Global Cell Therapy Human Raw Materials Market 2026 – 2035

In 2025, the size of the global cell therapy human raw materials market is estimated to be USD 3.62 billion, and it is projected to grow to USD 4.21 billion in 2026 to about USD 18.94 billion by 2035 with a CAGR of 16.3% between the periods 2026 and 2035.

The rapid clinical and commercial development of cell-based therapies especially CAR-T, NK cell and stem cell therapies, the high regulatory demand on human-derived or recombinant human raw materials in GMF compliant cell production, the fast global expansion in cell therapy production facilities, and the ongoing innovation in purity, characterization, and traceability of raw materials respectively all combine to catalyze outstanding growth in the market over the forecast.

Market Highlight

• North America was the top market with a 44% market share of cell therapy human raw materials in 2025.

• Asia Pacific will be the highest area in terms of CAGR with 20.1%.

• By product type, the human serum albumin segment was able to gain about 31% of the market share in 2025.

• By product type, the human platelet lysate segment has the highest CAGR of 21.4% between 2026 and 2035.

• Application-wise, the CAR-T cell therapy segment has the largest market share of 38% in 2025 with the NK cell therapy application segment anticipated to grow at the highest CAGR of 24.7% during the forecasted 2026-2035.

• By source, the recombinant human-derived segment has conquered 57% of the market share in 2025.

Significant Growth Factors

The Cell Therapy Human Raw Materials Market Trends present significant growth opportunities due to several factors:

• Explosive Growth of the Cell Therapy Clinical and Commercial Pipeline: The structural driver of demand of high-quality, GMP-compliant human raw materials in cell culture media, expansion protocols, and manufacturing processes is the unprecedented growth of the cell therapy development pipeline - including autologous and allogeneic CAR-T cell therapies, tumor-infiltrating lymphocyte (TIL) therapies, natural killer (NK) cell therapies, mesenchymal stem cell (MSC) therapies, and induced pluripotent The Alliance for Regenerative Medicine (ARM) estimates that by the end of 2024, the global cell and gene therapy clinical pipeline consisted of more than 2,100 active clinical trials, which is over five times as many as there were trials in 2016, and that cell therapies, which are the focus of this pipeline, represent about 60% of this total number of trials. Six CAR-T cell therapies were approved in 2017 through 2024, including Kymriah (tisagenleucel, Novartis), Yescarta (axicabtagene ciloleucel, Kite/Gilead), Tecartus, Breyanzi, Abecma, and Carvykti, with each commercial approval having a direct product translation to increased manufacturing needs and sustained commercial demand of GMP-grade human raw material. GlobalData values the global CAR-T cell therapy market at USD 4.8 billion in 2024 with a projection of USD 19.7 billion in 2030 with a CAGR of 26.3 which represents the most valuable near-term demand driver of GMP-grade human serum albumin, human transferrin, human platelet lysate, and other cell culture supplements. In addition to CAR-T, the new TIL therapy market (tumor inactivation and ligand) is generating additional sources of demand for raw materials as TIL production has been intensive in demands for human serum albumin, human IL-2, and human fibronectin in ex vivo expansion regimes. All cell therapies is expected to increase to over USD 35 billion by 2030 out of USD 8.4 billion in 2024 as forecasted by McKinsey and Company, continuing to drive an unprecedented rate of growth in the demand for the human raw materials that are the basis of all cell manufacturing at all clinical and commercial levels.

