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    Cell Gene Therapy CDMO Market

    ID: MRFR/HC/26419-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Cell and Gene Therapy CDMO Market Research Report By Product (Cell Therapy, Gene Therapy), By Service (Contract Development, Contract Manufacturing), By Application (Oncology, Immunology, Neurology, Cardiovascular, Other Diseases), By End User (Biopharmaceutical Companies, Academic Institutions, Hospitals, Other End Users) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    Cell Gene Therapy CDMO Market Infographic
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    Cell Gene Therapy CDMO Market Summary

    As per MRFR analysis, the Cell and Gene Therapy CDMO Market was estimated at 35.89 USD Billion in 2024. The Cell and Gene Therapy CDMO industry is projected to grow from 44.34 USD Billion in 2025 to 366.93 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 23.53 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Cell and Gene Therapy CDMO Market is poised for substantial growth driven by technological advancements and increasing demand for personalized medicine.

    • North America remains the largest market for cell and gene therapy CDMO services, reflecting a robust biopharmaceutical landscape.
    • Asia-Pacific is emerging as the fastest-growing region, fueled by increasing investments in healthcare infrastructure and innovation.
    • Cell therapy continues to dominate the market, while gene therapy is rapidly gaining traction as a key growth segment.
    • The expansion of biopharmaceutical companies and advancements in manufacturing technologies are significant drivers of market growth.

    Market Size & Forecast

    2024 Market Size 35.89 (USD Billion)
    2035 Market Size 366.93 (USD Billion)
    CAGR (2025 - 2035) 23.53%

    Major Players

    Lonza (CH), Catalent (US), WuXi AppTec (CN), Samsung Biologics (KR), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), Aldevron (US), Novartis (CH), Celerion (US)

    Cell Gene Therapy CDMO Market Trends

    The Cell and Gene Therapy CDMO Market is currently experiencing a transformative phase, characterized by a surge in demand for advanced therapeutic solutions. This market appears to be driven by the increasing prevalence of genetic disorders and the growing need for personalized medicine. As biotechnology continues to evolve, contract development and manufacturing organizations (CDMOs) are adapting their capabilities to meet the specific requirements of cell and gene therapies. This adaptation includes the integration of cutting-edge technologies and streamlined processes, which may enhance efficiency and reduce time-to-market for innovative therapies. Moreover, the Cell and Gene Therapy CDMO Market seems to be influenced by strategic collaborations between pharmaceutical companies and CDMOs. These partnerships are likely aimed at leveraging expertise and resources to accelerate the development of novel therapies. Additionally, regulatory frameworks are evolving, potentially providing a more conducive environment for the approval of cell and gene therapies. As the market progresses, it may witness an increase in investment, fostering further advancements in manufacturing capabilities and quality assurance practices. Overall, the landscape of the Cell and Gene Therapy CDMO Market appears poised for substantial growth, driven by innovation and collaboration across the industry.

    Technological Advancements

    The Cell and Gene Therapy CDMO Market is witnessing rapid technological advancements that enhance manufacturing processes. Innovations in automation, data analytics, and bioprocessing are likely to improve efficiency and scalability. These developments may enable CDMOs to produce therapies more effectively, meeting the rising demand for personalized treatments.

    Strategic Partnerships

    Strategic partnerships between pharmaceutical companies and CDMOs are becoming increasingly common in the Cell and Gene Therapy CDMO Market. These collaborations appear to facilitate knowledge sharing and resource optimization, potentially accelerating the development timeline for new therapies. Such alliances may also enhance the overall quality of products.

    Regulatory Evolution

    The regulatory landscape surrounding cell and gene therapies is evolving, which could impact the Cell and Gene Therapy CDMO Market. As regulatory bodies adapt their guidelines, CDMOs may find it easier to navigate the approval process. This evolution may encourage more companies to invest in developing innovative therapies.

    The increasing complexity of cell and gene therapies necessitates a robust contract development and manufacturing organization (CDMO) ecosystem to support innovation and regulatory compliance in the biopharmaceutical landscape.

