醫療設備洩漏測試市場規模、佔有率和成長分析（按技術、設備類型、設備類型和地區）：產業預測（2025-2032 年）

全球醫療設備洩漏測試市場預計將在 2023 年達到 18 億美元，並從 2024 年的 20 億美元成長到 2032 年的 45.7 億美元，預測期內（2025-2032 年）的複合年成長率為 10.9%。

全球醫療設備洩漏檢測市場正經歷顯著成長，這得益於注重病患安全的嚴格法規以及醫療設備日益複雜的特徵。製造商需要對導管、植入和藥物輸送系統等產品進行徹底的測試，以確保其完整性並防止污染和故障。一次性設備和組合產品產量的增加也推動了這項需求。主要的市場促進因素包括法規遵循和對可靠、經過驗證的測試解決方案的需求。然而，挑戰依然存在，包括先進洩漏檢測設備高成本，以及跨各種設備幾何形狀驗證檢驗的複雜性。熟練技術人員的短缺和設備設計的不斷發展使得對新的洩漏檢測技術進行持續投資成為必要。

目錄

介紹

• 分析目的
• 市場覆蓋
• 定義

分析方法

• 資訊收集
• 二次資料和一次資料方法
• 市場規模預測
• 市場假設與約束

執行摘要

• 市場概況與展望
• 供需趨勢分析
• 按細分市場進行機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機會
  • 限制與挑戰
• 波特分析

關鍵市場考量因素

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場魅力指數（2024年）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 案例研究
• 技術分析

全球醫療設備洩漏測試市場規模及複合年成長率（按技術分類）（2025-2032 年）

• 市場概覽
• 壓降測試
• 真空崩壞測試
• 示踪氣體檢測
  • 氦
  • 氫
• 流動測試
• 氣泡釋放測試

全球醫療設備洩漏測試市場規模及複合年成長率（按設備類型）（2025-2032）

• 市場概覽
• 桌上型測試儀
• 可攜式測試儀
• 線上/自動化系統

全球醫療設備洩漏測試市場規模及複合年成長率（按設備類型）（2025-2032）

• 市場概覽
• 導管
• 植入式裝置（心律調節器）
• 藥物輸送系統
  • 點滴幫浦
  • 吸入器
• 手術器械
• 軟性內視鏡
• 醫療包
  • 點滴袋
  • 血袋

全球醫療設備洩漏測試市場規模及複合年成長率（2025-2032）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭格局

• 前五大公司對比
• 主要企業的市場定位（2024年）
• 主要企業採取的策略
• 近期市場趨勢
• 主要企業市場佔有率（2024年）
• 主要企業簡介
  • 公司簡介
  • 產品系列分析
  • 按細分市場分析市場佔有率
  • 收益同比對比（2022-2024 年）

主要企業簡介

• 普發真空有限公司（德國）
• 英福康（瑞士）
• AMETEK, Inc.（Uson）（美國）
• 辛辛那提測試系統（CTS）（美國）
• LACO科技（美國）
• InterTech開發公司（美國）
• TASI集團（包括ATC Automation和Sciemetric）（美國）
• 氦洩漏測試公司（HLT）（美國）
• CETA Testsysteme GmbH（德國）
• ATEQ洩漏測試（法國）
• 真空儀器公司（VIC）（美國）
• 艾默生電氣公司（美國）
• 科斯莫儀器有限公司（日本）
• 福田株式會社（日本）
• TQC有限公司（英國）

結論和建議

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