세계의 바이오의약품 부형제 시장 보고서(2025년)
Biopharmaceutical Excipients Global Market Report 2025
상품코드 : 1889318
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

바이오의약품 부형제 시장 규모는 최근 현저한 성장을 이루고 있습니다. 2024년 29억 9,000만 달러로 평가되었고, 2025년에는 32억 7,000만 달러에 달할 것으로 추정되며, CAGR 9.4%로 확대될 전망입니다. 지난 수년간의 성장은 바이오 의약품에 대한 수요 증가, 만성 질환의 유병률 상승, 통제된 약물 전달에 대한 관심 증가, 바이오의약품 제조 능력 확대, 바이오의약품에 대한 규제 당국의 승인 증가와 관련이 있습니다.

바이오의약품 부형제 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 46억 3,000만 달러에 달할 것으로 예측되며, CAGR 9.1%로 성장할 전망입니다. 예측 기간의 성장은 바이오의약품 연구에 대한 투자 확대, 맞춤형 의료의 도입 증가, 위탁제조기관(CMO)에 대한 아웃소싱 증가, 세계적인 콜드체인 인프라의 확충, 첨단 제제 개발에 대한 주력 강화에 의해 견인될 것으로 전망됩니다. 예측 기간 주요 추세는 부형제 적합성 시험의 진보, 약물 전달 기술의 혁신, 지속 가능한 부형제 제조 기술의 개발, 신규 안정제의 연구 개발, 분석적 특성화 기법의 진보를 포함합니다.

백신 개발에 대한 수요 증가는 바이오의약품 부형제 시장의 성장을 이끌 것으로 예측됩니다. 백신 개발은 감염의 예방과 공중 보건의 향상을 목적으로 하는 면역제의 창조 및 제제화를 말합니다. 고품질 부형제는 백신의 안정성, 효능 및 안전성을 보장하는 데 필수적입니다. 백신 수요 증가는 전염병 예방, 공중 보건 시스템 강화, 보다 빠르고 효과적인 예방 접종 솔루션의 조사 가속화를 위한 세계적인 노력을 통해 추진되고 있습니다. 바이오의약품 부형제는 항원의 안정화, 용해성의 향상, 보관 및 유통 시의 완전성 유지를 통해 백신 제제에 있어서 중요한 역할을 합니다. 예를 들어 2025년 미국 질병예방관리센터(CDC)가 발표한 데이터에 따르면 파상풍, 디프테리아 및 무세포 백일해 등 주요 백신에서 사춘기층의 접종률은 2022년 89.9%에서 2024년 91.3%로 상승했습니다. 수막염균 결합 백신의 접종률은 88.6%에서 90.1%로 상승했고, 인유두종 바이러스 백신의 접종률은 동기 사이에 76.0%에서 92.6%로 크게 증가했습니다. 이 예방 접종률의 급증은 백신 개발 수요를 견인해, 결과적으로 바이오의약품 부형제 시장의 성장을 가속하고 있습니다.

바이오의약품 부형제 시장의 기업은 주사제 제형에서 단백질 안정성 향상, 분해 방지, 규제 준수 지원을 목적으로 한 초고순도 계면활성제 등의 기술 혁신에 주력하고 있습니다. 이러한 계면활성제는 불순물을 최소화하고 조성을 균일화한 특수 정제 표면활성제로 민감한 바이오의약품 제제에서 안정성, 안전성, 성능을 보장합니다. 예를 들어, 2025년 9월에 독일의 화학기업 에보닉 인더스트리즈 AG가 주사제 및 바이오의약품 용도를 위한 'MaxiPure Polysorbate 80'을 발표했습니다. 이 부형제는 98% 이상의 올레산 함량, 탁월한 투명성, 유럽 약전, 미국 약국, 일본 약국, 중국 약전의 기준에 대한 완전 준거를 실현하고 있습니다. 본 제품은 단백질 안정성의 과제 해결, 산화 열화 방지, 소수성 유효 성분의 안정적인 가용화를 실현하여 제제의 신뢰성을 높입니다. 에보닉은 본 부형제의 채용에 의해 제약 기업이 복잡한 생물학적 제제나 주사제를 보다 효율적으로 개발함과 동시에 안전성 및 규제 준수를 확보하는 것을 지원하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향 및 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁 및 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석 및 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도 및 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹 및 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문 및 전략

제36장 부록

AJY
영문 목차

영문목차

Biopharmaceutical excipients are inactive components combined with active pharmaceutical ingredients to support the development, stability, and delivery of biologic drugs. They improve the effectiveness, safety, and shelf-life of biopharmaceutical products without providing any therapeutic action themselves. These excipients consist of various substances such as sugars, polymers, and proteins that assist in drug formulation and administration.

The key product types of biopharmaceutical excipients include binders, coatings, diluents, disintegrants, lubricants and glidants, polyols, preservatives, solubilizers and surfactants or emulsifiers, and suspending and viscosity agents. Binders are materials added to powders or granules in pharmaceutical, food, or material formulations to keep ingredients together, ensuring cohesion and structural integrity in the final product. The different types of biologics include antibodies, vaccines, cell therapies, and others. Their multiple functionalities consist of fillers and diluents, binders, suspending and viscosity agents, flavoring agents and sweeteners, coating agents, colorants, disintegrants, lubricants and glidants, and preservatives. The various applications include injectable formulations, oral formulations, topical formulations, transdermal formulations, and cell and gene therapies, and they are used by several end users such as biopharmaceutical and pharmaceutical companies, contract manufacturers, and research institutes.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The biopharmaceutical excipients market research report is one of a series of new reports from The Business Research Company that provides biopharmaceutical excipients market statistics, including the biopharmaceutical excipients industry global market size, regional shares, competitors with the biopharmaceutical excipients market share, detailed biopharmaceutical excipients market segments, market trends, and opportunities, and any further data you may need to thrive in the biopharmaceutical excipients industry. This biopharmaceutical excipients market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The biopharmaceutical excipients market size has grown strongly in recent years. It will grow from $2.99 billion in 2024 to $3.27 billion in 2025 at a compound annual growth rate (CAGR) of 9.4%. The growth in the historic period can be linked to increasing demand for biologics, growing prevalence of chronic diseases, rising focus on controlled drug delivery, expansion of biopharmaceutical manufacturing capacity, and increasing regulatory approvals for biologics.

The biopharmaceutical excipients market size is expected to see strong growth in the next few years. It will grow to $4.63 billion in 2029 at a compound annual growth rate (CAGR) of 9.1%. The growth in the forecast period can be driven by growing investment in biopharmaceutical research, rising adoption of personalized medicine, increasing outsourcing to contract manufacturing organizations, expansion of global cold chain infrastructure, and growing focus on advanced formulation development. Major trends in the forecast period include advancements in excipient compatibility testing, innovations in drug delivery technologies, developments in sustainable excipient manufacturing, research and development in novel stabilizers, and advancements in analytical characterization methods.

The increasing demand for vaccine development is expected to drive the growth of the biopharmaceutical excipients market. Vaccine development involves creating and formulating immunizations to prevent infectious diseases and improve public health. High-quality excipients are essential in ensuring the stability, efficacy, and safety of vaccines. The rising demand for vaccines is driven by global efforts to prevent infectious diseases, strengthen public health systems, and accelerate research for faster, more effective immunization solutions. Biopharmaceutical excipients play a critical role in vaccine formulations by stabilizing antigens, enhancing solubility, and maintaining integrity during storage and distribution. For example, in 2025, the Centers for Disease Control and Prevention (CDC) reported that adolescent vaccination coverage for key vaccines, such as tetanus, diphtheria, and acellular pertussis, increased from 89.9% in 2022 to 91.3% in 2024. Coverage for the meningococcal conjugate vaccine rose from 88.6% to 90.1%, and human papillomavirus vaccine coverage grew significantly from 76.0% to 92.6% over the same period. This surge in immunization coverage is driving the demand for vaccine development and, consequently, the growth of the biopharmaceutical excipients market.

Companies in the biopharmaceutical excipients market are focusing on technological innovations, such as ultra-high purity surfactants, to improve protein stability, prevent degradation, and support regulatory compliance in injectable formulations. These surfactants are specially refined surface-active agents with minimal impurities and consistent composition, ensuring stability, safety, and performance in sensitive biopharmaceutical formulations. For example, in September 2025, Evonik Industries AG, a Germany-based chemicals company, launched MaxiPure Polysorbate 80 for injectable and biopharmaceutical applications. This excipient is engineered with over 98% oleic acid content, exceptional clarity, and full compliance with the European Pharmacopoeia, United States Pharmacopoeia, Japanese Pharmacopoeia, and Chinese Pharmacopoeia standards. It addresses challenges in protein stability, prevents oxidative degradation, enables consistent solubilization of hydrophobic active ingredients, and enhances formulation reliability. By integrating this excipient, Evonik helps pharmaceutical companies develop complex biologics and injectable therapies more efficiently while ensuring safety and regulatory compliance.

