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市場調查報告書
商品編碼
1912010

醫療設備洩漏測試市場規模、佔有率和成長分析（按技術、器材類型、設備類型和地區分類）－2026-2033年產業預測

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個工作天內

價格
簡介目錄

全球醫療設備洩漏測試市場規模預計在 2024 年達到 20 億美元，從 2025 年的 22.1 億美元成長到 2033 年的 50.7 億美元，在預測期（2026-2033 年）內複合年成長率為 10.9%。

全球醫療設備洩漏測試市場正經歷顯著成長，這主要得益於旨在保障病患安全的嚴格法規以及醫療設備日益複雜的特性。製造商必須對導管、植入和藥物輸送系統等產品進行全面測試，以防止污染和故障。一次性醫療設備和複雜產品的產量不斷成長，進一步推動了這項需求。儘管法規遵循和檢驗測試是市場的主要促進因素，但仍存在一些挑戰，例如先進洩漏測試設備的高成本以及驗證檢驗以確保符合法規要求的複雜性。此外，醫療設備的形狀和類型多種多樣，需要客製化的解決方案，而熟練操作先進設備的技師短缺，進一步加劇了製造商跟上不斷變化的設計步伐的困難。

全球醫療設備洩漏測試市場促進因素

國際監管機構對醫療設備的完整性提出了日益嚴格的標準。這種日益嚴格的審查迫使製造商實施全面的洩漏測試程序，以防止患者受到污染並確保器械的可靠性。遵守這些監管要求是確保進入市場的必要條件，從而推動了全球醫療設備洩漏測試市場的成長。醫療產業對維持高安全性和品質標準的重視，凸顯了對有效測試解決方案的需求，使得對先進洩漏測試技術的需求成為市場格局的關鍵因素。

限制全球醫療設備洩漏測試市場的因素

全球醫療設備洩漏檢測市場面臨許多挑戰，主要原因在於新興檢測技術高成本。採用示踪氣體技術或高度自動化的先進洩漏檢測系統價格極為昂貴。這種經濟負擔不僅包括初始購買成本，還包括安裝和檢驗費用，對中小型醫療設備製造商和Start-Ups公司構成了巨大的進入門檻。因此，這些成本阻礙了先進檢測解決方案的普及，限制了洩漏檢測技術在整個行業中的成長和廣泛應用。

全球醫療設備洩漏測試市場趨勢

全球醫療設備洩漏測試市場正經歷著向自動化和在線連續測試的重大轉變，製造商擴大將先進的洩漏測試系統直接整合到生產線中。這一趨勢使得所有器械的洩漏測試速度更快、一致性更高，進而提高了整體營運效率。透過流程自動化，企業可以大幅降低人事費用，改善品管措施，並確保更可靠的流程驗證，進而提升產品品質並符合監管標準。隨著業界對這些技術的應用，對自動化洩漏測試解決方案的需求預計將會成長，這與醫療設備製造領域提高營運效率和促進創新的更廣泛目標相契合。

目錄

介紹

  • 調查目標
  • 調查範圍
  • 定義

調查方法

  • 資訊收集
  • 二手資料和一手資料方法
  • 市場規模預測
  • 市場假設與限制

執行摘要

  • 全球市場展望
  • 供需趨勢分析
  • 細分市場機會分析

市場動態與展望

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

關鍵市場考察

  • 關鍵成功因素
  • 競爭程度
  • 關鍵投資機會
  • 市場生態系統
  • 市場吸引力指數（2025）
  • 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（按技術及複合年成長率分類）（2026-2033 年）

  • 壓力衰減試驗
  • 真空衰變試驗
  • 示踪氣體檢測
    • 氦
    • 氫
  • 流量測試
  • 氣泡釋放試驗

全球醫療設備洩漏測試市場規模（按器材類型分類）及複合年成長率（2026-2033 年）

  • 桌上型測試機
  • 可攜式測試儀
  • 在線連續/自動化系統

全球醫療設備洩漏測試市場規模（按器材類型分類）及複合年成長率（2026-2033 年）

  • 導管和管子
  • 植入式裝置（心臟心律調節器）
  • 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（2026-2033）

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 西班牙
    • 法國
    • 英國
    • 義大利
    • 其他歐洲地區
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 拉丁美洲
    • 巴西
    • 其他拉丁美洲地區
  • 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

競爭資訊

  • 前五大公司對比
  • 主要企業的市場定位（2025 年）
  • 主要市場參與者所採取的策略
  • 近期市場趨勢
  • 公司市佔率分析（2025 年）
  • 主要企業公司簡介
    • 公司詳情
    • 產品系列分析
    • 依業務板塊進行公司股票分析
    • 2023-2025年營收年比比較

主要企業簡介

  • 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）

結論與建議

簡介目錄
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