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市场调查报告书
商品编码
1912010

医疗设备洩漏测试市场规模、份额和成长分析（按技术、器材类型、设备类型和地区划分）－2026-2033年产业预测

Medical Device Leak Testing Market Size, Share, and Growth Analysis, By Technology (Pressure Decay Testing, Vacuum Decay Testing), By Equipment Type (Benchtop Testers, Portable Testers), By Device Type, By Region - Industry Forecast 2026-2033
出版日期: | 出版商: SkyQuest | 英文 176 Pages | 商品交期: 3-5个工作天内

价格
简介目录

全球医疗设备洩漏测试市场规模预计在 2024 年达到 20 亿美元，从 2025 年的 22.1 亿美元成长到 2033 年的 50.7 亿美元，在预测期（2026-2033 年）内复合年增长率为 10.9%。

全球医疗设备洩漏测试市场正经历显着成长，这主要得益于旨在保障病患安全的严格法规以及医疗设备日益复杂的特性。製造商必须对导管、植入和药物输送系统等产品进行全面测试，以防止污染和故障。一次性医疗设备和复杂产品的产量不断增长，进一步推动了这项需求。儘管法规遵循和检验测试是市场的主要驱动因素，但仍存在一些挑战，例如先进洩漏测试设备的高成本以及验证检验以确保符合法规要求的复杂性。此外，医疗设备的形状和类型多种多样，需要客製化的解决方案，而熟练操作先进设备的技师短缺，进一步加剧了製造商跟上不断变化的设计步伐的困难。

全球医疗设备洩漏测试市场驱动因素

国际监管机构对医疗设备的完整性提出了日益严格的标准。这种日益严格的审查迫使製造商实施全面的洩漏测试程序，以防止患者受到污染并确保器械的可靠性。遵守这些监管要求是确保进入市场的必要条件，从而推动了全球医疗设备洩漏测试市场的成长。医疗产业对维持高安全性和品质标准的重视，凸显了对有效测试解决方案的需求，使得对先进洩漏测试技术的需求成为市场格局的关键因素。

限制全球医疗设备洩漏测试市场的因素

全球医疗设备洩漏检测市场面临许多挑战，主要原因在于新兴检测技术高成本。采用示踪气体技术或高度自动化的先进洩漏检测系统价格极为昂贵。这种经济负担不仅包括初始购买成本，还包括安装和检验费用，对中小型医疗设备製造商和Start-Ups公司构成了巨大的进入门槛。因此，这些成本阻碍了先进检测解决方案的普及，限制了洩漏检测技术在整个行业中的成长和广泛应用。

全球医疗设备洩漏测试市场趋势

全球医疗设备洩漏测试市场正经历着向自动化和在线连续测试的重大转变，製造商越来越多地将先进的洩漏测试系统直接整合到生产线中。这一趋势使得所有器械的洩漏测试速度更快、一致性更高，进而提高了整体营运效率。透过流程自动化，企业可以大幅降低人事费用，改善品管措施，并确保更可靠的流程验证，进而提升产品品质并符合监管标准。随着业界对这些技术的应用，对自动化洩漏测试解决方案的需求预计将会成长，这与医疗设备製造领域提高营运效率和促进创新的更广泛目标相契合。

目录

介绍

  • 调查目标
  • 调查范围
  • 定义

调查方法

  • 资讯收集
  • 二手资料和一手资料方法
  • 市场规模预测
  • 市场假设与限制

执行摘要

  • 全球市场展望
  • 供需趋势分析
  • 细分市场机会分析

市场动态与展望

  • 市场规模
  • 市场动态
    • 驱动因素和机会
    • 限制与挑战
  • 波特分析

关键市场考察

  • 关键成功因素
  • 竞争程度
  • 关键投资机会
  • 市场生态系统
  • 市场吸引力指数（2025）
  • PESTEL 分析
  • 总体经济指标
  • 价值链分析
  • 定价分析
  • 案例研究
  • 技术分析

全球医疗设备洩漏测试市场规模（按技术及复合年增长率划分）（2026-2033 年）

  • 压力衰减试验
  • 真空衰变试验
  • 示踪气体检测
    • 氦
    • 氢
  • 流量测试
  • 气泡释放试验

全球医疗设备洩漏测试市场规模（按器材类型划分）及复合年增长率（2026-2033 年）

  • 桌上型测试机
  • 可携式测试仪
  • 在线连续/自动化系统

全球医疗设备洩漏测试市场规模（按器材类型划分）及复合年增长率（2026-2033 年）

  • 导管和管子
  • 植入式装置（心臟起搏器）
  • 药物输送系统
    • 点滴帮浦
    • 吸入器
  • 手术器械
  • 柔性内视镜
  • 医疗包
    • 点滴袋
    • 血袋