    U.S. Food and Drug Administration (FDA)

    Cell Gene Therapy CDMO Market Drivers

    Regulatory Support and Frameworks

    The Cell and Gene Therapy CDMO Market is positively impacted by evolving regulatory support and frameworks. Regulatory agencies are increasingly recognizing the potential of cell and gene therapies, leading to the establishment of more streamlined approval processes. This regulatory evolution is crucial for CDMOs, as it facilitates quicker market access for new therapies. In recent years, several countries have implemented expedited pathways for the approval of innovative treatments, which is expected to continue. As a result, CDMOs are likely to play a pivotal role in ensuring compliance with these regulations, thereby enhancing their value proposition to biopharmaceutical companies. The supportive regulatory environment not only encourages investment in the sector but also fosters innovation, ultimately benefiting patients in need of advanced therapies.

    Expansion of Biopharmaceutical Companies

    The Cell and Gene Therapy CDMO Market is witnessing a significant expansion of biopharmaceutical companies, which is a key driver of market growth. As these companies increasingly focus on developing innovative therapies, the demand for specialized manufacturing services provided by CDMOs is likely to rise. In recent years, the number of biopharmaceutical firms has increased, with many entering the cell and gene therapy space. This expansion is expected to continue, with estimates suggesting that the biopharmaceutical sector could grow at a compound annual growth rate of over 8% through the next decade. Consequently, CDMOs are becoming essential partners for these companies, offering expertise in complex manufacturing processes and regulatory compliance, thereby facilitating the timely delivery of new therapies to the market.

    Advancements in Manufacturing Technologies

    The Cell and Gene Therapy CDMO Market is significantly influenced by advancements in manufacturing technologies. Innovations such as automation, continuous manufacturing, and improved bioreactor designs are enhancing the efficiency and scalability of production processes. These technological improvements are crucial for meeting the increasing demand for cell and gene therapies, which often require complex and precise manufacturing techniques. In 2025, the market for advanced manufacturing technologies in biopharmaceuticals is expected to grow substantially, reflecting the industry's shift towards more efficient production methods. CDMOs that adopt these technologies are likely to gain a competitive edge, as they can offer faster turnaround times and reduced costs, ultimately benefiting their clients in the rapidly evolving therapeutic landscape.

    Increasing Demand for Personalized Medicine

    The Cell and Gene Therapy CDMO Market is experiencing a notable surge in demand for personalized medicine. This trend is driven by advancements in genetic research and the growing understanding of individual genetic profiles. As therapies become more tailored to specific patient needs, the role of contract development and manufacturing organizations (CDMOs) becomes increasingly critical. In 2025, the market for personalized medicine is projected to reach substantial figures, indicating a robust growth trajectory. CDMOs are positioned to support the development and production of these customized therapies, thereby enhancing their relevance in the healthcare landscape. This increasing demand not only reflects a shift in treatment paradigms but also underscores the necessity for CDMOs to adapt their capabilities to meet the evolving needs of biopharmaceutical companies.

    Growing Investment in Research and Development

    The Cell and Gene Therapy CDMO Market is experiencing a surge in investment in research and development (R&D). This trend is driven by the increasing recognition of the potential of cell and gene therapies to address previously untreatable conditions. In 2025, R&D spending in the biopharmaceutical sector is projected to reach unprecedented levels, reflecting a commitment to innovation and therapeutic advancement. CDMOs are integral to this process, as they provide the necessary infrastructure and expertise to support the development of new therapies. The influx of investment not only accelerates the pace of discovery but also enhances the collaboration between CDMOs and biopharmaceutical companies, fostering an environment conducive to innovation. This growing investment landscape is likely to propel the Cell and Gene Therapy CDMO Market forward, creating opportunities for both established and emerging players.

    Market Segment Insights

    By Product: Cell Therapy (Largest) vs. Gene Therapy (Fastest-Growing)

    In the Cell and Gene Therapy CDMO market, the product segment is primarily divided into Cell Therapy and Gene Therapy. Cell Therapy holds a significant share, recognized for its established protocols and wide-range applications in treating various diseases, including cancers and genetic disorders. Gene Therapy, while currently smaller in market share, is gaining traction due to advancements in genomic technology and its potential for innovative cures. This dynamic showcases the dual pathway approach in therapy development, catering to diverse patient needs.

