의료기기 누출 검사 시장 : 검사 유형별, 용도별, 제품 유형별, 세계 예측(2024-2032년)

Medical Device Leak Testing Market size is projected to record nearly 11.4% CAGR from 2024 to 2032, due to the increase in healthcare expenditure. Of late, there is heightened emphasis on ensuring the reliability and safety of medical devices through rigorous leak testing protocols. As healthcare spending is growing globally, the need for stringent quality assurance measures in medical device manufacturing is intensifying.

Lately, advancements in leak testing technologies are also improving the accuracy and efficiency of these procedures for aligning with escalating regulatory standards and patient safety requirements. For instance, Uson launched no-cost one-on-one leak detection training for medical device manufacturers to enhance their expertise in medical device leak testing. This initiative ensured rigorous quality assurance in medical device manufacturing to meet the industry demands for reliable and safe products.

The overall market is segmented into test type, application, product type, and region.

In terms of test type, the medical device leak testing industry from the vacuum decay segment is predicted to record a significant CAGR from 2024 to 2032 owing to the strong need for ensuring product integrity. Vacuum decay in medical device leak testing plays a pivotal role in detecting minute leaks that could compromise device performance or patient safety.

By product type, the medical device leak testing industry from the blood devices segment is projected to rise from 2024 to 2032. Medical device leak testing involves the process of assessing and ensuring the integrity of blood devices. Manufacturers are employing advanced techniques like pressure decay testing and helium leak detection to identify potential leaks. These methods are also essential for maintaining the safety and reliability of blood devices. In addition, innovations, such as real-time monitoring and predictive analytics are enhancing the efficiency and accuracy of leak testing processes, thereby ensuring the quality and safety of blood devices in healthcare settings.

Regionally, the Asia Pacific medical device leak testing industry size is projected to exhibit robust growth between 2024 and 2032, fueled by the increasing focus on the prevention of contamination for ensuring safe and hygienic use for patients. Manufacturers are integrating antimicrobial materials and disposable components to reduce infection risks. As the demand for home healthcare devices is growing in the region, the focus on preventing contamination will remain critical for aligning with efforts to promote health and wellness in home-based care settings.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing demand for ensuring medical device quality and safety
    • 3.2.1.2 Growing emphasis towards reducing the risk of adverse events and patient harm
    • 3.2.1.3 Increasing complexities in medical devices
    • 3.2.1.4 Increasing patient admissions due to rise in chronic diseases
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 High cost associated with medical device leak testing procedures
    • 3.2.2.2 Lack of standardization in leak testing procedures
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Pressure decay
• 5.3 Vacuum decay
• 5.4 Tracer gas
• 5.5 Other test types

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Urology
• 6.3 Cardiology
• 6.4 Minimally invasive surgery/general surgery
• 6.5 Orthopedics
• 6.6 Diabetes care
• 6.7 Other applications

Chapter 7 Market Estimates and Forecast, By Product Type, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Catheters
• 7.3 Blood devices
• 7.4 Bags
• 7.5 Implantable devices
• 7.6 Capital equipment
• 7.7 Other product types

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
  • 8.3.7 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 Alliance Concept
• 9.2 ATEQ Leaktesting
• 9.3 Cincinnati Test Systems
• 9.4 FasTest
• 9.5 InterTech Development Company
• 9.6 LACO Technologies, Inc.
• 9.7 Pfeiffer Vacuum GmbH
• 9.8 TQC Ltd
• 9.9 Uson LP
• 9.10 Zaxis Inc.