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시장보고서
상품코드
2107755
IVDR 인증 시장 : 의료기기 유형별, 규제 클래스별, 조달 형태별, 최종사용자별, 지역별IVDR Certification Market, By Device Type, By Regulatory Class, By Sourcing Type, By End User, By Geography |
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IVDR 인증 시장 규모는 2026년에 63억 2,490만 달러로 추정되고 있으며, 2033년까지 98억 7,010만 달러에 달할 것으로 전망되고 있습니다. 2026-2033년에는 CAGR 6.6%로 성장할 것으로 예측됩니다.
| 리포트 범위 | 리포트 상세 | ||
|---|---|---|---|
| 기준연도 : | 2025년 | 2026년 시장 규모 : | 63억 2,490만 달러 |
| 과거 데이터 기간 : | 2020-2024년 | 예측 기간 : | 2026-2033년 |
| 2026-2033년 예측 기간의 CAGR : | 6.60% | 2033년 시장 규모 예측 : | 98억 7,010만 달러 |
EU IVDR(2017/746)에서 의무화하고 있는 IVDR 인증이란 체외진단용 의료기기(IVD)가 유럽 시장에 진입하기 전에 EU가 정한 안전성, 임상적 근거, 분석 성능, 위험 관리 및 시판 후 감시에 관한 특정 기준을 충족하기 위한 엄격한 절차입니다. 일반적으로 이 절차에는 IVD의 기술 문서, 품질관리 시스템 및 성능 평가가 포함되며, 그 결과 의료기기의 위험 등급에 따라 지정 기관(Notified Body)에 의한 적합성 평가가 이루어집니다.
전 세계 IVDR 인증 시장은 EU의 IVDR 광범위한 도입, 모든 IVD를 대상으로 한 규제 강화, 그리고 인증된 동반 진단, 분자 진단, 현장 진단(Point-of-Care) 애플리케이션에 대한 수요 증가를 배경으로 급속히 확대되고 있습니다. 규제 관련 컨설팅 회사 및 지정 기관의 중요성이 높아지고, 규정 준수 서비스 및 기술 문서 작성 서비스에 대한 투자가 증가함에 따라 기존 및 신흥 IVD 개발자들 사이에서 IVDR 인증 도입이 가속화되고 있습니다.
시장 역학
전 세계 IVDR 인증 시장은 유럽연합 체외진단용 의료기기 규정(EU IVDR)의 엄격한 시행에 힘입어 성장하고 있습니다. 이 규정에 따라 체외진단용 의료기기 제조업체는 새로운 요건을 충족하기 위해 임상적 증거, 성능 평가 및 시판 후 조사 프로그램을 마련해야 할 의무가 있습니다. 적합성 평가가 필요한 체외진단용 의료기기의 증가와 더불어 규제 및 인증 활동의 활성화로 인해 아웃소싱이 확대되고 있습니다.
그러나 IVDR 지정 인증 기관의 수가 제한적이고, 인증에 소요되는 기간이 길며, 특히 중소규모 제조업체의 경우 규정 준수 비용이 높다는 점 등의 요인으로 인해 IVDR 인증 시장의 성장은 제약을 받고 있습니다. 그럼에도 불구하고 디지털 규제 관리 툴의 기능 강화, 규제 컨설팅 서비스에 대한 투자 확대, 그리고 인증 기관의 대응 능력 확충은 IVDR 인증 시장에 새로운 성장 기회를 가져다줄 것입니다.
본 조사의 주요 특징
- 본 조사에서는 다양한 부문의 잠재적 수익 기회를 밝히고, 이 시장의 매력적인 투자 제안 매트릭스에 대해 해설하고 있습니다.
- 또한 본 조사에서는 시장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 그리고 주요 기업이 채택하는 경쟁 전략에 관한 중요 인사이트도 제공합니다.
- 본 조사에서는 다음 매개변수(기업 개요, 제품 포트폴리오, 주요 하이라이트, 재무 실적 및 전략)를 바탕으로 전 세계 IVDR 인증 시장의 주요 기업 개요을 소개하고 있습니다.
- 이 보고서에서 얻은 인사이트를 통해 기업의 마케팅 담당자 및 경영진은 향후 제품 출시, 제품 유형 업그레이드, 시장 확대 및 마케팅 전략에 대해 충분한 정보를 바탕으로 의사결정을 내릴 수 있습니다.
- 본 글로벌 IVDR 인증 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 진입 기업, 금융 애널리스트 등 이 업계의 다양한 이해관계자를 대상으로 합니다.
- 이해관계자들은 전 세계 IVDR 인증 시장 분석에 사용된 다양한 전략 매트릭스를 활용함으로써 의사결정을 원활하게 수행할 수 있을 것입니다.
목차
제1장 조사 목적과 전제조건
제2장 시장 전망
제3장 시장 역학·규제·동향 분석
제4장 세계의 IVDR 인증 시장 : 디바이스 유형별, 2021-2033년
제5장 세계의 IVDR 인증 시장 : 규제 클래스별, 2021-2033년
제6장 세계의 IVDR 인증 시장 : 조달 형태별, 2021-2033년
제7장 세계의 IVDR 인증 시장 : 최종사용자별, 2021-2033년
제8장 세계의 IVDR 인증 시장 : 지역별, 2021-2033년
제9장 경쟁 구도
제10장 애널리스트의 제안
제11장 참고 문헌 및 조사 방법
KSAIVDR Certification Market is estimated to be valued at USD 6,324.9 Mn in 2026 and is expected to reach USD 9,870.1 Mn by 2033, growing at a compound annual growth rate (CAGR) of 6.6% from 2026 to 2033.
| Report Coverage | Report Details | ||
|---|---|---|---|
| Base Year: | 2025 | Market Size in 2026: | USD 6,324.9 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2026 To 2033 |
| Forecast Period 2026 to 2033 CAGR: | 6.60% | 2033 Value Projection: | USD 9,870.1 Mn |
IVDR certification, as required under the EU IVDR (2017/746) is the rigorous process through which in-vitro diagnostics (IVDs) meet specific EU safety, clinical evidence, analytical performance, risk management and post-market surveillance standards, prior to their entry to the market in Europe. It typically comprises the technical documentation, quality management system, and performance evaluation of an IVD, the result of which is a conformity assessment conducted by a Notified Body according to the risk class of the device.
The global IVDR certification market is experiencing significant expansion fueled by the widespread rollout of the EU IVDR, tightened regulations across all IVDs and the elevated demand for certified companion diagnostics, molecular and point-of-care diagnostic applications. As regulatory affairs consultancies and Notified Bodies rise in importance and investment in compliance services and technical documentation services increases, there has been accelerated adoption of IVDR certification among existing and emerging IVD developers.
Market Dynamics
The global IVDR certification market is driven by stringent implementation of the European Union In Vitro Diagnostic Regulation (EU IVDR) that necessitates in vitro diagnostic device makers have clinical evidence, a performance evaluation, and a post-market surveillance program in place to meet new requirements. Increasing in vitro diagnostic devices needing a conformity assessment, along with the rise in regulatory and certification activities, have resulted in an upswing in outsourcing.
However, the growth of the IVDR certification market is limited by factors such as limited availability of IVDR-designated Notified Bodies, lengthy certification timelines, and the high cost of compliance, particularly for small and medium-sized manufacturers. Nevertheless, enhancements to digital regulatory management tools, increasing investments in regulatory consulting services, and the expansion of Notified Body capacity will offer new opportunities for growth in IVDR certification market.
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 approvals, market trends, regional outlook, and competitive strategies adopted by key players
- It profiles key players in the global IVDR certification market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
- Key companies covered as a part of this study include TUV SUD AG, TUV Rheinland AG, DEKRA SE, BSI Group, SGS SA, Intertek Group plc, UL Solutions Inc., DNV Group AS, Kiwa N.V., and Eurofins Scientific SE
- 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 IVDR certification 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 IVDR certification market
Market Segmentation
- Device Type Insights (Revenue, USD Mn, 2021 - 2033)
- Laboratory-based
- Point-of-Care
- Regulatory Class Insights (Revenue, USD Mn, 2021 - 2033)
- Class I
- Class II
- Class III
- Class IV
- Sourcing Type Insights (Revenue, USD Mn, 2021 - 2033)
- In-house
- Outsource
- End User Insights (Revenue, USD Mn, 2021 - 2033)
- Medical Device Companies
- Hospitals and Clinics
- Diagnostic Laboratories / Centers
- CDMO and CMO
- Others
- Regional Insights (Revenue, USD Mn, 2021 - 2033)
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
- Key Players Insights
- TUV SUD AG
- TUV Rheinland AG
- DEKRA SE
- BSI Group
- SGS SA
- Intertek Group plc
- UL Solutions Inc.
- DNV Group AS
- Kiwa N.V.
- Eurofins Scientific SE
Table of Contents
1. Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
2. Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Global IVDR Certification Market, By Device Type
- Global IVDR Certification Market, By Regulatory Class
- Global IVDR Certification Market, By Sourcing Type
- Global IVDR Certification Market, By End User
- Global IVDR Certification Market, By Region
3. Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Impact Analysis
- Key Highlights
- Regulatory Scenario
- Product Launches/Approvals
- PEST Analysis
- PORTER's Analysis
- Market Opportunities
- Regulatory Scenario
- Industry Trends
4. Global IVDR Certification Market, By Device Type, 2021-2033, (USD Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
- Laboratory-based
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Point-of-Care
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
5. Global IVDR Certification Market, By Regulatory Class, 2021-2033, (USD Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
- Class I
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Class II
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Class III
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Class IV
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
6. Global IVDR Certification Market, By Sourcing Type, 2021-2033, (USD Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
- In-house
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Outsource
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
7. Global IVDR Certification Market, By End User, 2021-2033, (USD Mn)
- Introduction
- Market Share Analysis, 2026 and 2033 (%)
- Y-o-Y Growth Analysis, 2022 - 2033
- Segment Trends
- Medical Device Companies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Hospitals and Clinics
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Diagnostic Laboratories / Centers
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- CDMO and CMO
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
8. Global IVDR Certification Market, By Region, 2021 - 2033, Value (USD Mn)
- Introduction
- Market Share (%) Analysis, 2026, 2029 & 2033, Value (USD Mn)
- Market Y-o-Y Growth Analysis (%), 2022 - 2033, Value (USD Mn)
- Regional Trends
- North America
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
- U.S.
- Canada
- Latin America
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- Introduction
- Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
- Market Size and Forecast, By Country/Region, 2021 - 2033, Value (USD Mn)
- South Africa
- North Africa
- Central Africa
9. Competitive Landscape
- Company Profile
- TUV SUD AG
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- TUV Rheinland AG
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- DEKRA SE
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- BSI Group
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- SGS SA
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Intertek Group plc
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- UL Solutions Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- DNV Group AS
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Kiwa N.V.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- Eurofins Scientific SE
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
- TUV SUD AG
10. Analyst Recommendations
- Wheel of Fortune
- Analyst View
- Coherent Opportunity Map
11. References and Research Methodology
- References
- Research Methodology
- About us
