The global gene therapy market was valued at USD 5.54 billion in 2023 and is anticipated to expand at a compound annual growth rate (CAGR) of 18.88% from 2024 to 2030. This growth is driven by several key factors, including the rising advancement in therapeutic technologies and gene delivery methods, as well as intensifying competition among major industry players aiming to commercialize their therapies. Biotechnology firms are actively pursuing mergers, acquisitions, collaborations, and strategic partnerships to build internal expertise and strengthen their product pipelines.

The COVID-19 pandemic had an adverse impact on market performance. The industry faced significant disruptions in supply chains, production capabilities, and logistics operations. For example, certain companies experienced prolonged delays in obtaining specific components and later encountered shortages in clinical trial supplies after one of their contract manufacturing partners was forced to cease operations.

Despite this, the market is expected to gain momentum in the coming years, supported by a strong development pipeline. Researchers are striving to bring gene therapy into routine clinical practice. Numerous academic institutions and research centers have an extensive range of products under development, which is projected to contribute to revenue growth throughout the forecast period. Notably, clinical trials for gene therapy surged following the FDA’s approval of the first gene therapy in 2017. According to the American Society of Gene & Cell Therapy (ASGCT), there are currently approximately 1,986 gene therapy-related products in development, including CAR T-cell therapies and other genetically engineered cell treatments.

In addition, evolving regulatory frameworks are expected to foster further growth. Several global regulatory agencies have implemented positive changes to facilitate the advancement of gene therapies. For instance, the FDA has expressed strong support for CAR-T cell technology. During Phase II and III clinical studies, regulators are showing increased flexibility in the traditional trial structure. The FDA anticipates approving between 10 and 20 new gene therapies annually by 2025.

Increased funding and investment in gene therapy is also projected to offer promising growth prospects for industry players. Many biopharmaceutical companies are channeling resources into the development of new products. For example, Ori Biotech secured over USD 100.0 million in Series B funding in January 2022 to launch an innovative platform for cell and gene therapy development, enabling a swift progression from pre-commercialization to full market entry.

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Regional Overview
In 2023, North America led the global gene therapy market, capturing a revenue share of 18.95%. This dominance is expected to continue throughout the forecast period, both in terms of regulatory approvals and revenue generation. Strong investment in research and development by both established and emerging companies is anticipated to drive further market expansion in the region.

Leading Companies in the Gene Therapy Market:
The key players shaping the gene therapy landscape and holding significant market shares include:

  • Amgen Inc.

  • Novartis AG

  • F. Hoffmann-La Roche

  • Gilead Sciences, Inc.

  • bluebird bio, Inc.

  • Bristol-Myers Squibb Company

  • Legend Biotech

  • BioMarin

  • uniQure N.V.

  • Merck & Co.

  • Sarepta Therapeutics, Inc.

  • Krystal Biotech, Inc.

  • CRISPR Therapeutics

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