Product Code: GVR-4-68040-682-3
Sterilization Monitoring Market Summary
The global sterilization monitoring market size was estimated at USD 962.8 million in 2024 and is projected to reach USD 1,843.2 million by 2033, growing at a CAGR of 7.57% from 2025 to 2033. The market is experiencing significant growth driven by various factors. Increasing cases of Healthcare-Associated Infections (HAIs) worldwide and a growing number of inpatient surgeries are a primary catalyst.
Increasing prevalence of healthcare-associated infections (HAIs) is projected to significantly contribute to the growth of the sterilization monitoring market. Hospitals and clinics are under continuous pressure to improve sterilization standards to prevent infections caused by inadequately sterilized equipment. For instance, according to data released by the European Centre for Disease Prevention and Control, a European Union Agency, in May 2024, approximately 4.3 million hospitalized patients across the EU and European Economic Area (EEA) are affected by HAIs annually. These infections pose serious health risks and also place a significant strain on healthcare systems.
Another significant factor is the stringent regulatory environment. Governments and health authorities worldwide mandate strict sterilization standards, compelling healthcare institutions to adopt effective monitoring systems. For instance, in November 2024, the FDA issued a guidance "Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices".This guidance outlines a policy of transitional enforcement discretion for manufacturers of specific Class III devices. It aims to address expected changes in ethylene oxide (EtO) sterilization processes and to help prevent or reduce the risk of medical device supply chain disruptions or shortages during the period when sterilization facilities are transitioning to meet new Environmental Protection Agency (EPA) regulations.
Another major factor driving the sterilization monitoring industry growth is growing surgical procedures in hospitals. For instance, according to the Eurostat report, the two most common surgical operations and procedures performed in EU hospitals are cataract surgery and caesarean sections.
Global Sterilization Monitoring Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global sterilization monitoring market report based on technology, product, method, end use, and region:
- Technology Outlook (Revenue, USD Million, 2021 - 2033)
- Biological Indicators
- Chemical Indicators
- Product Outlook (Revenue, USD Million, 2021 - 2033)
- Strips
- Indicator Tapes
- Cards
- Others
- Method Outlook (Revenue, USD Million, 2021 - 2033)
- Steam Sterilization
- Ethylene Oxide Sterilization
- Hydrogen Peroxide Sterilization
- Others
- End Use Outlook (Revenue, USD Million, 2021 - 2033)
- Hospitals & Clinics
- Biopharma/Biotech Companies
- Ambulatory Surgery Centers
- Research and Academic Institutes
- Other End Use
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- Japan
- China
- India
- Australia
- Thailand
- South Korea
- Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
- Kuwait
- UAE
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Technology
- 1.2.2. Product
- 1.2.3. Method
- 1.2.4. End Use
- 1.2.5. Regional scope
- 1.2.6. Estimates and forecasts timeline
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR's internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.4.5.1. Data for primary interviews in North America
- 1.4.5.2. Data for primary interviews in Europe
- 1.4.5.3. Data for primary interviews in Asia Pacific
- 1.4.5.4. Data for primary interviews in Latin America
- 1.4.5.5. Data for Primary interviews in MEA
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.2. Approach 1: Commodity flow approach
- 1.7.3. Volume price analysis (Model 2)
- 1.7.4. Approach 2: Volume price analysis
- 1.8. List of Secondary Sources
- 1.9. List of Primary Sources
- 1.10. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Competitive Insights
Chapter 3. Sterilization Monitoring Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Ancillary Market Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Increasing prevalence of healthcare-associated infections (HAIs)
- 3.2.1.2. Growing demand for sterilization validation and compliance with regulatory standards
- 3.2.1.3. Expansion of biopharmaceutical and biotechnology industries requiring strict sterilization protocols
- 3.2.1.4. Increase in the number of surgical procedures and healthcare infrastructure development
- 3.2.1.5. Rising demand for automated and real-time sterilization monitoring solutions
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Stringent regulatory requirements
