알부민 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the albumin market size is expected to grow from USD 7.83 billion in 2025 to USD 8.43 billion in 2026 and is forecast to reach USD 12.19 billion by 2031 at 7.66% CAGR over 2026-2031.

This report is Segmented by Type (Human Serum Albumin, and More), Source (Plasma-Derived, Recombinant), Application (Drug Delivery, Therapeutics, and More), End-User (Pharmaceutical & Biotechnology Companies, Research Institutes & CROs, Hospitals & Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Albumin Market Trends and Insights

Growing Demand for Albumin-Based Stabilizers in Vaccine Manufacturing

Vaccine manufacturers are increasing the use of albumin stabilizers to protect antigens during lyophilization and distribution, which gained momentum when ERVEBO for Ebola, a live vaccine, incorporated rice-derived recombinant albumin in its formulation. This practice aligns with efforts to reduce cold-chain sensitivity and maintain stability for critical immunization programs serving high-risk populations. Recombinant albumin removes donor-derived pathogen risks, which is a core advantage for programs that support immunocompromised patients and regions with fragile logistics. China's significant albumin needs and the advancement of rice-derived recombinant human serum albumin through late-stage clinical trials are prompting greater attention to domestic supply options that bypass plasma sourcing constraints. Public-health agencies encourage the use of defined, animal-component-free excipients where feasible because they reduce variability and ease post-approval changes to regulated filings. This demand pattern supports a steady expansion of albumin use in vaccine stabilization as programs for viral-vector and protein-subunit platforms broaden their portfolios in the forecast window.

Expanding Use of Albumin as an Excipient in Biologic Drug Formulations

Albumin's role as a stabilizer and solubility enhancer in biologic formulations is expanding as developers focus on product integrity across manufacturing, storage, and administration. Subcutaneous and high-concentration injectable formats benefit from albumin's ability to reduce aggregation and oxidation, thereby helping maintain consistent performance throughout shelf life. Ophthalmology injectables, such as Lucentis, are examples in which excipient choices support durability in prefilled presentations that must withstand refrigerated storage without loss of activity. The regulatory track record of albumin in human use supports predictable filings, which shorten development timelines for specific formulations compared with newer excipients that lack extensive safety histories. Recombinant albumin's batch-to-batch consistency further reduces variability and documentation burden, which is essential for lifecycle management. As biologics programs focus on supply resilience and lean change-control workflows, albumin's position as a proven excipient is becoming more central across select high-value therapy classes.

Safety Concerns Around Pathogen Transmission from Plasma-Derived Albumin

Plasma-derived albumin carries a residual risk of pathogen transmission despite validated steps such as solvent-detergent treatment, pasteurization, and nanofiltration that reduce viral load. Donor screening and deferral criteria reduce risk, yet window periods for certain infections can still lead to recalls or added oversight in cases that demand investigation. The FDA maintains standards for blood and blood components in 21 CFR Part 640, which frames collection, processing, and testing requirements for the U.S. plasma supply. FDA's 2024 draft guidance on cattle-derived materials for human use underscores ongoing BSE risk management. It strengthens expectations for traceability and sourcing controls, which add cost and complexity when animal derivatives are used. These constraints motivate vaccine and biologics makers to consider recombinant albumin for patient safety and compliance reasons. As a result, plasma-based albumin retains demand in well-established care settings, while high-growth applications turn to animal-component-free options to mitigate risk.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Plasma-Fractionation Capacity in Asia-Pacific (China and India)
2. Uptake of Recombinant Albumin in Cell-Culture Media for Cultivated-Meat R&D
3. Rapid Shift Toward Chemically Defined, Protein-Free Media in Bioprocessing

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Human Serum Albumin accounted for 59.14% in 2025, reflecting its central role in volume expansion, burn care, and the management of hypoalbuminemia in clinical practice. These uses remain anchored in established protocols, where clinicians rely on known safety and reimbursement pathways to support steady utilization. Recombinant Albumin is set to grow at an 11.80% CAGR through 2031, driven by gains in vaccines, biologics formulations, and specialized cell-culture media, where batch consistency and pathogen-free sourcing are preferred. In this context, the albumin market is splitting between legacy therapeutic settings and advanced applications where supply predictability and defined excipients matter. Bovine Serum Albumin is seeing slower growth as chemically defined media replace protein supplements in mainstream monoclonal antibody manufacturing. However, it retains roles in diagnostics and lab protocols that are less sensitive to regulatory pressure to eliminate animal components. The evolution of type preferences is driving suppliers to align production with compliant, scalable routes that meet both clinical and non-clinical needs.

Plasma-derived albumin held 82.02% of the supply in 2025, supported by extensive U.S. collection networks and established fractionation hubs in North America and Europe. The United States supplies a large share of global plasma, which promotes domestic fractionation output and exports to import-dependent regions. Regulatory frameworks in the United States that allow frequent plasma donations help maintain capacity, while policy limits in parts of Europe and Asia constrain collection volumes and slow response to demand spikes. These constraints reinforce price swings for plasma-derived inputs and increase interest in dual sourcing strategies. Recombinant albumin from yeast, rice, and other expression platforms is projected to grow at a 10.65% CAGR from 2026 to 2031 as manufacturers seek to limit supply shocks and compliance complexity for tightly regulated applications.

Geography Analysis

North America captured 35.50% in 2025, supported by the United States' large plasma-collection footprint and established fractionation base that ensures a steady therapeutic albumin supply. The region's high-acuity care settings and mature reimbursement systems help sustain demand for infusions used in critical care, surgery, and emergency medicine. U.S. regulators set standards for blood and blood components that influence global practices, and these frameworks enable frequent plasma donations that support both domestic demand and exports. North America's research and biopharma ecosystems also contribute to growth in vaccine stabilization and drug-delivery reformulations that utilize albumin-based technologies. As a result, the albumin market in the region combines legacy therapeutic use with growing innovation-led demand.

Asia-Pacific is projected to grow at an 8.03% CAGR through 2031 as countries invest in plasma-protein infrastructure and encourage the development of recombinant routes for albumin supply. Domestic needs in China and India are central to regional growth, with initiatives to reduce import dependence and to bring more of the value chain onshore. Late-stage development of rice-derived recombinant human serum albumin in China adds a future source of supply that can support vaccines, excipients, and other regulated uses once approvals are secured. India's investments in fractionation capacity, such as ViNS Bioproducts' 2026 funding for PlasmaGen, reflect this goal of greater self-sufficiency in albumin and related plasma proteins. The albumin market in the region benefits from strong policy support, which should attract both plasma-derived and recombinant suppliers to scale capabilities in step with local demand.

1. Akron Biotechnology, LLC
2. Albumedix Ltd.
3. Albumin Therapeutics LLC
4. Baxter
5. Bio Products Laboratory
6. CSL Behring GmbH
7. Grifols SA (Biotest AG)
8. HiMedia Laboratories Pvt. Ltd.
9. Hualan Biological
10. Kedrion Biopharma
11. Medxbio Pte Ltd.
12. Merck
13. Novozymes A/S
14. Octapharma
15. Shanghai RAAS Blood Products Co., Ltd.
16. Takeda Pharmaceuticals
17. Thermo Fisher Scientific
18. Ventria Bioscience
19. ViruSure GmbH

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Growing Demand for Albumin-Based Stabilizers in Vaccine Manufacturing
  • 4.2.2 Expanding Use of Albumin as an Excipient in Biologic Drug Formulations
  • 4.2.3 Rising Plasma-Fractionation Capacity in Asia-Pacific (China & India)
  • 4.2.4 Uptake of Recombinant Albumin in Cell-Culture Media for Cultivated-Meat R&D
  • 4.2.5 Adoption of Albumin Nanoparticles in Next-Gen Targeted Drug-Delivery Platforms
  • 4.2.6 Regulatory Push for Safer Blood-Product Handling (EU MDR & U.S. CGMP Upgrades)
• 4.3 Market Restraints
  • 4.3.1 Safety Concerns Around Pathogen Transmission from Plasma-Derived Albumin
  • 4.3.2 Price Volatility Due To Plasma-Collection Bottlenecks
  • 4.3.3 Rapid Shift Toward Chemically Defined, Protein-Free Media in Bioprocessing
  • 4.3.4 Competition From Plant-Derived Albumin Mimetics in Food & Cosmetics
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porters Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers/Consumers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitute Products
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type
  • 5.1.1 Human Serum Albumin
  • 5.1.2 Bovine Serum Albumin
  • 5.1.3 Recombinant Albumin
• 5.2 By Source
  • 5.2.1 Plasma-derived
  • 5.2.2 Recombinant (Yeast, Rice, Transgenic Plants)
• 5.3 By Application
  • 5.3.1 Drug Delivery
  • 5.3.2 Therapeutics
  • 5.3.3 Culture-Media Ingredient
  • 5.3.4 Vaccine Ingredient
  • 5.3.5 Diagnostics
  • 5.3.6 Other Applications
• 5.4 By End-user
  • 5.4.1 Pharmaceutical & Biotechnology Companies
  • 5.4.2 Research Institutes & CROs
  • 5.4.3 Hospitals & Clinics
  • 5.4.4 Diagnostic Centers
  • 5.4.5 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Akron Biotechnology, LLC
  • 6.3.2 Albumedix Ltd.
  • 6.3.3 Albumin Therapeutics LLC
  • 6.3.4 Baxter International Inc.
  • 6.3.5 Bio Products Laboratory Limited
  • 6.3.6 CSL Behring GmbH
  • 6.3.7 Grifols SA (Biotest AG)
  • 6.3.8 HiMedia Laboratories Pvt. Ltd.
  • 6.3.9 Hualan Biological Engineering Inc.
  • 6.3.10 Kedrion Biopharma
  • 6.3.11 Medxbio Pte Ltd.
  • 6.3.12 Merck KGaA (Sigma-Aldrich)
  • 6.3.13 Novozymes A/S
  • 6.3.14 Octapharma AG
  • 6.3.15 Shanghai RAAS Blood Products Co., Ltd.
  • 6.3.16 Takeda Pharmaceutical Company Limited
  • 6.3.17 Thermo Fisher Scientific Inc.
  • 6.3.18 Ventria Bioscience Inc.
  • 6.3.19 ViruSure GmbH

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment