Cell and Gene Therapy Market Size
Cell and Gene Therapy Market size reached US$ 13.90 Billion in 2024 and is expected to reach US$ 105.83 Billion by 2033, growing at a CAGR of 21.5% during the forecast period 2025-2033.
Cell and Gene Therapy Market Overview
Cell and gene therapy approaches can be combined to create gene-modified cell therapies. In this case, a patient's cells are genetically modified (gene therapy) and then reintroduced as a therapeutic agent (cell therapy). A prominent example is CAR-T cell therapy, where a patient’s T cells are genetically modified to target cancer cells and then reinfused to combat the disease. Both cell and gene therapies hold transformative potential for treating chronic, inherited, and otherwise incurable diseases by addressing them at a fundamental level rather than managing symptoms.
The cell and gene therapy market demand is driven by several approvals and strong growth in all stages of clinical development and by the potential of these therapies to address unmet medical needs, especially for chronic and life-threatening diseases that lack effective treatment options.
For instance, according to the American Society of Cell and Gene Therapy, the cell and gene therapy field has continued its impressive momentum in the first quarter of 2024 with several notable approvals and strong growth in all stages of clinical development. More than 4,000 gene, cell, and RNA treatments are now in research, which is exciting. The number of medicines in the clinical pipeline increased significantly in all three stages of development, with Phase I projects seeing the largest gain (11 percent).
Executive Summary
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Cell and Gene Therapy Market Dynamics: Drivers & Restraints
Growing utilization of advanced delivery vectors or vehicles is significantly driving the market growth
Growing utilization of advanced delivery vectors or vehicles is significantly driving the cell and gene therapy market growth and is expected to drive it over the forecast period. Introducing genetic material (DNA or RNA) into a patient's cells to treat an illness is known as cell and gene therapy. Delivery vectors are used in these treatments to carry the genetic material into the target cells. The efficacy of gene and cell therapy is hampered by the limits of current delivery vectors. To transfer genetic material into target cells more effectively, newer delivery vectors are being developed. Better treatment results and possibly a lower dosage requirement could arise with it.
Patients will occasionally experience an immunological reaction to the current delivery vectors. To reduce this immunological reaction, more sophisticated vectors are being developed. For instance, in May 2023, AGC Biologics launched its BravoAAV and ProntoLVV viral vector platforms. AGC Biologics’ new platforms offer fast, efficient, and reproducible clinical and commercial GMP production and release.
Additionally, in May 2024, Charles River Laboratories International, Inc. announced the launch of its reference materials for adeno associated virus (AAV) and lentiviral vector (LVV) portfolio, designed to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice- (GMP) quality.
High development costs and expensive manufacturing processes are hampering the market growth
High development costs and expensive manufacturing processes are expected to hamper the cell and gene therapy market. The production of cell and gene therapy is highly intricate, requiring specialized equipment, cleanroom facilities, and adherence to rigorous regulatory standards. Each therapy often needs to be customized to individual patients, as seen in autologous therapies like CAR-T, where cells are harvested from each patient, modified, and then reinfused. This level of customization drastically increases production costs and time.
For instance, the cost of goods for manufacturing CAR-T cell therapies can exceed $100,000 per patient. For therapies like Zolgensma, a one-time gene therapy treatment for spinal muscular atrophy, the cost is around $2.1 million per patient, making it one of the most expensive therapies worldwide.
Cell and gene therapy production relies on specialized raw materials, such as viral vectors for gene delivery and specific growth media for cell culture. These materials are costly and often sourced from limited suppliers, increasing expenses. Additionally, viral vector manufacturing, in particular, is complex, requiring significant time and resources.
For instance, according to the National Institute of Health (NIH), estimating the prevalence and incidence of their corresponding diseases, applying a model of the increase in quality-adjusted life years for each therapy and simulating the launch prices and expected spending of all available gene therapies annually. The results of NIH simulation suggest that annual spending on gene therapies will be approximately $20.4 billion, under conservative assumptions.
FDA Approved Cell & Gene Therapies
Cell and Gene Therapy Market, Segment Analysis
The global cell and gene therapy market is segmented based on therapy type, application, and region.
Therapy Type:
The cell therapy segment is expected to hold 61.2% of the market share in 2024 in the cell and gene therapy market
The cell therapy segment holds a major portion of the cell and gene therapy market share and is expected to continue to hold a significant portion of the market share over the forecast period due to its broad applications, robust clinical success, and technological advancements in regenerative medicine and oncology. Cell therapies, particularly CAR-T therapies and stem cell-based treatments, have shown impressive efficacy in treating certain cancers and regenerative conditions, which has accelerated their adoption and positioned them as key drivers of growth in the market.
