Cell Therapy CDMO Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Service Type (Drug Development and Manufacturing, Testing and Regulatory Services, and Other Service Types), En

The cell therapy CDMO market size is expected to grow from US$ 4.12 billion in 2024 to US$ 21.92 billion by 2031; it is projected to register a CAGR of 27.1% during 2025-2031. The increasing prevalence of chronic and rare diseases, surging outsourcing of cell therapy manufacturing by biotech and pharma companies, and expanding clinical trials for innovative therapies are noteworthy factors contributing to the expansion of the cell therapy CDMO market size. Additionally, the rising integration of AI and digital transformation, and increased adoption of advanced and automated manufacturing technologies are projected to bring new cell therapy CDMO market trends in the near future.

The requirement for the large-scale production of therapies like CAR-T cells is the main reason for the move toward advanced and automated manufacturing technologies. This trend alleviates the problems associated with manual processes, like the risk of contamination and variability, by incorporating AI, robotics, and closed systems. AI and machine learning not only optimize production parameters but also enhance quality control, and predict outcomes as evidenced by Kite Pharma's (Gilead Sciences) adoption of AI-driven process optimization, automated cell culture systems, and closed bioreactors for Yescarta. These breakthroughs cut the conventional timeframes of 7 to 14 days down to as little as 24 hours, thus simplifying logistics and improving patient access.

Per AGC Biologics, automation lays the foundation for the change in the way of handling autologous therapies by cutting back on the number of manual steps involved, allowing the splitting up of the treatment process across facilities, and even making use of AI-driven process controls for real-time quality testing. The CliniMACS Prodigy from Miltenyi Biotec and the Cocoon from Lonza are among the tools that facilitate batch reproducibility by employing AI analytics in decentralized manufacturing and also minimizing human contact through robotics to less than 10% of the conventional level, thus greatly reducing the hands-on time.

The benefits that accrue from this technology include increased efficiency, price reductions, and better quality, all of which are backed up by the FDA and EMA who make the use of closed systems mandatory for the industry. Robots and machines are changing the landscape of cell therapy contract development and manufacturing organizations (CDMOs) that now have the ability to do almost entirely “lights-off” manufacturing with very little human intervention. Automated bioreactor systems, closed workflows, and robotics are not only reducing manufacturing time but also conducting research in the area of same-day CAR-T processing capabilities. This increased adoption accelerates innovation and the CDMOs are the ones to lead it by using their specialized knowledge to meet the ever-increasing demand in clinical trials, thereby emerging as a significant trend in the cell therapy CDMO market.

End User-Based Insights

Based on end user, the cell therapy CDMO market is segmented into pharmaceutical companies, biopharmaceutical companies, and other end users. The biopharmaceutical companies segment held the largest cell therapy CDMO market share in 2024. Biopharmaceutical companies, and especially small and medium-sized innovators, are the main consumers of cell therapy CDMO services. These companies often take the initiative in the early discovery and clinical development of new cellular therapies, but they do not always possess the necessary high-quality manufacturing facility and regulatory know-how for the Good Manufacturing Practice (GMP) production. They resort to CDMOs for outsourcing which allows them to overcome this barrier thereby converting scientific innovation into potential clinical candidates. An example of such a collaboration is the agreement between Charles River Laboratories and the Gates Institute on lentiviral vector CDMO which enables biopharma companies to keep their focus on research while at the same time drawing on the CDMO's expertise in dealing with the intricate processes of viral vector and cell handling.

Through outsourcing, biopharma companies are able to minimize their capital expenditures and risks substantially while speeding up the development process. Besides that, the increasing regulatory support and the facilitation of the approval processes are among the factors that lure biopharma companies into the arms of CDMOs who would make the access to cutting-edge therapies possible without the financial burden of in-house production. Thus, partnerships with CDMOs are a must for the biopharmaceutical industry to smoothly and rapidly carry out the process from laboratory to clinic, thereby fueling the cell therapy CDMO market growth.

The World Health Organization and Australian Institute of Health and Welfare are among the primary and secondary sources referred to while preparing the cell therapy CDMO market report.

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