세계의 임상시험용 의약품 CDMO 시장 보고서(2025년)
Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025
상품코드 : 1810930
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

임상시험용 의약품 CDMO 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 CAGR 6.7%로 성장할 전망이며, 76억 7,000만 달러로 성장이 예측됩니다. 이 예측 기간의 성장은 희귀 및 희소약 개발에 대한 중시 확대, 전임상부터 임상시험까지의 일관된 서비스에 대한 수요 증가, 생물제제 및 유전자 치료의 복잡화, 소분자의 혁신에 대한 투자 확대, 가상 파마의 비즈니스 모델 채용 확대 등에 기인하고 있습니다. 이 기간에 예상되는 주요 동향으로는 통합형 의약품 개발 플랫폼의 발전, AI를 활용한 임상시험 설계 출현, 맞춤형 의료 제조의 혁신, 규제 준수 기술의 진보, 유연한 모듈식 제조 시설의 개발 등이 있습니다.

임상시험 증가는 향후 임상시험용 의약품 CDMO 시장의 성장을 견인할 것으로 예측됩니다. 임상시험은 관리된 조건 하에서 치료, 처치, 개입의 안전성 및 효능을 평가하기 위해 인간 참가자를 포함하여 신중하게 설계된 시험입니다. 만성 질환 및 복잡한 질병이 증가함에 따라 제약 기업과 생명 공학 기업이 새로운 치료법을 개발하고 시험하며 혁신적인 치료법에 대한 수요가 증가하고 있음이 임상시험의 성장을 뒷받침하고 있습니다. 임상시험용 의약품 CDMO는 임상시험용 제제의 개발과 제조를 합리화함으로써 임상시험을 지원하고, 임상시험의 각 단계에서 임상시험약의 시기적절하고 컴플라이언스에 기반한 공급을 보장합니다. 예를 들어 영국을 거점으로 하는 업계 단체인 영국 제약공업협회는 2023년 11월 영국에서 업계 주도의 임상시험 건수가 연간 4.3% 증가했으며, 2021년 394건에서 2022년에는 411건으로 보고했습니다. 따라서 임상시험 증가는 임상시험용 의약품 CDMO 시장의 성장을 이끌고 있습니다.

임상시험용 의약품 CDMO 시장의 주요 기업은 개발 능력을 강화하고 임상시험 진입을 가속화하기 위해 전략적 파트너십에 주력하고 있습니다. 전략적 파트너십은 독립적인 운영을 유지하면서 서로의 강점, 자원 및 전문 지식을 활용하고 공통 목표를 달성하기 위해 협력하는 두 개 이상의 조직 간의 공식적인 협력 관계입니다. 예를 들어, 2023년 8월 독일의 생명과학기업인 잘트리우스 AG는 미국의 생명과학기업인 리플리젠 코퍼레이션과 제휴하여 BIOSTAT STR과 XCell ATF 기술을 결합한 업스트림 공정 강화를 위한 통합 시스템을 발표했습니다. 이 제휴는 효율성 및 확장성을 향상시켜 바이오 의약품 생산을 최적화하는 것을 목표로 합니다. 이 제휴는 바이오프로세싱 솔루션의 혁신과 바이오 매뉴팩처링 산업의 발전에 대한 잘토리우스사의 지속적인 헌신을 강조합니다.

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

An investigational new drug contract development and manufacturing organization (CDMO) refers to a service provider that assists in the development and manufacturing of pharmaceutical compounds intended for clinical trial use under an Investigational New Drug (IND) application. These organizations operate in accordance with regulatory standards applicable to early-stage drug development, ensuring adherence to the guidelines necessary for progressing experimental therapies toward regulatory approval.

The primary products offered by investigational new drug CDMOs include small molecules and large molecules. Small molecules are low molecular weight compounds capable of easily penetrating cell membranes and interacting with intracellular targets to affect biological functions. These are developed into various formulations, such as solid, liquid, and injectable forms, and are supported by a range of services including preclinical studies, clinical trial material supply, regulatory support, and manufacturing services. The end users include pharmaceutical companies, biotechnology firms, academic and research institutions, among 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 investigational new drug contract development and manufacturing organization (CDMO) market research report is one of a series of new reports from The Business Research Company that provides investigational new drug contract development and manufacturing organization (CDMO) market statistics, including investigational new drug contract development and manufacturing organization (CDMO) industry global market size, regional shares, competitors with a investigational new drug contract development and manufacturing organization (CDMO) market share, detailed investigational new drug contract development and manufacturing organization (CDMO) market segments, market trends and opportunities, and any further data you may need to thrive in the investigational new drug contract development and manufacturing organization (CDMO) industry. This investigational new drug contract development and manufacturing organization (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 investigational new drug contract development and manufacturing organization (CDMO) market size has grown strongly in recent years. It will grow from $5.53 billion in 2024 to $5.91 billion in 2025 at a compound annual growth rate (CAGR) of 7.0%. The growth during the historic period can be attributed to the increasing demand for early-phase clinical trials, greater outsourcing by pharmaceutical companies, a rise in the development of biologics and complex molecules, enhanced regulatory support for expedited drug approvals, and a heightened emphasis on cost-efficiency and reducing time-to-market.

The investigational new drug contract development and manufacturing organization (CDMO) market size is expected to see strong growth in the next few years. It will grow to $7.67 billion in 2029 at a compound annual growth rate (CAGR) of 6.7%. The growth in the forecast period can be attributed to the expanding emphasis on rare and orphan drug development, the increasing demand for integrated preclinical-to-clinical services, the rising complexity of biologics and gene therapies, growing investments in small molecule innovation, and the wider adoption of virtual pharma business models. Key trends expected during this period include advancements in integrated drug development platforms, the emergence of AI-driven clinical trial designs, innovations in personalized medicine manufacturing, progress in regulatory compliance technologies, and the development of flexible, modular manufacturing facilities.

The increase in clinical trials is expected to drive the growth of the investigational new drug contract development and manufacturing organization (CDMO) market moving forward. Clinical trials are carefully designed studies involving human participants to evaluate the safety and efficacy of medical treatments, procedures, or interventions under controlled conditions. The growth in clinical trials is primarily fueled by the rising demand for innovative treatments, as escalating rates of chronic and complex diseases push pharmaceutical and biotech companies to develop and test new therapies. Investigational new drug CDMOs support clinical trials by streamlining the development and manufacturing of trial-ready drug formulations, ensuring timely and compliant supply of investigational products for each phase of the study. For example, in November 2023, the Association of the British Pharmaceutical Industry, a UK-based trade association, reported a 4.3% increase in the annual number of industry-led clinical trials in the UK, rising from 394 in 2021 to 411 in 2022. Therefore, the rise in clinical trials is driving growth in the investigational new drug CDMO market.

Key players in the investigational new drug CDMO market are focusing on strategic partnerships to enhance development capabilities and accelerate clinical trial entry. Strategic partnerships are formal collaborations between two or more organizations that work together to achieve shared goals, leveraging each other's strengths, resources, or expertise while maintaining independent operations. For instance, in August 2023, Sartorius AG, a Germany-based life sciences company, partnered with Repligen Corporation, a US-based life sciences firm, to introduce an integrated system combining the BIOSTAT STR and XCell ATF technologies for upstream process intensification. This partnership aims to optimize biopharmaceutical production by improving efficiency and scalability. The collaboration highlights Sartorius' ongoing commitment to innovation in bioprocessing solutions and advancing the biomanufacturing industry.

In January 2024, Alcami Corporation, a US-based pharmaceutical contract development and manufacturing organization (CDMO), acquired Pacific Pharmaceutical Services for an undisclosed amount. This acquisition enables Alcami to expand its presence on the West Coast and strengthen its analytical testing and quality control capabilities. Pacific Pharmaceutical Services is a US-based company specializing in pharmaceutical testing and quality assurance services.

Major players in the investigational new drug contract development and manufacturing organization (CDMO) market are Thermo Fisher Scientific Inc., 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 SAS, Grand River Aseptic Manufacturing Inc., INCOG BioPharma Services, Aurigene Pharmaceutical Services, Jubilant HollisterStier LLC, Symbiosis Pharmaceutical Services Ltd., Afton Scientific Corp., and Amaran Biotech Inc.

North America was the largest region in the investigational new drug contract development and manufacturing organization (CDMO) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in investigational new drug contract development and manufacturing organization (CDMO) report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the investigational new drug contract development and manufacturing organization (CDMO) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The investigational new drug contract development and manufacturing organization (CDMO) market includes revenues earned by entities through analytical method development, clinical trial material manufacturing, process development, and quality control testing. 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 and 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.

Investigational New Drug Contract Development And Manufacturing Organization (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 investigational new drug contract development and manufacturing organization (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 investigational new drug contract development and manufacturing organization (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 investigational new drug contract development and manufacturing organization (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. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Characteristics

3. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Trends And Strategies

4. Investigational New Drug Contract Development And Manufacturing Organization (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 Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Growth Analysis And Strategic Analysis Framework

6. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Segmentation

7. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Regional And Country Analysis

8. Asia-Pacific Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

9. China Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

10. India Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

11. Japan Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

12. Australia Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

13. Indonesia Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

14. South Korea Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

15. Western Europe Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

16. UK Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

17. Germany Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

18. France Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

19. Italy Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

20. Spain Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

21. Eastern Europe Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

22. Russia Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

23. North America Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

24. USA Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

25. Canada Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

26. South America Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

27. Brazil Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

28. Middle East Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

29. Africa Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

30. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Competitive Landscape And Company Profiles

31. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Other Major And Innovative Companies

32. Global Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

34. Recent Developments In The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market

35. Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market High Potential Countries, Segments and Strategies

36. Appendix

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