医療機器検査・認証市場：サービスタイプ別、調達タイプ別、機器クラス別、技術別、地域別

医療機器検査・認証市場は、2025年に109億5,790万米ドルの市場規模を維持し、2032年には147億1,360万米ドルに達すると予測されます。2025年から2032年までのCAGRは4.3%と予測されます。

医療機器検査・認証は、医療機器の安全性と有効性を確保するために必要です。米国は食品医薬品局（FDA）のガイドラインに従い、カナダはカナダ保健省（Health Canada）の登録を必要とし、欧州は欧州適合（CE）認可を考慮し、インドは中央医薬品標準管理機構（CDSCO）の認可が必要です。

市場力学：

医療機器検査・認証への注目の高まり、厳しい政府規制、医療機器における人工知能（AI）とモノのインターネット（IoT）の統合の高まり、COVID-19の発生は、予測期間中に世界の医療機器検査・認証市場の成長を促進すると予想される主な要因です。

例えば、2022年1月、TUV SUDはミネソタ州ニューブライトンに医療機器試験ラボを拡張しました。この最新鋭の試験所は、あらゆる医療機器に対してエンドツーエンドの試験ソリューションを提供し、TUV SUDの現在のアクティブな医療機器試験能力を補完する医療機器の生物学的・化学的試験も幅広く行う予定です。

本調査の主な特徴

• 本レポートは、世界の医療機器検査・認証市場を詳細に分析し、2024年を基準年として、2025年から2032年の予測期間における市場規模および複合年間成長率（CAGR）を提供しています。
• また、さまざまなセグメントにわたる潜在的な収益機会を明らかにし、この市場の魅力的な投資提案マトリクスについて解説しています。
• また、市場促進要因、抑制要因、機会、新製品の上市や承認、市場動向、地域別の展望、主要企業が採用する競争戦略などに関する主要考察も提供しています。
• 企業ハイライト、製品ポートフォリオ、主要なハイライト、財務実績、戦略などの以下のパラメータに基づいて、世界の医療機器試験および認証市場の主要企業プロファイルを掲載しています。
• このレポートからの洞察は、マーケティング担当者や企業の経営陣が、将来の製品の発売、タイプのアップグレード、市場拡大、マーケティング戦術に関する情報に基づいた意思決定を行うことを可能にします。
• 世界の医療機器検査・認証市場レポートは、投資家、サプライヤー、製品メーカー、流通業者、新規参入者、財務アナリストなど、この業界の様々な利害関係者を対象としています。
• 利害関係者は、世界の医療機器検査および認証市場の分析に使用される様々な戦略マトリックスを通じて、意思決定を容易にすることができます。

目次：

第1章 調査の目的と前提条件

• 調査目的
• 前提条件
• 略語

第2章 市場の展望

• レポートの説明
  • 市場の定義と範囲
• エグゼクティブサマリー
• Coherent Opportunity Map（COM）

第3章 市場力学、規制、動向分析

• 市場力学
  • 厳格な規則と規制
  • 規制の多様性
  • COVID-19（パンデミック）の発生
• 影響分析
• 主なハイライト
• 規制シナリオ
• 製品の発売/承認
• PEST分析
• PORTERの分析
• 合併と買収のシナリオ

第4章 世界の医療機器検査・認証市場-コロナウイルス（COVID-19）パンデミックの影響

• COVID-19疫学
• 供給側と需要側の分析
• 経済への影響

第5章 世界の医療機器検査・認証市場、サービスタイプ別、2020年～2032年

• 試験サービス
• 検査サービス
• 認証サービス

第6章 世界の医療機器検査・認証市場、調達タイプ別、2020年～2032年

• 社内
• アウトソーシング

第7章 世界の医療機器検査・認証市場（機器クラス別、2020年～2032年）

• クラスI
• クラスII
• クラスIII

第8章 世界の医療機器検査・認証市場、技術別、2020年～2032年

• アクティブインプラント医療機器
• 能動医療機器
• 非能動医療機器
• 体外診断用医療機器
• 眼科医療機器
• 整形外科および歯科医療機器
• 血管医療機器
• その他の技術

第9章 世界の医療機器検査・認証市場、地域、2020年～2032年

• 北米
• 欧州
• アジア太平洋
• ラテンアメリカ
• 中東・アフリカ

第10章 競合情勢

• Medistri SA
• BSI Group
• Ente Certificazione Macchine
• GMED
• IMQ Group SRL
• TOXIKON
• TUV SUD
• WuXi AppTec
• Pace Analytical Services LLC
• Gateway Analytical LLC
• Boston Analytical
• Bureau Veritas
• UL LLC
• TUV Rheinland
• SGS SA
• Intertek Group PLC
• Eurofins Scientific
• Element Materials Technology
• Dekra Testing and Certification GmbH
• Institute for testing and Certification Inc.

第11章 セクション

• 調査手法
• 出版社について

Medical Device Testing and Certification Market is poised to hold a valuation of USD 10,957.9 Mn in 2025 and is expected to reach USD 14,713.6 Mn in 2032. The market is expected to exhibit a CAGR of 4.3% from 2025 to 2032.

Medical device testing and certification is necessary to ensure safety and effectiveness of medical devices. The U.S. follows the Food and Drug Administration (FDA) guidelines, Canada needs the Health Canada Registration, Europe considers Conformite Europeenne (CE) approval, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).

Market Dynamics:

Rise in focus on the medical device testing and certification, stringent government regulations, rise in integration of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices, and the outbreak of COVID-19 are major factors expected to drive growth of the global medical device testing and certification market during the forecast period.

For instance, in January 2022, TUV SUD expanded its medical device testing laboratory in New Brighton, Minnesota. The state-of-the-art laboratory will offer an end-to-end testing solution for all medical devices and will also provide a wide range of biological and chemical testing of medical devices that complements TUV SUD's current active medical device testing capabilities.

Key features of the study:

• This report provides in-depth analysis of the global medical device testing and certification market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period 2025-2032, considering 2024 as the base year.
• 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 medical device testing and certification market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
• Key companies covered as a part of this study include Medistri SA, BSI Group, GMED, IMQ Group SRL, TOXIKON, TUV SUD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, Ente Certificazione Macchine, and Institute for testing and Certification Inc., among others.
• 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 medical device testing and 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 medical device testing and certification market.

Detailed Segmentation:

• Global Medical Device Testing and Certification Market, By Service Type
  • Testing Services
  • Inspection Services
  • Certification Services
• Global Medical Device Testing and Certification Market, By Sourcing Type
  • In-house
  • Outsourced
• Global Medical Device Testing and Certification Market, By Device Class
  • Class I
  • Class II
  • Class III
• Global Medical Device Testing and Certification Market, By Technology
  • Active Implant Medical Device
  • Active Medical Device
  • Non-Active Medical Device
  • In-Vitro Diagnostic Medical Device
  • Ophthalmic Medical Device
  • Orthopedic and Dental Medical Device
  • Vascular Medical Device
  • Other Technologies
• Global Medical Device Testing and Certification Market, By Geography
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa
• Company Profiles
  • Medistri SA
  • BSI Group
  • Ente Certificazione Macchine
  • GMED
  • IMQ Group SRL
  • TOXIKON
  • TUV SUD
  • WuXi AppTec
  • Pace Analytical Services LLC
  • Gateway Analytical LLC
  • Boston Analytical
  • Bureau Veritas
  • UL LLC
  • TUV Rheinland
  • SGS SA
  • Intertek Group PLC
  • Eurofins Scientific
  • Element Materials Technology
  • Dekra Testing and Certification GmbH
  • Institute for testing and Certification Inc.

Table of Contents:

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Snapshot, By Services Type
  • Market Snapshot, By Sourcing Type
  • Market Snapshot, By Device Class
  • Market Snapshot, By Technology
  • Market Snapshot, By Geography
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Stringent rules and regulations
  • Diversity in regulations
  • Outbreak of COVID-19 (pandemic)
• Impact Analysis
• Key Highlights
• Regulatory Scenario
• Product launch/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario

4. Global Medical Device Testing and Certification Market - Impact of Coronavirus (COVID-19) Pandemic

• COVID-19 Epidemiology
• Supply Side and Demand Side Analysis
• Economic Impact

5. Global Medical Device Testing and Certification Market, By Service Type, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Testing Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Inspection Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Certification Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

6. Global Medical Device Testing and Certification Market, By Sourcing Type, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• In-house
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Outsourced
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

7. Global Medical Device Testing and Certification Market, By Device Class, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Class I
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Class II
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Class III
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

8. Global Medical Device Testing and Certification Market, By Technology, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Active Implant Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Active Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Non-Active Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• In-Vitro Diagnostic Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Ophthalmic Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Orthopedic and Dental Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Vascular Medical Device
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Other Technologies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

9. Global Medical Device Testing and Certification Market, By Geography, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• North America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
• Europe
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
• Asia Pacific
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
• Latin America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
• Middle East & Africa
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)

10. Competitive Landscape

• Medistri SA
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• BSI Group
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Ente Certificazione Macchine
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• GMED
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• IMQ Group SRL
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• TOXIKON
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• TUV SUD
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• WuXi AppTec
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Pace Analytical Services LLC
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Gateway Analytical LLC
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Boston Analytical
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Bureau Veritas
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• UL LLC
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• TUV Rheinland
  • 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
• Eurofins Scientific
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Element Materials Technology
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Dekra Testing and Certification GmbH
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Institute for testing and Certification Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Analyst Views

11. Section

• Research Methodology
• About us