- Home
- Industries
Aerospace And Defence
Agriculture
Automotive And Transportation
Banking And Finance
Business
Chemicals And Materials
Consumer And Retail
Electronics And Semiconductors
Food And Beverages
Machinery & Equipments
Manufacturing And Construction
Medical Devices
Others
Pharmaceuticals And Healthcare
Power And Energy
Sports
Technology
- Services
- News Room
- About us
- Contact Us
-
Recombinant Human Serum Albumin Market Size | 9.7% CAGR Growth
Global Recombinant Human Serum Albumin Market Size, Share & Forecast 2025–2034 | Cell Therapy & Gene Therapy Growth, Serum-Free Media Adoption, Biologics Manufacturing, Parenteral Formulations, Protein Stabilization, Pathogen-Free Alternatives to Plasma-Derived Albumin & Bioprocess Optimization Supporting Pharmaceutical, Vaccines & Regenerative Medicine Industries Worldwide
Report Overview
The Recombinant Human Serum Albumin market is estimated at US$ 105.4 Million in 2024 and is on track to reach roughly US$ 240.1 Million by 2034, implying a compound annual growth rate of 9.7% over 2025–2034. Growth has been steady. Industry revenue rose from US$ 75.9 Million in 2020 to US$ 103.4 Million in 2024, an 8.0% CAGR, with sequential gains of US$ 81.5 Million in 2021, US$ 90.3 Million in 2022, and US$ 95.9 Million in 2023. You can expect demand to track the expansion of biologics manufacturing and the shift to animal component–free processes. Recombinant HSA provides a pathogen-free, consistent alternative to plasma-derived albumin, supporting compliance and batch reproducibility in cell culture media, vaccine antigen stabilization, and parenteral formulations.
Demand-side drivers include the scale-up of monoclonal antibodies, vaccines, and gene and cell therapies. rHSA serves as a stabilizer and excipient in these use cases and supports serum-free and chemically defined media. Adoption in advanced therapies is broadening. In March 2023, Recombumin was selected for Heartseed’s HS-001 investigational cell therapy for cardiac remuscularization, highlighting traction in regenerative medicine. Supply-side momentum stems from higher-yield recombinant expression systems, wider use of perfusion and single-use bioreactors, and tighter process analytics that reduce lot variability. These factors improve supply reliability and support cost curves as volumes grow.
Key challenges remain. Prices face pressure from cost-sensitive media formulations. Manufacturers must navigate long validation cycles when switching critical raw materials, often 12 to 18 months, which can delay adoption. Regulatory expectations for traceability and viral safety testing are stringent. Fermentation scale-up and downstream purification capacity can be bottlenecks during rapid demand spikes.
North America led in 2024 with 35.6% share and revenue of US$ 36.8 Million, supported by a dense base of biologics producers and active cell therapy pipelines. Europe follows with strong vaccine and biosimilar infrastructure and consistent GMP standards. Asia Pacific is the investment hotspot to watch. China, South Korea, and India are adding biomanufacturing capacity and are expected to outpace the global average growth through 2034, with mid-to-high single-digit approvals in advanced therapies each year driving media and excipient demand. For investors, facility expansions tied to serum-free processes and partnerships with CDMOs offer the most visible near-term order growth.
Key Takeaways
- Market Growth: The global rHSA market reached US$ 105.4 million in 2024 and is projected to hit US$ 240.1 million by 2034 at an 10.7% CAGR. Expansion tracks serum-free process adoption and biologics scale-up across vaccines, mAbs, and cell and gene therapies.
- Expression Platform: Pichia pastoris led with 38.7% revenue share in 2024. Users favor its high volumetric yields, robust fermentation performance, and cost alignment for large media runs.
- Application: Cell culture media held 34.5% share in 2024. Adoption reflects the shift to chemically defined, animal component–free media to improve batch consistency and reduce pathogen risk.
- End Use: Pharmaceutical and biotechnological companies accounted for 54.5% of revenue in 2024. Their cGMP requirements and late-stage biologics pipelines drive recurring, validated demand.
- Driver: Demand accelerated as market revenue rose from US$ 75.9 million in 2020 to US$ 103.4 million in 2024, a 36% uplift. rHSA supports stabilization and yield in bioprocessing while enabling serum-free qualification in commercial media.
- Restraint: Switching critical raw materials requires lengthy validation. Typical supplier qualification spans 12 to 18 months, which delays adoption and raises switching costs for you and your CDMO partners.
- Opportunity: The market adds about US$ 134.7 million in absolute value between 2024 and 2034. Capturing a 5-point share of the 2034 market represents roughly US$ 12 million in annual revenue potential for suppliers with secured GMP capacity.
- Trend: rHSA use is extending into advanced therapies and regenerative medicine. In March 2023, Recombumin supported Heartseed’s HS-001 investigational cell therapy, signaling broader uptake in cell-based products and higher-value clinical supply.
- Regional Analysis: North America led with 35.6% share in 2024, or about US$ 36.8 million, supported by a dense biologics and cell therapy base. Asia Pacific is the growth hotspot; expanding facilities in China, South Korea, and India are expected to outpace the global CAGR, lifting regional share through 2034.
Source Analysis
Pichia pastoris remains the primary host for recombinant human serum albumin (rHSA) production. It held 38.7% share in 2024, equal to about US$ 40 million of the global market, and is expected to stay above 38% through 2027 as capacity ramps in single-use fermenters. Producers cite high volumetric productivity, with reported expression levels of roughly 5–10 g/L, robust methanol-induction processes, and straightforward downstream polishing that supports consistent GMP supply. You can expect continued preference for Pichia in media-grade and clinical excipient grades where cost, yield, and batch-to-batch consistency matter.
Saccharomyces cerevisiae and Oryza sativa platforms account for most of the remaining volume. Plant-based Oryza systems have gained traction in fully animal component–free workflows and now sit near parity with Pichia in several parenteral applications; adoption should rise as additional lots clear multi-site qualifications. Yeast-based S. cerevisiae remains relevant in specialty grades where specific glycation profiles or legacy validations are in place. Together with “Others,” these sources are projected to grow in the mid to high single digits from 2025 to 2030 as more CDMOs qualify dual-source supply.
Application Analysis
Cell culture media is the largest application, contributing 34.5% of revenue in 2024, or about US$ 35.7 million. rHSA supports cell viability, reduces shear-related stress, and stabilizes growth factors in chemically defined and serum-free media. With biologics manufacturing expanding and more programs moving to intensified and continuous modes, media use of rHSA is set to grow near or above the total market rate; the segment is projected at roughly US$ 38.8 million in 2025.
Therapeutic use cases are scaling. Stem cell therapy, drug formulations, and cryopreservation together accounted for more than 50% of 2024 revenue and are rising with approvals in cell and gene therapies and wider use of nanoparticle and liposomal delivery. Sponsors report double-digit improvements in viable cell density or product stability in certain CHO and vector processes when rHSA is included as a stabilizer. Expect stem cell therapy to be the fastest-growing application through 2030, with a projected high single-digit to low double-digit CAGR as clinical pipelines mature.
End-Use Analysis
Pharmaceutical and biotechnological companies dominate demand with 54.5% share in 2024, or about US$ 56.4 million, reflecting validated use of rHSA as an excipient and process supplement across late-stage programs. On a 2025 market of about US$ 112.4 million, this end-use group should exceed US$ 61 million as more products enter PPQ and commercial manufacturing. Major suppliers include Sartorius (Albumedix Recombumin), Thermo Fisher Scientific, Merck KGaA, and InVitria.
CROs are the next-largest buyers at roughly US$ 28.6 million in 2024. Outsourced development and pilot-scale runs drive steady uptake as CDMOs seek interchangeable grades that shorten tech-transfer timelines. Hospitals and diagnostic laboratories represent smaller but stable demand, concentrated in cryopreservation media, reagent kits, and select specialty formularies. You should plan for CRO demand to grow faster than the market average through 2030 as outsourcing penetrates earlier in the development lifecycle.
Regional Analysis
North America led with 35.6% share in 2024, or about US$ 36.8 million, supported by a dense base of biologics manufacturing and active cell and gene therapy pipelines. The region is projected to expand at roughly 8.4% CAGR through 2034, lifted by capacity additions and continued conversion to animal component–free processes. Europe followed with about US$ 29.3 million in 2024 on the strength of vaccine, biosimilar, and advanced therapy activity across Germany, the U.K., and the Nordics.
Asia Pacific is the key growth market. It reached about US$ 24.7 million in 2024 and is expected to outpace the global CAGR from 2025 onward as China, South Korea, and India add commercial suites and qualify local rHSA supply. Latin America and the Middle East and Africa remain smaller in value but show steady adoption in diagnostic and vaccine programs; these regions provide optionality for suppliers seeking geographic diversification and secondary distribution hubs.
Market Key Segments
By Source
- Pichia pastoris
- Saccharomyces cerevisiae
- Oryza Sativa
- Others
By Application
- Cell Culture Media
- Stem Cell Therapy
- Drug Formulations
- Cryopreservation
- Others
By End-Use
- Pharmaceutical and Biotechnological Industries
- CROs
- Hospitals
- Diagnostic Laboratories
By Regions
- North America
- Latin America
- East Asia And Pacific
- Sea And South Asia
- Eastern Europe
- Western Europe
- Middle East & Africa
Driver
Rising Critical-Care Demand Accelerates Shift to Recombinant HAS
The demand for recombinant human serum albumin (rHSA) is increasing quickly as global healthcare faces more cases of serious conditions like liver failure and sepsis. With nearly 2 million deaths related to liver issues and 49 million sepsis cases each year, doctors need safer and more reliable sources of albumin to provide effective care. Plasma-derived albumin has limitations in availability, variability between batches, and concerns about transmitting pathogens; rHSA addresses these problems effectively. As a result, hospitals, biopharma companies, and research institutions are increasingly moving toward recombinant solutions to maintain stable supply chains and meet regulatory standards.
rHSA Enhances Consistency and Cuts Variability in Bioprocessing
At the same time, improvements in biomanufacturing and biologic development continue to enhance the importance of rHSA. It is increasingly used in cell culture media, vaccine stabilization, cryopreservation, and injectable formulations, where consistency and purity are vital. Its ability to reduce variability between batches and simplify release investigations lessens the operational load during late-stage development. With spending on biologics research and development rising and regulatory agencies promoting processes free of animal components, the adoption of rHSA is likely to maintain a growth rate of 8–9% annually through 2034, highlighting its strategic value in the pharmaceutical supply chain.
Restraint
High Production Costs and Complex Purification Limit Rapid Adoption
Despite its benefits, the adoption of rHSA faces challenges related to production costs and technical difficulties. Recombinant systems demand advanced fermentation methods, multi-step purification, and stringent quality checks to match or exceed the performance of plasma-derived products. These requirements increase costs by 20–40%, making it harder for manufacturers in cost-sensitive markets, especially in emerging economies. High-density bioprocessing also requires specialized equipment and trained staff, raising both capital and operational expenses for suppliers and users.
Lengthy Supplier Requalification Delays Switching and Increases Risk
Regulatory and operational challenges slow market entry. Transitioning from plasma-derived albumin to rHSA involves extensive comparability studies, supplier audits, and material requalification; these processes can take 12–18 months. Such lengthy timelines deter quick transitions and often benefit established suppliers already integrated into existing processes. As global portfolios of biologics expand, these obstacles can hinder modernization efforts, forcing procurement teams to plan for longer technology transfer periods, increased initial costs, and strict quality control cycles.
Opportunity
Cell & Gene Therapy Workflows Create Major Growth Potential for rHSA
Cell and gene therapy (CGT) offers the most promising growth opportunity for rHSA in the next decade. Regulatory agencies expect double-digit annual approvals for advanced therapies, leading manufacturers to expand allogeneic and autologous platforms that need serum-free, high-purity materials. rHSA is crucial for stabilizing cells, viral vectors, and biologic components during development and production. With CGT workflows expected to grow by 12–15% annually through 2030, demand for rHSA from this area alone could yield an additional US$ 40–45 million in revenue by the end of the decade.
GMP Capacity and Long-Term Supply Deals Offer Strong Revenue Upside
In addition to therapeutic applications, rHSA use is increasing in formulation science, controlled-release technologies, and new cryopreservation systems. Companies that invest early in good manufacturing practice (GMP) production capacity, dual-site manufacturing, and long-term supply contracts will be well-positioned to meet the needs of CGT developers, vaccine producers, and contract development and manufacturing organizations (CDMOs) seeking reliable supply. As the global market approaches US$ 171 million by 2030, vendors with strong compliance support and scalability will gain a lasting competitive advantage with minimal risk of displacement.
Trend
Shift Toward Serum-Free, Chemically Defined Processes Boosts rHSA Use
The biopharmaceutical industry is rapidly moving toward animal component–free (ACF) and chemically defined (CD) workflows to boost consistency and meet regulatory requirements. By 2025, over 60% of new biologics programs will specify serum-free media, placing rHSA at the heart of formulation plans. Yeast-based platforms, especially Pichia pastoris, are becoming the preferred expression systems due to their 5–10 g/L yields, dependable scalability, and strong safety profiles against viruses. This industry shift is changing supplier competitiveness and speeding up the transition to high-purity recombinant excipients.
Yeast-Based Platforms and Localized Capacity Strengthen Supply Security
At the same time, CDMOs and media suppliers are increasing single-use fermentation and perfusion processing capabilities across North America and Asia to localize production and reduce logistical risks. Regulatory demands for transparency, dual-site manufacturing, and validated viral safety documentation are influencing partner choices more than ever before. As procurement leaders focus on sustainability, supply chain stability, and consistent quality, rHSA suppliers that can provide automated, traceable, and globally compliant production will set the stage for the next level of market leadership.
Key Player Analysis
Thermo Fisher Scientific Inc.: Challenger. Thermo Fisher participates in rHSA primarily as an ancillary material embedded in its Cell Therapy Systems portfolio rather than as a standalone excipient line. CTS Dynabeads CD3/CD28 and related immune-cell tools include rHSA as a defined component, with GMP documentation and supply-assurance programs that align with late-stage filings. The company anchors adoption through integrated workflows that pair reagents with automation such as the CTS Rotea counterflow centrifugation system for closed processing. This model ties rHSA consumption to clinical scaling of cell therapies and to standardization of release packages. You benefit from a global GMP footprint and regulatory support that shortens tech-transfer.
Thermo Fisher’s differentiator is platform reach. CTS media, accessories, and documentation enable consistent raw-material specifications across sites, which reduces batch investigations and downtime. The approach positions the company to capture incremental rHSA pull-through as CAR-T and stem-cell programs expand in 2025–2027.
Merck KGaA: Challenger. Merck’s MilliporeSigma business supplies CellPrime rAlbumin, a recombinant HSA expressed in Pichia pastoris and produced in facilities adhering to GMP. The product targets cell culture, cryopreservation, and drug-delivery research, and is provided with COA access and documentation for qualification. This breadth positions Merck as a preferred secondary source where sponsors want dual-vendor strategies for albumin in defined media.
Merck’s edge is portfolio integration across upstream chemicals and media. The company links rHSA supply with ADME tools and bioprocess raw materials, improving continuity for your procurement teams. As serum-free specifications tighten in 2025, CellPrime rAlbumin’s GMP positioning and Pichia expression support faster comparability and reduces change-control risk.
Sartorius AG: Leader. Through Albumedix, Sartorius markets the Recombumin rHSA franchise used as an excipient and process supplement across vaccines, biologics, and advanced therapies. Recombumin is manufactured under ICH Q7 GMP and is USP-NF compliant, with long shelf-life formats for clinical and commercial use. The brand reports extensive in-market dosing, supporting regulatory familiarity and broad qualification.
Strategically, Sartorius has continued to invest in capacity and regional resiliency. The group announced multi-site expansions in 2024–2025, and Albumedix has completed recent upgrade phases at its Nottingham commercial plant in partnership with Scitech to boost throughput. This scale, combined with Sartorius’ bioprocess portfolio and CDMO relationships, gives you a low-risk route to dual-site supply and reliable allocations as cell and gene therapy volumes rise.
ACROBiosystems: Niche player. ACROBiosystems offers recombinant serum albumin across research and premium grades, with product lines validated for FcRn binding, and provides custom GMP-grade protein services aimed at cell-therapy manufacturing. The company’s positioning targets developers that need agile specifications, smaller batch sizes, or rapid turnaround for early clinical programs.
Its differentiator is service flexibility. ACROBiosystems combines catalog rHSA with GMP documentation pathways and tailored specifications, which helps you bridge from preclinical to Phase 1 without a supplier change. As regional programs in Asia and the U.S. scale through 2025, this model captures demand from emerging sponsors that prioritize speed and method fit over long-term volume discounts.
Market Key Players
- Abcam Limited
- Sartorius AG
- Lee Biosolutions, Inc.
- Thermo Fisher Scientific Inc.
- Atlantis Bioscience Pte Ltd.
- Albumin Bioscience
- InVitria
- ACROBiosystems
- Merck KGaA
- HiMedia Laboratories
Recent Developments
Dec 2024 – Merck KGaA (MilliporeSigma Process Solutions): Merck signed an agreement to acquire HUB Organoids B.V., a leader in organoid models and services, with closing targeted for late December 2024. The deal expands Merck’s advanced cell modeling portfolio that relies on serum-free workflows where recombinant albumin is a common supplement. It strengthens Merck’s position across upstream media and documentation suites, creating cross-sell pull for CellPrime rAlbumin in organoid and cell therapy programs.
Feb 2025 – InVitria: InVitria introduced Optibumin 25, a 25 percent recombinant human serum albumin offered in closed-system liquid bags for GMP manufacturing. Application notes released the same month highlight performance in low-DMSO cryopreservation and cell retention use cases in CGT workflows. The launch broadens albumin options beyond 10 percent solutions and targets faster tech transfer into closed systems for you and your CDMO partners.
Apr 2025 – Thermo Fisher Scientific: Thermo Fisher opened an Advanced Therapies Collaboration Center in Greater San Diego to accelerate cell therapy development through process design and regulatory support. The center integrates raw-material qualification within end-to-end CTS workflows, which can increase adoption of animal-origin-free excipients such as recombinant HSA in formulation and cryopreservation.
Jul 2025 – Healthgen Biotech (Oryzogen): China’s NMPA approved the first rice-derived recombinant human albumin injection for hypoalbuminemia in cirrhosis, packaged as 10 g (20 percent, 50 mL). Industry groups noted the indication covers a subset of albumin use today, but the approval marks a regulatory milestone that could expand clinical rHSA adoption in Asia.
Sep 2025 – Sartorius (Albumedix): Albumedix completed two phases of expansion at its Nottingham Commercial Albumin Production Plant, adding downstream purification capacity and upgraded clean utilities. The project increases manufacturing resilience for Recombumin supply and improves lead-time reliability for late-stage biologics and CGT customers.
| Report Attribute | Details |
| Market size (2024) | US$ 105.4 Million |
| Forecast Revenue (2034) | US$ 240.1 Million |
| CAGR (2024-2034) | 9.7% |
| Historical data | 2018-2023 |
| Base Year For Estimation | 2024 |
| Forecast Period | 2025-2034 |
| Report coverage | Revenue Forecast, Competitive Landscape, Market Dynamics, Growth Factors, Trends and Recent Developments |
| Segments covered | By Source (Pichia pastoris, Saccharomyces cerevisiae, Oryza Sativa, Others), By Application (Cell Culture Media, Stem Cell Therapy, Drug Formulations, Cryopreservation, Others), By End-Use (Pharmaceutical and Biotechnological Industries, CROs, Hospitals, Diagnostic Laboratories) |
| Research Methodology |
|
| Regional scope |
|
| Competitive Landscape | Abcam Limited, Sartorius AG, Lee Biosolutions, Inc., Thermo Fisher Scientific Inc., Atlantis Bioscience Pte Ltd., Albumin Bioscience, InVitria, ACROBiosystems, Merck KGaA, HiMedia Laboratories |
| Customization Scope | Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements. |
| Pricing and Purchase Options | Avail customized purchase options to meet your exact research needs. We have three licenses to opt for: Single User License, Multi-User License (Up to 5 Users), Corporate Use License (Unlimited User and Printable PDF). |
Select Licence Type
Connect with our sales team
Recombinant Human Serum Albumin Market
Published Date : 08 Dec 2025 | Formats :Why Intelevo Research
100%
Customer
Satisfaction
24x7+
Availability - we are always
there when you need us
200+
Fortune 50 Companies trust
Intelevo Research
80%
of our reports are exclusive
and first in the industry
100%
more data
and analysis
1000+
reports published
till date
