医疗设备外包市场规模、份额及成长分析（按服务、应用、类别及地区划分）－2026-2033年产业预测

预计到 2024 年，医疗设备外包市场规模将达到 1,428.2 亿美元，到 2025 年将达到 1,601 亿美元，到 2033 年将达到 3992.3 亿美元，在预测期（2026-2033 年）内复合年增长率为 12.1%。

由于对各种医疗设备的需求不断增长，以及外包供应商之间为提供先进设备而展开的竞争日益激烈，医疗设备外包市场正经历显着增长。自动化和人工智慧在医疗诊断领域的应用，推动了医疗保健产业对创新医疗解决方案的需求不断增长。因此，外包供应商正抓住各种机会，显着促进市场发展。主要原始设备製造商 (OEM) 和分包商，尤其是在北美和欧洲等已开发地区，比开发中国家的同行更快地采用这些先进技术。此外，主要外包公司正致力于创新，开发更优质、更有效率的设备，以满足不断增长的全球医疗保健需求，并提升整体市场潜力。

医疗设备外包市场驱动因素

心血管疾病发生率的上升，以及研发投入的不断增加，正显着推动医疗设备外包市场的成长。随着医疗服务提供者和製造商为满足日益增长的创新医疗解决方案需求，他们越来越多地将外包作为一种提高效率和降低成本的策略手段。此外，技术进步和对改善病患疗效的追求，也进一步促进了医疗设备製造商与外包合作伙伴之间的合作。在这种充满活力的环境下，随着相关人员积极应对新的医疗保健挑战，医疗器材产业正朝着强劲的成长轨道发展。

医疗设备外包市场的限制因素

全球医疗设备外包市场的成长受到各国政府严格的医疗设备认证和核准流程监管的显着限制。这些严苛的要求可能导致漫长的审批流程，并使新产品的上市变得复杂。企业为遵守这些法规通常需要投入大量资源和资金，这可能会阻碍新进入者，并减缓整个产业的发展速度。因此，不断变化的监管环境限制了市场扩张，并对竞争构成重大挑战，进而影响医疗设备外包产业的动态。

医疗设备外包市场趋势

医疗设备外包市场正经历显着成长，这主要得益于先进机器人技术在医疗技术领域的日益普及。这一趋势反映出市场对能够提升医疗设备製造精度、效率和创新能力的专用机器人系统的需求不断增长。随着製造商寻求提高营运效率和降低成本，他们越来越多地将生产外包，以充分利用机器人技术专长。这种策略转变不仅推动了尖端设备的研发，也开启了新的合作与投资管道，使外包产业成为医疗设备业发展中的关键力量。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 二手资料和一手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特分析及其影响

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 技术进步
• 监管环境
• 价值链分析
• 案例研究分析
• PESTEL 分析
• 总体经济指标
• 市场吸引力指数

全球医疗设备外包市场规模（按服务类型和复合年增长率划分）（2026-2033 年）

• 品质保证
• 监管事务服务
  • 临床试验申请和产品註册
  • 监管文件的编制和发布
  • 法律代理
  • 其他的
• 产品设计与开发服务
  • 设计与工程
  • 加工
  • 模具
  • 包装
• 产品测试和灭菌服务
• 产品实施服务
• 产品升级服务
• 产品维护服务
• 契约製造
  • 配件製造
  • 组装製造
  • 零件製造
  • 医疗设备製造

全球医疗设备外包市场规模（按应用领域及复合年增长率划分）（2026-2033 年）

• 心臟病学
• 诊断影像
• 整形外科
• 体外诊断医疗设备（IVD）
• 眼科
• 一般外科和整形外科
• 药物输送
• 牙科
• 内视镜检查
• 糖尿病护理
• 其他的

全球医疗设备外包市场规模（按类别划分）及复合年增长率（2026-2033 年）

• 一级
• 二类
• 三级

全球医疗设备外包市场规模及复合年增长率（2026-2033）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 英国
  • 德国
  • 西班牙
  • 法国
  • 义大利
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2025 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2025 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2021-2023年营收年比比较

主要企业简介

• 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.

结论与建议

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