Cell Therapy Human Raw Materials Market- Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Cell Culture Media, Cell Culture Sera, Cell Culture Supplements, Reagents & Buffers, Other), By End User (Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutions), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.01 Billion
CAGR (2026-2031)	12.43%
Fastest Growing Segment	Biopharmaceutical & Pharmaceutical Companies
Largest Market	North America
Market Size (2031)	USD 6.08 Billion

Market Overview

The Global Cell Therapy Human Raw Materials Market will grow from USD 3.01 Billion in 2025 to USD 6.08 Billion by 2031 at a 12.43% CAGR. Cell therapy human raw materials consist of biological substances sourced from human donors, such as leukopaks and serum albumin, which are essential for manufacturing therapeutic products. The primary drivers propelling market expansion include the rising global incidence of oncological diseases requiring personalized interventions and increased capital allocation toward regenerative medicine research. This robust clinical environment fuels the necessity for high-quality biological inputs to support the development of new immunotherapies.

However, the market faces a significant challenge regarding the stringent regulatory compliance required for sourcing donor-derived materials, which often leads to supply chain complexities. Manufacturers must navigate varying international standards for donor eligibility and material safety, which can impede rapid scalability. According to the International Society for Cell & Gene Therapy, in 2024, there were 3,063 therapies in the global pipeline, representing a 7.5% increase from the first half of the year, a volume that places immense pressure on existing supply networks.

Key Market Drivers

The surge in cell therapy clinical trials and R&D investments is acting as a primary catalyst for the raw materials market, creating an urgent need for scalable supply chains. As biopharmaceutical companies and research institutions accelerate their development programs, the demand for high-grade biological inputs such as human serum and leukopaks has intensified. This influx of capital allows developers to progress candidates through costly late-stage trials, thereby increasing the volume of raw materials required for process development and manufacturing. According to the Alliance for Regenerative Medicine, in October 2024, the sector attracted $10.9 billion in investment during the first half of the year, providing the necessary liquidity to sustain these resource-intensive development phases.

Simultaneously, the expansion of manufacturing capabilities by CDMOs and biopharma companies is directly addressing the bottleneck in raw material availability. To mitigate supply shortages and ensure compliance with Good Manufacturing Practice (GMP) standards, key industry players are investing heavily in infrastructure that supports the production of ancillary materials. This strategic broadening of internal and external capacity ensures that the supply chain can withstand the pressures of commercial-scale production. According to BioIVT, in August 2024, the company opened a new cleanroom manufacturing facility in Winchester, Virginia, specifically designed to enhance the output of GMP-compliant ancillary materials. These advancements are critical to supporting the broader ecosystem, which is growing rapidly; according to the American Society of Gene & Cell Therapy, in April 2024, the global development pipeline comprised over 4,000 gene, cell, and RNA therapies.

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Key Market Challenges

The stringent regulatory compliance required for sourcing donor-derived materials acts as a significant restraint on the Global Cell Therapy Human Raw Materials Market. Since these inputs are biological, they are subject to rigorous safety protocols regarding donor eligibility. However, the lack of global harmonization creates a fragmented landscape where material validated for one region may not meet the criteria of another. This discrepancy compels manufacturers to establish segregated supply chains and conduct redundant testing, which directly impedes operational efficiency and slows the commercialization of therapies.

These regulatory hurdles are particularly damaging given the intensification of industry activity, which demands a seamless flow of resources. The inability to easily transfer raw materials across borders restricts the flexibility needed to meet global clinical trial demands. According to the Alliance for Regenerative Medicine, in 2025, the sector reported a 6% increase in the number of developers globally. This expansion in companies vying for limited, compliant donor material exacerbates supply shortages, ultimately hampering the overall growth potential of the market.

Key Market Trends

The Increased Utilization of Characterized Leukopaks for Allogeneic Therapies is fundamentally reshaping the raw materials landscape by prioritizing scalable, donor-derived starting materials over patient-specific sources. As developers shift toward off-the-shelf modalities to reduce manufacturing costs, there is a critical requirement for leukopaks that are GMP-compliant and extensively characterized for specific HLA types to ensure consistency across large batches. This transition necessitates robust donor networks and high-throughput processing capabilities to maintain a steady supply of high-quality cellular starting material. According to BioLife Solutions, November 2024, in the 'Third Quarter 2024 Financial Results', the company reported a 43% increase in cell processing platform revenue compared to the prior year, highlighting the surging industrial demand for validated biopreservation and starting material solutions.

