Albumin Market Size & Outlook, 2025-2033

Albumin Market Overview

The global albumin market size was valued at USD 5.21 billion in 2024 and is projected to grow from USD 5.56 billion in 2025 to USD 8.91 billion by 2033, exhibiting a CAGR of 6.0% during the forecast period (2025-2033). The market is witnessing steady growth, fueled by its wide-ranging applications across pharmaceutical, clinical diagnostics, biotechnology, and life sciences sectors.

Key Market Insights

• The North America region dominated the global albumin market with the largest revenue share of 40% in 2024.
• Based on product type, the human serum albumin segment dominated the albumin industry in 2024.
• Based on application, the drug delivery and vaccine stabilisation segment has emerged as the most dynamic application segment.
• Based on distribution channel, the hospital pharmacies segment dominates the distribution landscape for albumin.

Market Size & Forecast

• 2024 Market Size: USD 5.21 billion
• 2033 Projected Market Size: USD 8.91 billion
• CAGR (2025–2033): 6.0%
• North America: Largest market in 2024
• Asia-Pacific: Fastest-growing region

Albumin, a water-soluble protein derived from human plasma or recombinant sources, plays a key role in maintaining oncotic pressure and transporting vital substances like hormones and fatty acids. Its widespread clinical use in critical care, hypoalbuminemia treatment, and drug delivery continues to drive demand globally. The market is growing, especially in emerging economies with improved healthcare infrastructure and rising access to plasma-derived therapies. Increasing cases of liver disease, nephrotic syndrome, and burns, along with more surgical procedures, are boosting consumption.

Albumin Market Trend

Recombinant Albumin Gains Ground as Safer, Scalable Alternative to Plasma-Derived Sources

The albumin market is undergoing a notable transformation as biotechnology companies and pharmaceutical manufacturers shift toward recombinant human serum albumin (rHSA) to address concerns around plasma supply limitations, pathogen safety, and regulatory compliance. This reflects a broader move within the life sciences industry to adopt more consistent, ethically sourced, and scalable inputs, especially for vaccines, biologics, and cell-based therapies.

• For instance, in June 2024, Sartorius announced that its recombinant albumin, developed through its acquisition of Albumedix, played a key role in stabilising the world’s first FDA-approved chikungunya vaccine, IXCHIQ®. The rHSA was used as a formulation stabiliser, supporting cold-chain storage without compromising the vaccine’s potency.

Institutions focused on biomanufacturing, gene therapy, and regenerative medicine are linking procurement decisions to quality certifications and recombinant sourcing, positioning suppliers of rHSA for long-term strategic growth.

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Albumin Market Driver

Plant-Based Biotech Breakthrough Accelerates Albumin Supply Shift

One of the most significant drivers for the market is the push for scalable, plant-based production methods that reduce dependence on plasma-derived sources, particularly in countries with high import reliance for critical biologics like albumin.

For instance, in April 2025, Healthgen Biotechnology, a China-based biotech firm, received regulatory approval from the National Medical Products Administration (NMPA) for its rice-derived recombinant human albumin injection. Targeted at treating hypoalbuminemia, the injectable is produced using a proprietary plant-based platform that enables large-scale output: 25 kilograms of rice can generate albumin equivalent to five litres of human plasma.

As countries like China ramp up investment in recombinant biologics, demand for scalable, animal-free albumin sources is expected to rise.

Market Restraint

Complex Regulatory Landscape and Supply Limitations

One central constraint in the global albumin market is the complex and often fragmented regulatory framework surrounding plasma-derived and recombinant albumin products. When used in medical and biopharmaceutical applications, Albumin must meet stringent quality, safety, and traceability standards, which vary significantly across regions and product types. For manufacturers, navigating diverse compliance expectations from bodies such as the U.S. FDA, EMA, CFDA, and other national health agencies can delay product approvals and inflate development costs.

In addition, supply constraints tied to plasma sourcing remain a persistent issue. Plasma-derived albumin production depends on blood donations and is vulnerable to seasonal shortages, donor hesitancy, and geopolitical disruptions. This supply volatility directly impacts pricing and availability in regions reliant on imports.

Market Opportunity

Nanogold–Albumin Conjugates Open New Frontiers in Targeted Oncology Nanomedicine

The integration of albumin-based nanocarriers in precision oncology, particularly through innovations in nanogold–albumin conjugates, is an emerging opportunity. As researchers seek to improve the efficacy and safety of cancer therapeutics, albumin is being redefined from a passive excipient to a key functional material in next-generation nanomedicine platforms.

For example, in March 2025, a pivotal review article in Nanoscale explored breakthrough developments in this domain, detailing nanosystems such as supramolecular albumin-coated gold nanoparticles and albumin-templated ultra-small gold nanoclusters. These conjugates are engineered for high-performance drug delivery and diagnostic imaging. Their customizable surface chemistry, prolonged circulation, and low immunogenicity make them ideal candidates for delivering a wide spectrum of therapeutic agents from chemotherapeutics to nucleic acids while enabling real-time imaging.

As clinical interest in albumin-functionalized nanocarriers intensifies, this innovation opens a compelling avenue for biotech firms, diagnostic developers, and pharmaceutical companies to invest in albumin as a core platform material.

Regional Analysis

North America holds a leading position in the global albumin market, supported by a robust biopharmaceutical industry and widespread clinical demand for albumin-based therapies. The region benefits from extensive adoption of albumin across hospital settings for volume resuscitation, shock treatment, and surgical support, especially in trauma care and critical care units. Additionally, advanced research infrastructure and biotech innovation hubs have expanded albumin’s use beyond traditional applications. Its incorporation in drug delivery systems, plasma fractionation, and emerging diagnostics reflects the region’s shift toward high-value therapeutic solutions. Regulatory clarity, strong reimbursement frameworks, and consistent clinical uptake reinforce North America’s dominance in the albumin landscape.

The U.S.remains the largest and most mature market for albumin, bolstered by a highly developed biopharmaceutical sector and a strong regulatory framework. Major players like CSL Behring and Grifols continue to expand their plasma collection networks across the U.S., aiming to increase domestic supply in light of rising demand. Furthermore, academic research institutions and CROs are ramping up preclinical studies utilising recombinant and serum albumin in drug formulation and delivery systems. The growing emphasis on plasma-derived therapies in rare disease management fuels market growth, especially in tertiary-care hospitals.

Canada’s albumin sector is steadily gaining momentum, underpinned by public healthcare spending and increasing adoption of albumin in critical care protocols. Canadian hospitals are increasingly adopting human albumin for surgical recovery, traumatic brain injury care, and oncological applications. Additionally, plasma fractionation initiatives supported by Canadian Blood Services are helping enhance domestic availability. Biotech firms in Montreal and Toronto also contribute to innovation in recombinant albumin for drug delivery applications. As reimbursement frameworks improve for biologics in Canada, stakeholders expect sustained growth in clinical demand and manufacturing capabilities.

Asia-Pacific Albumin Market Trends

Asia-Pacific is the fastest-growing region in the market, driven by rising healthcare access, expanding critical care infrastructure, and increasing plasma collection capacity. The area is witnessing heightened demand for albumin in surgical care, liver disorders, and burn treatments. Regional pharmaceutical companies are also investing in albumin-integrated drug formulations and biosimilar development, widening the scope of application. Alongside therapeutic usage, albumin is gaining traction in cell culture systems and protein drug stabilisation, supported by growing regional biotech investments. The expanding role of albumin in novel delivery systems, such as nanoparticle conjugates and sustained-release formulations, is further diversifying its applications.

China is witnessing rapid growth in its albumin market, driven by expanding healthcare access and government-led biopharma development strategies. Domestic producers like Hualan Biological and China Biologic Products Holdings are scaling up albumin production through plasma fractionation and recombinant technologies. Albumin use is expanding beyond traditional indications to include anti-ageing formulations in cosmetics and as a stabiliser in vaccine development. With the government investing heavily in plasma collection infrastructure and clinical trials, China's role in the global albumin supply chain is becoming increasingly significant.

India's albumin industry is expanding quickly, supported by a rise in critical care admissions and growing demand for protein-based therapeutics in hospitals. The pharmaceutical manufacturing sector, particularly in Hyderabad and Ahmedabad, is also driving demand for albumin as a stabilizer in drug formulation. Meanwhile, public-private partnerships invest in recombinant protein R&D, where albumin is key in enhancing drug solubility and bioavailability. The growing clinical trials ecosystem in India, supported by global sponsors, also enables accelerated research into albumin-based nanocarriers for oncology.

Europe Market Trends

Europe represents a steadily expanding market for albumin, backed by a well-structured blood plasma collection and fractionation network. Countries across the region maintain standardised clinical protocols for albumin use, especially in surgical procedures, liver diseases, and sepsis management. Regulatory alignment under centralised oversight ensures consistent product quality, while national health systems continue to prioritise albumin for critical care. In addition to therapeutic use, the region is increasingly exploring albumin’s role in biologics formulation and protein-bound drug delivery. Academic and industry-led collaborations further fuel innovation in recombinant albumin technologies, helping to balance sustainability concerns with rising clinical need.

Germany continues to lead Europe in albumin innovation, supported by a robust plasma fractionation industry and strong demand from hospitals and research institutions. Leading pharmaceutical firms such as Octapharma and Biotest are investing in advanced purification technologies and recombinant albumin platforms to reduce dependency on donor plasma. Germany’s academic labs, especially in Munich and Heidelberg, also explore novel uses of albumin in tissue engineering and personalised medicine. With the country’s healthcare system emphasising quality and sustainability, demand for high-purity, GMP-certified albumin continues to grow.

The UK’s market is shaped by healthcare modernisation efforts and increased use of plasma-derived products in the NHS. Research institutes like the University of Oxford are involved in projects exploring albumin-bound drug delivery systems, including those targeting brain and ocular diseases. British regulatory authorities also support the entry of biosimilar and recombinant albumin products to increase affordability. With the NHS prioritising efficient procurement of essential biologics, suppliers offering high-quality albumin with extended shelf life and traceable supply chains are gaining a competitive edge.

Product Type Insights

Human Serum Albumin (HSA) represents the most widely used product type in the albumin market, owing to its unmatched biocompatibility and clinical versatility. Extracted from donated human plasma, HSA plays a critical role in maintaining oncotic pressure and transporting hormones, fatty acids, and drugs throughout the bloodstream. Its application extends across diverse medical settings, from volume resuscitation during trauma and surgery to the stabilisation of patients with liver disease or burns. Pharmaceutical formulations using HSA often benefit from its high binding affinity and lack of immunogenicity, making it a reliable choice in both acute care and chronic treatment settings. Advances in purification techniques and pathogen inactivation have further reinforced its safety profile, positioning it as a gold standard in clinical albumin therapy.

Application Insights

Drug Delivery and Vaccine Stabilisation has emerged as the most dynamic application segment in the global market, driven by the molecule’s unique capacity to bind and transport a wide range of therapeutic compounds. Albumin’s long half-life and natural recycling through the neonatal Fc receptor (FcRn) pathway allow for extended circulation time of bound drugs, thereby enhancing therapeutic efficacy and reducing dosage frequency. This characteristic is especially valuable in developing next-generation biologics, cancer therapies, and gene delivery systems. Moreover, albumin’s structural integrity under varying pH and temperature conditions makes it an ideal excipient for vaccines, where it acts as a stabilizing agent that preserves antigen potency during formulation and storage.

