Automated And Closed Cell Therapy Processing Systems Market

The market for Automated And Closed Cell Therapy Processing Systems was estimated at $1.9 billion in 2025; it is anticipated to increase to $4.3 billion by 2030, with projections indicating growth to around $9.8 billion by 2035.

Report ID:DS1801063

Author:Debadatta Patel - Senior Consultant

Published Date:January 2025

Datatree

Life Science

Medical Device

Automated And Closed Cell Therapy Processing Systems

Customization Available

Automated And Closed Cell Therapy Processing Systems - 2025-2035

Market Outlook
Market Key Insights
Growth Opportunity
Market Dynamics
Application
Recent Development
Impact Analysis

Report Summary

Market Data

Methodology

Table of Contents

Report Summary

Market Data

Methodology

Table of Contents

Global Automated And Closed Cell Therapy Processing Systems Market Outlook

Revenue, 2025

$1.9B

Forecast, 2035

$9.8B

CAGR, 2026 - 2035

17.8%

The Automated And Closed Cell Therapy Processing Systems industry revenue is expected to be around $1.9 billion in 2026 and expected to showcase growth with 17.8% CAGR between 2026 and 2035. Automated and closed cell therapy processing systems represent a critical technology that will allow the cell therapy industry to manufacture products on a large scale, in accordance with international regulations, and with consistent quality. The main drivers of demand are the extensive use of the industry in oncology and haematology and the dominance of the closed system bioprocessing technology. In 2025, this latter segment is expected to generate $1.16 billion. Closed systems are expected to reduce operator variability and costs as well as the risk of contamination. As cell therapy production scales up through the accelerated translation of autologous and allogeneic therapies particularly in immuno oncology and CAR T cell therapy there is a growing view amongst stakeholders that automated platforms for cell therapy production are critical in order to achieve quicker time to market, increased production volumes and product consistency.

Cell therapy processing systems are closed automated systems. These systems perform the cell isolation, selection, activation, modification, expansion, harvesting and formulation of cells all within the same sterile environment. The entire process takes place in a single use, closed system. This system offers automation that adheres to GMP specifications, in line monitoring and analytics, digital batch records and a flexible design that accommodates various clinical, stem cell and non stem cell therapy processes. Automated cell therapy systems are gaining ground due to a shift away from manual cleanroom working practices. There is also a growing need for standardised production lines for allogenic cell therapies, along with the use of real time process control in conjunction with advanced analytics. As a result, long term adoption of cell processing technology is becoming more widespread.

Automated And Closed Cell Therapy Processing Systems market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035 — Automated And Closed Cell Therapy Processing Systems Market Outlook

Market Key Insights

The Automated And Closed Cell Therapy Processing Systems market is projected to grow from $1.9 billion in 2025 to $9.8 billion in 2035. This represents a CAGR of 17.8%, reflecting rising demand across Oncology, Hematology, and Immunology.
This market is dominated by companies such as Fresenius Kabi, Lonza and Miltenyi Biotec, which are responsible for shaping the markets competitive landscape.
The United States and Germany are likely to be the most significant markets for the automated and closed cell therapy processing systems. The respective Compound Annual Growth Rates of the market in these regions are forecast to be 17.1% and 24.9% between 2025 and 2030.
The fastest growth rates, estimated at 13.4 18.5% , are predicted for emerging markets such as South Africa, India and Brazil.
The growth of the Closed Automated and Cell Therapy Processing Systems market by 2030 is predicted to be $564 million due to the growing trend towards automation.
The closed Automated and Cell Therapy processing systems market is due to rise by $7.9 billion over the period between 2025 and 2035. It is predicted that the systems for the processing of haematology and immunology applications will dominate the market in terms of share.
The growth of chronic diseases, alongside advancements in cell therapy, implies a 415% increase in the demand for closed automated cell processing systems by 2035 relative to 2025.

