Automated and Closed Cell Therapy Processing Systems Market By Type (Stem Cell Therapy and Non-stem Cell Therapy), By Workflow (Cryopreservation, Separation, Fill-finish, Expansion, Apheresis, and Others), By Scale (Commercial Scale and R&D Scale), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The Automated and Closed Cell Therapy Processing Systems Market Size is expected to be worth around US$ 9.1 billion by 2034 from US$ 1.5 billion in 2024, growing at a CAGR of 19.7% during the forecast period 2025 to 2034. North America held a dominant market position, capturing more than a 42.4% share and holds US$ 0.6 Billion market value for the year.

Increasing demand for personalized medicine and the rapid advancement of cell and gene therapies have significantly boosted the growth of the automated and closed cell therapy processing systems market. These systems are crucial in ensuring the precise and efficient production of cellular therapies, minimizing human error and maintaining the sterility and integrity of the processes. The growing focus on regenerative medicine and the need for scalable production technologies create substantial opportunities for innovation and market expansion.

In October 2024, a strategic alliance formed between Cellular Origins and Fresenius Kabi aimed to combine innovative cell therapy processing technologies with Cellular Origins’ sophisticated Constellation CGT robotic manufacturing platform. This collaboration seeks to optimize and scale up the production of cell therapies, advancing the efficiency of the cell and gene therapy (CGT) sector.

Furthermore, the increasing regulatory support for cell therapies, along with continuous research into their broader applications for diseases such as cancer, autoimmune disorders, and genetic conditions, further drives the market. The adoption of closed systems in these processes ensures safety, reduces contamination risks, and increases overall yield, further accelerating the growth of the market.

Key Takeaways

• In 2023, the market for automated and closed cell therapy processing systems generated a revenue of US$ 1.5 billion, with a CAGR of 19.7%, and is expected to reach US$ 9.1 billion by the year 2033.
• The type segment is divided into stem cell therapy and non-stem cell therapy, with non-stem cell therapy taking the lead in 2023 with a market share of 54.3%.
• Considering workflow, the market is divided into cryopreservation, separation, fill-finish, expansion, apheresis, and others. Among these, expansion held a significant share of 43.7%.
• Furthermore, concerning the scale segment, the market is segregated into commercial scale and R&D scale. The R&D scale sector stands out as the dominant player, holding the largest revenue share of 57.8% in the automated and closed cell therapy processing systems market.
• North America led the market by securing a market share of 42.4% in 2023.

Type Analysis

The non-stem cell therapy segment led in 2023, claiming a market share of 54.3% owing to the significant progress and commercialization of non-stem cell therapies, particularly in the field of cancer immunotherapy, such as CAR T-cell therapies. The established manufacturing protocols and the higher number of approved non-stem cell therapies compared to stem cell therapies have contributed to the larger market share of this segment.

The increasing clinical success and broader application of non-stem cell therapies in treating various hematological malignancies and solid tumors are further driving the demand for automated and closed processing systems tailored to these specific cell types.

Workflow Analysis

The expansion held a significant share of 43.7% owing to several factors. Cell expansion is a critical step in the manufacturing of most cell therapies, requiring the in vitro proliferation of therapeutic cells to obtain the necessary quantities for patient doses. Automated and closed systems for cell expansion offer significant advantages in terms of scalability, consistency, and reduced contamination risks compared to traditional manual methods.

The increasing demand for large volumes of therapeutic cells for both clinical trials and commercial therapies has made automated expansion systems a crucial component of cell therapy manufacturing, driving the dominance of this workflow segment.

Scale Analysis

The R&D scale segment had a tremendous growth rate, with a revenue share of 57.8% owing to the extensive research and development activities ongoing in the field of cell therapy. The need for flexible, adaptable, and closed systems for process development, optimization, and small-batch production for preclinical and early-phase clinical trials drives the demand for systems suitable for R&D purposes.

The increasing number of cell therapy candidates in the discovery and preclinical stages, coupled with the need for robust manufacturing platforms for clinical translation, contributes to the significant market share of the R&D scale segment.

