医療機器検査サービス市場規模、シェア、成長分析、サービスタイプ別、デバイスクラス別、検査タイプ別、デバイスタイプ別、エンドユーザー別、地域別 - 産業予測、2025～2032年

医療機器検査サービス市場規模は2023年に88億3,000万米ドルとなり、予測期間（2025-2032年）のCAGRは9.0%で、2024年の96億2,000万米ドルから2032年には191億8,000万米ドルに成長する見通しです。

医療機器検査サービス市場は、イントロダクション前の医療機器の安全性と規制遵守を確保するために不可欠です。機器が複雑化し、規制が強化されるにつれて、包括的な試験サービスの需要が急増しています。これらのサービスは、性能試験や生体適合性評価から滅菌バリデーションやユーザビリティ評価まで多岐にわたる。これらのサービスは、リスクを特定し、ISO 13485やFDAガイドラインのような規格を確実に遵守する上で重要な役割を果たしています。市場の成長には、技術の進歩、患者の安全性への関心の高まり、メーカーが複雑な規制の枠組みを乗り越える必要性などが追い風となっています。さらに、こうしたサービスの重要性に対するメーカーや規制当局の認識が高まっていることも、市場の拡大を後押ししており、主要企業は多様な医療機器に特化したソリューションを提供しています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 技術の進歩
• 規制情勢
• 特許分析
• ケーススタディ

医療機器検査サービス市場規模：サービスタイプ別

• 市場概要
• 検査サービス
  • 生体適合性試験
  • 化学検査
  • 微生物学および無菌試験
  • 電気安全試験
  • 電磁両立性（EMC）テスト
  • その他
• 検査サービス
  • 目視検査
  • 寸法検査
  • 非破壊検査（NDT）
• 認証サービス
  • ISO認証
  • CEマーキング
  • FDA承認

医療機器検査サービス市場規模：デバイスクラス別

• 市場概要
• クラス Iデバイス
  • 非侵襲性デバイス
  • 再利用可能な手術器具
• クラス IIデバイス
  • 診断装置
  • 治療機器
• クラスIIIデバイス
  • 埋め込み型デバイス
  • 生命維持装置

医療機器検査サービス市場規模：検査タイプ別

• 市場概要
• 社内テスト
• アウトソーシングテスト

医療機器検査サービス市場規模：デバイスタイプ別

• 市場概要
• 能動医療機器
  • ペースメーカー
  • 除細動器
• 非能動医療機器
  • 手術器具
  • 病床
• 体外診断装置
  • 試薬
  • 検査キット

医療機器検査サービス市場規模：エンドユーザー別

• 市場概要
• 病院
• 臨床検査室
• 調査機関
• メーカー

医療機器検査サービス市場規模

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• SGS（Switzerland）
• Eurofins Scientific（UK）
• Bureau Veritas（France）
• Intertek（UK）
• TUV SUD（Germany）
• DEKRA（Germany）
• TUV Rheinland（Germany）
• UL LLC（USA）
• Element Materials Technology（UK）
• Charles River Laboratories（USA）
• Pace Analytical Services（USA）
• NSF International（USA）
• BSI Group（UK）
• LGC Group（UK）
• Medistri SA（Switzerland）
• Sterigenics International LLC（USA）
• Nelson Laboratories（USA）
• NTS（USA）
• Avomeen Analytical Services（USA）
• Accurate Chemical & Scientific Corporation（USA）

結論と推奨事項

Medical Device Testing Services Market size was valued at USD 8.83 Billion in 2023 and is poised to grow from USD 9.62 Billion in 2024 to USD 19.18 Billion by 2032, growing at a CAGR of 9.0% during the forecast period (2025-2032).

The Medical Device Testing Services market is essential for ensuring the safety and regulatory compliance of medical devices prior to market introduction. As devices grow in complexity and regulations tighten, the demand for comprehensive testing services has skyrocketed. These services range from performance testing and biocompatibility assessments to sterilization validation and usability evaluations. They play a critical role in identifying risks and ensuring adherence to standards like ISO 13485 and FDA guidelines. Market growth is fueled by technological advancements, heightened focus on patient safety, and the necessity for manufacturers to navigate intricate regulatory frameworks. Moreover, the increasing awareness among manufacturers and regulators about the vital nature of these services further propels market expansion, with key players offering specialized solutions for diverse medical devices.

