Cell and Gene Therapy Manufacturing Services Market is projected to grow to US$ 23.42 billion by 2033 | Oxford Biomedica plc, SGS SA, Catalent Inc, Takara Bio Inc, FUJIFILM Irvine Scientific, Lonza

The Cell and Gene Therapy Manufacturing Services market was valued at US$ 6.61 billion in 2024 and is anticipated to grow substantially, reaching around US$ 23.42 billion by 2033. This reflects a compound annual growth rate (CAGR) of 15.2% over the forecast period from 2025 to 2033.

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Key Market Drivers:

Rising Demand for Advanced Therapies:
The increasing number of approved and pipeline cell and gene therapies for rare diseases, oncology, and genetic disorders is driving demand for scalable, compliant manufacturing services.

Growth of Outsourcing Models:
Biopharma companies are increasingly outsourcing manufacturing to specialized CMOs/CDMOs to reduce costs, accelerate time to market, and access technical expertise particularly for viral vector production and cell expansion.

Regulatory Support and Fast-Track Approvals:
Favorable regulatory frameworks across multiple regions such as FDA's RMAT, EMA's PRIME, and Japan's SAKIGAKE program encourage investment and accelerate product development timelines.

Technological Advancements in Bioprocessing:
Innovations in closed system bioprocessing, automation, and single-use technologies are enhancing production efficiency and product consistency, making it easier to meet regulatory and commercial demands.

Surge in Clinical Trials:
The expanding number of clinical trials for CAR-T therapies, stem cell-based interventions, and gene-editing treatments is fueling demand for GMP-compliant manufacturing support, from early-stage development through to commercialization.

Strategic Collaborations and Investments:
Collaborations between biotech firms, academic institutions, and manufacturing service providers are fostering the development of robust supply chains and scalable production models globally.

Market Segments:
• By Type (Cell Therapy, Gene Therapy)
• By Indication (Cancer, Cardiovascular Diseases, Orthopedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases, Others)
• By Application (Clinical Manufacturing, Commercial Manufacturing)
• By End User (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, Others)

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Market Geographical Share:
• North America holds a dominant share in the cell and gene therapy manufacturing services market. This is largely due to the region's advanced healthcare infrastructure, significant investment in regenerative medicine, and the presence of leading biotech companies. The U.S., in particular, benefits from expedited regulatory pathways like the FDA's RMAT designation and growing numbers of clinical trials for novel therapies.

• Europe is a major contributor, with countries such as Germany, the UK, France, and Switzerland at the forefront. Supportive regulatory frameworks, including the European Medicines Agency's (EMA) accelerated pathways for advanced therapy medicinal products (ATMPs), contribute to the growth. Strong academic-industry collaborations and funding for gene therapy research further enhance the region's position.

• Asia-Pacific is emerging as a high-growth region in this market. Japan and South Korea have made considerable advances in cell-based therapies, supported by government policies that fast-track approval and encourage local innovation. China is rapidly expanding its capabilities, with large investments in biomanufacturing infrastructure and a rising number of contract manufacturing organizations (CMOs).

• Latin America & Middle East/Africa: These regions are currently in earlier stages of development but show potential. Brazil and South Africa are investing in biotechnological capabilities, while other countries in these regions are forming partnerships with global players to gain access to cell and gene therapy manufacturing services.

Cell and Gene Therapy Manufacturing Services Market Major Companies:
The major companies are Charles River Laboratories, Thermo Fisher Scientific Inc., Lonza, Merck KGaA, Catalent, Inc, Takara Bio Inc., FUJIFILM Irvine Scientific, Oxford Biomedica plc, SGS SA, and Made Scientific.

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Key M&A Moves:

AstraZeneca acquirES EsoBiotec (~$1 billion): In March 2025, AstraZeneca completed an acquisition of Belgian biotech EsoBiotec for up to $1 billion, securing novel in‐vivo CAR‐T technology that simplifies treatment to a single injection rather than multi-week ex vivo processes significantly reducing manufacturing complexity and cost.

Eli Lilly acquires Verve Therapeutics (~$1.3 billion): Lilly agreed to acquire Verve Therapeutics in mid‐2025 (up to $1.3 billion), integrating its CRISPR-based gene-editing platform targeting cardiovascular disease marking a major strategic expansion into in vivo gene therapy manufacturing capacity.

Roche acquires Poseida Therapeutics (up to $1.5 billion): Finalized in early 2025, Roche acquired Poseida Therapeutics, gaining CAR T and cell therapy manufacturing platforms to scale off the shelf cell therapies for oncology and immunology.

AbbVie to acquire Capstan Therapeutics (~$2.1 billion): Announced in 2025, AbbVie will purchase Capstan Therapeutics to secure its in vivo anti CD19 CAR T platform (CPTX2309) and supporting lipid nanoparticle delivery capabilities.

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