Key Market Segments

By Type

• Stem Cell Therapy
• Non-stem Cell Therapy

By Workflow

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

By Scale

• Commercial Scale
• R&D Scale

Drivers

Increasing Number of Cell Therapy Clinical Trials and Approvals is Driving the Market

The rapidly increasing number of cell therapy clinical trials and regulatory approvals is a major driver for the Automated and Closed Cell Therapy Processing Systems Market. According to the Alliance for Regenerative Medicine (ARM) data from 2024, the number of ongoing cell and gene therapy clinical trials globally has continued to rise.

The regulatory approvals of several CAR T-cell therapies and other advanced cell therapies by agencies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) since 2021 have created a strong demand for scalable and compliant manufacturing solutions. This growing pipeline of cell therapies progressing towards commercialization necessitates the adoption of automated and closed processing systems to ensure efficient and safe production.

Restraints

High Upfront Costs and Complexity of Implementation

High Upfront Costs and Complexity of Implementation May Restrain Market Growth The high upfront costs associated with automated and closed cell therapy processing systems and the complexity of their implementation can act as restraints on market growth, particularly for smaller biotech companies and academic institutions.

The initial investment in sophisticated automated equipment and the expertise required for their installation, validation, and operation can be substantial. Furthermore, the integration of these systems into existing manufacturing workflows may require significant process development and optimization. These financial and technical barriers can slow down the adoption of automated and closed systems, especially for organizations with limited resources or experience in cell therapy manufacturing.

Opportunities

Technological Advancements in Automation and Closed System Design are Creating Growth Opportunities

Continuous technological advancements in automation and closed system design are creating significant growth opportunities within the cell therapy processing market. Innovations such as integrated bioreactors with automated control, advanced cell separation and sorting technologies within closed systems, and automated fill-finish systems are improving the efficiency and reducing the complexity of cell therapy manufacturing.

The development of modular and flexible automated platforms that can be adapted for different cell therapy types and manufacturing scales is also gaining traction. These technological advancements are making automated and closed systems more versatile and attractive to cell therapy developers and manufacturers.

Impact of Macroeconomic / Geopolitical Factors

The Automated and Closed Cell Therapy Processing Systems Market in 2025 is influenced by macroeconomic factors affecting investment in biotechnology and healthcare infrastructure. According to the “Global Biopharmaceutical Industry Outlook 2024” report by EvaluatePharma, global biotechnology research and development spending reached approximately US$230 billion in 2023, a significant portion of which is directed towards cell and gene therapies, driving the demand for advanced manufacturing systems.

Government funding initiatives for regenerative medicine research, such as the US National Institutes of Health (NIH) allocating over US$ 6 billion to cell and gene therapy research in fiscal year 2024, directly support the adoption of sophisticated processing technologies. However, economic downturns can impact venture capital funding for biotech startups, which saw a 15% decrease globally in 2023 compared to the peak in 2021, as per recent reports.

Geopolitical factors, including international collaborations in cell therapy research (e.g., the EU’s Horizon Europe program, as detailed on the European Commission’s website, funding numerous cell therapy projects since 2021), can foster innovation and market growth. Disruptions in the global supply chain for specialized bioreactor components, which experienced a 10-12 week lead time increase in 2022 due to geopolitical tensions, as per recent reports, can affect manufacturing timelines and costs for cell therapy processing systems.

The recent US tariff policies implemented in April 2025 could have specific implications for the Automated and Closed Cell Therapy Processing Systems Market. The United States imports a significant amount of specialized laboratory equipment and precision components used in these systems. Data from the United States International Trade Commission (USITC) indicates that imports of advanced bioreactors and cell separation technologies were valued at over US$1.5 billion in 2024.

Tariffs on these imports could increase the capital expenditure for US-based cell therapy developers and manufacturers by an estimated 5-10%, as per recent reports. This could particularly affect smaller and mid-sized companies. Furthermore, retaliatory tariffs from key trading partners on US-made cell therapy processing equipment could hinder export opportunities for US manufacturers, who exported approximately US$ 300 million worth of such equipment in 2024. The long-term effects will depend on the duration and scope of these tariffs and the strategic responses of companies within the cell therapy manufacturing ecosystem.

Trends

Recent Need for Scalable and Reproducible Manufacturing Processes is Driving Adoption

The critical need for scalable and reproducible manufacturing processes to support the commercialization of cell therapies is a significant driver for the adoption of automated and closed systems. Traditional open and manual processing methods are often labor-intensive, prone to variability, and carry a higher risk of contamination, making them unsuitable for large-scale production.

Automated and closed systems offer the advantages of increased throughput, reduced manual handling, and improved process consistency, which are essential for meeting the growing demand for cell therapies and ensuring their cost-effectiveness. The ability of these systems to maintain a controlled environment and minimize contamination risks is also crucial for regulatory compliance and patient safety.

Regional Analysis

North America is leading the Automated and Closed Cell Therapy Processing Systems Market

North America dominated the market with the highest revenue share of 42.4% owing to its robust cell therapy research ecosystem and a strong biopharmaceutical industry. The US National Institutes of Health (NIH) invested over US$ 6 billion in cell and gene therapy research in fiscal year 2024, fostering innovation and the development of new therapies requiring advanced manufacturing.

The FDA has approved over 20 cell and gene therapies since 2017, with a significant number of these approvals occurring since 2021, driving the demand for scalable manufacturing solutions. Furthermore, the presence of numerous leading academic research institutions and biotech companies, which attracted over US$ 10 billion in venture capital funding for cell and gene therapy development in 2023, as per recent reports, actively fuels the adoption of automated and closed processing systems to support both clinical trials and commercialization.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to increasing investments in biotechnology and a growing focus on cell therapy research and development. Countries like China, which increased its biotech R&D spending by over 18% annually between 2021 and 2024, are making significant strides in cell therapy. The number of cell therapy clinical trials in the Asia Pacific region has increased by over 30% since 2021, as per recent reports.

Furthermore, the increasing prevalence of target diseases and government initiatives to promote the biopharmaceutical sector are driving the demand for automated and closed processing systems to support the anticipated commercialization of new cell therapies in this rapidly expanding market.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

Key players in the Automated and Closed Cell Therapy Processing Systems Market are characterized by their focus on providing integrated and customizable solutions for cell therapy manufacturing. These companies offer a range of products, including automated cell culture systems, closed cell separation and processing platforms, and automated fill-finish solutions.

Strategic collaborations with cell therapy developers and contract manufacturing organizations (CMOs) are crucial for understanding specific manufacturing needs and tailoring their systems accordingly. Continuous innovation to improve the efficiency, scalability, and cost-effectiveness of their systems is a key competitive strategy.

Lonza Group AG, headquartered in Basel, Switzerland, is a leading contract development and manufacturing organization (CDMO) that also offers automated and closed cell therapy processing systems as part of its integrated service offerings. Their experience in cell therapy manufacturing provides them with valuable insights into the design and development of effective processing technologies.

Top Key Players in the Automated and Closed Cell Therapy Processing Systems Market

• Vertex Pharmaceuticals
• Terumo Corporation
• Replay Pharmaceuticals
• Miltenyi Biotec
• Lonza
• Fresenius Kabi AG
• Danaher Corporation
• BioSpherix, LLC

Recent Developments

• In September 2024, Vertex Pharmaceuticals established a long-term commercial supply agreement with Lonza for the manufacture of Casgevy, a gene-edited cell therapy utilizing CRISPR/Cas9 technology to treat sickle cell disease and β thalassemia. This agreement signifies a crucial move toward the broader availability of transformative therapies for these hematologic conditions.
• In December 2023, Miltenyi Biotec and Replay Pharmaceuticals entered into a licensing and manufacturing agreement to develop GMP-grade T-cell receptor (TCR) and natural killer (NK) cell therapies that target PRAME, a neoantigen associated with tumors. This partnership is set to accelerate the creation of advanced immunotherapies with the potential to significantly impact cancer treatment.

Report Scope