PUBLISHER: Mordor Intelligence | PRODUCT CODE: 1521706
PUBLISHER: Mordor Intelligence | PRODUCT CODE: 1521706
The Cell Therapy Contract Development And Manufacturing Organization Market size is estimated at USD 1.63 billion in 2024, and is expected to reach USD 6.40 billion by 2029, growing at a CAGR of 25.70% during the forecast period (2024-2029).
The major factors boosting the growth of the cell therapy market are the rise in preclinical and clinical activities around cell therapy, the increasing burden of chronic diseases, and high investment in cell therapy development. The growing disease burden, characterized by diverse health challenges ranging from chronic diseases to infectious threats, drives significant demand for cell therapy contract development and manufacturing services. For instance, as stated in the British Heart Foundation England Factsheet released in January 2024, about 7.6 million people live with cardiovascular diseases in England in 2022. As per the same source, around 620 million people had heart and circulatory diseases (cardiovascular diseases) across the world in 2022. Cell therapies targeting cells associated with chronic conditions. Hence, the growing chronic disease burden is poised to drive market expansion during the forecast period.
The growth of preclinical and clinical activities in cell therapy creates increased demand for CDMO. These specialized service providers offer expertise in process development, manufacturing, and regulatory compliance, supporting the progression of cell therapies from research to commercialization. As the cell therapy market expands, CDMOs play a pivotal role in accelerating product development, ensuring quality, and navigating regulatory complexities, thereby boosting the overall demand for cell therapy CDMO services. For instance, in September 2023, C3i provided process development and manufacturing to Phase III with the expected goal of commercial launch at the end of 2024. C3i Center Inc. announced the manufacturing of a cell therapy product for Europe that is currently in Phase II clinical trials.
Further, growing collaboration and partnerships between biopharmaceutical companies and CDMOs are anticipated to provide an opportunity for market players in the growth of the cell and gene therapy CDMO services market during the forecast period. For instance, in October 2023, eXmoor Pharma launched its new Cell and Gene Therapy Centre good manufacturing practice (GMP) facility to support the production of multiple therapies for clinical trials. Similarly, in June 2023, Quell Therapeutics and AstraZeneca signed a licensing deal to develop, manufacture, and commercialize engineered Treg cell therapies for autoimmune disorders.
Hence, increasing preclinical and clinical trial activities around cell therapy and market players' strategic activities, such as mergers and acquisitions, are expected to boost the market during the forecast period. However, the high cost of researching complex manufacturing processes and regulatory challenges hamper market growth.
Cell therapy has emerged as a promising therapy in the treatment of cancer. Approaches like CAR-T (chimeric antigen receptor T-cell) therapy involve genetically modifying a patient's T cells to express a receptor. CDMOs contribute to optimizing the manufacturing processes for cell therapies, ensuring scalability, efficiency, and consistency. This is vital for producing sufficient therapeutic cells needed for each patient.
The growing prevalence of cancer is driving the demand for advanced and effective therapeutics, leading to new investments by companies and other stakeholders, like governments, to identify, test, and develop novel cancer therapeutics. For instance, as per the Canadian Cancer Statistics 2023 report, about 239.2 thousand new cancer cases were reported in 2023 in Canada, compared to 233.9 thousand in 2022. Thus, the growing burden of cancer is expected to create the demand for drug research and manufacturing services, which will likely contribute to segment growth.
The increasing research & development activities and collaboration with CDMO providers to effectively complete the drug development process for cancer drugs are expected to contribute to segment growth. For instance, in March 2023, Eutilex, a partner of GenScript ProBio, a CDMO, announced the Ministry of Food and Drug Safety (MFDS) clearance of its hepatocellular carcinoma clinical trial application for innovative CAR-T program (EU307). Additionally, in October 2023, BioCina Pty Ltd partnered with GenomeFrontier Therapeutics AU Pty Ltd to develop innovative virus-free chimeric antigen receptor T cell products (CAR-T) for cancer treatment.
Hence, increasing research and development activities involving cell therapy will create demand for CDMO services during the forecast period.
Due to established research facilities, significant R&D investment in cell therapy, and the rising prevalence of chronic conditions, the cell therapy CDMO market in North America is projected to expand. The market's growth is fueled by the influx of new cell therapy products, their potential in treating autoimmune diseases, cancer, and infectious diseases, and the numerous ongoing clinical trials.
As of October 2023, ClinicalTrials.gov implied over 581 ongoing clinical trials in North America exploring cell therapies and other cell-based approaches for potential applications in treating diverse disease conditions. Consequently, the demand for advanced manufacturing services specializing in cell and gene therapies is expected to surge.
Additionally, the market's growth trajectory is anticipated to be further driven by enhanced investment in the development of cell-based therapies. For instance, Cellares secured a USD 255 million Series C investment in August 2023, which will fund the completion of its commercial-scale cell therapy manufacturing facility in Bridgewater, New Jersey. Thus, the expansion of research and development initiatives and the availability of a robust healthcare infrastructure contribute significantly to the regional market's overall growth. In November 2022, Charles River Laboratories International Inc. expanded its cell therapy CDMO facility in Memphis, United States, and the expanded space is suitable for clinical and commercial cell therapy manufacturing. This increase in the growth of the CDMO sector facilitates the increasing cell therapy manufacturing services, thereby propelling the market's growth. Moreover, in October 2022, FUJIFILM Diosynth Biotechnologies and RoosterBio announced a collaboration to enable GMP manufacturing of Cell and Exosome therapies.
Thus, factors like the rise in cancer incidence and advancements made by companies are anticipated to fuel market expansion in this region.
The market for cell therapy contract development and manufacturing organizations is moderately competitive, with the presence of both small and large players who are involved in strategic activities such as the expansion of services, partnerships, collaborations, as well as mergers, and acquisitions. Catalent Inc., Lonza, Wuxi Biologics, and Recipharm AB are the key players in this market.