세계의 의약품 첨가제 시장 : 유형, 제제, 기능, 최종사용자별 - 예측(2025-2030년)

The Pharmaceutical Excipient Market was valued at USD 8.62 billion in 2023 and is projected to grow to USD 9.22 billion in 2024, with a CAGR of 7.62%, reaching USD 14.42 billion by 2030.

The pharmaceutical excipient market has evolved into a dynamic and multifaceted ecosystem, reflecting a keen balance between innovation, regulatory compliance, and cost-effective production. In today's competitive landscape, excipients are not mere additives; they are essential agents that impact the efficacy, stability, and overall quality of pharmaceutical formulations. Over the past decade, advancements in material science, a deeper understanding of active pharmaceutical ingredients (API) interactions, and a steady demand for tailored drug delivery systems have spurred robust growth and diversification within the excipient arena.

Manufacturers and researchers alike are leaning into sophisticated processes and quality benchmarks that push beyond the traditional roles of excipients. This development comes at the intersection of technological progress, rigorous standardization protocols, and an increasing emphasis on sustainability. As the market evolves, companies are now tasked with balancing innovation and conforming to strict regulatory controls, ensuring that the end products are both safe and effective. This introduction sets the stage for a comprehensive deep-dive into the trends, segmentation strategies, regional developments, and key company highlights that are defining the current state of the pharmaceutical excipient industry.

Transformative Shifts in the Pharmaceutical Excipient Landscape

The pharmaceutical excipient market is undergoing transformative shifts that are reshaping industry dynamics and redefining best practices. Rapid advancements in biotechnological research coupled with evolving patient-focused demands have catalyzed an environment where excipients are now expected to perform multiple functions beyond their original purpose. Enhanced focus on patient-centric formulations has driven the need for excipients that offer better bioavailability, controlled release properties, and minimized adverse reactions.

Technological breakthroughs in formulation science are enabling manufacturers to blend traditional excipients with novel materials, yielding products that are more adaptable across diverse therapeutic areas. Furthermore, the regulatory environment has become more stringent; agencies worldwide are rigorously enforcing quality and safety benchmarks that make excipient selection a critical component of the development process. This push for higher standards compels manufacturers to innovate continuously and invest in research and development initiatives.

Market players are also experiencing disruptive shifts driven by globalization, where cross-border partnerships and strategic alliances facilitate knowledge exchange and bolster supply chains. With these trends in mind, the market landscape is evolving at a pace that demands immediate attention, strategic partnerships, and agile decision-making processes to harness emerging opportunities.

Key Segmentation Insights Driving Market Nuances

Market segmentation in the pharmaceutical excipient space provides a granular overview of the diverse product offerings and their multiple applications. The segmentation based on type distinguishes between inorganic and organic categories. Inorganic excipients are analyzed further into varieties such as calcium carbonate, calcium phosphate, calcium sulfate, halites, and metal oxides, each with its own set of unique properties that cater to specific formulation needs. Conversely, the organic category is divided into carbohydrates, oleochemicals, petrochemicals, and proteins, demonstrating the importance of both naturally derived and synthetically engineered materials. Carbohydrates are particularly scrutinized in terms of cellulose, starch, and sugars, which play critical roles in binding and stability, while oleochemicals are examined via fatty alcohols, glycerin, and mineral stearates to highlight their multifaceted roles in emulsion stability and lubricity. Additionally, within the petrochemicals category, factors such as acrylic polymers, glycols, mineral hydrocarbons, and povidones are assessed for their unique capabilities in enhancing product performance. Glycols, another distinct sub-segment, are meticulously analyzed across butylene glycol, diethylene glycol, ethylene glycol, hexylene glycol, macrogol, microglycol, and propylene glycol, illustrating the fine distinctions that guide formulation choices.

Beyond product type, segmentation based on formulation further refines market analysis through the lens of oral, parenteral, and topical formulations. Oral formulations are sub-divided into hard gelatin capsules, liquid formulations, soft gelatin capsules, and tablets, each differentiating the end-use based on delivery efficiency and patient compliance. Functional segmentation adds an extra layer of depth by classifying excipients as binders, coating agents, colorants, disintegrants, emulsifying agents, fillers and diluents, flavoring agents and sweeteners, lubricants and glidants, preservatives, and suspending and viscosity agents. This categorization helps understand how different functionalities drive formulation efficiency and final product performance. Finally, segmentation based on end-user-covering biopharmaceutical companies, contract manufacturing organizations, pharmaceutical companies, and research laboratories-provides valuable insights into who is driving demand, ultimately influencing product design, quality control measures, and market deployment strategies.

Based on Type, market is studied across Inorganic and Organic. The Inorganic is further studied across Calcium Carbonate, Calcium Phosphate, Calcium Sulfate, Halites, and Metal Oxides. The Organic is further studied across Carbohydrates, Oleochemicals, Petrochemicals, and Proteins. The Carbohydrates is further studied across Cellulose, Starch, and Sugars. The Oleochemicals is further studied across Fatty Alcohols, Glycerin, and Mineral Stearates. The Petrochemicals is further studied across Acrylic Polymers, Glycols, Mineral Hydrocarbons, and Povidones. The Glycols is further studied across Butylene Glycol, Diethylene Glycol, Ethylene Glycol, Hexylene Glycol, Macrogol, Microglycol, and Propylene Glycol.

Based on Formulation, market is studied across Oral Formulations, Parenteral Formulations, and Topical Formulations. The Oral Formulations is further studied across Hard Gelatin Capsules, Liquid Formulations, Soft Gelatin Capsules, and Tablets.

Based on Function, market is studied across Binders, Coating Agents, Colorants, Disintegrants, Emulsifying Agents, Fillers & Diluents, Flavoring Agents & Sweeteners, Lubricants & Glidants, Preservatives, and Suspending & Viscosity Agents.

Based on End-User, market is studied across Biopharmaceutical Companies, Contract Manufacturing Organizations, Pharmaceutical Companies, and Research Laboratories.

Key Regional Insights Shaping Market Growth

Regional dynamics play a significant role in shaping the trends and growth drivers of the pharmaceutical excipient market. In the Americas, there is a pronounced focus on innovative drug delivery systems and the enhancement of existing formulations, making it a fertile ground for breakthrough advancements. Meanwhile, the Europe, Middle East & Africa region is characterized by its stringent regulatory framework and emphasis on quality control, which has compelled manufacturers to adopt state-of-the-art production and quality assurance practices. In Asia-Pacific, rapid industrialization combined with an expanding healthcare infrastructure creates a vibrant market fueled by both domestic and international investments.

Each of these regions presents unique challenges and opportunities. For instance, while the Americas benefit from a robust network of research institutions that continuously drive innovation, the Europe, Middle East & Africa segment highlights a commitment to meeting both consumer safety and regulatory standards. Asia-Pacific, on the other hand, is positioned as a crucial hub for scaling production and enabling cost efficiencies. This regional analysis underscores the importance of tailored strategies for each geographical area, ensuring that market participants can effectively align their offerings with specific regional demands and regulatory stipulations.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key Companies Insights in the Pharmaceutical Excipient Sphere

The market is dominated by a robust array of key players, each contributing to the innovation and advancement of pharmaceutical excipients. Notable companies such as ABITEC Corporation, Actylis, and Archer Daniels Midland Company leverage deep industry knowledge and extensive research capabilities to drive product enhancements. Industry leaders like ARMOR PROTEINES S.A.S. by Savencia Group and Asahi Kasei Corporation continue to set benchmarks in quality and regulatory compliance, while Ashland Inc. and BASF SE are recognized for their extensive portfolios and diversified market presence.

Further, key entities such as BIOGRUND GmbH, Chemische Fabrik Budenheim KG by Geschwister Oetker Beteiligungen KG, and Clariant AG have undertaken significant research investments to ensure that their excipients meet the evolving demands of modern drug formulations. Companies including Colorcon Inc., Corel Pharma Chem Private Limited, and Croda International Plc are continuously exploring innovative applications and derivatives to expand their market influence. The competitive landscape is further enriched by Darling Ingredients, Inc., DFE Pharma GmbH & Co KG by Royal FrieslandCampina N.V., and DuPont de Nemours, Inc., whose presence underscores the convergence of scientific excellence and market-driven insights. With additional contributions from Evonik Industries AG, Fuji Chemical Industries Co., Ltd., and GATTEFOSSE SAS among others, the market landscape is defined by a blend of legacy expertise and forward-thinking innovation. This powerful collective of market players is pivotal in steering industry trends and forging collaborations that enhance overall market resilience.

The report delves into recent significant developments in the Pharmaceutical Excipient Market, highlighting leading vendors and their innovative profiles. These include ABITEC Corporation, Actylis, Archer Daniels Midland Company, ARMOR PROTEINES S.A.S. by Savencia Group, Asahi Kasei Corporation, Ashland Inc., BASF SE, BIOGRUND GmbH, Chemische Fabrik Budenheim KG by Geschwister Oetker Beteiligungen KG, Clariant AG, Colorcon Inc., Corel Pharma Chem Private Limited, Croda International Plc, Darling Ingredients, Inc., DFE Pharma GmbH & Co KG by Royal FrieslandCampina N.V., DuPont de Nemours, Inc., Evonik Industries AG, Fuji Chemical Industries Co., Ltd., GATTEFOSSE SAS, Innophos Holdings, Inc. by Iris Parent LLC, International Flavors & Fragrances Inc., JRS PHARMA GmbH + Co. KG, Kerry Group P.L.C., Lipoid GmbH, Lubrizol Corporation, L'AIR LIQUIDE S.A., Mallinckrodt plc, MEGGLE GmbH & Co. KG, Merck KGaA, Nagase & Co., Ltd., Nipon Soda Co., Ltd., NOF Corporation, Omya International AG, Peter Greven GmbH & Co. KG, Roquette Freres S.A., Shin-Etsu Chemical Co., Ltd., Solvay S.A., SPI Pharma, Inc., Sumitomo Seika Chemicals Company, Limited, Thermo Fisher Scientific Inc., and Vanderbilt Minerals LLC. Actionable Recommendations for Industry Leaders

Industry leaders are advised to invest in R&D and embrace innovative formulation technologies to create multifunctional excipients that cater to evolving therapeutic needs. Continuous monitoring of regulatory changes is crucial, and strategies should incorporate agile quality control processes. Companies must explore strategic partnerships to leverage geographic advantages and cost-effective metabolic innovations, while focusing on sustainability initiatives that align with stringent environmental practices. Emphasizing consumer-centric research and adopting digital solutions for real-time quality analytics can offer competitive advantages in a rapidly evolving marketplace.

Conclusion on Emerging Trends and Long-term Prospects

In conclusion, the pharmaceutical excipient market is poised for significant transformation, driven by innovation, enhanced segmentation strategies, and a rigorous regulatory environment. Market players who successfully integrate research innovation with operational agility will be best positioned to capture emerging opportunities and secure long-term growth. The evolving landscape underscores the importance of strategic alignment, continuous investment, and a keen understanding of regional and functional market drivers.

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

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Rising incidence of cancer and other chronic and infectious diseases worldwide
    • 5.1.1.2. Growth of the pharmaceuticals industry coupled with significant need for generics & orphan drugs
    • 5.1.1.3. Significant emphasis on the production of multifunctional excipients
  • 5.1.2. Restraints
    • 5.1.2.1. High cost associated with the production of advanced excipient
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological advancements in nanotechnology for excipients
    • 5.1.3.2. Ongoing research and development of excipients with numerous properties (Biobased)
  • 5.1.4. Challenges
    • 5.1.4.1. Increasing regulatory stringency and issues regarding the compatibility of excipients
• 5.2. Market Segmentation Analysis
  • 5.2.1. Type: Increasing utilization of organic excipients in oral solid dose formulations
  • 5.2.2. Formulation: Rising popularity of gelatin-based shell for ease of swallowing
  • 5.2.3. Function: Expanding utilization of binders in tablet formulations to provide physical and chemical protection
  • 5.2.4. End-User: Rising need for excipients in biopharmaceutical companies to support the novel drug delivery systems
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Pharmaceutical Excipient Market, by Type

• 6.1. Introduction
• 6.2. Inorganic
  • 6.2.1. Calcium Carbonate
  • 6.2.2. Calcium Phosphate
  • 6.2.3. Calcium Sulfate
  • 6.2.4. Halites
  • 6.2.5. Metal Oxides
• 6.3. Organic
  • 6.3.1. Carbohydrates
    • 6.3.1.1. Cellulose
    • 6.3.1.2. Starch
    • 6.3.1.3. Sugars
  • 6.3.2. Oleochemicals
    • 6.3.2.1. Fatty Alcohols
    • 6.3.2.2. Glycerin
    • 6.3.2.3. Mineral Stearates
  • 6.3.3. Petrochemicals
    • 6.3.3.1. Acrylic Polymers
    • 6.3.3.2. Glycols
    • 6.3.3.2.1. Butylene Glycol
    • 6.3.3.2.2. Diethylene Glycol
    • 6.3.3.2.3. Ethylene Glycol
    • 6.3.3.2.4. Hexylene Glycol
    • 6.3.3.2.5. Macrogol
    • 6.3.3.2.6. Microglycol
    • 6.3.3.2.7. Propylene Glycol
    • 6.3.3.3. Mineral Hydrocarbons
    • 6.3.3.4. Povidones
  • 6.3.4. Proteins

7. Pharmaceutical Excipient Market, by Formulation

• 7.1. Introduction
• 7.2. Oral Formulations
  • 7.2.1. Hard Gelatin Capsules
  • 7.2.2. Liquid Formulations
  • 7.2.3. Soft Gelatin Capsules
  • 7.2.4. Tablets
• 7.3. Parenteral Formulations
• 7.4. Topical Formulations

8. Pharmaceutical Excipient Market, by Function

• 8.1. Introduction
• 8.2. Binders
• 8.3. Coating Agents
• 8.4. Colorants
• 8.5. Disintegrants
• 8.6. Emulsifying Agents
• 8.7. Fillers & Diluents
• 8.8. Flavoring Agents & Sweeteners
• 8.9. Lubricants & Glidants
• 8.10. Preservatives
• 8.11. Suspending & Viscosity Agents

9. Pharmaceutical Excipient Market, by End-User

• 9.1. Introduction
• 9.2. Biopharmaceutical Companies
• 9.3. Contract Manufacturing Organizations
• 9.4. Pharmaceutical Companies
• 9.5. Research Laboratories

10. Americas Pharmaceutical Excipient Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Pharmaceutical Excipient Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Pharmaceutical Excipient Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. GELITA launches endotoxin-controlled excipients portfolio with VACCIPRO and MEDELLAPRO to drive biocompatible innovations
  • 13.3.2. Nucleus Biologics secures EXCiPACT and ISO 9001 certifications to guarantee premium GMP-quality cell culture media and reagents
  • 13.3.3. Nagase Viita to launch SUCROSE SG as an eco-friendly, injectable-grade stabilizer to enhance the stability of biopharmaceuticals
  • 13.3.4. Clariant revolutionizes pharmaceuticals with the launch of high-purity excipients
  • 13.3.5. Shin-Etsu SE Tylose and LBB Specialties forms strategic distribution partnership for cellulose excipients in North and Central America
  • 13.3.6. Evonik's new spray drying facility enhances global supply and sustainability of oral excipients
  • 13.3.7. Roquette's strategic acquisition of IFF Pharma Solutions to bolster global influence in drug delivery solutions and excipients market
  • 13.3.8. Shin-Etsu Chemical to invest JPY 10 billion in expanding global reach of pharmaceutical excipient production
  • 13.3.9. Asahi Kasei enhances pharmaceutical safety with low-nitrite Ceolus MCC excipient and expanded production
  • 13.3.10. Roquette Introduces New Advancement in Moisture Protection
  • 13.3.11. Clariant Launches New Range Of Excipients To Improve Stability And Solubility of Apis at CPHI Barcelona
  • 13.3.12. BASF, IFF Partner on Virtual Pharma Assistant Platform ZoomLab
  • 13.3.13. Lubrizol's Apisolex excipient empowers Welton Pharma to tackle cancer drug solubility challenges
  • 13.3.14. Ingredion leverages strategic acquisitions to strengthen its global pharmaceutical excipient portfolio and enhance offering diversity
  • 13.3.15. Roquette Expands Global Reach of Plant-Based Excipients Portfolio with Complete Acquisition of Crest Cellulose
  • 13.3.16. DFE Pharma Expands its Inhalation Portfolio with the Launch of Lactohale 400
  • 13.3.17. Evonik invests USD 220 million in partnership with the U.S. Government to build a new lipid production facility for mRNA-based therapies in the U.S.
  • 13.3.18. Lubrizol Launches Apisolex Technology
  • 13.3.19. Univar Solutions Expands Pharmaceutical Products Portfolio Through New Distribution Agreement with Ashland
  • 13.3.20. Azelis Strengthens Its Pharmaceutical Presence in India By Expanding its Partnership With Roquette
• 13.4. Strategy Analysis & Recommendation
  • 13.4.1. Thermo Fisher Scientific Inc.
  • 13.4.2. Archer Daniels Midland Company
  • 13.4.3. Clariant AG
  • 13.4.4. BASF SE

Companies Mentioned

• 1. ABITEC Corporation
• 2. Actylis
• 3. Archer Daniels Midland Company
• 4. ARMOR PROTEINES S.A.S. by Savencia Group
• 5. Asahi Kasei Corporation
• 6. Ashland Inc.
• 7. BASF SE
• 8. BIOGRUND GmbH
• 9. Chemische Fabrik Budenheim KG by Geschwister Oetker Beteiligungen KG
• 10. Clariant AG
• 11. Colorcon Inc.
• 12. Corel Pharma Chem Private Limited
• 13. Croda International Plc
• 14. Darling Ingredients, Inc.
• 15. DFE Pharma GmbH & Co KG by Royal FrieslandCampina N.V.
• 16. DuPont de Nemours, Inc.
• 17. Evonik Industries AG
• 18. Fuji Chemical Industries Co., Ltd.
• 19. GATTEFOSSE SAS
• 20. Innophos Holdings, Inc. by Iris Parent LLC
• 21. International Flavors & Fragrances Inc.
• 22. JRS PHARMA GmbH + Co. KG
• 23. Kerry Group P.L.C.
• 24. Lipoid GmbH
• 25. Lubrizol Corporation
• 26. L'AIR LIQUIDE S.A.
• 27. Mallinckrodt plc
• 28. MEGGLE GmbH & Co. KG
• 29. Merck KGaA
• 30. Nagase & Co., Ltd.
• 31. Nipon Soda Co., Ltd.
• 32. NOF Corporation
• 33. Omya International AG
• 34. Peter Greven GmbH & Co. KG
• 35. Roquette Freres S.A.
• 36. Shin-Etsu Chemical Co., Ltd.
• 37. Solvay S.A.
• 38. SPI Pharma, Inc.
• 39. Sumitomo Seika Chemicals Company, Limited
• 40. Thermo Fisher Scientific Inc.
• 41. Vanderbilt Minerals LLC