시장보고서

상품코드

2084778

마테리오비질런스(Materiovigilance) 시장 : 제공 방식별, 용도별, 최종사용자별, 지역별

Materiovigilance Market, By Delivery Mode, By Application, By End Users, By Geography

발행일: 2026년 06월 | 리서치사: 구분자

Coherent Market Insights | 페이지 정보: 영문 | 배송안내 : 2-3일 (영업일 기준)

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※ 부가세 별도

한글목차

영문목차

샘플 요청 목록에 추가

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

마테리오비질런스 시장은 2026년에 974억 달러 규모에 달할 것으로 추정되며, 2033년까지 1,670억 달러에 달할 것으로 예상됩니다. 2026년부터 2033년까지 CAGR 8.0%로 성장할 것으로 전망됩니다.

분석 범위		분석 상세
기준 연도	2025년	시장 규모(2026년)	974억 달러
실적 데이터	2020-2024년	예측 기간	2026-2033년
예측 기간 CAGR(2026-2033년)	8.00%	예측 금액(2033년)	1,670억 달러

마테리오비질런스(의료기기 비질런스라고도 함)란, 의료기기 사용으로 인해 발생하는 사고에 관한 정보를 수집·평가·보고하고 동향을 파악하는 것을 말합니다. 의료기기 감시 제도는 유해 사건이나 유해한 영향을 초래하는 오류의 발생을 방지하거나 줄임으로써, 환자 및 의료기기를 사용하는 의료기관 등을 보호하는 것을 목적으로 합니다. 의료기기와 관련된 기술적 문제나 잠재적인 유해 영향의 탐지는 마테리오비질런스를 통해 모니터링됩니다. 물질 감시에는 시판 후 조사, 이상반응, 사고 및 의료기기 리콜이 포함됩니다. 유해 사건은 의료기기의 사용으로 인해 발생할 수 있으며, 심각한 결과를 초래할 우려가 있습니다.

시장 역학

의료기기용 보안 계획의 도입 증가 및 의료기기 플랫폼의 확대와 같은 요인들이 예측 기간 동안 전 세계 마테리오비질런스 시장의 성장을 견인할 것으로 예상됩니다. 예를 들어, 2017년 7월, 의료기기의 안전성과 보안에 중점을 둔 비영리 전문 단체인 ‘의료기기 혁신·안전·보안 컨소시엄(MDISS)’은 의료기기 전용의 새로운 보안 시험 기관인 ‘세계 의료정보 보안 시험 연구소(WHISTL)’를 설립했습니다. WHISTL은 의료기기의 보안 관리·개선 및 교육에 주력하고 있습니다. 예를 들어, 보안 및 개인정보 보호 위험 평가 솔루션을 제공하는 IT 기업인 Meditology Services가 공개한 자료에 따르면, 2021년 8월 미국 식품의약국(FDA)은 공급망 전반의 사이버 보안 강화를 목표로 하는 백악관의 노력에 부응하여, 의료기기의 사이버 보안 대책 개선 계획을 발표했습니다.

본 보고서의 주요 특징

본 보고서는 각 부문의 잠재적 수익 기회를 밝히고, 이 시장의 매력적인 투자 제안 매트릭스에 대해 설명하고 있습니다.
또한, 시장의 촉진요인 및 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업들이 채택하는 경쟁 전략 등에 관한 중요한 인사이트도 제공하고 있습니다.
전 세계 마테리오비질런스 시장의 주요 기업 개요을 각종 지표(기업 개요, 제품 포트폴리오, 주요 동향, 재무 실적, 전략 등)를 바탕으로 소개하고 있습니다.
본 보고서의 인사이트를 바탕으로, 마케팅 담당자와 기업 경영진은 향후 제품 출시, 기술 업데이트, 시장 확대 및 마케팅 전략에 대해 충분한 정보를 바탕으로 의사결정을 내릴 수 있습니다.
'세계 마테리오비질런스 시장' 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 진입 기업, 재무 분석가 등 이 업계의 다양한 이해관계자들을 대상으로 합니다.
이해관계자들은 전 세계 마테리오비질런스 시장 분석에 사용되는 다양한 전략 매트릭스를 통해 의사결정을 보다 수월하게 할 수 있습니다.

Report Coverage	Report Details
Base Year:	2025	Market Size in 2026:	USD 97.4 Bn
Historical Data for:	2020 To 2024	Forecast Period:	2026 To 2033
Forecast Period 2026 to 2033 CAGR:	8.00%	2033 Value Projection:	USD 167.0 Bn

Materiovigilance, also known as medical device vigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Medical device vigilance aims to protect the patients, healthcare facilities utilizing medical devices, and others by preventing or reducing the occurrence of errors that leads to harmful incidents and adverse effects. The detection of technical issues and potential adverse effects associated with medical devices is monitored by materiovigilance. Materiovigilance includes postmarket surveillance, adverse reactions, incidents and recalls of medical devices. Adverse reactions can occur due to use of medical devices and can have severe consequences.

Market Dynamics

Factors such as increasing launches of security plans for medical devices and increasing number of medical device platforms are expected to drive the growth of the global materiovigilance market over the forecast period. For instance, in July 2017, Medical Device Innovation, Safety and Security Consortium (MDISS), a non-profit professional organization with a focus on the safety and security of medical devices, launched a new security testing lab called the World Health Information Security Testing Lab (WHISTL) for medical devices. WHISTL focuses on management and improvement of medical device security and education. For instance, according to data published by Meditology Services, is an IT company that provides security and privacy risk assessment solutions, in August 2021, the U.S. Food and Drug Administration announced a plan to improve cybersecurity practices for medical devices in response to the White House's effort to bolster cybersecurity across the supply chain.

Key features of the study

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
It profiles key players in the global materiovigilance market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, strategies
Key companies covered as a part of this study include AssurX, Sparta Systems, Oracle Corporation, Xybion Corporation, Sarjen Systems Pvt. Ltd., MDI Consultants, AB-Cube, QVigilance, Qserve, and ZEINCRO
Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
The global materiovigilance market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global materiovigilance market

Market Segmentation

By Delivery Mode (Revenue, USD Bn, 2021-2033)
On-premise
On-cloud
By Application (Revenue, USD Bn, 2021-2033)
Diagnostic Application
Therapeutic Application
Surgical Application
Research Application
Others
By End User (Revenue, USD Bn, 2021-2033)
Contract Research Organization
Business Process Outsourcing
Original Equipment Manufacturers
Others
By Region (Revenue, USD Bn, 2021-2033)
North America
- U.S.
- Canada
Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
Middle East
- GCC
- Israel
- Rest of Middle East
Africa
- South Africa
- Central Africa
- North Africa
Key Players
AssurX
Sparta Systems
Oracle Corporation
Xybion Corporation
Sarjen Systems Pvt. Ltd.
MDI Consultants
AB-Cube
QVigilance
Qserve
ZEINCRO

1. Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

2. Market Purview

Report Description
- Market Definition and Scope
Executive Summary
- Market Snapshot, By Delivery Mode
- Market Snapshot, By Application
- Market Snapshot, By End User
- Market Snapshot, By Region
Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

Market Dynamics
- Drivers
- Restraints
- Market Opportunities
Impact Analysis
Market Trends
Key Developments
Product Approval
Collaboration/Merge/Acquisition
Regulatory Landscape
PEST Analysis
Porter's Five Forces Analysis
Epidemiology
Robust Pipeline Analysis

4. Global Materiovigilance Market, By Delivery Mode, 2021 - 2033, (USD Billion)

Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022- 2033
- Segment Trends
On-premise
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
On-cloud
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)

5. Global Materiovigilance Market, By Application, 2021 - 2033, (USD Billion)

Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
Diagnostic Application
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Therapeutic Application
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Surgical Application
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Research Application
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)

6. Global Materiovigilance Market, By End User, 2021 - 2033, (USD Billion)

Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
Contract Research Organization
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Business Process Outsourcing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Original Equipment Manufacturers
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)
Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Billion)

7. Global Materiovigilance Market, By Region, 2021 - 2033, (USD Billion)

Introduction
- Market Share Analysis, By Region, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, For Regions, 2022-2033
- Regional Trends
North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - U.S.
  - Canada
Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - Brazil
  - Mexico
  - Argentina
  - Rest of Latin America
Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - U.K.
  - Germany
  - Italy
  - France
  - Spain
  - Russia
  - Rest of Europe
Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - China
  - India
  - Japan
  - ASEAN
  - Australia
  - South Korea
  - Rest of Asia Pacific
Middle East
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - GCC
  - Israel
  - Rest of Middle East
Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Delivery Type, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Application, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2021 - 2033, (USD Billion)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2021 - 2033, (USD Billion)
  - North Africa
  - Central Africa
  - South Africa

8. Competitive Landscape

Heat Map Analysis
Market Share Analysis
Company Profile
- AssurX
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- Sparta Systems
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- Oracle Corporation
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- Xybion Corporation
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- Sarjen Systems Pvt. Ltd.
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- MDI Consultants
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- AB-Cube
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- QVigilance
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- Qserve
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
- ZEINCRO
  - Company Highlights
  - Product Portfolio
  - Financial Performance
  - Recent Highlights
  - Market Strategies
Analyst Views

9. Section

References
Research Methodology
About Us

마테리오비질런스(Materiovigilance) 시장 : 제공 방식별, 용도별, 최종사용자별, 지역별