Cell Therapy Manufacturing Market: Overview
As per Roots Analysis, the cell therapy manufacturing market is estimated to grow from USD 7,172 million in the current year to USD 14,017 million by 2035, at a CAGR of 7.7% during the forecast period, till 2035.
Cell Therapy Manufacturing Market: Growth and Trends
Over the years, numerous technological innovations and discoveries have transformed the field of medicine. One notable advancement is the emergence of cell-based therapies, which have shown substantial therapeutic promise and are largely free from many of the toxicity issues linked to traditional pharmacological treatments. Researchers are exploring over 1,000 cell and gene therapy candidates targeting a wide range of disease indications. Of these, approximately 45 cell-based therapies have already received approval from various global regulatory agencies. In addition, several organizations are implementing initiatives to tackle manufacturing challenges and ensure the ongoing success of these innovative therapies.
The manufacturing of cell and gene therapies is a complex process that occurs in a meticulously controlled, contamination-free environment and involves multiple critical stages, such as isolating, modifying, and expanding immune cells, including T-cells and stem cells. Each of these stages demand the use of specialized closed systems and rigorous compliance with regulatory standards to guarantee the safety and effectiveness of the final products. Companies are focused on enhancing cell handling and processing equipment, improving ancillary materials and cell counting techniques, and addressing current logistical challenges. Consequently, it is becoming increasingly essential for cell therapy developers to invest in flexible and automated technologies to mitigate the risks associated with human error during the production of these advanced therapeutic candidates. These improvements are expected to help companies maintain quality and consistency of products while keeping costs manageable.
Growth Drivers: Strategic Enablers of Market Expansion
The field of cell therapy is experiencing rapid growth, characterized by an increase in clinical trial and a rise in regulatory approvals. With a greater number of therapies advancing from initial research to late-stage clinical trials, patients have more opportunities to access these treatments. A report from the American Society of Gene & Cell Therapy (ASGCT) indicates that there are currently 4,418 active programs in the combined gene, cell, and RNA therapy pipeline, comprising 2,155 gene therapies and 966 non-genetically modified cell therapies, along with 79 new gene therapy trials (57% focused on oncology) and 27 new cell therapy trials (74% in non-oncology) that were initiated during that quarter. This progress will be bolstered by the establishment of local manufacturing facilities for cell therapies.
Market Challenges: Critical Barriers Impeding Progress
Despite strong demand, the cell therapy manufacturing sector faces multiple challenges in moving cell-based therapy products from the lab to clinical scale. These obstacles include a shortage of skilled workers, regulatory compliance issues, and insufficient advanced facilities and infrastructure. The manufacturing processes for cell therapy necessitate sterile, high-grade clean rooms and strict monitoring of containment levels to ensure product integrity and compliance. Due to these intricate procedures, scaling up cell therapy manufacturing can be considerably difficult.
Cell Therapy Manufacturing Market: Key Insights
The report delves into the current state of the cell therapy manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
- Currently, close to 200 industry players are engaged in cell therapy manufacturing; of these, ~45% of players are headquartered in the US.

- More than 40% of industry players offer both T-cells and stem cells, as T-cells have a lower risk of rejection while stem cells possess a unique ability to regenerate or repair damaged cells and tissues.
- More than 80 non-industry players are currently engaged in the manufacturing of cell therapies; around 55% of these players are based in the US.
- ~30% of the non-industry cell therapy manufacturers were established before 2001; among these, more than 60% of players utilize both autologous and allogeneic source of cells.
- Several clinical trials evaluating immune cell therapies have been registered till date; majority (65%) of these studies have been conducted across various trial sites in Asia-Pacific.
- The rising interest in this market is reflected from the diverse partnerships established among various stakeholders in the recent past; in fact, >55% of the deals have been inked post 2022.

- 70% of the industry players have expanded their existing capacities and capabilities through establishment of new facilities; more than 40% facilities are dedicated to manufacturing of T cells.
- Over 55% of major big pharma initiatives in this domain have been pursued through partnerships and collaborations; of these, a sizeable proportion of the initiatives were undertaken by Bristol-Myers Squibb.
- ~95% of the current installed cell therapy manufacturing capacity (in terms of number of cleanrooms) is presently available with industry players; maximum capacity is installed in facilities based in North America.
- The rising demand for cell-based therapies stems from increasing product approvals, advancing therapies, expanding healthcare infrastructure, and growing patient awareness.
- The cell therapy manufacturing domain is poised to grow at a CAGR of 8.25%, owing to high capital costs and advanced technologies; ~60% of manufacturing activities are expected to be outsourced to CMOs.

- Owing to the rising prevalence of cancer, and shift in patient preferences towards tailored cell therapies and advancements in cell therapy manufacturing technologies, the market is poised for a steady growth in the future.
- North America is expected to capture a significant share of the cell therapy manufacturing market in the current year owing to rapid innovation of technologies within the region.
- Driven by the success of approved cell therapies developed by prominent players in the US, the commercial cell therapy manufacturing market is expected to grow at CAGR of 12.93%.
- Given the rapid clinical success and rising demand for cell therapies, coupled with their extensive potential in treating disorders like blood cancer, the industry is well-positioned for future growth.
Cell Therapy Manufacturing Market
The market sizing and opportunity analysis has been segmented across the following parameters:
By Type of Cell Therapy
- CAR-T Cell Therapy
- Stem Cell Therapy
- TCR Therapy
- TIL Therapy
- Dendritic Cell Therapy
- Others
By Source of Cells
- Autologous Cells
- Allogeneic Cells
- Unspecified Cells
By Scale of Operation
- Clinical Scale
- Commercial Scale
By Type of Manufacturer
- In-house Manufacturers
- Contract Manufacturing Organizations
By Geographical Regions
- North America
- US
- Canada
- Europe
- France
- Germany
- Italy
- Spain
- UK
- Rest of Europe
Asia-Pacific and Rest of the World
- Argentina
- Australia
- Brazil
- China
- India
- Israel
- Japan
- Singapore
- South Africa
- South Korea
- Taiwan
Cell Therapy Manufacturing Market: Key Segments
CAR-T Cell Therapies Accounts for the Largest Share in the Cell Therapy Manufacturing Market
In the present year, the CAR-T cell therapies segment holds the largest market share (approximately 65%), attributed to the shorter treatment regimen that requires fewer infusions. Further, the segment of other cell therapies, which includes natural killer cell therapies and gene-modified cell therapies, is anticipated to experience a higher compound annual growth rate (CAGR) of 16.15% throughout the forecast period. The favorable safety profile of NK cells reduces the risk of conditions such as graft-versus-host disease. Additionally, their potential to function as off-the-shelf therapies propels this growth.
Autologous Cells Hold the Highest Share in the Cell Therapy Manufacturing Market
In 2035, the autologous segment is projected to hold a larger share of the cell therapy manufacturing market, accounting for over 50%. Additionally, this segment is expected to experience a notable growth rate throughout the forecast period. This can be attributed mainly to the focus of autologous cell therapy manufacturing on the patient's own cells, which minimizes the risk of immune rejection that can result in severe complications such as graft-versus-host disease.
North America Dominates the Market by Securing Highest Share
Based on our market forecast, North America is expected to hold the largest share of the cell therapy manufacturing market, accounting for approximately 45% by 2025. Further, we anticipate that North America will experience a comparatively faster growth rate of 9.70% until 2035. It is important to highlight that around 60% of this market derives from clinical cell therapy manufacturing. In the clinical cell therapy manufacturing sector, the U.S. has become a central hub for manufacturers, bolstered by their innovation-friendly regulatory framework and highly qualified workforce. This regional concentration enables efficient scaling of cell therapy production, from initial development stages to commercial supply.
Primary Research Overview
The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market report includes detailed transcripts of interviews conducted with the following individuals:
- Marketing Manager, Cell Therapy, Mid-sized Company, Australia
- Director, UK
- Marketing Director, Small Company, Belgium
- Management Board Vice-President, Large Company, Poland
- Senior Director of Sales Advanced Therapies; Vice President of Marketing, Small Company, US
- Business Administration Department Manager, Mid-sized Company, Japan
- Chief Business Officer, Small Company, Netherlands
- Director of Finance and Facility Operations, US
- Senior Director, Very Large Company, Japan
- Chief Executive Officer, Mid-sized Company, UK
- Former Chief Technical Officer, Large Company, US
- Former Chief Executive Officer, Small Company, Netherlands
- Former General Manager, Small Company, France
- Chief Executive Officer, Large Company, China
- Executive Vice President Research and Development, Small Company, Israel
- Former Business Development Manager, Mid-sized Company, UK
- Professor and American Red Cross Chair in Transfusion Medicine, US
- Former Co-Founder and Chief Executive Officer, Small Company, Singapore
- Former Manager, Business Development and Operations-cGMP Manufacturing Unit, Mid-sized Company, Canada
- Manager of Business Development, Small Company, US
- Former Department Leader, Cell Therapy Innovation and Development, Mid-sized Company, France
- Former Chief Executive Officer, Mid-sized Company, Australia
- Chief Executive Officer, Small Company, Netherlands
Example Players in Cell Therapy Manufacturing Market
- Advanced Therapies
- AGC Biologics
- Astellas Pharma
- Catalent
- Charles River Laboratories
- City of Hope
- Clinical Cell and Vaccine Production Facility (CVPF)
- Evotec
- Fraunhofer Institute for Cell Therapy and Immunology
- ImmunityBio
- Lonza
- Merck Millipore
- Miltenyi Biotec
- Minaris Advanced Therapies
- Newcastle Advanced Therapies
- NHS Blood and Transplant
- OBiO Tech
- Pharmaron
- Rayne Cell Therapy Suite
- Resilience
- Sartorius
- Scottish National Blood Transfusion Service (SNBTS) Cellular Therapy Facility
- SK pharmteco (Subsidiary of SK Inc.)
- Takara Bio
- Thermo Fisher Scientific
Cell Therapy Manufacturing Market: Research Coverage
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the cell therapy manufacturing market, focusing on key market segments, including [A] type of cell therapy, [B] source of cells, [C] scale of operation, [D] type of manufacturer, and [E] geographical regions.
- Industry Players - Market Landscape 1: A detailed overview of the current market landscape of companies engaged of industry players in cell therapy manufacturing domain, featuring information on, along with information on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facility, [E] type of immune cell offered, [F] source of cells, [G] scale of operation, and [H] type of additional service offered.
- Non-industry Players - Market Landscape 2: A detailed overview of the current market landscape of non-industry players in cell therapy manufacturing domain along with information on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facility, [E] type of immune cell offered, [F] source of cells, [G] scale of operation, and [H] type of additional service offered.
- Regulatory Landscape: An overview of cell therapy manufacturing related regulations across various geographies, including North America (focusing on the US), Europe and Asia (focusing on Japan and China), featuring an analysis of the diverse certifications / accreditations awarded to the manufacturing facilities by important regulatory bodies across the globe.
- Case Study 1: An overview of the various roadmaps published by different agencies across the globe in order to provide strategies to advance cell therapy manufacturing process.
- Case Study 2: A detailed role of technology automation in cell therapy manufacturing in order to optimize the current manufacturing practices with the use of closed and single use systems. Further, it features a roadmap that provides information on the steps to develop automation devices, supported by two case studies
- Company Profiles: In-depth profiles of prominent industry and non-industry players in North America, Europe and Asia-Pacific that are involved in cell therapy manufacturing based on [A] year of establishment, [B] location of headquarters, [C] product portfolio, [D] recent developments and [E] an informed future outlook.
- Clinical Trial Analysis: An analysis of completed, ongoing and planned clinical trial, based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, patient gender, study design, type of allocation, intervention model, type of masking, type of sponsor / collaborator most active players (in terms of number of clinical trial conducted) and geographical distribution of trials.
- Partnerships and Collaborations: An in-depth analysis of the partnerships and collaborations that have been inked by cell therapy manufacturers, based on several relevant parameters, such as year of partnership, type of partnership, type of immune cell offered, scale of operation and most active players (in terms of number of partnerships). The chapter also highlights the regional distribution of partnership activity in this market.
- Recent Expansions: A detailed analysis of expansions reported in the domain, along with analysis on several relevant parameters, such as [A] year of expansion, [B] status of expansion, [C] type of expansion, [D] location of facility, [E] amount invested, [F] type of immune cell offered, [G] type of service offered and [H] most active players.
- Big Pharma Initiatives: An in-depth analysis of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as [A] year of initiative, [B] type of initiative, [C] number of initiatives, [D] type of partnership, [E] number of partnerships, [F] type of facility expansion, [G] number of facility expansions, [H] region of facility expansion, [I] number of mergers and acquisitions, [J] number of funding and investment, [K] type of immune cell offered, and [L]scale of operation.
- Capacity Analysis: An estimate an estimate of the overall installed capacity for the manufacturing of cell-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity in terms of cleanroom area and number of cleanrooms.
- Demand Analysis: An informed estimate of the annual commercial and clinical demand for cell therapies, across several relevant parameters, such as [A] type of cell therapy, and [B] key geographical regions.
- Cost Price Analysis: A detailed analysis of various factors that are likely to influence the price of cell-based therapies, featuring different models / approaches adopted by manufacturers in order to determine the price of their proprietary offerings.
- Make Versus Buy Decision Making Framework: A qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
- Total Cost of Ownership: A detailed total cost of ownership analysis based on company size, for cell therapy manufacturing organizations, over a period of 20 years.
- SWOT Analysis: a discussion on strength, weaknesses, opportunities and threats, highlighting the relative effect of each SWOT parameter on the overall market dynamics.
Key Questions Answered in this Report
- Which are the leading companies in cell therapy manufacturing market?
- Which region dominates the cell therapy contract manufacturing market?
- What are the key trends observed in the cell therapy manufacturing market?
- What factors are likely to influence the evolution of this market?
- What are the primary challenges faced by cell therapy contract manufacturers?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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