마테리오비질런스(Materiovigilance) : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the materiovigilance market size is projected to expand from USD 95.25 billion in 2025 and USD 103.01 billion in 2026 to USD 152.41 billion by 2031, registering a CAGR of 8.15% between 2026 and 2031.

Global Materiovigilance Market Trends and Insights

Expansion of Mandatory Device Incident Reporting

Mandatory incident reporting is moving from a compliance backstop to a central source of demand in the materiovigilance market. The European Commission made 4 EUDAMED modules compulsory from May 28, 2026, covering actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. These requirements direct manufacturers, authorized representatives, importers, and notified bodies toward a shared digital reporting structure. The FDA Quality Management System Regulation became effective on February 2, 2026, and incorporated ISO 13485:2016 into 21 CFR Part 820. Smaller manufacturers face a greater need for external reporting platforms and managed services because they may lack dedicated regulatory resources. The materiovigilance market benefits from obligations that continue regardless of device demand cycles or broader economic conditions.

Cloud Consolidation of Complaint, Vigilance, and PMS Data

Cloud adoption supports regulatory readiness because surveillance records must remain current, connected, and accessible across reporting locations. The materiovigilance market is favoring platforms that bring complaint data, field safety corrective actions, clinical follow-up records, and risk documentation into one controlled workflow. This arrangement can reduce manual handoffs between case intake, corrective action, and surveillance teams. It also supports the documented quality systems required under the FDA QMSR, which now incorporates ISO 13485:2016. Providers can strengthen client retention when reporting taxonomies, regulatory rules, and periodic safety report templates are configured within the same environment. The value of cloud consolidation is limited in locations where patient identifiers and related safety data must remain within national or regional boundaries.

Fragmented Reporting Taxonomies and Cross-Border Rules

The materiovigilance market must operate across national reporting rules that differ in classifications, filing languages, data fields, and submission deadlines. A 2025 review found continuing differences between the European Union's EudraVigilance and EUDAMED structures and the more centralized U.S. FAERS and MAUDE approach. A manufacturer selling a device in 15 jurisdictions may need 15 differently formatted periodic safety reports and separate regulatory contacts. These requirements raise the effort needed to design and validate global reporting software. The burden falls most heavily on mid-size OEMs that do not have the regulatory affairs capacity of larger multinational companies. As a result, some manufacturers may concentrate surveillance investment in their largest sales jurisdictions, which can leave gaps in global safety records.

Other drivers and restraints analyzed in the detailed report include:

1. AI-Assisted Signal Detection From Unstructured Complaints
2. Rising Complexity of Connected and Software-Enabled Devices
3. Cybersecurity, Privacy, and Data-Residency Exposure

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Adverse Event Reporting held 44.31% of the materiovigilance market share in 2025 because it remains the legally required base of device post-market surveillance. The FDA MAUDE system and the EUDAMED vigilance framework require timely reporting of relevant events. Missed reporting obligations can lead to inspection scrutiny and other compliance consequences. Post-Market Surveillance services support structured evidence collection rather than only reactive complaint handling. Risk Assessment and Management services support ongoing review of device risks and benefits. Material Safety Monitoring also addresses biocompatibility information and early signs of product issues.

Regulatory Compliance and Reporting is forecast to grow at a 12.65% CAGR through 2031. The materiovigilance market is being shaped by concurrent implementation of EUDAMED requirements and the U.S. QMSR. The service can become a broader entry point when OEMs expand from case processing to inspection preparation and regulatory documentation. Countries such as India, Australia, Canada, and the United States have established post-marketing systems, while other locations are still developing similar structures. This uneven maturity creates demand for providers that can apply requirements across jurisdictions. Documentation linkages under ISO 13485:2016 further support the need for integrated compliance services.

Cloud-Based delivery accounted for 66.24% of the materiovigilance market size in 2025. It supports large reporting volumes, multi-site coordination, and real-time aggregation of complaint and surveillance information. Cloud platforms can also embed regulatory rules that reduce the specialized expertise required to maintain current workflows. This feature is important for mid-size OEMs managing changing U.S. and European requirements. On-Premise delivery remains relevant for large OEMs, public institutions, and national health authorities with strict data-sovereignty controls. It is also relevant where rules restrict transfers of identifiable health information outside a country or region.

Hybrid deployment is forecast to grow at a 13.42% CAGR through 2031. This approach combines cloud-based analytics and signal detection with local storage for sensitive patient identifiers. It responds to the need for analysis at scale while respecting local data controls in Asia-Pacific, the Middle East, and Europe. Hybrid configurations can increase switching costs because a new provider must revalidate connections between local infrastructure and analytical systems. AB Cube's 2026 roadmap highlighted security, resilience, and future-readiness features, including CasEasy V3 and Converter V2. These product investments reflect the emphasis on configurations that can serve different data-control requirements.

