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U.S. Sterilization Monitoring Market Size, Share, Trends, Industry Analysis Report By Technology (Biological Indicators, Chemical Indicators), By Product, By Method, By End Use – Market Forecast, 2025–2034

Publisher Polaris Market Research & Consulting LLP
Published Aug 01, 2025
Length 129 Pages
SKU # PLRS20381559

Description

The U.S. sterilization monitoring market size is expected to reach USD 401.79 million by 2034, according to a new study by Polaris Market Research. The report “U.S. Sterilization Monitoring Market Share, Size, Trends, Industry Analysis Report By Technology (Biological Indicators, Chemical Indicators), By Product, By Method, By End Use; Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Sterilization monitoring refers to the validation process used to confirm that sterilization methods effectively eliminate all forms of microbial life on medical instruments. This quality assurance function is becoming increasingly vital as healthcare providers respond to the rising incidence of hospital-acquired infections (HAIs), driving demand for more rigorous sterilization oversight. The growing concern surrounding infection control has prompted healthcare facilities to adopt more standardized and frequent monitoring practices to ensure patient safety. There is an increasing need for reliable indicators and validation tools that confirm the effectiveness of sterilization cycles across various healthcare environments as regulatory scrutiny boosts.

The increased reliance on outsourced sterilization services drives the U.S. sterilization monitoring market growth. Many are turning to third-party sterilization providers as hospitals and surgical centers seek to optimize operational efficiency and reduce infrastructure costs. This transition reinforces the importance of independent monitoring systems to verify the effectiveness and compliance of outsourced processes. Consequently, the demand for user-friendly, high-accuracy monitoring technologies is on the rise, as healthcare institutions seek to ensure sterilization integrity regardless of where or how the procedure is conducted.

U.S. Sterilization Monitoring Market Report Highlights

In terms of technology, the biological indicators segment captured 57.17% of 2024 revenue, as they remain essential for sterilization validation.

Based on method, the hydrogen peroxide sterilization is expected to witness the strongest growth during the forecast period, due to its quick processing, eco-benefits, and ability to safely treat delicate instruments.

In terms of product, the sterilization strips segment led market share in 2024 due to their versatility, user-friendly design, and broad application across multiple sterilization technologies.

Based on end use, the ambulatory centers segment emerges as the fastest-growing end users, reflecting healthcare's ongoing transition to outpatient surgical services.

A few key market players include 3M (Solventum); ASP; Crosstex International, Inc.; Hu-Friedy Mfg. Co., LLC.; Mesa Labs, Inc.; Propper Manufacturing Co., Inc.; Sterilex; STERIS; True Indicating; and Tuttnauer USA.

Polaris Market Research has segmented the market report on the basis of technology, product, method, and end use:

By Technology Outlook (Revenue, USD Million, 2020–2034)

Biological Indicators

Chemical Indicators

By Product Outlook (Revenue, USD Million, 2020–2034)

Strips

Indicator Tapes

Cards

Others

By Method Outlook (Revenue, USD Million, 2020–2034)

Steam Sterilization

Ethylene Oxide Sterilization

Hydrogen Peroxide Sterilization

Others

By End Use Outlook (Revenue, USD Million, 2020–2034)

Hospitals & Clinics

Biopharma/Biotech Companies

Ambulatory Surgery Centers

Research and Academic Institutes

Other End Use

Table of Contents

129 Pages
1. Introduction
1.1. Report Description
1.1.1. Objectives of the Study
1.1.2. Market Scope
1.1.3. Assumptions
1.2. Stakeholders
2. Executive Summary
2.1. Market Highlights
3. Research Methodology
3.1. Overview
3.1.1. Data Mining
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. U.S. Sterilization Monitoring Market Insights
4.1. U.S. Sterilization Monitoring Market – Market Snapshot
4.2. U.S. Sterilization Monitoring Market Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. Growth of Outsourced Sterilization Services
4.2.1.2. Increasing Adoption of Advanced Sterilization Technologies
4.2.2. Restraints and Challenges
4.2.2.1. High Costs of Advanced Monitoring Systems
4.3. Porter’s Five Forces Analysis
4.3.1. Bargaining Power of Suppliers (Moderate)
4.3.2. Threats of New Entrants: (Low)
4.3.3. Bargaining Power of Buyers (Moderate)
4.3.4. Threat of Substitute (Moderate)
4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. U.S. Sterilization Monitoring Market Trends
4.6. Value Chain Analysis
5. U.S. Sterilization Monitoring Market, by Product
5.1. Key Findings
5.2. Introduction
5.2.1. U.S. Sterilization Monitoring Market, by Product, 2020-2034 (USD Million)
5.3. Biological Indicators
5.3.1. U.S. Sterilization Monitoring Market, by Biological Indicators, 2020-2034 (USD Million)
5.4. Chemical Indicators
5.4.1. U.S. Sterilization Monitoring Market, by Chemical Indicators, 2020-2034 (USD Million)
6. U.S. Sterilization Monitoring Market, by Offering
6.1. Key Findings
6.2. Introduction
6.2.1. U.S. Sterilization Monitoring Market, by Offering, 2020-2034 (USD Million)
6.3. Strips
6.3.1. U.S. Sterilization Monitoring Market, by Strips, 2020–2034 (USD Million)
6.4. Indicator Tapes
6.4.1. U.S. Sterilization Monitoring Market, by Indicator Tapes, 2020–2034 (USD Million)
6.4.2. Cards
6.4.2.1. U.S. Sterilization Monitoring Market, by Cards, 2020–2034 (USD Million)
6.4.3. Others
6.4.3.1. U.S. Sterilization Monitoring Market, by Others, 2020–2034 (USD Million)
7. U.S. Sterilization Monitoring Market, by Component
7.1. Key Findings
7.2. Introduction
7.2.1. U.S. Sterilization Monitoring Market, by Component, 2020-2034 (USD Million)
7.3. Steam Sterilization
7.3.1. U.S. Sterilization Monitoring Market, by Steam Sterilization, 2020–2034 (USD Million)
7.4. Ethylene Oxide Sterilization
7.4.1. U.S. Sterilization Monitoring Market, by Ethylene Oxide Sterilization, 2020–2034 (USD Million)
7.5. Hydrogen Peroxide Sterilization
7.5.1. U.S. Sterilization Monitoring Market, by Hydrogen Peroxide Sterilization, 2020–2034 (USD Million)
7.6. Others
7.6.1. U.S. Sterilization Monitoring Market, by Others, 2020–2034 (USD Million)
8. U.S. Sterilization Monitoring Market, by End Use
8.1. Key Findings
8.2. Introduction
8.2.1. U.S. Sterilization Monitoring Market, by End Use, 2020-2034 (USD Million)
8.3. Hospitals & Clinics
8.3.1. U.S. Sterilization Monitoring Market, by Hospitals & Clinics, 2020-2034 (USD Million)
8.4. Biopharma/Biotech Companies
8.4.1. U.S. Sterilization Monitoring Market, by Biopharma/Biotech Companies, 2020-2034 (USD Million)
8.5. Ambulatory Surgery Centers
8.5.1. U.S. Sterilization Monitoring Market, by Ambulatory Surgery Centers, 2020-2034 (USD Million)
8.6. Research and Academic Institutes
8.6.1. U.S. Sterilization Monitoring Market, by Research and Academic Institutes, 2020-2034 (USD Million)
8.7. Other End Use
8.7.1. U.S. Sterilization Monitoring Market, by Other End Use, 2020-2034 (USD Million)
9. Competitive Landscape
9.1. Expansion and Acquisition Analysis
9.1.1. Expansion
9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions
10. Company Profiles
10.1. 3M (Solventum)
10.1.1. Company Overview
10.1.2. Financial Performance
10.1.3. Product Benchmarking
10.1.4. Recent Development
10.2. ASP
10.2.1. Company Overview
10.2.2. Financial Performance
10.2.3. Product Benchmarking
10.2.4. Recent Development
10.3. Crosstex International, Inc.
10.3.1. Company Overview
10.3.2. Financial Performance
10.3.3. Product Benchmarking
10.3.4. Recent Development
10.4. Hu-Friedy Mfg. Co., LLC.
10.4.1. Company Overview
10.4.2. Financial Performance
10.4.3. Product Benchmarking
10.4.4. Recent Development
10.5. Mesa Labs, Inc.
10.5.1. Company Overview
10.5.2. Financial Performance
10.5.3. Product Benchmarking
10.5.4. Recent Development
10.6. Propper Manufacturing Co., Inc.
10.6.1. Company Overview
10.6.2. Financial Performance
10.6.3. Product Benchmarking
10.6.4. Recent Development
10.7. Sterilex
10.7.1. Company Overview
10.7.2. Financial Performance
10.7.3. Product Benchmarking
10.7.4. Recent Development
10.8. STERIS
10.8.1. Company Overview
10.8.2. Financial Performance
10.8.3. Product Benchmarking
10.8.4. Recent Development
10.9. True Indicating
10.9.1. Company Overview
10.9.2. Financial Performance
10.9.3. Product Benchmarking
10.9.4. Recent Development
10.10. Tuttnauer USA
10.10.1. Company Overview
10.10.2. Financial Performance
10.10.3. Product Benchmarking
10.10.4. Recent Development

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