Chicago, Jan. 06, 2026 (GLOBE NEWSWIRE) -- The global cell and gene therapy market was valued at US$ 36.5 billion in 2025 and is expected to reach US$ 183.1 billion by 2035, growing at a CAGR of 17.5% during 2026–2035.
The foundation of the cell and gene therapy market's growth is its vibrant and expanding clinical trial landscape. A remarkable number of studies are currently underway, indicating a global commitment to innovation. There are over 2,000 active CGT clinical trials in progress globally. This immense activity highlights a deep and diverse pipeline that is continually being refreshed with novel therapeutic candidates. The pace of new research initiation is also accelerating, with 79 new gene therapy clinical trials and 27 new non-genetically modified cell therapy trials kicking off in the first quarter of 2025 alone, demonstrating sustained momentum.
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Further analysis of the trial stages reveals a healthy progression of assets toward commercialization. The global gene therapy pipeline currently includes 318 candidates in Phase 1 trials and 289 candidates advancing through Phase 2. Nearing the final stages of clinical validation, 35 gene therapies are in Phase 3 trials, poised to potentially enter the market soon. Geographically, the Asia-Pacific region has become a critical hub, now hosting 44% of all CGT clinical trials. This global distribution of research efforts is diversifying the sources of innovation and expanding the potential patient reach of the market.
Key Findings in Cell and Gene Therapy Market
| Market Forecast (2035) | US$ 183.1 billion |
| CAGR | 17.5% |
| Largest Region (2025) | North America (50.46%) |
| By Therapy Type | Gene Therapy (Largest) |
| By Therapeutic Class | Infectious Disease (Largest) |
| By Delivery Method | In-Vivo (Largest) |
| By End-Users | Cancer Care Centers (Largest) |
| Top Drivers |
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| Top Trends |
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| Top Challenges |
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Development Pipeline Depth Promises A Sustained Wave of Future Therapies
The development pipeline for the cell and gene therapy market is not just wide but also incredibly deep, ensuring a continuous flow of innovation for years to come. The total global pipeline for gene, cell, and RNA therapies comprises an impressive 4,099 candidates currently in development. Within this, the specific gene therapy pipeline includes 2,117 candidates, with a substantial 1,424 of these in the preclinical phase. This large preclinical base represents the next generation of therapies that will fuel market growth well into the next decade. The ecosystem supporting this development is robust, with nearly 3,000 developers actively working in the CGT space.
This extensive pipeline in the cell and gene therapy market is supported by a strong regulatory framework, with companies actively filing for and maintaining their investigational programs. As of early 2025, there are more than 2,500 active Investigational New Drug (IND) applications for CGTs on file with the FDA. Specifically for gene therapies, there are around 1,300 active INDs. A significant portion of the pipeline, 1,053 gene therapies, is being developed to target rare diseases, addressing significant unmet medical needs and highlighting the market's focus on providing solutions for previously untreatable conditions.
Regulatory Approvals Accelerate Pathways for Transformative New Market Entrants
Regulatory agencies worldwide are establishing clearer and often accelerated pathways for CGTs, bolstering the commercial prospects of the cell and gene therapy market. In 2024, the U.S. FDA granted eight novel cell and gene therapy approvals, along with at least six new indications for existing products, expanding their use to new patient populations. This positive regulatory environment is leading to a growing number of available treatments. By March 2025, a cumulative total of 76 cell and gene therapies have been brought to market globally, with a combined 68 genetically modified cell, gene, and RNA therapies having received global approval for clinical use by the first quarter of 2025.
The forward-looking pipeline reflects this encouraging trend. In the United States, 11 gene therapy candidates are in the preregistration phase as of early 2025, representing the next near-term commercial launches. Furthermore, U.S. and European regulators anticipate a steady cadence of 10 to 20 new CGT approvals annually, signaling a mature and sustainable approvals process. To facilitate the development of high-impact treatments, the FDA selected four investigational CGTs for its START program in 2024, a clear indicator of regulatory support for accelerating the development of promising therapies.
High-Value Mergers And Acquisitions Radically Reshape The Competitive Landscape
The strategic importance of the cell and gene therapy market is being validated by a surge in high-value mergers and acquisitions. Large pharmaceutical companies are actively acquiring innovative biotechs to secure cutting-edge technology platforms and promising clinical assets. The first half of 2025 has already seen 2 major M&A transactions for gene therapies and vectors. This follows a busy 2024, which saw 5 M&A deals in the gene therapy space, and the first half of 2024, which recorded 3 M&A deals in the sector.
