Drug Development and Manufacturing Segment, by Product Type to Account Largest Share in Cell and Gene Therapy Contract Development and Manufacturing Organization Market during 2025-2031
According to our new research study on "Cell and Gene Therapy Contract Development and Manufacturing Organization Market Forecast to 2031 - Global Analysis - by Service Type, Product Type, End User, and Geography," the market was valued at US$ 6.22 billion in 2024 and is projected to reach US$ 31.86 billion by 2031; it is expected to register a CAGR of 26.4% during 2025-2031. Increasing clinical trials for innovative therapies and surging regulatory approvals and commercialization are contributing to the growing cell and gene therapy contract development and manufacturing organization market size. However, the high manufacturing complexities hampers the cell and gene therapy contract development and manufacturing organization market growth. Further, rising integration of AI and digital transformation is expected to bring in new cell and gene therapy contract development and manufacturing organization market trends in the coming years.
Cell and Gene Therapy Contract Development and Manufacturing Organization Market Analysis
Cell and gene therapies require specialized manufacturing processes, including the production of viral vectors, transduced cells, and other specialized biological materials. These therapies target rare or complex diseases, such as genetic disorders, cancer, and autoimmune diseases. According to the Alliance for Regenerative Medicine (ARM), the total number of clinical trials focused on gene therapies alone reached over 1,000 as of 2024, with hundreds more in the pipeline, creating the demand for contract development and manufacturing organizations (CDMOs).
The increasing number of biotech startups and biopharmaceutical companies entering the gene and cell therapy field has propelled the demand for CDMOs. Biopharmaceutical companies, especially small and medium-sized enterprises, lack the infrastructure and expertise required for manufacturing these specialized therapies. Consequently, they turn to CDMOs for their comprehensive expertise in managing clinical trial production, ensuring regulatory compliance, and scaling up manufacturing processes. The Autologus Therapeutics and AGC Biologics Milan Partnership started in 2020 when the company was involved in the development, manufacturing, and supply of viral vectors for Autolus's obe-cel CAR-T product candidate, AUCATZYL. The collaboration between the two parties was instrumental in bringing the therapy to market in a timely manner. In May 2025, Astraveus SAS entered into a strategic partnership with the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) to evaluate the Lakhesys Benchtop Cell Factory for the manufacturing of CAR-T therapies.
Technological advancements such as artificial intelligence (AI) optimize manufacturing processes for clinical trials. These innovations enable efficient and cost-effective production methods, which are critical based on the complexities involved. Thus, increasing clinical trials for innovative therapies, along with increasing demand for CDMOs for increasing research, development, and commercialization, drive the growth of the cell and gene therapy contract development and manufacturing organization market.
Cell and Gene Therapy Contract Development and Manufacturing Organization Market Report Scope
The cell and gene therapy contract development and manufacturing organization market analysis has been carried out by considering the following segments: Service Type, Product Type, and Geography.
Based on service type, the cell and gene therapy contract development and manufacturing organization market is segmented into drug development and manufacturing, testing and regulatory services, and others. The drug development and manufacturing segment held the largest share of the market in 2024. CDMOs play a crucial role in the pre-clinical and clinical drug development phases of cell and gene therapies (CGT). They provide expertise in vector design, cell line development, process optimization, and analytical testing. Manufacturing is a critical component, encompassing upstream and downstream processes. CDMOs offer services such as cell expansion, viral vector production, purification, and formulation. The surge in the clinical pipeline has amplified the need for specialized drug development and manufacturing services, leading biopharmaceutical companies to partner with CDMOs that possess the technical expertise, infrastructure, and regulatory know-how to bring these therapies to market.
CGT products require cleanrooms and bioreactors as well as skilled personnel capable of handling viral vectors, cell culturing, and gene editing technologies. Establishing such capabilities internally is impractical, especially for small to mid-sized biotech firms. For instance, building a commercial-ready cell therapy facility can cost over US$ 10 million, making outsourcing an attractive and cost-effective alternative. Lonza, Catalent, and WuXi Advanced Therapies are expanding their global CGT capabilities, offering end-to-end services from pre-clinical development to commercial manufacturing. Companies are outsourcing manufacturing services to CDMOs to mitigate risks and reduce costs associated with in-house production. According to the article titled "CMOs: Are You Ready for CGT Manufacturing" published in March 2021, approximately 65% of the manufacturing process for cell and gene therapies is outsourced, compared to nearly 35% for traditional biologics.
Integrating artificial intelligence (AI) into manufacturing processes has enhanced efficiency and scalability. OmniaBio, a CDMO focused on cell and gene therapies, introduced a new manufacturing facility in Canada designed to meet the needs of cold chain logistics and the production of cell and gene therapies with the help of AI.
In terms of product type, the cell and gene therapy contract development and manufacturing organization market is bifurcated into gene therapy and cell therapy. The cell therapy segment dominated the market in 2024. Cell therapy aids in treating disorders and diseases by restoring/changing certain groups of cells or providing cells to carry therapy through the body. It forms or modifies cells outside the body before being introduced into the patient. The cells may derive from the patient (autologous cells) or a donor (allogeneic cells). Autologous therapies involve modifying a patient's cells to treat their disease. This approach is exemplified by chimeric antigen receptor T-cell (CAR-T) therapies, such as Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), which are approved for B-cell malignancies, including acute lymphoblastic leukemia and non-Hodgkin lymphoma. These therapies have shown significant efficacy, with complete remission rates of up to 54% in certain lymphoma cases. Allogeneic therapies utilize donor-derived cells, offering the advantage of immediate availability and the potential for off-the-shelf treatments. For example, lifileucel (Amtagvi) is an adoptive T-cell therapy for melanoma, which involves infusing expanded tumor-infiltrating lymphocytes into patients.
Over 360 clinical trials focusing on cell-based therapies are being studied to interpret the potential of these therapies for treating various disease indications. Therefore, the demand for advanced therapy development and manufacturing services is rising. Lonza and Catalent have invested in state-of-the-art facilities to meet the growing demand for cell-based treatments. Charles River Laboratories is investing in technologies to streamline manufacturing processes, aiming to reduce production timelines by up to 60%. This acceleration is essential to meet the increasing demand for personalized therapies. As manufacturing capabilities advance and regulatory landscapes evolve, these therapies are becoming integral components of modern healthcare.
By end user, the cell and gene therapy contract development and manufacturing organization market is categorized into pharmaceutical companies, biopharmaceutical companies, and others. The biopharmaceutical companies segment dominated the market in 2024. Biopharmaceutical firms, especially small and medium-sized enterprises (SMEs), often lack the extensive infrastructure required for the complex processes involved in cell and gene therapy production. Collaborating with CDMOs allows these companies to access advanced manufacturing technologies and expertise without the substantial capital investment needed for in-house facilities. This partnership model is beneficial for startups and SMEs aiming to bring innovative therapies to market.
Established biopharmaceutical companies, including Lonza, Catalent, and Thermo Fisher Scientific, have expanded their services to include cell and gene therapy manufacturing. In 2020, Catalent's acquisition of MaSTherCell, a Belgian gene and cell therapy manufacturer, underscored its commitment to advancing cell and gene therapy capabilities. Collaborations between biopharmaceutical companies and CDMOs facilitate the sharing of risks and resources, accelerating the development process, and further enhancing cell and gene therapy contract development and manufacturing organization market growth. In June 2024, Charles River Laboratories International and the Gates Institute at the University of Colorado Anschutz Medical Campus entered into a lentiviral vector CDMO agreement. Gates Institute will leverage Charles River's premier cell and gene therapy CDMO expertise for the development of GMP-grade lentiviral vectors for CAR T-cell therapies, advancing treatment options for hematological cancers. Such partnership models enable biopharmaceutical companies to focus on R&D while ensuring that manufacturing processes meet the rigorous standards required for cell and gene therapy products. Thus, as the cell and gene therapy sector expands, the symbiotic relationship between biopharmaceutical companies and CDMOs will be essential for bringing innovative therapies to patients in need.
WuXi Biologics Inc, Charles River Laboratories International Inc, Catalent Inc, Lonza Group AG, Thermo Fisher Scientific Inc., AGC Biologics AS, Takara Bio Inc, FUJIFILM Holdings Corp, Pluri Inc, SK pharmteco Inc, Aenova Holding GmbH, and Minaris Advanced Therapies are among the leading companies operating in the global cell and gene therapy contract development and manufacturing organization market.
Companies operating in the cell and gene therapy contract development and manufacturing organization market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the cell and gene therapy contract development and manufacturing organization market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall cell and gene therapy contract development and manufacturing organization market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.
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