Automated And Closed Cell Therapy Processing Systems - Country Share Analysis

Opportunities in the Automated And Closed Cell Therapy Processing Systems

The demand in Asia for stem cell treatments is also driving the development of automated and closed systems for processing cells. In the Asia Pacific region, regenerative medicine utilises closed and automated cell therapy systems to increase the expansion of stem cells for orthopaedic, cardiovascular and dermatological applications. Systems such as decentralised production and analysis at the point of care have the advantage of greatly reducing logistics problems in clinical environments, along with creating a closed system which complies with Good Manufacturing Practice. By 2030, regenerative therapy is anticipated to reach $1.60 billion from 2025s $0.74 billion with a Compound Annual Growth Rate of 16.7%. Autologous and allogenic treatments are expected to experience the greatest growth within this field.

Growth Opportunities in North America and Asia Pacific

In North America the Automated and Closed Cell Therapy Processing Systems market is primarily driven by large volume CAR T and gene modified cell therapy pipelines of advanced oncology programmes. Oncology is the leading application region here, with immunology being a very rapidly developing region for the treatment of auto immune diseases. Key region's for investment will centre on automating cell therapy production using machines in labs already complying with Good Manufacturing Practice and where cell handling takes place, located in university hospitals or in firms that offer development and manufacturing services on contract. As the market becomes increasingly competitive, companies which supply automation systems on a global basis are now competing with cell handling specialists and digital manufacturing companies in terms of the integration of workflows, data quality and systems interoperability. Advanced therapy has a strong reimbursement in the region. The regions science environment is well established and is one which rewards companies that put robust automated control into their manufacturing process. Payers in the region want lower cost per dose which will be achieved by moving from manual techniques to automation in cell therapy production in accordance with value based care plans.

Owing to the national cell and gene therapy initiatives in Asia Pacific, the Automated And Closed Cell Therapy Processing Systems market is being increasingly driven. Oncology remains the most prominent application in the region, with an upsurge in the use of haematology in allogeneic and stem cell transplantations occurring beyond the tier one cities. Opportunities exist for the creation of cost effective, closed system manufacturing of cell therapies, particularly for space restricted cleanrooms in hospitals and emerging regional biotechnology hubs. This approach facilitates innovation in the domestic sphere and the transfer of technology from global partners. The market for Automated and Closed Cell Therapy Processing Systems is being driven by a combination of both international companies providing platforms and regional manufacturers which are expanding rapidly. These firms compete on grounds of price, service and how well they can adapt their products to the various different environments they operate in. The main growth drivers for the industry are the increased need for cancer treatment, supportive government policies, investments from hospitals in cell therapy and the need for facilities to treat patients without paying too much while still offering high quality care.

Market Dynamics and Supply Chain

Driver: Rising Demand for Advanced Cell Therapies and Growth in Personalized Medicine Adoption

The market for automated and closed cell therapy processing systems is also strongly driven by the growing demand for advanced cell therapies and the rapid expansion of personalized medicine. Advanced therapies including CAR-T, TCR, and stem cell treatments are also increasingly used in oncology, hematology, and immunology. These treatments require precise, reproducible cell processing steps such as isolation, activation, expansion, and formulation, which automated and closed systems perform with greater consistency and reduced contamination risk compared to manual methods. At the same time, personalized medicine strategies tailored to individual patient profiles have also expanded clinical pipelines and commercial readiness, necessitating scalable, GMP-compliant platforms. Automation enhances manufacturing efficiency while reducing labor costs, making bespoke cell therapy production more feasible for biopharma companies, academic centers, and contract development and manufacturing organizations. This dual acceleration of complex therapeutic demand and personalized treatment frameworks underpins rapid market growth as stakeholders seek robust, high-throughput processing solutions.

Another key driver for automated and closed cell therapy processing systems is also ongoing technological innovation in closed-loop and smart manufacturing platforms. These advancements integrate automation with real-time monitoring, digital control, and quality analytics, enabling seamless transitions between cell processing steps with minimal human intervention. Smart sensors, artificial intelligence, and digital twins technologies enhance process control, improve reproducibility, and ensure compliance with stringent regulatory standards. As a result, manufacturers can also shorten development timelines, reduce batch failures, and scale production more reliably, supporting broader adoption of complex cell-based therapies across clinical and commercial landscapes.

Restraint: High Capital Investment and Complex Regulatory Compliance Restrict Adoption and Scalability

One major restraint for automated and closed cell therapy processing systems is the high upfront costs and complex regulatory landscape. These systems require substantial investment in instrumentation, cleanroom infrastructure, software validation, and operator training, limiting adoption especially among smaller clinics and research facilities. Additionally, stringent regulatory requirements for Good Manufacturing Practice (GMP) compliance and documentation increase time to market and operational costs. For example, facilities may delay purchasing automated platforms due to budget constraints or prolonged validation cycles, which reduces short-term revenue growth and slows market expansion in emerging regions.

Opportunity: Rising U.S. Oncology Center Adoption of Automated Closed Systems for CAR-T Manufacturing and European and North American CDMOs adopting automated closed systems for oncology cell therapy manufacturing

The growing demand for CAR T treatments in U.S. oncology centres necessitates cell processing technology. By using automated and closed systems for CAR-T cell therapy, US oncology networks have been able to standardise the production of such treatments. This also minimises the risk of contamination occurring and reduces manual errors. In response to the pressure from clients for a more cost effective cell therapy manufacturing process, cancer treatment centres and hospitals are turning to closed system biotechnology and single use technologies to accelerate the process from vein to vein. Worldwide, non stem cell therapy will expand from $1.16 billion in 2025 to $2.71 billion in 2030 at a compound annual growth rate of 18.48% the most rapid application region for these systems.

Contract Development and Manufacturing Organisations for cell therapy are investing in modern digital technology and automation to produce cell therapies. Contract development and manufacturing organisations are requiring a closed and automated system for the cell processing of therapies which combines analytics, robotics and software. With cell therapy manufacturing lines that feature digital batch records, bioprocess automation and remote monitoring capabilities, it is now possible for multi product facilities to comply with Good Manufacturing Practice requirements. Industry insiders expect the most rapid expansion to take place amongst European and North American CDMOs who are operating in the complex oncology and rare disease markets, where the non stem cell therapy workflows and allogenic high throughput platforms require greater production capabilities.

Challenge: Limited Skilled Workforce and Technical Expertise Hinder Efficient Implementation and Use

Another key challenge is the shortage of trained professionals and specialized technicians capable of operating and maintaining complex automated systems. Cell therapy manufacturing demands expertise in cell biology, automation, and quality systems. Many academic and hospital labs still rely on manual processes due to workforce gaps, slowing digitization and automation uptake. This skill deficit can lead to operational inefficiencies, increased error rates, and underutilization of advanced platforms, affecting overall demand and hindering broader commercialization of cell therapy solutions.

Supply Chain Landscape

Automated Components Supply

Danaher CorporationFresenius KabiSartorius

Closed System Assembly

Miltenyi BiotecLonzaBioSpherix LLC

Validation Distribution

LonzaCryoportMarken

Cell Therapy End-users

Cell therapy CDMOsAcademic medical centersHospital transplant units

Automated Components Supply

Danaher CorporationFresenius KabiSartorius

Closed System Assembly

Miltenyi BiotecLonzaBioSpherix LLC

Validation Distribution

LonzaCryoportMarken

Cell Therapy End-users

Cell therapy CDMOsAcademic medical centersHospital transplant units

Automated And Closed Cell Therapy Processing Systems - Supply Chain

Use Cases of Automated And Closed Cell Therapy Processing Systems in Oncology & Immunology

Oncology : In oncology, automated and closed cell therapy processing systems streamline the production of advanced cancer treatments such as CAR-T and other adoptive cell therapies, using platforms that automate cell isolation, activation, expansion and formulation with minimal manual intervention. Technologies like MAGnetic-activated cell sorting and closed bioreactors provide consistent, GMP-compliant manufacturing that reduces contamination risks and improves product quality, addressing the rigorous demands of cancer immunotherapies. Leading providers like Miltenyi Biotec, Lonza and Thermo Fisher Scientific are recognized for their integrated, scalable systems that support clinical trial and commercial-scale oncology workflows, enhancing throughput while maintaining viability and functional performance critical for effective cancer treatment development and delivery.

Hematology : In hematology, automated cell therapy processing systems are used extensively for blood-derived cellular therapies, including stem cell expansion and targeted immune cell products for blood disorders. Systems such as Terumo BCT’s Quantum® Cell Expansion System and Thermo Fisher’s CTS DynaCellect™ magnetic separation platform combine closed loop processing with high viability and reproducibility, crucial for hematological applications where consistency directly affects clinical outcomes. These platforms reduce human error, enhance cell recovery, and support standardized processes for clinical laboratories, biopharma firms, and hospitals working on treatments for leukemia, lymphoma, and related conditions.

Immunology : In immunology, automated and closed cell therapy processing systems play an important role in developing immunomodulatory and immune cell-based therapies for autoimmune diseases and immune dysfunctions. Closed systems enable precise cell selection, activation and expansion of T-cells, NK cells, and other immune subsets with reduced contamination risk, improving process control and scalability. Platforms from Miltenyi Biotec and Cytiva’s FlexFactory™ solutions are widely used in immunology research and clinical applications, offering integrated workflows that support early-stage development through to commercial manufacturing while enhancing process reproducibility and regulatory compliance.

Recent Developments

The automated and closed cell therapy processing systems market continues gaining traction as the cell and gene therapy pipeline expands, particularly in oncology, hematology, and immunology applications. Growing demand for scalable, GMP-compliant manufacturing drives adoption of closed-loop processing platforms that reduce contamination risk and improve reproducibility. Increasing integration of automation, digital monitoring and AI-driven analytics enables real-time process control and higher throughput, meeting stringent regulatory standards and supporting commercial-scale production of advanced cell therapies. This trend reflects broader industry moves toward bioprocess automation and enhanced quality assurance in cell therapy manufacturing.

December 2025 : Thermo Fisher Scientific released Gibco CTS Detachable Dynabeads CD4 and CD8, enhancing automated cell isolation and activation steps critical for downstream closed system processing of T‑cell therapies.

April 2025 : Thermo Fisher Scientific announced the expansion of its cell therapy manufacturing facility in Carlsbad, California, adding 50,000 sq ft of space with advanced automated processing systems to support growing demand for CAR‑T and other cell therapies. This expansion enhances capacity for closed, GMP‑compliant production workflows

Impact of Industry Transitions on the Automated And Closed Cell Therapy Processing Systems Market

As a core segment of the Medical Device industry, the Automated And Closed Cell Therapy Processing Systems market develops in line with broader industry shifts. Over recent years, transitions such as Shift Towards Automation and Upswing in Closed Cell Therapy Processing Systems have redefined priorities across the Medical Device sector, influencing how the Automated And Closed Cell Therapy Processing Systems market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.

Shift Towards Automation

Automation trends in the market for automated and closed cell therapy processing systems are being influenced by increased regulatory scrutiny and also rising process complexity. By 2030 the automation trend is forecast to contribute to a rise of $564 million in the market. Cell therapy manufacturers are implementing automation to achieve consistent production, to lower the risk of deviations and to enhance GMP compliance. Furthermore, automation allows for large scale manufacturing within closed systems across a variety of regenerative medicine applications. The use of fully integrated, closed and software controlled production systems is driving manufacturing away from manual and one off processes and towards more consistent, industrial level processes for cell therapies. Automated and closed cell therapy processing systems are becoming crucial for innovators and contract development and manufacturing organisations as cell therapy adoption continues to grow. They are the key to reducing costs and increasing production. This can lead to a competitive edge.

Upswing in Closed Cell Therapy Processing Systems

The automated and closed cell therapy processing systems market is undergoing a clear transition toward wider adoption of fully closed, integrated platforms across cell and gene therapy workflows. This shift is driven by the need to reduce contamination risks, ensure GMP compliance, and improve batch-to-batch consistency as therapies move from clinical trials to commercial scale. In the biopharmaceutical industry, contract development and manufacturing organizations are increasingly replacing open, manual processing with automated closed systems to improve throughput and regulatory readiness. Hospitals and academic centers are also adopting closed systems to support decentralized manufacturing of autologous therapies, reducing cleanroom dependence and operating costs. This transition is influencing associated industries such as single-use consumables, sterile connectors, and automation software, accelerating innovation and reshaping supplier value chains.