醫療設備外包市場規模、佔有率及成長分析（按服務、應用、類別及地區分類）－2026-2033年產業預測

預計到 2024 年，醫療設備外包市場規模將達到 1,428.2 億美元，到 2025 年將達到 1,601 億美元，到 2033 年將達到 3992.3 億美元，在預測期（2026-2033 年）內複合年成長率為 12.1%。

由於對各種醫療設備的需求不斷成長，以及外包供應商之間為提供先進設備而展開的競爭日益激烈，醫療設備外包市場正經歷顯著成長。自動化和人工智慧在醫療診斷領域的應用，推動了醫療保健產業對創新醫療解決方案的需求不斷成長。因此，外包供應商正抓住各種機遇，顯著促進市場發展。主要原始設備製造商 (OEM) 和分包商，尤其是在北美和歐洲等已開發地區，比開發中國家的同行更快地採用這些先進技術。此外，主要外包公司正致力於創新，開發更優質、更有效率的設備，以滿足不斷成長的全球醫療保健需求，並提升整體市場潛力。

醫療設備外包市場促進因素

心血管疾病發生率的上升，以及研發投入的不斷增加，正顯著推動醫療設備外包市場的成長。隨著醫療服務提供者和製造商為滿足日益成長的創新醫療解決方案需求，他們擴大將外包作為一種提高效率和降低成本的策略手段。此外，技術進步和對改善病患療效的追求，也進一步促進了醫療設備製造商與外包合作夥伴之間的合作。在這種充滿活力的環境下，隨著相關人員積極應對新的醫療保健挑戰，醫療器材產業正朝著強勁的成長軌道發展。

醫療設備外包市場的限制因素

全球醫療設備外包市場的成長受到各國政府嚴格的醫療設備認證和核准流程監管的顯著限制。這些嚴苛的要求可能導致漫長的核准流程，並使新產品的上市變得複雜。企業為遵守這些法規通常需要投入大量資源和資金，這可能會阻礙新進入者，並減緩整個產業的發展速度。因此，不斷變化的監管環境限制了市場擴張，並對競爭構成重大挑戰，進而影響醫療設備外包產業的動態。

醫療設備外包市場趨勢

醫療設備外包市場正經歷顯著成長，這主要得益於先進機器人技術在醫療技術領域的日益普及。這一趨勢反映出市場對能夠提升醫療設備製造精度、效率和創新能力的專用機器人系統的需求不斷成長。隨著製造商尋求提高營運效率和降低成本，他們擴大將生產外包，以充分利用機器人技術專長。這種策略轉變不僅推動了尖端設備的研發，也開啟了新的合作與投資管道，使外包產業成為醫療設備業發展中的關鍵力量。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 二手資料和一手資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分市場機會分析

市場動態與展望

• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析及其影響

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 技術進步
• 監管環境
• 價值鏈分析
• 案例研究分析
• PESTEL 分析
• 總體經濟指標
• 市場吸引力指數

全球醫療設備外包市場規模（按服務類型和複合年成長率分類）（2026-2033 年）

• 品質保證
• 監管事務服務
  • 臨床試驗申請和產品註冊
  • 監管文件的編制和發布
  • 法律代理
  • 其他
• 產品設計與開發服務
  • 設計與工程
  • 加工
  • 模具
  • 包裝
• 產品測試和滅菌服務
• 產品實施服務
• 產品升級服務
• 產品維護服務
• 契約製造
  • 配件製造
  • 組裝製造
  • 零件製造
  • 醫療設備製造

全球醫療設備外包市場規模（按應用領域及複合年成長率分類）（2026-2033 年）

• 心臟病學
• 診斷影像
• 整形外科
• 體外診斷醫療設備（IVD）
• 眼科
• 一般外科和整形外科
• 藥物輸送
• 牙科
• 內視鏡檢查
• 糖尿病護理
• 其他

全球醫療設備外包市場規模（按類別分類）及複合年成長率（2026-2033 年）

• 一級
• 二類
• 三級

全球醫療設備外包市場規模及複合年成長率（2026-2033）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 英國
  • 德國
  • 西班牙
  • 法國
  • 義大利
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業的市場定位（2025 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2025 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2021-2023年營收年比比較

主要企業簡介

• SGS SA
• Laboratory Corporation of America Holdings
• Eurofins Scientific SE
• Pace Analytical Services, Inc.
• Intertek Group plc
• WuXiAppTec
• North American Science Associates, LLC
• TUV SUD
• GTCR（Sterigenics US, LLC）
• Charles River Laboratories
• RJR Consulting, Inc.
• Mandala International
• Freyr
• Global Regulatory Partners
• EQT Private Equity（PAREXEL International Corporation）
• UL LLC（Emergo）
• Accell Clinical Research, LLC
• Criterium, Inc.
• iuvo BioScience（Promedica International）
• ICON plc.

結論與建議

Medical Device Outsourcing Market size was valued at USD 142.82 Billion in 2024 and is poised to grow from USD 160.1 Billion in 2025 to USD 399.23 Billion by 2033, growing at a CAGR of 12.1% during the forecast period (2026-2033).

The medical device outsourcing market is witnessing significant growth driven by rising demand for diverse medical equipment and heightened competition among outsourcing vendors aiming to deliver advanced devices. The integration of automation and artificial intelligence in health diagnostics fuels an increasing need for innovative medical solutions within the healthcare sector. Consequently, outsourcing vendors are capitalizing on various opportunities, significantly boosting market development. Major original equipment manufacturers and subcontractors, particularly in developed regions such as North America and Europe, are adopting these advanced technologies more rapidly than their counterparts in developing nations. Furthermore, leading outsourcing firms are emphasizing innovation to create superior and efficient devices, addressing the escalating healthcare demands globally and enhancing overall market potential.

Top-down and bottom-up approaches were used to estimate and validate the size of the Medical Device Outsourcing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Medical Device Outsourcing Market Segments Analysis

Global Medical Device Outsourcing Market is segmented by Service, Application, Class and Region. Based on Service, the market is segmented into Quality Assurance, Regulatory Affairs Services (Clinical Trials Applications And Product Registrations, Regulatory Writing And Publishing, Legal Representation, Others), Product Design and Development Services (Designing & Engineering, Machining, Molding, Packaging), Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing (Accessories Manufacturing, Assembly Manufacturing, Component Manufacturing, Device Manufacturing). Based on Application, the market is segmented into Cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others. Based on Class, the market is segmented into Class I, Class II, Class III. Based on Region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Medical Device Outsourcing Market

The rising incidence of cardiovascular diseases, coupled with the escalating investments in research and development, is significantly propelling the growth of the Medical Device Outsourcing market. As healthcare providers and manufacturers strive to meet the increasing demand for innovative medical solutions, there is a heightened focus on outsourcing as a strategic approach to enhance efficiency and reduce costs. Additionally, advancements in technology and the pursuit of improved patient outcomes are further stimulating collaboration between medical device companies and outsourcing partners. This dynamic environment is fostering a robust growth trajectory within the industry as stakeholders adapt to emerging healthcare challenges.

Restraints in the Medical Device Outsourcing Market

The growth of the global medical device outsourcing market is significantly hindered by the rigorous government regulations that govern the certification and approval processes for medical devices. These stringent requirements can lead to lengthy delays, complicating the path to market for new innovations. Compliance with such regulations often demands substantial resources and investment from companies, which can deter potential entrants and slow down the overall pace of development in the sector. Consequently, the evolving regulatory landscape poses a formidable challenge that can restrict market expansion and stifle competition, thereby impacting the dynamics of the medical device outsourcing industry.

Market Trends of the Medical Device Outsourcing Market

The medical device outsourcing market is witnessing significant growth driven by the increasing integration of advanced robotics across healthcare technologies. This trend reflects a growing demand for specialized robotic systems that enhance precision, efficiency, and innovation in medical device manufacturing. As manufacturers seek to streamline operations and reduce costs, they are increasingly outsourcing production to leverage expert capabilities in robotics. This strategic shift not only fosters the development of cutting-edge devices but also opens up new avenues for collaboration and investment, positioning the outsourcing sector as a key player in the evolution of the medical device landscape.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Driver & Opportunities
  • Restraints & Challenges
• Porters Analysis & Impact
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Technological Advancement
• Regulatory Landscape
• Value Chain Analysis
• Case Study Analysis
• PESTEL Analysis
• Macro-Economic Indicators
• Market Attractiveness Index

Global Medical Device Outsourcing Market Size by Service & CAGR (2026-2033)

• Market Overview
• Quality Assurance
• Regulatory Affairs Services
  • Clinical Trials Applications And Product Registrations
  • Regulatory Writing And Publishing
  • Legal Representation
  • Others
• Product Design and Development Services
  • Designing & Engineering
  • Machining
  • Molding
  • Packaging
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing

Global Medical Device Outsourcing Market Size by Application & CAGR (2026-2033)

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

Global Medical Device Outsourcing Market Size by Class & CAGR (2026-2033)

• Market Overview
• Class I
• Class II
• Class III

Global Medical Device Outsourcing Market Size & CAGR (2026-2033)

• North America (Service, Application, Class)
  • US
  • Canada
• Europe (Service, Application, Class)
  • UK
  • Germany
  • Spain
  • France
  • Italy
  • Rest of Europe
• Asia-Pacific (Service, Application, Class)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America (Service, Application, Class)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service, Application, Class)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

• SGS SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Laboratory Corporation of America Holdings
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific SE
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXiAppTec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• North American Science Associates, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV SUD
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GTCR (Sterigenics U.S., LLC )
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• RJR Consulting, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mandala International
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Freyr
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Global Regulatory Partners
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• EQT Private Equity (PAREXEL International Corporation)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• UL LLC (Emergo)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accell Clinical Research, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Criterium, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• iuvo BioScience (Promedica International)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendation