MEDICAL DEVICE VIGILANCE MARKET ANALYSIS

Medical Device Vigilance Market Size and Trends

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, exhibiting a compound annual growth rate (CAGR) of 10.7% from 2025 to 2032. Strict regulations regarding medical device safety along with the increasing usage of electronic health records can drive the market growth.

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Global medical device vigilance market growth is driven by growing need for companies to comply with international regulations and standards set by regulatory bodies like the U.S. FDA and the EU's MDR. Rising awareness among end users about reporting device issues and malfunctions also contributes to increase in surveillance programs being adopted across the healthcare industry.  Demand for quality care by aging population and increasing expenditure on healthcare worldwide can also drive the market growth.

Rising incidence of chronic diseases

Chronic diseases like cancer, diabetes, cardiovascular diseases, and other  poses a serious health threat. There has been  increase in risk factors associated with these chronic diseases like sedentary lifestyle, smoking, obesity, stress, and others. This has led to growing incidence rates of chronic conditions. As per some estimates, chronic diseases now account for over 60% of all deaths globally. Managing these chronic illnesses requires prolonged use of medical devices like insulin pumps, pacemakers, implantable defibrillators, and others. This long term reliance on medical devices increases the chances of adverse events or device malfunctions. Device manufacturers are compelled to have robust vigilance systems to quickly detect, analyze and take corrective actions for any issues. Proactive post market surveillance allows companies to ensure patient safety and also protect their brand name.