    Cell Therapy: Dominant vs. Gene Therapy: Emerging

    Cell Therapy remains the dominant force in the Cell and Gene Therapy CDMO market, leveraging established manufacturing processes and regulatory frameworks. It addresses a variety of applications, from hematopoietic stem cell transplants to CAR T-cell therapies, allowing for personalized treatment approaches. On the other hand, Gene Therapy is emerging as a groundbreaking segment, driven by innovations in vector design and delivery mechanisms. It offers promising solutions for inherited diseases and is increasingly being adopted in clinical settings. As research continues, gene therapy’s profile is expected to rise, supported by investment and regulatory support aimed at accelerating product development.

    By Service: Contract Development (Largest) vs. Contract Manufacturing (Fastest-Growing)

    In the Cell and Gene Therapy CDMO Market, the service segment is predominantly driven by contract development services, which hold the largest share due to their established processes and strong reliance among biopharma companies for early-stage development needs. This segment is crucial for translating innovative therapies from the laboratory to clinical stages, thereby enhancing its appeal and demand in the market. On the other hand, contract manufacturing services are experiencing rapid growth as the demand for large-scale production of biologics increases. The emergence of personalized therapies and advanced therapeutic medicinal products is fuelling this trend, as companies seek reliable partners for manufacturing complex cell and gene therapies that meet stringent regulatory standards and production scalability requirements.

    Contract Development (Dominant) vs. Contract Manufacturing (Emerging)

    Contract development services in the Cell and Gene Therapy CDMO Market are characterized by their extensive expertise in protocol design, regulatory affairs, and scalability. This segment is deemed dominant due to its integral role in the early phases of drug development, where companies rely on CDMOs for guidance and cost-effective solutions. Conversely, contract manufacturing services are emerging as a key player, gaining traction from the increasing need for large-scale production capabilities. These services are pivotal in accommodating the growing volumes of gene therapies, particularly with innovations that cater to individualized medicine, which require tailored production approaches and flexible capacity options. Both segments are essential, yet they cater to different stages of the therapeutic development lifecycle.

    By Application: Oncology (Largest) vs. Immunology (Fastest-Growing)

    In the Cell and Gene Therapy CDMO Market, the application segment is primarily dominated by Oncology, reflecting a significant share due to the escalating demand for innovative cancer treatments. Immunology follows closely and has begun to capture attention as a rapidly expanding sector, evidencing the increasing focus on immunotherapies and their pivotal role in treating various immune-related disorders. Moreover, Neurology and Cardiovascular applications are showing promising developments, although at a slower pace. Emerging therapies targeting neurological diseases and heart conditions are gaining traction, driven by advancements in research and technology. However, the spotlight remains on Oncology and Immunology, where substantial investments and R&D are fueling rapid progress and adoption in clinical settings.

    Oncology: Dominant vs. Immunology: Emerging

    Oncology remains the dominant application segment within the Cell and Gene Therapy CDMO Market due to its vast array of clinical trials and the push towards personalized medicine. The complexity of cancer treatments necessitates advanced manufacturing capabilities, which CDMOs are well-positioned to provide. In contrast, Immunology represents an emerging field, characterized by groundbreaking therapies aimed at harnessing the immune system against diseases. While still catching up to Oncology, Immunology is witnessing a rapid increase in research funding and partnerships, positioning it as a promising frontier in cell and gene therapies, and leading to innovative approaches in managing autoimmune diseases and allergies.

    By End User: Biopharmaceutical Companies (Largest) vs. Academic Institutions (Fastest-Growing)

    The Cell and Gene Therapy CDMO market is predominantly driven by biopharmaceutical companies, which command the largest market share. These firms require extensive outsourcing of manufacturing capabilities to meet the high demand for innovative therapies. In contrast, academic institutions currently hold a smaller slice of the pie but are gaining momentum due to increased research funding and collaboration with industry leaders, impacting the overall market dynamics significantly. As biopharmaceutical companies continue to leverage contract services for scalability, the diverse nature of academic research is expected to contribute positively to the capabilities and offerings within the market.

