Number of pages: 100 | Report Format: PDF | Published date: June 20, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 981.04 million |
Revenue Forecast in 2031 |
US$ 6,275.58 million |
CAGR |
22.9% |
Base Year for Estimation |
2022 |
Forecast Period |
2023 to 2031 |
Historical Year |
2021 |
Segments Covered |
Workflow, Type, Scale, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global automated and closed cell therapy processing systems market was valued at US$ 981.04 million in 2022 and is expected to register a revenue CAGR of 22.9% to reach US$ 6,275.58 million by 2031.
Automated and Closed Cell Therapy Processing Systems Market Fundamentals
Automation in cell therapy processing or manufacturing systems has provided remarkable benefits to the global pharmaceutical industry. Cell therapy manufacturing encompasses cell selection, isolation, manipulation, and expansion. Any slightest inaccuracy in this complicated operation may result in incorrect cell infusion. The automated and closed cell therapy processing system reduces the final formulation's risk. Automation in cell therapy processing lowers the possibility of contamination caused by the manual technique. The automated and closed cell therapy processing system is used to increase the scale of cell operations by lowering the risk of error during bioprocessing.
Automated and Closed Cell Therapy Processing Systems Market Dynamics
The growing demand for cell-based therapies, including CAR-T cell therapies, stem cell therapies, and regenerative medicine, is driving the need for automated and closed cell therapy processing systems. These systems enable efficient and standardized manufacturing processes to meet the rising demand for these innovative therapies. Additionally, this system provides a controlled environment with a reduced risk of contamination, thereby enhancing safety and maintaining product quality throughout the manufacturing process. In addition, advancements in automation, robotics, and digital technologies enable precise control over critical parameters, real-time monitoring, data integration, and process optimization, ultimately improving manufacturing efficiency and product quality. Automated and closed systems streamline manufacturing processes, reduce manual labor, and minimize the risk of errors and contamination. To accelerate the development and adoption of automated and closed cell therapy processing systems, collaborations and partnerships are forming between technology providers, pharmaceutical companies, research institutions, and regulatory bodies. For instance, in August 2020, IsoPlexis collaborated with Lonza to use IsoPlexis' IsoLight platform. The automated functional proteomics analysis platform will provide quality analytics for cell therapy products generated on Lonza's Cocoon Platform, an automated, highly flexible cell therapy manufacturing platform. These collaborations aim to leverage expertise, share knowledge, and collectively address the challenges associated with cell therapy manufacturing. The development and adoption of industry standards for automated and closed cell therapy processing systems are gaining momentum. These standards ensure interoperability, compatibility, and consistent quality across different systems, facilitating the seamless integration of various components in the cell therapy manufacturing workflow.
However, the lack of uniform standards can hinder interoperability between automated and closed systems, leading to challenges in integrating and scaling manufacturing operations. Integrating automated and closed cell therapy processing systems with existing manufacturing workflows can be challenging. These systems need to seamlessly integrate with upstream and downstream processes, such as cell isolation, expansion, and final product formulation. Compatibility issues and process modifications may arise during integration, requiring careful planning and implementation. The successful implementation of automated and closed systems relies on skilled operators and personnel trained in their operation and maintenance. The shortage of experienced personnel with expertise in cell therapy manufacturing and familiarity with automated systems can be a restraint. Adequate training and education programs are needed to address this challenge and ensure the efficient utilization of these systems. The validation and regulatory compliance requirements for automated and closed cell therapy processing systems can be complex and time-consuming. Ensuring compliance with regulations, such as good manufacturing practices (GMP), requires extensive documentation, process validation, and quality control measures. Meeting these requirements can be challenging, particularly for organizations without prior experience in cell therapy manufacturing.
Automated and Closed Cell Therapy Processing Systems Market Ecosystem
The global automated and closed cell therapy processing systems market has been analyzed from the following perspectives: by workflow, type, scale, and region.
Automated and Closed Cell Therapy Processing Systems Market by Workflow
Based on the workflow, the global automated and closed cell therapy processing systems market is segmented into apheresis, cryopreservation, expansion, fill- finish, separation, and others.