• Stringent GMP Regulatory Requirements Mandating Human-Origin and Recombinant Human Materials: The regulatory regime defining clinical-grade cell therapy manufacture places extra strict demands on sourcing raw materials, characterization and quality assurance which establish sustainable competitive advantages for approved, qualified human material source suppliers. FDA 21 CFR Part 1271, EU Advanced Therapy Medicinal Products (ATMP) Regulation 1394/2007, and related regulatory systems in Japan, South Korea, China, and other important markets require that the raw materials used in the production of cell-based products to be used clinically must be fully described regarding their identity, purity, potency, and safety, including the absence of adventitious agents, mycoplasma, endotoxin, and human transmissible pathogens. Raw materials of human origin, such as albumin, transferrin, insulin, and growth factors need to satisfy other requirements such as donor screening, pathogen inactivation, and traceability to certified human donors that complex supply chains and demand high costs in quality assurance, which can be justified at a very high price over animal-derived or non-GMP alternatives. The FDA guideline on chemistry, manufacturing, and controls (CMC) of gene and cell therapy products specifically mentions raw material qualification as a manufacturing risk area of significant concern, and material-based manufacturing failures are mentioned to be among the most common reasons for clinical hold action. A 2024 survey of the Bioprocess Technology Group found that qualification of raw material and assurance of supply chain were the top-ranked manufacturing issues indicated by 67% of developers of cell therapies, providing a strategic role of qualified human raw material suppliers in facilitating clinical program advancement. There is growing judging of regulatory agencies regarding raw material animal-origin components in cell therapy production, with ICH Q5A guidelines on viral safety of biotechnology products and FDA animal component-free (ACF) manufacturing guidance leading to systematic replacement of animal-derived components by recombinant human equivalents in the industry - directly expanding the addressable market of recombinant human albumin, recombinant human transferrin, and recombinant human growth factors.

What are the Major Advances Changing the Cell Therapy Human Raw Materials Market Today?

• Recombinant Human Albumin Technology Replacing Plasma-Derived Sources: The wholesome replacement of plasma-derived human serum albumin (HSA) by recombinant human albumin (rHA) expressed in yeast, rice, or other expression systems is one of the most radical shifts in raw material technology in the cell therapy manufacturing industry, instigated by the extenuating benefits of recombinant production in supply security, batch-to-batch reproducibility, absence of human plasma-derived donor variation, and hypothetical eradication of theoretical transmissible illness of plasma-derived biologics. Although the use of traditional plasma-derived HSA has been extensively tested in terms of safety and widely used in cell culture media, as well as in cryopreservation formulations, inherent supply chain risks in the use of plasma-derived HSA include the small size and geographic concentration of the global plasma collection infrastructure, seasonal fluctuation in plasma supply, and the logistical challenge of matching fractionation capacity with cell therapy manufacturing demand that has proven to be highly difficult to predict due to the personalized nature of autologous therapy manufacturing. In 2024, the global recombinant human albumin market stood at around USD 410 million and is expected to increase by a CAGR of 18.3% to 2030, which is much higher than the growth rate of plasma-derived HSA as the cell therapy developers start to use rHA more frequently in their approved manufacturing procedures. Key suppliers of GMP-grade human recombinant albumin to use in cell therapy, such as Albumedix (until 2007, known as Novozymes Biopharma), InVitria, and OPK Biotech, have their Recombumin platform and Cellastim product line respectively occupying a large market share in approved cell therapy production processes around the world. Recombinant albumin expression systems developed in Oryza sativa (rice) expression systems, commercialized by Wuhan Healthgen Biotechnology and others, provide a platform of production using plant sources that is completely devoid of human or animal components in the production process, meeting the most demanding animal component-free needs of next-generation cell therapy developers. According to industry reports by cell therapy developers, rHA offers 1525% better batch to batch consistency of cell expansion results than plasma-derived HSA, a consistency of performance that has great commercial value in autologous cell therapy manufacturing where batch failures directly translate to patient treatment delays and manufacturing cost write-offs.

• Human Platelet Lysate as the Emerging Replacement for Fetal Bovine Serum: The ever-growing adoption of human platelet lysate (HPL) as the serum supplement of choice in ex vivo culture of mesenchymal stem cells, T cells, NK cells, and other cell types of interest in cell therapy reflects a significant paradigm shift in cell therapy raw materials strategy due to regulatory guidance favoring the use of animal component-free manufacturing and clinical data to support the superior or equivalent performance of cell expansion with HPL compared to fetal bovine Historically, FBS has been utilized in cell culture regimens in research and early clinical development on account of its abundant growth factor, cell adhesion and transport protein content enabling cell growth, but its animal origin, batch-to-batch inconsistency, undefined composition and its linkage with potential xenogeneic immunogenicity upon human patients undergoing cell therapy have led to a systematic elimination to replace it with human-derived substitutes. Human platelet lysate (HPL) is created by pooling and collecting platelet units in blood donors and exposing the platelets to freeze-thaw lysis to release growth factor-controlling components and undergoes pathogen inactivation and filtration steps to obtain a rich cocktail of human-native growth factors, such as PDGF, FGF, EGF, and IGF-1 and TGF-2 at concentrations permitting robust cell expansion without the safety issues that animal-derived sera have. In 2024 the global human platelet lysate market has a value of USD 312 million, with a CAGR of 24.8 to reach USD 1.84 billion in 2032, which is one of the fastest-growing growth profiles in the entire cell therapy raw materials market space. The main commercial suppliers of HPL are Merck KGaA (MilliporeSigma), Macopharma, Cook Regentec, and PL BioScience, and UltraGROWTH by Merck and MultiPL-H by Macopharma have a prominent place in the validated workflows of MSC and T cell propagation worldwide. In a meta-analysis of 47 clinical studies published in 2024 by Cytotherapy, HPL-expanded MSCs were found to have the same or better clinical safety and efficacy outcome than FBS-expanded cells in 89% of the reviewed studies, which forms the clinical evidence base on which widespread adoption can be based.

• Advanced Human Cytokine and Growth Factor Platforms for Next-Generation Cell Manufacturing: The development of recent progress in manufacturing pharmaceutical-grade recombinant human cytokines, including interleukins (IL-2, IL-7, IL-15, and IL-21), interferons, and colony-stimulating factors manufactured under GMP conditions with full characterization, specified potency, and traceable supply chains is facilitating next-generation cell therapy manufacturing protocols yielding better therapeutic cell phenotypes than the protocols that utilize research-grade cytokine preparations. Cytokines play a functional role in virtually all cell therapy manufacturing regimens - IL-2 is necessary in T cell and NK cell expansion; IL-7 and IL-15 maintain memory T cell phenotype, which is essential to CAR-T survival; SCF, FLT3L, and TPO are necessary in hematopoietic stem cell expansion; and M-CSF and IL-4 are needed in dendritic cell differentiation. The cell therapy recombinant cytokines industry in the world is estimated at USD 680 million in 2024 and in 2030 at a CAGR of 22.6 with an estimated USD 2.8 billion owing to the growing commercial cell therapy production base. The most popular GMP-grade cytokine suppliers of cell therapy production are Miltenyi Biotec, PeproTech (Thermo Fisher Scientific), R&D Systems (Bio-Techne), and CellGenix GmbH, although the GMP -grade cytokine portfolio of CellGenix (more than 30 recombinant human proteins) occupies a very prominent niche in the production of CAR-T and TIL therapies. Some of the critical quality attributes of GMP cytokines in cell therapy production are specific biological activity (usually expressed in units per milligram of protein), endotoxin level (usually less than 1 EU per microgram), host cell protein level, glycosylation pattern of glycosylated cytokines, and storage at manufacturing conditions relevant conditions. The sector is moving towards specified, animal component-free cytokine preparations generated in E. coli, yeast, or CHO expression systems, which removes lot-to-lot randomness linked to the antique cell-line-derived cytokine expression systems.

• Human Fibronectin and Extracellular Matrix Proteins for Enhanced Viral Transduction and Cell Activation: Human Fibronectin and Extracellular Matrix proteins to enhance Viral Transduction and Cell Activation: Recombinant human fibronectin fragments - especially the RetroNectin product (recombinant human fibronectin fragment CH-296) developed and commercialized by Takara bio - have gained a role as critical raw material in CAR-T and other genetically modified cell therapy manufacturing processes, where they are used to co-localize retroviral and lentiviral vectors to target T cells on surfaces of the culture vessels to produce significant The most costly aspect in the production of CAR-T cells is the retroviral and lentiviral vectors that transfer the CAR gene construct into the T cells to form CAR-T cells, with the cost of the viral vectors taking 30-50% of the overall manufacturing cost of goods in autologous CAR-T processes according to an analysis by the Cell and Gene Therapy Catapult. RetroNectin-based transduction protocols enhance viral transduction by 3-10 fold over traditional suspension transduction protocols and can achieve equivalent quality CAR-T cell products at significantly lower viral vector inputs and therefore considerable savings in manufacturing costs. RetroNectin as a cell therapy application was estimated to represent USD 145 million in the global market in 2024 with Takara Bio enjoying a large market share due to its state of the art position in fibronectin fragment technology development and the extensive penetration of its product into proven manufacturing processes in leading cell therapy developers. In addition to fibronectin, recombinant human collagen, laminin, and vitronectin are becoming key raw materials in cell therapy production using iPSCs, in which cell lineage maintenance and efficient differentiation into therapeutic lineages depend on controlled extracellular matrix environments but not the undefined biological diversity of Matrigel and other animal-derived matrices. The global cell therapy recombinant human extracellular matrix protein market is expected to expand at a 19.8% CAGR between 2025 and 2032 indicating the intense growth of iPSC-based therapy development, as well as the systematization of the industry to defined, animal component-free manufacturing platforms.

Category Wise Insights

By Product Type

Why Does Human Serum Albumin Lead the Market?

By 2025, human serum albumin (HSA), both plasma-derived and recombinant, will constitute the greatest proportion of the product type, with about 31% of the market share. Such domination is related to the invaluable and versatile functions that HSA has in the cell therapy manufacturing process, such as serving as a crucial supplement in cell culture media formulations to stabilize growth factors, minimize non-specific protein adsorption to the surfaces of culture vessels, and support cell membrane integrity; as a major constituent of cryopreservation formulations such as the well-known 10% DMSO/HSA solution used to freeze cell products; and in the cell therapy final drug product formulation of cell therapy infusion bags where it preserves cell viability during transportation and in In 2024, the global human serum albumin market in pharmaceutical and cell therapy applications was noted to be worth about USD 1.12 billion, with the cell therapy manufacturing segment being the highest growth of demand at an estimated CAGR of 19.2 due to the commercial scale-up of CAR-T manufacturing by Novartis, Gilead/Kite, Bristol Myers Squibb, and Johnson and Johnson. A standard commercial autologous CAR-T production lot can use approximately 150 to 300 grams of pharmaceutical grade HSA in cell culture, washing, formulation and cryopreservation processes and that the about 30,000 commercial doses of CAR-T cells produced worldwide in the year 2024 would translate into about 5000 to 9000 kilograms of HSA used in CAR-T production alone. Pharmaceutical human serum albumin of GMP grade sells at USD 800-USD 2,500 per kilogram by grade of purity and endotoxin specification and grade of supplier qualification such as cell therapy manufacturing application, imposing a huge premium over clinical grade of IV albumin that is used in hospital settings.

Human platelet lysate is witnessing the highest growth with the CAGR of 21.4% between 2026 and 2035 due to the systematic industry-wide replacement of the fetal bovine serum in MSC, T cell, and NK cell culture protocols by the regulatory preference of animal component-free manufacturing and growing clinical evidence of the use of human platelet lysate in terms of its performance and safety profile. The HPL market is expected to expand to USD 1.84 billion in 2032 upon USD 312 million in 2024, and commercial HPL suppliers are scurrying to have pooled, pathogen-inactivated, pharmaceutical-grade HPL products certified to manufacture GMP cells. The shift from research-grade to GMC grade HPL is a major market upgrade cycle, as the cell therapy developers who started at preclinical and initial clinical studies with laboratory-grade HPL now move on to actual commercial production with fully characterized, regulatory submission-ready GMC HPL with full donor traceability and pathogen inactivation records.