Several landmark deals highlight this trend of strategic consolidation. In 2024, Novartis acquired Kate Therapeutics to bolster its capabilities. The momentum continued into 2025, with several significant transactions in the first half of the year. AbbVie moved to acquire Capstan Therapeutics, while in a major European deal, BioNTech took over its German rival CureVac. In another key move, Eli Lilly purchased Verve Therapeutics to gain access to its advanced base editing platform. These acquisitions demonstrate a clear strategy by big pharma to buy, rather than build, their way into market leadership.
Strategic Industry Collaborations And Partnerships Significantly Fuel Ongoing Innovation
Beyond outright acquisitions, strategic partnerships remain a vital mechanism for driving progress and mitigating risk in the complex cell and gene therapy market. Companies are pooling resources and expertise to tackle the scientific and logistical challenges of developing these sophisticated treatments. In 2024, the gene therapy field recorded 13 R&D partnerships. While a decrease from the 20 R&D partnerships seen in the previous year, deal-making remains robust. The first half of 2025 saw 3 sizable partnerships for gene therapy and vectors signed, following 4 R&D partnerships in the first half of 2024.
The breadth of these collaborations is significant, with a total of 101 transactions, including partnerships and other deals, recorded in the third quarter of 2024 alone. Two notable 2024 collaborations exemplify this trend. One key partnership was formed between AviadoBio and Astellas, focusing on a gene therapy targeting frontotemporal dementia. In another significant alliance, Dyno Therapeutics and Roche agreed to a collaboration to advance AAV gene therapy vectors for neurological diseases, showcasing how partnerships are crucial for technological advancement within the cell and gene therapy market.
Venture Capital Investment Confidently Backs Next-Generation Therapy Development Efforts
Venture capital continues to be a critical source of funding for the capital-intensive cell and gene therapy market, with investors demonstrating confidence in the sector's long-term potential. While the investment climate has become more discerning, innovative companies with strong science continue to attract significant capital. In 2024, gene therapy ventures completed 20 funding rounds, a figure comparable to the 21 funding rounds in 2023. Through August 2024, CGT developers had initiated 16 venture rounds, a more measured pace compared to the 65 venture deals recorded for the full year in 2023, reflecting a focus on quality over quantity.
Activity in 2025 shows continued, selective investment in promising early-stage companies. The first half of 2025 saw gene therapy and vector companies complete 14 financing rounds, compared to 19 financing rounds in the first half of 2024. A healthy seed and early-stage environment is also evident, with 12 start-ups in the advanced molecular therapy space successfully raising seed and Series A funding in the first quarter of 2025. This sustained flow of venture capital is essential for nurturing the next wave of innovators that will drive future market growth.
Manufacturing Infrastructure Expansion is Scaling Up To Meet Future Commercial Demand in the Cell and Gene Therapy Market
Anticipating a surge in demand from newly approved therapies, the industry is making substantial investments in manufacturing infrastructure. The ability to produce these complex treatments at a commercial scale is a critical success factor for the market. In the U.S. alone, there are now over 500 manufacturing and development facilities dedicated to cell and gene therapies. In August 2025, Made Scientific opened a new 60,000 sq. ft. GMP manufacturing facility in Princeton, New Jersey, a move set to add over 100 skilled professionals and increase its capacity by up to 2,000 additional batches per year.
The expansion is a global phenomenon for the cell and gene therapy market. In August 2025, Minaris Advanced Therapies opened a new GMP manufacturing facility in Munich, Germany, to serve the European market. Contract development and manufacturing organizations (CDMOs) are also seeing a boom in business; in the first half of 2025, CDMO Matica Biotechnology secured over 10 new manufacturing projects. Furthermore, therapy developers are building their own capacity, with Encoded Therapeutics completing the construction of a new manufacturing facility in 2025 for its Dravet syndrome gene therapy candidate.
