PUBLISHER: Grand View Research | PRODUCT CODE: 1790278
PUBLISHER: Grand View Research | PRODUCT CODE: 1790278
U.S. Sterilization Monitoring Market Size, Share & Trends Analysis Report By Technology (Biological Indicators, Chemical Indicators), By Product (Strips, Indicator Tapes), By Method (Steam Sterilization), By End-use, And Segment Forecasts, 2025 - 2033
U.S. Sterilization Monitoring Market Summary
The U.S. sterilization monitoring market size was estimated at USD 231.8 million in 2024 and is projected to reach USD 382.3 million by 2033, growing at a CAGR of 5.76% from 2025 to 2033. This growth is driven by the rising healthcare associated infections (HAIs), awareness of infection control, and regulatory mandates.
According to estimates from the Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services, in hospitals nationwide, at any given time, 1 in 31 hospitalized patients has at least one healthcare-associated infection (HAI). Annually, there are over 680,000 infections and billions of dollars in additional healthcare costs linked to HAIs across the U.S.
The sterilization monitoring industry in the U.S. is primarily driven by the increasing emphasis on infection control, patient safety, and regulatory compliance. As healthcare facilities strive to prevent healthcare-associated infections (HAIs), the demand for effective sterilization processes and monitoring solutions has grown significantly. According to U.S. Centers for Disease and Prevention, sterilization monitoring is an essential process to confirm that instruments and devices are properly sterilized and safe for use on subsequent patients. Furthermore, medical devices are sterilized through various methods, such as moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other techniques such as chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide. Hence, the growing industry of medical devices is further boosting the market in the U.S.
This market encompasses a range of products and technologies designed to verify the efficacy of sterilization procedures, including biological indicators, chemical indicators, sterilization integrators, and automated monitoring systems.
One of the primary drivers of market growth is the rising adoption of sterilization monitoring products across hospitals, surgical centers, dental clinics, and biopharmaceutical manufacturing units. Hospitals, in particular, are under stringent regulatory pressures to adhere to standards set by agencies such as the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the Association for the Advancement of Medical Instrumentation (AAMI). These organizations mandate rigorous sterilization protocols, which necessitate accurate and reliable monitoring to ensure device sterility and patient safety. As a result, healthcare providers are increasingly investing in advanced sterilization monitoring technologies that offer real-time data, automated recording, and compliance reporting capabilities.
U.S. Sterilization Monitoring Market Report Segmentation
This report forecasts revenue growth at the country level 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 U.S. sterilization monitoring market report based on technology, product, method, and end-use:
- 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 and Clinics
- Biopharma/Biotech Companies
- Ambulatory Surgery Centers
- Research and Academic Institutes
- Other End-Use
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
- 1.3. Estimates and Forecast Timeline
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR's Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.5.5. Information Analysis
- 1.5.6. Data Analysis Models
- 1.6. Market Formulation & Data Visualization
- 1.7. Model Details
- 1.7.1. Commodity Flow Analysis
- 1.8. List of Secondary Sources
- 1.9. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Competitive Insights
Chapter 3. U.S. 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 Healthcare-Associated Infections (HAIs)
- 3.2.1.2. Growing focus on patient safety and infection control in hospitals
- 3.2.1.3. Rising number of inpatient surgeries
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. High costs of sterilization monitoring systems
- 3.2.2.2. Technological limitations
- 3.2.3. Market Opportunities Analysis
- 3.2.3.1. Growing adoption of automated monitoring systems
- 3.2.3.2. Technological innovations
- 3.2.4. Market Challenges Analysis
- 3.2.4.1. Stringent regulatory compliance
- 3.2.4.2. Intense market competition
- 3.2.1. Market Driver Analysis
- 3.3. U.S. 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
- 3.3.1. Industry Analysis - Porter's
Chapter 4. U.S. Sterilization Monitoring Market: Technology Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. U.S. Sterilization Monitoring Market Technology Movement Analysis
- 4.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Technology, 2021 to 2033 (USD Million)
- 4.4. Biological Indicators
- 4.4.1. Biological Indicators U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.5. Chemical indicators
- 4.5.1. Chemical indicators U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. Sterilization Monitoring Market: Product Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. U.S. Sterilization Monitoring Market Product Movement Analysis
- 5.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
- 5.4. Strips
- 5.4.1. Strips U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5. Indicator Tapes
- 5.5.1. Indicator Tapes U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.6. Cards
- 5.6.1. Cards U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.7. Others
- 5.7.1. Others U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. Sterilization Monitoring Market: Method Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. U.S. Sterilization Monitoring Market Method Movement Analysis
- 6.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Method, 2021 to 2033 (USD Million)
- 6.4. Steam Sterilization
- 6.4.1. Steam Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5. Ethylene Oxide Sterilization
- 6.5.1. Ethylene Oxide Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6. Hydrogen Peroxide Sterilization
- 6.6.1. Hydrogen Peroxide Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.7. Others
- 6.7.1. Others Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. Sterilization Monitoring Market: End Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. U.S. Sterilization Monitoring Market End-Use Movement Analysis
- 7.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by End-Use, 2021 to 2033 (USD Million)
- 7.4. Hospitals and Clinics
- 7.4.1. Hospitals and Clinics U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5. Biopharma/Biotech Companies
- 7.5.1. Biopharma/Biotech Companies U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6. Ambulatory Surgery Centers
- 7.6.1. Ambulatory Surgery Centers U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.7. Research and Academic Institutes
- 7.7.1. Research and Academic Institutes U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8. Other End Use
- 7.8.1. Other End Use U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
- 8.1. Market Participant Categorization
- 8.2. Key Company Profiles
- 8.2.1. 3M
- 8.2.1.1. Company Overview
- 8.2.1.2. Financial Performance
- 8.2.1.3. Product Benchmarking
- 8.2.1.4. Strategic Initiatives
- 8.2.2. ASP
- 8.2.2.1. Company Overview
- 8.2.2.2. Financial Performance
- 8.2.2.3. Product Benchmarking
- 8.2.2.4. Strategic Initiatives
- 8.2.3. STERIS
- 8.2.3.1. Company Overview
- 8.2.3.2. Financial Performance
- 8.2.3.3. Product Benchmarking
- 8.2.3.4. Strategic Initiatives
- 8.2.4. Solventum
- 8.2.4.1. Company Overview
- 8.2.4.2. Financial Performance
- 8.2.4.3. Product Benchmarking
- 8.2.4.4. Strategic Initiatives
- 8.2.5. Getinge
- 8.2.5.1. Company Overview
- 8.2.5.2. Financial Performance
- 8.2.5.3. Product Benchmarking
- 8.2.5.4. Strategic Initiatives
- 8.2.6. Propper Manufacturing Co., Inc.
- 8.2.6.1. Company Overview
- 8.2.6.2. Financial Performance
- 8.2.6.3. Product Benchmarking
- 8.2.6.4. Strategic Initiatives
- 8.2.7. Mesa Labs, Inc.
- 8.2.7.1. Company Overview
- 8.2.7.2. Financial Performance
- 8.2.7.3. Product Benchmarking
- 8.2.7.4. Strategic Initiatives
- 8.2.8. Hu-Friedy Mfg. Co., LLC.
- 8.2.8.1. Company Overview
- 8.2.8.2. Financial Performance
- 8.2.8.3. Product Benchmarking
- 8.2.8.4. Strategic Initiatives
- 8.2.9. Terragene
- 8.2.9.1. Company Overview
- 8.2.9.2. Financial Performance
- 8.2.9.3. Product Benchmarking
- 8.2.9.4. Strategic Initiatives
- 8.2.10. Tuttnauer
- 8.2.10.1. Company Overview
- 8.2.10.2. Financial Performance
- 8.2.10.3. Product Benchmarking
- 8.2.10.4. Strategic Initiatives
- 8.2.11. True Indicating
- 8.2.11.1. Company Overview
- 8.2.11.2. Financial Performance
- 8.2.11.3. Product Benchmarking
- 8.2.11.4. Strategic Initiatives
- 8.2.1. 3M
- 8.3. Company Market Share Analysis, 2024
- 8.4. List of Other Key Market Players
List of Tables
- Table 1 List of Secondary Sources
- Table 2 List of Abbreviations
- Table 3 U.S. Sterilization Monitoring Market, by Technology, 2021 - 2033 (USD Million)
- Table 4 U.S. Sterilization Monitoring Market, by Product, 2021 - 2033 (USD Million)
- Table 5 U.S. Sterilization Monitoring Market, by Method, 2021 - 2033 (USD Million)
- Table 6 U.S. Sterilization Monitoring Market, by End-Use, 2021 - 2033 (USD Million)
- Table 7 Participant's Overview
- Table 8 Financial Performance
- Table 9 Product Benchmarking
- Table 10 Strategic Initiatives
List of Figures
- Fig. 1 Information Procurement
- Fig. 2 Primary Research Pattern
- Fig. 3 Market Research Approaches
- Fig. 4 Value Chain-Based Sizing & Forecasting
- Fig. 5 Market Formulation & Validation
- Fig. 6 U.S. Sterilization Monitoring Market, Market Segmentation
- Fig. 7 Market Driver Analysis (Current & Future Impact)
- Fig. 8 Market Restraint Analysis (Current & Future Impact)
- Fig. 9 Market Opportunity Analysis (Current & Future Impact)
- Fig. 10 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
- Fig. 11 Porter's Five Forces Analysis
- Fig. 12 Regional Marketplace: Key Takeaways
- Fig. 13 U.S. Sterilization Monitoring Market, for Technology, 2021 - 2033 (USD Million)
- Fig. 14 U.S. Sterilization Monitoring Market, for Biological Indicators, 2021 - 2033 (USD Million)
- Fig. 15 U.S. Sterilization Monitoring Market, for Chemical indicators, 2021 - 2033 (USD Million)
- Fig. 16 U.S. Sterilization Monitoring Market, for Strips, 2021 - 2033 (USD Million)
- Fig. 17 U.S. Sterilization Monitoring Market, for Indicator Tapes, 2021 - 2033 (USD Million)
- Fig. 18 U.S. Sterilization Monitoring Market, for Cards, 2021 - 2033 (USD Million)
- Fig. 19 U.S. Sterilization Monitoring Market, for Others, 2021 - 2033 (USD Million)
- Fig. 20 U.S. Sterilization Monitoring Market, for Method, 2021 - 2033 (USD Million)
- Fig. 21 U.S. Sterilization Monitoring Market, for Steam Sterilization, 2021 - 2033 (USD Million)
- Fig. 22 U.S. Sterilization Monitoring Market, for Ethylene Oxide Sterilization, 2021 - 2033 (USD Million)
- Fig. 23 U.S. Sterilization Monitoring Market, for Hydrogen Peroxide Sterilization, 2021 - 2033 (USD Million)
- Fig. 24 U.S. Sterilization Monitoring Market, for Others, 2021 - 2033 (USD Million)
- Fig. 25 U.S. Sterilization Monitoring Market, for End Use, 2021 - 2033 (USD Million)
- Fig. 26 U.S. Sterilization Monitoring Market, for Hospitals and Clinics, 2021 - 2033 (USD Million)
- Fig. 27 U.S. Sterilization Monitoring Market, for Biopharma/Biotech Companies, 2021 - 2033 (USD Million)
- Fig. 28 U.S. Sterilization Monitoring Market, for Ambulatory Surgery Centers, 2021 - 2033 (USD Million)
- Fig. 29 U.S. Sterilization Monitoring Market, for Research and Academic Institutes, 2021 - 2033 (USD Million)
- Fig. 30 U.S. Sterilization Monitoring Market, for Other End-Use, 2021 - 2033 (USD Million)
