Automated and Closed Cell Therapy Processing Systems Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Automated And Closed Cell Therapy Processing Systems Market is projected to expand from USD 931.08 Million in 2025 to USD 1.59 billion by 2031, achieving a compound annual growth rate of 9.37%. These systems function as integrated platforms designed to isolate, enrich, expand, and harvest therapeutic cells within a sealed environment, effectively minimizing contamination risks and reducing the need for manual handling. Primary drivers fueling this market include the urgent requirement for scalable manufacturing solutions to meet the rising demand for advanced therapies and the strict regulatory mandates for Good Manufacturing Practice compliance. According to the American Society of Gene & Cell Therapy, over 4,000 gene, cell, and RNA-based treatments were in research and development globally in 2024, highlighting the necessity for efficient processing technologies to support this robust clinical pipeline.

However, the market encounters 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, necessitating a highly specialized workforce to operate and maintain this infrastructure effectively.

Market Drivers

The exponential growth in the global cell and gene therapy pipeline acts 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, there is a surging demand for equipment capable of ensuring sterility and scalability.

Data from the Alliance for Regenerative Medicine indicates that 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 the 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 and 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.

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.

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, in 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, in 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.

Key Players Profiled in the Automated And Closed Cell Therapy Processing Systems Market

• 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.

Report Scope

In this report, the Global Automated And Closed Cell Therapy Processing Systems Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Automated And Closed Cell Therapy Processing Systems Market.

Available Customization

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• Detailed analysis and profiling of additional market players (up to five).

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