Cell and Gene Therapy Market to reach US$ 105.83 Billion by 2033, growing at a CAGR of 21.5%, Cell Therapy segment holds 61.2% Market Revenue, North America led 46.8% share of Global Market

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.

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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.

United States: Key Industry Developments
✅ October 2025: Pfizer Inc. received FDA approval for its gene therapy Beqqsurion targeting hemophilia B, advancing one-time curative treatments with an optimized AAV vector for improved durability and safety profile.​

✅ September 2025: Vertex Pharmaceuticals and CRISPR Therapeutics launched Casgevy, the first CRISPR-based gene editing therapy approved for sickle cell disease and beta-thalassemia in the U.S

✅ March 2025: AstraZeneca acquired EsoBiotec - a Belgian biotech firm specialising in in-vivo cell therapy - for up to US$ 1 billion (US$ 425 million upfront + up to US$ 575 million in milestone-based payments). This deal brings EsoBiotec's novel lentiviral Platform (ENaBL) - capable of reprogramming immune cells in vivo via a simple IV injection - under AstraZeneca's umbrella, signalling a big push into scalable, off-the-shelf cell therapies for oncology and immune-mediated diseases.

✅ March 11, 2025: Bristol Myers Squibb completed acquisition of 2seventy bio for approximately US$ 286 million in cash. 2seventy bio is known for the CAR-T therapy product for multiple myeloma (sold under a brand name). The acquisition eliminates future profit-sharing on that therapy and consolidates BMS's position in CAR-T / cell therapy drugs.

Germany: Key Industry Developments
✅ June 10, 2025: Cellex Cell Professionals GmbH a Germany-based Contract Development and Manufacturing Organization (CDMO) in Cell & Gene Therapy announced a major GMP facility expansion. The upgraded facility now spans over 2,500 m with 43% cleanroom space across 37 workstations, bolstering its capacity to produce CGT/ATMP batches (autologous and allogeneic). This expansion strengthens manufacturing backbone for European CGT, supporting both clinical and commercial demand.

Recent Merges & acquisition
→ Pfizer completed its acquisition of FabCyte, a clinical-stage gene therapy startup focused on Duchenne muscular dystrophy, for USD 1.2 billion in July 2025, instantly broadening its gene therapy footprint.​

→ Bristol Myers Squibb secured a $600 million upfront deal with Mammoth Biosciences in June 2025 to co-develop CRISPR-based therapies for rare genetic disorders.​

→ Novartis expanded its U.S. manufacturing capabilities by acquiring Cellura Bioproduction in early 2025.​

→ AbbVie pursued a $2.1 billion deal in in vivo chimeric antigen receptor (CAR) T-cell therapy, marking one of the hottest areas in cell and gene therapy dealmaking for 2025

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Market Segmentation-

Segmentation by Therapy Type
→ Cell Therapy: This segment encompasses therapies using living cells, such as stem cell treatments (hematopoietic, mesenchymal) and T-cell therapies (CAR-T and T-cell receptor-based), targeting regeneration and immune modulation for conditions like cancer and musculoskeletal disorders. It dominates the market with an estimated share of 61.2% in 2024-2025, fueled by clinical successes in oncology, regulatory approvals, and advancements in personalized medicine.​

→ Gene Therapy: This involves modifying genes via viral vectors (e.g., AAV, lentivirus) or non-viral systems, delivered ex vivo or in vivo, to treat genetic disorders and chronic diseases. In manufacturing contexts, it holds about 63.9% share in 2025 due to rising clinical trials and approved products for rare diseases.​

Segmentation by End User
→ Hospitals & Clinics: These facilities administer specialized cell and gene therapies by skilled professionals, often collaborating with pharma firms for new treatments. They lead with approximately 55.8% market share in 2025, driven by high demand for cancer therapies and infrastructure investments.​

→ Specialty Clinics and Others: Includes academic institutions, research labs, and contract organizations focused on R&D and niche applications. These hold the remaining ~44.2% share, supported by pipeline innovation but trailing due to scale limitations compared to hospitals.​

Segmentation by Application
→ Oncology: Targets cancers via CAR-T and immunotherapies, addressing unmet needs in hard-to-treat cases. It represents the largest application segment, with dominant visibility in CDMO markets due to high prevalence and urgent therapy demands.​

→ Other Indications (Rare Genetic Disorders, Neurological, etc.): Covers genetic, cardiovascular, and infectious diseases using tailored cell/gene approaches. These account for the balance (~60-70% combined outside oncology), growing via expanded trials but secondary to cancer focus.

Regional insights:-

→ North America
North America leads the global CGT market due to strong FDA approval pipelines, high adoption of CAR-T therapies, advanced biomanufacturing capacity, and heavy biotech investment.
It holds the dominant market share of approximately 46.8% in 2025, driven by major players based in the U.S., supportive regulatory frameworks, and strong reimbursement momentum.

→ Europe
Europe is the second-largest regional market, supported by EMA approvals, expanding CGT manufacturing hubs in Germany, the UK, and Switzerland, and increasing rare-disease therapy uptake.
Europe accounts for around 29.5% of the market, with growth fueled by government-backed innovation programs and major clinical trial activity.

→ Asia-Pacific (APAC)
APAC is the fastest-growing region, with strong investments in CGT manufacturing, stem-cell therapy expansion, and government support in China, Japan, South Korea, and Singapore.
The region holds about 17.6% of the global market, driven by lower manufacturing costs and rapid clinical research expansion.

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Competitive Landscape
→ 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

→ 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.

→ 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 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.

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