Cell Therapy Manufacturing Market - Global Industry Size, Share, Trends, Competition, Opportunity, and Forecast, Segmented By Therapy (T-Cell Therapies, Dendritic Cell Therapies, Tumor Cell Therapies, Stem Cell Therapies), By Source of Cell (Autologous v/s Allogenic), By Scale of Operation (Preclinical, Clinical, Commercial), By Source (In-House v/s Contract Manufacturing), By Application (Oncology, Cardiovascular Diseases, Orthopedic Diseases, Others), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Others) 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 5.71 Billion
CAGR (2026-2031)	12.25%
Fastest Growing Segment	T-Cell Therapies
Largest Market	North America
Market Size (2031)	USD 11.42 Billion

Market Overview

The Global Cell Therapy Manufacturing Market will grow from USD 5.71 Billion in 2025 to USD 11.42 Billion by 2031 at a 12.25% CAGR. Global cell therapy manufacturing encompasses the specialized bioprocessing workflows required to isolate, genetically modify, expand, and cryopreserve viable cells for autologous or allogeneic therapeutic applications. The expansion of this market is fundamentally driven by the rising global incidence of oncological and rare genetic diseases, which generates urgent demand for curative treatments. Additionally, the maturation of regulatory frameworks facilitates faster product approvals, thereby incentivizing robust investment in production infrastructure distinct from temporary technological trends.

According to the American Society of Gene & Cell Therapy and Citeline, in 2025, the global pipeline remained robust with more than 3,200 trials underway worldwide. This high volume of clinical candidates necessitates substantial manufacturing capacity; however, the sector encounters a significant impediment regarding cost-efficiency. The inherent complexity of maintaining vein-to-vein supply chain integrity while scaling production poses a formidable challenge to reducing the high cost of goods sold for these advanced therapies.

Key Market Drivers

Favorable Regulatory Frameworks and Expedited Approval Pathways are fundamentally reshaping the manufacturing landscape by accelerating the commercialization of complex treatments. As health authorities streamline review processes for advanced therapies, the industry is witnessing a rapid transition from clinical-scale production to high-volume commercial manufacturing. This shift is evidenced by the rising number of market entrants. According to the Alliance for Regenerative Medicine, in January 2025, the sector secured nine new product approvals in 2024. This wave of commercial authorizations necessitates immediate and robust supply chains capable of maintaining strict quality control standards, thereby intensifying the need for scalable production infrastructure that can adapt to expedited timelines.

The Increasing Reliance on Contract Development and Manufacturing Organizations is a direct response to this commercial pressure as developers seek to bypass the significant capital expenditure and technical challenges of in-house facility construction. CDMOs are aggressively expanding capacity to accommodate this surge in outsourcing demand. For instance, according to Samsung Biologics, in December 2025, the company announced a $4.8 billion investment to construct a new bio-campus that will include dedicated capabilities for next-generation cell and gene therapies. This strategic shift toward outsourcing is further reflected in robust order books. According to Oxford Biomedica, in September 2025, the company reported signing £149 million in new client orders during the first half of the year, highlighting the sector's dependence on specialized manufacturing partners.

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Key Market Challenges

The critical lack of cost-efficiency and the complexity of maintaining supply chain integrity stand as the primary impediments to the expansion of the Global Cell Therapy Manufacturing Market. High costs of goods sold (COGS), driven by labor-intensive and unscalable processes, directly hamper growth by inflating final therapy prices to levels that strain healthcare reimbursement models. This economic friction limits the addressable patient population and discourages the commercialization of therapies for conditions with larger patient bases, effectively confining the market to niche indications where high prices are tolerated by payers.

According to the Alliance for Regenerative Medicine, in 2025, 75% of global sector revenue was derived from fewer than 10 commercial products. This heavy concentration of revenue highlights a severe disconnect between the robust clinical pipeline and commercial viability; the industry faces a significant bottleneck in translating clinical success into scalable, profitable manufacturing operations. Consequently, the market’s trajectory is stunted by an inability to support a diverse range of products, as the financial risks associated with manufacturing at scale remain prohibitively high for many developers.

Key Market Trends

The adoption of automated and closed-system processing platforms is emerging as a critical solution to the sector's labor-intensive bottlenecks and variability challenges. Manufacturers are increasingly deploying integrated "smart factory" modules that replace manual open-handling steps with robotic precision, thereby ensuring batch-to-batch consistency and minimizing contamination risks. This technological shift allows for massive throughput scaling without a proportional increase in facility footprint or headcount, effectively industrializing the production of personalized medicines. According to Cellares, September 2024, in the "Cellares Announces Completion of First cGMP Cell Shuttle at IDMO Smart Factory" press release, the company commissioned a new facility in New Jersey capable of producing up to 40,000 standard CAR-T cell therapy doses per year, demonstrating the industrial scalability of these automated systems.

Concurrently, the emergence of decentralized and point-of-care production models is disrupting traditional centralized supply chains by locating manufacturing directly within or near clinical settings. This approach significantly reduces vein-to-vein timelines and logistical complexities by processing patient material on-site, effectively transforming hospitals into biomanufacturing hubs. Leading academic and clinical centers are actively funding this vertical integration to accelerate the delivery of autologous and off-the-shelf treatments, reducing the reliance on distant commercial manufacturing sites. According to The University of Texas MD Anderson Cancer Center, November 2024, in the "MD Anderson Launches Institute for Cell Therapy Discovery & Innovation" announcement, the organization launched a new institute backed by over $80 million in philanthropic and institutional support to advance the internal discovery and manufacturing of impactful cell therapies.

Segmental Insights

The T-cell therapy segment represents the fastest-growing category in the global cell therapy manufacturing market, largely fueled by the rising adoption of Chimeric Antigen Receptor T-cell treatments for blood cancers. This trajectory is sustained by a surge in clinical trials and subsequent approvals from regulatory bodies like the US Food and Drug Administration, which necessitates expanded production capabilities. Manufacturers are responding by prioritizing the development of robust supply chains and specialized facilities required to process these autologous and allogeneic immune therapies, thereby securing the segment's dominant developmental position.

Regional Insights

North America maintains a leading position in the Global Cell Therapy Manufacturing Market, driven by a high concentration of key industry players and robust research infrastructure. The region benefits from substantial investments in biotechnology and a large volume of ongoing clinical trials that require extensive local production capabilities. Additionally, the United States Food and Drug Administration offers a supportive regulatory framework that streamlines the approval process for new treatments. This established ecosystem fosters continuous development and secures the region's status as the primary hub for cell therapy manufacturing.

Recent Developments

• In April 2025, Thermo Fisher Scientific inaugurated its new Advanced Therapies Collaboration Center in Carlsbad, California, to accelerate the development and commercialization of cell-based immunotherapies. The 6,000-square-foot facility was established to provide biotech and pharmaceutical customers with access to comprehensive manufacturing workflows and deep process optimization expertise. By facilitating the transition from research to clinical and commercial scales, the center aimed to overcome common manufacturing hurdles associated with complex advanced therapies. This launch reinforced the company's role in driving innovation and supporting the infrastructure requirements of the Global Cell Therapy Manufacturing Market.
• In October 2024, Lonza completed the acquisition of a large-scale manufacturing facility in Vacaville, California, from Roche for $1.2 billion. This acquisition significantly expanded the company’s global capacity for mammalian contract manufacturing, positioning the site to support the production of biologics and advanced therapies. The company announced plans to invest an additional CHF 500 million to upgrade the facility with next-generation technologies and enhance its capabilities. This expansion underscored the company's commitment to meeting the sustained demand for commercial-scale manufacturing capacity within the broader biopharmaceutical and Global Cell Therapy Manufacturing Market.
• In June 2024, Cryoport, Inc. and Minaris Regenerative Medicine Co., Ltd. formed a strategic partnership to provide integrated logistics and manufacturing support for the cell and gene therapy sector. This alliance combined Cryoport’s supply chain capabilities with Minaris’ extensive experience as a contract development and manufacturing organization for regenerative medicine products, including stem cells and gene therapies. The collaboration aimed to offer biotechnology and pharmaceutical companies a cohesive solution spanning the entire product lifecycle, from raw material collection to the delivery of final therapies. This development highlighted the growing importance of streamlined operations in the Global Cell Therapy Manufacturing Market.
• In April 2024, Cellares announced a worldwide capacity reservation and supply agreement with Bristol Myers Squibb valued at up to $380 million to advance the manufacturing of CAR-T cell therapies. Through this collaboration, the company agreed to deploy its automated Cell Shuttle platform and high-throughput quality control systems at its smart factories in the United States, Europe, and Japan exclusively for the pharmaceutical partner. This strategic agreement was designed to address the critical need for scalable and efficient production in the Global Cell Therapy Manufacturing Market, enabling faster delivery of personalized treatments to patients by automating labor-intensive processes.

Key Market Players

• Lonza
• Thermo Fisher
• Catalent
• WuXi AppTec
• Novartis
• Gilead
• Bristol Myers Squibb
• Merck KGaA
• Cytiva
• Charles River

By Therapy	By Source of Cell	By Scale of Operation	By Source	By Application	By End User	By Region
T-Cell Therapies Dendritic Cell Therapies Tumor Cell Therapies Stem Cell Therapies	Autologous v/s Allogenic	Preclinical Clinical Commercial	In-House v/s Contract Manufacturing	Oncology Cardiovascular Diseases Orthopedic Diseases Others	Pharmaceutical & Biotechnology Companies Academic & Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cell Therapy Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cell Therapy Manufacturing Market, By Therapy:

• T-Cell Therapies
• Dendritic Cell Therapies
• Tumor Cell Therapies
• Stem Cell Therapies

• Cell Therapy Manufacturing Market, By Source of Cell:

• Autologous v/s Allogenic

• Cell Therapy Manufacturing Market, By Scale of Operation:

• Preclinical
• Clinical
• Commercial

• Cell Therapy Manufacturing Market, By Source:

• In-House v/s Contract Manufacturing

• Cell Therapy Manufacturing Market, By Application:

• Oncology
• Cardiovascular Diseases
• Orthopedic Diseases
• Others

• Cell Therapy Manufacturing Market, By End User:

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes
• Others

• Cell Therapy Manufacturing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE