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세계의 바이오의약품 수탁 제조 시장 보고서(2025년)
Biopharmaceuticals Contract Manufacturing Global Market Report 2025
상품코드 : 1807784
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

바이오의약품 수탁 제조 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 11.2%로 339억 9,000만 달러로 성장할 것으로 예상됩니다. 예측 기간 성장 배경으로는 아웃소싱 동향 증가, 바이오시밀러 개발, 시장 개척 기간의 단축 요건, 세계 시장 확대, 전문 서비스 중시 등이 있습니다. 예측기간 주요 동향으로는 기술통합, 고분자 이외의 아웃소싱 확대, 첨단제조기술의 채택, 품질과 컴플라이언스 중시, 바이오시밀러 제조 대두 등이 있습니다.

향후 5년간 성장률 11.2%라고 하는 예측은 이 시장에 관한 전회의 예측으로부터 0.2%의 소폭 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세 영향 때문입니다. 관세 부과는 스위스나 덴마크에서 조달하는 일회용 바이오리액터 및 세포 배양 배지의 가격을 상승시키고, 임상시험 생산을 지연시키고, 생물 제제의 제조 비용을 상승시킬 수 있기 때문에 미국의 의약품 개발 기업에 혼란을 초래할 가능성이 있습니다. 또한 상호 관세와 무역 긴장 증가와 제한으로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 더 광범위하게 늘어날 것으로 보입니다.

맞춤형 의료에 대한 수요 증가는 앞으로 수년간의 바이오의약품 수탁 제조 시장의 성장을 크게 뒷받침할 것으로 예측됩니다. 맞춤형 의료는 유전, 환경, 라이프 스타일 등 환자 개인의 특성을 고려하여 치료 효과와 치료 결과를 향상시키는 맞춤형 의료 접근법을 의미합니다. 유전체학 진보, 환자의 증진 증대, 치료 효과의 향상 등 몇 가지 요인이 맞춤형 의료 수요를 촉진하고 있습니다. 수탁 제조자는 개인화된 치료 특유한 필요를 충족하는 주문을 받아서 만들어진 제조 과정을 개발할 수 있고, 작은 배치 크기 및 독점적인 제형을 수용할 수 있습니다. 예를 들어 미국을 거점으로 하는 비영리단체인 맞춤형 의료연합(Personalized Medicine Coalition)의 보고서에 따르면 2024년 2월에 FDA가 희소질환 환자용으로 승인한 신규맞춤형 치료제는 2022년에는 불과 6유형였지만 2023년에는 16유형에 이르렀습니다. 그 결과, 맞춤형 의료에 대한 수요 증가가 바이오의약품 수탁 제조 시장의 성장을 뒷받침하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

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

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/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 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

Biopharmaceutical contract manufacturing involves a process where a biopharmaceutical company engages a third-party manufacturer to produce drugs or biologic products on its behalf. This practice is employed when pharmaceutical businesses utilize external facilities to manufacture pharmaceuticals under their brand, akin to private label or third-party production.

The primary products of biopharmaceutical contract manufacturing encompass a range of biologics, monoclonal antibodies (mABs), recombinant proteins, vaccines, antisense, mai, molecular therapy, and biosimilars. Monoclonal antibodies (MABs) are laboratory-engineered proteins designed to mimic the function of antibodies within the human body. These antibodies are derived from mammalian and non-mammalian sources. Services offered in this domain include process development, fill and finish operations, analytical and quality control studies, as well as packaging, catering to both clinical and commercial applications.

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 sharp rise in U.S. tariffs and the ensuing trade tensions in spring 2025 are taking a toll on the professional services sector, especially within legal, consulting, architectural, and engineering fields. Increased duties on imported technology, software, office hardware, and digital infrastructure have pushed up operational costs for firms that rely on global systems and resources. Cross-border consulting engagements are experiencing delays and higher expenses due to elevated travel costs and limited access to international data and tools. Moreover, industries heavily impacted by tariffs such as manufacturing, construction, and logistics are reducing their reliance on outsourced services, dampening demand for professional support. In response, service providers are reassessing pricing models, strengthening ties with domestic vendors, and accelerating the adoption of AI and automation to maintain profitability and client satisfaction in an increasingly volatile environment.

The biopharmaceutical contract manufacturing market research report is one of a series of new reports from The Business Research Company that provides biopharmaceutical contract manufacturing optical components market statistics, including biopharmaceutical contract manufacturing optical components industry global market size, regional shares, competitors with a biopharmaceutical contract manufacturing optical components market share, detailed biopharmaceutical contract manufacturing optical components market segments, market trends and opportunities, and any further data you may need to thrive in the biopharmaceutical contract manufacturing optical components industry. This biopharmaceutical contract manufacturing optical components 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 biopharmaceuticals contract manufacturing market size has grown rapidly in recent years. It will grow from $20.13 billion in 2024 to $22.22 billion in 2025 at a compound annual growth rate (CAGR) of 10.4%. The growth in the historic period can be attributed to increased biopharmaceutical development, cost efficiency and risk mitigation, growing pipeline of biologics, globalization of biopharmaceutical industry, flexible manufacturing solutions.

The biopharmaceuticals contract manufacturing market size is expected to see rapid growth in the next few years. It will grow to $33.99 billion in 2029 at a compound annual growth rate (CAGR) of 11.2%. The growth in the forecast period can be attributed to increasing outsourcing trends, biosimilar development, shorter time-to-market requirements, global market expansion, focus on specialized services. Major trends in the forecast period include technological integration, outsourcing expansion beyond large molecules, advanced manufacturing technologies adoption, focus on quality and compliance, rise of biosimilars manufacturing,.

The forecast of 11.2% growth over the next five years reflects a modest reduction of 0.2% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. drug developers by inflating prices for single-use bioreactors and cell culture media sourced from Switzerland and Denmark, potentially delaying clinical trial production and increasing biologics manufacturing costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The rising demand for personalized medicine is anticipated to significantly boost the growth of the biopharmaceutical contract manufacturing market in the coming years. Personalized medicine represents a tailored healthcare approach that considers individual patient characteristics, such as genetics, environment, and lifestyle, to improve treatment effectiveness and outcomes. Several factors are driving the demand for personalized medicine, including advancements in genomics, increased patient empowerment, and enhanced treatment efficacy. Contract manufacturers are able to develop customized production processes that meet the specific needs of personalized therapies, accommodating small batch sizes and unique formulations. For example, a report from the Personalized Medicine Coalition, a U.S.-based non-profit organization, noted that in February 2024, the FDA approved 16 new personalized therapies for patients with rare diseases in 2023, compared to just six in 2022. Consequently, the increasing demand for personalized medicine is fueling the growth of the biopharmaceutical contract manufacturing market.

The growth trajectory of the biopharmaceuticals contract manufacturing market is strongly influenced by the increasing number of clinical trials. These trials, crucial for assessing medical interventions, rely on efficient production and supply of investigational drugs facilitated by biopharmaceutical contract manufacturing. As indicated by Xtalks in May 2023, there has been a substantial rise in registered clinical trials globally on ClinicalTrials.gov, reaching 452,604, a significant increase from early 2021's over 365,000. Hence, the upsurge in clinical trials directly propels the biopharmaceuticals contract manufacturing market.

A prominent trend shaping the biopharmaceuticals contract manufacturing market is product innovation. Major industry players are investing in innovative products to maintain their market position. An example is the strategic contract manufacturing agreement between Thermo Fisher Scientific and Elektrofi in February 2023. This collaboration aims to support the commercial production of Elektrofi's pioneering ultra-high concentration subcutaneous products using innovative microparticle technology. This advancement allows patients to self-administer biologics at home, revolutionizing the delivery of crucial medications.

A significant focus within the biopharmaceutical contract manufacturing market is the development of monoclonal antibodies using advanced platforms such as the go-to cell line platform. KBI Biopharma Inc's launch of SUREmAb in September 2023 exemplifies this focus. Leveraging KBI's SUREtechnology Platform, SUREmAb streamlines processes, enabling swift research cell bank development and a rapid transition from DNA to GMP drug substance. The collaboration between KBI Biopharma and Selexis contributed to this operational optimization, enhancing monoclonal antibody development.

In June 2022, Asahi Kasei Medical Co. Ltd., a chemical company based in Japan, successfully acquired Bionova Scientific, LLC, for an undisclosed sum. This strategic acquisition enables Asahi Kasei Medical to broaden its bioprocess business by integrating a biopharmaceutical Contract Development and Manufacturing Organization (CDMO), thereby expanding its reach to a more diverse customer base, including those at the forefront of developing cutting-edge next-generation biopharmaceuticals. Bionova Scientific, LLC, based in the US, specializes in providing contract process development services and Good Manufacturing Practice (GMP)-compliant contract manufacturing services to biopharmaceutical firms.

Major companies operating in the biopharmaceuticals contract manufacturing market include Boehringer Ingelheim GmbH, Lonza Group Ltd., Inno Biologics Sdn Bhd, Rentschler Biopharma SE, Samsung Biologics Co. Ltd., AGC Biologics, ProBioGen AG, FUJIFILM Diosynth Biotechnologies, Thermo Fisher Scientific Inc., Binex Co. Ltd., AbbVie Inc., Catalent Inc, Pfizer Inc., Merck KGaA, Pressure BioSciences, Novartis International AG, Cambrex Corporation, Emergent BioSolutions Inc., JRS Pharma GmbH & Co. KG, WuXi Biologics, Siegfried Holding AG, Toyobo Co. Ltd., ADMA Biologics Inc., UCB S.A., AstraZeneca PLC, Johnson & Johnson, Takeda Pharmaceutical Company Limited, Shire Pharmaceuticals LLC, Baxter International Inc., Becton Dickinson and Company, Polyphor Ltd., Patheon Inc., Alcami Corporation

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

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

The biopharmaceutical contract manufacturing market includes revenues earned by entities providing services such as formulation development, GMP manufacturing, and supply chain management. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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.

Biopharmaceuticals Contract 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 biopharmaceuticals contract 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 biopharmaceuticals contract 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 biopharmaceuticals contract 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. Biopharmaceuticals Contract Manufacturing Market Characteristics

3. Biopharmaceuticals Contract Manufacturing Market Trends And Strategies

4. Biopharmaceuticals Contract 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 Biopharmaceuticals Contract Manufacturing Growth Analysis And Strategic Analysis Framework

6. Biopharmaceuticals Contract Manufacturing Market Segmentation

7. Biopharmaceuticals Contract Manufacturing Market Regional And Country Analysis

8. Asia-Pacific Biopharmaceuticals Contract Manufacturing Market

9. China Biopharmaceuticals Contract Manufacturing Market

10. India Biopharmaceuticals Contract Manufacturing Market

11. Japan Biopharmaceuticals Contract Manufacturing Market

12. Australia Biopharmaceuticals Contract Manufacturing Market

13. Indonesia Biopharmaceuticals Contract Manufacturing Market

14. South Korea Biopharmaceuticals Contract Manufacturing Market

15. Western Europe Biopharmaceuticals Contract Manufacturing Market

16. UK Biopharmaceuticals Contract Manufacturing Market

17. Germany Biopharmaceuticals Contract Manufacturing Market

18. France Biopharmaceuticals Contract Manufacturing Market

19. Italy Biopharmaceuticals Contract Manufacturing Market

20. Spain Biopharmaceuticals Contract Manufacturing Market

21. Eastern Europe Biopharmaceuticals Contract Manufacturing Market

22. Russia Biopharmaceuticals Contract Manufacturing Market

23. North America Biopharmaceuticals Contract Manufacturing Market

24. USA Biopharmaceuticals Contract Manufacturing Market

25. Canada Biopharmaceuticals Contract Manufacturing Market

26. South America Biopharmaceuticals Contract Manufacturing Market

27. Brazil Biopharmaceuticals Contract Manufacturing Market

28. Middle East Biopharmaceuticals Contract Manufacturing Market

29. Africa Biopharmaceuticals Contract Manufacturing Market

30. Biopharmaceuticals Contract Manufacturing Market Competitive Landscape And Company Profiles

31. Biopharmaceuticals Contract Manufacturing Market Other Major And Innovative Companies

32. Global Biopharmaceuticals Contract Manufacturing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Biopharmaceuticals Contract Manufacturing Market

34. Recent Developments In The Biopharmaceuticals Contract Manufacturing Market

35. Biopharmaceuticals Contract Manufacturing Market High Potential Countries, Segments and Strategies

36. Appendix

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