Distribution Channel Insights

Hospital Pharmacies dominate the distribution landscape for albumin, driven by the need for secure, traceable, and compliant sourcing of this critical biological product. These pharmacies maintain direct relationships with manufacturers and authorised distributors, ensuring that albumin used in clinical procedures meets the highest standards for purity, sterility, and cold chain integrity. Hospital pharmacies often follow centralised procurement models, enabling them to manage inventory efficiently, reduce wastage, and negotiate pricing contracts for high-volume purchases. In addition to handling standard therapeutic formulations, hospital pharmacies also manage custom compounding and reconstitution of albumin for specialised use cases, such as pediatric dosing or drug conjugation.

End-User Insights

Hospitals and Clinics form the primary end-user group in the albumin market, owing to their central role in patient stabilisation and acute care procedures. Albumin is frequently administered in emergency rooms, operating theatres, and intensive care units where rapid volume expansion or colloidal support is needed for patients with hypovolemia, sepsis, or hypoalbuminemia. Healthcare providers rely on its rapid onset of action and predictable pharmacokinetics, especially critical in critical care and post-operative recovery. Beyond emergency interventions, hospitals also use albumin with antibiotics or chemotherapy agents to enhance their bioavailability, particularly in patients with compromised liver or kidney function.

Company Market Share

The global albumin market remains moderately consolidated, with a few key biopharmaceutical firms leading plasma-derived and recombinant albumin production. Companies are driven by their vertical integration, extensive plasma collection networks, and strong regulatory alignment. These companies dominate therapeutic, diagnostic, and biotechnological segments, offering albumin for critical care, drug delivery systems, and cell culture applications.

Grifols, S.A.: Grifols, S.A. is a global biopharmaceutical company headquartered in Barcelona, Spain, specialising in plasma-derived medicines such as albumin, immunoglobulins, and clotting factors. With a strong presence in the U.S. and over 23,000 employees, Grifols operates one of the largest plasma collection networks worldwide and focuses heavily on bioscience, diagnostics, and innovative drug delivery systems.

• In March 2025, Grifols acquired 14 U.S. plasma donation centers from Immunotek, effectively gaining full control of 28 centers previously operated jointly through Biotek America LLC. The transition to direct management was finalised on May 1, 2025, under its subsidiary Biomat Holdings LLC.

List of key players in Albumin Market

1. CSL Behring
2. Grifols S.A.
3. Takeda Pharmaceutical Company Limited
4. Octapharma AG
5. Merck KGaA
6. Baxter International Inc.
7. Kedrion Biopharma Inc.
8. HiMedia Laboratories Pvt. Ltd.
9. Thermo Fisher Scientific Inc.
10. Albumedix Ltd. (a part of Sartorius AG)
11. Recombinant Technologies Inc.
12. Mitsubishi Tanabe Pharma Corporation
13. InVitria (a division of Ventria Bioscience)

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Recent Developments

• March 2025- InVitria achieved a major milestone: Exbumin®, its plant-based recombinant human serum albumin (rHSA), received regulatory approval as an excipient in injectable therapeutics by both the FDA and EMA. Manufactured in a cGMP, ISO 9001:2015 certified facility in Kansas, Exbumin provides a chemically defined, animal- and blood-free alternative to plasma-derived albumin. Its ultra-low endotoxin levels and proven stability in vaccine and gene therapy formulations make it a critical enabler of scalable, safe biologics manufacturing.
• May 2025- CSL Behring significantly strengthened its position in the global albumin market by expanding its biotechnology manufacturing facility in Broadmeadows, Victoria, Australia. Backed by an AU$230 million investment and recognised with the 2025 ISPE Facility of the Year Award in the Pharma 4.0 category, the site is designed to process over 10 million litres of plasma annually.
• May 2025- Orion Corporation entered a strategic partnership with Shilpa Biocare, gaining exclusive distribution, marketing, and sales rights across Europe for Shilpa’s recombinant human albumin, produced via a non-human expression system. The collaboration includes milestone-based payments tied to regulatory and commercial progress. This deal enhances albumin availability in regulated hospital markets and supports the adoption of scalable, virus-free manufacturing of albumin for therapeutic applications.