Dublin, March 02, 2026 (GLOBE NEWSWIRE) — The “Cell Therapy Manufacturing Market (7th Edition): Trends and Forecast Till 2035 – Distribution by Type of Cell Therapy, Source of Cells, Scale of Operation, Type of Manufacturer, and Geography” report has been added to ResearchAndMarkets.com’s offering.
The cell therapy manufacturing market is estimated to grow from USD 7.17 billion in the current year to USD 14.01 billion by 2035, at a CAGR of 7.7% during the forecast period, till 2035.
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 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.
Cell Therapy Manufacturing Market: Key Insights
- 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.
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?
Companies Featured
- 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
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 656 |
| Forecast Period | 2026 – 2035 |
| Estimated Market Value (USD) in 2026 | $7.17 Billion |
| Forecasted Market Value (USD) by 2035 | $14.01 Billion |
| Compound Annual Growth Rate | 7.7% |
| Regions Covered | Global |
For more information about this report visit https://www.researchandmarkets.com/r/py1mn1
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