Medical Device Vigilance Market Is Estimated To Witness High Growth Owing To Increasing Stringency Of Medical Device Regulations

The Medical Device Vigilance Market is estimated to be valued at US$ 59.30 Bn in 2024 and is expected to exhibit a CAGR of 10.5% over the forecast period 2024-2031, as highlighted in a new report published by Coherent Market Insights.

The medical device vigilance market is driven by increasing stringency of medical device regulations across various regions. Stringent regulations imposed by regulatory authorities are compelling medical device manufacturers to adhere to post-marketing surveillance activities for marketed medical devices. This is positively impacting demand for medical device vigilance services. Growing need for centralized reporting of adverse events and product problems to regulatory authorities is another major factor fueling growth of the global medical device vigilance market. Furthermore, increasing number of medical device recalls owing to safety issues is prompting manufacturers to outsource vigilance activities to third-party service providers, thereby supporting market growth over the forecast period.

Key Market Trends:

Cloud-based vigilance solution is gaining significant traction in the market. Key players are focusing on developing HIPAA-compliant cloud-based platforms for providing end-to-end medical device vigilance services. For instance, in February 2020, AssurX Inc. launched a cloud-based platform named “Vigilence Cloud” for medical device and IVD manufacturers. Such platforms offer benefits such as easy access, improved collaboration, data security, and reduced cost of ownership. Additionally, rising adoption of automated adverse event reporting is another key trend witnessed in the market. Automated reporting helps in improving the accuracy and completeness of case reports. It also helps in saving time and cost associated with manual reporting. More coverage can be found in the sample copy.

Medical Device Vigilance Market Opportunities

By Delivery Mode

The by delivery mode segment of the medical device vigilance market is expected to be dominated by the cloud-based subsegment, holding around 60% market share by 2031.

Cloud-based delivery mode provides benefits such as scalability, cost-effectiveness and easy accessibility which is driving its adoption among organizations. The ability of cloud-based software to integrate with other applications and platforms is further contributing to the growth of this subsegment.

By Application

The adverse event reporting application segment accounted for over 35% of the total market share in 2024 owing to stringent regulatory requirements for reporting any adverse event. Medical device manufacturers and organizations are compelled to swiftly report any adverse events associated with their products to the relevant authorities. This is propelling the demand for automated adverse event reporting solutions. Furthermore, the growing need to track performance, reporting and analysis of medical devices is augmenting the market size of the problem management application segment.

Key Market Takeaways

The global medical device vigilance market is anticipated to witness a CAGR of 10.5% during the forecast period 2024-2031, owing to increasing complex regulatory requirements for medical devices.

On the basis of delivery mode, cloud-based segment is expected to hold a dominant position, holding around 60% market share due to benefits such as scalability, cost-effectiveness and easy accessibility.

By application, adverse event reporting segment accounted for over 35% of the total market share in 2024 due to stringent regulatory mandates for timely adverse event reporting.

Regionally, North America is expected to hold a dominant position over the forecast period, accounting for around 40% of the global market share due to presence of large medical device manufacturers and favorable government initiatives for healthcare IT.

Competitor Insights:

ZEINCRO
Oracle Corporation
Sarjen Systems
Sparta Systems
EXTEDO

Recent Developments in Medical Device Vigilance Market

In May 2023, the European Union implemented new revisions to its medical device vigilance regulations. The updated EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) have strengthened requirements for post-market surveillance and vigilance reporting. Manufacturers must now have a post-market surveillance plan in place before devices receive a CE marking and enter the EU market.

The rising complexity of combination products comprising drug/device/biologic components requires harmonized and collaborative vigilance across previously distinct regulatory frameworks. Stakeholders have been working on convergence initiatives to address challenges in adverse event reporting, evaluation, and corrective actions for such multi-component systems. New guidelines clarifying labelling, submission requirements and responsibilities are making the process more streamlined. Over the next year, combination product-specific vigilance best practices can be expected to solidify further with coordinated oversight models. Full coverage of the report available here.