- 3.2.3. Market Opportunities Analysis
- 3.2.3.1. Growing adoption of automated monitoring systems
- 3.2.3.2. Expansion in developing regions
- 3.2.3.3. Technological innovations
- 3.2.4. Market Challenges Analysis
- 3.2.4.1. High implementation costs
- 3.2.4.2. Regulatory complexity
- 3.3. Sterilization Monitoring Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Bargaining power of suppliers
- 3.3.1.2. Bargaining power of buyers
- 3.3.1.3. Threat of substitutes
- 3.3.1.4. Threat of new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political & Legal Landscape
- 3.3.2.2. Economic and Social Landscape
- 3.3.2.3. Technological landscape
Chapter 4. Sterilization Monitoring Market: Technology Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Sterilization Monitoring Market: Technology Movement Analysis & Market Share, 2024 & 2033
- 4.3. Biological Indicators
- 4.3.1. Biological Indicators Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.4. Chemical Indicators
- 4.4.1. Chemical Indicators Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. Sterilization Monitoring Market: Product Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Sterilization Monitoring Market: Product Movement Analysis & Market Share, 2024 & 2033
- 5.3. Strips
- 5.3.1. Strips Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4. Indicator Tapes
- 5.4.1. Indicator Tapes Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5. Cards
- 5.5.1. Cards Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.6. Others
- 5.6.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. Sterilization Monitoring Market: Method Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. Sterilization Monitoring Market: Method Movement Analysis & Market Share, 2024 & 2033
- 6.3. Steam Sterilization
- 6.3.1. Steam Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4. Ethylene Oxide Sterilization
- 6.4.1. Ethylene Oxide Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5. Hydrogen Peroxide Sterilization
- 6.5.1. Hydrogen Peroxide Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6. Others
- 6.6.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. Sterilization Monitoring Market: End Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. Sterilization Monitoring Market: End Use Movement Analysis & Market Share, 2024 & 2033
- 7.3. Hospitals & Clinics
- 7.3.1. Hospitals & Clinics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4. Biopharma/Biotech Companies
- 7.4.1. Biopharma/Biotech Companies Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5. Ambulatory Surgery Centers
- 7.5.1. Ambulatory Surgery Centers Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6. Research and Academic Institutes
- 7.6.1. Research and Academic Institutes Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.7. Other End Use
- 7.7.1. Other End Use Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Sterilization Monitoring Market: Regional Estimates & Trend Analysis
- 8.1. Regional Outlook
- 8.2. Sterilization Monitoring Market: Regional Movement Analysis & Market Share, 2024 & 2033
- 8.3. North America
- 8.3.1. North America Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.3.2. U.S.
- 8.3.2.1. Key Country Dynamics
- 8.3.2.2. Competitive Scenario
- 8.3.2.3. Regulatory Scenario
- 8.3.2.4. Reimbursement Scenario
- 8.3.2.5. U.S. Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.3.3. Canada
- 8.3.3.1. Key Country Dynamics
- 8.3.3.2. Competitive Scenario
- 8.3.3.3. Regulatory Scenario
- 8.3.3.4. Reimbursement Scenario
- 8.3.3.5. Canada Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.3.4. Mexico
- 8.3.4.1. Key Country Dynamics
- 8.3.4.2. Competitive Scenario
- 8.3.4.3. Regulatory Scenario
- 8.3.4.4. Reimbursement Scenario
- 8.3.4.5. Mexico Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4. Europe
- 8.4.1. Europe Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.2. UK
- 8.4.2.1. Key Country Dynamics
- 8.4.2.2. Competitive Scenario
- 8.4.2.3. Regulatory Scenario
- 8.4.2.4. Reimbursement Scenario
- 8.4.2.5. UK Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.3. Germany
- 8.4.3.1. Key Country Dynamics
- 8.4.3.2. Competitive Scenario
- 8.4.3.3. Regulatory Scenario
- 8.4.3.4. Reimbursement Scenario
- 8.4.3.5. Germany Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.4. France
- 8.4.4.1. Key Country Dynamics
- 8.4.4.2. Competitive Scenario
- 8.4.4.3. Regulatory Scenario
- 8.4.4.4. Reimbursement Scenario
- 8.4.4.5. France Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.5. Italy
- 8.4.5.1. Key Country Dynamics
- 8.4.5.2. Competitive Scenario
- 8.4.5.3. Regulatory Scenario
- 8.4.5.4. Reimbursement Scenario
- 8.4.5.5. Italy Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.6. Spain
- 8.4.6.1. Key Country Dynamics
- 8.4.6.2. Competitive Scenario
- 8.4.6.3. Regulatory Scenario
- 8.4.6.4. Reimbursement Scenario
- 8.4.6.5. Spain Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.7. Denmark
- 8.4.7.1. Key Country Dynamics
- 8.4.7.2. Competitive Scenario
- 8.4.7.3. Regulatory Scenario
- 8.4.7.4. Reimbursement Scenario
- 8.4.7.5. Denmark Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.8. Sweden
- 8.4.8.1. Key Country Dynamics
- 8.4.8.2. Competitive Scenario
- 8.4.8.3. Regulatory Scenario
- 8.4.8.4. Reimbursement Scenario
- 8.4.8.5. Sweden Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.4.9. Norway
- 8.4.9.1. Key Country Dynamics
- 8.4.9.2. Competitive Scenario
- 8.4.9.3. Regulatory Scenario
- 8.4.9.4. Reimbursement Scenario
- 8.4.9.5. Norway Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5. Asia Pacific
- 8.5.1. Asia Pacific Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.2. Japan
- 8.5.2.1. Key Country Dynamics
- 8.5.2.2. Competitive Scenario
- 8.5.2.3. Regulatory Scenario
- 8.5.2.4. Reimbursement Scenario
- 8.5.2.5. Japan Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.3. China
- 8.5.3.1. Key Country Dynamics
- 8.5.3.2. Competitive Scenario
- 8.5.3.3. Regulatory Scenario
- 8.5.3.4. Reimbursement Scenario
- 8.5.3.5. China Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.4. India
- 8.5.4.1. Key Country Dynamics
- 8.5.4.2. Competitive Scenario
- 8.5.4.3. Regulatory Scenario
- 8.5.4.4. Reimbursement Scenario
- 8.5.4.5. India Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.5. South Korea
- 8.5.5.1. Key Country Dynamics
- 8.5.5.2. Competitive Scenario
- 8.5.5.3. Regulatory Scenario
- 8.5.5.4. Reimbursement Scenario
- 8.5.5.5. South Korea Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.6. Australia
- 8.5.6.1. Key Country Dynamics
- 8.5.6.2. Competitive Scenario
- 8.5.6.3. Regulatory Scenario
- 8.5.6.4. Reimbursement Scenario
- 8.5.6.5. Australia Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.5.7. Thailand
- 8.5.7.1. Key Country Dynamics
- 8.5.7.2. Competitive Scenario
- 8.5.7.3. Regulatory Scenario
- 8.5.7.4. Reimbursement Scenario
- 8.5.7.5. Thailand Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.6. Latin America
- 8.6.1. Latin America Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.6.2. Brazil
- 8.6.2.1. Key Country Dynamics
- 8.6.2.2. Competitive Scenario
- 8.6.2.3. Regulatory Scenario
- 8.6.2.4. Reimbursement Scenario
- 8.6.2.5. Brazil Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.6.3. Argentina
- 8.6.3.1. Key Country Dynamics
- 8.6.3.2. Competitive Scenario
- 8.6.3.3. Regulatory Scenario
- 8.6.3.4. Reimbursement Scenario
- 8.6.3.5. Argentina Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.7. Middle East & Africa
- 8.7.1. Middle East & Africa Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.7.2. South Africa
- 8.7.2.1. Key Country Dynamics
- 8.7.2.2. Competitive Scenario
- 8.7.2.3. Regulatory Scenario
- 8.7.2.4. Reimbursement Scenario
- 8.7.2.5. South Africa Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.7.3. Saudi Arabia
- 8.7.3.1. Key Country Dynamics
- 8.7.3.2. Competitive Scenario
- 8.7.3.3. Regulatory Scenario
- 8.7.3.4. Reimbursement Scenario
- 8.7.3.5. Saudi Arabia Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.7.4. UAE
- 8.7.4.1. Key Country Dynamics
- 8.7.4.2. Competitive Scenario
- 8.7.4.3. Regulatory Scenario
- 8.7.4.4. Reimbursement Scenario
- 8.7.4.5. UAE Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 8.7.5. Kuwait
- 8.7.5.1. Key Country Dynamics
- 8.7.5.2. Competitive Scenario
- 8.7.5.3. Regulatory Scenario
- 8.7.5.4. Reimbursement Scenario
- 8.7.5.5. Kuwait Sterilization Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 9. Sterilization Monitoring Market: Competitive Landscape
- 9.1. Market Participant Categorization
- 9.2. Key Company Profiles
- 9.2.1. 3M
- 9.2.1.1. Company Overview
- 9.2.1.2. Financial Performance
- 9.2.1.3. Technology Benchmarking
- 9.2.1.4. Strategic Initiatives
- 9.2.2. ASP
- 9.2.2.1. Company Overview
- 9.2.2.2. Financial Performance
- 9.2.2.3. Technology Benchmarking
- 9.2.2.4. Strategic Initiatives
- 9.2.3. STERIS
- 9.2.3.1. Company Overview
- 9.2.3.2. Financial Performance
- 9.2.3.3. Technology Benchmarking
- 9.2.3.4. Strategic Initiatives
- 9.2.4. Solventum
- 9.2.4.1. Company Overview
- 9.2.4.2. Financial Performance
- 9.2.4.3. Technology Benchmarking
- 9.2.4.4. Strategic Initiatives
- 9.2.5. Getinge
- 9.2.5.1. Company Overview
- 9.2.5.2. Financial Performance
- 9.2.5.3. Technology Benchmarking
- 9.2.5.4. Strategic Initiatives
- 9.2.6. Propper Manufacturing Co., Inc.
- 9.2.6.1. Company Overview
- 9.2.6.2. Financial Performance
- 9.2.6.3. Technology Benchmarking
- 9.2.6.4. Strategic Initiatives
- 9.2.7. LISTER BioMedical
- 9.2.7.1. Company Overview
- 9.2.7.2. Financial Performance
- 9.2.7.3. Technology Benchmarking
- 9.2.7.4. Strategic Initiatives
- 9.2.8. GKE (Mesa Labs, Inc.)
- 9.2.8.1. Company Overview
- 9.2.8.2. Financial Performance
- 9.2.8.3. Technology Benchmarking
- 9.2.8.4. Strategic Initiatives
- 9.2.9. Hu-Friedy
- 9.2.9.1. Company Overview
- 9.2.9.2. Financial Performance
- 9.2.9.3. Technology Benchmarking
- 9.2.9.4. Strategic Initiatives
- 9.2.10. Zhejiang Tailin Bioengineering Co., Ltd.
- 9.2.10.1. Company Overview
- 9.2.10.2. Financial Performance
- 9.2.10.3. Technology Benchmarking
- 9.2.10.4. Strategic Initiatives
- 9.2.11. Miracle Industries
- 9.2.11.1. Company Overview
- 9.2.11.2. Financial Performance
- 9.2.11.3. Technology Benchmarking
- 9.2.11.4. Strategic Initiatives
- 9.2.12. STERIVIC Medical Co.,Ltd
- 9.2.12.1. Company Overview
- 9.2.12.2. Financial Performance
- 9.2.12.3. Technology Benchmarking
- 9.2.12.4. Strategic Initiatives
- 9.2.13. Cole-Parmer Instrument Company, LLC.
- 9.2.13.1. Company Overview
- 9.2.13.2. Financial Performance
- 9.2.13.3. Technology Benchmarking
- 9.2.13.4. Strategic Initiatives
- 9.2.14. Terragene
- 9.2.14.1. Company Overview
- 9.2.14.2. Financial Performance
- 9.2.14.3. Technology Benchmarking
- 9.2.14.4. Strategic Initiatives
- 9.2.15. Anhui Tianrun Medical Packaging Materials Co., Ltd.
- 9.2.15.1. Company Overview
- 9.2.15.2. Financial Performance
- 9.2.15.3. Technology Benchmarking
- 9.2.15.4. Strategic Initiatives
- 9.2.16. Tuttnauer
- 9.2.16.1. Company Overview
- 9.2.16.2. Financial Performance
- 9.2.16.3. Technology Benchmarking
- 9.2.16.4. Strategic Initiatives
- 9.2.17. Andersen Sterilizers
- 9.2.17.1. Company Overview
- 9.2.17.2. Financial Performance
- 9.2.17.3. Technology Benchmarking
- 9.2.17.4. Strategic Initiatives
- 9.2.18. MMM Group
- 9.2.18.1. Company Overview
- 9.2.18.2. Financial Performance
- 9.2.18.3. Technology Benchmarking
- 9.2.18.4. Strategic Initiatives
- 9.2.19. MATACHANA
- 9.2.19.1. Company Overview
- 9.2.19.2. Financial Performance
- 9.2.19.3. Technology Benchmarking
- 9.2.19.4. Strategic Initiatives
- 9.2.20. HiMedia Laboratories
- 9.2.20.1. Company Overview
- 9.2.20.2. Financial Performance
- 9.2.20.3. Technology Benchmarking
- 9.2.20.4. Strategic Initiatives
- 9.2.21. Steelco S.p.A.
- 9.2.21.1. Company Overview
- 9.2.21.2. Financial Performance
- 9.2.21.3. Technology Benchmarking
- 9.2.21.4. Strategic Initiatives
- 9.3. Heat Map Analysis/ Company Market Position Analysis
- 9.4. Company Market Share Analysis, 2024