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市場調查報告書

商品編碼

2107755

IVDR認證市場：依醫療設備類型、監管分類、採購方式、最終用戶和地區分類

IVDR Certification Market, By Device Type, By Regulatory Class, By Sourcing Type, By End User, By Geography

出版日期: 2026年07月13日 | 出版商:

Coherent Market Insights | 英文 250 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

預計到 2026 年，體外診斷醫療器材法規 (IVDR) 認證市場規模將達到 63.249 億美元，到 2033 年將達到 98.701 億美元。預計從 2026 年到 2033 年，該市場將以 6.6% 的複合年成長率成長。

報告範圍		報告詳情
基準年：	2025	2026年市場規模：	63.249億美元
歷史數據時期：	2020年至2024年	預測期：	2026年至2033年
2026年至2033年預測期間的複合年成長率：	6.60%	2033年市場規模預測：	98.701億美元

根據歐盟體外診斷醫療設備(IVD) 必須經過嚴格的認證流程才能進入歐洲市場。該流程要求 IVD 在安全性、臨床證據、分析性能、風險管理和上市後監管等方面符合歐盟的特定標準。通常，該流程包括對 IVD 的技術文件、品管系統和性能評估，最終由公告機構根據醫療設備的風險等級進行合格評定。

全球體外診斷醫療器材法規 (IVDR) 認證市場正經歷顯著擴張，這主要得益於歐盟廣泛採用 IVDR、涵蓋所有體外診斷產品的法規日益嚴格，以及對經認證的伴隨診斷、分子診斷和即時診斷應用的需求不斷成長。監管顧問公司和指定機構的重要性日益凸顯，同時，合規服務和技術文件服務的投入不斷增加，也加速了現有和新興 IVD 開發商對 IVDR 認證的採用。

市場動態

全球體外診斷醫療設備醫療設備法規 (IVDR) 認證市場正受到歐盟體外診斷醫療器材法規 (EU IVDR) 嚴格執行的推動。該法規要求 IVDR 製造商開發臨床證據、性能評估和上市後調查計畫，以滿足新的要求。越來越多的醫療設備要求進行合格評定，加上監管和認證活動的活性化，導致外包業務日益增加。

然而，體外診斷醫療器材法規（IVDR）認證市場的成長受到許多因素的限制，例如IVDR指定認證機構數量有限、認證流程漫長以及合規成本高昂，尤其對於中小型製造商而言更是如此。儘管如此，數位化監管管理工具的改進、監管諮詢服務投入的增加以及認證機構能力的提升，都將為IVDR認證市場帶來新的成長機會。

本次調查的主要特點

本研究揭示了各個細分市場的潛在商機，並為該市場說明了一個具有吸引力的投資提案矩陣。
此外，本研究還深入分析了市場促進因素、限制因素、機會、新產品發布和批准、市場趨勢、區域展望以及主要參與者採取的競爭策略。
本研究根據以下參數介紹了全球體外診斷醫療器材法規 (IVDR) 認證市場中主要公司的概況：公司概況、產品系列、主要亮點、財務績效和策略。
本報告提供的見解將使企業行銷負責人和經營團隊能夠就未來的產品發布、產品類型升級、市場擴張和行銷策略做出明智的決策。
這份全球體外診斷醫療器材法規 (IVDR) 認證市場報告針對產業內的各種相關人員，包括投資者、供應商、產品製造商、經銷商、新參與企業和金融分析師。
相關人員可以透過利用全球體外診斷醫療器材法規 (IVDR) 認證市場分析中使用的各種策略矩陣來簡化決策過程。

北美洲
- 美國
- 加拿大
拉丁美洲
- 巴西
- 阿根廷
- 墨西哥
- 其他拉丁美洲國家
歐洲
- 德國
- 英國
- 西班牙
- 法國
- 義大利
- 俄羅斯
- 其他歐洲國家
亞太地區
- 中國
- 印度
- 日本
- 澳洲
- 韓國
- ASEAN
- 其他亞太國家
中東
- 海灣合作理事會國家
- 以色列
- 其他中東國家
非洲
- 南非
- 北非
- 中非

第9章競爭情勢

公司簡介
- TUV SUD AG
- TUV Rheinland AG
- DEKRA SE
- BSI Group
- SGS SA
- Intertek Group plc
- UL Solutions Inc.
- DNV Group AS
- Kiwa NV
- Eurofins Scientific SE

第10章分析師建議

機會分析
分析師意見
Coherent Opportunity Map

第11章參考文獻與調查方法

參考
調查方法
關於本公司

簡介目錄

Product Code: CMI9763

IVDR 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

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