세계의 무균 주사제 CDMO 시장 보고서(2025년)
Sterile Injectables CDMO Global Market Report 2025
상품코드 : 1811037
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

세계의 무균 주사제 CDMO 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년까지 CAGR 10.4%로 확대되어 98억 9,000만 달러로 성장할 것으로 예상됩니다. 예측 기간 동안의 성장은 만성 질환의 유병률 증가, 노인 증가, 생물학적 제제 및 바이오시밀러에 대한 세계적인 수요 증가, 단일클론항체의 사용 확대, 백신 접종 프로그램의 세계적인 보급으로 인한 것으로 예측됩니다. 이 기간에 예상되는 주요 동향으로는 무균 처리와 충전 마무리 기술의 진보, 아이솔레이터 및 액세스 제한 배리어 시스템의 채용, 무균 주사제 제조에서 자동화와 로봇화의 진전, 동결 건조법의 강화, 생산 효율을 높이기 위한 디지털화와 실시간 모니터링의 통합 등이 있습니다.

생물제제와 바이오시밀러에 대한 수요가 증가함에 따라 향후 무균 주사제 CDMO 시장의 성장을 이끌 것으로 예측됩니다. 생물학적 제제는 특정 질병 성분을 표적으로 하는 살아있는 세포 및 유기체로부터 유래된 의약품이며, 바이오시밀러 의약품은 승인된 생물학적 제제와 품질, 안전성 및 효능에서 거의 동일합니다. 만성 및 복잡한 질병 증가는 기존의 의약품에 비해 더 좁은 효과적인 치료법을 제공하므로 이러한 치료법에 대한 수요가 증가하고 있습니다. 이러한 수요 증가는 무균 주사제 CDMO 서비스에 대한 의존도를 증가시킵니다. 왜냐하면 이러한 치료는 일반적으로 주사에 의해 투여되고 안전성, 품질, 규정 준수를 보장하기 위해 엄격한 무균 상태가 요구되기 때문입니다. 예를 들어, 2023년 11월, 미국의 건강 관리 기업인 Cardinal Health는 미국 의료비가 2022년에 4조 5,000억 달러에 달했고, 그 중 생물 제제가 2,520억 달러를 차지한다고 보고했습니다. 이 금액은 2021년 4조 3,000억 달러에서 증가했습니다. 이와 같이 생물제제와 바이오시밀러에 대한 수요 증가가 무균 주사제 CDMO 시장의 확대에 박차를 가하고 있습니다.

무균 주사제 CDMO 부문의 주요 기업은 자동 무균 충전 시스템과 같은 혁신적인 솔루션에 주력하여 무균 보증을 향상시키고 사람의 참여를 최소화합니다. 이러한 시스템은 관리된 환경 내에서 무균 의약품 및 생물학적 제제를 용기에 채우는 데 사용되는 특수 장비로, 수작업을 제한하여 오염의 위험을 줄입니다. 예를 들어, 2022년 7월, 대만의 생명공학 기업인 Amaran Biotech은 전 자동 로봇식 무균 충전 라인인 Vanrx SA25를 도입했습니다. 이 시스템은 단백질 기반 치료, 항체 치료, 나노입자 의약품을 포함한 고급 바이오 의약품의 무균 처리를 전문으로 설계되었습니다. 이 시스템에는 Cytiva Vanrx SA25 기술이 내장되어 있으며 글로블리스 아이솔레이터 내에서 로봇 부품을 사용하여 생산 전반에 걸쳐 무균 환경을 유지합니다. 이 접근법은 사람의 접촉을 최소화하고 오염 위험을 줄이고 주사제의 무균성을 보장합니다. 또한이 시스템은 다양한 유형의 무균 주사제 용기를 지원하며 FDA, EMA, PIC/S, ISPE 등 주요 세계 규제 표준을 준수합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 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, 전략

제36장 부록

JHS
영문 목차

영문목차

Sterile injectables CDMO refers to a contract development and manufacturing organization that focuses on producing injectable pharmaceutical products in sterile environments. These organizations adhere to strict regulatory requirements to guarantee the safety, effectiveness, and quality of the products. They serve a vital role in the pharmaceutical supply chain by offering the facilities, specialized knowledge, and aseptic processing conditions necessary for sterile manufacturing.

The primary categories of sterile injectable CDMO include small molecule and large molecule products. Small molecules are low molecular weight compounds that can readily penetrate cells due to their simple chemical makeup. These CDMOs provide a range of services such as formulation development, analytical and testing support, manufacturing, packaging, storage, and more. Administration routes include subcutaneous (SC), intravenous (IV), intramuscular (IM), and others. These services are utilized across various therapeutic areas, including oncology, cardiovascular diseases, central nervous system disorders, infectious diseases, musculoskeletal conditions, hormonal disorders, and more, catering to a range of end-users such as pharmaceutical companies, biopharmaceutical firms, research institutions, and others.

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 sterile injectables CDMO market research report is one of a series of new reports from The Business Research Company that provides sterile injectables CDMO market statistics, including sterile injectables CDMO industry global market size, regional shares, competitors with a sterile injectables CDMO market share, detailed sterile injectables CDMO market segments, market trends and opportunities, and any further data you may need to thrive in the sterile injectables CDMO industry. This sterile injectables CDMO 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 sterile injectables CDMO market size has grown rapidly in recent years. It will grow from $6.01 billion in 2024 to $6.65 billion in 2025 at a compound annual growth rate (CAGR) of 10.7%. The growth during the historic period can be attributed to the rising incidence of infectious diseases, increased use of self-injection and home-administered injectables, growing government investments in domestic sterile manufacturing, the emergence of virtual pharma companies dependent on CDMOs, and the expansion of treatment options for rare diseases.

The sterile injectables CDMO market size is expected to see rapid growth in the next few years. It will grow to $9.89 billion in 2029 at a compound annual growth rate (CAGR) of 10.4%. The projected growth in the forecast period can be attributed to the increasing prevalence of chronic diseases, a growing elderly population, rising global demand for biologics and biosimilars, expanded use of monoclonal antibodies, and the widespread implementation of vaccination programs worldwide. Key trends expected during this period include advancements in aseptic processing and fill-finish technologies, adoption of isolators and restricted access barrier systems, increased automation and robotics in sterile injectable manufacturing, enhanced lyophilization methods, and the integration of digitalization and real-time monitoring to boost production efficiency.

The rising demand for biologics and biosimilars is expected to drive the growth of the sterile injectables CDMO market in the future. Biologics are medicines derived from living cells or organisms that target specific disease components, while biosimilars are nearly identical versions of approved biologics, matching them in quality, safety, and effectiveness. The increasing incidence of chronic and complex diseases is fueling demand for these therapies, as they provide more targeted and effective treatment options compared to conventional drugs. This growing demand leads to greater reliance on sterile injectable CDMO services, since these treatments are typically administered by injection and require strict sterile conditions to ensure safety, quality, and compliance with regulations. For example, in November 2023, Cardinal Health, a US-based healthcare company, reported that healthcare expenditures in the United States reached $4.5 trillion in 2022, with biologics accounting for $252 billion of that total. This amount increased from $4.3 trillion spent in 2021. Thus, the rising demand for biologics and biosimilars is fueling the expansion of the sterile injectables CDMO market.

Leading companies in the sterile injectables CDMO sector are focusing on innovative solutions such as automated aseptic filling systems to improve sterility assurance and minimize human involvement. These systems are specialized equipment used to fill sterile pharmaceutical or biological products into containers within a controlled environment, reducing the risk of contamination by limiting manual handling. For instance, in July 2022, Amaran Biotech, a biotechnology firm based in Taiwan, introduced Vanrx SA25, a fully automated robotic aseptic filling line. This system is designed specifically for the sterile processing of advanced biopharmaceuticals, including protein-based therapies, antibody treatments, and nanoparticle drugs. It incorporates the Cytiva Vanrx SA25 technology, which uses robotic components within a gloveless isolator to maintain a sterile environment throughout production. This approach minimizes manual contact, lowering contamination risk and ensuring sterility of injectable products. Additionally, the system supports various types of sterile injectable containers and complies with major global regulatory standards, such as those from the FDA, EMA, PIC/S, and ISPE.

In October 2023, Advent International and Warburg Pincus, two US-based private equity firms, acquired Baxter's BioPharma Solutions business for $4.25 billion. After the acquisition, the business became an independent contract development and manufacturing organization named Simtra BioPharma Solutions, continuing to provide sterile manufacturing, parenteral delivery, and specialized services for pharmaceutical and biotech clients. Supported by Advent and Warburg Pincus, Simtra now operates as a fully standalone CDMO, offering comprehensive services from clinical-stage development to commercial fill-finish production. Baxter International is a US-based provider of sterile injectable CDMO services.

Major players in the sterile injectables CDMO market are Pfizer Inc., Thermo Fisher Scientific Inc., Boehringer Ingelheim, Fresenius Kabi AG, Lonza Group Ltd., Catalent Inc., Samsung Biologics Co. Ltd., Fareva SA, Recipharm AB, PCI Pharma Services, Vetter Pharma, Delpharm, Kindeva Drug Delivery LP, Ajinomoto Bio-Pharma Services, Cenexi, Grand River Aseptic Manufacturing Inc., INCOG BioPharma Services, Aurigene Pharmaceutical Services, Jubilant HollisterStier LLC, Symbiosis Pharmaceutical Services Ltd., Afton Scientific Corp., and Amaran Biotechnology Inc.

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

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

The sterile injectables CDMO market consists of revenues earned by entities by providing services such as microbiological testing, sterilization validation, labeling, and regulatory support. The market value includes the value of related goods sold by the service provider or included within the service offering. The sterile injectables CDMO market also includes sales of cartridges, emulsions, infusion bags, and implants. 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.

Sterile Injectables 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 sterile injectables 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 sterile injectables 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 sterile injectables 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. Sterile Injectables CDMO Market Characteristics

3. Sterile Injectables CDMO Market Trends And Strategies

4. Sterile Injectables 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 Sterile Injectables CDMO Growth Analysis And Strategic Analysis Framework

6. Sterile Injectables CDMO Market Segmentation

7. Sterile Injectables CDMO Market Regional And Country Analysis

8. Asia-Pacific Sterile Injectables CDMO Market

9. China Sterile Injectables CDMO Market

10. India Sterile Injectables CDMO Market

11. Japan Sterile Injectables CDMO Market

12. Australia Sterile Injectables CDMO Market

13. Indonesia Sterile Injectables CDMO Market

14. South Korea Sterile Injectables CDMO Market

15. Western Europe Sterile Injectables CDMO Market

16. UK Sterile Injectables CDMO Market

17. Germany Sterile Injectables CDMO Market

18. France Sterile Injectables CDMO Market

19. Italy Sterile Injectables CDMO Market

20. Spain Sterile Injectables CDMO Market

21. Eastern Europe Sterile Injectables CDMO Market

22. Russia Sterile Injectables CDMO Market

23. North America Sterile Injectables CDMO Market

24. USA Sterile Injectables CDMO Market

25. Canada Sterile Injectables CDMO Market

26. South America Sterile Injectables CDMO Market

27. Brazil Sterile Injectables CDMO Market

28. Middle East Sterile Injectables CDMO Market

29. Africa Sterile Injectables CDMO Market

30. Sterile Injectables CDMO Market Competitive Landscape And Company Profiles

31. Sterile Injectables CDMO Market Other Major And Innovative Companies

32. Global Sterile Injectables CDMO Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Sterile Injectables CDMO Market

34. Recent Developments In The Sterile Injectables CDMO Market

35. Sterile Injectables CDMO Market High Potential Countries, Segments and Strategies

36. Appendix

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