全球医疗设备洩漏测试市场规模及复合年增长率（2026-2033）

  • 北美洲
    • 美国
    • 加拿大
  • 欧洲
    • 德国
    • 西班牙
    • 法国
    • 英国
    • 义大利
    • 其他欧洲地区
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 韩国
    • 亚太其他地区
  • 拉丁美洲
    • 巴西
    • 其他拉丁美洲地区
  • 中东和非洲
    • 海湾合作委员会国家
    • 南非
    • 其他中东和非洲地区

竞争资讯

  • 前五大公司对比
  • 主要企业的市场定位（2025 年）
  • 主要市场参与者所采取的策略
  • 近期市场趋势
  • 公司市占率分析（2025 年）
  • 主要企业公司简介
    • 公司详情
    • 产品系列分析
    • 依业务板块进行公司股票分析
    • 2023-2025年营收年比比较

主要企业简介

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

结论与建议

简介目录
Product Code: SQMIG35A3107

Global Medical Device Leak Testing Market size was valued at USD 2 Billion in 2024 and is poised to grow from USD 2.21 Billion in 2025 to USD 5.07 Billion by 2033, growing at a CAGR of 10.9% during the forecast period (2026-2033).

The global medical device leak testing market is experiencing significant growth, driven by stringent regulations promoting patient safety and the increasing complexity of medical devices. Manufacturers are compelled to conduct thorough testing on products such as catheters, implants, and drug delivery systems to prevent contamination and failure. The rising production of single-use medical devices and combination products intensifies this demand. While regulatory compliance and validated testing serve as key market drivers, challenges persist, including the high costs of advanced leak testing equipment and the complexities of validating tests to meet regulations. Additionally, the diverse shapes and types of medical devices necessitate customized solutions, coupled with a shortage of skilled technicians to operate sophisticated equipment, further complicating manufacturers' efforts to keep pace with evolving designs.

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

Regulatory authorities internationally are increasingly enforcing stringent standards regarding the integrity of medical devices. This heightened scrutiny compels manufacturers to implement comprehensive leak testing protocols to prevent patient contamination and guarantee the reliability of their devices. Compliance with these regulatory demands is essential for securing market access, thereby driving the growth of the global medical device leak testing market. The focus on maintaining high safety and quality standards in the medical industry underscores the necessity for effective testing solutions, making the demand for advanced leak testing technologies a critical factor in the market landscape.

Restraints in the Global Medical Device Leak Testing Market

The Global Medical Device Leak Testing market faces notable challenges primarily due to the high costs associated with emerging testing technologies. Advanced leak testing systems that utilize tracer gas technology or incorporate extensive automation come with substantial price tags. This financial burden, which includes not only the initial purchase price but also installation and validation expenses, poses significant obstacles for smaller medical device manufacturers and startups. As a result, these costs hinder their ability to adopt these advanced testing solutions, ultimately restricting the overall growth and accessibility of leak testing technologies within the industry.

Market Trends of the Global Medical Device Leak Testing Market

The Global Medical Device Leak Testing market is experiencing a significant shift towards automation and in-line testing, as manufacturers increasingly integrate advanced leak testing systems directly into production lines. This trend facilitates leak testing of all devices rapidly and consistently, enhancing overall operational efficiency. By automating the process, companies can significantly reduce labor costs, improve quality control measures, and ensure more reliable process validation, contributing to superior product quality and compliance with regulatory standards. As the industry embraces these technologies, the demand for automated leak testing solutions is set to rise, aligning with broader goals of operational excellence and innovation in medical device manufacturing.

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, 2025
  • PESTEL Analysis
  • Macro-Economic Indicators
  • Value Chain Analysis
  • Pricing Analysis
  • Case Studies
  • Technology Analysis

Global Medical Device Leak Testing Market Size by Technology & CAGR (2026-2033)

  • 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 (2026-2033)

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

Global Medical Device Leak Testing Market Size by Device Type & CAGR (2026-2033)

  • 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 (2026-2033)

  • 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, 2025
  • Strategies Adopted by Key Market Players
  • Recent Developments in the Market
  • Company Market Share Analysis, 2025
  • Company Profiles of All Key Players
    • Company Details
    • Product Portfolio Analysis
    • Company's Segmental Share Analysis
    • Revenue Y-O-Y Comparison (2023-2025)

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