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    Cell And Gene Therapy Manufacturing Service Market

    ID: MRFR/HC/40089-HCR
    200 Pages
    Garvit Vyas
    October 2025

    Cell and Gene Therapy Manufacturing Service Market Research Report By Service Type (Cell Therapy Manufacturing, Gene Therapy Manufacturing, Plasmid DNA Manufacturing), By Cell Type (T Cells, Stem Cells, B Cells, Natural Killer Cells), By Product Type (Autologous Products, Allogeneic Products, Gene Edited Products), By End Use (Pharmaceutical Companies, Biotechnology Companies, Academic Research Institutions, Contract Manufacturing Organizations) and  By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) For...

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    Cell And Gene Therapy Manufacturing Service Market Infographic
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    Cell And Gene Therapy Manufacturing Service Market Summary

    As per MRFR analysis, the Cell and Gene Therapy Manufacturing Service Market was estimated at 8.311 USD Billion in 2024. The market is projected to grow from 9.528 USD Billion in 2025 to 37.36 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 14.64 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Cell and Gene Therapy Manufacturing Service Market is experiencing robust growth driven by technological advancements and increasing patient demand.

    • The market is witnessing an increased focus on personalized medicine, particularly in North America, which remains the largest market.
    • Advancements in biomanufacturing technologies are propelling the efficiency and scalability of cell and gene therapies.
    • Growing collaborations and partnerships are becoming prevalent, especially in the Asia-Pacific region, which is the fastest-growing market.
    • Rising prevalence of genetic disorders and increased investment in biopharmaceuticals are key drivers fueling market expansion.

    Market Size & Forecast

    2024 Market Size 8.311 (USD Billion)
    2035 Market Size 37.36 (USD Billion)
    CAGR (2025 - 2035) 14.64%

    Major Players

    Lonza (CH), Catalent (US), WuXi AppTec (CN), Boehringer Ingelheim (DE), Thermo Fisher Scientific (US), Sartorius (DE), Miltenyi Biotec (DE), Celerion (US), Kite Pharma (US)

    Cell And Gene Therapy Manufacturing Service Market Trends

    The Cell and Gene Therapy Manufacturing Service Market is currently experiencing a transformative phase, characterized by rapid advancements in biomanufacturing technologies and an increasing demand for personalized medicine. This market appears to be driven by a growing recognition of the potential of cell and gene therapies to address previously untreatable conditions. As regulatory frameworks evolve, they seem to facilitate the development and commercialization of innovative therapies, thereby attracting significant investments from both established pharmaceutical companies and emerging biotech firms. Furthermore, collaborations between academic institutions and industry players are likely to enhance research and development efforts, fostering a more robust pipeline of therapeutic candidates. In addition, the Cell and Gene Therapy Manufacturing Service Market is witnessing a shift towards more integrated and efficient manufacturing processes. Companies are increasingly adopting automation and digital technologies to streamline production, reduce costs, and improve product quality. This trend suggests a move towards a more sustainable manufacturing model, which could potentially address the challenges associated with scalability and reproducibility in therapy production. As the market continues to evolve, it may also see a rise in the demand for contract manufacturing organizations that specialize in cell and gene therapies, further shaping the competitive landscape of this dynamic sector.

    Increased Focus on Personalized Medicine

    The Cell and Gene Therapy Manufacturing Service Market is likely to see a heightened emphasis on personalized medicine. This trend indicates a shift towards therapies tailored to individual patient profiles, which may enhance treatment efficacy and patient outcomes.

    Advancements in Biomanufacturing Technologies

    Innovations in biomanufacturing technologies appear to be reshaping the Cell and Gene Therapy Manufacturing Service Market. These advancements could lead to more efficient production processes, potentially reducing costs and improving scalability.

    Growing Collaborations and Partnerships

    The market seems to be characterized by an increase in collaborations between various stakeholders, including biotech firms, pharmaceutical companies, and academic institutions. Such partnerships may facilitate knowledge sharing and accelerate the development of novel therapies.

