Cell and Gene Therapy CDMO Market Size & Share 2026-2035

Cell and Gene Therapy CDMO Market Size

The cell and gene therapy CDMO market was valued at approximately USD 3.8 billion in 2025. The market is expected to grow from USD 4.4 billion in 2026 to USD 16.4 billion by 2035, registering a CAGR of 15.7% during the forecast period, as per the latest report published by Global Market Insights Inc. The market is experiencing robust growth, driven by the expanding pipeline of cell and gene therapies, increasing outsourcing of complex manufacturing activities, and rising demand for specialized contract development and manufacturing services. As the number of clinical and commercial advanced therapy products continues to increase, biotechnology and pharmaceutical companies are increasingly partnering with specialized CDMOs to access advanced manufacturing capabilities, reduce capital investments, accelerate development timelines, and ensure regulatory compliance.

The cell & gene therapy CDMO market comprises contract development and manufacturing organizations that provide end-to-end services for the development, manufacturing, testing, and commercialization of cell- and gene-based therapies. These services include process development, analytical method development, technology transfer, viral vector manufacturing, plasmid DNA production, cell processing, clinical and commercial manufacturing, aseptic fill-finish, quality control, regulatory support, cold-chain logistics, and supply chain management. By offering integrated solutions across the product lifecycle, from preclinical development through commercial manufacturing, CDMOs enable therapy developers to efficiently advance innovative cell and gene therapies while minimizing operational complexity.

Major participants operating in the cell & gene therapy CDMO market include Lonza Group, Catalent (Novo Holdings), Thermo Fisher Scientific, FUJIFILM Diosynth Biotechnologies, WuXi Advanced Therapies, Charles River Laboratories, Samsung Biologics, and other leading contract manufacturing organizations. These companies continue to strengthen their market positions through strategic capacity expansions, investments in viral vector manufacturing, plasmid DNA production, cell processing technologies, and automated manufacturing platforms, as well as acquisitions, technology platform enhancements, and long-term partnerships with biotechnology innovators. Their ongoing focus on closed-system manufacturing, process automation, digital manufacturing technologies, and regulatory compliance is improving manufacturing scalability, product quality, and commercialization efficiency.

The growing incidence of cancer, rare genetic disorders, autoimmune diseases, and inherited metabolic disorders continues to drive demand for specialized cell and gene therapy manufacturing services. Cell and gene therapies are increasingly being developed for indications such as hematological malignancies, spinal muscular atrophy (SMA), sickle cell disease, β-thalassemia, hemophilia, inherited retinal disorders, Duchenne muscular dystrophy, Parkinson's disease, and various solid tumors. According to the World Health Organization (WHO), approximately 10 million cancer-related deaths occurred globally in 2022, while more than 300 million people worldwide are estimated to be living with rare diseases. The expanding clinical pipeline targeting these conditions is driving biotechnology companies to increasingly outsource development and manufacturing activities to specialized CDMOs capable of providing flexible manufacturing capacity, process development expertise, and regulatory support.

The cell & gene therapy CDMO market demonstrated strong historical growth between 2022 and 2024, supported by increasing outsourcing activities, expansion of GMP-compliant manufacturing infrastructure, and rising investments in advanced therapy manufacturing capabilities. During this period, CDMOs announced multiple facility expansions across North America, Europe, and Asia Pacific to address growing capacity requirements for viral vector manufacturing, plasmid DNA production, cell processing, and aseptic fill-finish services. In addition, strategic collaborations between biotechnology companies and CDMOs became increasingly prevalent, enabling faster technology transfer, accelerated clinical development, and efficient commercial manufacturing while allowing therapy developers to focus on research, clinical advancement, and regulatory approvals.

Cell and Gene Therapy CDMO Market Trends

• The cell & gene therapy CDMO market is expected to witness robust growth, driven by the expanding pipeline of advanced therapies, increasing regulatory approvals, rising outsourcing of complex manufacturing processes, and continuous advancements in manufacturing technologies. As biotechnology and pharmaceutical companies accelerate the development of cell and gene therapies, the demand for specialized CDMO services across development, clinical manufacturing, and commercial production continues to increase.
• A key trend shaping the cell & gene therapy CDMO market is the growing number of regulatory approvals and positive late-stage clinical outcomes for advanced therapies, which is increasing the demand for scalable contract development and manufacturing services.
• Another major trend is the increasing adoption of next-generation manufacturing technologies, including closed-system automation, digital process monitoring, single-use bioprocessing systems, continuous manufacturing platforms, and AI-enabled process optimization. These technologies improve manufacturing consistency, enhance process reproducibility, reduce contamination risks, and support efficient commercial-scale production.
• The market is also witnessing substantial investments in manufacturing capacity for adeno-associated virus (AAV) vectors, lentiviral vectors, retroviral vectors, plasmid DNA, and other critical components used in cell and gene therapies. To address growing commercial demand and ongoing capacity constraints, leading CDMOs are expanding manufacturing facilities across North America, Europe, and Asia Pacific, while investing in modular cleanrooms, automation technologies, and large-scale bioprocessing infrastructure.
• Strategic collaborations among biotechnology companies, pharmaceutical manufacturers, and CDMOs continue to reshape the competitive landscape. Long-term manufacturing agreements, co-development partnerships, technology transfer collaborations, licensing agreements, and strategic acquisitions are enabling therapy developers to accelerate clinical and commercial programs while allowing CDMOs to broaden their service capabilities and strengthen long-term customer relationships.
• Supported by a rapidly expanding clinical pipeline, increasing regulatory approvals, continuous technological innovation, broader therapeutic applications, and sustained investments in advanced manufacturing infrastructure, the cell & gene therapy CDMO market is expected to maintain strong growth throughout the forecast period.

Cell and Gene Therapy CDMO Market Analysis

Based on the product type, the cell and gene therapy CDMO market is divided into cell therapy and gene therapy. The cell therapy segment dominated the market in 2025, with revenue of USD 2.8 billion.

• The segment accounted for the largest share of the market, driven by the growing commercialization of cell therapies, an expanding clinical pipeline, and increasing outsourcing of complex manufacturing processes to specialized CDMOs.
• Manufacturing autologous and allogeneic cell therapies requires advanced expertise in cell isolation, genetic modification, cell expansion, cryopreservation, quality control, aseptic processing, and cold-chain logistics, prompting biotechnology and pharmaceutical companies to increasingly partner with experienced CDMOs.
• The commercial success of approved CAR-T cell therapies, including Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti, and Aucatzyl, has significantly increased demand for commercial-scale manufacturing services. In addition, approvals of next-generation cell therapies such as Amtagvi (tumor-infiltrating lymphocyte [TIL] therapy) and Tecelra (T-cell receptor [TCR-T] therapy) have broadened the therapeutic scope of cell therapy, particularly in oncology.
• A robust clinical pipeline, expanding investments in cell processing infrastructure, and ongoing development of allogeneic cell therapies, natural killer (NK) cell therapies, stem cell therapies, and other next-generation cell-based treatments continue to reinforce the segment's market leadership.
• The gene therapy segment is projected to expand at a CAGR of 16.1% during the forecast period. Growth is driven by increasing commercialization of gene therapies for rare genetic disorders, hematological diseases, inherited retinal disorders, neuromuscular disorders, and metabolic diseases, along with rising demand for outsourced manufacturing of viral vectors, plasmid DNA, gene-editing components, and other specialized biologics.

Based on the services, the cell and gene therapy CDMO market is segmented into contract development, contract manufacturing, analytical testing & quality control, fill-finish & packaging, regulatory support, and other services. The contract manufacturing segment dominated the market with a market share of 41.8% in 2025.

• The segment dominates the market due to increasing outsourcing of GMP-compliant manufacturing for viral vectors, plasmid DNA, autologous cell therapies, and allogeneic cell therapies.
• Growing commercialization of approved advanced therapies, combined with the need for scalable manufacturing capacity and specialized production expertise, continues to drive demand for end-to-end manufacturing services.
• The contract development segment is expected to grow at a CAGR of 15.5%, supported by increasing demand for process development, cell line development, technology transfer, manufacturing process optimization, and process scale-up. Early-stage biotechnology companies increasingly rely on CDMOs to accelerate product development while minimizing capital expenditure and operational complexity.
• The analytical testing & quality control segment is witnessing steady growth as regulatory agencies require comprehensive product characterization, potency assays, sterility testing, impurity analysis, and product release testing for advanced therapies. Increasing regulatory scrutiny continues to drive demand for specialized analytical and quality assurance services.
• The fill-finish & packaging segment is also gaining momentum due to the growing need for aseptic filling, cryogenic packaging, labeling, storage, and cold-chain logistics for temperature-sensitive cell and gene therapy products. Expanding commercial manufacturing and global product distribution are further supporting segment growth.

