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Medical Devices Vigilance Market Size By Delivery Mode (On-demand, On-premise), By Application (Diagnostic, Therapeutic, Surgical, Research), By End-user (Clinical Research Organizations [CROs], Original Equipment Manufacturers [OEMs], Business Process Outsourcing [BPO]), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2019 – 2025

  • Report ID: GMI3140
  • Published Date: Feb 2019
  • Report Format: PDF

Medical Devices Vigilance Market Size

Medical devices vigilance market size was valued at USD 52.8 billion in 2018 and is expected to witness 8.2% CAGR from 2019 to 2025.

Medical devices vigilance market

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.

Medical Devices Vigilance Market Analysis

On-demand delivery mode segment held 80.2% revenue share in 2018 and is projected to witness robust growth during the forthcoming years. Companies such as AssurX, AB-Cube focus on development of advanced cloud-based quality management software systems will increase its adoption over the forecast period.

On-premise delivery mode segment accounted for USD 10.4 billion in 2018 and will witness considerable growth over the coming years. However, shift from on-premises to cloud-based systems owing to technological advancement may negatively impact business growth during the upcoming years.

Diagnostic application segment dominated the medical devices vigilance market with 32.5% revenue share in 2018 and is estimated to witness similar growth during the analysis period. Growing disease burden across the globe increases the demand for diagnostic medical devices. Safety issues pertaining to diagnostic devices such as endoscopes may lead to serious microbial infections that may be life threatening for the patients. Aforementioned factors will escalate the segmental growth during the forthcoming years.

Research application segment is estimated to show lucrative CAGR of 8.5% over the forecast period. Growing investments by public sector has accelerated the pace of R&D in healthcare. Wide range of medical devices involved in R&D activities will increase the need to ensure safety of these devices thereby fostering the segmental growth.

Germany Medical Devices Vigilance Market By Application

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. 

North America market dominated the global market with 33.7% revenue share in 2018 and the high revenue can be attributed to the high demand for medical devices vigilance in the region. Growing number of adverse events reported will increase adoption of vigilance systems in the region. Strong foothold of medical devices manufacturing companies in the region will further augment regional business growth.

Asia Pacific market is estimated to witness lucrative CAGR of 9.8% over the forecast period owing to increasing focus of medical device manufacturers on product safety. Additionally, presence of large and diverse patient pool in the region coupled with surge in clinical research outsourcing will further accelerate regional industry growth.

Asia Pacific Medical Devices Vigilance Market By Country

Medical Devices Vigilance Market Share

Notable industry players operating in the global market include

  • AB-Cube
  • AssurX
  • Oracle
  • Sarjen Systems
  • Sparta Systems
  • Xybion
  • Omnify Software
  • MDI Consultants
  • Numerix

Industry players focus on strategic alliance such as mergers, collaboration, partnerships as well as novel offerings to capitalize on market opportunities and sustain competition. For instance, AssurX introduced AssurX Cloud QMS, a cloud-based quality management software system. The software ensures faster production of better products by monitoring and managing quality of medical devices across operations in a single centralized as well as streamlined system.

Medical Devices Vigilance Industry Background

The medical devices vigilance market can be traced back in 1992 when the Global Harmonization Task Force (GHTF) that was conceived, to achieve standardization among the national medical device regulatory systems. It aimed at increasing access to effective, safe, as well as clinically beneficial medical technologies. In 2006, the Medical Device Regulation Bill was endorsed to consolidate medical devices laws as well as establish Medical Device Regulatory Authority of India.

With advent of new technology, medical devices vigilance system is projected to remain in growth phase during the forthcoming years. Currently, focus of companies on development of advanced medical devices vigilance systems to ensure safety and efficiency will further ensure industry growth over the forecast period.

Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

The market size of medical devices vigilance surpassed USD 52.8 billion in 2018.

The industry share of medical devices vigilance is expected to witness 8.2% CAGR from 2019 to 2025.

Medical Devices Vigilance Market Scope

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Premium Report Details

  • Base Year: 2018
  • Companies covered: 11
  • Tables & Figures: 202
  • Countries covered: 20
  • Pages: 145
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