医療機器リークテストの市場規模・シェア・成長分析 (技術別、機器の種類別、デバイスの種類別、地域別)：産業予測 (2025～2032年)

世界の医療機器リークテストの市場規模は2023年に18億米ドルとなり、予測期間（2025～2032年）のCAGRは10.9%で、2024年の20億米ドルから2032年には45億7,000万米ドルに成長する見通しです。

世界の医療機器リークテスト市場は、患者の安全性に焦点を当てた厳しい規制と医療機器の複雑化によって大きな成長を遂げています。製造業者は、カテーテル、インプラント、ドラッグデリバリーシステムなどの製品の完全性を保証し、汚染や故障を防止するために徹底的な試験を行うことが求められています。シングルユースデバイスやコンビネーション製品の生産が増加していることも、この必要性を高めています。主な市場促進要因には、規制の順守や、信頼性が高く妥当性が確認された試験ソリューションへの需要があります。しかし、高度なリークテスト機器に関連する高コストや、様々な形状のデバイスにまたがるテストの検証の複雑さなどの課題も残っています。熟練技術者の不足と機器設計の絶え間ない進化は、新しいリークテスト技術への継続的な投資を必要とします。

目次

イントロダクション

• 分析目的
• 市場範囲
• 定義

分析手法

• 情報調達
• 二次・一次データの手法
• 市場規模予測
• 市場の想定と制約

エグゼクティブサマリー

• 市場の概要と展望
• 需給動向の分析
• セグメント別の機会分析

市場力学と展望

• 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
• ポーター分析

市場の主な考察

• 主な成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場魅力度指数 (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
• ケーススタディ
• 技術分析

世界の医療機器リークテストの市場規模・CAGR：技術別 (2025～2032年)

• 市場概要
• 圧力低下試験
• 真空崩壊試験
• トレーサーガス検知
  • ヘリウム
  • 水素
• フローテスト
• 気泡放出試験

世界の医療機器リークテストの市場規模・CAGR：機器の種類別 (2025～2032年)

• 市場概要
• ベンチトップテスター
• ポータブルテスター
• インライン/自動化システム

世界の医療機器リークテストの市場規模・CAGR：デバイスの種類別 (2025～2032年)

• 市場概要
• カテーテル・チューブ
• 植え込み型デバイス（ペースメーカー）
• ドラッグデリバリーシステム
  • 輸液ポンプ
  • 吸入器
• 手術器具
• フレキシブル内視鏡
• 医療用バッグ
  • 点滴バッグ
  • 血液バッグ

世界の医療機器リークテストの市場規模・CAGR (2025～2032年)

• 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
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング (2024年)
• 主要企業が採用した戦略
• 市場の近年の動向
• 主要企業の市場シェア (2024年)
• 主要企業のプロファイル
  • 企業概要
  • 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年)

主要企業プロファイル

• Pfeiffer Vacuum GmbH（ドイツ）
• INFICON（スイス）
• AMETEK, Inc.（Uson）（米国）
• Cincinnati Test Systems（CTS）（米国）
• LACO Technologies（米国）
• InterTech Development Company（米国）
• TASI Group（which includes ATC Automation and Sciemetric）（米国）
• Helium Leak Testing, Inc.（HLT）（米国）
• CETA Testsysteme GmbH（ドイツ）
• ATEQ Leak Testing（フランス）
• Vacuum Instruments Corporation（VIC）（米国）
• Emerson Electric Co.（米国）
• Cosmo Instruments Co., Ltd.（日本）
• FUKUDA CO., LTD.（日本）
• TQC Ltd（英国）

結論と提言

Global Medical Device Leak Testing Market size was valued at USD 1.8 billion in 2023 and is poised to grow from USD 2.0 billion in 2024 to USD 4.57 billion by 2032, growing at a CAGR of 10.9% during the forecast period (2025-2032).

The global medical device leak testing market is experiencing significant growth, fueled by stringent regulations focused on patient safety and the increasing complexity of medical devices. Manufacturers are required to thoroughly test products such as catheters, implants, and drug delivery systems to ensure integrity and prevent contamination or failure. The rise in production of single-use devices and combination products amplifies this necessity. Key market drivers include adherence to regulations and the demand for reliable, validated testing solutions. However, challenges persist, including the high costs associated with advanced leak testing equipment and the complexity of validating tests across various device shapes. A scarcity of skilled technicians and the continuous evolution of device designs necessitate ongoing investment in novel leak testing technologies.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Medical Device Leak Testing 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.

