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January 2025
The global automated and closed cell therapy processing systems market size is calculated at USD 1.45 billion in 2024, grew to USD 1.74 billion in 2025, and is projected to reach around USD 8.86 billion by 2034. The market is expanding at a CAGR of 19.84% between 2025 and 2034. The growing demand for regenerative medicine, technological advancements, and the rising prevalence of chronic disorders drive the market.
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Cell therapy manufacturing is a rapidly evolving field with the latest advancements. Manufacturers and researchers are adopting automated and closed systems to overcome several limitations of conventional cell therapy processing. Conventional processes, i.e., open systems, risk contamination, and manufacturing failures. Conversely, closed systems offer numerous benefits, including reduced risk of contamination, improved batch-to-batch consistency, and the ability to operate in a grade C manufacturing facility. Integrating automation in the cell therapy processing systems streamlines the entire workflow and can be a critical part of large-scale cGMP manufacturing. Automated and closed processing systems are generally of two categories: integrated closed systems and modular closed systems.
The rising incidences and prevalence of chronic disorders such as cancer and neurological disorders, necessitate the development of cell therapy for their treatment. The favorable regulatory policies and new product launches boost the market. The increasing number of clinical trials is a result of growing research and development activities related to cell therapy. The advent of advanced technologies facilitates the latest innovations in the cell therapy manufacturing process. Additionally, several government and private organizations provide funding to conduct cell therapy research and its large-scale manufacturing.
Artificial intelligence (AI) plays a crucial role in incorporating automation in cell therapy processing systems. It enhances precision, reduces manual error, and accelerates cell therapy production. Automation helps to reduce manufacturing failure rates by allowing checkpoint analysis and minimizing human intervention. AI can result in either semi-automated or automated systems. The type of system is selected based on the product requirements. AI facilitates cell therapy manufacturing from lab scale to pilot scale and large scale, enabling process robustness and reproducibility. AI transforms all steps of cell manufacturing including cell separation, activation and genetic modification, expansion, and fill/finish. Additionally, AI-enabled predictive analytics predict the potential defects and errors during manufacturing, allowing manufacturers to make timely decisions.
Growing Demand for Cell Therapy
The major growth factor of the automated and closed cell therapy processing systems market is the growing demand for cell therapy products. The rising prevalence of chronic disorders increases the demand for cell therapy. Cell therapy products such as CAR T-cells, immune cells, and stem cells are transplanted into humans to replace or repair damaged tissue or cells. These therapies help slow or completely stop such disorders and can target any of the thousands of genes in the body. The increasing investments in cell therapy research and favorable government support promote cell therapy development. The new product launches also augment market growth. The U.S. Food and Drug Administration approved around 10 cell and gene therapy products from 2023 to May 2024. Of these, 5 are cell therapy products, including stem cells and CAR T-cells.
High Installation Cost
The major challenge of the automated and closed cell therapy processing systems market is the high installation cost. These processing systems cost thousands of dollars, limiting the affordability of numerous manufacturers, especially in low- and middle-income countries. This restricts the adoption of automated and closed systems for cell therapy manufacturing.
Increasing Number of Clinical Trials
The future of the automated and closed cell therapy processing systems market is promising, driven by the increasing number of clinical trials. The growing demand for cell therapy favors continuous research and development to produce novel products. This leads to an increasing number of clinical trials. The purpose of the trials is to assess the optimal dosing frequency, safety, and effectiveness of cell therapies on humans. Numerous regulatory agencies ask for clinical trial data for product marketing approval. The increasing investments from government and private organizations support clinical trials. According to the IQVIA report, the total spending on cell and gene therapies amounted to $5.9 billion in 2023, an increase of 38% from 2022. Researchers are eager to find extended applications of existing cell therapy products or develop novel products, leading to increasing clinical trials.
By workflow, the separation segment held a dominant presence in the automated and closed cell therapy processing systems market in 2024. It is an essential step of cell therapy processing, wherein the collected cells are segregated from whole blood or serum and thawed. The cell viability and cellular integrity are maintained throughout the process, making it a complex process. Hence, automated systems are used for gentle sample handling and minimizing the risk of contamination. The growing demand for enhanced efficiency and scalability promotes the use of automated and closed systems for isolation.