For instance, in April 2024, India's first indigenously developed CAR T-cell therapy was launched for cancer treatment, hailing it as a major breakthrough that provides "new hope for humankind" in the battle against the disease. Developed by the Indian Institute of Technology (IIT) Bombay and Tata Memorial Centre, the therapy is being rolled out in India at about one-tenth of its price outside the country.
Significant funding from research institutes and governments has bolstered cell therapy R&D, particularly in cancer and regenerative medicine. Increased funding has facilitated clinical trials and advancements in technology and infrastructure, supporting cell therapy’s market leadership.
For instance, researchers at the University of California, San Francisco (UCSF) have begun enrollment for a clinical trial that uses a new, powerful version of CAR T as a potential therapy for glioblastoma, the most common and deadly adult brain cancer. The clinical trial is funded by an $11 million grant to UCSF by the California Institute for Regenerative Medicine (CIRM), which funds stem cell and gene therapy research.
Cell and Gene Therapy Market Geographical Share
North America is expected to dominate the cell and gene therapy market with 43.7% of the market share
North America region is expected to hold the largest share in cell and gene therapy market over the forecast period. North America, especially the United States, has a well-established ecosystem for medical research and innovation, with numerous top-tier academic and research institutions focused on biotechnology and life sciences. This R&D infrastructure supports groundbreaking research in cell and gene therapy, leading to rapid innovation and commercialization.
For instance, Broad Stem Cell Research Center researchers are also innovating approaches that combine gene and cell therapy techniques. Center member Donald Kohn, M.D., has been developing therapies of this kind to treat genetic blood and immune disorders such as sickle cell disease for over 30 years. While advancing several of these therapies through clinical trials, center collaborators are working to enhance and adapt these therapeutic approaches to treat a wider array of diseases.
The U.S. Food and Drug Administration (FDA) has implemented specific pathways, designations, and guidance to support the development and approval of cell and gene therapies. Programs like the Regenerative Medicine Advanced Therapy (RMAT) designation expedite the review process for promising therapies, making the U.S. an attractive market for cell and gene therapy companies to launch their products.
For instance, in August 2024, Ocugen, Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines, cleared that it has received notification from the FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400 a modifier gene therapy product candidate.
Cell and Gene Therapy Market Top Companies
Top companies in the Cell and Gene Therapy market include Novartis AG, Gilead Sciences, Inc., Bristol Myers Squibb Company, Vertex Pharmaceuticals Incorporated, Sarepta Therapeutics, Inc., CSL Behring LLC, Amgen, Inc., Orchard Therapeutics group, Krystal Biotech, Inc., bluebird bio, Inc., and among others. Emerging market players include Editas Medicine, Intellia Therapeutics, Rocket Pharmaceuticals, Regenxbio, Affinia Therapeutics, and others.
Key Developments
- In September 2024, CPC (Colder Products Company), part of Dover and a leading manufacturer of connection technologies used in biopharmaceutical processing, launched a new aseptic micro-connector that fits directly into the freeze cassettes used in cell and gene therapy (CGT) processing.
- In April 2024, Walgreens cleared that it will start to work directly with drugmakers to bring cell and gene therapy to U.S. patients as part of a broader expansion of its specialty pharmacy services.The company said it is launching a new business unit dedicated to its specialty pharmacy segment, which will include specialty pharmacy subsidiary AllianceRx.
- In May 2024, in partnership with Italy-based PBL, ProPharma, a US-headquartered provider of regulatory, clinical and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, launched the Cell Factory Box (CF Box), an enclosed, fully automated cell factory device. This device enables the decentralized manufacturing of all types of cell and gene therapy (CGT) in Class D (ISO8) or controlled not classified surrounding areas.
Market Scope
| Metrics | Details | |
| CAGR | 21.5% | |
| Market Size Available for Years | 2022-2033 | |
| Estimation Forecast Period | 2025-2033 | |
| Revenue Units | Value (US$ Bn) | |
| Segments Covered | Therapy Type | Cell Therapy and Gene Therapy |
| Application | Oncology, Musculoskeletal Conditions, Ophthalmology, Blood Disorders, Immunodeficiency Disorders, Graft-versus-host disease (GVHD), Rare Diseases, Others | |
| Regions Covered | North America, Europe, Asia-Pacific, South America, and the Middle East & Africa | |
The global cell and gene therapy market report delivers a detailed analysis with 54 key tables, more than 46 visually impactful figures, and 187 pages of expert insights, providing a complete view of the market landscape.
