바이오의약품 첨가제 시장 : 제품, 기능, 용도, 최종사용자별 - 세계 예측(2025-2030년)

The Biopharmaceutical Excipients Market was valued at USD 2.29 billion in 2023, expected to reach USD 2.53 billion in 2024, and is projected to grow at a CAGR of 10.75%, to USD 4.70 billion by 2030.

Biopharmaceutical excipients are inactive substances formulated alongside the active ingredient in a medication, serving as carriers and enhancing the stability, absorption, and manufacturability of pharmaceuticals. They play a pivotal role in drug formulation, including tablets, capsules, and injectable products. The market scope encompasses various end-use applications, such as oral, topical, and parenteral delivery systems. Increasing demand for biopharmaceuticals, driven by an aging population and a rise in chronic disease prevalence, underscores the necessity for advanced excipient solutions that improve drug efficacy and patient compliance. A key market growth factor is the ongoing innovation in drug delivery systems, providing opportunities for companies to develop multifunctional excipients that cater to specific medical needs. The expansion of the biologics and biosimilars markets further propels demand, as excipients tailored for protein and peptide drugs are crucial. Opportunities exist in developing sustainable, non-toxic, and multifunctional excipients that align with regulatory standards and environmental considerations. However, the market faces challenges, such as stringent regulatory requirements and the high cost of developing novel excipients. Additionally, potential excipient-drug interactions and quality control issues may pose limitations. To thrive, companies should focus on research in biocompatible and efficient delivery excipients, including exploring natural polymer-based options which align with green chemistry principles. This could provide a breakthrough in addressing safety and environmental concerns, offering a competitive edge in the market. The market landscape is dynamic, with increasing consolidation among players to harness synergies and enhance R&D capabilities. Innovation is crucial, either through novel chemical structures or advanced manufacturing technologies, such as nanotechnology, to fulfill complex formulation needs. By capitalizing on these opportunities and addressing associated challenges, businesses can drive growth in the biopharmaceutical excipients market while fostering a sustainable and robust pipeline of innovative solutions.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biopharmaceutical Excipients Market

The Biopharmaceutical Excipients Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rising Demand for Advanced and Functional Biopharmaceutical Drug Formulations
  • Increasing Need for Large-Molecule Development
  • Increasing Development of Biosimilars
  • Increasing Demand for Hormone and Gene Therapy
  • Bulk Vaccine Production Worldwide
• Market Restraints
  • High Price of Biopharmaceutical Excipients
• Market Opportunities
  • Emerging Trends of Outsourcing for the Production of Biologics
  • Substantial Rise in Need of Functional Excipients
  • Developments in Recombinant DNA Technologies
• Market Challenges
  • Manufacturing Complexities and Contamination Issues of Biopharmaceutical Excipients
  • Time Consuming Biopharmaceutical Clinical Trials

Porter's Five Forces: A Strategic Tool for Navigating the Biopharmaceutical Excipients Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biopharmaceutical Excipients Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Biopharmaceutical Excipients Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biopharmaceutical Excipients Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Biopharmaceutical Excipients Market

A detailed market share analysis in the Biopharmaceutical Excipients Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Biopharmaceutical Excipients Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biopharmaceutical Excipients Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Key Company Profiles

The report delves into recent significant developments in the Biopharmaceutical Excipients Market, highlighting leading vendors and their innovative profiles. These include ABITEC Corporation, Actylis, Ashland Global Holdings Inc., BASF SE, Clariant International Ltd., Colorcon, Inc., 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., J. Rettenmaier & Sohne GmbH + Co KG, Meggle Group GmbH, Merck KGaA, Roquette Freres S.A., Sigachi Industries Limited, Spectrum Laboratory Products, Inc., SPI Pharma, Inc., The Dow Chemical Company, The Lubrizol Corporation, VWR International, LLC by Avantor, and Wacker Chemie AG.

Market Segmentation & Coverage

This research report categorizes the Biopharmaceutical Excipients Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Product, market is studied across Carbohydrates, Polyols, Solubilizers & Surfactants/Emulsifiers, and Specialty Excipients. The Carbohydrates is further studied across Dextrose, Starch, and Sucrose. The Polyols is further studied across Mannitol and Sorbitol. The Solubilizers & Surfactants/Emulsifiers is further studied across Esters and Triglycerides.
• Based on Function, market is studied across Binders, Coatings, Disintegrants, Lubricants & glidants, Pharmaceutical Fillers, and Preservatives.
• Based on Application, market is studied across Advanced Delivery System, Oral, Parenteral, and Topical.
• Based on End User, market is studied across Contract Manufacturing Organizations and Pharmaceutical & Biotechnology Companies.
• 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.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

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 Demand for Advanced and Functional Biopharmaceutical Drug Formulations
    • 5.1.1.2. Increasing Need for Large-Molecule Development
    • 5.1.1.3. Increasing Development of Biosimilars
    • 5.1.1.4. Increasing Demand for Hormone and Gene Therapy
    • 5.1.1.5. Bulk Vaccine Production Worldwide
  • 5.1.2. Restraints
    • 5.1.2.1. High Price of Biopharmaceutical Excipients
  • 5.1.3. Opportunities
    • 5.1.3.1. Emerging Trends of Outsourcing for the Production of Biologics
    • 5.1.3.2. Substantial Rise in Need of Functional Excipients
    • 5.1.3.3. Developments in Recombinant DNA Technologies
  • 5.1.4. Challenges
    • 5.1.4.1. Manufacturing Complexities and Contamination Issues of Biopharmaceutical Excipients
    • 5.1.4.2. Time Consuming Biopharmaceutical Clinical Trials
• 5.2. Market Segmentation Analysis
  • 5.2.1. Product: Carbohydrates are prominent excipients used in pharmaceutical formulations for formulation stability and patient compliance
  • 5.2.2. Function: Increasing utilization of preservatives in biologic formulation for improved stability
  • 5.2.3. Application: Growing significance of biopharmaceutical excipients in advanced delivery systems for control drug release
• 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
• 5.5. Client Customization

6. Biopharmaceutical Excipients Market, by Product

• 6.1. Introduction
• 6.2. Carbohydrates
  • 6.2.1. Dextrose
  • 6.2.2. Starch
  • 6.2.3. Sucrose
• 6.3. Polyols
  • 6.3.1. Mannitol
  • 6.3.2. Sorbitol
• 6.4. Solubilizers & Surfactants/Emulsifiers
  • 6.4.1. Esters
  • 6.4.2. Triglycerides
• 6.5. Specialty Excipients

7. Biopharmaceutical Excipients Market, by Function

• 7.1. Introduction
• 7.2. Binders
• 7.3. Coatings
• 7.4. Disintegrants
• 7.5. Lubricants & glidants
• 7.6. Pharmaceutical Fillers
• 7.7. Preservatives

8. Biopharmaceutical Excipients Market, by Application

• 8.1. Introduction
• 8.2. Advanced Delivery System
• 8.3. Oral
• 8.4. Parenteral
• 8.5. Topical

9. Biopharmaceutical Excipients Market, by End User

• 9.1. Introduction
• 9.2. Contract Manufacturing Organizations
• 9.3. Pharmaceutical & Biotechnology Companies

10. Americas Biopharmaceutical Excipients Market

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

11. Asia-Pacific Biopharmaceutical Excipients 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 Biopharmaceutical Excipients 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. Roquette showcases innovation in biopharmaceutical excipients with launch of PEARLITOL 200 INH
  • 13.3.2. Strategic agreement between Barentz and Ashland enhances distribution of high-purity Vialose excipient in the United States biopharmaceutical market
  • 13.3.3. Roquette launches three moisture-protecting ingredients for nutraceuticals
  • 13.3.4. Croda Pharma Breaks Ground on Excipients Manufacturing Facility

Companies Mentioned

• 1. ABITEC Corporation
• 2. Actylis
• 3. Ashland Global Holdings Inc.
• 4. BASF SE
• 5. Clariant International Ltd.
• 6. Colorcon, Inc.
• 7. Croda International PLC
• 8. DFE Pharma GmbH & Co KG
• 9. Eastman Chemical Company
• 10. Evonik Industries AG
• 11. Fuji Chemical Industries Co., Ltd.
• 12. IMCD N.V.
• 13. Innophos Holdings, Inc.
• 14. J. Rettenmaier & Sohne GmbH + Co KG
• 15. Meggle Group GmbH
• 16. Merck KGaA
• 17. Roquette Freres S.A.
• 18. Sigachi Industries Limited
• 19. Spectrum Laboratory Products, Inc.
• 20. SPI Pharma, Inc.
• 21. The Dow Chemical Company
• 22. The Lubrizol Corporation
• 23. VWR International, LLC by Avantor
• 24. Wacker Chemie AG