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.
Report Coverage
Report Details
Base Year:
2024
Market Size in 2025:
USD 65.65 Bn
Historical Data for:
2020 To 2024
Forecast Period:
2025 To 2032
Forecast Period 2025 to 2032 CAGR:
10.70%
2032 Value Projection:
USD 133.83 Bn
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)