By Application

Why Does CAR-T Cell Therapy Dominate the Market?

The largest end-use segment is applications of CAR-T cell therapy, with the six FDA-approved CAR-T products sharing a total market share of about 38% in 2025, which is indicative of the commercial maturity of the CAR-T cell therapy and manufacturing scale due to the exceptionally high raw material-intensive nature of the cell manufacturing protocols compared with other cell therapy modalities. Commercial production of autologous CAR-T cells is a multi-step process that is currently embodied by leukapheresis collection, T cell enrichment and activation, viral vector transduction, ex vivo expansion, harvest, formulation and cryopreservation - each of which requires large amounts of GMP-grade human raw materials such as fibronectin to improve transduction, HSA to supplement and formulate media, IL-2, IL-7, and IL-15 to activate and expand T cells; and human AB serum or HPL to some activation path. All six commercially licensed CAR-T therapies were expected to drive some USD 4.8 billion of global revenue in 2024, and production capacity was rapidly increasing as commercial demand increased, and new geographic locations such as Europe, Japan, South Korea, and China were getting regulatory approvals and, in turn, reimbursement authorizations. The manufacturing of Bristol Myers Squibb's Breyanzi and Abecma, Novartis's Kymriah, and Gilead/Kite's Yescarta and Tecartus are the largest GMP cell therapy manufacturing operations in the world and are the largest consumers of pharmaceutical grade human raw materials used in the cell therapy market. Another application that will generate more raw material demand at potentially increased volume per run of manufacturing is the allogeneic CAR-T segment where off-the-shelf CAR-T products are produced using healthy donor T cells instead of patient-specific T cells, with developers of allogeneic programs including Allogene Therapeutics, Precision BioSciences, and Cellectis undergoing clinical development.

The NK cell therapy segment is undergoing the most rapid growth with a CAGR of 24.7% between the years 2026 and 2035 due to the advent of NK cell therapies as a viable allogeneic cell therapy consisting of significant safety benefits compared to CAR-T (it is less prone to cytokine release syndrome or neurotoxicity) and scalability in manufacturing because of peripheral blood, cord blood, or iPSC sources of NK cells. The Alliance for Regenerative Medicine listed more than 200 ongoing clinical trials in the field in 2024, a more than tenfold improvement over 2018, and initial clinical data on programs at MD Anderson Cancer Center, Fate Therapeutics, Nkarta, and Artiva Biotherapeutics generated considerable clinical and commercial excitement. NK cell production regimens depend on recombinant human cytokines such as IL-15, IL-2, IL-21 and SCF to activate and proliferate NK cells, feeder-cell-free expansion systems that demand prescribed human raw material supplements.

By End-User

Why Do Biopharmaceutical and Biotechnology Companies Dominate?

The largest end-user segment, at 52% market share in 2025 is biopharmaceutical and biotechnology companies, who will cluster around the established pharmaceutical organizations with the GMP infrastructure, regulatory skill, and financial resources necessary to qualify and validate pharmaceutical-grade human raw materials. The 20 (or so) cell therapy products commercially approved worldwide by 2025, of CAR-T, TIL and MSC therapies, are produced by biopharma companies such as Novartis, Gilead Sciences, Bristol Myers Squibb, Johnson & Johnson, Iovance Biotherapeutics, and JCR Pharmaceuticals, all of which are consuming most of the commercial-scale volumes of GMF human raw materials. The production programs are also characterized by commercial scale manufacturing of cell therapies which normally demand 10-100 times as much raw material per year as clinical-scale programs, which generate a step-change demand load as therapies advance through regulatory approval and market access approval. The quickest expanding segment of end-users, at a forecasted CAGR of 22.1% in 2026-2035, is CDMOs, which will offer an integrated manufacturing capacity and procurement expertise of raw materials, allowing asset-light development models which leave capital to clinical and commercial development.

By Source

Why Does Recombinant Human-Derived Lead the Market?

In 2025, Recombinant human-derived materials are 57% of the market share due to regulatory benefits and operational benefits of defined, characterized, animal component-free recombinant proteins compared to plasma-derived products in cell therapy manufacturing applications. Recombinant production platforms -E. coli fermentation is used to produce non-glycosylated proteins, yeast (Saccharomyces cerevisiae and Pichia pastoris) is used to produce certain glycoproteins, CHO cell culture is used to produce complex glycoproteins and the rice grain expression system is used to produce albumin -The manufacturing processes have greater scalability, greater controllability, and greater amenability to the rigorous characterization demanded of cell therapy raw material qualification than plasma fractionation. By 2030 the recombinant segment is forecasted to achieve 68% of total market share as the industry undergoes a systematic transition of all animal components, which does not exclude the use of plasma-derived materials in that the biological complexity of pooled plasma (especially in human platelet lysate) offers functional benefits not yet entirely substituted by defined recombinant formulations.

Report Scope

Regional Analysis

How Big is the North America Market Size?

The North America cell therapy human raw materials market size is estimated at USD 1.59 billion in 2025 and is projected to reach approximately USD 7.13 billion by 2035, with a 16.2% CAGR from 2026 to 2035.

Why Did North America Dominate the Market in 2025?

In 2025, the dominance of cell therapy innovation and production in North America is estimated to command a global market share of about 44%, given its status as the cell therapy products and manufacturing centre of the world, hosting most cell therapy product approvals, the greatest concentration of clinical-stage cell therapy programs in the world, the most advanced cell therapy products regulatory framework under FDA control, and the highest density of specialised cell therapy CDMOs, raw material suppliers, and ancillary bioprocessing infrastructure. In 2024, the Alliance for Regenerative Medicine found more than 60% of cell therapy clinical trials in the world originated in the United States, and the Center for Biologics Evaluation and Research (CBER) of FDA has given more products based on cell therapy approvals than any other regulatory body in the world. The 6 commercially approved CAR-T products in the U.S. would collectively serve an estimated 8,000 -10,000 patients in 2024, and the treatment of patients would require large amounts of GMP-grade human raw materials in the production process. In 2024, according to PitchBook, the USD 4.2 billion in venture capital invested in U.S. cell therapy companies created a strong pipeline of clinical-stage programs, which stimulated preclinical and clinical production of raw materials upstream of commercial approval.

U.S. Market Trends

The U.S. commercial market is characterized by the scale-up, which is currently under commercial manufacturing, of FDA-approved CAR-T therapies, the acceleration of the development of TIL therapy following the approval of Amtagvi by Iovance in February 2024, and the intense development of next-generation NK cell, MSC, and iPSC-derived cell therapies, which together amount to the subsequent stage in raw material demand growth. The Medicare drug price negotiation of the Inflation Reduction Act and the continued reimbursement reworking of cell therapies (commercial CAR-T products are already costing USD 373,000 - USD 475,000 per treatment) both mean that there is an enormous commercial incentive to motivate cell therapies development and pressure on manufacturing cost-of-goods that is compelling investment in the optimization of raw materials and the minimization of costs. The new paradigm proposed by the FDA to rapidly approve allogeneic cell therapies is likely to drive a new manufacturing model in which the amount of raw materials per production cycle is significantly higher than autologous manufacturing, which is a considerable demand inflection point that is likely to occur in the 2027-2030 period.

Why is Europe a Strategically Critical Market?

The second-largest regional market is Europe, which is supported by a highly advanced regulatory framework on Advanced Therapy Medicinal Products (ATMPs) administered by the European Medicines Agency through its Committee on Advanced Therapies (CAT); a robust academic and hospital-based base on cell therapy research, which generates significant clinical trial demand; the presence of leading raw material suppliers Sartorius AG, Merck KGaA, CellGenix GmbH, Macopharma, and PL BioScience, which are based in Europe; and a growing cell therapy CDMO base at Lonza ( The four biggest European national markets are Germany, the United Kingdom, France, and the Netherlands, which have a combined market revenue of around 65% of the European market. Since Brexit, The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has taken a proactive approach to ATMP innovation and has instituted expedited approval processes that are drawing cell therapy clinical investment. CellGenix is an internationally established manufacturer of leading quality GMP cytokines in the manufacture of cell therapies, having a portfolio of more than 30 GMP-grade recombinant human cytokines that are indicated in approved manufacturing schemes at cell therapy manufacturing companies in Europe, North America, and Asia Pacific.

Why is Asia Pacific Experiencing the Fastest Growth?

Asia pacific represents the most rapidly developing regional market with a projected CAGR of 20.1% between 2026 and 2035 due to the presence of Japan, the world leader in regulatory frameworks on regenerative medicine products under the Act on the Safety of Regenerative Medicine, and the Pharmaceutical and Medical device Act, which has provided a conditional approval pathway that allows commercialization of regenerative medicine products based on previous safety and efficacy evidence on a faster basis compared to conventional pharmaceutical approval requirements, South Korea, with an emerging cell therapy manufacturing industry. The regulatory framework on multiple MSC-based products in Japan through its regulatory system on regenerative medicine has opened the commercial market of cell therapy within Japan and has become the force behind the high level of GMO raw material demand currently being targeted by Japanese manufacturers JCR Pharmaceuticals and Healios. The cell therapy market is undergoing frenetic growth in China, and the National Medical Products Administration (NMPA) approved the first domestic CAR-T (Relma-cel by JW Therapeutics) in 2023 and more than 20 other CAR-Ts at different phases of regulatory approval is establishing an expanding domestic base of GMP raw material production that is currently mostly satisfied by international providers but is experiencing the entry of domestic raw material manufacturers.

China Market Trends

The Chinese market of cell therapy human raw materials is projected to reach about USD 280 million in 2025 and grow at 22.3% CAGR through 2035 due to the approval and commercial scale-up of Chinese CAR-T therapies, government-level priorities in biomedical industries embedded in the Healthy China 2030 plan, and the high rate of expansion of Chinese biopharmaceutical CDMO industry - such as the Advanced Therapies division of WuXi AppTec - that is also meeting domestic and foreign needs of cell therapy Local raw material suppliers in China such as Wuhan Healthgen Biotechnology, Sino Biological and Novoprotein are looking to produce and market GMP-grade recombinant human albumin, cytokines and growth factors to capture the quickly expanding domestic market and strategize the entry of the international market as the quality capabilities are developed.

Why is the Middle East & Africa Region Emerging?

The LAMEA region is a new market opportunity fuelled by Saudi Arabia and UAE health system investment in advanced therapy access under Vision 2030 and under Abu Dhabi healthcare development programs, Burgeoning academic cell therapy research centers in Israel, the home of leading cell therapy research programs in the Weizmann Institute of Science and Hebrew University, Brazil with a growing biopharmaceutical manufacturing industry with government support under advanced therapy manufacturing capabilities, and India with an emerging but rapidly developing cell therapy ecosystem centered around the National Centre of Cell Science and increasing clinical trial activities at specialist academic medical centers.

Top Players in the Market and Their Offerings

• Thermo Fisher Scientific Inc.

• Merck KGaA (MilliporeSigma)

• Sartorius AG

• Albumedix Ltd.

• Takara Bio Inc.

• CellGenix GmbH

• Macopharma SA

• Miltenyi Biotec GmbH

• InVitria (Ventria Bioscience)

• PeproTech Inc. (Thermo Fisher Scientific)

• Wuhan Healthgen Biotechnology Corp.

• Others

Key Developments

The market has experienced tremendous changes with players in the industry trying to increase GMP manufacturing capacity, increase the product line in the application of clinical cell therapy, and secure the supply chain in case of the unavailability of essential human raw materials.

• In April 2021: Albumedix Ltd. stated it would expand its recombinant human albumin GMP manufacturing plant by USD 35 million in Nottingham, United Kingdom, which would boost its production capacity by about 40% to keep up with the growing demand of commercial CAR-T manufacturers and cell therapy CDMOs. As the main driver of demand, Albumedix pointed to the commercial-scale-up of various FDA/EMA-approved CAR-T products, and the company was reporting that a number of large commercial cell therapy manufacturers had added over 200% of annual Recombumin purchasing volumes by 2024 compared to 2022.

• In January 2025: Merck KGaA (MilliporeSigma) will introduce its UltraGROWTH Classic HPL and UltraGROWTH Select HPL expanded product line, which includes two new pathogen-inactivated human platelet lysate grades with increased lot-to-lot consistency through an extended donor pool comprising more than 5,000 qualified donors and improved viral inactivation by using solvent detergent treatment with nanofiltration. The new grades are specifically designed to suit regulatory submission standards of commercial ATMP manufacturing dossials in EU or BLA filings with the FDA, to respond to a market emergency as cell therapy developers move HPL-based manufacturing processes from clinical to commercial manufacturing.

• In March 2025: Takara Bio Inc. signed a strategic alliance with a large cell therapy CDMO in North America to develop special RetroNectin supply deals to allocate priority to GMP-grade recombinant human fibronectin fragment CH-296 to commercially produce CAR-T cells. The relationship involved joint investment in committed manufacturing capacity at a GMP production facility of Takara Bio in Otsu, Japan, with assured volumes of supply allotted per year as a guiding force in manufacturing in guaranteeing the supply chain of cell therapy is planned commercially. Takara bio reported an increased world demand for RetroNectin by around 180% in 2022 to 2024 because of the proliferation of business CAR-T manufacturing facilities nationwide.

These strategic moves have enabled the companies to consolidate positions in the marketplace, enhance crucial production capacity, diversify product lines to develop the new cell therapy modalities, and comply with the supply chain security issues that are one of the biggest operational risks to developers and manufacturing companies of the cell therapy that are moving to commercial size.

The Cell Therapy Human Raw Materials Market is segmented as follows:

By Product Type

• Human Serum Albumin (Plasma-Derived and Recombinant)

• Human Transferrin (Plasma-Derived and Recombinant)

• Human Insulin

• Human Fibronectin and ECM Proteins

• Human Platelet Lysate (HPL)

• Recombinant Human Cytokines and Growth Factors (IL-2, IL-7, IL-15, SCF, FGF, etc.)

• Human AB Serum

• Other Human Raw Materials

By Application

• CAR-T Cell Therapy

• Stem Cell Therapy (HSC, MSC, iPSC-Derived)

• Natural Killer (NK) Cell Therapy

• Dendritic Cell Therapy

• Tumor-Infiltrating Lymphocyte (TIL) Therapy

• Other Cell Therapy Applications

By End-User

• Biopharmaceutical & Biotechnology Companies

• Academic & Research Institutes

• Contract Development and Manufacturing Organizations (CDMOs)

• Hospitals & Specialized Cell Therapy Centers

• Other End-Users

By Source

• Recombinant Human-Derived

• Plasma-Derived Human Materials

• Other Sources

Regional Coverage:

North America

• U.S.

• Canada

• Mexico

• Rest of North America 

Europe

• Germany

• France

• U.K.

• Russia

• Italy

• Spain

• Netherlands

• Rest of Europe

Asia Pacific

• China

• Japan

• India

• New Zealand

• Australia

• South Korea

• Taiwan

• Rest of Asia Pacific 

The Middle East & Africa

• Saudi Arabia

• UAE

• Egypt

• Kuwait

• South Africa

• Rest of the Middle East & Africa

Latin America

• Brazil

• Argentina

• Rest of Latin America