한글목차

의료기기 아웃소싱 세계 시장 규모는 2024년에 1,316억 6,000만 달러에서 2030년에는 2,708억 6,000만 달러에 달할 것으로 예상되며, 예측 기간 동안 연평균 12.75%의 CAGR로 확대될 것으로 예상됩니다.

이러한 성장의 배경에는 고품질 의료기기에 대한 수요 증가, 복잡한 규제, 비용 효율적인 운영의 필요성이 있습니다. 주문자상표부착생산(OEM)은 설계, 제조, 포장, 물류 등의 프로세스를 간소화하기 위해 아웃소싱을 활용하고 있으며, 이를 통해 혁신과 핵심 역량에 집중할 수 있게 되었습니다. 이 산업의 진화는 자동화, 디지털 통합의 발전, 개인화된 의료기기에 대한 선호도 증가에 의해 형성되고 있습니다. 경쟁이 치열해짐에 따라 아웃소싱은 시장 출시 시간을 단축하고, 제품 품질을 향상시키며, 규제 준수를 유지하는 데 있어 전략적 이점을 제공합니다.

시장 촉진요인

비용 효율적인 솔루션에 대한 수요 증가

주요 시장 과제

지적재산권(IP) 리스크

주요 시장 동향

분석 시험 서비스 확대

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 소리

제5장 세계의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
  • 금액별
• 시장 점유율과 예측
  • 서비스별(품질 보증, 규제 관련 서비스, 제품 설계·개발 서비스, 제품 시험·멸균 서비스, 제품 구현 서비스, 제품 업그레이드 서비스, 제품 보수 서비스, 계약 제조)
  • 용도별(심장병학, 진단 영상, 정형외과, 체외진단, 안과, 일반외과 및 성형외과, 약물전달, 치과, 내시경 검사, 당뇨병 치료, 기타)
  • 클래스별(클래스 I, 클래스 II, 클래스 III)
  • 기업별(2024년)
  • 지역별
• 시장 맵

제6장 북미의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 북미 : 국가별 분석
  • 미국
  • 멕시코
  • 캐나다

제7장 유럽의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 유럽 : 국가별 분석
  • 프랑스
  • 독일
  • 영국
  • 이탈리아
  • 스페인

제8장 아시아태평양의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 아시아태평양 : 국가별 분석
  • 중국
  • 인도
  • 한국
  • 일본
  • 호주

제9장 남미의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 남미 : 국가별 분석
  • 브라질
  • 아르헨티나
  • 콜롬비아

제10장 중동 및 아프리카의 의료기기 아웃소싱 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 중동 및 아프리카 : 국가별 분석
  • 남아프리카공화국
  • 사우디아라비아
  • 아랍에미리트

제11장 시장 역학

• 성장 촉진요인
• 과제

제12장 시장 동향과 발전

• 인수합병
• 제품 출시
• 최근 동향

제13장 Porter's Five Forces 분석

• 업계내 경쟁
• 신규 참여의 가능성
• 공급업체의 능력
• 고객의 능력
• 대체품의 위협

제14장 경쟁 구도

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• Charles River Laboratories
• Medical Device Testing Services
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

제15장 전략적 제안

제16장 조사 회사 소개 및 면책사항

영문목차

The Global Medical Device Outsourcing Market was valued at USD 131.66 Billion in 2024 and is projected to reach USD 270.86 Billion by 2030, expanding at a CAGR of 12.75% during the forecast period. This growth is driven by rising demand for high-quality medical devices, increasing regulatory complexities, and the need for cost-efficient operations. Original Equipment Manufacturers (OEMs) are increasingly turning to outsourcing to streamline processes like design, manufacturing, packaging, and logistics, allowing them to focus on innovation and core competencies. The industry's evolution is also being shaped by advancements in automation, digital integration, and a growing preference for personalized medical devices. As competition intensifies, outsourcing offers a strategic edge in reducing time-to-market, enhancing product quality, and maintaining regulatory compliance.

Key Market Drivers

Rising Demand for Cost-Effective Solutions

The rising need for cost-effective production strategies is a primary force fueling the global medical device outsourcing market. As healthcare expenditures escalate worldwide, manufacturers are under pressure to maintain high product quality while cutting operational costs. Outsourcing offers a viable solution, allowing OEMs to delegate non-core tasks such as product design, manufacturing, testing, and packaging to third-party experts, often in cost-effective regions. This shift reduces capital investment in facilities, labor, and technology, enabling companies to focus on R&D and innovation. In addition to reducing costs, outsourcing accelerates product development cycles and time-to-market, especially important in highly competitive markets. Furthermore, in cost-sensitive emerging economies, outsourcing helps deliver affordable medical devices without compromising on safety or standards, thereby increasing market accessibility and driving strategic collaborations across the industry.

Key Market Challenges

Intellectual Property (IP) Risks

Intellectual property protection remains a critical challenge in the global medical device outsourcing landscape. As OEMs outsource core functions, they often share proprietary technologies and designs with external partners, raising concerns over IP theft and unauthorized replication. This is particularly concerning in regions with limited regulatory enforcement or weaker IP laws. Infringements can result in financial losses, reputational harm, and reduced market competitiveness. Furthermore, disagreements over ownership rights and licensing can delay product development and lead to legal disputes. To mitigate these risks, companies must adopt stringent contractual frameworks, enforce non-disclosure agreements, and carefully vet outsourcing partners for compliance with international IP standards. Vigilance in IP management is vital for sustaining innovation and securing competitive advantage in the outsourcing ecosystem.

Key Market Trends

Expansion of Analytical Testing Services

The growing complexity of medical devices has increased the demand for advanced analytical testing services, a key trend shaping the global medical device outsourcing market. Regulatory authorities like the FDA are intensifying scrutiny, especially for emerging technologies such as AI-enabled devices. In 2023 alone, the FDA approved 221 AI-powered devices, up from just six in 2015. This surge requires rigorous testing to ensure safety and effectiveness, propelling the need for outsourced analytical expertise. Additionally, adherence to global standards such as ISO 13485-which had over 20,000 valid certifications globally by the end of 2023-further underscores the critical role of robust quality management systems. Outsourcing analytical testing allows manufacturers to access specialized labs, reduce compliance risks, and maintain consistent quality throughout the product lifecycle. This trend is expected to gain momentum as medical devices become increasingly sophisticated and regulated.

Key Market Players

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• Charles River Laboratories
• Medical Device Testing Services
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

Report Scope:

In this report, the Global Medical Device Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Medical Device Outsourcing Market, By Service:

• Quality Assurance
• Regulatory Affairs Services
• Product Design and Development Services
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing

Medical Device Outsourcing Market, By Application:

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

Medical Device Outsourcing Market, By Class:

• Class I
• Class II
• Class III

Medical Device Outsourcing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Medical Device Outsourcing Market.

Available Customizations:

Global Medical Device Outsourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, and Trends

4. Voice of Customer

5. Global Medical Device Outsourcing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing)
  • 5.2.2. By Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others)
  • 5.2.3. By Class (Class I, Class II, Class III)
  • 5.2.4. By Company (2024)
  • 5.2.5. By Region
• 5.3. Market Map

6. North America Medical Device Outsourcing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service
  • 6.2.2. By Application
  • 6.2.3. By Class
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Medical Device Outsourcing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Class
  • 6.3.2. Mexico Medical Device Outsourcing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Class
  • 6.3.3. Canada Medical Device Outsourcing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Class

7. Europe Medical Device Outsourcing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service
  • 7.2.2. By Application
  • 7.2.3. By Class
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Medical Device Outsourcing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Class
  • 7.3.2. Germany Medical Device Outsourcing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Class
  • 7.3.3. United Kingdom Medical Device Outsourcing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Class
  • 7.3.4. Italy Medical Device Outsourcing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Class
  • 7.3.5. Spain Medical Device Outsourcing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Class

8. Asia-Pacific Medical Device Outsourcing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service
  • 8.2.2. By Application
  • 8.2.3. By Class
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Medical Device Outsourcing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Class
  • 8.3.2. India Medical Device Outsourcing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Class
  • 8.3.3. South Korea Medical Device Outsourcing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Class
  • 8.3.4. Japan Medical Device Outsourcing Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Class
  • 8.3.5. Australia Medical Device Outsourcing Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Class

9. South America Medical Device Outsourcing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service
  • 9.2.2. By Application
  • 9.2.3. By Class
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Medical Device Outsourcing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Class
  • 9.3.2. Argentina Medical Device Outsourcing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Class
  • 9.3.3. Colombia Medical Device Outsourcing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Class

10. Middle East and Africa Medical Device Outsourcing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service
  • 10.2.2. By Application
  • 10.2.3. By Class
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Medical Device Outsourcing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Class
  • 10.3.2. Saudi Arabia Medical Device Outsourcing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Class
  • 10.3.3. UAE Medical Device Outsourcing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Class

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Laboratory Corporation of America Holdings
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Pace Analytical Services, Inc.
• 14.3. Intertek Group plc
• 14.4. Charles River Laboratories
• 14.5. Medical Device Testing Services
• 14.6. PAREXEL International Corporation
• 14.7. Accell Clinical Research, LLC
• 14.8. Criterium, Inc.
• 14.9. ICON plc.
• 14.10. IQVIA Inc.
• 14.11. Integer Holdings Corporation

15. Strategic Recommendations

16. About Us & Disclaimer