Gene Therapy Industry Overview

The global gene therapy market size was estimated at USD 5.54 billion in 2023 and is projected to grow at a CAGR of 18.88% from 2024 to 2030.

The market growth is attributed to many factors such as the expanding area of advanced therapies along with gene delivery technologies and progressive competition among key players focused on commercialization of their therapies. The biotechnology companies are investing in acquisitions, mergers/collaborations, and deals as a key strategy to increase in-house expertise and strengthen the product pipelines.

Gather more insights about the market drivers, restrains and growth of the Gene Therapy Market

The robust pipeline is expected to boost the market growth over the forecast period. Researchers are working to make gene therapy available at clinics. Various universities and institutes exhibit a broad portfolio of products in the pipeline which is expected to boost revenue generation over the forecast period. Clinical trials for gene therapy increased significantly from 2017 to 2018, after the FDA approved the first gene therapy. According to the American Society of Gene & Cell Therapy (ASGCT), around 1,986 products, including CAR T-cell therapies and other genetically modified cell therapies, are currently under development.

Moreover, improving regulatory support creates growth opportunities for the market over the forecast period. Several positive changes have been made by many international regulatory organizations to promote therapies. Support for CAR-T technology from the FDA is one of the examples. In phase II and III studies, in particular, regulators allow flexibility in the usual hierarchy of how clinical trials are conducted. Moreover, the FDA expects 10 to 20 new therapies to be approved annually by 2025.

Furthermore, an increase in funding and investments in this sector is expected to provide lucrative growth opportunities to market players. Several biopharma companies are investing in this sector for novel product launches. For instance, in January 2022, Ori Biotech raised more than USD 100.0 million in Series B funding to introduce a novel cell & gene therapy developing platform. This funding allowed for a rapid transition from pre-commercialization to market launch.

Browse through Grand View Research's Biotechnology Industry Research Reports.

  • The global clinical trials market size was valued at USD 80.7 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.49% from 2024 to 2030.
  • The global stem cells market size was valued at USD 14.80 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 11.43% from 2024 to 2030.

Gene Therapy Market Segmentation

Grand View Research has segmented the global gene therapy market report based on indication, vector type, route of administration, and region:

Gene Therapy Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Large B-Cell Lymphoma
  • Multiple Myeloma
  • Spinal Muscular Atrophy (SMA)
  • Acute Lymphoblastic Leukemia (ALL)
  • Melanoma (lesions)
  • Inherited Retinal Disease
  • Beta-Thalassemia Major/SCD
  • Others

Gene Therapy Vector Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Lentivirus
  • RetroVirus & gamma RetroVirus
  • AAV
  • Modified Herpes Simplex Virus
  • Adenovirus
  • Others

Gene Therapy Route of Administration Outlook (Revenue, USD Million, 2018 - 2030)

  • Intravenous
  • Others

Gene Therapy Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • UK
    • Germany
    • Switzerland
  • Asia Pacific
    • Japan
    • China
    • South Korea
    • Australia
  • Rest of the world 

Key Companies profiled:

  • Amgen Inc.
  • Novartis AG
  • Hoffmann-La Roche
  • Gilead Sciences, Inc.
  • bluebird bio, Inc.
  • Bristol-Myers Squibb Company
  • Legend Biotech.
  • uniQure N.V.
  • Merck & Co.
  • Sarepta Therapeutics, Inc.
  • Krystal Biotech, Inc.
  • CRISPR Therapeutics.

Key Gene Therapy Company Insights

The market players operating in the gene therapy market are adopting product approval to increase the reach of their products in the market and improve the availability of their products in diverse geographical areas, along with expansion as a strategy to enhance production/research activities. In addition, several market players are acquiring smaller players to strengthen their market position. This strategy enables companies to increase their capabilities, expand their product portfolios, and improve their competencies.

Recent Developments

  • In January 2024, Biogen and Ginkgo Bioworks announced the completion of their gene therapy collaboration involving AAV based vectors. This is expected to fuel the demand for gene therapies in the coming years.
  • In December 2023, the Swiss Agency for Therapeutic Products granted approval to Libmeldy for the treatment of early-onset metachromatic leukodystrophy.
  • In May 2023, Krystal Biotech was granted approval for VYJUVEK gene therapy for Dystrophic Epidermolysis Bullosa treatment
  • In June 2023, the U.S. FDA granted approval to Sarepta for  ELEVIDYS gene therapy to treat DMD in children of age 4-5 years

Order a free sample PDF of the Gene Therapy Market Intelligence Study, published by Grand View Research.