Competitive Focus Intensifies On Oncology and Intellectual Property Dominance
The competitive landscape of the cell and gene therapy market is being defined by a sharp focus on high-need areas like oncology and the strategic accumulation of intellectual property. A remarkable 13 of the 15 largest pharmaceutical companies are now actively investing in cell and gene therapy, signaling its establishment as a core area of future growth. Oncology remains a dominant focus, with 178 new oncology-focused drug candidates having entered the late-stage pipeline in the past year. The pipeline is crowded with candidates for specific cancers, including 98 gene therapies for myeloma, 79 each for acute myelogenous leukemia and non-Hodgkin's lymphoma, 74 for B-cell lymphoma, and 64 for ovarian cancer.
Alongside pipeline development, key players in the cell and gene therapy market are building formidable patent estates to protect their innovations. An analysis of patents from 2020-2024 reveals Bristol Myers Squibb as a leader, holding a total of 164 patents, including 92 specifically for gene therapies. Other major players are also solidifying their positions, with Novartis having secured 61 patents in the CGT field. Gilead and its subsidiary Kite have a portfolio of 40 total patents in this area, 34 of which are specifically focused on cancer treatments, reflecting the deep strategic link between oncology and intellectual property in this market.
Expanding Patient Access Defines The Next Vital Frontier For Growth
Ultimately, the success of the cell and gene therapy market will be measured by its ability to reach patients in need. The potential patient populations for many targeted diseases are significant, representing a massive opportunity for growth and societal impact. Key estimates include a patient population of 25,000 for severe sickle cell disease and a potential patient pool of 39,000 individuals for Duchenne muscular dystrophy. In the US alone, over 100,000 patients are living with sickle cell disease who could potentially be cured by new therapies. Other targeted rare diseases include dystrophic epidermolysis bullosa, with 9,000 patients, and Danon disease, which affects an estimated 15,000 to 30,000 patients.
Real-world treatment data is beginning to demonstrate the impact of these therapies. In Saudi Arabia, the King Faisal Specialist Hospital has already treated over 100 patients with advanced CAR-T cell therapy, showcasing the global adoption of these treatments. The long-term outlook is exceptionally promising. The FDA projects that by 2034, over one million patients globally will have benefited from CGT treatments. This expanding patient access, driven by a growing number of approvals and increasing clinical adoption, represents the most crucial and promising frontier for the continued expansion of the cell and gene therapy market.
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Cell and Gene Therapy Market Major Players:
- ALLOGENE THERAPEUTICS
- Amgen Inc.
- Astellas Pharma Inc.
- Atara Biotherapeutics, Inc.
- Bayer AG
- Biomarin
- Bluebird Bio, Inc.
- Bristol-Myers Squibb Company
- Celgene Corporation
- Cellectis
- Gilead Sciences, Inc.
- Hoffmann-La Roche Ltd
- ImmunoACT
- Johnson & Johnson
- Krystal Biotech, Inc
- Novartis AG
- Orchard Therapeutics plc
- Sana Biotechnology
- uniQure NV.
- Vericel Corporation
- Other Prominent Players
Key Market Segmentation:
By Therapy Type
- Cell Therapy
- Stem Cell Therapy
- T-Cells
- Dendritic Cells
- NK Cells
- Gene Therapy
- In-vivGene Therapy
- Ex-vivGene Therapy
- Gene Editing Therapies
- RNA-Based Therapies
- Others
By Indication / Therapeutic Area
- Oncology
- Solid Tumors
- Genetic Disorders
- Neurological Disorders
- Cardiovascular Diseases
- Ophthalmology
- Musculoskeletal / Orthopedic Disorders
- Infectious Diseases
- Metabolic Disorders
- Others
By Vector Type (Gene Delivery Method)
- Viral Vectors
- Adeno-Associated Virus (AAV)
- Lentivirus
- Retrovirus
- Herpes Simplex Virus (HSV)
- Adenovirus
- Others
- Non-Viral Vectors
- Lipid Nanoparticles (LNPs)
- Naked DNA/RNA Plasmids
- Electroporation
- Gene gun / microinjection
- CRISPR-Cas Delivery Systems (non-viral)
- Others
By Manufacturing Type
- In-house
- Contract Development & Manufacturing Organizations (CDMOs)
- Hybrid Models (e.g., early stage in-house, scale-up outsourced)
- Others
By End User
- Hospitals and Specialty Clinics
- Academic and Research Institutes
- Biopharma and Biotech Companies
- CDMOs and CROS
- Government/Public Health Bodies
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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