Complete Report Scope:

• By Service Type
  • Adverse Event Reporting
  • Post-Market Surveillance
  • Risk Assessment and Management
  • Regulatory Compliance and Reporting
  • Material Safety Monitoring
• By Delivery Mode
  • Cloud-Based
  • On-Premise
  • Hybrid
• By Device Type
  • Diagnostic Devices
  • Therapeutic Devices
  • Monitoring Devices
  • Surgical Devices
  • Other Device Types
• By End User
  • Original Equipment Manufacturers
  • Contract Research Organizations
  • Business Process Outsourcing Providers
  • Healthcare Institutions
  • Regulatory Authorities and Public-Health Programs
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 38.42% of the materiovigilance market share in 2025. The region benefits from an established adverse-event reporting infrastructure and a dense U.S. medical-device ecosystem. The FDA QMSR took effect in February 2026 and incorporated ISO 13485:2016 into 21 CFR Part 820. U.S. demand includes enterprise quality management platforms, AI-supported signal tools, and contract research organization services. FDA cybersecurity guidance also supports investment in systems that connect safety reporting with connected-device and software-update records.

Europe remains an important geography because the EU MDR provides a shared regulatory baseline for the 27-member market. Germany, France, the United Kingdom, Italy, and Spain provide much of the region's demand. EUDAMED's first 4 modules become mandatory on May 28, 2026, which increases the need for coordinated digital reporting. The United Kingdom retains a separate MHRA framework after Brexit, creating additional submission requirements for manufacturers operating in both systems. Germany's medical-device manufacturing base supports domestic demand for platform and service providers. The region also faces scrutiny of privacy, security, and data-transfer controls.

Asia-Pacific is forecast to grow at a 12.33% CAGR through 2031. The region's expansion reflects stronger reporting expectations and a growing device base in China, India, South Korea, and Japan. India's February 2026 notice reinforced reporting compliance for medical-device marketing authorization holders under MvPI. Japan and South Korea are mature enforcement-focused systems, so their contribution is more incremental. The Middle East and Africa remain early-stage areas supported by healthcare investment and regional partnerships. South America is supported by Brazil's ANVISA framework and Argentina's evolving regulatory structure.

1. AB Cube
2. AssurX
3. Bioexcel Lifesciences Pvt. Ltd.
4. Cloudtheapp
5. EmpowerReg
6. Erythos
7. Honeywell International
8. IQVIA
9. Kintavo
10. mdi Consultants, Inc.
11. Oracle
12. Qserve Group B.V.
13. QVigilance
14. RealBit S.r.l.
15. Remedical
16. Sarjen Systems Pvt. Ltd.
17. Smarteeva
18. Xybion Corporation
19. ZEINCRO

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expansion of Mandatory Device Incident Reporting
  • 4.2.2 Cloud Consolidation of Complaint, Vigilance, and PMS Data
  • 4.2.3 AI-Assisted Signal Detection From Unstructured Complaints
  • 4.2.4 Rising Complexity of Connected and Software-Enabled Devices
  • 4.2.5 Localization of Surveillance Programs in Emerging Device Markets
  • 4.2.6 Continuous Evidence Linkage Across PMS, PMCF, Risk, and CAPA
• 4.3 Market Restraints
  • 4.3.1 Fragmented Reporting Taxonomies and Cross-Border Rules
  • 4.3.2 Cybersecurity, Privacy, and Data-Residency Exposure
  • 4.3.3 Scarcity of Device-Specific Regulatory and Clinical Expertise
  • 4.3.4 Weak Causality and Denominator Data in Voluntary Reporting
• 4.4 Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Service Type
  • 5.1.1 Adverse Event Reporting
  • 5.1.2 Post-Market Surveillance
  • 5.1.3 Risk Assessment and Management
  • 5.1.4 Regulatory Compliance and Reporting
  • 5.1.5 Material Safety Monitoring
• 5.2 By Delivery Mode
  • 5.2.1 Cloud-Based
  • 5.2.2 On-Premise
  • 5.2.3 Hybrid
• 5.3 By Device Type
  • 5.3.1 Diagnostic Devices
  • 5.3.2 Therapeutic Devices
  • 5.3.3 Monitoring Devices
  • 5.3.4 Surgical Devices
  • 5.3.5 Other Device Types
• 5.4 By End User
  • 5.4.1 Original Equipment Manufacturers
  • 5.4.2 Contract Research Organizations
  • 5.4.3 Business Process Outsourcing Providers
  • 5.4.4 Healthcare Institutions
  • 5.4.5 Regulatory Authorities and Public-Health Programs
  • 5.4.6 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 AB Cube
  • 6.3.2 AssurX, Inc.
  • 6.3.3 Bioexcel Lifesciences Pvt. Ltd.
  • 6.3.4 Cloudtheapp
  • 6.3.5 EmpowerReg
  • 6.3.6 Erythos
  • 6.3.7 Honeywell International Inc.
  • 6.3.8 IQVIA Inc.
  • 6.3.9 Kintavo
  • 6.3.10 mdi Consultants, Inc.
  • 6.3.11 Oracle Corporation
  • 6.3.12 Qserve Group B.V.
  • 6.3.13 QVigilance
  • 6.3.14 RealBit S.r.l.
  • 6.3.15 Remedical
  • 6.3.16 Sarjen Systems Pvt. Ltd.
  • 6.3.17 Smarteeva
  • 6.3.18 Xybion Corporation
  • 6.3.19 ZEINCRO

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment