vector type?
• What is the breakup of the United States gene therapy market on the basis of delivery method?
• What is the breakup of the United States gene therapy market on the basis of application?
• What are the various stages in the value chain of the United States gene therapy market?
• What are the key driving factors and challenges in the United States gene therapy market?
• What is the structure of the United States gene therapy market and who are the key players?
• What is the degree of competition in the United States gene therapy market?

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the United States gene therapy market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the United States gene therapy market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the United States gene therapy industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.