생물제제 부형제 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the biologic excipients market size is projected to expand from USD 5.30 billion in 2025 and USD 5.70 billion in 2026 to USD 8.70 billion by 2031, registering a CAGR of 8.61% between 2026 to 2031.

This report is Segmented by Product Category (Solubilizers & Surfactants, Carbohydrates, and More), Dosage Form (Parenteral, Lyophilized, and More), Therapeutic Modality (Monoclonal Antibodies, Vaccines, Cell & Gene Therapies, and More), End User (Biopharma, CMOs/CDMOs, and More), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Biologic Excipients Market Trends and Insights

Biologics Pipeline Expansion and Approvals Accelerate Demand for Injectable-Grade Excipients

Global regulators cleared 55 novel drugs in 2024, and biologics accounted for a significant share of them. Each biologic typically employs four-to-eight discrete excipients, so every approval magnifies consumption of buffers, stabilizers, surfactants, and tonicity agents. The subcutaneous share of monoclonal antibody launches now has a significant share in the market, which pushes purity specifications even tighter to avoid local reactions. EMA cleared 12 biosimilars in 2025, obliging each developer to match or justify every excipient choice, thereby multiplying demand for injectable-grade ingredients. Innovators and biosimilar manufacturers consequently compete for the same finite pool of ultra-pure stabilizers.

Dominance of Parenteral Routes Increases Need for High-Purity Stabilizers, Buffers, and Surfactants

Parenteral products impose endotoxin limits of ≤ 0.5 EU / mg and elemental impurity controls under ICH Q3D. USP tightened particulate limits for prefilled syringes in 2024, compelling suppliers to adopt cleanroom packaging. High-concentration monoclonal antibody formats rely on arginine hydrochloride or proline at 50-200 mM to suppress viscosity. Croda's 2025 "Super Refined" polysorbate 80, with peroxide below 5 ppm, illustrates the pivot toward engineered excipients that address oxidation in dense protein solutions.

Lack of Independent Global Excipient Approval Pathways Delays Novel Excipient Uptake

Because excipients are approved within each drug dossier, suppliers must piggyback on biopharma partners, creating a circular risk that stalls innovation. The FDA's database lists only 42 excipients permitted for parenteral biologics, unchanged since 2022. Emerging economies also impose local studies, adding up to 18 months, and discouraging smaller innovators.

Other drivers and restraints analyzed in the detailed report include:

1. Monoclonal Antibodies and High-Concentration Formulations Require Viscosity-Reducing / Stabilizing Excipients
2. APAC Biomanufacturing and CDMO Expansion Boosts Excipient Consumption
3. High Cost and Supply Complexity for Parenteral-Grade Excipients vs Oral Grades

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

Segment Analysis

Polymers commanded 41.68% of 2025 revenue within the biologic excipients market size, anchored by PEG and HPMC for sustained-release syringes. Specialty and co-processed grades, however, are on track for an 8.80% CAGR, benefiting suppliers that combine buffering and viscosity control in one particle. Roquette's mannitol-sucrose blend trims lyophilization cycles by 20%, demonstrating why formulators are migrating from single-function fillers to engineered composites. Carbohydrates such as trehalose safeguard protein tertiary structure during freeze-dry, while amino acids like arginine hydrochloride now appear in the majority of subcutaneous mAb recipes.

Surfactant demand remains dominated by polysorbate 20 and 80, yet oxidation has accelerated the search for poloxamers and recombinant albumin. Inorganic salts preserve tonicity, with phosphate still preferred for mAbs. The biologic excipients market continues to reward suppliers that document ultra-low endotoxin and peroxide profiles, a trend likely to cement premium-tier pricing over the forecast window.

Parenteral formats delivered 58.93% of 2025 revenue and are projected to hold the biologic excipients market share lead through 2031 as oral bioavailability hurdles persist. Lyophilized vials are the fastest-growing sub-segment because they extend shelf life and can eliminate cold-chain logistics; a trastuzumab biosimilar approved in 2024 validated room-temperature storage for 36 months. High-purity sugars and bulking polyols are essential for these freeze-dry cycles, keeping excipient demand strong even as equipment costs remain high.

Oral peptides such as oral semaglutide showcase gradual diversification, but volumes are dwarfed by injectables. Topical biologics stay niche. Consequently, suppliers continue to expand cleanroom capacity for injectable-grade buffers, reinforcing a virtuous cycle in which parenteral requirements dictate quality benchmarks for the wider biologic excipients market.

Geography Analysis

North America contributed 43.87% of 2025 revenue, buoyed by FDA guidance that cut excipient qualification timelines by two years. Twelve of the world's 20 largest biologic producers call the United States home, and their 2025 formulation R&D outlays exceeded USD 8 billion. Canada's CAD 2.2 billion biomanufacturing plan funds three new plants that will absorb polysorbate and trehalose once operational. Mexican near-shoring adds further pull, exemplified by Pfizer's USD 500 million Toluca syringe line expanded in 2025.

Europe is projected to log the fastest regional CAGR at 8.78% through 2031. German CDMOs have added 180,000 L since 2024, and France's EUR 1 billion Sanofi upgrade embeds dedicated suites for high-concentration mAbs. The MHRA's 2025 realignment with EMA standards restored regulatory clarity in the United Kingdom. Italy and Spain are emerging low-cost hubs that nevertheless meet EU monograph requirements, attracting biosimilar contracts.

Asia-Pacific saw USD 6.8 billion in 2024-2025 capacity investments, pushing local biologic output above 2 million L. China's Wuxi and Henlius sites, India's biosimilar expansions, and South Korea's Samsung Biologics mega-plant collectively tighten the loop between formulation labs and excipient suppliers. Japan's NOF Corporation now supplies injectable polysorbate domestically, trimming lead times to four weeks. Australia and ASEAN markets remain smaller but benefit from harmonized TGA and EMA excipient rules.

The Middle East and Africa segment is nascent but strategic. Saudi Arabia aims to cover nearly one third of its pharmaceutical needs locally by 2030, and South Africa's Biovac Institute is retrofitting capacity for mRNA vaccines. South America's activity centers on Brazil's USD 300 million Rio facility and Argentina's mAbxience expansion, both of which will depend on regional trehalose and buffer imports until local purification capacity matures.

1. Actylis
2. Ashland
3. Avantor
4. BASF
5. BioSpectra
6. Clariant
7. Colorcon
8. Croda International
9. DFE Pharma
10. Dow
11. Evonik Industries
12. Gattefosse
13. InVitria
14. JRS Pharma
15. Kerry Group
16. Kirsch Pharma
17. Lubrizol Life Science
18. MEGGLE
19. Merck
20. NOF Corporation
21. Pfanstiehl
22. Roquette Freres
23. Spectrum Chemical
24. Wacker Chemie

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 Biologics Pipeline Expansion and Approvals Accelerate Demand For Injectable-Grade Excipients
  • 4.2.2 Dominance Of Parenteral Routes Increases Need for High-Purity Stabilizers, Buffers, Surfactants
  • 4.2.3 Monoclonal Antibodies and High-Concentration Formulations Require Viscosity-Reducing/Stabilizing Excipients
  • 4.2.4 APAC Biomanufacturing And CDMO Expansion Boosts Excipient Consumption
  • 4.2.5 FDA/USP Initiatives Lower Uncertainty for Novel Excipients Adoption In Biologics
  • 4.2.6 Shift To Ultra-Pure/Engineered Excipients (E.G., Super-Refined Surfactants, Chelators) To Mitigate Degradation
• 4.3 Market Restraints
  • 4.3.1 Lack of Independent Global Excipient Approval Pathways Delays Novel Excipient Uptake
  • 4.3.2 High Cost and Supply Complexity for Parenteral-Grade Excipients Vs Oral Grades
  • 4.3.3 Stringent Endotoxin/Elemental Impurity Controls Complicate Supplier Changes and Documentation
  • 4.3.4 Polysorbate Degradation Risks (Oxidation/Enzymatic) Raise QC Burden And Reformulation Cycles
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Category
  • 5.1.1 Solubilizers & Surfactants/Emulsifiers
  • 5.1.2 Carbohydrates (Sugars)
  • 5.1.3 Polyols
  • 5.1.4 Polymers
  • 5.1.5 Amino Acids
  • 5.1.6 Inorganic Salts
  • 5.1.7 Specialty / Co-processed Excipients
  • 5.1.8 Others
• 5.2 By Dosage Form
  • 5.2.1 Parenteral (Injectables)
  • 5.2.2 Lyophilized (Freeze-dried)
  • 5.2.3 Oral
  • 5.2.4 Topical
• 5.3 By Therapeutic Modality
  • 5.3.1 Monoclonal Antibodies
  • 5.3.2 Vaccines
  • 5.3.3 Cell & Gene Therapies (incl. mRNA)
  • 5.3.4 Recombinant Proteins/Enzymes
  • 5.3.5 Insulins & Analogs
  • 5.3.6 ADCs & Long-acting Injectables
• 5.4 By End User
  • 5.4.1 Biopharma & Biotech Companies (Drug Developers)
  • 5.4.2 CMOs/CDMOs
  • 5.4.3 Academic/Research & 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 South Korea
    • 5.5.3.5 Australia
    • 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 as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 Actylis
  • 6.3.2 Ashland
  • 6.3.3 Avantor
  • 6.3.4 BASF SE
  • 6.3.5 BioSpectra
  • 6.3.6 Clariant
  • 6.3.7 Colorcon
  • 6.3.8 Croda International
  • 6.3.9 DFE Pharma
  • 6.3.10 Dow
  • 6.3.11 Evonik Industries
  • 6.3.12 Gattefosse
  • 6.3.13 InVitria
  • 6.3.14 JRS Pharma
  • 6.3.15 Kerry Group
  • 6.3.16 Kirsch Pharma
  • 6.3.17 Lubrizol Life Science
  • 6.3.18 MEGGLE
  • 6.3.19 Merck KGaA
  • 6.3.20 NOF Corporation
  • 6.3.21 Pfanstiehl
  • 6.3.22 Roquette Freres
  • 6.3.23 Spectrum Chemical
  • 6.3.24 Wacker Chemie

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment