How Has the Medical Devices Vigilance Market Size Evolved in Recent Years?
The medical devices vigilance market has seen considerable growth due to a variety of factors.
• The market size of medical devices vigilance has seen substantial growth in the past few years. Projected growth from $90.26 billion in 2024 to $97.94 billion in 2025 shows a compound annual growth rate (CAGR) of 8.5%.
The historical growth can be credited to increasing understanding about medical device vigilance, improved awareness among doctors and patients on its advantages, escalating pressure on producers of medical devices, growth in government initiatives, and a rise in the utilization of medical devices.
What Is The Forecast For The Medical Devices Vigilance Market Size?
The medical devices vigilance market is expected to maintain its strong growth trajectory in upcoming years.
• Anticipated to experience significant growth in the coming times, the medical devices vigilance sector's size is projected to expand to $137.61 billion by 2029 at an 8.9% compound annual growth rate (CAGR). The surge during the prediction period can be linked to the rising introduction of recall systems for medical devices, escalating amount of post market monitoring schemes for medical devices, increased reports of adverse incidents, growing demand for therapeutic and surgical procedures, and the escalating intricacy of patient safety norms. The major trends during the prediction period will constitute technological progress, the framework of the International Medical Device Regulators Forum (IMDRF), elevation in the cross-border exchange of safety data, devices for monitoring patients remotely, 3D printing, and individualized devices.
What Are The Essential Drivers Behind The Growth Of The Medical Devices Vigilance Market?
The surge in the number of medical recalls is projected to drive the expansion of the medical device vigilance market in the future. Medical recalls are actions taken by regulatory bodies, manufacturers, or distributors to recall or rectify medical products that are either harmful to public health or do not meet regulatory requirements. Medical device vigilance involves a consistent observance of medical devices on the market to notice any adverse events, malfunctions, or safety concerns, which are reported to the regulatory authorities upon detection. This could potentially result in further scrutiny and a product recall if necessary. For example, the US-based federal agency, Food and Drug Administration (FDA), noted in December 2022 an escalation in medical device recalls, with 442 documented recalls in 2022, a rise from 331 in 2021, marking nearly 10% increase from 2021. Consequently, the surge in the number of medical recalls is fueling the expansion of the medical device vigilance market.
How Is The Global Medical Devices Vigilance Market Divided Into Key Segments?
The medical devices vigilance market covered in this report is segmented –
1) By Delivery Mode: On-Demand, On-Premise
2) By Application: Therapeutics, Diagnostics, Surgical, Research, Other Applications
3) By End-User: Original Equipment Manufacturers (OEMs), Clinical Research Organizations (CROs), Business Process Outsourcing (BPO) Firms
Subsegments:
1) By On-Demand: Cloud-Based Solutions, Subscription Services, Remote Monitoring And Reporting
2) By On-Premise: In-House Software Solutions, Local Server Deployments, Customized System Implementations
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Which Emerging Market Trends Are Altering The Medical Devices Vigilance Industry?
In the medical device vigilance market, major corporations are advancing customer satisfaction by creating innovative offerings like quality management software (QMS). QMS is a standardized system that formally records processes, procedures, and duties for accomplishing quality strategies and targets. For example, Greenlight Guru, an American company that supplies systems and software to medical device corporations, introduced a QMS software in December 2022. This software aims to enable such companies to update their procedures, reduce clinical testing time, and expedite the launch of safer products to the market. Moreover, Greenlight Guru's software comes pre-validated in accordance with FDA and ISO best practices, with the intention to assist companies in adhering to ever evolving standards. Notably, they also provide training and credentials to promote career growth in product development, quality, and regulatory assurance.
Who Are the Key Players In The Medical Devices Vigilance Market?
Major companies operating in the medical devices vigilance market are:
• Johnson & Johnson
• Intel Corporation
• Oracle Corporation
• Medtronic
• Siemens Healthineers
• RELX Group plc
• MasterControl Inc.
• Laerdal Medical
• Numerix
• Smithers
• Omnify Software Inc.
• Freyr
• Sparta Systems
• MDI Consultants Inc.
• Greenlight Guru
• Jama Software
• Sarjen Systems Pvt. Ltd
• Arena Solutions Inc.
• Xybion Corporation
• ZEINCRO Group
• Extedo Gmbh
• AssurX Inc.
• AB-Cube
• Panacea Pharma Projects Limited
• Qvigilance
• General Electric (GE) Healthcare
• Philips Healthcare
• Baxter International
• Stryker Corporation
• Boston Scientific
What Are The Regional Insights Into The Medical Devices Vigilance Market?
North America was the largest region in the medical devices vigilance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
