세계의 생물제제 제조 시장 보고서(2025년)
Biologics Manufacturing Global Market Report 2025
상품코드 : 1889316
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

생물제제 제조 시장 규모는 최근 수년간 비약적으로 확대되고 있습니다. 2024년 348억 2,000만 달러로 평가되었고, 2025년에는 420억 4,000만 달러에 달할 것으로 추정되며, CAGR 20.7%로 성장할 전망입니다. 지난 수년간의 성장은 치료 단백질에 대한 수요 증가, 만성 질환의 유병률 증가, 단일클론 항체의 사용 확대, 바이오 의약품 개발에 대한 정부 지원 강화, 그리고 수탁 제조 기관에 대한 의존도 증가로 인한 것으로 예측됩니다.

생물제제 제조 시장 규모는 향후 수년간 급격한 성장이 예상됩니다. 2029년에는 882억 8,000만 달러에 달할 것으로 예측되며, CAGR 20.4%로 성장할 전망입니다. 예측 기간의 성장은 맞춤형 의료에 대한 수요 증가, 세포 및 유전자 치료에 대한 투자 확대, 고도의 바이오프로세싱 기술 활용 확대, 지속 가능한 제조 방법에 대한 주목의 고조, 바이오의약품 후보의 파이프라인 확충에 기인할 것으로 보입니다. 예측 기간의 주요 동향으로는 연속 바이오프로세싱으로의 이행, 일회용 기술의 이용 확대, 모듈형 바이오 제조 시설 성장, 생산에서 AI 및 자동화의 통합, 지속가능하고 친환경 제조 방법에 대한 중점화를 들 수 있습니다.

만성질환의 유병률 상승은 향후 생물학적 제조 시장의 성장을 가속할 것으로 예측됩니다. 만성 질환은 천천히 진행되고 장기간 지속되는 건강 상태이며, 지속적인 의료 케어가 필요한 경우가 많습니다. 만성 질환 증가는 앉기 쉬운 생활 습관이나 운동 부족이 심장 질환이나 당뇨병 등의 리스크를 높이는 것에도 일부 기인하고 있습니다. 생물제제 제조는 당뇨병, 암, 자가면역 질환 등의 상태에 대해 효과적인 표적요법을 생산함으로써 만성질환의 관리를 강화합니다. 일관되고 고품질의 생물학적 의약품을 제공함으로써 질병 부담을 줄이고 환자의 치료 성과 및 치료 효율을 향상시킵니다. 예를 들어 영국 정부 기관인 국민보건서비스(NHS)에 따르면 2024년 6월 시점에서 2023년 일반개업의에 등록된 361만 5330명이 비당뇨병성 고혈당증 또는 전당뇨병으로 진단되고 있으며 2022년 306만 5825례에서 18% 증가 따라서 만성 질환 증가 추세는 생물제제 제조 시장의 성장을 이끌고 있습니다.

생물제제 제조 시장에서 사업을 전개하는 주요 기업은 통합형 생물 제제 수탁 개발 제조 조직(CDMO) 플랫폼 등의 고도 솔루션의 개발에 주력하여 엔드 투 엔드 생물제제 개발, 생산 효율, 여러 치료 영역에 걸친 공급망 통합의 강화를 도모하고 있습니다. 통합형 생물제제 수탁 개발 제조 플랫폼은 단일 통합 시스템 내에서 생물제제 개발, 생산 및 공급 서비스를 결합한 종합적인 프레임워크를 말합니다. 예를 들어 2023년 6월 미국에 본사를 둔 수탁 개발 제조 기업인 캐터런트사는 생물제제 영역 전체에서의 통합 개발, 제조 및 공급을 목적으로 한 'OneBio Suite'를 확대했습니다. 향상된 OneBio Suite는 항체, 세포 및 유전자 치료 및 mRNA 기반 제품을 지원하는 완전 통합 생물제제 CDMO 플랫폼을 설명합니다. 단일 계약 및 조화로운 프로젝트 관리를 통해 개발부터 충전 포장까지 엔드 투 엔드 서비스를 실현하여 개발 기간 단축, 확장성 향상, 원활한 세계 공급 통합을 가능하게 합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향 및 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁 및 관세, 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

Biologics manufacturing is the complex process of producing medicines derived from living organisms or their components. It involves cultivating genetically engineered cells or microorganisms in bioreactors to generate therapeutic proteins or other biological products, followed by purification methods such as filtration and chromatography to ensure safety and quality. This process supports the development of safe, effective, and high quality biologic drugs, advancing personalized medicine and improving patient outcomes.

The main modes of manufacturing in biologics manufacturing are contract manufacturing and in-house manufacturing. Contract manufacturing refers to a production approach in which a company assigns the manufacturing of its biologic products to a specialized third party organization. The different modalities include monoclonal antibodies (mAbs), biosimilar and recombinant proteins, vaccines, cell and gene therapies, and ribonucleic acid based therapeutics, and are indicated for oncology, autoimmune disorders, infectious diseases, neurological disorders, and other disease areas.

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

The biologics manufacturing market size has grown exponentially in recent years. It will grow from $34.82 billion in 2024 to $42.04 billion in 2025 at a compound annual growth rate (CAGR) of 20.7%. The growth in the historic period can be attributed to rising demand for therapeutic proteins, increasing prevalence of chronic diseases, expanding use of monoclonal antibodies, growing government support for biologics development, and increasing reliance on contract manufacturing organizations.

The biologics manufacturing market size is expected to see exponential growth in the next few years. It will grow to $88.28 billion in 2029 at a compound annual growth rate (CAGR) of 20.4%. The growth in the forecast period can be attributed to rising demand for personalized medicine, increasing investments in cell and gene therapies, growing use of advanced bioprocessing technologies, increasing emphasis on sustainable manufacturing methods, and expanding pipeline of biologic drug candidates. Major trends in the forecast period include a move toward continuous bioprocessing, increasing use of single use technologies, growth in modular biomanufacturing facilities, integration of AI and automation in production, and emphasis on sustainable and green manufacturing approaches.

The rising prevalence of chronic diseases is expected to propel the growth of the biologics manufacturing market going forward. Chronic diseases are persistent health conditions that develop slowly and last for an extended period, often requiring continuous medical care. The growing prevalence of chronic diseases is partly due to inactive lifestyles, as prolonged sitting and minimal physical activity raise the risk of diseases such as heart conditions and diabetes. Biologics manufacturing enhances chronic disease management by producing targeted therapies, making them effective for conditions such as diabetes, cancer, and autoimmune disorders. It reduces disease burden by providing consistent, high quality biologic medicines, improving patient outcomes and treatment efficiency. For instance, in June 2024, according to the National Health Service, a UK based government department, 3615330 individuals registered with a general practitioner were diagnosed with non diabetic hyperglycemia or pre diabetes in 2023, marking an 18 percent increase from 3065825 cases in 2022. Therefore, the rising prevalence of chronic diseases is driving the growth of the biologics manufacturing market.

Major companies operating in the biologics manufacturing market are focusing on developing advanced solutions such as integrated biologics contract development and manufacturing organization platforms to enhance end to end biologics development, production efficiency, and supply chain integration across multiple therapeutic modalities. Integrated biologics contract development and manufacturing organization platform refers to a comprehensive framework that combines biologics development, production, and supply services within a single unified system. For instance, in June 2023, Catalent Inc., a US based contract development and manufacturing company, expanded its OneBio Suite for integrated development, manufacturing, and supply across biologic modalities. The enhanced OneBio Suite offers a fully integrated biologics contract development and manufacturing organization platform that supports antibodies, cell and gene therapies, and mRNA based products. It provides end to end services from development to fill finish and packaging through a single contract and harmonized project management, enabling faster development timelines, improved scalability, and seamless global supply integration.

In September 2025, Terumo Corporation, a Japan based medical technology company, acquired WuXi Biologics Cayman Inc. for an undisclosed amount. Through this acquisition, Terumo aims to expand its contract development and manufacturing organization production capacity and global presence, enhancing its ability to provide integrated biologics manufacturing and fill finish services for injectable therapies. WuXi Biologics Cayman Inc. is a China based company offering end to end solutions for the discovery, development, and manufacturing of biologics.

Major companies operating in the biologics manufacturing market are Johnson & Johnson, F. Hoffmann La-Roche Ltd., Pfizer Inc, AbbVie Inc., Eli Lilly and Company, Novartis AG, Bristol-Myers Squibb Company, Thermo Fisher Scientific Inc., LG Life Sciences Ltd., Novo Nordisk A/S, Amgen Inc., FUJIFILM Holdings Corporation, Boehringer Ingelheim International GmbH, Teva Pharmaceutical Industries Ltd., Lonza Group Ltd., Intas Pharmaceuticals Ltd., Samsung Biologics Co. Ltd., Fareva SA, Celltrion Inc., Evotec SE

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

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

The biologics manufacturing market consists of sales of therapeutic proteins, enzymes, recombinant DNA products, blood factors, and other biologic-based therapeutics. 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.

Biologics Manufacturing 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 biologics manufacturing 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 biologics manufacturing ? 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 biologics manufacturing 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. Biologics Manufacturing Market Characteristics

3. Biologics Manufacturing Market Trends And Strategies

4. Biologics Manufacturing 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 Biologics Manufacturing Growth Analysis And Strategic Analysis Framework

6. Biologics Manufacturing Market Segmentation

7. Biologics Manufacturing Market Regional And Country Analysis

8. Asia-Pacific Biologics Manufacturing Market

9. China Biologics Manufacturing Market

10. India Biologics Manufacturing Market

11. Japan Biologics Manufacturing Market

12. Australia Biologics Manufacturing Market

13. Indonesia Biologics Manufacturing Market

14. South Korea Biologics Manufacturing Market

15. Western Europe Biologics Manufacturing Market

16. UK Biologics Manufacturing Market

17. Germany Biologics Manufacturing Market

18. France Biologics Manufacturing Market

19. Italy Biologics Manufacturing Market

20. Spain Biologics Manufacturing Market

21. Eastern Europe Biologics Manufacturing Market

22. Russia Biologics Manufacturing Market

23. North America Biologics Manufacturing Market

24. USA Biologics Manufacturing Market

25. Canada Biologics Manufacturing Market

26. South America Biologics Manufacturing Market

27. Brazil Biologics Manufacturing Market

28. Middle East Biologics Manufacturing Market

29. Africa Biologics Manufacturing Market

30. Biologics Manufacturing Market Competitive Landscape And Company Profiles

31. Biologics Manufacturing Market Other Major And Innovative Companies

32. Global Biologics Manufacturing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Biologics Manufacturing Market

34. Recent Developments In The Biologics Manufacturing Market

35. Biologics Manufacturing Market High Potential Countries, Segments and Strategies

36. Appendix

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