Cell and Gene Therapy Manufacturing Services Market is set to reach US$ 23.42 Billion by 2033, at a strong CAGR of 15.2%, North America leads the market with 45.47% of market share | Major Players:- Charles River Laboratories, Thermo Fisher Scientific Inc

Cell and Gene Therapy Manufacturing Services Market size reached US$ 6.61 Billion in 2024 and is expected to reach US$ 23.42 Billion by 2033, growing at a CAGR of 15.2% during the forecast period 2025-2033.

DataM Intelligence unveils its latest report on the "Cell and Gene Therapy Manufacturing Market size 2025," offering an in-depth analysis of market trends, growth drivers, competitive landscape, and regional dynamics. The study covers market size in value and volume, CAGR forecasts, and emerging opportunities that can guide businesses in seizing growth potential and crafting winning strategies. Packed with data-driven insights on current developments and future trends, this report is essential for companies aiming to stay ahead in the competitive Market.

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United States: Key Industry Developments ( 2025)

✅ October 2025: Catalent launched new gene therapy fill-finish services for clinical and commercial products, enhancing speed and scalability of GMP manufacturing workflows in the U.S. advanced therapy market.

✅ September 2025: Charles River Laboratories expanded its cell therapy manufacturing capabilities to provide integrated services spanning early development through GMP production, streamlining workflows for biotech clients.

✅ August 2025: Samsung Biologics partnered with U.S. stakeholders to offer contract manufacturing services for both autologous and allogeneic cell therapies, accelerating production timelines and quality standards.

✅ July 2025: WuXi AppTec expanded its U.S. cell therapy production platforms, focusing on high-throughput capabilities and enhanced GMP-compliant operations to meet increased clinical and commercial demand.

Japan: Key Industry Developments (2025)

✅ November 2025: Takeda Pharmaceutical expanded its gene therapy manufacturing facilities to boost viral vector production capacity, supporting next-generation treatments and scalability for domestic and global pipelines.

✅ October 2025: CMIC Group launched GMP-compliant cell therapy manufacturing services aimed at domestic biotech companies, accelerating clinical trial readiness and scalable production.

✅ October 2025: Cell Therapies Pty Ltd and Teijin Limited signed a strategic collaboration to expand GMP manufacturing capacity and streamline cross-border CGT supply and regulatory alignment in Japan and the Asia Pacific region.

✅ September 2025: Nikon CeLL Innovation committed 10 billion yen investment to expand regenerative medicine CDMO facilities in Tokyo, enhancing manufacturing space and capabilities for CAR-T, iPS, and other cell therapy products.

✅ September 2025: JCR Pharmaceuticals invested in automated cell processing systems to improve throughput, consistency, and regulatory compliance in regenerative medicine manufacturing.

📌 Cell and Gene Therapy Manufacturing Market 2025-26 M&A Deals

→ In January 2026, Minaris Advanced Therapies expanded its manufacturing partnership with Genetix Biotherapeutics to scale commercial manufacturing of LYFGENIATM (lovotibeglogene autotemcel), increasing production capacity and operational efficiency to meet rising gene therapy demand (partnership rather than acquisition)

→ In August 2025, AbbVie completed the acquisition of Capstan Therapeutics, a clinical-stage cell therapy biotechnology company developing in vivo targeted lipid nanoparticle (tLNP) CAR-T platforms, for up to $2.1 billion in cash. This deal adds Capstan's proprietary in-body CAR-T engineering capabilities and complements AbbVie's cell therapy strategy.

→ In August 2025, Kite, a division of Gilead Sciences, acquired Interius BioTherapeutics for $350 million in cash to integrate its in-vivo CAR-T cell therapy platform into Kite's cell therapy pipeline and enhance next-generation cell therapy manufacturing and delivery capabilities.

→ In January 2025, Genenta Science strengthened its collaboration with AGC Biologics by amending their Development and Master Services Agreement to include an exclusive GMP suite at AGC's Cell and Gene Center of Excellence in Milan, significantly enhancing Genenta's capacity for manufacturing its cell therapy product under GMP conditions (strategic manufacturing partnership rather than outright M&A).

Market Growth Drivers:-

● One of the most compelling data points driving this market is the sheer volume of emerging therapies moving through development. Today, there are over 1,500 registered cell and gene therapy clinical trials, with a heavy concentration in early phases (Phase I and II). This robust pipeline is a bellwether for future commercial demand, as therapies advance toward later-stage trials and eventual approval.

● 65% of advanced therapy production is outsourced to Contract Development and Manufacturing Organizations (CDMOs), compared to only ~35% for typical biologics.

● This trend underscores the strategic importance of external partners who can provide infrastructure and expertise that many biotech firms lack in-house.

● Cell therapies such as CAR-T are demonstrating unprecedented efficacy in oncology segments that were previously underserved.

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Cell and Gene Therapy Manufacturing Market Major Players:-

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, among others

Key players highlights:-

● Lonza Group AG (15.24% market share) - Lonza leads with the largest share in CGT manufacturing services and strong global viral vector & cell therapy production capabilities.
Lonza is widely recognized for its end-to-end contract manufacturing solutions supporting clinical through commercial supply.

● Thermo Fisher Scientific Inc. (11.35% market share) - Thermo Fisher commands a major share with integrated bioprocessing platforms and modular manufacturing solutions for cell/gene therapies.
The company's offerings include closed systems and automated workflows that help reduce contamination risk and accelerate production.

● Catalent, Inc. (10.21% market share) - Catalent holds significant share driven by its expanding CGT CDMO services and plasmid DNA/viral vector capabilities.
It focuses on scalable manufacturing and specialized delivery solutions for advanced therapies globally.

● Charles River Laboratories (8% market share) - Charles River is a key CDMO player known for high-quality analytical, process development, and lentiviral vector support.
Its global network and collaborations help accelerate preclinical to clinical manufacturing for gene therapies.

● Merck KGaA (5% market share) - Merck provides critical bioprocessing tools and services that support CGT production, including media, reagents and platform technologies.
Its focus on innovation in scalable workflows strengthens its positioning among cell and gene therapy manufacturers.

Cell and Gene Therapy Manufacturing Services Market Regional Highlights

North America

North America holds the largest global share (45.47%) of the cell and gene therapy manufacturing services market driven by a strong biopharmaceutical base and robust R&D infrastructure.
The U.S. and Canada benefit from favorable regulatory pathways and high concentration of leading CDMOs supporting commercial and clinical manufacturing.
Continuous investments, advanced facilities, and governmental support sustain market leadership and ongoing expansion in service capabilities.

Europe

Europe is the second-largest regional market with a significant share (2.29%) owing to established regulatory frameworks and collaborative research networks.
Countries like Germany, the U.K., and France lead in manufacturing infrastructure development and cross-border partnerships.
Robust government support and EMA harmonization efforts are driving increasing commercialization of advanced therapies.

Asia Pacific

Asia Pacific is a rapidly growing region (19.2% share) with the fastest CAGR expected due to rising healthcare investments and expanding biotech sectors.
China, Japan, and South Korea are key markets expanding clinical trials and local CDMO capacities.
Improved regulatory frameworks and government initiatives are accelerating adoption and infrastructure build-out.

Latin America

Latin America currently holds a smaller share (5%) but shows growth potential with rising healthcare investments and adoption of innovative therapies.
Brazil leads regional development with expanding manufacturing and clinical activities.
Increasing awareness and partnerships with global players support broader service uptake

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Market Segmentation:-

The Cell and Gene Therapy Manufacturing Services Market is segmented across multiple dimensions to capture its diverse service landscape and demand patterns.

By Type, the market includes cell therapy manufacturing services and gene therapy manufacturing services. Cell therapy services dominate due to rising demand for autologous and allogeneic therapies, while gene therapy services are expanding rapidly with increased viral vector production needs.

By Indication, the market is segmented into oncology, cardiovascular diseases, neurological disorders, rare diseases, and others. Oncology holds the largest share, driven by the growing number of CAR-T and gene-modified cancer therapies in clinical pipelines.

By Application, the market is divided into clinical manufacturing and commercial manufacturing. Clinical manufacturing accounts for a significant share due to the high volume of therapies in early- and mid-stage trials, while commercial manufacturing is growing as more therapies receive regulatory approvals.

By End User, the market includes pharmaceutical and biotechnology companies, contract research organizations (CROs), and academic & research institutes. Pharmaceutical and biotechnology companies lead the segment due to their strong investment in outsourced manufacturing to reduce costs and accelerate timelines.

By Region, North America dominates the market owing to advanced biomanufacturing infrastructure and high therapy approvals, followed by Europe with strong regulatory support. Asia Pacific is the fastest-growing region due to expanding CDMO capabilities, while Latin America and the Middle East & Africa show steady growth with improving healthcare investments.

Cell and Gene Therapy Manufacturing Services Market - FAQs

Q1: What is driving growth in the Cell and Gene Therapy Manufacturing Services Market?
A: Rising clinical pipelines, outsourcing by biopharma firms, and demand for scalable GMP manufacturing are key drivers.

Q2: Which services dominate the Cell and Gene Therapy Manufacturing Services Market?
A: Process development, viral vector manufacturing, and fill-finish services hold major market share.

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