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세계의 의료기기 임상시험 시장 보고서(2025년)
Medical Device Clinical Trials Global Market Report 2025
상품코드 : 1760609
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 175 Pages
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한글목차

의료기기 임상시험은 의료기기의 인체에 대한 안전성과 유효성을 평가하기 위해 실시되는 연구입니다. 이 과정에는 규제 당국의 승인을 위해 필수적인 타당성, 중추적, 승인 후 연구 등의 단계가 포함됩니다. 이러한 임상시험을 통해 기기의 시장 승인 및 지속적인 안전 모니터링에 필요한 중요한 데이터가 생성됩니다.

만성 질환의 유병률이 증가함에 따라 의료기기 임상시험 시장의 성장이 촉진될 것으로 예상됩니다. 만성 질환은 서서히 진행되고 지속적인 관리가 필요한 장기적인 건강 상태입니다. 이러한 질환은 개인이 책상에 앉아 있거나 전자 기기를 사용하는 등 앉아 있는 생활 방식이 증가함에 따라 칼로리 소모량이 감소하고 심혈관 건강이 약화되어 증가하고 있습니다. 이는 비만, 당뇨병, 고혈압과 같은 질환으로 이어집니다. 만성 질환의 확산으로 진단, 치료, 관리에 혁신적인 의료기기를 개발하고 검증하기 위한 의료기기 임상시험의 필요성이 증가하고 있습니다. 예를 들어, 2023년 6월 미국 기반 공중 보건 연구 기관인 건강 측정 및 평가 연구소(Institute for Health Metrics and Evaluation)는 전 세계에서 5억 명 이상이 당뇨병을 앓고 있으며, 이 숫자는 2050년까지 13억 명으로 두 배 이상 증가할 것으로 예상된다고 보고했습니다. 결과적으로 만성 질환의 유병률이 증가하면서 의료기기 임상시험 시장의 성장이 촉진되고 있습니다.

의료기기 임상시험 시장의 기업들은 임상시험 프로토콜과 자원 배분을 최적화하여 시험 효율성을 개선하고 비용을 절감하기 위해 AI 기반 의료기기 소프트웨어에 집중하고 있습니다. AI 기반 의료기기 소프트웨어는 기계 학습이나 딥 러닝과 같은 인공 지능(AI) 알고리즘을 사용하여 의료 업무를 지원하거나 자동화합니다. 예를 들어, 2025년 1월 스위스 기반 제약 회사 Risklick은 의료기기 임상시험을 가속화하고 최적화하기 위해 설계된 AI 기반 소프트웨어인 Protocol AI를 출시했습니다. Protocol AI는 자연어 처리(NLP)와 머신러닝(ML)을 활용해 임상 데이터, 논문, 규제 문서를 분석하고 몇 분 내에 임상시험 프로토콜을 자동으로 작성합니다. 이 혁신은 전통적으로 약 6개월이 소요되던 프로토콜 개발에 필요한 시간과 비용을 크게 줄였으며, 의약품의 문서 개발 시간도 최대 50% 단축하는 성과를 이미 입증했습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 - 금리, 인플레이션, 지정학, 무역전쟁과 관세, 코로나 19 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

Medical device clinical trials are research studies conducted to evaluate the safety and effectiveness of medical devices in humans. The process includes phases such as feasibility, pivotal, and post-approval studies, which are essential for regulatory approval. These trials generate critical data for device market authorization and continued safety monitoring.

The main study types in medical device clinical trials include feasibility and pilot studies, pivotal studies, FDA premarket approval (PMA) applications, and post-approval studies. Feasibility and pilot studies are early-phase trials with a small group of participants to assess the practicality, safety, and potential challenges of a new device before progressing to larger-scale trials. These studies span various indications such as cardiovascular, neurology, orthopedic, diagnostic imaging, anesthesia and respiratory devices, and others. Study designs typically include interventional, observational, and expanded access categories.

The medical device clinical trials market research report is one of a series of new reports from The Business Research Company that provides medical device clinical trials market statistics, including the medical device clinical trials industry global market size, regional shares, competitors with the medical device clinical trials market share, detailed medical device clinical trials market segments, market trends, and opportunities, and any further data you may need to thrive in the medical device clinical trials industry. This medical device clinical trials 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 clinical trials market size has grown strongly in recent years. It will grow from $16.87 billion in 2024 to $18.12 billion in 2025 at a compound annual growth rate (CAGR) of 7.4%. The growth in the historic period can be attributed to the rising prevalence of chronic diseases, increasing demand for innovative medical technologies, regulatory support for clinical research, growing aging population, expansion of healthcare infrastructure, and increased investment from public and private sectors.

The medical device clinical trials market size is expected to see strong growth in the next few years. It will grow to $23.91 billion in 2029 at a compound annual growth rate (CAGR) of 7.2%. The growth in the forecast period can be attributed to the increasing demand for personalized medical devices, rising focus on real-world evidence, growing use of AI in trial design and monitoring, expansion of decentralized and virtual trials, regulatory support for faster approvals, and increasing investments in digital health innovations. Major trends in the forecast period include the adoption of decentralized trials, integration of AI and big data analytics, use of wearable monitoring devices, enhanced regulatory harmonization, and advancements in trial design and data analytics.

The increasing prevalence of chronic diseases is expected to drive the growth of the medical device clinical trials market. Chronic diseases are long-term health conditions that progress slowly and require continuous management. These diseases are on the rise due to sedentary lifestyles, where individuals spend extended hours sitting at desks or using electronic devices, reducing calorie expenditure and weakening cardiovascular health. This leads to conditions such as obesity, diabetes, and hypertension. As chronic diseases become more prevalent, there is a greater need for medical device clinical trials to develop and validate innovative devices for diagnosis, treatment, and management. For example, in June 2023, the Institute for Health Metrics and Evaluation, a U.S.-based public health research institute, reported that over half a billion people worldwide were living with diabetes, and this number is projected to more than double, reaching 1.3 billion people by 2050. Consequently, the rising prevalence of chronic diseases is driving the growth of the medical device clinical trials market.

Companies in the medical device clinical trials market are focusing on AI-powered medical device software to optimize clinical trial protocols and resource allocation, improving trial efficiency and reducing costs. AI-powered medical device software uses artificial intelligence (AI) algorithms, such as machine learning or deep learning, to support or automate medical tasks. For instance, in January 2025, Risklick, a Switzerland-based pharmaceutical company, launched Protocol AI, an AI-based software designed to accelerate and optimize clinical trials for medical devices. Protocol AI uses Natural Language Processing (NLP) and Machine Learning (ML) to analyze clinical data, publications, and regulatory documents, automatically drafting clinical trial protocols in minutes. This innovation significantly reduces the time and cost required for protocol development, which traditionally takes around six months, and has already demonstrated up to a 50% reduction in document development time for medicinal products.

In January 2024, eMed, a U.S.-based health services company, acquired Science 37 for $38 million. This acquisition strengthens eMed's clinical research capabilities by combining telehealth and diagnostic services with decentralized trial technology to improve patient enrollment and reach underrepresented groups. Science 37 is a U.S.-based research company specializing in decentralized clinical trials, including those for medical devices.

Major players in the medical device clinical trials market are Abbott Laboratories, Siemens Healthineers, Stryker Corporation, Philips Healthcare, Baxter International, Roche Diagnostics, ICON, Intuitive Surgical, Edwards Lifesciences, Fortrea, Medidata, NAMSA, Veranex, TFS HealthScience, Avania, Parexel, Meditrial, Syneos Health, Qserve CRO, Clinius Ltd, Eclevar Medtech, 1med Sa, and ISS AG.

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

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

The medical device clinical trials market includes revenues earned by entities by providing services such as clinical trial design and management, regulatory consulting, site selection and monitoring, patient recruitment, data management, and statistical analysis. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device clinical trials market also includes sales of diagnostic devices, therapeutic devices, surgical instruments, monitoring equipment, implantable devices, wearable health technologies, and medical imaging systems. 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 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

Medical Device Clinical Trials 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 clinical trials 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 clinical trials ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The medical device clinical trials 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 Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.

Scope

Table of Contents

1. Executive Summary

2. Medical Device Clinical Trials Market Characteristics

3. Medical Device Clinical Trials Market Trends And Strategies

4. Medical Device Clinical Trials 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 Clinical Trials Growth Analysis And Strategic Analysis Framework

6. Medical Device Clinical Trials Market Segmentation

7. Medical Device Clinical Trials Market Regional And Country Analysis

8. Asia-Pacific Medical Device Clinical Trials Market

9. China Medical Device Clinical Trials Market

10. India Medical Device Clinical Trials Market

11. Japan Medical Device Clinical Trials Market

12. Australia Medical Device Clinical Trials Market

13. Indonesia Medical Device Clinical Trials Market

14. South Korea Medical Device Clinical Trials Market

15. Western Europe Medical Device Clinical Trials Market

16. UK Medical Device Clinical Trials Market

17. Germany Medical Device Clinical Trials Market

18. France Medical Device Clinical Trials Market

19. Italy Medical Device Clinical Trials Market

20. Spain Medical Device Clinical Trials Market

21. Eastern Europe Medical Device Clinical Trials Market

22. Russia Medical Device Clinical Trials Market

23. North America Medical Device Clinical Trials Market

24. USA Medical Device Clinical Trials Market

25. Canada Medical Device Clinical Trials Market

26. South America Medical Device Clinical Trials Market

27. Brazil Medical Device Clinical Trials Market

28. Middle East Medical Device Clinical Trials Market

29. Africa Medical Device Clinical Trials Market

30. Medical Device Clinical Trials Market Competitive Landscape And Company Profiles

31. Medical Device Clinical Trials Market Other Major And Innovative Companies

32. Global Medical Device Clinical Trials Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Device Clinical Trials Market

34. Recent Developments In The Medical Device Clinical Trials Market

35. Medical Device Clinical Trials Market High Potential Countries, Segments and Strategies

36. Appendix

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