CGT CDMO Market Size, Share, Growth, and Industry Analysis, By Type (Immune Cells, Stem Cells, Viral Vectors, Plasmid DNA), By Application (Pharmaceutical and Biotechnology Companies, Research and Academic Institutions, Hospitals, Others) and Regional Forecast to 2034

CGT CDMO MARKET OVERVIEW

The global CGT CDMO Market size was USD 18.37 billion in 2025 and is projected to touch USD 57.41 billion by 2034, exhibiting a CAGR of 10.91% during the forecast period. 

The Cell and Gene Therapy (CGT) Contract Development and Manufacturing Organization (CDMO) market is experiencing strong growth, driven by the rapid expansion of advanced therapies targeting rare diseases, cancers, and genetic disorders. The CGT CDMOs offer complete integrated solutions that consist of process development, manufacture, analytical testing, regulatory and commercialization support, which allow biopharmaceutical firms to expedite their time-to-market and cut the costs of infrastructure investments. The market has increased approval of cell and gene therapies, cell and gene spend by R&D and a global pipeline of clinical stage candidates which increases the market. The highly specialized manufacturing processes including viral vector production, cell processing and gene editing/modification technologies are in huge demand and are aided by the advances in automation, closed-system commercial manufacturing and single-use technologies to the extent of greater scalability and low parts contamination risks. The competitive environment is reorganizing itself in terms of strategic alliance, mergers, and capacity expansion efforts as players are investing in state of the art facilities, quality performance, and global supply chain networks in order to stay compliant with high regulatory compliances across regions. North America dominates the current market as biotechnology in the region is highly developed and favorable policies are combined with increasing clinical trial activity and increasing investment inflow whereas Asia-Pacific, as well as Europe, are the emerging market due to favorable policies and increasing clinical trial activities and investment inflow. Problems continue to be shown along the lines of expensive production capabilities, lack of skills and talent pool and complex regulatory pathways but the move towards decentralization of manufacturing, integration of services and improvement of processes is predicted to overcome this. With ongoing addition of the pipeline of CGT products and subsequent growth in the rates of commercialization, CGT CDMO market is set to grow in the long-term to provide vital infrastructure and services that fill a gap between innovative science and patient access on the large scale.

GLOBAL CRISES IMPACTING CGT CDMO MARKET- US TARIFF IMPACT

Primary Impact on the CGT CDMO Market with Focus on its Relation to US Tariffs

There is a tariff on imported raw materials and equipment necessitated by the US that is imposing cost pressure on the CDMO Market in the CGT. Such tariffs are raising the cost of production, and in particular advanced cell and gene therapy manufacturing processes. The increase in operation cost can also result in higher service prices that could affect the small biotechnology companies. Nonetheless, the domestic producers in the United States enjoy less competition through lower priced imports. This movement in the estimation of trade is inviting local production ability in the United States CGT CDMO market.

LATEST TRENDS

Rising demand for full-service providers as One of the Leading Factors of Change

The most recent shift in the CGT CDMO market is the increased need of companies in full-service suppliers as more biotech and pharmaceutical firms are finding advantage in collaborating with partners that can do it all, especially early-stage development to commercial production. The integrated way of doing things helps to cut down timelines, save costs and manage resources better. Long-term and strategic partnerships are also being increasingly popular, leading to greater cooperation and the possibility of producing at a large scale. The advanced manufacturing technologies are also gaining attraction in order to enhance efficiency and quality of the processes. Venturing into this will be propelling innovation and competitiveness in the CGT CDMO sector.

CGT CDMO MARKET SEGMENTATION

BASED ON TYPES

• Immune Cells: Immuno segment The immuno segment in CGT CDMO market is expanding at a high pace with evidence of rising use of CAR-T and TCR-based products in the fields of cancer and autoimmune disorders. CDMOs are paying attention to increased production, regulatory compliance related to increased demand in the global market.
• Stem Cells: Stem cells are an area of interest in regenerative medicine, which leads to demand in cell-specific CDMO services in cell isolation, expansion and differentiation. The evolution of the stem cell therapies is driving the CDMOs to invest in the most modern manufacturing platforms.
• Viral Vectors: Viral vectors are still an important delivery tool regarding gene therapy and high demand as part of therapies in clinical and commercial purposes. CDMOs are creating more capacity as well as implementing superior technologies to scale production of high-quality vectors.
• Plasmid DNA: One crucial raw material that both will power the viral vector and mRNA-based therapies is plasmid DNA, which is driving expansion of its CDMO segment. Manufacturers are improving output and intervention on quality control to aid the upsurge of gene therapy and vaccines.

BASED ON APPLICATIONS

• Pharmaceutical and Biotechnology Companies: Clients of CGT CDMOs are mostly pharmaceutical and biotechnology companies, which outsource the manufacture to drive proceedings with therapies development and commercialisation. Development efforts in the increasing pipeline of cell and gene therapies are fuelling collaborations to develop scalable, compliant and cost-effective manufacturing.
• Research and Academic Institutions: CGT CDMOs assist research and academic institutions with specialized manufacturing solutions that can be used in early-stage discovery, and the clinical trial phase. Such partnerships allow ready access to high technologies and the knowledge with no internal infrastructure.
• Hospitals: CGT CDMOs are working in hospitals to help provide personalized cell and gene therapy manufacturing to inject customized medicines into patients. This partnership increases access to the most advanced treatments at the same time as meeting high quality and regulatory standards.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

DRIVING FACTORS

Rising Demand for Cell and Gene Therapies Drives Growth

The growing market need of advanced cell and gene therapies across the world to treat rare, chronic and gene-based diseases is driving the CGT CDMO Market growth. These treatments provide curative and precise solutions, which contributes to the interests of health practitioners and patients. The growth in the pipeline of new therapies at various stages of development has generated outward advancement in the outsourcing requirements. CGT CDMOs offer the experience, facilities, and regulatory processes needed to produce on an industrial scale. This trend is likely to intensify with the increase in the number of therapies getting regulatory approvals across the globe.

Increasing Outsourcing by Biopharma Companies Drives Growth

There are more biopharmaceutical companies bringing their cell and gene therapy manufacturing in-house to CDMOs as they are complex and expensive to produce internally. Creation of high-quality therapy involves constructions of special premises, qualified staff, and strict oversight and observance of regulations. CDMOs can provide flexible and scalable services to companies so that they can concentrate on the R&D with the assurance of effective production. The model condenses the time to market and contributes to the fast commercialization in the competitive environment. Consequently, the number of strategic alliances between CDMOs and biopharma companies is rising considerably.

RESTRAINING FACTOR

High Manufacturing and Development Costs Impedes Growth

The extreme expense concerning the manufacturing and the development of the cell and the gene therapies is also one of the central inhibitors in the CGT CDMO market. Such treatments involve the use of sophisticated technologies, specialized centres and highly competent practitioners, which make them costly to invest in. Also, their highly complicated production processes tend to cause low yields, and excessive wastage thereby demanding more money. Biotech companies of smaller size might not be able to come out with mass productions causing unreliability in the market. Such cost obstacle may decelerate the overall adoption and commercializing of CGT therapy.

OPPORTUNITY

Expansion in Personalized Medicine Creates Opportunities

Personalized medicine is a focus that is growing and this is a massive opportunity to the CGT CDMO market. The cell and gene therapies have generic compatibility with the personalised treatment options, depending on the genetic disease pathway and profile of patients. The increased ability to stratify patients and use genetic testing and diagnostics will lead to an increase in demand of bespoke manufacturing. CDMOs have the advantage of using this trend to position their services based on flexible production, small batch, and adaptive production. This is also a move towards precision healthcare and as such this will make the market to grow in the long run.

CHALLENGE

Complex Manufacturing and Quality Control Creates Challenge

One industry challenge with the CGT CDMO market is the complexity of the process of manufacturing and its assurance of high quality control. Advanced biological materials used in cell and gene therapies are at a sensitive level and should be handled in special facilities, by highly qualified staff and must comply with strict regulatory measures. Raw materials and process variability expose the company to risk of producing an inconsistent end product. Production is made more complicated and expensive by the needs to comply with regulators globally. This complexity may reduce scalability and reduce commercialization activity.

