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, the analyst 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
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This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Sterilization Monitoring Market Variables, Trends, & Scope
Chapter 4. U.S. Sterilization Monitoring Market: Technology Estimates & Trend Analysis
Chapter 5. U.S. Sterilization Monitoring Market: Product Estimates & Trend Analysis
Chapter 6. U.S. Sterilization Monitoring Market: Method Estimates & Trend Analysis
Chapter 7. U.S. Sterilization Monitoring Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- 3M
- ASP
- STERIS
- Solventum
- Getinge
- Propper Manufacturing Co., Inc.
- Mesa Labs, Inc.
- Hu-Friedy Mfg. Co., LLC.
- Terragene
- Tuttnauer
- True Indicating
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 300 |
| Published | July 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 231.8 Million |
| Forecasted Market Value ( USD | $ 382.3 Million |
| Compound Annual Growth Rate | 5.7% |
| Regions Covered | United States |
| No. of Companies Mentioned | 11 |