Widespread Adoption of Human Platelet Lysate (HPL) as a Xeno-Free Supplement is accelerating as manufacturers seek to eliminate the safety risks associated with animal-derived components like Fetal Bovine Serum. This trend is driven by the need for chemically defined, pathogen-reduced media that supports the clinical-grade expansion of Mesenchymal Stem Cells and T-cells without compromising phenotypic stability. Consequently, suppliers are expanding their manufacturing infrastructure to provide standardized, viral-inactivated HPL formulations that meet stringent international quality standards. According to PL BioScience, August 2024, in the press release 'PL BioScience closes Series A Financing', the company secured €7.8 million specifically to scale up its production capacities, reflecting the sector's urgent move toward sustainable, non-animal derived culture systems.

Segmental Insights

Biopharmaceutical and pharmaceutical companies represent the fastest-growing segment in the global cell therapy human raw materials market, driven by intensified investment in therapeutic development and commercial production. These organizations are increasingly prioritizing the procurement of high-quality biological materials to meet the rigorous safety standards required for clinical applications. The expansion of manufacturing capabilities to support late-stage trials and approved treatments has created substantial demand for compliant starting materials. Furthermore, strict guidelines from regulatory bodies such as the U.S. Food and Drug Administration necessitate reliable supply chains, compelling companies to secure consistent sources of human-derived inputs for their developing portfolios.

Regional Insights

North America maintains a dominant position in the global cell therapy human raw materials market due to a high concentration of biopharmaceutical companies and academic research institutions. The region benefits from a robust regulatory framework established by the U.S. Food and Drug Administration (FDA), which supports the development and approval of regenerative medicines. Furthermore, substantial investment in research and development has led to a significant volume of clinical trials within the United States. This extensive clinical activity directly drives the demand for high-quality human raw materials, ensuring the region remains the primary revenue generator in the global sector.

Recent Developments

• In August 2025, Sartorius Stedim Biotech established a partnership with Nanotein Technologies to distribute advanced immune cell activation reagents globally. The collaboration focused on supplying soluble activators designed to enhance the expansion and quality of T cells and natural killer cells, which are essential components in chimeric antigen receptor T-cell therapies. As part of the agreement, the company also invested in the partner to support the commercialization of these next-generation ancillary materials. This strategic move aimed to address manufacturing challenges by providing feeder-free solutions that improve the consistency and yield of therapeutically functional immune cells for clinical applications.
• In January 2025, Bio-Techne Corporation announced the launch of a new portfolio of designer proteins engineered through artificial intelligence platforms to advance cell therapy workflows. The product line included heat-stable agonists and hyperactive growth factors, such as IL-2 and Activin A, available in both research and Good Manufacturing Practice grades. These innovative recombinant proteins were specifically developed to address critical challenges in cellular therapy, including the need for improved cell culture performance and optimized expansion of immune cells. This development underscored the company's commitment to providing high-performance raw materials that enhance the production and efficacy of regenerative medicine therapies.
• In April 2024, NMDP BioTherapies introduced significant enhancements to its cellular starting material offerings to support allogeneic cell therapy development. The organization launched a rapid-delivery, GMP-compliant leukopak that included a Drug Master File to streamline regulatory filings for therapy developers. These upgraded raw materials were designed to meet the evolving demands of the industry by offering optimized delivery times and customizable options. By providing high-quality, compliant cellular source materials derived from a diverse donor registry, the organization aimed to facilitate the manufacturing of next-generation cell and gene therapies and improve patient access to life-saving treatments.
• In February 2024, Charles River Laboratories International, Inc. entered into a strategic agreement with Pluristyx Inc. to distribute a comprehensive portfolio of human pluripotent stem cells. This collaboration provided the company with access to highly characterized embryonic stem cells and induced pluripotent stem cells, which serve as critical starting materials for the development of novel therapeutic treatments. The partnership enabled the distribution of wild-type and genetically engineered cell lines, including those produced under Good Tissue Practice. This expansion of the company's portfolio was designed to support researchers in accelerating the timeline for therapeutic development and reducing downstream costs in the cell therapy sector.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Merck KgaA
• Danaher Corporation
• Sartorius AG
• Aceto Holding GmbH
• Acrobiosystems Inc.
• Grifols, S.A
• Charles River Laboratories International, Inc.
• RoosterBio, Inc

By Product	By End User	By Region
Cell Culture Media Cell Culture Sera Cell Culture Supplements Reagents & Buffers Other	Biopharmaceutical & Pharmaceutical Companies CROs & CMOs Academic & Research Institutions	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Cell Therapy Human Raw Materials Market, By Product:

• Cell Culture Media
• Cell Culture Sera
• Cell Culture Supplements
• Reagents & Buffers
• Other

• Cell Therapy Human Raw Materials Market, By End User:

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutions

• Cell Therapy Human Raw Materials 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