CGT CDMO MARKET REGIONAL INSIGHTS

• NORTH AMERICA

The North American leads the CGT CDMO Market Share because of its developed healthcare system, good research abilities, and large biotechnology corporations. United States CGT CDMO Market is the biggest in the region owing to heavy investments into cell and gene therapy research and manufacture buildings. Beneficial regulatory channels and government funding helps in supporting the pace in which therapies develop in the country. Another advantage that the U.S. poses to other competitors is a strong network of CDMOs that have specialties in viral vector and plasmid DNA manufacturing. Such an ecosystem makes the United States a world leader in terms of CGT CDMO developments.

• EUROPE

In Europe, the biopharmaceutical industry market and efforts towards growing investments in ATMP are giving a boost to the CGT CDMO Market. Germany, the U.K. and France are ahead in cell and gene therapy R&D and clinical trials. The area has favorable regulatory categories, including fast-track processes of innovative treatment that the EMA provides. Production capabilities are being propelled by collaborations between academia institutions, biotech firms, and CDMOs. The union of innovation and infrastructure makes Europe a stronger part of the CDMO industry in the entire world.

• ASIA

Asia contributes to the CGT CDMO Market through rapid expansion of biotech hubs in countries like China, Japan, and South Korea. Rising government funding and favorable policies are accelerating cell and gene therapy research. The region is witnessing growing investments from global CDMOs to establish manufacturing facilities. Strong talent pools and cost-effective production capabilities attract international partnerships. This growth positions Asia as a competitive player in the global CGT CDMO industry.

KEY INDUSTRY PLAYERS

Major Players Consider the Use of Strategy Partnerships, Innovative Technologies

Major players in the industry are also playing a major role in ensuring that CGT CDMO Market grows, considering the use of strategy partnerships, innovative technologies, as well as capacity. They are not only spending a lot of money in the newest manufacturing plants to ensure the ever-increasing need of cell and gene therapy. Mergers, acquisitions and partnerships are some of the activities many are resorting to in boosting service portfolios and coverage. They also simplify operations of clients by providing integrated services that include process development, to subsequent commercial manufacturing. Constant reinvention in production and the quality control is optimizing the product efficiency and regulatory compliance. All these initiatives enhance the competitiveness and growth pattern of the CGT CDMO Market on the international front.

LIST OF TOP CGT CDMO COMPANIES

• Lonza (Switzerland)
• Catalent (U.S.)
• Thermo Fisher Scientific (U.S.)
• WuXi AppTec (China)
• Charles River Laboratories (U.S.)
• GenScript (China)
• Oxford Biomedica (U.K.)
• Fujifilm Diosynth Biotechnologies (Japan)
• Minaris Regenerative Medicine (Japan)
• AGC Biologics (U.S.)

KEY INDUSTRY DEVELOPMENT

June 2025:  ProBio Inc. has established a 128,000 square foot cGMP Plant focusing on plasmid DNA and viral vector production that has demonstrated quality yet cost-effective manufacturing of cutting-edge biopharmaceuticals to Hopewell, New Jersey- its flagship Cell & Gene Therapy Center of Excellence. The new facility has been built specifically to suit a higher end of manufacturing and has generated more than 110 high skilled biomanufacturing positions.

REPORT COVERAGE

This report is based on historical analysis and forecast calculation that aims to help readers get a comprehensive understanding of the global CGT CDMO Market from multiple angles, which also provides sufficient support to readers’ strategy and decision-making. Also, this study comprises a comprehensive analysis of SWOT and provides insights for future developments within the market. It examines varied factors that contribute to the growth of the market by discovering the dynamic categories and potential areas of innovation whose applications may influence its trajectory in the upcoming years. This analysis encompasses both recent trends and historical turning points into consideration, providing a holistic understanding of the market’s competitors and identifying capable areas for growth.

This research report examines the segmentation of the market by using both quantitative and qualitative methods to provide a thorough analysis that also evaluates the influence of strategic and financial perspectives on the market. Additionally, the report's regional assessments consider the dominant supply and demand forces that impact market growth. The competitive landscape is detailed meticulously, including shares of significant market competitors. The report incorporates unconventional research techniques, methodologies and key strategies tailored for the anticipated frame of time. Overall, it offers valuable and comprehensive insights into the market
dynamics professionally and understandably.