Global Medical Device Leak Testing Market Segments Analysis

Global Medical Device Leak Testing Market is segmented by Technology, Equipment Type, Device Type and region. Based on Technology, the market is segmented into Pressure Decay Testing, Vacuum Decay Testing, Tracer Gas Detection, Flow Testing and Bubble Emission Testing. Based on Equipment Type, the market is segmented into Benchtop Testers, Portable Testers and In-line/Automated Systems. Based on Device Type, the market is segmented into Catheters & Tubing, Implantable Devices (Pacemakers), Drug Delivery Systems, Surgical Instruments, Flexible Endoscopes and Medical Bags. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Medical Device Leak Testing Market

The Global Medical Device Leak Testing market is significantly driven by the increasing scrutiny from regulatory agencies like the FDA and EMA regarding the integrity of medical devices. Consequently, manufacturers are compelled to implement stringent leak testing measures to prevent patient contamination and guarantee the reliability of their products. Complying with these stringent regulatory standards is crucial for gaining market access, making it an essential factor that propels the demand for advanced leak testing solutions. As the focus on patient safety and device quality intensifies, the need for comprehensive testing methods continues to grow, further energizing the market.

Restraints in the Global Medical Device Leak Testing Market

The Global Medical Device Leak Testing market faces notable challenges, particularly due to the high costs associated with advanced testing devices and systems. Innovative solutions, such as those employing tracer gas technology and high-level automation, come with hefty price tags that include not only the equipment itself but also substantial installation and validation expenses. These financial burdens create significant obstacles for smaller medical device manufacturers and startups, hindering their ability to adopt such sophisticated testing methods. As a result, the widespread implementation of these advanced systems remains restricted, limiting overall market growth and development in the sector.

Market Trends of the Global Medical Device Leak Testing Market

The Global Medical Device Leak Testing market is significantly influenced by the growing trend toward automated, in-line testing systems. Manufacturers are increasingly integrating leak testing technologies directly into their production lines, enabling the testing of every device at high speeds. This shift not only reduces labor costs but also enhances quality control by ensuring consistent process validation. As a result, companies benefit from increased efficiency and reliability in their manufacturing operations, meeting stringent regulatory requirements while minimizing the risk of product failures. Overall, this trend underscores a commitment to technological advancements and improved operational efficacy within the medical device industry.

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
• Case Studies
• Technology Analysis

Global Medical Device Leak Testing Market Size by Technology & CAGR (2025-2032)

• Market Overview
• Pressure Decay Testing
• Vacuum Decay Testing
• Tracer Gas Detection
  • Helium
  • Hydrogen
• Flow Testing
• Bubble Emission Testing

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

• Market Overview
• Benchtop Testers
• Portable Testers
• In-line/Automated Systems

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

• Market Overview
• Catheters & Tubing
• Implantable Devices (Pacemakers)
• Drug Delivery Systems
  • Infusion Pumps
  • Inhalers
• Surgical Instruments
• Flexible Endoscopes
• Medical Bags
  • IV bags
  • Blood Bags

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

• North America (Technology, Equipment Type, Device Type)
  • US
  • Canada
• Europe (Technology, Equipment Type, Device Type)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Technology, Equipment Type, Device Type)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Technology, Equipment Type, Device Type)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Technology, Equipment Type, Device Type)
  • 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

• Pfeiffer Vacuum GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• INFICON (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AMETEK, Inc. (Uson) (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cincinnati Test Systems (CTS) (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LACO Technologies (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• InterTech Development Company (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TASI Group (which includes ATC Automation and Sciemetric) (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Helium Leak Testing, Inc. (HLT) (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CETA Testsysteme GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ATEQ Leak Testing (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Vacuum Instruments Corporation (VIC) (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Emerson Electric Co. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cosmo Instruments Co., Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• FUKUDA CO., LTD. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TQC Ltd (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations