+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)
Sale

Biopharmaceutical Excipients Market - Global Forecast 2025-2032

  • PDF Icon

    Report

  • 191 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5337416
UP TO OFF until Jan 01st 2026
1h Free Analyst Time
1h Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

The biopharmaceutical excipients market is rapidly evolving as industry leaders work to address rising pressures related to compliance, quality, and supply chain complexity. Senior decision-makers must navigate new expectations around operational agility, transparency, and partnership in a sector where innovation and risk mitigation shape competitive advantage.

Market Snapshot: Biopharmaceutical Excipients Market Outlook

As the biopharmaceutical excipients market undergoes steady expansion, organizations are adapting their sourcing and development strategies to meet elevated industry standards. The primary drivers of progress include increased demand for excipients that improve drug safety, stability, and therapeutic delivery, especially in biologic formulations. Advances in formulation science, along with the introduction of next-generation delivery solutions, are prompting organizations to refine procurement practices and prioritize strategic alliances. With regulatory requirements becoming more stringent and a pronounced emphasis on quality throughout the value chain, businesses are moving away from legacy approaches to ensure sustainable growth and compliance.

Scope & Segmentation: Strategic Insights for Senior Decision-Makers in the Biopharmaceutical Excipients Market

This report delivers sector-focused intelligence for executives responsible for procurement, compliance, and R&D strategy across the biopharmaceutical excipients industry. It supports multinational operational alignment and identifies efficiencies throughout the entire value chain with comprehensive segmentation and targeted recommendations.

  • Product Types: Binders, coatings, diluents, disintegrants, lubricants, polyols, preservatives, solubilizers, surfactants, emulsifiers, suspending agents, and viscosity agents, each tailored to enable formulation innovations for both injectable and non-injectable platforms.
  • Binder Categories: Cellulosic binders, hydroxypropyl methylcellulose, povidone, starch, and modified starches address the consistently rising quality benchmarks for advanced biologics, ensuring ingredient uniformity and manufacturing reliability.
  • Coating Categories: Controlled release, enteric, film, seal, and sugar coatings provide flexibility to align drug release profiles with new and emerging therapy modalities, supporting precision in targeted drug delivery.
  • Diluent Types: Calcium phosphates, lactose, and microcrystalline cellulose deliver diverse production capabilities suitable for a wide array of dosage forms, further enhancing scalability and adaptability.
  • Polyol Types: Mannitol and sorbitol are selected for their capacity to enhance solubility and compatibility, facilitating successful formulation of future-directed therapies.
  • Solubilizers, Surfactants, Emulsifiers: Esters, polysorbates, and triglycerides optimize drug dissolution and lifecycle performance, supporting both process efficiency and patient outcomes.
  • Source Origin: Sourcing strategies balance natural and synthetic ingredients in response to sustainability initiatives and regulatory developments around raw material usage.
  • Formulation Types: Injectable, oral, and topical preparations each require distinct excipient profiles to meet shifting therapeutic tactics and regulatory requirements.
  • End Users: Target segments include biopharmaceutical firms, contract manufacturing and service providers, and research organizations focused on efficient, reliable sourcing, and manufacturing process improvement.
  • Geographic Regions: Analysis spans Americas, Europe, Middle East and Africa, and Asia-Pacific, with special attention to China, India, and Japan for detailed regional benchmarking and informed go-to-market planning.
  • Company Profiles: The report provides a comparative analysis 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 emerging regional innovators, delivering critical competitive context.

Key Takeaways for Senior Decision-Makers

  • Prioritizing strategic excipient selection streamlines biologic development and sustains competitive product pipelines.
  • Implementation of robust quality controls for impurity management and traceability enhances supplier qualification and brand reputation.
  • Embedding ethical sourcing and ESG criteria into decision-making fortifies stakeholder relationships and helps fulfill evolving compliance mandates.
  • Regional regulatory harmonization, particularly within Asia-Pacific markets, can create paths for simplified approval and cross-border scalability.
  • Leveraging digital platforms for compliance and advanced supply chain analytics strengthens risk management and ensures agility in adapting to regulatory changes.

Tariff Impact: Responding to US Policy Changes

Evolving US tariff policies are prompting companies to broaden supplier networks and investigate nearshoring to secure manufacturing operations. These measures are designed to boost manufacturing reliability, enable more responsive contract execution, and better protect against disruptions in the global trading landscape.

Methodology & Data Sources

Report recommendations are grounded in direct interviews with research, procurement, and quality professionals, alongside scrutiny of authoritative regulatory materials and industry case studies. This multifaceted approach ensures all insights reflect practical, sector-specific expertise.

Why This Report Matters

  • Integrates procurement, formulation, and compliance functions to heighten operational effectiveness across diverse organizational structures.
  • Provides comprehensive benchmarking tools for regulated biopharmaceutical settings, supporting sourcing optimization and market expansion strategies.
  • Equips senior leaders with up-to-date regulatory and technical perspectives to facilitate proactive adaptation as industry requirements shift.

Conclusion

Organizations that refine their strategies for agility, compliance, and cross-functional integration will be best equipped to keep pace with the evolving biopharmaceutical excipients market, ensuring long-term stability and operational excellence.

 

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