医疗设备警戒市场按交付模式、应用、最终用户和地区划分

2025 年全球医疗设备监控市场规模预估为 656.5 亿美元，预计到 2032 年将达到 1,338.3 亿美元，2025 年至 2032 年的年复合成长率（CAGR）为 10.7%。

数字。医疗设备警戒市场区域占有率（%）（2025 年）

慢性病发病率的上升和对病人安全的日益重视，推动了全球对医疗设备警戒的需求。各监管机构都制定了严格的规范和指导方针，以确保对医疗设备在核准和上市后的警觉性。随着医疗设备变得越来越复杂，製造商必须拥有强大的风险评估、故障报告和事件分析警戒系统。然而，各地区法律规范缺乏统一，阻碍了市场的成长。持续研究和开发创新的安全解决方案可以在不久的将来为市场参与企业提供成长机会。

市场动态

全球癌症、糖尿病、心血管疾病等慢性疾病负担日益加重，推动了对各种医疗设备的需求。同时，与设备故障、错误和失效相关的事故发生率较高，凸显了有效的上市后监控系统的必要性。要求製造商实施监控程序的严格监管准则可能会推动市场成长。然而，在整个设备生命週期中建立和维护警戒过程的高成本可能会阻碍市场成长。数位健康技术的持续创新可能为医疗设备警戒解决方案中人工智慧和云端运算的整合提供新的机会。

研究的主要特点

本报告对全球医疗设备警戒市场进行了详细分析，并以 2024 年为基准年，给出了预测期（2025-2032 年）的市场规模（十亿美元）和年复合成长率（CAGR%）。

它还强调了各个领域的潜在商机并说明了该市场的有吸引力的投资提案矩阵。

它还提供了关于市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景以及主要企业采用的竞争策略的主要考察。

全球医疗设备警戒市场的主要企业会根据以下参数进行分析，例如公司亮点、产品系列、关键亮点、财务表现和策略。

研究涉及的主要企业包括飞利浦、通用电气医疗、西门子医疗、美敦力等。

本报告的见解将使负责人和企业经营团队能够就未来产品发布、新兴趋势、市场扩张和行销策略做出明智的决策。

全球医疗设备警戒市场报告迎合了该行业的各个相关人员，例如投资者、供应商、产品製造商、经销商、新进业者和金融分析师。

相关人员将透过全球医疗设备警戒市场分析中使用的各种策略矩阵更轻鬆地做出决策。

目录

第一章 调查目的与前提条件

• 研究目标
• 先决条件
• 简称

第二章 市场展望

• 报告描述
  • 市场定义和范围
• 执行摘要
• 一致的机会图 (COM)

第三章市场动态、法规与趋势分析

• 市场动态
  • 驱动程式
  • 限制因素
  • 机会
• 影响分析
• 市场趋势
• 监管情景
• 收购和合作场景
• 资金筹措和投资
• PEST分析
• 波特的分析

第四章 全球医疗设备警戒市场-冠状病毒 (COVID-19) 大流行的影响

• 整体影响
• 政府倡议
• COVID-19 市场影响

5. 2020 年至 2032 年全球医疗设备警戒市场以交付模式划分（十亿美元）

• 介绍
• 云端基础
• 本地

6. 2020 年至 2032 年全球医疗设备警戒市场（按应用划分）（十亿美元）

• 介绍
• 治疗
• 诊断
• 外科手术
• 研究

7. 2020 年至 2032 年全球医疗设备警戒市场（以最终用户划分）（十亿美元）

• 介绍
• 医院
• 诊断影像中心
• 业务研究组织（CRO）
• 业务流程外包（BPO）
• OEM
• 其他的

8. 2020 年至 2032 年全球医疗设备警戒市场（按地区划分）（单位：十亿美元）

• 介绍
• 北美洲
• 拉丁美洲
• 欧洲
• 亚太地区
• 中东
• 非洲

第九章 竞争格局

• 公司简介
  • ZEINCRO
  • AssurX, Inc.
  • Sparta Systems
  • Oracle Corporation
  • Xybion Corporation
  • Sarjen Systems Pvt. Ltd.
  • Omnify Software, Inc.
  • Medidata Solutions
  • Vigilanz Corporation
  • Qualio
  • MasterControl
  • Greenlight Guru
  • eQMS
  • BioClinica
  • Medpace
  • PAREXEL International
  • Celerion
  • Charles River Laboratories

第 10 章分析师建议

• 兴衰
• 一致的机会地图

第 11 章 参考文献与调查方法

• 参考
• 调查方法

Global Medical Device Vigilance Market is estimated to be valued at USD 65.65 Bn in 2025 and is expected to reach USD 133.83 Bn by 2032, growing at a compound annual growth rate (CAGR) of 10.7% from 2025 to 2032.

Figure. Medical Device Vigilance Market Share (%), By Region 2025

Rising incidence of chronic diseases and increasing emphasis on patient safety can boost demand for medical device vigilance across the world. Various regulatory bodies have implemented stringent norms and guidelines to ensure vigilance over medical devices post approval and marketing. With increasing complexity of medical devices, it is imperative for manufacturers to have robust vigilance systems for risk assessment, malfunction reporting and incident analysis. However, lack of harmonization and variation in regulatory framework across different regions can hamper the market growth. Ongoing research and development of innovative vigilance solutions can offer growth opportunities for market players in the near future.

Market Dynamics:

Growing burden of chronic diseases such as cancer, diabetes, and cardiovascular disorders globally has boosted demand for various types of medical devices. At the same time, numerous incidents related to device malfunctions, errors, and failures have emphasized the need for an effective post-market surveillance system. Stringent regulatory guidelines mandating implementation of vigilance procedures by manufacturers can drive the market growth. However, high costs associated with setting up and maintaining vigilance processes throughout the device lifecycle can hamper the market growth. Ongoing innovation in digital health technologies can offer new opportunities with integration of artificial intelligence and cloud computing in medical device vigilance solutions.

Key features of the study:

This report provides in-depth analysis of the global medical device vigilance market, and provides market size (USD Billion) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players

It profiles key players in the global medical device vigilance market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies

Key companies covered as a part of this study include Philips, GE Healthcare, Siemens Healthineers, and Medtronic

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

Global medical device vigilance market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global medical device vigilance market

Detailed Segmentation-

• By Delivery Mode
  • Cloud Based
  • On-Premise
• By Application
  • Therapeutics
  • Diagnostics
  • Surgical
  • Research
• By End User
  • Hospitals
  • Diagnostic Imaging Center
  • Contract Research Organization (CRO)
  • Business Process Outsourcing (BPO)
  • Original Equipment Manufacturers (OEM)
  • Others
• By Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa
• Company Profiles:
  • ZEINCRO
  • AssurX, Inc.
  • Sparta Systems
  • Oracle Corporation
  • Xybion Corporation
  • Sarjen Systems Pvt. Ltd.
  • Omnify Software, Inc.
  • Medidata Solutions
  • Vigilanz Corporation
  • Qualio
  • MasterControl
  • Greenlight Guru
  • eQMS
  • BioClinica
  • Medpace
  • PAREXEL International
  • Celerion
  • Charles River Laboratories

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Snapshot, By Delivery Mode
  • Market Snapshot, By Application
  • Market Snapshot, By End User
  • Market Snapshot, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restraints
  • Opportunities
• Impact Analysis
• Market Trends
• Key Developments
• Regulatory Scenario
• Acquisitions and Partnerships Scenario
• Funding and Investments
• PEST Analysis
• Porter's Analysis

4. Global Medical Device Vigilance Market- Impact of Coronavirus (COVID-19) Pandemic

• Overall Impact
• Government Initiatives
• COVID-19 Impact on the Market

5. Global Medical Device Vigilance Market, By Delivery Mode, 2020 - 2032, (USD Bn)

• Overview
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Cloud Based
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• On-Premise
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

6. Global Medical Device Vigilance Market, By Application, 2020 - 2032, (USD Bn)

• Overview
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Therapeutics
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Diagnostics
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Surgical
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Research
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

7. Global Medical Device Vigilance Market, By End User, 2020 - 2032, (USD Bn)

• Overview
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Hospitals
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Diagnostic Imaging Center
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Contract Research Organization (CRO)
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Business Process Outsourcing (BPO)
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Original Equipment Manufacturers (OEM)
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Others
  • Overview
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

8. Global Medical Device Vigilance Market, By Region, 2020 - 2032, (USD Bn)

• Introduction
  • Market Share Analysis, By Region, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, For Region, 2021-2032
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
    • U.S.
    • Canada
• Latin America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
    • U.K.
    • Germany
    • Italy
    • France
    • Spain
    • Russia
    • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
    • China
    • India
    • Japan
    • ASEAN
    • Australia
    • South Korea
    • Rest of Asia Pacific
• Middle East
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
    • GCC Countries
    • Israel
    • Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Delivery Mode, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Application, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country/Region, 2020 - 2032, (USD Bn)
    • North Africa
    • Central Africa
    • South Africa

9. Competitive Landscape

• Company Profiles
  • ZEINCRO
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • AssurX, Inc.
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • Sparta Systems
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • Oracle Corporation
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • Xybion Corporation
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • Sarjen Systems Pvt. Ltd.
    • Company Highlights
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Market Strategies
  • Omnify Software, Inc.
  • Medidata Solutions
  • Vigilanz Corporation
  • Qualio
  • MasterControl
  • Greenlight Guru
  • eQMS
  • BioClinica
  • Medpace
  • PAREXEL International
  • Celerion
  • Charles River Laboratories

10. Analyst Recommendations

• Wheel of Fortune
• Analyst View
• Coherent Opportunity Map

11. References and Research Methodology

• References
• Research Methodology
• About Us and Sales Contact