The Medical Devices Vigilance Market is set to exceed USD 91.5 billion by 2025; according to a new research report by Global Market Insights. Demand for medical devices vigilance systems is increasing over recent years owing to surge in the number of adverse events reported related to medical devices. High adoption of medical device vigilance system to ensure safety of patients, healthcare professionals and other users will positively impact business growth. Furthermore, strict government regulations for manufacturers to develop safe and highly efficient devices will favour medical devices vigilance industry growth.
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Surge in the number of medical device recalls due to safety issues is the key factor driving the global market growth during the forecast period. According to FDA, in 2015, around 1.4 million adverse events reported in the U.S. agency were sent to the FDA through medical device reporting system. Growing awareness among people pertaining to availability of medical device vigilance software and reporting of adverse events will positively influence medical devices vigilance industry growth over the analysis timeframe.
Additionally, favourable government scenario pertaining to medical devices vigilance to ensure patient safety will serve to be another impact rendering factor that will foster the business growth. Increasing burden on medical devices manufacturers to produce safe medical equipment as well as stringent safety regulations laid by regulatory authorities pertaining to pre- and post-commercialization of medical devices will further spur the market size. However, negligence of manufacturing companies towards product safety may restrain medical devices vigilance industry growth over the coming years.
Original equipment manufacturers (OEMs) segment accounted for more than 45% revenue share in 2018 and will witness significant growth over the forecast timeframe. Increasing number of adverse events related to medical devices will surge adoption of medical device vigilance systems among the manufacturers thus, positively influencing the business growth.
Business process outsourcing (BPO) segment held significant revenue share in 2018 and is estimated to show 9.0% CAGR over the analysis period. Growing trend of companies towards outsourcing vigilance activities and retaining its focus on company’s core competencies will favor segmental growth. Increasing adoption of medical device vigilance software by business process outsourcing firms will further escalate revenue growth.
U.S. medical devices vigilance market dominated the North America region with more than 89% revenue share in 2018 and is projected to witness similar growth in the foreseeable future. High growth can be attributed to the rising number of medical device adverse events reported in the country. As per the FDA, more than 1 million adverse events related to medical devices were reported in the U.S. in 2015. Such factors will increase adoption of medical device vigilance systems thereby augmenting business growth.
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UK medical devices vigilance market is anticipated to witness fastest CAGR of 9.5% over the analysis timeframe. In line with the UK medical device regulations, MHRA strictly investigates any complaints about products with or without CE mark, examines manufacturing facilities in case of breach of regulations as well as investigates results of vigilance reports. Favorable regulatory policies in the country will further spur the market size.
Medical Devices Vigilance Market, By Delivery Mode (USD Million)
On-demand or cloud based (SaaS)
Medical Devices Vigilance Market, By Application (USD Million)