The expansion segment of automated and closed cell therapy processing systems caters to the growing demand for cell-based therapies, thus, dominating the global market with 37.02% of the market share. Expansion systems enable manufacturing operations to scale up, allowing for larger production volumes and higher throughput. Expansion systems optimize and streamline the cell expansion process, which is a critical step in cell therapy manufacturing. These systems provide automated and closed platforms for cell culture, media handling, and process monitoring, reducing manual labor and minimizing the risk of contamination. Additionally, the expansion segment is often associated with closed systems, which offer a controlled and contained environment for cell culture and expansion. Moreover, closed systems minimize the risk of contamination, maintain sterility, and enhance product safety. The use of closed systems aligns with regulatory requirements and supports the trend towards closed processing in cell therapy manufacturing. Furthermore, expansion systems also benefit from ongoing technological advancements that further enable precise control over critical parameters, real-time monitoring, and data integration, leading to improved process efficiency, reproducibility, and product quality.
Automated and Closed Cell Therapy Processing Systems Market by Type
Based on the type, the global automated and closed cell therapy processing systems market is bifurcated into stem cell therapy and non-stem cell therapy.
Non-stem cell therapies encompass a wide range of cell-based treatments beyond stem cells, thus leading the global market with more than 62.3% of revenue share in 2022. These therapies include immune cell therapies, such as CAR-T cell therapies, dendritic cell therapies, and natural killer (NK) cell therapies, as well as other cell-based therapies targeting specific cell types or tissues. The diverse applications of non-stem cell therapies contribute to their dominance in the market. Non-stem cell therapies, particularly CAR-T cell therapies, have demonstrated remarkable clinical success in treating certain types of cancer. These therapies have received regulatory approvals, such as the approval of CAR-T therapies for certain blood cancers by regulatory authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The clinical success and regulatory approvals have led to significant investments and focus on non-stem cell therapies, including the adoption of automated and closed cell therapy processing systems. Non-stem cell therapies, particularly CAR-T cell therapies, have gained significant attention and market demand. The commercialization efforts and investments in non-stem cell therapies have been substantial, with various pharmaceutical and biotechnology companies actively developing and marketing these therapies. The research and development efforts in the field of non-stem cell therapies have been extensive, with significant investments in clinical trials, manufacturing optimization, and technology development. The focus on non-stem cell therapies has led to advancements in manufacturing technologies, including the adoption of automated and closed cell therapy processing systems, further strengthening their dominance in the market.
Automated and Closed Cell Therapy Processing Systems Market by Scale
Based on the scale, the global automated and closed cell therapy processing systems market is segmented into pre-commercial/ R&D scale and commercial scale.
Pre-commercial/ R&D scale accounts for a prominent revenue share of more than 74.5% in the global market. As cell therapies advance through the research and development pipeline, they eventually reach the commercialization stage. Commercial-scale systems are designed to address large-scale production requirements, including automation, scalability, and cost-efficiency. The growing quantity of innovative activities is assisting the segment's expansion. Simultaneously, growing government expenditure in R&D activities to improve the discovery of innovative processing systems is observed to fuel the market's development of the R&D scale segment. One of the primary factors driving the expansion of the R&D scale market is the increasing number of clinical studies worldwide.
Automated and Closed Cell Therapy Processing Systems Market by Region
Based on the region, the global automated and closed cell therapy processing systems market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
Europe registered a sizeable revenue share in the global market. Europe has a well-established healthcare infrastructure with advanced hospitals, research institutions, and regulatory frameworks that support developing and adopting advanced therapies, including cell therapies. The presence of leading academic centers, medical institutions, and clinical trial capabilities in countries like Germany, the United Kingdom, and France contributes to the advancement of the field. Additionally, Europe is known for its strong emphasis on scientific research and development. Numerous academic institutions, research organizations, and biotech companies in Europe actively contribute to advancements in cell therapy research, technology development, and clinical trials. This research excellence fosters innovation and positions Europe as a key player in the global cell therapy market. Europe has witnessed increasing adoption and commercialization of cell therapies. Companies in Europe are actively engaged in the development and manufacturing of cell-based products, including automated and closed cell therapy processing systems.
Competitive Landscape
The prominent players operating in the global automated and closed cell therapy processing systems market are:
Strategic Developments
The automated and closed cell therapy processing system is used to enhance the scale of cell operations by reducing the risk of errors during bioprocessing.
Sartorius AG, Thermo Fisher Scientific Inc., and Miltenyi Biotec B.V. & CO., KG are some of the major market players in the global automated and closed cell therapy processing systems market.
Biological variations associated with various therapies and complex processes of automation are some of the restraints obstructing the growth of the global market.
Pre-commercial/ R&D scale segment dominated the global automated and closed cell therapy processing systems market in 2022.
Increasing R&D activities in the biopharmaceutical industry and rising demand for regenerative medicine are some of the major factors driving the global market.
*Insights on financial performance are subject to the availability of information in the public domain