의료기기 수탁연구기관 시장 규모, 점유율, 동향 분석 보고서 : 단계별, 서비스별, 기기 유형별, 지역별, 부문별 예측(2024-2030년)

Medical Device Contract Research Organization Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Service, By Device Type, By Region, And Segment Forecasts, 2024 - 2030

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한글목차

의료기기 수탁연구기관 시장 성장 및 동향:

Grand View Research, Inc.의 최신 보고서에 따르면, 세계 의료기기 수탁연구기관 시장 규모는 2030년까지 140억 달러에 달할 것으로 예상되며, 2024년부터 2030년까지 연평균 8.95%의 성장률을 보일 것으로 전망됩니다.

주요 시장 촉진요인으로는 시간 단축, 비용 효율성, 전문 지식에 대한 수요 증가가 꼽히며, 이는 기기가 시장에 출시되는 과정을 가속화할 수 있습니다. 또한, 의료기기에 대한 세부적인 전문 지식을 갖춘 CRO에 아웃소싱하면 일상적으로 의료기기를 다루기 때문에 복잡한 규제 요건과 감사에 더 쉽게 대응할 수 있습니다. 이는 의료기기 CRO 서비스에 대한 수요를 더욱 촉진하고 있습니다.

CRO는 또한 Iqvia, Inc., ICON Plc, Charles River 등 최신의 최첨단 하드웨어, 소프트웨어, 인터넷 기반 애플리케이션과 같은 최첨단 기술 자원을 모두 활용하여 프로세스를 가속화하고 품질을 유지할 수 있습니다, Iqvia, Inc., ICON Plc, Charles River와 같이 고품질의 의료기기 관련 연구 서비스를 제공하는 CRO가 다수 존재하기 때문에 향후 몇 년 동안 의료기기 관련 연구 공동연구가 개선되고 시장 성장을 촉진할 것으로 예상됩니다.

의료 시술은 복강경 및 카테터 기반 기술로 전환되고 있습니다. 최소침습 수술은 다른 수술에 비해 위험이 적기 때문에 전 세계적으로 수요가 증가하고 있습니다. 이에 따라 수술의 스크리닝 및 모니터링을 위한 첨단 장비에 대한 수요가 증가할 것으로 예상됩니다. 최소침습 수술은 새로운 소형화 기술에 대한 수요도 증가시키고 있습니다. 이에 따라 최소침습적 첨단 의료기기에 대한 연구 건수가 증가하여 시장 성장을 촉진할 것으로 예상됩니다.

이러한 의료기기의 복잡성, 소비자 선호도의 변화, 휴대용 기기에 대한 수요 증가는 의료기기의 시장 개척을 위한 전문가 팀의 필요성을 촉진하고 시장에서 CRO에 대한 수요를 증가시킬 것으로 예상되는 요인 중 하나입니다.

의료기기 수탁연구기관 시장 보고서 하이라이트

• 2023년에는 임상 단계 부문이 시장을 주도했습니다. 이는 수많은 임상시험이 수반되는 새로운 의료기기의 개발에 기인합니다. 따라서 의료기기 기업들은 필요한 인프라, 직원 및 전문 지식을 갖춘 임상시험 서비스를 제공하는 CRO를 지정하거나 별도의 연구소를 설립하는 것을 선호합니다.
• 서비스별로는 임상 모니터링이 2023년 21.0%로 가장 큰 시장 점유율을 차지했습니다. 임상시험의 성공을 위해서는 종합적인 모니터링이 필요합니다. 따라서 기업들은 임상 모니터링 기능을 전문 지식과 최신 교육 프로그램을 갖춘 CRO에 위탁하고 있습니다. CRO는 스폰서의 임상시험 계획서, 표준 업무 절차서, FDA 규정 및 우수 임상시험 관리기준(GCP)에 따라 모니터링 활동을 수행합니다.
• 기기 유형별로는 진단기기 부문이 2023년 44.9%의 매출 점유율을 차지했습니다. 전 세계 질병의 확산은 진단 기기 CRO 활동에 대한 수요를 뒷받침하고 있습니다. 또한 심혈관 질환, 암 및 기타 질병의 유병률 증가가 시장 성장의 원동력이 되고 있습니다.
• 아시아태평양은 2023년 매출 점유율 41.9%로 시장을 주도했습니다. 이 시장의 강력한 성장은 규제 프레임워크 개선, 비용 절감, 장비의 복잡성 증가, 이 지역의 의료기기 연구 기관 증가 등 다양한 요인에 기인합니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 의료기기 수탁연구기관 시장 : 변수, 동향, 범위

• 시장 계통 전망
• COVID-19가 임상시험 서비스 시장에 미치는 영향
• 의료기기 수탁연구기관 시장 역학
• 의료기기 수탁연구기관 시장 분석 툴
• 의료기기 개발비와 임상 상황

제4장 의료기기 수탁연구기관 시장 : 단계 부문 분석

• 의료기기 수탁연구기관 시장 : 단계별 부문 : 주요 포인트
• 의료기기 수탁연구기관 시장 : 단계 변동 분석
• 단계 유형별
• 전임상
• 임상

제5장 의료기기 수탁연구기관 시장 : 서비스 부문 분석

• 의료기기 수탁연구기관 시장 : 서비스 부문별 : 주요 포인트
• 의료기기 수탁연구기관 시장 : 서비스 변동 분석
• 서비스별
• 프로젝트 관리/임상 서플라이 관리
• 데이터 관리
• 규제/MA(Medical Affairs)
• 메디컬 라이팅
• 품질 관리/보증
• 생물 통계
• 임상시험약 지불
• 실험실
• 환자·임상시험 사이트 모집
• 기술
• 기타

제6장 의료기기 수탁연구기관 시장 : 기기 유형 부문 분석

• 의료기기 수탁연구기관 시장 : 기기 유형별 부문 : 중요한 포인트
• 의료기기 수탁연구기관 시장 : 기기 유형 변동 분석
• 기기 유형별
• 프로젝트 관리/임상 서플라이 관리
• 메드테크 기기
• 진단 기기
• 헨드헬드 기기
• 기타

제7장 의료기기 수탁연구기관 시장 : 지역 분석

• 지역 부문별 의료기기 수탁연구기관 시장 : 주요 포인트
• 의료기기 수탁연구기관 : 시장 점유율 분석, 2023년 및 2030년
• 지역 마켓플레이스, 주요 포인트
• 지역별
• 북미
• 유럽
• 아시아태평양
• 라틴아메리카
• 중동 및 아프리카

제8장 경쟁 분석

• 진출 기업 개요
  • IQVIA, Inc.
  • Charles River Laboratories
  • ICON, Plc
  • Syneos Health
  • Laboratory Corporation Of America Holdings
  • Wuxi Apptec
  • Medpace
  • Eurofins Scientific SE
  • Promedica International
  • Qserve
• 재무 실적
• 서비스 벤치마크
• 진출 기업
• 시장 리더
  • 의료기기 수탁연구기관 시장 점유율 분석, 2023년
• 전략 매핑
  • 서비스 개시/업그레이드
  • 합병/인수/합작투자
  • 파트너십/계약
  • 확장
• 시장 상황 분석,2022/2023(히트맵 분석)

제9장 요점

ksm

영문 목차

영문목차

Medical Device Contract Research Organization Market Growth & Trends:

The global medical device contract research organization market size is expected to reach USD 14.0 billion by 2030, growing at a CAGR of 8.95% from 2024 to 2030, according to a new report by Grand View Research, Inc. The key market growth drivers include rising demand for time-saving, cost efficient, and expertise in the area, which accelerates the process of devices reaching the market. In addition, outsourcing to a CRO with detailed expertise in a medical device helps in meeting the complex regulatory requirements and audits as they work on it on a daily basis. This further supports the demand for medical device CRO services.

CROs also have access to the most advanced technological resources, such as all the latest and most advanced hardware, software, and internet-based applications, to make the process fast and maintain quality. A significant number of CROs such as Iqvia, Inc., ICON Plc, Charles River, and others offering high-quality medical device-related research services are expected to improve medical device-related research collaborations in the coming years and thus boost the market growth.

Medical procedures are moving toward more laparoscopic and catheter-based technology. There has been a growing demand for minimally invasive procedures worldwide, as they are less risky compared to other surgical procedures. This is expected to boost the demand for advanced devices for screening and monitoring surgical procedures. Minimally invasive procedures are also enhancing the demand for new miniature technology. This is expected to improve the number of research in advanced less invasive medical devices and hence promote market growth.

Thus, growing complexities in medical devices, changing consumer preferences, and increasing demand for portable devices are among the factors expected to drive the need for an expert team for the development of medical devices, thereby increasing the demand for CROs in the market.

Medical Device Contract Research Organization Market Report Highlights:

• The clinical phase segment dominated the market in 2023. This can be attributed to the development of novel medical devices, which involves numerous clinical trials. Hence, medical device companies prefer appointing a CRO to provide clinical trial services with the required infrastructure, staff, and expertise or opening a separate laboratory
• Based on service, clinical monitoring held the largest market share of 21.0% in 2023. Clinical trials need comprehensive monitoring for their success. Therefore, companies outsource clinical monitoring functions to CROs with staff expertise and updated training programs. These CRO conduct monitoring activities in accordance with a sponsor's study protocol, standard operating procedures, FDA regulations, and Good Clinical Practice (GCP)
• Based on device type, the diagnostic devices segment held a revenue share of 44.9% in 2023. The growing prevalence of diseases worldwide is supporting the demand for CRO activities for diagnostic devices. Besides, increasing prevalence of cardiovascular diseases, cancer, among other diseases drives the market growth
• Asia Pacific dominated the market with a revenue share of 41.9% in 2023. The market's strong growth is due to various factors such as improvements in the regulatory framework, higher cost savings, increasing complexity in devices, and a growing number of medical device research organizations in the region

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market Segmentation & Scope
  • 1.1.1 Regional Scope
  • 1.1.2 Estimates And Forecast Timeline
• 1.2 Research Methodology
• 1.3 Information Procurement
  • 1.3.1 Purchased Database
  • 1.3.2 GVR's Internal Database
  • 1.3.3 Secondary Sources
  • 1.3.4 Primary Research
  • 1.3.5 Details Of Primary Research
• 1.4 Information Or Data Analysis
  • 1.4.1 Information Analysis
• 1.5 Market Formulation & Visualization
• 1.6 Data Validation & Publishing
• 1.7 Model Details
  • 1.7.1 Commodity Flow Analysis (Model 1)
• 1.8 List Of Secondary Sources
• 1.9 List Of Primary Sources
• 1.10 List Of Abbreviations
• 1.11 Objectives
  • 1.11.1 Objective - 1
  • 1.11.2 Objective - 2
  • 1.11.3 Objective - 3
  • 1.11.4 Objective - 4

Chapter 2 Executive Summary

• 2.1 Market Snapshot
• 2.2 Segment Snapshot
• 2.3 Segment Snapshot
• 2.4 Competitive Landscape Snapshot

Chapter 3 Medical Device Contract Research Organization Market: Variables, Trends, & Scope

• 3.1 Market Lineage Outlook
  • 3.1.1 Parent Market Outlook
    • 3.1.1.1 Global Healthcare CRO Market
    • 3.1.1.2 Global Medical Device Outsourcing Market
  • 3.1.2 Ancillary Market Outlook
    • 3.1.2.1 Global Regulatory Affairs Outsourcing Market
    • 3.1.2.2 Global Regulatory Affairs Market
• 3.2 COVID-19 Impact On The Clinical Trial Services Market
  • 3.2.1 COVID-19 Impact On Medical Devices Clinical Trial
  • 3.2.2 COVID-19 Impact On Medical Device Approvals
  • 3.2.3 COVID-19 Impact On Medical Device Supply Chain
  • 3.2.4 COVID-19 Impact On The Revenue Of Key Industry Players
  • 3.2.5 Post-COVID-19 Impact On The Market
• 3.3 Medical Device Contract Research Organizations Market Dynamics
  • 3.3.1 Market Driver Analysis
    • 3.3.1.1 Rising Demand For Advanced Products
    • 3.3.1.2 Increasing Complexity In Product Design And Engineering
    • 3.3.1.3 Increasing Outsourcing To Emerging Countries Due To Cost-Benefit
  • 3.3.2 Market Restraint Analysis
    • 3.3.2.1 Compliance Issues While Outsourcing
  • 3.3.3 Industry Challenges
    • 3.3.3.1 Quality Issues Associated With Outsourcing
• 3.4 Medical Device Contract Research Organizations Market Analysis Tools
  • 3.4.1 Porter's Five Forces Analysis
  • 3.4.2 PESTEL Analysis
• 3.5 Medical Device Development Cost And Clinical Landscape
  • 3.5.1 FDA Classifications For Medical Devices
  • 3.5.2 Development Cost Analysis
  • 3.5.3 Average Total Expenditure By Stage For 510(K) PRODUCTS (2022)
  • 3.5.4 Unique Challenges In Medical Device Clinical Trials
  • 3.5.5 Drivers And Constraints In Medical Device Clinical Trials Contract Research Organizations

Chapter 4 Medical Device Contract Research Organization Market: Phase Segment Analysis

• 4.1 Medical Device Contract Research Organization Market By Phase Segment: Key Takeaways
• 4.2 Medical Device Contract Research Organization Market: Phase Movement Analysis
• 4.3 Medical Device Contract Research Organization Market Estimates & Forecast By Phase Type (USD Million)
  • 4.3.1 Preclinical
    • 4.3.1.1 Preclinical Market, 2018 - 2030 (USD Million)
  • 4.3.2 Clinical
    • 4.3.2.1 Clinical Market, 2018 - 2030 (USD Million)

Chapter 5 Medical Device Contract Research Organization Market: Service Segment Analysis

• 5.1 Medical Device Contract Research Organization Market By Service Segment: Key Takeaways
• 5.2 Medical Device Contract Research Organization Market: Service Movement Analysis
• 5.3 Medical Device Contract Research Organization Market Estimates & Forecast By Service (USD Million)
  • 5.3.1 Project Management/Clinical Supply Management
    • 5.3.1.1 Project Management/Clinical Supply Management Market, 2018 - 2030 (USD Million)
  • 5.3.2 Data Management
    • 5.3.2.1 Data Management Market, 2018 - 2030 (USD Million)
  • 5.3.3 Regulatory/Medical Affairs
    • 5.3.3.1 Regulatory/Medical Affairs Market, 2018 - 2030 (USD Million)
  • 5.3.4 Medical Writing
    • 5.3.4.1 Medical Writing Market, 2018 - 2030 (USD Million)
  • 5.3.5 Clinical Monitoring
    • 5.3.5.1 Clinical Monitoring Market, 2018 - 2030 (USD Million)
  • 5.3.6 Quality Management/Assurance
    • 5.3.6.1 Quality Management/Assurance Market, 2018 - 2030 (USD Million)
  • 5.3.7 Bio-Statistics
    • 5.3.7.1 Bio-Statistics Market, 2018 - 2030 (USD Million)
  • 5.3.8 Investigator Payments
    • 5.3.8.1 Investigator Payments Market, 2018 - 2030 (USD Million)
  • 5.3.9 Laboratory
    • 5.3.9.1 Laboratory Market, 2018 - 2030 (USD Million)
  • 5.3.10 Patient And Site Recruitment
    • 5.3.10.1 Patient And Site Recruitment Market, 2018 - 2030 (USD Million)
  • 5.3.11 Technology
    • 5.3.11.1 Technology Market, 2018 - 2030 (USD Million)
  • 5.3.12 Others
    • 5.3.12.1 Others Market, 2018 - 2030 (USD Million)

Chapter 6 Medical Device Contract Research Organization Market: Device Type Segment Analysis

• 6.1 Medical Device Contract Research Organization Market By Device Type Segment: Key Takeaways
• 6.2 Medical Device Contract Research Organization Market: Device Type Movement Analysis
• 6.3 Medical Device Contract Research Organization Market Estimates & Forecast By Device Type (USD Million)
  • 6.3.1 Medtech Devices
    • 6.3.1.1 Medtech Devices Market, 2018 - 2030 (USD Million)
  • 6.3.2 Diagnostic Devices
    • 6.3.2.1 Diagnostic Devices Market, 2018 - 2030 (USD Million)
  • 6.3.3 Handled Devices
    • 6.3.3.1 Handled Devices Market, 2018 - 2030 (USD Million)
  • 6.3.4 Others
    • 6.3.4.1 Others Market, 2018 - 2030 (USD Million)

Chapter 7 Medical Device Contract Research Organization Market: Regional Analysis

• 7.1 Medical Device Contract Research Organization Market By Regional Segment: Key Takeaways
• 7.2 Medical Device Contract Research Organization: Market Share Analysis, 2023 & 2030
• 7.3 Regional Marketplace, Key Takeaways
• 7.4 Medical Device Contract Research Organization: Market Estimates And Forecast, By Region (USD Million)
• 7.5 North America
  • 7.5.1 Competitive Scenario
  • 7.5.2 North America Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.5.3 U.S.
    • 7.5.3.1 Key Country Dynamics
    • 7.5.3.2 Competitive Scenario
    • 7.5.3.3 U.S. Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.5.4 Canada
    • 7.5.4.1 Key Country Dynamics
    • 7.5.4.2 Competitive Scenario
    • 7.5.4.3 Canada Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
• 7.6 Europe
  • 7.6.1 Competitive Scenario
  • 7.6.2 Europe Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.3 UK
    • 7.6.3.1 Key Country Dynamics
    • 7.6.3.2 Competitive Scenario
    • 7.6.3.3 UK Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.4 Germany
    • 7.6.4.1 Key Country Dynamics
    • 7.6.4.2 Competitive Scenario
    • 7.6.4.3 Germany Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.5 France
    • 7.6.5.1 Key Country Dynamics
    • 7.6.5.2 Competitive Scenario
    • 7.6.5.3 France Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.6 Italy
    • 7.6.6.1 Key Country Dynamics
    • 7.6.6.2 Competitive Scenario
    • 7.6.6.3 Italy Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.7 Spain
    • 7.6.7.1 Key Country Dynamics
    • 7.6.7.2 Competitive Scenario
    • 7.6.7.3 Spain Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.8 Sweden
    • 7.6.8.1 Key Country Dynamics
    • 7.6.8.2 Competitive Scenario
    • 7.6.8.3 Sweden Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.9 Denmark
    • 7.6.9.1 Key Country Dynamics
    • 7.6.9.2 Competitive Scenario
    • 7.6.9.3 Denmark Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.6.10 Norway
    • 7.6.10.1 Key Country Dynamics
    • 7.6.10.2 Competitive Scenario
    • 7.6.10.3 Norway Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
• 7.7 Asia Pacific
  • 7.7.1 Competitive Scenario
  • 7.7.2 Asia Pacific Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.3 Japan
    • 7.7.3.1 Key Country Dynamics
    • 7.7.3.2 Competitive Scenario
    • 7.7.3.3 Japan Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.4 China
    • 7.7.4.1 Key Country Dynamics
    • 7.7.4.2 Competitive Scenario
    • 7.7.4.3 China Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.5 India
    • 7.7.5.1 Key Country Dynamics
    • 7.7.5.2 Competitive Scenario
    • 7.7.5.3 India Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.6 Thailand
    • 7.7.6.1 Key Country Dynamics
    • 7.7.6.2 Competitive Scenario
    • 7.7.6.3 Thailand Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.7 South Korea
    • 7.7.7.1 Key Country Dynamics
    • 7.7.7.2 Competitive Scenario
    • 7.7.7.3 South Korea Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.7.8 Australia
    • 7.7.8.1 Key Country Dynamics
    • 7.7.8.2 Competitive Scenario
    • 7.7.8.3 Australia Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
• 7.8 Latin America
  • 7.8.1 Competitive Scenario
  • 7.8.2 Latin America Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.8.3 Brazil
    • 7.8.3.1 Key Country Dynamics
    • 7.8.3.2 Competitive Scenario
    • 7.8.3.3 Brazil Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.8.4 Mexico
    • 7.8.4.1 Key Country Dynamics
    • 7.8.4.2 Competitive Scenario
    • 7.8.4.3 Mexico Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.8.5 Argentina
    • 7.8.5.1 Key Country Dynamics
    • 7.8.5.2 Competitive Scenario
    • 7.8.5.3 Argentina Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
• 7.9 Middle East & Africa
  • 7.9.1 Competitive Scenario
  • 7.9.2 Middle East & Africa Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.9.3 South Africa
    • 7.9.3.1 Key Country Dynamics
    • 7.9.3.2 Competitive Scenario
    • 7.9.3.3 South Africa Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.9.4 Saudi Arabia
    • 7.9.4.1 Key Country Dynamics
    • 7.9.4.2 Competitive Scenario
    • 7.9.4.3 Saudi Arabia Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.9.5 UAE
    • 7.9.5.1 Key Country Dynamics
    • 7.9.5.2 Competitive Scenario
    • 7.9.5.3 UAE Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)
  • 7.9.6 Kuwait
    • 7.9.6.1 Key Country Dynamics
    • 7.9.6.2 Competitive Scenario
    • 7.9.6.3 Kuwait Medical Device Contract Research Organization Market, 2018 - 2030 (USD Million)

Chapter 8 Competitive Analysis

• 8.1 Participants' Overview
  • 8.1.1 IQVIA, Inc.
  • 8.1.2 Charles River Laboratories
  • 8.1.3 ICON, Plc
  • 8.1.4 Syneos Health
  • 8.1.5 Laboratory Corporation Of America Holdings
  • 8.1.6 Wuxi Apptec
  • 8.1.7 Medpace
  • 8.1.8 Eurofins Scientific SE
  • 8.1.9 Promedica International
  • 8.1.10 Qserve
• 8.2 Financial Performance
• 8.3 Service Benchmarking
• 8.4 Participant Categorization
• 8.5 Market Leaders
  • 8.5.1 Medical Device Contract Research Organization Market Share Analysis, 2023
• 8.6 Strategy Mapping
  • 8.6.1 Service Launches/upgrades
  • 8.6.2 Mergers/acquisitions/joint Ventures
  • 8.6.3 Partnerships/agreements
  • 8.6.4 Expansions
• 8.7 Market Position Analysis, 2022/2023 (Heat Map Analysis)

Chapter 9 Key Takeaways

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