Based on the therapeutic area, the cell and gene therapy CDMO market is segmented into oncology, hematological disorders, rare genetic disorders, neurological disorders, ophthalmological disorders, dermatological disorders, immunological disorders, and other indications. The oncology segment dominated the market with a market share of 38.2% in 2025, while the rare genetic disorders segment accounted for the second-largest share.

• The oncology segment holds the largest market share owing to the high volume of clinical trials and commercial manufacturing of CAR-T, TCR-T, TIL, and other engineered cell therapies for hematological malignancies and solid tumors.
• Increasing regulatory approvals, expanding clinical pipelines, and growing commercialization of advanced oncology therapies continue to drive demand for specialized CDMO services across development and manufacturing.
• The rare genetic disorders segment accounted for the second-largest market share of 22%, supported by the growing commercialization of gene therapies for conditions such as spinal muscular atrophy (SMA), hemophilia, sickle cell disease, β-thalassemia, and other inherited disorders. The expanding orphan drug pipeline continues to increase demand for viral vector manufacturing and GMP production services.
• The neurological disorders segment is projected to register the fastest growth at a CAGR of 15.2%, driven by increasing development of gene therapies for Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Huntington's disease, and other central nervous system disorders. Advancements in CNS-targeted gene delivery technologies are expected to further accelerate outsourcing demand.
• The immunological disorders segment is also expected to witness strong growth, supported by increasing research into cell- and gene-based therapies for autoimmune and inflammatory diseases. Rising clinical activity and investments in engineered immune cell therapies are creating substantial opportunities for specialized CDMOs.

Based on the end use, the cell and gene therapy CDMO market is segmented into pharmaceutical companies, biotechnology companies, and other end users. The pharmaceutical companies segment dominated the market in 2025 and are anticipated to witness growth at a CAGR of 15.6%.

• The segment's leadership is driven by increasing investments by large pharmaceutical companies in advanced therapies through acquisitions, licensing agreements, strategic collaborations, and expansion of internal cell and gene therapy portfolios.
• Growing reliance on outsourced commercial manufacturing, integrated CDMO services, and specialized manufacturing infrastructure is expected to further strengthen demand from pharmaceutical companies.
• The biotechnology companies segment is anticipated to witness strong growth, driven by the large number of emerging biotechnology firms developing cell and gene therapies with limited in-house manufacturing capabilities.
• These companies increasingly depend on CDMOs for process development, GMP manufacturing, analytical testing, technology transfer, regulatory support, and commercial manufacturing to accelerate clinical development, optimize production processes, and successfully commercialize innovative advanced therapies.

North America Cell and Gene Therapy CDMO Market

In 2025, North America dominated the cell and gene therapy CDMO industry with a market share of 45.7% and is expected to maintain its leadership throughout the forecast period.

• The region benefits from a highly developed biotechnology ecosystem, advanced biomanufacturing infrastructure, and the presence of leading CDMOs such as Lonza, Thermo Fisher Scientific, Charles River Laboratories, Catalent, and FUJIFILM Diosynth Biotechnologies.
• North America remains at the forefront of cell and gene therapy innovation, supported by a robust clinical pipeline, strong venture capital funding, and a favorable regulatory environment that continues to accelerate the development and commercialization of advanced therapies.
• For instance, the U.S. FDA has approved nearly 50 cell and gene therapy (CGT) products through the Center for Biologics Evaluation and Research (CBER) over the past decade, driving sustained demand for specialized CDMO services, including process development, viral vector manufacturing, analytical testing, and commercial GMP manufacturing.
• The U.S. cell and gene therapy CDMO market was valued at USD 1.1 billion and USD 1.2 billion in 2022 and 2023, respectively. The market size reached USD 1.6 billion in 2025, growing from USD 1.4 billion in 2024.
• The U.S. represents the largest market in the region owing to its high concentration of therapy developers, extensive clinical trial activity, well-established funding ecosystem, and large-scale commercial manufacturing infrastructure.
• The country hosts one of the world's largest networks of cell and gene therapy developers and manufacturing facilities, generating strong demand for integrated CDMO services spanning preclinical development, clinical manufacturing, and commercial production.
• Increasing long-term manufacturing partnerships, technology transfer agreements, and strategic collaborations between therapy developers and CDMOs continue to strengthen the U.S. manufacturing ecosystem.

Europe Cell and Gene Therapy CDMO Market

Europe contributes substantially to the cell and gene therapy CDMO industry owing to its strong biotechnology research base, favorable regulatory environment, and growing commercialization of advanced therapies.

• The region benefits from well-established GMP manufacturing capabilities, a mature biotechnology industry, and increasing commercialization of cell and gene therapies across major European markets.
• Countries such as Germany, the UK, Switzerland, France, and Belgium are emerging as key hubs for viral vector manufacturing, cell processing, and advanced therapy development, supported by strong academic research and biotechnology innovation.
• The presence of leading CDMOs, coupled with continued investments in viral vector manufacturing, cell therapy production facilities, and advanced bioprocessing technologies, is driving regional market growth.
• A collaborative ecosystem involving academic institutions, biotechnology companies, pharmaceutical manufacturers, and CDMOs continues to accelerate process development, clinical manufacturing, technology transfer, and commercialization of advanced therapies throughout Europe.

Asia Pacific Cell and Gene Therapy CDMO Market

The Asia Pacific market is anticipated to witness the fastest growth at a CAGR of 16.7% during the forecast period.

• Asia Pacific has emerged as a major center for cell and gene therapy research and manufacturing, driven by increasing healthcare expenditure, rapid expansion of the biotechnology sector, and supportive government initiatives promoting regenerative medicine.
• Countries including China, Japan, South Korea, and India are making substantial investments in regenerative medicine, gene-editing technologies, viral vector production, and cell therapy manufacturing infrastructure.
• China has become one of the world's leading markets for cell and gene therapy clinical research, with a rapidly expanding pipeline of CAR-T therapies, stem cell therapies, and gene-editing programs, creating significant demand for contract manufacturing services.
• Japan continues to benefit from an accelerated regulatory pathway for regenerative medicine products, encouraging faster clinical development and commercialization of advanced therapies while supporting demand for specialized CDMO services.
• Growing outsourcing activities, competitive manufacturing costs, expanding patient populations, and the increasing prevalence of cancer, rare genetic disorders, and other chronic diseases continue to drive demand for cell and gene therapy CDMO services across the region.

Latin America Cell and Gene Therapy CDMO Market

Latin America is witnessing steady growth in the cell and gene therapy CDMO industry, driven by expanding biotechnology capabilities, increasing clinical research, and growing outsourcing of manufacturing services.

• Countries such as Brazil, Mexico, and Argentina are investing in biotechnology infrastructure, GMP manufacturing facilities, and advanced biopharmaceutical research to strengthen regional manufacturing capabilities.
• Rising clinical trial activity, increasing prevalence of cancer and rare genetic disorders, and growing interest in advanced therapeutic modalities are driving demand for specialized CDMO services, particularly for process development, viral vector manufacturing, and clinical-scale production.
• Strategic collaborations between regional biotechnology companies, academic institutions, healthcare organizations, and global CDMOs are facilitating technology transfer and improving access to advanced manufacturing capabilities.
• Continued investments in biotechnology innovation and expanding regulatory support are expected to strengthen the region's long-term growth prospects.

Middle East and Africa Cell and Gene Therapy CDMO Market

The Middle East & Africa market is expected to witness gradual growth during the forecast period.

• Countries including Saudi Arabia, the UAE, and South Africa are increasing investments in biotechnology infrastructure, precision medicine initiatives, regenerative medicine research, and biopharmaceutical manufacturing capabilities.
• Government-led healthcare transformation programs and growing efforts to establish local biologics manufacturing are creating new opportunities for CDMOs offering process development, analytical testing, viral vector manufacturing, and GMP production services.
• The region is witnessing increasing collaborations between healthcare providers, research institutions, biotechnology companies, and international CDMOs to strengthen technology transfer, workforce development, and manufacturing expertise.