    The ongoing advancements in biomanufacturing technologies are poised to enhance the scalability and efficiency of cell and gene therapy production, potentially transforming treatment paradigms for various diseases.

    U.S. Food and Drug Administration (FDA)

    Cell And Gene Therapy Manufacturing Service Market Drivers

    Regulatory Support and Frameworks

    The establishment of supportive regulatory frameworks is crucial for the Cell and Gene Therapy Manufacturing Service Market. Regulatory bodies are increasingly recognizing the potential of gene and cell therapies, leading to expedited approval processes and guidelines that facilitate innovation. For instance, the introduction of programs like the FDA's Breakthrough Therapy Designation has accelerated the development of promising therapies. This regulatory support encourages investment in manufacturing capabilities, as companies seek to navigate the complex landscape of compliance while bringing novel therapies to market. As a result, the Cell and Gene Therapy Manufacturing Service Market is likely to experience robust growth driven by these favorable regulatory conditions.

    Rising Prevalence of Genetic Disorders

    The increasing incidence of genetic disorders is a pivotal driver for the Cell and Gene Therapy Manufacturing Service Market. As more individuals are diagnosed with conditions such as hemophilia, muscular dystrophy, and various inherited diseases, the demand for innovative therapies rises. According to recent estimates, genetic disorders affect approximately 1 in 10 individuals, underscoring the urgent need for effective treatments. This growing patient population propels investments in research and development, leading to a surge in the production of gene therapies. Consequently, manufacturers are compelled to enhance their capabilities to meet the escalating demand for tailored therapeutic solutions, thereby driving growth in the Cell and Gene Therapy Manufacturing Service Market.

    Increased Investment in Biopharmaceuticals

    The surge in investment within the biopharmaceutical sector significantly influences the Cell and Gene Therapy Manufacturing Service Market. Venture capital and private equity funding have seen remarkable increases, with billions allocated to companies focused on gene and cell therapies. This influx of capital not only supports research and development but also enhances manufacturing capabilities, allowing for the scaling of production processes. As biopharmaceutical companies expand their portfolios to include gene therapies, the demand for specialized manufacturing services rises. This trend indicates a promising trajectory for the Cell and Gene Therapy Manufacturing Service Market, as financial backing fuels innovation and operational expansion.

    Technological Advancements in Gene Editing

    Technological innovations, particularly in gene editing techniques like CRISPR and TALEN, are transforming the landscape of the Cell and Gene Therapy Manufacturing Service Market. These advancements enable precise modifications to genetic material, facilitating the development of targeted therapies. The global market for gene editing technologies is projected to reach substantial figures, reflecting the increasing adoption of these methods in therapeutic applications. As researchers and manufacturers harness these technologies, the efficiency and effectiveness of gene therapies improve, leading to a broader acceptance and integration into clinical practice. This trend not only enhances the therapeutic potential but also stimulates the growth of the Cell and Gene Therapy Manufacturing Service Market.

    Growing Patient Demand for Innovative Therapies

    The rising patient demand for innovative therapies is a driving force in the Cell and Gene Therapy Manufacturing Service Market. Patients increasingly seek advanced treatment options that offer potential cures for previously untreatable conditions. This shift in patient expectations is prompting healthcare providers to explore and adopt gene therapies, which are often seen as a last resort for severe diseases. Market Research Future indicates that the willingness to pay for these therapies is high, reflecting the perceived value of innovative solutions. As patient advocacy groups and healthcare professionals promote awareness of gene therapies, the demand for manufacturing services tailored to these products is likely to escalate, further propelling the growth of the Cell and Gene Therapy Manufacturing Service Market.