    End Users: Biopharmaceutical Companies (Dominant) vs. Academic Institutions (Emerging)

    Biopharmaceutical companies stand out as the dominant players in the Cell and Gene Therapy CDMO market due to their established infrastructure and extensive expertise in developing therapeutic products. Their robust R&D operations and commercialization strategies create a high demand for contract manufacturing organizations (CMOs). Conversely, academic institutions represent an emerging segment, focusing on pioneering research and collaborative projects with industry counterparts. These institutions have begun to adopt more sophisticated techniques and form strategic partnerships to transition their innovations into viable therapies, thereby enhancing their significance in the value chain of cell and gene therapies.

    Get more detailed insights about Cell Gene Therapy CDMO Market

    Regional Insights

    The Cell and Gene Therapy CDMO Market is segmented into five major regions, including North America, Europe, APAC, South America, and MEA. Among these regions, North America held the largest market share in 2023 and is projected to continue its dominance throughout the forecast period owing to the presence of a large number of Contract Development And Manufacturing Organizations (CDMOs) and a supportive regulatory landscape. Europe is another significant market for Cell and Gene Therapy CDMO Market, driven by factors such as increasing government funding for cell and gene therapy research and the presence of leading pharmaceutical companies.

    The APAC region is expected to witness the highest growth rate during the forecast period due to rising healthcare expenditure and growing awareness about cell and gene therapies. South America and MEA represent emerging markets for Cell and Gene Therapy CDMO Market, with increasing investment in healthcare infrastructure and growing demand for cell and gene therapies.

    Cell and Gene Therapy CDMO Market3

    Source Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    Most of the major providers operating in the Cell and Gene Therapy CDMO market are investing in research and development to expand the scope of their services and gain an edge over their competitors. In addition, expansion is another strategy used by prominent players in the Cell and Gene Therapy CDMO market to accommodate the region-wise growth in demand across various industry sectors. The Cell and Gene Therapy CDMO market is anticipated to remain a highly fragmented marketplace and see the presence of a multitude of small and medium-sized players and a few large players within the market.

    The leading market players in the Cell and Gene Therapy CDMO market are focusing on the development of novel technologies and expanding their presence in new geographies. One of the biggest players in the Cell and Gene Therapy CDMO market is Catalent, Inc. Catalent offers a comprehensive range of services such as cell and gene therapy development, delivery, manufacturing, and testing.

    Founded in 2007 and headquartered in Somerset, the United States, Catalent has a huge customer base and is swiftly expanding in Asia and Europe. A team of more than 1,300 scientists is continually contributing to the cell and gene therapy sector. One of the notable companies offering services relatively similar to that of Catalent, Inc. is Lonza. The key characteristic is that Lonza and the client are located in North America, Europe, and Asia. The expert scientific team is also interested in investing more in research and development.

