Automated and Closed Cell Therapy Processing System Market Set for Robust Growth, Projected to Reach USD 11.11 Billion by 2035

The automated and closed cell therapy processing systems market is experiencing rapid growth, driven by the increasing demand for regenerative medicine and the need for advanced, scalable biomanufacturing solutions. Over the forecast period from 2025 to 2035, the market is projected to grow at a robust compound annual growth rate (CAGR) of 20.0%, with market revenues expected to increase from USD 1.79 billion in 2025 to USD 11.11 billion by 2035. This growth trajectory is fueled by advancements in bioprocessing technologies and an increasing number of FDA and EMA approvals for cell-based therapies. As the market continues to evolve, it is clear that automation, scalability, and real-time monitoring are key to meeting the demands of modern biopharmaceutical manufacturing.

Key Drivers of Market Growth

Several factors are driving the growth of the automated and closed cell therapy processing system market. One of the primary drivers is the increasing adoption of regenerative medicine, particularly in cell therapies such as CAR-T (Chimeric Antigen Receptor T-cell) therapy, stem cell therapy, and gene-modified therapies. These therapies are becoming more prevalent as treatments for a variety of serious and chronic conditions, including cancer, genetic disorders, and autoimmune diseases.

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The biopharmaceutical manufacturing industry is undergoing a significant transformation as it shifts towards more advanced manufacturing methodologies. These advanced approaches streamline and standardize production processes, which is crucial to meeting the growing demand for these therapies. Automated closed systems, which allow for more efficient, scalable, and controlled manufacturing environments, are becoming increasingly necessary to ensure product quality, regulatory compliance, and cost-effectiveness.

Moreover, the increasing number of approvals from regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for cell-based therapies is a key factor driving market growth. These approvals provide the foundation for the expanded use of cell therapies and encourage further investments in biopharmaceutical manufacturing technologies.

Technological Advancements and Market Dynamics

The shift towards automated and closed cell therapy processing systems is a response to the growing complexity of cell therapy manufacturing. These systems offer numerous advantages, including enhanced cell viability, sterility, and standardization of therapeutic processes. Automation in the production of cell-based therapies has become increasingly important in reducing the risks of human error and increasing the efficiency of the manufacturing process.

Real-time monitoring and single-use bioprocess technology are two key innovations that are helping to streamline the manufacturing of cell therapies. Single-use bioreactors, in particular, are gaining traction in the market due to their ability to reduce contamination risks, lower capital expenditures, and improve overall production efficiency. These technologies enable faster production cycles, which is essential for meeting the growing demand for cell-based therapies.

Artificial intelligence (AI) is also playing a significant role in optimizing the biomanufacturing process. AI-driven bioprocess monitoring systems allow for real-time adjustments to be made during production, ensuring that the therapy meets the required quality standards. This integration of AI and automation is creating a more efficient, precise, and scalable manufacturing process.

Key Takeaways

• United States: Dominating the automated and closed cell therapy processing systems market due to strong biotechnology and pharmaceutical industries. The demand for regenerative medicine and personalized therapies drives the need for cell processing automation. High investments in cell therapy research and favorable FDA regulations support market growth.

CAGR (2025 to 2035): 21.5%

• United Kingdom: The market is growing due to increased government funding for cell therapy research and advancements in bioprocessing technology. Biotech companies and research institutes drive innovation in automated cell processing. Closed systems ensure real-time monitoring, compliance, and scalability in cell therapy production.

CAGR (2025 to 2035): 21.2%

• European Union (EU): Significant growth is seen in countries like Germany, France, and Belgium, fueled by strong biotech ecosystems and government-backed initiatives. The rising prevalence of chronic diseases and the demand for regenerative medicine further drive the need for automated and closed cell therapy systems. The European Medicines Agency’s stringent quality control standards are expected to increase adoption of these systems.

CAGR (2025 to 2035): 22.0%

• Japan: A strong pharmaceutical industry and focus on regenerative medicine boost the adoption of automated cell therapy processing systems. Government policies promote innovation in biopharmaceuticals, especially in cell therapy manufacturing. Academic and biotech collaborations spur technological advancements.