Top-down and bottom-up approaches were used to estimate and validate the size of the Medical Device Testing Services market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Medical Device Testing Services Market Segmental Analysis

Global Medical Device Testing Services Market is segmented by service type, device class, testing type, device type, end-user and region. Based on service type, the market is segmented into testing services, inspection services and certification services. Based on device class, the market is segmented into class I devices, class II devices and class III devices. Based on testing type, the market is segmented into in-house testing and outsourced testing. Based on device type, the market is segmented into active medical devices, non-active medical devices and in-vitro diagnostic devices. Based on end-user, the market is segmented into hospitals, clinical laboratories, research institutes and manufacturers. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Medical Device Testing Services Market

The Medical Device Testing Services market is significantly driven by the growing rigor of regulatory compliance and quality assurance demands. As regulatory bodies implement more stringent standards and requirements for medical devices, manufacturers are compelled to utilize extensive testing services to verify that their products fulfill the necessary safety and effectiveness benchmarks. This ensures not only regulatory approval but also enhances the likelihood of market acceptance. Consequently, the emphasis on maintaining high-quality standards and adhering to regulatory protocols is a crucial factor propelling the expansion of the Medical Device Testing Services market, as stakeholders strive to navigate the complexities of product testing and approval.

Restraints in the Medical Device Testing Services Market

The Medical Device Testing Services market faces significant constraints due to elevated testing costs. The complexity inherent in medical device evaluation, which requires detailed protocols and advanced equipment, can result in substantial financial burdens. This situation poses challenges, particularly for smaller manufacturers and startups with limited financial resources, as they may struggle to secure comprehensive testing services. Consequently, these constraints can hinder their ability to efficiently develop products and enter the market, ultimately stifling innovation and slowing down overall progress within the industry. Addressing these cost-related barriers is essential to support diverse participants in the medical device landscape.

Market Trends of the Medical Device Testing Services Market

The Medical Device Testing Services market is witnessing significant growth driven by heightened regulatory scrutiny from agencies like the FDA and European Medicines Agency. Manufacturers are increasingly prioritizing compliance with rigorous quality and safety standards, resulting in a surge in demand for comprehensive testing services. This trend has prompted service providers to enhance their offerings, addressing a broad spectrum of regulatory requirements encompassing both pre-market and post-market testing. As medical device companies seek to mitigate risks and streamline the approval process, investments in advanced testing methodologies and technologies are becoming integral, positioning the market for robust expansion in the coming years.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Technological Advancement
• Regulatory Landscape
• Patent Analysis
• Case Studies

Global Medical Device Testing Services Market Size by Service Type & CAGR (2025-2032)

• Market Overview
• Testing Services
  • Biocompatibility Testing
  • Chemistry Testing
  • Microbiology & Sterility Testing
  • Electrical Safety Testing
  • Electromagnetic Compatibility (EMC) Testing
  • Others
• Inspection Services
  • Visual Inspection
  • Dimensional Inspection
  • Non-Destructive Testing (NDT)
• Certification Services
  • ISO Certification
  • CE Marking
  • FDA Approval

Global Medical Device Testing Services Market Size by Device Class & CAGR (2025-2032)

• Market Overview
• Class I Devices
  • Non-Invasive Devices
  • Reusable Surgical Instruments
• Class II Devices
  • Diagnostic Devices
  • Therapeutic Devices
• Class III Devices
  • Implantable Devices
  • Life-Supporting Devices

Global Medical Device Testing Services Market Size by Testing Type & CAGR (2025-2032)

• Market Overview
• In-House Testing
• Outsourced Testing

Global Medical Device Testing Services Market Size by Device Type & CAGR (2025-2032)

• Market Overview
• Active Medical Devices
  • Pacemakers
  • Defibrillators
• Non-Active Medical Devices
  • Surgical Instruments
  • Hospital Beds
• In-Vitro Diagnostic Devices
  • Reagents
  • Test Kits

Global Medical Device Testing Services Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Hospitals
• Clinical Laboratories
• Research Institutes
• Manufacturers

Global Medical Device Testing Services Market Size & CAGR (2025-2032)

• North America (Service Type, Device Class, Testing Type, Device Type, End-User)
  • US
  • Canada
• Europe (Service Type, Device Class, Testing Type, Device Type, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Service Type, Device Class, Testing Type, Device Type, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Service Type, Device Class, Testing Type, Device Type, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service Type, Device Class, Testing Type, Device Type, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• SGS (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bureau Veritas (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV SUD (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DEKRA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV Rheinland (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• UL LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Element Materials Technology (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NSF International (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BSI Group (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LGC Group (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medistri SA (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sterigenics International LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NTS (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Avomeen Analytical Services (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accurate Chemical & Scientific Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations