세계의 생물학적 제제 CDMO 시장 보고서(2025년)
Biologics CDMO Global Market Report 2025
상품코드 : 1815687
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

생물학적 제제 CDMO 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에 CAGR은 14.5%를 나타낼 것으로 예측되고 415억 3,000만 달러로 성장할 전망입니다. 예측 기간 동안의 성장은 생물학적 제제 수요 증가, 바이오시밀러 및 바이오베터의 등장, 바이오제조 인프라 투자, 복잡한 공정 아웃소싱으로의 전환, 공급망 회복탄력성 및 위험 완화를 위한 주력, 규제 조화, 신속한 승인 등에 기인할 수 있습니다. 예측 기간의 주요 동향으로는 엔드투엔드 솔루션 제공 역량 확장, 일회용 기술 채택, 연속 제조 공정 통합, 전문 CDMO의 등장이 포함됩니다.

향후 5년간 14.5% 성장 전망은 해당 시장에 대한 이전 추정치 대비 0.3% 소폭 하향 조정된 수치입니다. 이 같은 하향 조정은 주로 미국과 타국 간 관세 영향 때문입니다. 무역 긴장은 한국 및 독일의 계약 개발 및 위탁 제조 서비스 가격 상승을 유발하여 미국 내 의약품 개발을 저해할 수 있으며, 이는 임상 시험 지연과 생물학적 제제의 생산 비용 25-30% 증가로 이어질 수 있습니다. 상호 관세 부과와 무역 긴장 및 제한 강화로 인한 전 세계 경제 및 무역에 대한 부정적 영향으로 그 효과는 더욱 광범위하게 될 것입니다.

세포 및 유전자 치료에 대한 수요 급증은 향후 생물학적 제제 CDMO 시장 성장을 견인할 것으로 예상됩니다. 세포 및 유전자 치료는 살아있는 세포나 유전 물질을 활용해 세포 또는 유전자 수준에서 근본적인 질병 원인을 해결하는 혁신적인 의료 접근법으로, 기존 의약품으로는 관리가 어렵거나 불치인 질환에 대한 잠재적 치료법을 제공합니다. 세포 및 유전자 치료에 대한 수요는 근본적인 유전적 또는 세포적 원인을 해결함으로써 질병에 대한 혁신적인 치료법을 제공할 잠재력으로 인해 증가하고 있습니다. 생물학적 제제 CDMO는 살아있는 세포, 바이러스 벡터 및 유전 물질 처리 전문성을 제공하여 세포 및 유전자 치료제의 안전하고 효율적인 생산을 지원함과 동시에 바이오의약품 기업이 규제 요건과 기술적 과제를 해결하도록 돕고, 이를 통해 연구에서 임상 용도로의 전환을 촉진합니다. 예를 들어, 미국 기반 주요 전문 회원 조직인 미국 유전자 및 세포 치료 학회(ASGCT)에 따르면, 2023년 1월 기준 유전자, 세포 및 RNA 치료 파이프라인은 2022년 7% 성장하여 총 3,726개의 치료제가 개발 중입니다. 이 중 55%는 유전자 치료제, 22%는 비유전자 변형 세포 치료제, 23%는 RNA 치료제입니다. 따라서 세포 및 유전자 치료에 대한 수요 급증이 생물학적 제제 CDMO 시장 성장을 촉진하고 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

HBR
영문 목차

영문목차

A biologics contract development and manufacturing organization (CDMO) is a service provider that supports pharmaceutical companies in the development and production of biologic drugs, which include vaccines, blood and blood components, allergens, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins.

The main cell types in biologics CDMO are mammalian and non-mammalian. Mammalian refers to cell lines derived from mammals, commonly used in the production of biologics and cell-based therapies due to their ability to produce complex proteins and maintain post-translational modifications. The various products types include biologics and biosimilars.

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 resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment-many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.

The main cell types in biologics CDMO are mammalian and non-mammalian. Mammalian refers to cell lines derived from mammals, commonly used in the production of biologics and cell-based therapies due to their ability to produce complex proteins and maintain post-translational modifications. The various products types include biologics and biosimilars.

The biologics CDMO market size has grown rapidly in recent years. It will grow from $21.3 billion in 2024 to $24.15 billion in 2025 at a compound annual growth rate (CAGR) of 13.4%. The growth in the historic period can be attributed to rise in biologics development, cost efficiency and flexibility, focus on core competencies, regulatory compliance and quality assurance, globalization of pharmaceutical supply chains.

The biologics CDMO market size is expected to see rapid growth in the next few years. It will grow to $41.53 billion in 2029 at a compound annual growth rate (CAGR) of 14.5%. The growth in the forecast period can be attributed to increasing demand for biologic therapies, emergence of biosimilars and biobetters, investments in biomanufacturing infrastructure, shift towards outsourcing complex processes, focus on supply chain resilience and risk mitigation, regulatory harmonization, and expedited approvals. Major trends in the forecast period include expansion of capabilities to offer end-to-end solutions, adoption of single-use technologies, integration of continuous manufacturing processes, emergence of specialized CDMOs.

The forecast of 14.5% growth over the next five years reflects a modest reduction of 0.3% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. drug development by inflating prices of contract development and manufacturing services from South Korea and Germany, resulting in delayed clinical trials and 25-30% higher production costs for novel biologic therapies. 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 surge in demand for cell and genetic therapy is expected to propel the growth of the biologic CDMO market going forward. Cell and gene therapy are innovative medical approaches that utilize living cells or genetic material to address underlying disease causes at the cellular or genetic level, providing potential treatments for conditions that are difficult to manage or incurable with traditional pharmaceuticals. The demand for cell and gene therapy is rising due to their potential to offer innovative treatments for diseases by addressing underlying genetic or cellular causes. Biologic CDMOs provide expertise in handling living cells, viral vectors, and genetic material, facilitating safe and efficient production of cell and gene therapies while assisting biopharmaceutical companies in navigating regulatory requirements and technical challenges, thereby facilitating translation from research to clinical application. For instance, in January 2023, according to The American Society of Gene & Cell Therapy (ASGCT), a US-based primary professional membership organization, the gene, cell, and RNA therapy pipeline saw 7% growth in 2022, reaching a total of 3,726 therapies in development. Of these, 55% are gene therapies, while 22% are non-genetically modified cell therapies, and 23% are RNA therapies. Therefore, the surge in demand for cell and genetic therapy is driving the growth of the biologic CDMO market.

Major companies operating in the biologics CDMO market are developing technologically advanced solutions, such as new cell lines, to enhance biopharmaceutical development and manufacturing efficiency and capabilities. The technology produces therapeutic antibodies with enhanced potency, addressing immunotherapy research and development challenges. For instance, in November 2023, Lonza Group, a Switzerland-based manufacturing company that specializes in the pharmaceutical and biotechnology sectors, launched GS Effex cell lines, designed to produce antibodies that are 100% free of fucose, a sugar molecule and demonstrate increased potency without compromising on other performance attributes. It helps overcome immunotherapy research and development challenges related to the need for antibody therapeutics to increase potency. It is a stable, scalable, and productive cell line that provides a solution for therapeutic development from discovery-stage research through commercial manufacturing.

In May 2022, Bora Pharmaceuticals Co. Ltd., a Taiwan-based organization that specializes in manufacturing and selling pharmaceutical products, acquired the CDMO assets of Eden Biologics Inc. for $100 million. The aim of the acquisition is to expand its presence in the global CDMO market, particularly focusing on biologics, macromolecules, and cell and gene therapy markets. Eden Biologics Inc. is a Taiwan-based biotechnology company specializing in the contract development and manufacturing of innovative biologics for therapeutic applications.

Major companies operating in the biologics CDMO market are AbbVie Inc., Thermo Fisher Scientific Inc., Novartis AG, Evonik Industries AG, Sandoz International GmbH, ICON PLC, Grifols SA, Lonza Group Ltd., Boehringer Ingelheim International GmbH, Catalent Inc., JSR Corp., Parexel International Corporation, WuXi Biologics (Cayman) Inc., Samsung Biologics Co. Ltd., Emergent BioSolutions Inc., Rentschler Biopharma SE, FUJIFILM Diosynth Biotechnologies U.S.A. Inc., Binex Co. Ltd., Bora Pharmaceuticals Co. Ltd, 3P Biopharmaceuticals s.l.u, JRS Pharma LP, J Rettenmaier and SOHNE GmbH and Co KG, Kemwell Biopharma Pvt. Ltd., Cytovance Biologics, AGC Biologics, Shenzhen Hepalink Pharmaceutical Co. Ltd.

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

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

The biologics CDMO market consist of revenues earned by entities by providing services such as process development, analytical development, cell line development, supply chain management, and fill-finish services. The biologics CDMO market also includes sales of monoclonal antibodies, recombinant proteins, antisense and molecular therapy, and vaccines. 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.

Biologics CDMO 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 cdmo 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 cdmo ? 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 cdmo 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 CDMO Market Characteristics

3. Biologics CDMO Market Trends And Strategies

4. Biologics CDMO 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 CDMO Growth Analysis And Strategic Analysis Framework

6. Biologics CDMO Market Segmentation

7. Biologics CDMO Market Regional And Country Analysis

8. Asia-Pacific Biologics CDMO Market

9. China Biologics CDMO Market

10. India Biologics CDMO Market

11. Japan Biologics CDMO Market

12. Australia Biologics CDMO Market

13. Indonesia Biologics CDMO Market

14. South Korea Biologics CDMO Market

15. Western Europe Biologics CDMO Market

16. UK Biologics CDMO Market

17. Germany Biologics CDMO Market

18. France Biologics CDMO Market

19. Italy Biologics CDMO Market

20. Spain Biologics CDMO Market

21. Eastern Europe Biologics CDMO Market

22. Russia Biologics CDMO Market

23. North America Biologics CDMO Market

24. USA Biologics CDMO Market

25. Canada Biologics CDMO Market

26. South America Biologics CDMO Market

27. Brazil Biologics CDMO Market

28. Middle East Biologics CDMO Market

29. Africa Biologics CDMO Market

30. Biologics CDMO Market Competitive Landscape And Company Profiles

31. Biologics CDMO Market Other Major And Innovative Companies

32. Global Biologics CDMO Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Biologics CDMO Market

34. Recent Developments In The Biologics CDMO Market

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

36. Appendix

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