CAGR (2025 to 2035): 22.3%

• South Korea: Rapid advancements in biotechnology and stem cell research make South Korea one of the largest markets for automated cell therapy processing systems. Government support for cell and gene therapy and the country’s robust manufacturing infrastructure drive the demand for efficient closed processing systems.

CAGR (2025 to 2035): 22.1%

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Competitive Landscape

The competitive landscape of the automated and closed cell therapy processing system market is highly dynamic, with several leading players vying for market share. Companies are increasingly investing in automation, AI-driven solutions, and innovative bioprocessing technologies to maintain a competitive edge.

Prominent players in the market include:

• Lonza: A global leader in biopharmaceutical manufacturing services, Lonza is at the forefront of developing automated and closed cell therapy processing systems.
• BioSpherix: Known for its innovative closed-system bioreactors, BioSpherix is focused on improving cell culture environments for cell therapy production.
• Cellares: Cellares is developing a platform for scalable and automated cell therapy manufacturing, aimed at reducing the complexity and cost of production.
• Sortorius: A major player in the field of bioprocessing, Sortorius provides a range of automated solutions for cell therapy manufacturing.
• ThermoGenesis Holdings Inc.: Specializing in regenerative medicine, ThermoGenesis provides automated solutions for cell therapy production, including stem cell and gene-modified therapies.
• Thermo Fisher Scientific Inc.: Thermo Fisher offers a comprehensive portfolio of products for cell therapy processing, including automation systems and single-use bioreactors.

Market Segmentation

The automated and closed cell therapy processing system market can be segmented based on type, workflow, scale, and region.

By Type:

• Stem Cell Therapy: Stem cell therapies are among the most promising regenerative treatments, particularly in areas such as neurology, cardiology, and orthopedics. The increasing demand for stem cell therapies is driving the growth of automated processing systems in this area.
• Non-Stem Cell Therapy: Non-stem cell therapies, including CAR-T and gene-modified therapies, are also significant contributors to market growth. These therapies require highly controlled and automated manufacturing processes to ensure consistency and safety.

By Workflow:

• Separation: This process involves isolating the desired cells from a complex mixture, a critical step in producing effective cell therapies.
• Expansion: Expansion involves the proliferation of the isolated cells to obtain sufficient quantities for therapy, and automation ensures efficiency and scalability in this process.
• Apheresis: Apheresis is the process of collecting specific cells from a patient or donor, typically used in CAR-T therapy. Automated systems help to improve the precision and speed of this procedure.
• Fill-Finish: The fill-finish process involves the final preparation and packaging of cell-based therapies. Automation in this step ensures sterility and reduces the risk of contamination.
• Cryopreservation: Cryopreservation is crucial for preserving cells until they are needed for therapy. Automated systems enable more precise control over the freezing and storage process.

By Scale:

• Pre-commercial/Research and Development Scale: At this scale, systems are used primarily for R&D and pilot projects to optimize manufacturing processes.
• Commercial Scale: Commercial-scale systems are designed to meet the large-scale production demands of cell therapies, ensuring that they can be produced consistently and efficiently at a large scale.

By Region:

• North America: North America is the largest market for automated and closed cell therapy processing systems, driven by the presence of leading biopharmaceutical companies and robust regulatory support.
• Europe: Europe is also a key market, with significant investments in regenerative medicine and a strong focus on regulatory compliance.
• Asia Pacific: The Asia Pacific region is expected to witness significant growth due to increasing investments in biopharmaceutical manufacturing and expanding healthcare infrastructure.
• Latin America and Middle East & Africa: These regions are witnessing gradual growth, driven by increased adoption of advanced medical technologies and a rising demand for cell-based therapies.

Conclusion

The automated and closed cell therapy processing systems market is poised for significant growth over the next decade. As the demand for regenerative medicine continues to rise, the need for advanced manufacturing technologies that can deliver scalable, efficient, and cost-effective solutions becomes ever more critical. Automation, AI-driven bioprocess monitoring, and single-use bioreactors will continue to play a central role in shaping the future of cell therapy manufacturing. With increasing regulatory approvals and investments in biopharmaceutical manufacturing, the market is set to grow at a rapid pace, offering lucrative opportunities for stakeholders in the industry.