    Key Companies in the Cell Gene Therapy CDMO Market market include

    Industry Developments

    • Q2 2024: FUJIFILM Corporation to Invest $1.2 Billion to Expand Cell and Gene Therapy CDMO Business in the U.S. Fujifilm announced a $1.2 billion investment to expand its cell and gene therapy contract development and manufacturing organization (CDMO) capabilities in the United States, including the construction of a new facility in North Carolina.
    • Q2 2024: Catalent to Be Acquired by Novo Holdings for $16.5 Billion Novo Holdings agreed to acquire Catalent, a major CDMO player in the cell and gene therapy sector, in a $16.5 billion deal, aiming to strengthen its position in advanced therapies manufacturing.
    • Q2 2024: Lonza Opens New Cell and Gene Therapy Manufacturing Facility in Houston Lonza inaugurated a new state-of-the-art cell and gene therapy manufacturing facility in Houston, Texas, to meet growing demand for advanced therapy production services.
    • Q3 2024: Thermo Fisher Scientific Expands Viral Vector Services with New Manufacturing Site in Massachusetts Thermo Fisher Scientific opened a new viral vector manufacturing site in Plainville, Massachusetts, expanding its CDMO services for cell and gene therapy developers.
    • Q3 2024: Samsung Biologics Announces $500 Million Investment in Cell and Gene Therapy CDMO Expansion Samsung Biologics revealed a $500 million investment to expand its cell and gene therapy CDMO operations, including new facilities and technology platforms.
    • Q3 2024: WuXi AppTec Launches Integrated Cell and Gene Therapy Manufacturing Platform WuXi AppTec launched a fully integrated cell and gene therapy manufacturing platform, offering end-to-end CDMO services from process development to commercial production.
    • Q4 2024: Charles River Laboratories Acquires Cognate BioServices for $875 Million Charles River Laboratories completed the acquisition of Cognate BioServices, a leading cell and gene therapy CDMO, for $875 million to expand its advanced therapies portfolio.
    • Q4 2024: Fujifilm Diosynth Biotechnologies Wins Major Cell Therapy Manufacturing Contract Fujifilm Diosynth Biotechnologies secured a multi-year contract to manufacture cell therapy products for a top-10 global pharmaceutical company.
    • Q1 2025: Oxford Biomedica Appoints New CEO to Drive CDMO Growth Strategy Oxford Biomedica announced the appointment of a new CEO, focusing on accelerating the company's growth as a leading cell and gene therapy CDMO.
    • Q1 2025: Resilience Raises $500 Million to Expand Cell and Gene Therapy Manufacturing Network Resilience, a biomanufacturing company, raised $500 million in new funding to expand its cell and gene therapy CDMO network across North America.
    • Q2 2025: AGC Biologics Opens New Cell Therapy Manufacturing Facility in Milan AGC Biologics opened a new cell therapy manufacturing facility in Milan, Italy, to support European and global clients in the cell and gene therapy sector.
    • Q2 2025: Minaris Regenerative Medicine Signs Strategic Partnership with European Biotech for CAR-T Manufacturing Minaris Regenerative Medicine entered a strategic partnership with a European biotech company to provide CAR-T cell therapy manufacturing services at its European facilities.

    Future Outlook

    Cell Gene Therapy CDMO Market Future Outlook

    The Cell and Gene Therapy CDMO Market is projected to grow at a 23.53% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for personalized medicine, and regulatory support.

    New opportunities lie in:

    • Expansion of automated manufacturing platforms for scalability
    • Development of specialized cold chain logistics solutions
    • Investment in AI-driven analytics for process optimization

    By 2035, the market is expected to be robust, driven by innovation and strategic partnerships.

    Market Segmentation

    Cell Gene Therapy CDMO Market Product Outlook

    • Cell Therapy
    • Gene Therapy

    Cell Gene Therapy CDMO Market Service Outlook

    • Contract Development
    • Contract Manufacturing

    Cell Gene Therapy CDMO Market End User Outlook

    • Biopharmaceutical Companies
    • Academic Institutions
    • Hospitals
    • Other End Users

    Cell Gene Therapy CDMO Market Application Outlook

    • Oncology
    • Immunology
    • Neurology
    • Cardiovascular
    • Other Diseases

    Report Scope

    MARKET SIZE 202435.89(USD Billion)
    MARKET SIZE 202544.34(USD Billion)
    MARKET SIZE 2035366.93(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)23.53% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesAdvancements in personalized medicine drive demand for innovative Cell and Gene Therapy CDMO solutions.
    Key Market DynamicsRising demand for personalized medicine drives competition among Cell and Gene Therapy Contract Development and Manufacturing Organizations.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the projected growth of the Cell and Gene Therapy CDMO market?

    The Cell and Gene Therapy CDMO market is the expected increase in total market value of 366.93 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the Cell and Gene Therapy CDMO market?

    Cell and Gene Therapy CDMO market size was valued at approximately 35.89 billion USD in 2024. This figure will reach 366.93 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the Cell and Gene Therapy CDMO market?

    Cell and Gene Therapy CDMO market is expected to grow at a CAGR of 23.53% between 2025 and 2035.

    How much will the Cell and Gene Therapy CDMO market be worth by 2035?

    Cell and Gene Therapy CDMO market is expected to be worth of 366.93 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the Cell and Gene Therapy CDMO market perform over the next 10 years?

    Over the next 10 years the Cell and Gene Therapy CDMO market is expected to shift from usd billion 35.89 to 366.93 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    Which region is expected to hold the largest market share in the Cell and Gene Therapy CDMO Market?

    North America is expected to hold the largest market share in the Cell and Gene Therapy CDMO Market, owing to the presence of a large number of biotechnology and pharmaceutical companies, as well as a supportive regulatory environment.

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