    Market Segment Insights

    By Service Type: Cell Therapy Manufacturing (Largest) vs. Gene Therapy Manufacturing (Fastest-Growing)

    In the Cell and Gene Therapy Manufacturing Service Market, Cell Therapy Manufacturing remains the largest segment, capturing the significant share of the market, driven by its established applications in treating various diseases, including cancer and autoimmune disorders. Meanwhile, Gene Therapy Manufacturing is rapidly gaining traction, highlighting its potential in addressing genetic disorders and presenting a growing interest from both biopharmaceutical companies and investors due to its innovative treatment capabilities.

    Service Type: Cell Therapy Manufacturing (Dominant) vs. Gene Therapy Manufacturing (Emerging)

    Cell Therapy Manufacturing is characterized by its extensive application in regenerative medicine, primarily focused on the production of living cells for therapeutic use. This segment has demonstrated dominance in the market, benefiting from advanced technologies and increasing investment from biopharmaceutical firms, further solidifying its position in clinical settings. In contrast, Gene Therapy Manufacturing represents an emerging frontier marked by innovative techniques aimed at correcting defective genes. As regulatory frameworks evolve and technologies mature, this segment is experiencing rapid growth, attracting stakeholders keen on harnessing its vast potential for treating a variety of inherited and acquired conditions.

    By Cell Type: T Cells (Largest) vs. Stem Cells (Fastest-Growing)

    In the Cell and Gene Therapy Manufacturing Service Market, T Cells currently represent the largest share among various cell types, driven by their established application in immunotherapy. Following closely, Stem Cells are rapidly gaining traction due to their versatility and potential in regenerative medicine applications. This dynamic distribution indicates a strong preference for T Cells in current therapeutic practices while highlighting the increasing interest and investment in Stem Cell research and development. Growth trends within this segment are predominantly influenced by advancements in biotechnology and an expanding clinical pipeline. T Cells are experiencing sustained success in cancer therapies, propelling their dominance. Conversely, Stem Cells are classified as the fastest-growing segment, fueled by innovative approaches in treating spinal cord injuries and degenerative diseases, indicating a shift towards personalized medicine solutions in the future.

    T Cells (Dominant) vs. Stem Cells (Emerging)

    T Cells are a dominant force in the Cell and Gene Therapy Manufacturing Service Market, primarily utilized in therapies aimed at treating various cancers and infectious diseases. Their strong performance is anchored on their ability to be engineered for enhanced efficacy, making them a preferred choice by researchers and clinicians alike. In contrast, Stem Cells represent an emerging segment with enormous potential due to their ability to differentiate into various cell types and repair damaged tissues. The regenerative capabilities of Stem Cells open avenues for groundbreaking treatments in conditions such as heart diseases and diabetes, positioning them as a pivotal area of research. As innovation continues, both T Cells and Stem Cells will shape the landscape of future therapeutic options.

    By Product Type: Autologous Products (Largest) vs. Allogeneic Products (Fastest-Growing)

    In the Cell and Gene Therapy Manufacturing Service Market, autologous products dominate the landscape with a substantial share, primarily due to their personalized nature and effectiveness in treating various diseases. These therapies, derived from a patient’s own cells, continue to gain traction among healthcare providers and patients alike, establishing a solid market position. Conversely, allogeneic products are emerging rapidly, fueled by advancements in manufacturing processes and the demand for off-the-shelf solutions that provide broader accessibility and reduce treatment times. They are projected to experience substantial growth as technologies advance and more therapeutic applications are discovered.

    Products: Autologous (Dominant) vs. Allogeneic (Emerging)

    Autologous products, tailored to individual patients, represent the cornerstone of cell and gene therapy, showcasing remarkable clinical outcomes and personalized treatment plans. Their dominance lies in the precision of using the patient's own cells, resulting in fewer complications and higher acceptance. In contrast, allogeneic products, sourced from healthy donors, are gaining momentum as they offer immediate availability and can treat multiple patients simultaneously, addressing the market's urgent needs. This category is characterized by innovations aimed at scale-up production and diverse therapeutic applications, positioning it as the most promising segment in the near future. Together, these products illustrate the dynamic evolution of the Cell and Gene Therapy Manufacturing Service Market.

