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March 2025
The global cell and gene therapy CDMO market size is calculated at US$ 6.41 in 2024, grew to US$ 8.2 billion in 2025, and is projected to reach around US$ 75.32 billion by 2034. The market is expanding at a CAGR of 27.94% between 2025 and 2034.
Gene and cell therapies are highly essential for treating rare diseases, genetic disorders, and personalized treatments. Due to this, cell and gene therapies are in high demand, leading to challenges in supply chain management and product development. Hence, the cell and gene therapy CDMO market has become an essential industry to mitigate these challenges.
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Since CDMOs are adaptable third-party service providers, they help pharmaceutical businesses at every step of the medication-making process by supplying assistance with R&D, manufacturing, and formulation and finishing procedures. In the past ten years, CDMOs have become more prevalent due to a more dynamic mergers and acquisitions (M&A) environment that is fueled by consolidation.
Through the use of living cells and genetic alterations, the rapidly developing field of cell and gene therapy (C>) is revolutionizing healthcare by treating diseases that are challenging to treat. In a time when 90% of biotech companies depend on contract manufacturing and development, CDMOs are essential to the early stages and commercialization of your goods. CDMOs for cell and gene therapy function as specialized extensions of a biopharma team, providing you with their facilities, expertise, and tools to manage critical aspects of your C> development and production. From understanding the process and creating DNA to creating viral vectors and processing cells, they cover everything. From the first phases to administering treatments, they offer a full range of services to ensure a seamless experience.
Biomanufacturing is undergoing a revolution thanks to artificial intelligence (AI), which is solving important problems, particularly with production scalability. AI systems use real-time variability detection and analysis of large data sets to predict and fix bottlenecks. CDMOs are offering dependable, scalable solutions that are revolutionizing medicinal development and commercialization by seamlessly integrating AI-driven technologies to tackle chemistry, manufacturing, and controls (CMC) issues. Large molecule manufacturing processes can be optimized by CDMOs thanks to AI's predictive modeling capabilities. AI systems can spot trends and abnormalities in real-time data from production lines by continually monitoring and analyzing them. This allows for preemptive troubleshooting and helps to avoid expensive production problems.
Rising Demand in Pharmaceutical & Biotechnology Industries
Growth in the cell and gene therapy CDMO market has been aided by the growing demand for CDMOs from up-and-coming pharmaceutical and biotech firms. The growth of the target market is now significantly influenced by the increase in clinical trials. The FDA reports that both large and small biotech and pharmaceutical businesses are now conducting about 50 clinical studies in cell and gene therapy. Additional benefits of outsourcing include lower investment risks, specialist expertise, cutting-edge equipment and technology, increased productivity and efficiency, less labor work, and a favorable environment for startups and small enterprises. CAGT is one of the sectors of the biopharmaceutical industry that is expanding the quickest due to the increased need for innovative biologics. In January 2023, 621 biologics products were authorized by the Food and Drug Administration.
Complicated Manufacturing & High Cost
Complex manufacturing processes, which can be challenging and resource-intensive, are occasionally needed for gene and cellular treatments. Due to the intricacy of developing these medicines, CDMOs may have to pay more and have to wait longer. The development and manufacturing of gene and cellular treatments need significant financial investments in specialized equipment, infrastructure, and skilled personnel. Due to the significant costs associated with these efforts, CDMOs and their clients may be constrained.
Collaborations and Partnerships
Partnerships and collaborations between CDMOs, academic institutions, and biopharma businesses help to scale production, expedite clinical development, and speed up research. Faster innovation, cost sharing, and risk mitigation are made possible by these partnerships, especially in the intricate and expensive development of cell and gene treatments. Collaborations provide effective technological transfer, regulatory backing, and market entrance by utilizing each partner's unique capabilities, which eventually drive the market's expansion and success.
By indication, the oncology segment held the largest share of the cell and gene therapy CDMO market in 2024. Cancer is one of the leading causes of death worldwide. In 2022, there were around 20 million new instances of cancer worldwide, along with 9.7 million deaths from the disease. By 2040, it is projected that there will be 29.9 million new cases of cancer year and 15.3 million deaths from the disease. By 2050, there will likely be 35 million cases of cancer. CDMOs are a crucial part of ensuring the efficient, safe, and scalable production of cancer cell and gene therapies. They offer vital guidance and assistance throughout the complex process of creating a medication and introducing it to the market.
By indication, the rare diseases segment is estimated to grow at a significant rate in the cell and gene therapy CDMO market during the forecast. With more than 7000 distinct rare illness types, the worldwide burden is not insignificant. There are 300 million people with rare diseases nowadays. Approximately 80% of uncommon diseases have a genetic foundation, and almost 70% of them first appear in infancy. It takes an average of 4–8 years to get a correct diagnosis, and there are no approved treatments for almost 95% of uncommon disorders. Furthermore, about 30 percent of kids with uncommon disorders die before they are five. The need for novel medicines that can address the underlying genetic origins of these illnesses is growing along with knowledge of them. Biopharmaceutical firms are increasingly using CDMOs to meet this demand because of their particular knowledge in creating and producing these cutting-edge treatments. By providing end-to-end services, CDMOs are essential to the advancement of the development and commercialization of gene and cell treatments.
By phase, the pre-clinical segment dominated the cell and gene therapy CDMO market in 2024. Preclinical activities in this area are developing as a result of improvements in scientific knowledge, a greater awareness of the potential of these treatments to treat a range of illnesses and more funding for research and development. Another important driver bolstering the segment's growth throughout the analysis period is the expanding pipeline of CGT therapies in the preclinical stage.
By phase, the clinical segment is estimated to achieve a significant growth rate in the cell and gene therapy CDMO market during the forecast period. The primary driver of the clinical segment's expansion is the rise in clinical research pertaining to gene and cell therapy. Furthermore, when gene therapy-focused businesses go public through initial public offerings (IPOs), the rising demand for gene therapy opens up substantial investment opportunities. As a result, a number of gene treatments are expected to be introduced in the near future due to growing financing and investment. By the end of 2023, an estimated 13 novel cell and gene treatments might be approved in the United States and Europe. Furthermore, the U.S. FDA predicted in 2019 that between 10 and 20 novel gene and cell treatments will be authorized by 2025.
By product type, the cell therapy segment was dominant in the cell and gene therapy CDMO market in 2024. With the pipeline expanding at a double-digit compound annual growth rate and more than 2,000 preclinical and clinical studies to date, the development of cell treatments has accelerated. Recent treatment approvals show how important CDMOs are to the development of cell therapies by providing essential infrastructure and knowledge. CDMOs must make sure they are prepared to satisfy new client expectations and improve their technological know-how and skills to enable next-generation cell treatments as researchers expect the pace of the cell therapy pipeline to accelerate.
By product type, the gene-modified cell therapy segment is estimated to grow significantly in the cell and gene therapy CDMO market during the forecast period. In the battle against cancer, gene-modified cell treatments represent a significant breakthrough. There is now more hope for these eagerly awaited "drugs" of the future, thanks to advancements in the therapeutic effectiveness of gene-modified cell treatments across a range of preclinical models and clinical studies. Thanks to developments in genetic engineering, scientists can now more easily create these therapeutic cells, which will enable their broader use, more precise development, and, eventually, a larger range of applications. The rapidly developing area of gene-modified cells for the treatment of many malignant and non-malignant illnesses is highlighted in this special issue on cytotherapy.
North America dominated the cell and gene therapy CDMO market share by 41% in 2024. The market for cell therapy CDMO in North America is anticipated to grow as a result of well-established research facilities, substantial R&D expenditure in cell therapy, and the increasing incidence of chronic illnesses. The introduction of new cell therapy products, their potential to cure infectious illnesses, cancer, and autoimmune disorders, as well as the large number of current clinical trials, are driving the market's expansion.
According to ClinicalTrials.gov, as of October 2023, there were more than 581 active clinical studies in North America investigating the potential uses of cell therapies and other cell-based techniques in the treatment of various medical problems. As a result, there will likely be a sharp increase in demand for sophisticated manufacturing services that focus on cell and gene treatments. Increased investment in the development of cell-based therapeutics is also expected to propel the market's growth trajectory. For example, Cellares obtained a USD 255 million Series C investment in August 2023 to finance the development of its Bridgewater, New Jersey, commercial-scale cell therapy manufacturing plant. Therefore, the growth of the regional market as a whole is greatly aided by the expansion of R&D projects and the existence of a strong healthcare infrastructure.
Asia Pacific is estimated to host the fastest-growing cell and gene therapy CDMO market during the forecast period. Due to the increase in CGT clinical trials in nations like China, the area has experienced rapid expansion. The area is developing because of a number of factors, including increased investment in R&D, supportive regulatory settings that promote clinical trials, an increasing emphasis on healthcare innovation, and greater awareness of the potential advantages of gene and cell treatments. The Asia-Pacific area is also a desirable location for these trials due to partnerships between local and foreign research institutes and the availability of a variety of patient groups.
We are dedicated to helping meet the urgent patient needs, and collaboration is key to progress in the cell and gene therapy industry," stated Kathie Schneider, Director, Global Commercial Lead, Cell Therapy Technologies at Terumo BCT. "We have been working together with BioCentriq to improve manufacturing for the upcoming generation of cell treatments from the start of our partnership in 2021. They are, therefore, ideally suited to assist in showcasing the special qualities of our Finia platform and hollow-fiber perfusion technology.
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By Product
By Indication
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