Materiovigilance Market

Materiovigilance Market is Estimated to Witness High Growth Owing to Advanced Technologies Enabling Improved Pharmacovigilance


The materiovigilance market has witnessed significant growth in recent years owing to rising incidences of implant-associated adverse events and increasing use of biomaterials and medical devices in healthcare. Materiovigilance helps in monitoring the performance and adverse effects associated with biomaterials, medical devices and implants pre- and post-marketing to ensure patient safety. The increasing complexities involved in medical devices and implants have necessitated stringent regulations regarding the materiovigilance by various regulatory bodies globally.

The Global materiovigilance Market is estimated to be valued at US$ 89.09 Bn in 2024 and is expected to exhibit a CAGR of 14% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the materiovigilance are IQVIA Holdings Inc., Optum, Inc. (a subsidiary of UnitedHealth Group), Cerner Corporation, Flatiron Health, Inc. (a subsidiary of Roche), IBM Corporation, Tempus Labs Inc., Syneos Health Inc., Evidera, Inc., Palantir Technologies Inc., SAS Institute Inc.

The key opportunities in the market include increased adoption of artificial intelligence and machine learning-enabled technologies by key players for advanced signal detection from large volumes of data. Growing need for outsourcing of Materiovigilance Market activities to specialized third-party vendors also presents an opportunity for growth.
Advanced technologies like blockchain, cloud computing and mobile health applications enabling easier reporting and exchange of safety data in a secure manner further support the growth of the materiovigilance market.

Market drivers

Stringent regulations and increasing guidelines by global regulatory authorities regarding post-marketing surveillance of medical devices is a key factor driving the growth of materiovigilance market. Growing incorporation of artificial materials in implants and prostheses have necessitated continuous monitoring to ensure patient safety. Rising preference of minimally invasive surgeries using medical devices have further fueled the need for robust pharmacovigilance systems globally.

Current Challenges in Materiovigilance Market

The materiovigilance market is facing challenges related to data management, analytics, reporting and interoperability. Monitoring adverse events and medical device failures for ensuring safety requires collection and analysis of huge amounts of data from diverse sources. However, lack of standardized formats and platform interoperability issues create data silos, hampering effective data integration and analysis. Similarly, fulfilling strict regulatory reporting requirements in multiple countries poses operational challenges. The industry needs to overcome these challenges through adoption of advanced digital technologies like artificial intelligence, cloud and blockchains to enable centralized data sharing and streamlined reporting process.

SWOT Analysis

Strength: Growing regulatory emphasis on medical device safety results in increased adoption of materiovigilance programs.
Weakness: Lack of standardized data formats and interoperability between IT systems of different stakeholders.
Opportunity: Emerging technologies like AI and blockchain can help improve data integration, analytics and reporting capabilities.
Threats: Stringent regulations and strict penalties for non-compliance increase compliance costs for manufacturers.

Geographical Regions – Value concentration

North America currently holds the largest share in the materiovigilance market, both in terms of value and volume. This is owing to well-established regulatory frameworks and presence of majority manufacturers and CROs in the region. Europe is another prominent regional market supported by strict directives and mandates regarding medical device safety surveillance.

Fastest Growing Region

Asia Pacific region is poised to witness fastest growth during the forecast period owing to increasing healthcare spending, growing medical tourism industry and expanding device manufacturing sector in key emerging countries like China, India and South Korea. Rising awareness about regulatory requirements and efforts to strengthen post-market surveillance programs are driving the adoption of materiovigilance solutions in Asia Pacific.

1. Source: Coherent Market Insights, Public sources, Desk research.
2. We have leveraged AI tools to mine information and compile it.