Automated And Closed Cell Therapy Processing Systems Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Workflow (Separation, Expansion, Apheresis, Fill-Finish, Cryopreservation, Others), By Type (Stem Cell Therapy, Non-Stem Cell Therapy), By Scale (Pre-commercial/ R&D Scale, Commercial Scale), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 931.08 MIllion
CAGR (2026-2031)	9.37%
Fastest Growing Segment	Stem Cell Therapy
Largest Market	North America
Market Size (2031)	USD 1593.59 MIllion

Market Overview

The Global Automated And Closed Cell Therapy Processing Systems Market will grow from USD 931.08 MIllion in 2025 to USD 1593.59 MIllion by 2031 at a 9.37% CAGR. Automated and closed cell therapy processing systems are integrated platforms designed to isolate, enrich, expand, and harvest therapeutic cells within a sealed environment to minimize contamination risks and reduce manual intervention. The primary drivers fueling the market include the critical need for scalable manufacturing solutions to meet the rising demand for advanced therapies and the stringent regulatory requirements for Good Manufacturing Practice compliance. According to the American Society of Gene & Cell Therapy, in 2024, there were more than 4,000 gene, cell, and RNA-based treatments in research and development globally, underscoring the necessity for efficient processing technologies to support this robust clinical pipeline.

However, the market faces a significant challenge regarding the high capital investment required for implementation, as small and medium-sized enterprises often struggle with the costs of transitioning to fully automated workflows. Furthermore, the technical complexity of these systems creates a barrier to entry, requiring a highly specialized workforce to operate and maintain this infrastructure effectively.

Key Market Drivers

The exponential growth in the global cell and gene therapy pipeline serves as the primary catalyst propelling the adoption of automated and closed processing systems. As pharmaceutical developers transition candidates from research settings to late-stage clinical trials and commercial production, the demand for equipment capable of ensuring sterility and scalability has surged. According to the Alliance for Regenerative Medicine, in January 2024, there were approximately 1,900 active clinical trials globally, reflecting a massive accumulation of potential treatments requiring standardized manufacturing infrastructure. This pipeline expansion is directly translating into commercial reality, creating an urgent necessity for platforms that can support high-throughput production without compromising quality. According to Cell & Gene Therapy Review, as of November 2024, the U.S. FDA had granted approval to seven new cell and gene therapies in 2024, a trend that underscores the critical market shift toward commercial-ready, automated processing solutions.

Simultaneously, the imperative to reduce manufacturing costs and operational overheads is driving the industry away from labor-intensive manual workflows. Traditional open processing methods are prohibitively expensive due to the high reliance on skilled operators and the need for extensive cleanroom facilities. Automated, closed systems address these economic bottlenecks by significantly lowering the cost of goods sold (COGS) while enhancing batch consistency. According to Cellares, in March 2024, their cGMP-compliant automated manufacturing platform was reported to reduce labor and facility size requirements by 90% compared to conventional manual processes. By minimizing human intervention and footprint, these systems enable manufacturers to achieve the scalability and economic viability necessary to meet the growing global patient demand.

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Key Market Challenges

The high capital investment required to implement automated and closed cell therapy processing systems acts as a significant barrier to market expansion. These integrated platforms necessitate substantial upfront expenditure, which includes the cost of the equipment as well as expenses for facility integration and qualification. For small and medium-sized enterprises, which frequently drive innovation in this sector, such financial demands can be prohibitive. Consequently, many potential adopters are forced to rely on less expensive manual processing methods, thereby limiting the immediate customer base for automated solutions and slowing the overall rate of market penetration.

This financial constraint is particularly critical given the landscape of the industry. According to the Alliance for Regenerative Medicine, in 2024, the sector encompassed approximately 3,000 developers globally. A vast majority of these entities are emerging biotechnology firms with finite financial resources, making the transition to expensive automated infrastructure difficult to justify. The inability of this substantial segment to afford advanced processing systems directly restricts sales volume for manufacturers, while the rigorous capital approval processes required by larger firms further delay implementation and hamper the market's growth trajectory.

Key Market Trends

The strategic adoption of automated platforms by Contract Development and Manufacturing Organizations (CDMOs) represents a fundamental shift in the market's commercial structure. CDMOs are increasingly investing in versatile, closed-system technologies to secure long-term capacity reservations from major pharmaceutical developers, thereby standardizing production across different therapeutic modalities. This trend moves the industry toward a model where manufacturing capacity is flexible and rapidly scalable through third-party partners rather than solely internal builds. According to Cellares, April 2024, the company entered a worldwide capacity reservation and supply agreement valued at up to $380 million with Bristol Myers Squibb to manufacture CAR-T cell therapies using its automated Cell Shuttle platform.

Concurrently, the adoption of decentralized and point-of-care manufacturing models is gaining traction to address the logistical complexities of personalized treatments. By integrating processing systems directly within hospitals and clinical centers, stakeholders aim to drastically reduce vein-to-vein timelines and eliminate the risks associated with long-distance cryopreserved transport. This localization of manufacturing capability transforms treatment centers into production hubs, facilitating immediate patient access to fresh cellular products. According to MD Anderson Cancer Center, November 2024, the institution launched its Institute for Cell Therapy Discovery & Innovation with over $80 million in funding to accelerate the development and manufacturing of impactful cell therapies directly within a clinical setting.

Segmental Insights

The Stem Cell Therapy segment represents the fastest-growing category within the Global Automated And Closed Cell Therapy Processing Systems Market. This rapid expansion is driven by the rising demand for regenerative medicine to treat chronic conditions and tissue damage. Manufacturers are increasingly adopting automated closed frameworks to minimize contamination risks and ensure adherence to Good Manufacturing Practice guidelines enforced by the US Food and Drug Administration. This transition supports scalable production and consistent product quality, which remain critical for advancing successful clinical outcomes in stem cell research and commercialization.

Regional Insights

North America leads the Global Automated and Closed Cell Therapy Processing Systems Market, driven by a mature biotechnology sector and extensive clinical research initiatives. The region hosts a dense network of biopharmaceutical companies and GMP-certified manufacturing facilities that utilize automated platforms to ensure production scalability and consistency. Furthermore, the United States Food and Drug Administration (FDA) fosters industry growth by establishing clear regulatory pathways for advanced therapies, facilitating faster commercialization and attracting significant investment. This favorable ecosystem, underpinned by robust healthcare infrastructure, solidifies North America's position as the primary region for automated cell therapy processing.

Recent Developments

• In November 2024, a medical technology company specializing in blood and cell processing announced the formation of a new global business unit dedicated to therapy innovations. This strategic division was established to integrate disease-specific expertise across the entire patient care continuum, linking cell collection with downstream manufacturing and therapy delivery. By leveraging its portfolio of automated cell expansion and fill-finish systems, the company aimed to create a coordinated ecosystem for treating conditions like sickle cell disease. The initiative reflected a commitment to improving patient access to advanced therapies through the standardization and optimization of automated manufacturing processes.
• In September 2024, a leader in automated cell therapy manufacturing and a global technology corporation announced a joint development collaboration. The initiative aimed to integrate the technology corporation’s advanced flow cytometry-based cell sorting and analysis systems into the manufacturing organization’s automated, closed-loop platform. This technical integration was intended to facilitate the high-throughput production of complex cell therapies, such as regulatory T cells, which require precise sorting. The partnership sought to enable real-time quality control and process monitoring within a fully automated environment, thereby enhancing the efficiency, consistency, and scalability of cell therapy manufacturing for developers worldwide.
• In May 2024, a leading provider of life sciences technologies launched a next-generation automated platform dedicated to the manufacturing of autologous CAR-T cell therapies. Developed in collaboration with a specialized cell therapy company, this new system was designed to digitize and integrate multiple processing steps, including cell isolation, activation, and harvest, into a closed workflow. The platform aimed to increase manufacturing productivity by up to 50% annually compared to traditional methods. By minimizing manual operations and reducing the risk of contamination, the system addressed critical barriers in the scalability and affordability of producing personalized cancer treatments.
• In April 2024, a major global pharmaceutical company and a specialist in automated cell therapy manufacturing entered into a capacity reservation and supply agreement worth up to $380 million. The partnership focused on utilizing the manufacturing organization’s fully automated, high-throughput platform to produce select chimeric antigen receptor T-cell therapies. By securing exclusive access to these advanced manufacturing capabilities in the United States, Europe, and Japan, the pharmaceutical company aimed to overcome production bottlenecks and meet the increasing global demand for its cell therapies. This collaboration underscored the industry's strategic pivot toward automated, closed-system manufacturing to enhance scalability and reduce costs.

Key Market Players

• Miltenyi Biotec B.V. & Co. KG
• Lonza Group AG
• Fresenius Kabi AG
• Global Life Sciences Solutions USA LLC
• BioSpherix, LLC
• Terumo Corp
• Sartorius AG
• ThermoGenesis Holdings Inc
• Cellares Corporation
• Thermo Fisher Scientific Inc.

By Workflow	By Type	By Scale	By Region
Separation Expansion Apheresis Fill-Finish Cryopreservation Others	Stem Cell Therapy Non-Stem Cell Therapy	Pre-commercial/ R&D Scale Commercial Scale	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Automated And Closed Cell Therapy Processing Systems Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Automated And Closed Cell Therapy Processing Systems Market, By Workflow:

• Separation
• Expansion
• Apheresis
• Fill-Finish
• Cryopreservation
• Others

• Automated And Closed Cell Therapy Processing Systems Market, By Type:

• Stem Cell Therapy
• Non-Stem Cell Therapy

• Automated And Closed Cell Therapy Processing Systems Market, By Scale:

• Pre-commercial/ R&D Scale
• Commercial Scale

• Automated And Closed Cell Therapy Processing Systems Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE