At what pace is the medical devices vigilance market growing, and what is its estimated value?
The medical devices vigilance market size has grown strongly in recent years. It will grow from $90.26 billion in 2024 to $97.94 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to growing awareness regarding medical device vigilance, growing awareness among the physicians and patients regarding the benefits of medical devices vigilance, rising pressure on medical devices manufacturers, increasing number of government initiative, and rising medical device usage.
The medical devices vigilance market size is expected to see strong growth in the next few years. It will grow to $137.61 billion in 2029 at a compound annual growth rate (CAGR) of 8.9%. The growth in the forecast period can be attributed to increasing launches of recall systems for medical devices, increasing number of post market surveillance programs for medical devices, increasing number of adverse events reported, increasing need for therapeutics and surgical procedures, and growing complexity related to patient safety regulations. Major trends in the forecast period include technological advancements, international medical device regulators forum (IMDRF) framework, enhances the exchange of safety information across borders, remote patient monitoring devices, 3D printing and personalized devices.
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How have varous drivers impacted the growth of the medical devices vigilance market?
The increasing number of medical recalls is expected to propel the growth of the medical device vigilance market going forward. Medical recalls refer to the action taken by regulatory authorities, manufacturers, or distributors to remove or correct medical products that pose a risk to public health or do not comply with regulatory standards. Medical device vigilance entails continuous monitoring of medical devices in the market to identify adverse events, malfunctions, or safety concerns that, upon identification, are reported to regulatory authorities, potentially leading to further investigation and, if warranted, a product recall. For instance, in December 2022, the Food and Drug Administration (FDA), a US-based federal agency, observed a rise in medical device recalls, with 442 recalls documented in 2022, up from 331 in 2021, an almost 10% increase from 2021. Therefore, the increasing number of medical recalls is driving the growth of the medical device vigilance market.
What are the primary segments of the medical devices vigilance market?
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 firms are leading 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
How will industry trends affect the trajectory of the medical devices vigilance market?
Major companies operating in the medical device devices vigilance market are developing innovative products, such as quality management software, to improve customer satisfaction. Quality management software (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For instance, in December 2022, Greenlight Guru, a US-based company providing systems and software to medical device companies, launched QMS software designed to help medical device companies modernize their processes, cut time from clinical testing, and bring safer products to market faster. Greenlight Guru’s software is pre-validated per FDA and ISO best practices, aiming to help companies comply with the ever-changing standards. The company also offers training and certifications to help advance careers in product development, quality, and regulatory assurance.
Which geographic trends are shaping the medical devices vigilance market, and which region has the highest market share?
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.
What Does The Medical Devices Vigilance Market Report 2025 Offer?
The medical devices vigilance market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
Medical device vigilance refers to monitoring and reporting adverse events or incidents related to the use of medical devices. It is a critical component of post-market surveillance to ensure the safety and effectiveness of medical devices throughout their lifecycle. It identifies and addresses potential risks associated with medical devices, ensures patient safety, and maintains public trust in the healthcare system.
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