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세계의 의료기기 수탁연구기관 시장 보고서(2025년)
Medical Device Contract Research Organization Global Market Report 2025
상품코드 : 1825802
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의료기기 수탁연구기관 시장 규모는 향후 몇 년 동안 급성장할 것으로 예상됩니다. 2029년 연평균 성장률(CAGR)은 12.0%로 118억 8,000만 달러에 달할 것으로 예상됩니다. 예측 기간의 성장은 규제 요건 강화, 맞춤형 의료 수요 증가, 임상시험의 복잡성, 임상시험 수 증가에 기인하는 것으로 보입니다. 예측 기간의 주요 동향으로는 인공지능의 통합, 맞춤형 의료, 시험의 분산화, 환자 친화적 의료기기 개발, 새로운 소형화 기술에 대한 수요 등이 있습니다.

향후 5년간 12.0%의 성장률 전망은 지난번 전망치보다 0.2% 소폭 하락한 수치입니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향에 기인합니다. 무역 마찰은 이스라엘과 한국에서 개발된 인공지능(AI) 기반 임상시험 플랫폼과 센서 일체형 웨어러블의 가격을 급등시키고, 이로 인해 기기 승인 지연, 스폰서의 연구개발(R&D) 비용 상승으로 미국의 첨단 시험 기술 채택을 방해할 수 있습니다. 가능성이 있습니다. 또한, 상호 관세와 무역 긴장과 제한의 증가로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향은 더욱 광범위하게 나타날 것으로 보입니다.

의료기기 수탁연구기관(CRO) 시장의 성장은 임상시험의 증가에 의해 주도될 것으로 예상됩니다. 임상시험은 치료제가 널리 사용되기 전에 그 안전성과 유효성을 평가하기 위해 사람을 대상으로 하는 조사 연구입니다. 임상시험의 증가는 의료기술의 발전, 만성질환의 유병률 증가, 연구개발에 대한 투자 증가에 기인합니다. 의료기기 CRO는 전문 지식, 인프라, 규제에 대한 지식을 제공함으로써 연구 방법을 간소화하고 시험 일정을 단축함으로써 이러한 시험을 촉진하는 데 중요한 역할을 하고 있습니다. 예를 들어, 영국 제약산업협회에 따르면, 영국에서 매년 시작되는 임상시험의 수는 2021년 394건에서 2022년 411건으로 4.3% 증가했습니다. 이러한 추세는 의료기기 CRO 시장 확대에 기여하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세, 그리고 코로나와 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 개요

제31장 기타 주요 기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병

제34장 최근의 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

KSM
영문 목차

영문목차

A medical device contract research organization (CRO) is a company that provides specialized services for conducting research and clinical trials on behalf of medical device manufacturers. These CROs focus on performing clinical trials and other research tasks essential for the development, testing, and validation of medical devices.

The several categories of medical device CROs are finished medical devices, semi-finished medical devices, and medical device raw materials. Finished medical devices are products that have undergone the entire manufacturing process and are ready for use or distribution. These devices are categorized into different classes-Class 1, Class 2, and Class 3-and can be involved in various phases such as preclinical or clinical studies. They serve multiple fields, including cardiology, diagnostic imaging, orthopedics, in vitro diagnostics (IVD), ophthalmology, general and plastic surgery, and drug delivery.

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 resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

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

The medical device contract research organization market size has grown rapidly in recent years. It will grow from $6.74 billion in 2024 to $7.55 billion in 2025 at a compound annual growth rate (CAGR) of 12.0%. The growth in the historic period can be attributed to rising healthcare demand, the trend towards outsourcing research and trials, increased demand for diagnostic devices, and increased demand for support diagnostic devices.

The medical device contract research organization market size is expected to see rapid growth in the next few years. It will grow to $11.88 billion in 2029 at a compound annual growth rate (CAGR) of 12.0%. The growth in the forecast period can be attributed to stricter regulatory requirements, increasing personalized medicine demand, growing clinical trial complexity, and an increasing number of clinical trials. Major trends in the forecast period include artificial intelligence integration, personalized medicine, decentralized trials, the development of patient-friendly medical devices, and the demand for new miniature technology.

The forecast of 12.0% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. adoption of cutting-edge trial technologies by inflating prices of Artificial intelligence(AI)-driven clinical trial platforms and sensor-integrated wearables developed in Israel and South Korea, resulting in slower device approvals and higher research and development (R&D) costs for sponsors. 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 growth of the medical device contract research organization (CRO) market is expected to be driven by the increasing number of clinical trials. These trials are research studies involving human participants to evaluate the safety and effectiveness of medical treatments before they are widely used. The rise in clinical trials is attributed to advancements in medical technology, the growing prevalence of chronic diseases, and increased investment in research and development. Medical device CROs play a crucial role in facilitating these trials by offering specialized expertise, infrastructure, and regulatory knowledge to streamline research processes and speed up trial timelines. For example, according to the Association of the British Pharmaceutical Industry, the number of clinical trials initiated annually in the UK grew by 4.3%, from 394 trials in 2021 to 411 in 2022. This trend is contributing to the expansion of the medical device CRO market.

Major players in the medical device CRO market are concentrating on creating innovative services to improve regulatory compliance and enhance clinical trial efficiency. These services, known as comprehensive CRO services, include a broad array of support activities such as regulatory compliance and submissions, clinical trial design and management, patient recruitment and retention, data collection and analysis, monitoring and quality assurance, and post-market surveillance. For instance, Lindus Health Limited, a UK-based CRO, introduced a new all-in-one medical device CRO service in June 2024. This service integrates traditional CRO offerings with Lindus Health's specialized knowledge in medical device clinical trials, including regulatory pathways, participant recruitment, and virtual/hybrid trial capabilities. The comprehensive offering includes end-to-end CRO and study management, innovative recruitment strategies, study-specific eClinical software, medical device and regulatory expertise, and dedicated site services.

In August 2024, Labquality Corporation, a Finland-based contract research organization (CRO), acquired Scandinavian CRO for an undisclosed amount. This acquisition allows Labquality to reinforce its position as a full-service CRO, facilitating further geographical expansion and growth in Scandinavia, while enhancing its services for the health technology and pharmaceutical sectors. Scandinavian CRO, based in Sweden, is a contract research organization specializing in clinical research services.

Major companies operating in the medical device contract research organization market are Laboratory Corporation of America Holdings, ICON Public Limited Company, Eurofins Scientific Societas Europaea, Pharmaceutical Product Development LLC, WuXi AppTec Co. Ltd., Syneos Health Inc., Charles River Laboratories International Inc., Medpace Holdings Inc., Tigermed Consulting Co. Ltd., Novotech (Australia) Pty Ltd, NAMSA LLC, Promedica International, Excelya, Avania UK Ltd, OSMUNDA MEDICAL DEVICE SERVICE GROUP, CROMSOURCE, Musculoskeletal Clinical Regulatory Advisers LLC, BIO Agile Therapeutics Pvt Ltd, Vial, Qserve Group, CSSi LifeSciences, Medidee Services SA, Eclevar Medtech, Scandinavian CRO, Archer Research, Parexel International Corporation, Clinitude, Geneticist Inc.

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

The countries covered in the medical device contract research organization market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The medical device contract research organization market includes revenues earned by entities by providing services such as clinical trial management, data collection and database management, preclinical research, medical writing, and project 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.

Medical Device Contract Research Organization 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 medical device contract research organization 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 medical device contract research organization ? 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 medical device contract research organization 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. Medical Device Contract Research Organization Market Characteristics

3. Medical Device Contract Research Organization Market Trends And Strategies

4. Medical Device Contract Research Organization 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 Medical Device Contract Research Organization Growth Analysis And Strategic Analysis Framework

6. Medical Device Contract Research Organization Market Segmentation

7. Medical Device Contract Research Organization Market Regional And Country Analysis

8. Asia-Pacific Medical Device Contract Research Organization Market

9. China Medical Device Contract Research Organization Market

10. India Medical Device Contract Research Organization Market

11. Japan Medical Device Contract Research Organization Market

12. Australia Medical Device Contract Research Organization Market

13. Indonesia Medical Device Contract Research Organization Market

14. South Korea Medical Device Contract Research Organization Market

15. Western Europe Medical Device Contract Research Organization Market

16. UK Medical Device Contract Research Organization Market

17. Germany Medical Device Contract Research Organization Market

18. France Medical Device Contract Research Organization Market

19. Italy Medical Device Contract Research Organization Market

20. Spain Medical Device Contract Research Organization Market

21. Eastern Europe Medical Device Contract Research Organization Market

22. Russia Medical Device Contract Research Organization Market

23. North America Medical Device Contract Research Organization Market

24. USA Medical Device Contract Research Organization Market

25. Canada Medical Device Contract Research Organization Market

26. South America Medical Device Contract Research Organization Market

27. Brazil Medical Device Contract Research Organization Market

28. Middle East Medical Device Contract Research Organization Market

29. Africa Medical Device Contract Research Organization Market

30. Medical Device Contract Research Organization Market Competitive Landscape And Company Profiles

31. Medical Device Contract Research Organization Market Other Major And Innovative Companies

32. Global Medical Device Contract Research Organization Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Device Contract Research Organization Market

34. Recent Developments In The Medical Device Contract Research Organization Market

35. Medical Device Contract Research Organization Market High Potential Countries, Segments and Strategies

36. Appendix

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