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1714291

醫療器材外包市場－全球產業規模、佔有率、趨勢、機會和預測（按服務、應用、類別、地區和競爭細分，2020-2030 年）

Medical Device Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service, By Application, By Class, By Region and Competition, 2020-2030F
出版日期: | 出版商: TechSci Research | 英文 184 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2024 年全球醫療器材外包市場價值為 1,316.6 億美元，預計到 2030 年將達到 2,708.6 億美元，預測期內複合年成長率為 12.75%。這種成長是由對高品質醫療設備的需求不斷成長、監管複雜性不斷增加以及對成本效益高營運的需求所推動的。原始設備製造商 (OEM) 擴大轉向外包，以簡化設計、製造、包裝和物流等流程，使他們能夠專注於創新和核心競爭力。自動化、數位化整合的進步以及對個人化醫療設備的日益成長的偏好也影響著該行業的發展。隨著競爭加劇，外包在縮短產品上市時間、提高產品品質和維持法規遵循度方面具有策略優勢。

市場概覽
預測期 2026-2030
2024年市場規模 1316.6億美元
2030年市場規模 2708.6億美元
2025-2030 年複合年成長率 12.75%
成長最快的領域 一般外科和整形外科
最大的市場 北美洲

關鍵市場促進因素

對經濟高效解決方案的需求不斷成長

主要市場挑戰

智慧財產權（IP）風險

主要市場趨勢

分析測試服務的擴展

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：顧客之聲

第5章：全球醫療器材外包市場展望

  • 市場規模和預測
    • 按價值
  • 市場佔有率和預測
    • 依服務（品質保證、法規事務服務、產品設計及開發服務、產品測試及滅菌服務、產品實施服務、產品升級服務、產品維護服務、合約製造）
    • 依應用（心臟病學、診斷影像、骨科、體外診斷、眼科、一般外科和整形外科、藥物傳遞、牙科、內視鏡檢查、糖尿病護理、其他）
    • 按類別（I類、II類、III類）
    • 按公司分類（2024）
    • 按地區
  • 市場地圖

第6章：北美醫療器材外包市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 北美：國家分析
    • 美國
    • 墨西哥
    • 加拿大

第7章：歐洲醫療器材外包市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 歐洲：國家分析
    • 法國
    • 德國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太醫療器材外包市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 韓國
    • 日本
    • 澳洲

第9章：南美醫療器材外包市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第10章：中東與非洲醫療器材外包市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • MEA：國家分析
    • 南非
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國

第 11 章：市場動態

  • 驅動程式
  • 挑戰

第 12 章：市場趨勢與發展

  • 合併與收購（如有）
  • 產品發布（如有）
  • 最新動態

第 13 章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 顧客的力量
  • 替代產品的威脅

第 14 章：競爭格局

  • 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

第 15 章：策略建議

第16章調查會社について,免責事項

簡介目錄
Product Code: 28343

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.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 131.66 Billion
Market Size 2030USD 270.86 Billion
CAGR 2025-203012.75%
Fastest Growing SegmentGeneral and Plastic Surgery
Largest MarketNorth America

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