    By End Use: Pharmaceutical Companies (Largest) vs. Biotechnology Companies (Fastest-Growing)

    The Cell and Gene Therapy Manufacturing Service Market is primarily dominated by Pharmaceutical Companies, which account for the largest share of the market. These companies leverage their extensive resources, established distribution channels, and regulatory experience to drive advancements in gene and cell therapies. In contrast, Biotechnology Companies have emerged as a rapidly growing segment, reflecting their innovative approaches, agility in research, and specialized focus on developing cutting-edge therapies at a faster pace compared to their pharmaceutical counterparts. The growth trend in this market is significantly influenced by factors such as increasing investment in gene and cell therapy research, collaborations between pharmaceutical and biotechnology firms, and the rising prevalence of chronic diseases. As Biotechnology Companies continue to experience robust growth, their ability to adapt to market demands and push the boundaries of therapeutic possibilities positions them well in the dynamic landscape of cell and gene therapies, creating a competitive environment that propels industry advancements.

    Pharmaceutical Companies (Dominant) vs. Biotechnology Companies (Emerging)

    Pharmaceutical Companies represent the dominant force in the Cell and Gene Therapy Manufacturing Service Market. Their established infrastructure, wide-ranging expertise, and extensive resources enable them to lead in commercialization and production capacities. These companies typically invest heavily in R&D, allowing them to stay at the forefront of innovative therapies. On the other hand, Biotechnology Companies are often viewed as the emerging challengers in this landscape. They are defined by their focus on specialized treatments and agility in adapting to technological advancements. Their emphasis on innovative approaches and partnerships with academic institutions makes them critical players, driving forward the development of novel therapies and expanding the scope of cell and gene treatments.

    Get more detailed insights about Cell And Gene Therapy Manufacturing Service Market

    Regional Insights

    The Global Cell and Gene Therapy Manufacturing Service Market shows significant growth within the Regional segment, with a noteworthy valuation of 8.32 USD Billion in 2024. North America holds a majority share, valued at 4.2 USD Billion, accounting for more than half of the market's financial dynamics due to its advanced healthcare infrastructure and robust investment in biotechnology. Europe follows with a valuation of 2.0 USD Billion, reflecting its strong regulatory frameworks and a growing number of clinical trials focusing on gene therapies.

    APAC is valued at 1.8 USD Billion, showcasing promising growth opportunities triggered by increasing healthcare spending and research initiatives in the region. South America and MEA, holding values of 0.6 USD Billion and 0.72 USD Billion, respectively, are the smaller markets but demonstrate potential due to developing healthcare systems and rising interest in innovative treatment options. The variations in market valuation highlight the dominance of North America in this industry while underlining the emerging opportunities in APAC, South America, and MEA, contributing to the overall expansion of the Global Cell and Gene Therapy Manufacturing Service Market.

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

    Key Players and Competitive Insights

    The Global Cell and Gene Therapy Manufacturing Service Market has witnessed considerable growth and transformation, driven by advancements in biotechnology and increasing investments in research and development. The competitive landscape is characterized by a mix of established companies and new entrants, all striving to capture market share and innovate within this burgeoning sector. Key competitive insights indicate a strong focus on technological advancements, regulatory compliance, and partnerships with research institutions to enhance service offerings.

    Companies are leveraging their capabilities in process development, quality assurance, and scale-up manufacturing to meet the rising demand for personalized medicine and advanced therapeutic solutions. The market's competitiveness is further intensified by the need for companies to establish their presence globally and respond to regional regulations effectively while maintaining operational efficiency.

    AbbVie has established itself as a significant player in the Global Cell and Gene Therapy Manufacturing Service Market due to its extensive portfolio of biopharmaceuticals and commitment to research and development. The company's strength lies in its robust capabilities in manufacturing processes and quality control, ensuring that its gene and cell therapies meet stringent regulatory requirements. AbbVie’s strategic collaborations with various research institutes and academic organizations have enabled it to harness cutting-edge technologies and foster innovation in therapeutic development. Furthermore, the company benefits from a well-established global presence, allowing it to effectively distribute its services worldwide.

    This strategic positioning, coupled with strong financial backing and a focus on patient-centered solutions, enhances AbbVie’s competitive edge in the cell and gene therapy space. Thermo Fisher Scientific is another notable player in the Global Cell and Gene Therapy Manufacturing Service Market, recognized for its comprehensive portfolio of end-to-end solutions supporting gene and cell therapy development. The company offers a wide range of services, including plasmid DNA manufacturing, viral vector production, and cell banking, catering to the unique needs of biopharmaceutical companies engaged in the production of advanced therapies.

    Thermo Fisher's emphasis on innovation and technology integration has positioned it as a trusted partner in the manufacturing arena, allowing clients to streamline processes and improve production efficiency.

    The company's commitment to providing tailored solutions and its strong customer support network are key strengths that contribute to its competitive stature. Additionally, Thermo Fisher’s global footprint and extensive resources enable it to capitalize on emerging trends within the cell and gene therapy landscape, thereby reinforcing its market leadership.

    Key Companies in the Cell And Gene Therapy Manufacturing Service Market market include

    Industry Developments

    • Q2 2024: FUJIFILM Diosynth Biotechnologies Opens New Cell and Gene Therapy Manufacturing Facility in Texas FUJIFILM Diosynth Biotechnologies announced the opening of its new state-of-the-art cell and gene therapy manufacturing facility in College Station, Texas, expanding its capacity to support clinical and commercial manufacturing for advanced therapies.
    • Q2 2024: Lonza Expands Cell and Gene Therapy Manufacturing Capabilities with New Suite in Houston Lonza announced the launch of a new manufacturing suite at its Houston facility, designed to increase capacity for viral vector production and support growing demand from cell and gene therapy developers.
    • Q2 2024: Catalent Acquires Cell and Gene Therapy Manufacturing Site from Erytech Pharma Catalent completed the acquisition of Erytech Pharma’s cell and gene therapy manufacturing facility in Princeton, New Jersey, enhancing its North American manufacturing footprint for advanced therapies.
    • Q2 2024: Oxford Biomedica and Homology Medicines Announce Strategic Manufacturing Partnership Oxford Biomedica and Homology Medicines entered a multi-year partnership to leverage Oxford Biomedica’s viral vector manufacturing expertise for Homology’s gene therapy pipeline.
    • Q3 2024: Thermo Fisher Scientific Launches New Commercial Packaging Services for Cell and Gene Therapies Thermo Fisher Scientific introduced Patheon Commercial Packaging Services in the US and Europe, offering integrated logistics, serialization, and global distribution for cell and gene therapy products.
    • Q3 2024: AGC Biologics Opens New Viral Vector Manufacturing Facility in Milan AGC Biologics inaugurated a new viral vector manufacturing facility in Milan, Italy, to meet increasing demand for gene therapy manufacturing services in Europe.
    • Q3 2024: Takara Bio Expands Cell Therapy Manufacturing Operations in Shiga, Japan Takara Bio announced the expansion of its cell therapy manufacturing operations in Shiga, Japan, adding new cleanroom suites and increasing production capacity for clinical and commercial supply.
    • Q4 2024: Catalent Wins Major Manufacturing Contract for Commercial Supply of CAR-T Therapy Catalent secured a multi-year contract to manufacture a commercial CAR-T cell therapy for a leading biopharmaceutical company, strengthening its position in the cell therapy manufacturing market.
    • Q4 2024: Lonza Appoints New Head of Cell and Gene Therapy Manufacturing Division Lonza announced the appointment of a new executive to lead its global cell and gene therapy manufacturing division, aiming to accelerate growth and innovation in advanced therapy production.
    • Q1 2025: Oxford Biomedica Acquires Viral Vector Manufacturing Assets from Cellectis Oxford Biomedica completed the acquisition of viral vector manufacturing assets from Cellectis, expanding its capabilities in gene therapy manufacturing and strengthening its European operations.
    • Q2 2025: FUJIFILM Irvine Scientific Opens New Cell Culture Media Manufacturing Facility in the Netherlands FUJIFILM Irvine Scientific opened a new facility in Tilburg, Netherlands, dedicated to the production of cell culture media for cell and gene therapy manufacturing, supporting European and global clients.
    • Q2 2025: SGS SA Launches Expanded Cell and Gene Therapy Testing Services in North America SGS SA announced the launch of expanded analytical and quality control testing services for cell and gene therapy products at its North American laboratories, supporting regulatory compliance and product release.

