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Biopharmaceutical Excipients Market - Global Forecast 2025-2032

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    Report

  • 191 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5337416
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The biopharmaceutical excipients market is experiencing significant transformation as industry leaders navigate evolving regulatory requirements, technological advancements, and increasingly complex global supply chains. Senior decision-makers are focused on optimizing operational models, maintaining strict compliance, and fostering quality-driven innovation.

Market Snapshot: Biopharmaceutical Excipients Market Growth and Outlook

The biopharmaceutical excipients market is projected to grow from USD 3.61 billion in 2024 to USD 3.96 billion in 2025, reflecting a 9.94% compound annual growth rate. Market forecasts indicate an expansion to USD 7.72 billion by 2032. This trajectory underscores robust demand for excipients that enhance the safety, stability, and efficacy of biologic therapies. Industry momentum in biologic drug development, supported by advances in drug delivery technologies, drives organizations to refine compliance programs, improve sourcing strategies, and strengthen collaboration to keep pace with international regulatory expectations. Companies are responding dynamically to increased technical and quality demands, shaping a more competitive and resilient landscape.

Scope & Segmentation in the Biopharmaceutical Excipients Market

This analysis gives executives a comprehensive view of the market’s principal segments, operating factors, and industry trends, facilitating strategic planning across procurement, R&D, and regulatory teams. The report covers the following segments:

  • Product Types: Binders, coatings, diluents, disintegrants, lubricants, polyols, preservatives, solubilizers, surfactants, emulsifiers, suspending agents, and viscosity agents, which are integral for injectable, oral, and topical drugs.
  • Binder Categories: Cellulosic binders, hydroxypropyl methylcellulose (HPMC), povidone (PVP), starch, and modified starches enabling consistent manufacturing results.
  • Coating Categories: Controlled release, enteric, film, seal, and sugar coatings, all designed to protect dosage forms and affect drug delivery characteristics.
  • Diluent Types: Calcium phosphates, lactose, and microcrystalline cellulose, supporting formulation development for diverse dosage forms.
  • Polyol Types: Mannitol and sorbitol, offering enhanced solubility and compatibility with novel pharmaceutical formulations.
  • Solubilizers, Surfactants, Emulsifiers: Esters, polysorbates, and triglycerides that provide improved dissolution and performance in contemporary drug products.
  • Source Origin: Natural and synthetic excipients, with a growing emphasis on sustainable sourcing and enhanced regulatory oversight across supply chains.
  • Formulation Types: Injectable, oral, and topical forms, tailored to meet a broad range of clinical and manufacturing requirements.
  • End Users: Operational and procurement priorities for biopharmaceutical companies, manufacturers, contract service providers, and research organizations.
  • Geographic Regions: Analysis across the Americas, Europe, Middle East and Africa, and Asia-Pacific, with targeted insight on China, India, and Japan.
  • Company Profiles: Evaluation of major players such as BASF SE, The Dow Chemical Company, ABITEC Corporation, Ashland Inc., Avantor, Merck KGaA, Roquette Frères S.A., Shin-Etsu Chemical Co., The Lubrizol Corporation, and selected regional competitors.

Key Takeaways for Senior Decision-Makers

  • Choosing optimal excipients ensures smoother product commercialization pathways and accelerates access to innovative biologic therapies.
  • Increasing regulatory emphasis on impurity profiles and material traceability intensifies the need for stringent quality management and supplier evaluation.
  • Procurement functions are prioritizing ethical sourcing practices, aligning with environmental and social governance goals to build trust with stakeholders and meet sustainability benchmarks.
  • Collaboration with international and regional regulators fosters standardization in production processes and technical compliance, especially within the Asia-Pacific region.
  • Greater adoption of digital compliance and process automation tools enables executives to address emerging risks and adapt to regulatory shifts quickly.

Tariff Impact: Managing US Policy Shifts

Recent changes in US tariff policy have led organizations to diversify supply chains and consider nearshoring alternatives. These adjustments are driving investments in domestic manufacturing and contract management to mitigate uncertainties associated with evolving trade and tariff environments, ensuring operational continuity.

Methodology & Data Sources

This report is informed by structured interviews with senior professionals in R&D, procurement, and quality management, supported by a review of current regulatory updates, industry publications, and in-depth case studies. The multi-source methodology strengthens the reliability of findings for executive decisions in excipient selection and strategy.

Why This Report Matters

  • Aligns strategy across procurement, compliance, and formulation teams, helping reduce risk and streamline processes in biopharmaceutical development.
  • Offers clear benchmarks and supplier analyses for confident decision-making in regulated markets.
  • Delivers technical and regulatory insight, supporting agile, evidence-based planning amid global market complexity.

Conclusion

Evolving regulatory demands and complex global networks continue to shape the biopharmaceutical excipients market. Leaders leveraging integrated, flexible strategies are better positioned to drive sustainable growth and resilience in this vital sector.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of digital twin technologies for predictive excipient performance optimization
5.2. Shift toward sustainable and biodegradable excipients in biopharmaceutical production
5.3. Increasing adoption of high-purity, animal-free excipients for next-gen biologics manufacturing
5.4. Rising demand for tailored excipient formulations in mRNA-based vaccine development
5.5. Regulatory harmonization efforts driving standardized excipient qualification globally
5.6. Growing collaborations between excipient suppliers and biotech firms for novel delivery systems
5.7. Scaling up cGMP manufacturing capabilities to meet surging biologic excipient requirements
5.8. Supply chain diversification strategies enhancing resilience in excipient sourcing post pandemic
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Biopharmaceutical Excipients Market, by Product
8.1. Binders
8.1.1. Cellulosic Binders
8.1.2. Hydroxypropyl Methylcellulose (HPMC)
8.1.3. Povidone (Polyvinylpyrrolidone or PVP)
8.1.4. Starch & Modified Starches
8.2. Coatings
8.2.1. Controlled Release Coatings
8.2.2. Enteric Coatings
8.2.3. Film Coatings
8.2.4. Seal Coatings
8.2.5. Sugar Coatings
8.3. Diluents
8.3.1. Calcium Phosphates
8.3.2. Lactose
8.3.3. Microcrystalline Cellulose
8.4. Disintegrants
8.5. Lubricants & Glidants
8.6. Polyols
8.6.1. Mannitol
8.6.2. Sorbitol
8.7. Preservatives
8.8. Solubilizers & Surfactants/Emulsifiers
8.8.1. Esters
8.8.2. Polysorbates
8.8.3. Triglycerides
8.9. Suspending & Viscosity Agents
9. Biopharmaceutical Excipients Market, by Source
9.1. Natural Excipients
9.2. Synthetic Excipients
10. Biopharmaceutical Excipients Market, by Formulation Type
10.1. Injectable Formulations
10.1.1. Intramuscular
10.1.2. Intravenous
10.1.3. Subcutaneous
10.2. Oral Formulations
10.2.1. Capsules
10.2.2. Powders
10.2.3. Tablets
10.3. Topical Formulations
10.3.1. Creams
10.3.2. Gels & Ointments
10.3.3. Lotions
11. Biopharmaceutical Excipients Market, by End User
11.1. Biopharmaceutical & Pharmaceutical Companies
11.2. Contract Manufacturers
11.3. Research Institutes
12. Biopharmaceutical Excipients Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Biopharmaceutical Excipients Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Biopharmaceutical Excipients Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. BASF SE
15.3.2. The Dow Chemical Company
15.3.3. ABITEC Corporation
15.3.4. Asahi Kasei Corporation
15.3.5. Actylis
15.3.6. Ashland Inc.
15.3.7. Avantor, Inc.
15.3.8. Clariant International Ltd.
15.3.9. Colorcon Ltd.
15.3.10. Croda International PLC
15.3.11. DFE Pharma GmbH & Co KG
15.3.12. Eastman Chemical Company
15.3.13. Evonik Industries AG
15.3.14. Fuji Chemical Industries Co., Ltd.
15.3.15. IMCD N.V.
15.3.16. Innophos Holdings, Inc.
15.3.17. International Flavors & Fragrances Inc.
15.3.18. JRS PHARMA GmbH + Co. KG
15.3.19. Kerry Group PLC
15.3.20. Meggle Group GmbH
15.3.21. Merck KGaA
15.3.22. Mitsubishi Chemical Group Corporation
15.3.23. NOF Corporation
15.3.24. Novo Nordisk A/S
15.3.25. Pfanstiehl, Inc.
15.3.26. Roquette Frères S.A.
15.3.27. Shin-Etsu Chemical Co., Ltd.
15.3.28. Sigachi Industries Limited
15.3.29. Spectrum Laboratory Products, Inc.
15.3.30. SPI Pharma, Inc. By Associated British Foods
15.3.31. The Archer-Daniels-Midland Company
15.3.32. The Lubrizol Corporation
15.3.33. Wacker Chemie AG

Companies Mentioned

The companies profiled in this Biopharmaceutical Excipients market report include:
  • BASF SE
  • The Dow Chemical Company
  • ABITEC Corporation
  • Asahi Kasei Corporation
  • Actylis
  • Ashland Inc.
  • Avantor, Inc.
  • Clariant International Ltd.
  • Colorcon Ltd.
  • Croda International PLC
  • DFE Pharma GmbH & Co KG
  • Eastman Chemical Company
  • Evonik Industries AG
  • Fuji Chemical Industries Co., Ltd.
  • IMCD N.V.
  • Innophos Holdings, Inc.
  • International Flavors & Fragrances Inc.
  • JRS PHARMA GmbH + Co. KG
  • Kerry Group PLC
  • Meggle Group GmbH
  • Merck KGaA
  • Mitsubishi Chemical Group Corporation
  • NOF Corporation
  • Novo Nordisk A/S
  • Pfanstiehl, Inc.
  • Roquette Frères S.A.
  • Shin-Etsu Chemical Co., Ltd.
  • Sigachi Industries Limited
  • Spectrum Laboratory Products, Inc.
  • SPI Pharma, Inc. By Associated British Foods
  • The Archer-Daniels-Midland Company
  • The Lubrizol Corporation
  • Wacker Chemie AG

Table Information