(MENAFN- GlobeNewsWire - Nasdaq) Stem cell manufacturing landscape is rapidly advancing, driven by major clinical trial successes and new therapy approvals. A surge in strategic outsourcing and investments from major pharmaceutical players is addressing manufacturing bottlenecks and accelerating commercialization globally.

Chicago, Oct. 02, 2025 (GLOBE NEWSWIRE) -- The global stem cell manufacturing market was valued at US$ 24.26 billion in 2024 and is projected to reach US$ 65.49 billion by 2033, growing at a CAGR of 11.96% during the forecast period 2025–2033.

At the core of the stem cell manufacturing market's explosive growth is the remarkable volume and diversity of ongoing clinical trials. As of late 2024, there are 115 active global clinical trials evaluating 83 unique human pluripotent stem cell (hPSC) products. These trials have already provided advanced therapeutic candidates to over 1,200 patients, while the cumulative quantity of hPSC-derived cells administered exceeds an astonishing 100 billion.

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A comprehensive survey in May 2024 further underscored the market's depth, revealing 112 distinct stem cell-based trials targeting a wide variety of diseases. Particularly noteworthy is the rise of allogeneic "off-the-shelf" therapies, with more than 500 active clinical trials seeking scalable, ready-to-administer treatments. Leading pharmaceutical companies are advancing this momentum: Vertex Pharmaceuticals launched a Phase 1/2 trial for VX-264 by November 2024, GIOSTAR secured FDA clearance for its Phase 2 trial, and the iPSC-derived OpCT-001 therapy received FDA clearance to begin Phase I/IIa trials in September 2024.

The vibrant clinical pipeline in the stem cell manufacturing market drives substantial scale-up in manufacturing, demanding advanced GMP-grade components and processes to meet evolving production scales and patient needs.

Key Findings in Stem Cell Manufacturing Market

Market Forecast (2033)	US$ 65.49 Billion
CAGR	11.96%
Largest Region (2024)	North America (38.24%)
By Product Type	Consumables and Kits (42.51%)
By Application	Clinical Applications (52.33%)
By Distribution Channel	Direct Sales (69.93%)
By End Users	CROs, Pharmaceutical and Biotechnology Companies (44.67%)
Top Drivers	Rising prevalence of chronic diseases fuels regenerative medicine demand. Increasing funding and investments in cell and gene therapies. Technological advancements in bioprocessing and manufacturing are improving scalability.
Top Trends	Growing adoption of automation and AI in manufacturing processes. Shift towards allogeneic "off-the-shelf" therapies for broader accessibility. Increasing strategic collaborations between pharma, biotech, and research institutions.
Top Challenges	High manufacturing costs and complexity hinder widespread therapy adoption. Stringent and evolving regulatory landscapes create development hurdles. Ensuring consistent product quality and potency at a commercial scale.

Favorable Regulatory Climate Accelerates Market Entry and Investments

Regulators worldwide are playing a pivotal role by streamlining pathways for cell therapy approvals in the stem cell manufacturing market, thereby reducing commercialization risks and stimulating industry investments. The United Kingdom, for instance, enacted groundbreaking reforms in December 2024, the first sweeping update to its clinical trial framework in two decades. Meanwhile, the U.S. FDA approved the mesenchymal stromal cell therapy Ryoncil in December 2024, followed by endorsement of BlueRock Therapeutics' manufacturing platform in June 2025, validating innovative production technologies.

Global trends in the stem cell manufacturing market underscore this accelerating regulatory momentum: 2024 alone saw nine initial FDA approvals of new cell therapies. South Korea has emerged as a vital market with 16 authorized cell-based products, including three stem cell therapies. Regulatory engagement fosters investment confidence, invariably laying a foundation for scaling up manufacturing infrastructure and broadening commercial access globally.

Unprecedented Capital Investments Propel Manufacturing Infrastructure

The stem cell manufacturing market is benefiting from an unparalleled influx of public and private capital, critical to financing commercial-scale production capabilities. The U.S. National Institutes of Health (NIH) demonstrated strong commitment by earmarking more than $6 billion for related research in 2024 alone. Canada's Strategic Innovation Fund designated a $49.9 million March 2025 investment to STEMCELL Technologies, expected to generate 460 new jobs and support 900 student co-op placements-an investment in both infrastructure and skilled workforce development.

Venture capital remains robust across the stem cell manufacturing market, with Kenai Therapeutics raising $82 million in a Series A financing round in early 2024. Further large-scale investments include Catalent's $250 million initiative to expand bioproduction capacity and Novo Nordisk Foundation's $135 million commitment to build a new cell therapy plant. Industry titans like Thermo Fisher Scientific lead with $1.4 billion in R&D and the $3.1 billion acquisition of Olink in 2024. Lonza's ~500 million Swiss franc investment in its Vacaville facility exemplifies the scale and confidence underpinning this capital wave.

Strategic Mergers and Acquisitions Reshape Competitive Dynamics

M&A activity within the stem cell manufacturing market and its adjoining therapeutic landscapes is intensifying, driving consolidation and innovation. Notable deals in 2024 include Century Therapeutics' acquisition of Clade Therapeutics for approximately $120 million, and Bayer's acquisition of Spherical Therapeutics to strengthen its cell therapy portfolio.

The scale of investments is staggering: Vertex Pharmaceuticals acquired Alpine Immune Sciences for $4.9 billion in April 2024, Astellas procured Propella Therapeutics for $176 million, and Thermo Fisher completed its $3.1 billion acquisition of Olink. Novo Nordisk's March 2024 acquisition of Cardior Pharmaceuticals for up to €1.025 billion and Gilead's purchase of CymaBay Therapeutics for $4.3 billion further highlight an aggressive reshaping of market power. Additionally, companies like Aro Biotherapeutics and CRISPR Therapeutics secured significant financing and acquisitions indicating a rapidly evolving, competitive ecosystem.

Allogeneic Therapies Catalyze Industrial-Scale Manufacturing Evolution

A fundamental market shift in the stem cell manufacturing market is underway, driven by the adoption of allogeneic "off-the-shelf" cell therapies that enable industrial-scale production as opposed to personalized, batch-specific approaches. Over 60 allogeneic cell therapy products are currently in advanced Phase 2 or 3 clinical trials globally (Feb 2025). This requires large, scalable manufacturing runs supported by a growing number of master cell banks-a key milestone being a single bank holding over 500 billion cryopreserved cells established in late 2024.

The industrial community has responded strongly in the stem cell manufacturing market, investing more than $3.2 billion in allogeneic platform companies in 2024 alone. This has spurred expansion of manufacturing infrastructure with 8 new specialized suites in North America and 12 CDMOs launching new allogeneic-focused service packages. The FDA likewise is deeply engaged, conducting 7 formal meetings in 2024 on allogeneic manufacturing regulations. These developments align with over 950 related patents filed in 2024, signaling sustained innovation.

Aggressive Global Expansion of Manufacturing Capacity

Manufacturers worldwide are scaling physical footprint and operational capabilities to meet anticipated demand. Lonza spearheads expansion with a 300,000 sq. ft. cell and gene therapy facility in Houston, Texas, expected to create 200 new full-time jobs. Further collaboration with Vertex Pharmaceuticals underpins a new 130,000 sq. ft. facility in New Hampshire employing 300 staff. Their Vacaville, California site boasts an impressive 330,000-liter bioreactor capacity.

These trends across the stem cell manufacturing market are mirrored globally: Fate Therapeutics expanded California manufacturing in August 2025; Celyad Oncology opened a Belgium plant in July 2025; TiGenix launched European commercial production in Spain in May 2025; while Healios K.K. enhanced its iPSC-derived therapy capacity in Asia that same July. Thermo Fisher Scientific extended its New York dry powder media plant by over 45,000 sq. ft., highlighting the ongoing infrastructure buildout across continents.

Automation and AI Driving Next-Gen Manufacturing Efficiencies

The integration of automation, robotics, and AI is redefining manufacturing precision, consistency, and scalability in the stem cell manufacturing market. Lonza launched an AI-powered bioprocess monitoring platform in March 2024 to enhance reproducibility. In October 2024, Cellular Origins and Fresenius Kabi partnered to advance Constellation CGT, a fully automated manufacturing robotic platform. Thermo Fisher's July 2025 unveiling of next-gen CHO cell line technology aims to improve yields.

AI's impact extends well beyond automation: predictive models detected batch deviations 48 hours earlier than conventional methods in February 2025, enabling proactive control. At least 15 premier CDMOs have initiated AI integration pilots, while Corning's Ascent FBR System offers scalable automated bioprocess formats from 1 m2 to 1000 m2. Collectively, these advances promise enhanced process control, lower error rates, and elevated product quality.

High-Purity Raw Materials Face Supply Chain Challenges

Rapid growth of the stem cell manufacturing market has created critical bottlenecks in sourcing GMP-grade raw materials. Thermo Fisher Scientific's 2024 revenues reached $42.88 billion, with $17.59 billion driven by consumables crucial for stem cell production. Lonza reported 6.6 billion Swiss francs in sales in 2024, boosted by new facility rollouts expected to add 0.5 billion Swiss francs. Corning Incorporated recorded $13.12 billion in full-year GAAP sales in 2024, with over 3 million 3D cell culture microplates consumed for cancer research alone.

Yet bottlenecks remain: lead times for critical GMP reagents stretched to 14 weeks early in 2025. Global GMP-grade cell culture media production surpassed 1.2 million liters in Q1 2025. Suppliers met demand with 30+ new GMP-grade growth factors launched in 2024 and forged 22 major supply chain partnerships. Prices for key components, such as recombinant human albumin, steadied around $1,100 per gram, reflecting the high cost of uncompromising quality.

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Regional Market Leadership: North America Dominates; Asia Pacific Rising Rapidly

North America retains global leadership in the stem cell manufacturing market, projected to capture 49.58% of the market share by 2033, supported by substantial funding, robust regulatory frameworks, and a dense innovation ecosystem. The U.S. FDA authorized 8 new cell and gene therapies in 2024, with over 2,500 active Investigational New Drug applications early in 2025. The California Institute for Regenerative Medicine has been pivotal, financing 108 trials to date. Canada reported clinical trial initiation of a homegrown CAR T-cell therapy within 2024-2025.

Europe holds strong in second place with 26 Advanced Therapy Medicinal Products (ATMPs) authorized and six PRIME regulatory designations granted in 2024. However, the Asia Pacific region is the fastest-growing market, fueled by clinical trial registrations surpassing 115 in China alone during 2024. Japan continues refining regenerative medicine approval pathways while South Korea has approved 16 cell-based products, spotlighting the strategic importance of this region for future growth.

Global Stem Cell Manufacturing Market Major Players:

• Thermo Fisher Scientific
• Lonza
• nacalai
• BioRad
• Merck
• FujiFilm
• CellGenix
• Teknova
• Sartorius
• Stemcell Technologies
• Miltenyi Biotec
• Eppendorf
• Beckman Coulter
• Takara Bio
• Bio-Techne
• PromoCell
• Wellsky
• BD
• Corning Life Sciences
• HiMedia
• REPROCELL
• Other Prominent Players

Key Market Segmentation:

By Product

• Stem Cell Lines
• Mesenchymal Stem Cells
  • Differentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
      • Consumables and Kits
        • Culture Media
        • Growth Factors & Cytokines
        • Culture ware and Vessels
    • Undifferentiated
      • Instruments
        • Bioreactors & Cell Expansion Systems
        • Cell Sorters & Separation Devices
        • Flow Cytometers & Analysers
      • Consumables and Kits
        • Culture Media
        • Growth Factors & Cytokines
        • Culture ware and Vessels
  • Induced Pluripotent Stem Cells
    • Differentiated
      • Instruments
        • Bioreactors & Cell Expansion Systems
        • Cell Sorters & Separation Devices
        • Flow Cytometers & Analysers
      • Consumables and Kits
        • Culture Media
        • Growth Factors & Cytokines
        • Culture ware and Vessels
    • Undifferentiated
      • Instruments
        • Bioreactors & Cell Expansion Systems
        • Cell Sorters & Separation Devices
        • Flow Cytometers & Analysers
      • Consumables and Kits
        • Culture Media
        • Growth Factors & Cytokines
        • Culture ware and Vessels
• Hematopoietic Stem Cells
  • Differentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
  • Undifferentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
• Embryonic Stem Cells
  • Differentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
  • Undifferentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
• Neural Stem Cells
  • Differentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
  • Undifferentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
• Others
  • Differentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
  • Undifferentiated
    • Instruments
      • Bioreactors & Cell Expansion Systems
      • Cell Sorters & Separation Devices
      • Flow Cytometers & Analysers
    • Consumables and Kits
      • Culture Media
      • Growth Factors & Cytokines
      • Culture ware and Vessels
• Consumables and Kits
  • By Type
    • Culture Media
    • Growth Factors & Cytokines
    • Culture ware and Vessels
      • T-Flasks
      • Vials
      • Cell Culture Dishes / Multi-Well Plates
      • Cell Culture Bags
      • Others
    • Others
• By Application
  • Research Applications
    • Disease Modelling
    • Drug Discovery & Toxicology Testing
    • Others
  • Clinical Applications
    • Autologous Therapies
    • Allogeneic Therapies
  • Cell & Tissue Banking
• Instruments
  • Bioreactors & Cell Expansion Systems
  • Cell Sorters & Separation Devices
  • Flow Cytometers & Analysers
• Software and Services

By Application

• Research Applications
  • Disease Modelling
  • Drug Discovery & Toxicology Testing
  • Others
• Clinical Applications
  • Autologous Therapies
  • Allogeneic Therapies
• Cell & Tissue Banking

By Distribution Channel

• Direct Sales
• Distributors

By End User

• CROs, Pharmaceutical and Biotechnology Companies
• Academic & Research Institutions
• Hospitals & Surgical Centres
• Cell & Tissue Banks
• Other Users (Regenerative Medicine Startups, Diagnostic Firms)

By Region

• North America
• Europe
• Asia Pacific
• Middle East & Africa
• South America

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