    Future Outlook

    Cell And Gene Therapy Manufacturing Service Market Future Outlook

    The Cell and Gene Therapy Manufacturing Service Market is projected to grow at a 14.64% 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 modular cleanroom solutions for cost efficiency
    • Investment in AI-driven analytics for process optimization

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

    Market Segmentation

    Cell And Gene Therapy Manufacturing Service Market End Use Outlook

    • Pharmaceutical Companies
    • Biotechnology Companies
    • Academic Research Institutions
    • Contract Manufacturing Organizations

    Cell And Gene Therapy Manufacturing Service Market Cell Type Outlook

    • T Cells
    • Stem Cells
    • B Cells
    • Natural Killer Cells

    Cell And Gene Therapy Manufacturing Service Market Product Type Outlook

    • Autologous Products
    • Allogeneic Products
    • Gene Edited Products

    Cell And Gene Therapy Manufacturing Service Market Service Type Outlook

    • Cell Therapy Manufacturing
    • Gene Therapy Manufacturing
    • Plasmid DNA Manufacturing

    Report Scope

    MARKET SIZE 20248.311(USD Billion)
    MARKET SIZE 20259.528(USD Billion)
    MARKET SIZE 203537.36(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)14.64% (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 Manufacturing Service solutions.
    Key Market DynamicsRising demand for personalized medicine drives innovation and competition in the Cell and Gene Therapy Manufacturing Service Market.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the expected market size of the Global Cell and Gene Therapy Manufacturing Service Market in 2024?

    The Global Cell and Gene Therapy Manufacturing Service Market is expected to be valued at approximately 8.32 USD Billion in 2024.

    What will be the market value of the Global Cell and Gene Therapy Manufacturing Service Market in 2035?

    By 2035, the Global Cell and Gene Therapy Manufacturing Service Market is anticipated to reach a value of around 37.4 USD Billion.

    What is the expected CAGR for the Global Cell and Gene Therapy Manufacturing Service Market from 2025 to 2035?

    The market is projected to experience a CAGR of 14.64% during the forecast period from 2025 to 2035.

    Which region is expected to have the largest market share in 2024?

    North America is expected to dominate the market with an estimated value of 4.2 USD Billion in 2024.

    How much is the European market for Cell and Gene Therapy Manufacturing Services expected to be valued in 2035?

    The European market is projected to reach approximately 10.5 USD Billion by 2035.

    What is the expected market size for Cell Therapy Manufacturing by 2035?

    Cell Therapy Manufacturing is forecasted to be valued at about 13.8 USD Billion in 2035.

    What key applications are driving growth in the Global Cell and Gene Therapy Manufacturing Service Market?

    Key applications include Cell Therapy Manufacturing, Gene Therapy Manufacturing, and Plasmid DNA Manufacturing.

    What are some major players in the Global Cell and Gene Therapy Manufacturing Service Market?

    Major players in this market include AbbVie, Thermo Fisher Scientific, Novartis, Boehringer Ingelheim, and Catalent.

    What is the projected market value of Plasmid DNA Manufacturing in 2024?

    Plasmid DNA Manufacturing is expected to be valued at around 1.12 USD Billion in 2024.

    How much is the APAC region expected to grow by 2035?

    The APAC region is estimated to grow to approximately 6.7 USD Billion by 2035.

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