Automated and Closed Cell Therapy Processing Systems Market

Market Overview

The global automated and closed cell therapy processing systems market size was valued at USD 745.12 million in 2022. It is estimated to reach USD 4,301.23 million by 2031, growing at a CAGR of 21.50% during the forecast period (2023–2031). The widespread development of technology is anticipated to have a favorable effect on the uptake and approval of automated and closed-cell therapy processing systems.

The global pharmaceutical business has benefited from the automation of cell therapy processing or manufacturing systems. The selection, isolation, modification, and expansion of the cells are all steps in the manufacturing process for cell therapies. In this complex process, even a minor error could lead to the wrong injection of cells. Automated and closed-cell therapy processing technologies make the final formulation less risky. Automation reduces the probability of contamination resulting from manual handling in cell therapy. The automated and closed-cell treatment processing system is employed to enhance the scale of cell operations by reducing the likelihood of errors in bioprocessing.

Market Dynamics

Market Drivers

Rising Emphasis on Regenerative Medicines and Cell Therapies

Regenerative medicines play a vital role in replacing damaged cells and tissues with the help of stem cells, molecules, and a range of biomaterials. Awareness about this novel field is increasing due to its superior outcomes and effectiveness. These cells can also be carriers for gene and cultured cell therapies. Therefore, growing awareness about regenerative medicines is expected to raise the demand for stem cell therapies. This will eventually drive the demand for automated and closed-cell therapy processing systems, fueling the market growth. In addition, several key biopharmaceutical companies have identified the enormous potential of regenerative medicine technologies in clinical situations and disease indications where there is an unmet medical need owing to the limitations in the standard of care. In order to surmount this obstacle, corporations are implementing many tactics, including mergers and acquisitions within this industry, to broaden their range of products and revitalize and develop their pipelines.

Furthermore, academic institutions and companies across the globe are actively engaged in developing new therapies, which is likely to boost the demand for regenerative medicines. Moreover, businesses concentrate on funds and investments to increase their capacity for regenerative medicine and stem cell therapies. For instance, in September 2021, Locate Bio announced an investment of around USD 21.1 million to develop regenerative orthobiologics. Similarly, in March 2020, the Canadian government announced its plan to invest in regenerative medicine research to fight against diabetes, vision loss, heart disease, and blood disorders. Such constructive developments are anticipated to enhance the focus on regenerative medicines, which is expected to drive market growth for automated and closed-cell therapy processing systems.

Operational Superiority of Automated Systems Over Manual Processing

The comprehensive incorporation of software-based intelligent technologies into cell therapy processes has resulted in the creation of automated systems. These automated systems can perform complex cell processing workflows, including cell expansion, cell separation, cell cryopreservation/thawing, cell harvesting, and cell apheresis. Increasing focus on high consistency and procedural effectiveness, reducing cell contamination, and high-volume precision are among the key factors for a gradual shift toward cell therapy process automation.

Furthermore, the rising number of clinical trials for cell therapies will likely boost the adoption of automated systems, as they completely remove errors associated with manual operations and offer great production capabilities. A typical cell therapy manufacturing process is labor-intensive and demands more time for process completion. However, the utilization of automated systems can significantly reduce the cost of production along with high production throughput. For instance, according to a study published in October 2015, the Quantum Cell Expansion System, developed by Terumo Corporation, showed a 40% cost reduction and required cell quality during research. Such benefits of automated cell therapy processing systems are expected to propel market growth in the coming years.

Market Restraint

Biological Variations Associated with Different Therapies

Cell and gene therapy manufacturing is mostly manual, with most procedures in planar culture systems. These are time-consuming, frequently involve open procedures that are difficult to scale up and rely substantially on the operator's judgment and experience. As a result, they are susceptible to human errors, which can lead to high batch-to-batch variability, high manufacturing costs, increased contamination risk, and batch loss. The complexity of biological products causes substantial batch-to-batch variance in the production of cell and gene therapies, which normally use cells from patients or donors as their starting material. During such a manufacturing process, minor changes in the culture environment may also lead to alteration of product quality.

Furthermore, cell and gene therapy products must comply with stringent regulatory policies; thus, it is recommended that cell-based products must be manufactured by Good Manufacturing Practices (GMP), reducing process variability. Due to such stringent regulations, there is a certain slowdown in market growth. For instance, in December 2019, the FDA denied a market application of Enzyvant for a tissue therapy for treating rare immunodeficiency due to manufacturing concerns. Thus, regulatory compliance on GMPs is expected to hamper market growth to a certain extent.

Market Opportunities

Increasing Technological Advancements

Extensive growth in technological advancements is expected to positively impact the adoption and acceptance of automated and closed-cell therapy processing systems. Growing demand for high-throughput and an increasing number of clinical trials for cell therapies are among the factors expected to increase the number of product approvals and product launches in the global market. In July 2020, Miltenyi Biotec announced the launch of its novel CliniMACS Prodigy Adherent Cell Culture System. The newly introduced system is capable of scalable and automated manufacturing of various cell types, including stem cells. Moreover, in October 2019, Terumo Corporation announced the launch of an advanced device to accelerate cell therapy manufacturing. The newly introduced system is capable of enhancing the production and delivery of gene and cell therapy.

Furthermore, in August 2018, Cell Microsystems announced the launch of its automated AIR System. The system can offer integrated workflows comprising cell sorting, imaging, and isolation. In May 2021, Bristol Myers Squibb announced its plan to develop hi-tech cell therapy factories. According to the company, facilities will likely own pioneering cell therapy processing automation technologies. In February 2021, ThermoGenesis Holdings, Inc. received FDA approval for its new automated cell therapy processing system, PXP-LAVARE. The new system is capable of automated and rapid cell washing. Such developments are anticipated to provide lucrative market opportunities.

Regional Analysis

Based on region, the global automated and closed cell therapy processing systems market share is bifurcated into North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global automated and closed cell therapy processing systems shareholder and is anticipated to exhibit a CAGR of 21.70% during the forecast period. The substantial market growth is due to the rising involvement of companies in the R&D of cell therapies. The market growth can be attributed to the presence of many institutes and centers involved in manufacturing cell therapy. Moreover, robust government support, the presence of key operating players, and strategic initiatives for market expansion are further fueling the market growth. For instance, in June 2020, ThermoGenesis Holdings, Inc. and Corning Incorporated's Life Sciences Division entered into a global distribution agreement for its X-SERIES products. In August 2021, Artiva Biopharmaceuticals announced its expansion in the U.S. with a new R&D and manufacturing facility for cell therapies.

Europe is estimated to exhibit a CAGR of 20.80% over the forecast period. A strong workforce in European countries and a strong facility network are anticipated to fuel market growth in the region. Over the recent year, European research initiatives introduced a series of fully automated platforms capable of supporting the bioprocess from start to end. A stem cell factory is one such example, a fully automated production unit for cultivation, reprogramming, and differentiation of iPSCs (induced pluripotent stem cells). In addition, AUTOSTEM's fully automated platform is one of the versatile platforms that allow for a fully automated manufacturing and banking of cell therapies undertaking a donor-to-patient approach.

Furthermore, increasing funding for gene and cell therapy will fuel market growth. For instance, in the first half of 2020, European companies developing advanced therapies such as cell and gene therapies secured at least USD 2.6B. Moreover, in September 2021, TreeFrog Therapeutics raised USD 75.6 million in series B funding to provide stem cell-derived cell therapies for patients.

In Asia-Pacific, growing government and private investments, increasing healthcare needs, and establishing accelerated approval pathways are key market drivers. China is shown to be the fastest-growing market for cell therapy development. Favorable regulatory scenario, mature infrastructure for clinical studies, and a booming ecosystem with government–industry collaboration is driving China's cell and gene therapy development market. In addition, China has been ranked second in clinical trials globally, with over 1,000 clinical trials either completed or ongoing. Moreover, Japan is anticipated to witness significant market growth due to rising clinical studies on cell therapies and the number of cell therapies advancing from clinical trials to regulatory approval.

The Latin American automated and closed-cell therapy processing systems market has grown significantly in the past few years due to the increased prevalence of cancer in the region. More than 670,000 cancer deaths were reported in Latin America and the Caribbean in 2018. Stem cell research is attracting many countries in Latin America. Several countries in Latin America have defined regenerative medicine as a research preference and focus of investment.

Due to strong government support, Brazil is anticipated to witness significant market growth in Latin America. The Brazilian government has taken various initiatives to increase stem cell therapy research and development. Key initiatives include the Biosafety Act, which permits researchers to operate with human embryonic stem cells, a national cell therapy network, and various cell technology centers to cultivate cells under GMP guidelines, potentially fueling market growth.

Segmental Analysis

The global automated and closed cell therapy processing systems market growth is segmented by workflow, type, and scale.

Based on workflow, the global automated and closed cell therapy processing systems market is divided into separation, expansion, apheresis, fill-finish, cryopreservation, and others. 

The expansion segment is the most significant contributor to the market and is expected to exhibit a CAGR of 22.10% throughout the forecast period. Cell expansion is one of the crucial steps in cell manufacturing. Cell expansion is conducted in tissue culture vessels in the presence of growth factors such as serum and other additives. The growth of the automated cell expansion segment is majorly ascribed to the benefits offered by automation over manual processes. The process of automation can leverage output yield and efficiency. Automation also enhances reproducibility and speed.

Moreover, automated cell expansion reduces the risk of sample loss during procedures. An increasing number of inorganic and organic developments among market players is also projected to offer a lucrative environment for the growth of the expansion segment in the automated and closed cell therapy processing systems market by 2028. For instance, in January 2016, Angiocrine Bioscience announced a strategic collaboration with Terumo BCT to implement Terumo BCT's Quantum Cell Expansion System to accelerate cell therapy research.

Based on type, the global automated and closed cell therapy processing systems market is divided into stem cell therapy and non-stem cell therapy. 

The non-stem cell therapy dominates the global market and is predicted to exhibit a CAGR of 22.10% over the forecast period. The non-stem cell therapy type segment includes automation cell therapy processing for cells and tissues other than the stem cell category. Automation is becoming popular among biological researchers due to its high efficiency and capacity while offering reproducible, high-quality outputs. Moreover, closed systems protect cell cultures and reduce the risk of contamination. These factors are estimated to drive segment growth.

Furthermore, the market is witnessing many business transactions that will likely offer favorable segment growth opportunities during the forecast period. For instance, in March 2019, Thermo Fischer Scientific announced its plan to acquire Brammer Bio. The company took this constructive decision to extend its cell and gene therapy product portfolio.

Based on the scale, the global automated and closed cell therapy processing systems market is bifurcated into precommercial/R&D scale manufacturing and commercial-scale manufacturing segments. 

The precommercial/R&D scale manufacturing segment dominates the market and is expected to exhibit a CAGR of 22.70% over the forecast period. The precommercial/R&D scale manufacturing segment includes production by research and academic centers, innovation centers, and other research and development facilities. The high prevalence of chronic conditions is extensively increasing the number of research centers and innovation facilities across the globe.

The growing number of investments by research centers to conduct cell therapies is also estimated to impact segment growth positively. For instance, in September 2020, Takeda Pharmaceutical Company Limited declared the expansion of its cell therapy facility to expand its supply of innovative cell therapies. Similarly, in January 2018, Cellular Biomedicine Group, Inc. declared a strategic collaboration with GE Healthcare to expedite cell therapies for clinical trials.

Recent Developments

• June 2023 - Thermo Fisher Scientific showcased new mass spectrometry and chromatography instruments, software, and workflows that enable customers to unlock deeper analytical insights, improve productivity, and accelerate biological discovery. The company will highlight these innovations during the annual American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, from June 3-8, 2023, in Houston, Texas, in booth 700 at the George R. Brown Convention Center and the Hilton Americas-Houston Lanier Grand Ballroom A, B, C.
• May 2023 - Thermo Fisher, the world leader in serving science, signed a Memorandum of Understanding ("MOU") with the National Research and Innovation Agency of Indonesia (BRIN, Badan Riset dan Inovasi Nasional) to enable and enhance the country's national research and innovation infrastructure and capability. This will create opportunities for direct engagements between the senior organizational levels, strengthening the partnership between the two organizations.