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The cell and gene therapy market was valued at USD 21.43 Billion in 2025. It is poised to grow at a CAGR of 23.17% during the forecast period of 2026-2035, and reach USD 172.22 Billion by 2035. The market growth is driven by the increasing prevalence of genetic disorders, growing adoption of advanced therapies, and rapid technological advancements in gene editing and delivery systems, driving market growth.
Base Year
Historical Period
Forecast Period
In February 2026, Gilead announced a USD 7.8 billion acquisition of Arcellx to strengthen its CAR-T therapy pipeline, reflecting strong industry consolidation and investment in oncology-focused cell therapies.
In March 2026, the U.S. FDA approved the first gene therapy for leukocyte adhesion deficiency-I, a rare pediatric immune disorder. The therapy restores immune function and reduces infections, marking a major breakthrough in rare disease treatment.
In October 2025, AstraZeneca signed a deal worth up to USD 555 million with Algen Biotechnologies to develop gene therapies using AI-driven platforms. This collaboration highlights the increasing integration of AI in therapy development and strengthens pipeline innovation.
Compound Annual Growth Rate
23.17%
Value in USD Billion
2026-2035
*this image is indicative*
The market is expanding rapidly, driven by breakthroughs in genetic engineering and rising demand for targeted treatments. Increasing approvals of advanced therapies, including CAR-T therapy, strong clinical pipelines, and growing investments are supporting growth. Advancements in manufacturing and delivery technologies, along with favorable regulatory support, are further accelerating commercialization and global adoption of innovative therapeutic solutions. The market reached a value of approximately USD 21.43 Billion in 2025.
Increasing Regulatory Approvals for Advanced Therapies Driving the Market Value
Rising prevalence of rare diseases and growing regulatory support are key market drivers. For instance, in March 2026, the U.S. FDA approved the first gene therapy for leukocyte adhesion deficiency-I, restoring immune function. This milestone highlights the growing adoption of advanced therapy medicinal product (ATMP) solutions, accelerating commercialization, strengthening clinical confidence, and driving long-term growth in the market.
Key trends shaping the market include AI integration, gene editing advances, strategic collaborations, and expanding clinical pipelines globally.
Integration of AI in Therapy Development Shaping Market Landscape
Advancements in digital technologies and increasing R&D investments are shaping market trends. For instance, in October 2025, AstraZeneca partnered with Algen Biotechnologies in a USD 555 million deal to develop gene therapies using AI platforms. This collaboration is expected to enhance CRISPR-Cas9 innovation, optimize discovery timelines, and improve precision, supporting future market expansion.
Market Breakup by Therapy Type
Market Breakup by Type
Market Breakup by Delivery Mode
Market Breakup by Vector Type
Market Breakup by Therapeutic Area
Market Breakup by End User
Market Breakup by Region
Cell Therapy Manufacturing Expected to Dominate Market Segment by Therapy Type
By therapy type, the cell therapy manufacturing segment dominated the market with a revenue share of above 59% during the historical period, driven by increasing clinical adoption and commercialization of personalized treatments. The growing success of CAR-T therapy in oncology has significantly contributed to segment growth. Additionally, expanding clinical pipelines and investments in production capabilities continue to reinforce its leading position globally.
North America dominated the market with a revenue share of more than 47% during the historical period, supported by advanced healthcare infrastructure and strong regulatory frameworks. The region benefits from significant investments in biotechnology innovation, particularly in CRISPR-Cas9 technologies. Furthermore, the presence of major industry players and robust clinical trial activity continues to drive regional market expansion.
The key features of the market report comprise patent analysis, clinical trial analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
California-based Amgen Inc., founded in 1980 and headquartered in Thousand Oaks, is a leading biopharmaceutical company focused on innovative therapeutics for serious diseases. The company invests significantly in next-generation platforms, including CRISPR-Cas9, to advance cell and gene therapy pipelines. Its portfolio spans oncology, cardiovascular, and rare diseases, supported by strong R&D capabilities and global commercialization strategies.
Novartis AG, established in 1996 and headquartered in Basel, Switzerland, is a global pharmaceutical leader with a strong presence in advanced therapies. Its flagship product KYMRIAH, a pioneering CAR-T therapy, is approved for treating B-cell precursor acute lymphoblastic leukemia. The company continues expanding its portfolio across oncology, immunology, and gene therapies through innovation and strategic investments.
Pfizer Inc., founded in 1849 and headquartered in New York, United States, is a multinational biopharmaceutical company actively advancing gene therapy research. The company leverages partnerships and internal innovation to develop treatments using AAV delivery systems. Its portfolio includes therapies targeting rare genetic disorders, oncology, and vaccines, supported by extensive global manufacturing and distribution capabilities.
Bluebird Bio, Inc., established in 1992 and headquartered in Cambridge, Massachusetts, is a biotechnology company specializing in gene therapies for severe genetic diseases. The company focuses on developing treatments using lentiviral vector technologies. Its portfolio targets conditions such as sickle cell disease and beta-thalassemia, supported by expertise in clinical development and commercialization of transformative therapies.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market are Castle Creek Pharmaceutical Holdings, Bristol-Myers Squibb, Kite Pharma, Inc., Vericel Corporation Inc., Kolon TissueGene Inc., Vertex Pharmaceuticals, Inc., Spark Therapeutics, Inc., CORESTEM Inc., Biogen Inc., Dendreon Pharmaceuticals LLC., and JCR Pharmaceuticals Co. Ltd., among others.
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Therapy Type |
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| Breakup by Type |
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| Breakup by Delivery Mode |
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| Breakup by Vector Type |
|
| Breakup by Therapeutic Area |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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