Cell and Gene Therapy CDMO Market Share

The competitive landscape of the cell and gene therapy CDMO industry is characterized by the presence of large global contract development and manufacturing organizations (CDMOs) and advanced therapy manufacturing providers offering integrated development, analytical testing, GMP manufacturing, fill-finish, and regulatory support services. The top five players in this market include, Lonza Group, Thermo Fisher Scientific, Catalent, FUJIFILM Diosynth Biotechnologies, and WuXi Advanced Therapies, which collectively account for approximately 48% of the global market, supported by their extensive GMP manufacturing networks, broad service portfolios, and long-term partnerships with biotechnology and pharmaceutical companies. These companies continue to invest heavily in manufacturing capacity expansion, viral vector production, automation technologies, and global facility expansion to strengthen their market positions.

The market is also witnessing increasing strategic collaborations, long-term manufacturing agreements, acquisitions, and facility expansions aimed at expanding manufacturing capacity and supporting the rapidly growing pipeline of cell and gene therapies.

Cell and Gene Therapy CDMO Market Companies

Prominent players operating in the cell and gene therapy CDMO industry are as mentioned below:

• AGC Biologics
• Andelyn Biosciences
• Catalent, Inc. (Novo Holdings)
• Center for Breakthrough Medicines (CBM)
• Charles River Laboratories
• Forge Biologics
• FUJIFILM Diosynth Biotechnologies
• Genezen Laboratories
• Lonza Group
• Minaris Advanced Therapies
• National Resilience
• Oxford Biomedica
• Samsung Biologics
• SK pharmteco
• Thermo Fisher Scientific
• Viralgen
• WuXi Advanced Therapies (WuXi AppTec)

• Lonza Group

Lonza is one of the leading players in the global cell and gene therapy CDMO market, offering integrated services spanning process development, analytical testing, viral vector manufacturing, cell therapy manufacturing, aseptic fill-finish, and commercial GMP production. Through its global manufacturing network across North America, Europe, and Asia, the company supports biotechnology and pharmaceutical clients from early-stage development through commercial manufacturing.

• WuXi Advanced Therapies

WuXi Advanced Therapies is a prominent CDMO specializing in the development and manufacturing of cell and gene therapies, with expertise in viral vectors, plasmid DNA, cell processing, analytical testing, and GMP manufacturing. The company provides end-to-end solutions for autologous and allogeneic cell therapies as well as gene therapy products, supporting clients from preclinical development through commercial production. WuXi continues to expand its global manufacturing footprint and service capabilities through strategic investments in advanced manufacturing technologies, process optimization, and integrated development platforms, positioning itself as a key partner for biotechnology companies seeking scalable and cost-effective manufacturing solutions.

Cell and Gene Therapy CDMO Industry News

• In June 2024, Charles River Laboratories announced a strategic collaboration with the Gates Institute at the University of Colorado Anschutz Medical Campus to develop GMP-grade lentiviral vectors for next-generation CAR-T cell therapies targeting hematological cancers, strengthening the company's cell and gene therapy CDMO capabilities.
• In April 2025, Thermo Fisher Scientific announced an additional USD 2 billion investment in the U.S. over the next four years, including USD 1.5 billion to expand U.S. manufacturing operations and USD 500 million to accelerate innovation and R&D, reinforcing its contract development and manufacturing capabilities for the biopharmaceutical industry.
• In April 2025, Thermo Fisher Scientific launched the 5 L DynaDrive Single-Use Bioreactor, designed to provide seamless scalability from 5 L to 5,000 L, enabling faster process development and improved productivity while supporting efficient scale-up for biologics and cell and gene therapy manufacturing.
• In March 2025, WuXi Biologics launched the EffiX Microbial Expression Platform, a high-yield microbial expression system designed to enhance the production of recombinant proteins and plasmid DNA, supporting more efficient manufacturing of key components used in cell and gene therapies.

The cell and gene therapy CDMO market research report includes in-depth coverage of the industry with estimates and forecasts in terms of revenue in USD Million from 2022 - 2035 for the following segments:

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Market, By Product Type

• Cell therapy  
• Gene therapy
  • Viral vectors
  • Non-viral vectors

Market, By Services

• Contract development
• Contract manufacturing
• Analytical testing & quality control
• Fill-finish & packaging
• Regulatory support
• Other services

Market, By Therapeutic Area

• Oncology
• Hematological disorders
• Rare genetic disorders
• Neurological disorders
• Ophthalmological disorders
• Dermatological disorders
• Immunological disorders
• Other therapeutic areas

Market, By End Use

• Pharmaceutical companies
• Biotechnology companies
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea

• Latin America
  • Brazil
  • Mexico
  • Argentina

• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE