医疗设备外包市场规模、份额、成长分析，按服务、按应用、按类别、按地区 - 按行业预测，2024-2031 年

2022年全球医疗设备外包市场规模为1,125亿美元，从2023年的1,289亿美元成长到2031年的3,355亿美元，预测期间（2024-2031年）复合年增长率为12.7%，预计还将成长。

由于需求不断增长以及外包供应商之间对提供尖端产品的激烈竞争，全球医疗设备和设备市场正在显着成长。自动化和人工智慧的整合来识别健康疾病进一步增加了医疗保健产业对创新医疗设备的需求。这一趋势为外包供应商提供了充足的机会，并导致了市场的显着扩张。特别是，与开发中国家的目的地设备製造商相比，美国、法国、加拿大和日本等已开发国家的大型目的地设备製造商和分包商正在以更快的速度采用这些先进技术。此外，领先的外包公司正在优先考虑技术创新，推出高效设备，以满足世界不断增长的医疗保健需求。

目录

介绍

• 研究目的
• 调查范围
• 定义

调查方法

• 资讯采购
• 二手资料和主要资料方法
• 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
• 按细分市场的机会分析

市场动态及展望

• 市场概况
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 抑制因素和挑战
• 波特分析与影响
  • 竞争公司之间的敌对关係
  • 替代品的威胁
  • 买方议价能力
  • 新进入者的威胁
  • 供应商的议价能力

主要市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 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

医疗设备外包市场规模：依服务分类

• 市场概况
• 品质保证
• 监管服务
  • 临床试验申请和产品註册
  • 规范性文件的编制与发布
  • 法律代表
  • 其他的
• 产品设计及开发服务
  • 设计与工程
  • 加工
  • 成型
  • 包裹
• 产品测试和灭菌服务
• 产品实施服务
• 产品升级服务
• 产品维修服务
• 契约製造
  • 配件製造
  • 组装製造
  • 零件製造
  • 装置製造

医疗设备外包市场规模：依应用分类

• 市场概况
• 心臟病学
• 诊断影像
• 整形外科
• 体外诊断
• 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

医疗设备外包市场规模：依类别

• 市场概况
• Ⅰ类
• 二级
• 三级

医疗设备外包市场规模：依地区划分

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

竞争资讯

• 前5名企业对比
• 主要企业市场定位（2023年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2023）
• 主要企业简介
  • 公司简介
  • 产品系列分析
  • 按细分市场分類的份额分析
  • 收益与前一年同期比较（2021-2023）

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.

结论和建议

Global Medical Device Outsourcing Market size was valued at USD 112.5 billion in 2022 and is poised to grow from USD 128.9 billion in 2023 to USD 335.5 billion by 2031, growing at a CAGR of 12.7% during the forecast period (2024-2031).

The global medical equipment and device market is experiencing significant growth, driven by increasing demand and fierce competition among outsourcing vendors to deliver cutting-edge products. The integration of automation and artificial intelligence to identify health disorders is further amplifying the need for innovative medical devices in the healthcare industry. This trend is presenting ample opportunities for outsourcing vendors, leading to substantial market development. Notably, large original equipment manufacturers and subcontractors in developed nations like the US, France, Canada, and Japan are anticipated to adopt these advanced technologies at a quicker pace compared to their counterparts in developing countries. Moreover, leading outsourcing firms are prioritizing innovation to launch efficient devices, addressing the escalating global healthcare needs.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global 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.

Global Medical Device Outsourcing Market Segmental 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 Global Medical Device Outsourcing Market

The global medical device outsourcing market is significantly driven by the rising incidence of cardiovascular diseases and the escalation of research and development (R&D) investments aimed at improving treatment methodologies. Conditions like bradycardia are increasingly prevalent, with the National Centre for Biotechnology Information reporting the annual global implantation of over 1 million pacemakers, including approximately 200,000 in the United States. This surge in cardiovascular procedures necessitates enhanced medical device solutions, fostering a favorable environment for outsourcing. As R&D efforts intensify in pursuit of innovative treatments for these diseases, the market is poised for robust growth in the coming years.

Restraints in the Global Medical Device Outsourcing Market

The global medical device outsourcing market is anticipated to face significant obstacles in its growth due to stringent governmental regulations concerning the certification and approval processes for medical devices, which can lead to prolonged timelines and increased costs. Additionally, inadequate access to medical facilities in remote regions has created challenges in healthcare logistics, further contributing to a competitive disadvantage in the market. These factors combined are likely to hinder the expansion of the medical device outsourcing sector during the forecast period, as companies may struggle to navigate regulatory complexities and logistics issues that impede efficient operations and market entry.

Market Trends of the Global Medical Device Outsourcing Market

The Global Medical Device Outsourcing market is experiencing a notable surge, driven by the increasing integration of advanced robotics within the manufacturing processes of medical technology. This trend reflects a broader shift towards automation and efficiency, enabling manufacturers to enhance precision and reduce costs. As specialized robotics systems become essential across various applications-from surgical instruments to diagnostic equipment-the demand for outsourcing capabilities is growing significantly. This evolution not only fosters innovation but also attracts investment, creating lucrative opportunities for service providers equipped to meet the complex needs of an increasingly sophisticated medical 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 (2024-2031)

• 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 (2024-2031)

• 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 (2024-2031)

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

Global Medical Device Outsourcing Market Size & CAGR (2024-2031)

• 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, 2023
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2023
• 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