United States Gene Therapy Market Overview

Base Year: 2024

Forecast Years: 2025-2033

Historical Years: 2019-2024

Market Size in 2024: USD 1,312.2 Million

Market Forecast in 2033: USD 3,697.8 Million

Market Growth Rate (2025-2033): 12.1%

The United States gene therapy market is experiencing rapid growth, driven by advancements in genetic engineering and increasing patient needs. According to the latest report by IMARC Group, the market is projected to grow at a CAGR of 12.1% from 2025 to 2033.

United States Gene Therapy Industry Trends and Drivers:

The market in United States is expanding due to advancements in genetic engineering technologies, including CRISPR and viral vector-based delivery systems, enhancing precision and efficacy. Increasing investments from biotechnology and pharmaceutical companies are accelerating the development and commercialization of novel gene therapies. The rising prevalence of genetic disorders, rare diseases, and certain cancers is driving demand for targeted therapeutic solutions. Favorable regulatory frameworks, including expedited FDA approval pathways such as Breakthrough Therapy and Orphan Drug Designation, are facilitating faster market entry for gene therapy products. Growth in personalized medicine is fueling research in gene-modified cell therapies tailored to individual patient profiles. Expanding clinical trial pipelines and research collaborations between academia and industry are strengthening innovation in the sector. The integration of AI and bioinformatics in gene therapy research is improving target identification and treatment optimization. Additionally, the emergence of scalable manufacturing processes for viral vectors and gene-editing platforms is enhancing production efficiency and reducing costs.

The scope of the market in the United States is expanding as innovations in in vivo and ex vivo gene therapy approaches are broadening market scope by diversifying treatment applications. As per the market analysis, increasing efforts to develop off-the-shelf gene therapies are creating new growth opportunities by improving accessibility and reducing treatment timelines. Growth opportunities are emerging with the expansion of gene therapy applications beyond rare diseases to include neurodegenerative disorders, cardiovascular diseases, and metabolic conditions. The rise of gene therapy-based regenerative medicine is driving advancements in tissue engineering and stem cell therapies. The establishment of dedicated gene therapy manufacturing facilities is strengthening supply chain reliability and reducing dependency on outsourced production. Increasing government and private sector funding for gene therapy research is accelerating the pace of innovation. Advancements in non-viral delivery methods, such as lipid nanoparticles, are improving safety profiles and expanding potential applications. Additionally, the integration of gene therapy with immuno-oncology is opening new avenues for cancer treatment, enhancing long-term market growth.

For an in-depth analysis, you can refer to a sample copy of the report: https://www.imarcgroup.com/united-states-gene-therapy-market/requestsample

United States Gene Therapy Industry Segmentation:

The market report offers a comprehensive analysis of the segments, highlighting those with the largest market share. It includes forecasts for the period 2025-2033 and historical data from 2019-2024 for the following segments:

• Gene Type:
  • Antigen
  • Cytokine
  • Tumor Suppressor
  • Suicide Gene
  • Deficiency
  • Growth Factors
  • Receptors
  • Others
• Vector Type:
  • Viral Vector:
    • Adenoviruses
    • Lentiviruses
    • Retroviruses
    • Adeno-Associated Virus
    • Herpes Simplex Virus
    • Poxvirus
    • Vaccinia Virus
    • Others
  • Non-Viral Techniques:
    • Naked and Plasmid Vectors
    • Gene Gun
    • Electroporation
    • Lipofection
    • Others
• Delivery Method:
  • In-Vivo Gene Therapy
  • Ex-Vivo Gene Therapy
• Application:
  • Oncological Disorders
  • Rare Diseases
  • Cardiovascular Diseases
  • Neurological Disorders
  • Infectious Diseases
  • Others
• Region:
  • Northeast
  • Midwest
  • South
  • West

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape in the 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.

Key highlights of the report:

• Market Performance (2019-2024)
• Market Outlook (2025-2033)
• COVID-19 Impact on the Market
• Porter’s Five Forces Analysis
• Strategic Recommendations
• Historical, Current, and Future Market Trends
• Market Drivers and Success Factors
• SWOT Analysis
• Structure of the Market
• Value Chain Analysis
• Comprehensive Mapping of the Competitive Landscape

Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as a part of the customization.

About Us:

IMARC Group is a global management consulting firm that helps the world’s most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

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