In May 2025, Roquette Freres, a France-based provider of pharmaceutical excipients, acquired International Flavors & Fragrances (IFF) Pharma Solutions for an undisclosed amount. This acquisition strengthens Roquette's portfolio of pharmaceutical excipients by integrating IFF Pharma Solutions' expertise and innovative products. The move enhances Roquette's ability to deliver high-value drug delivery solutions and support the development of advanced pharmaceutical formulations worldwide. IFF Pharma Solutions, a U.S.-based company, specializes in pharmaceutical excipients and functional ingredients that aid in drug formulation and delivery within the biopharmaceutical industry.

Major companies operating in the biopharmaceutical excipients market are The Archer-Daniels-Midland Company, BASF SE, The Dow Chemical Company, Mitsubishi Chemical Group Corporation, Novo Nordisk A/S, Associated British Foods plc, Merck KGaA, Asahi Kasei Corporation, Evonik Industries AG, Kerry Group plc, Wacker Chemie AG, Clariant AG, Shin-Etsu Chemical Co. Ltd., Roquette Freres, IMCD Group N.V., Croda International Plc, Ashland Global Holdings Inc., NOF Corporation, Colorcon Limited, J. Rettenmaier & Sohne GmbH + Co. KG, Spectrum Chemical Manufacturing Corporation, BioSpectra Inc., Sigachi Industries Limited, DFE Pharma, FUJIFILM Toyama Chemical Co. Ltd, Kirsch Pharma GmbH, Meggle Group GmbH, InVitria Inc., BOC Sciences Inc.

North America was the largest region in the biopharmaceutical excipients market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in biopharmaceutical excipients report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the biopharmaceutical excipients market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The biopharmaceutical excipients market consists of sales of growth media, buffer solutions, stabilizers, cryoprotectants, preservatives, surfactants, salts, amino acids, sugars. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Biopharmaceutical Excipients Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on biopharmaceutical excipients market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for biopharmaceutical excipients ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The biopharmaceutical excipients market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Biopharmaceutical Excipients Market Characteristics

3. Biopharmaceutical Excipients Market Trends And Strategies

4. Biopharmaceutical Excipients Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Biopharmaceutical Excipients Growth Analysis And Strategic Analysis Framework

6. Biopharmaceutical Excipients Market Segmentation

7. Biopharmaceutical Excipients Market Regional And Country Analysis

8. Asia-Pacific Biopharmaceutical Excipients Market

9. China Biopharmaceutical Excipients Market

10. India Biopharmaceutical Excipients Market

11. Japan Biopharmaceutical Excipients Market

12. Australia Biopharmaceutical Excipients Market

13. Indonesia Biopharmaceutical Excipients Market

14. South Korea Biopharmaceutical Excipients Market

15. Western Europe Biopharmaceutical Excipients Market

16. UK Biopharmaceutical Excipients Market

17. Germany Biopharmaceutical Excipients Market

18. France Biopharmaceutical Excipients Market

19. Italy Biopharmaceutical Excipients Market

20. Spain Biopharmaceutical Excipients Market

21. Eastern Europe Biopharmaceutical Excipients Market

22. Russia Biopharmaceutical Excipients Market

23. North America Biopharmaceutical Excipients Market

24. USA Biopharmaceutical Excipients Market

25. Canada Biopharmaceutical Excipients Market

26. South America Biopharmaceutical Excipients Market

27. Brazil Biopharmaceutical Excipients Market

28. Middle East Biopharmaceutical Excipients Market

29. Africa Biopharmaceutical Excipients Market

30. Biopharmaceutical Excipients Market Competitive Landscape And Company Profiles

31. Biopharmaceutical Excipients Market Other Major And Innovative Companies

32. Global Biopharmaceutical Excipients Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Biopharmaceutical Excipients Market

34. Recent Developments In The Biopharmaceutical Excipients Market

35. Biopharmaceutical Excipients Market High Potential Countries, Segments and Strategies

36. Appendix

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