By workflow, the expansion segment is predicted to witness significant growth in the market over the forecast period. Expansion in cell therapy processing refers to growing cells in culture media after their transduction and activation. Since this process requires continuous monitoring and frequent manipulation of data gathering and analysis, automated systems are required. Automation significantly reduces human intervention, thereby saving time and facilitating consistency in results. The growing demand for cell culture processes and technological advancements augment the segment’s growth.
By type, the non-stem cell therapy segment held the largest share of the automated and closed cell therapy processing systems market in 2024 and is expected to grow at the fastest rate during the forecast period. Non-stem cell therapy products include fibroblasts, keratinocytes, hepatocytes, and immune cells such as T cells and natural killer cells. The demand for somatic cell therapies increases as they are highly specialized and can be manipulated. They have fewer chances for adverse effects and are generally employed as an in vivo source of enzymes, cytokines, and growth factors to treat chronic disorders. The rising incidences of cancer and congenital disorders promote the development of non-stem cell therapy.
By type, the stem cell therapy segment will gain a significant share of the market over the studied period. Stem cells are derived from either embryonic cells or adult cells. They possess the capability to divide into human cells, treating chronic disorders. The need to increase the accessibility of stem cells at affordable costs increases the development of automated and closed processing systems. The rising prevalence of chronic disorders and increasing organ transplantations potentiate the segment’s growth.
By scale, the pre-commercial/ R&D scale segment led the global automated and closed cell therapy processing systems market in 2024 and is expected to grow at the fastest rate during the forecast period. The segmental growth is attributed to increasing investments and growing research and development activities. Several government organizations support the development of cell therapy products at the R&D scale. Before commencing large-scale production, all cell therapy processing steps need to be validated at a lab scale to ensure an efficient process. This reduces significant errors during large-scale manufacturing.
By scale, the commercial segment is projected to grow significantly in the market in the coming years. Commercializing cell therapy manufacturing is a very complex process that includes upstream processing, downstream processing, process development, and testing. Integrating automation at a commercial scale maintains quality standards and efficiency. It ultimately reduces time and human efforts, enhancing reproducibility.
North America dominated the global automated and closed cell therapy processing systems market share by 50% in 2023. The presence of key players, favorable government support, and technological advancements drive the market. The increasing number of clinical trials also potentiates market growth. Key players such as Thermo Fisher Scientific, Sigma Aldrich, and Beckman Coulter hold the major share of the market. Out of the total 6,011 active and recruiting clinical trials registered on clinicaltrials.gov involving cell therapy, around 2,813 are conducted in the U.S. Thus, the highest number of clinical trials globally are performed in the U.S. New product launches and suitable regulatory framework fuel market growth in North America. The Center for Biologics Evaluation and Research (CBER) and Health Canada regulate cell therapy products in the U.S. and Canada, respectively.
Asia-Pacific is expected to grow at the fastest rate in the automated and closed cell therapy processing systems market during the forecast period. The increasing investments, growing research and development activities, and mergers & acquisitions drive the market. Countries like China, Japan, and South Korea are becoming significant players in cell therapy research due to lower costs and favorable policies. The Asia-Pacific countries like China, India, and Japan possess suitable manufacturing infrastructure. Governments attract foreign direct investments in emerging countries owing to affordable labor costs. Recently, the Chinese government lifted bans on foreign-invested enterprises in cell and gene therapy in selected free trade zones. Favorable government policies by the Indian government, such as “Make in India” and “Atmanirbhar Bharat,” promote indigenous development of cell therapy products. Moreover, the rising adoption of advanced technologies also contributes to market growth.
Jason Foster, CEO of Ori Biotech, commented that the company’s goal is to deliver a platform that is both flexible to perform research and scalable for commercial manufacturing. The company’s manufacturing platform can start with 50 million cells and deliver yields of up to 12 billion with 95% viability. He further said that a modular approach provides flexibility, scalability, and biological performance required to make cell therapy products efficiently and cost-effectively at scale.
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