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市场调查报告书
商品编码
1790278

美国灭菌监测市场规模、份额和趋势分析报告：按技术、产品、方法、最终用途和细分市场预测，2025 年至 2033 年

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
出版日期: | 出版商: Grand View Research | 英文 300 Pages | 商品交期: 2-10个工作天内

价格

美国灭菌监测市场概况

美国灭菌监测市场规模预计在 2024 年为 2.318 亿美元，预计到 2033 年将达到 3.823 亿美元，2025 年至 2033 年的复合年增长率为 5.76%。这一增长是由医疗相关感染 (HAI) 的增加、感染控制意识和监管要求所推动的。

美国卫生与公众服务部疾病预防与健康促进办公室、卫生服务部助理部长估计，在任何时候，全国每 31 名住院患者中就有 1 名患有至少一种医院相关感染 (HAI)，导緻美国每年发生超过 680,000 起感染疾病，并产生数十亿美元的与 HAI 相关的额外医疗费用。

美国的灭菌监测产业主要受到对感染控制、病人安全和法规遵循日益增长的关注的推动。随着医疗机构努力预防医院相关感染 (HAI)，对有效灭菌过程和监测解决方案的需求显着增加。根据美国疾病管制与预防中心的说法，灭菌监测是确保仪器和设备得到适当灭菌并确保病人后续使用安全的重要过程。此外，医疗设备使用各种方法灭菌，包括湿热（蒸气）、干热、辐射、环氧乙烷 (EtO) 气体、汽化过氧化氢、二氧化氯气体、汽化过乙酸和二氧化氮。因此，医疗设备产业的成长进一步推动了美国市场的发展。

该市场包括用于检验灭菌程序有效性的各种产品和技术，包括生物指示剂、化学指示剂、灭菌积分器和自动监控系统。

市场成长的关键驱动力之一是医院、外科中心、牙科诊所和生物製药生产设施对灭菌监测产品的日益普及。尤其是医院，它们面临巨大的监管压力，必须遵守美国美国食品药物管理局管理局 (FDA)、美国疾病管制与预防中心 (CDC) 和美国医疗设备促进协会 (AAMI) 等组织制定的标准。这些组织规定了严格的灭菌通讯协定，要求准确可靠的监测，以确保设备无菌和病人安全。因此，医疗保健提供者正在增加对先进灭菌监测技术的投资，这些技术可以提供即时数据、自动记录和合规性报告功能。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国灭菌监测市场变数、趋势与范围

  • 市场体系展望
    • 补贴市场前景
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 市场机会分析
    • 市场问题分析
  • 美国灭菌监测市场分析工具
    • 产业分析—波特五力分析
    • PESTEL分析

第四章美国灭菌监测市场：依技术、估计和趋势分析

  • 细分仪表板
  • 美国灭菌监测市场技术变革分析
  • 2021 年至 2033 年美国灭菌监测市场规模及趋势分析（依技术）
  • 生物指标
  • 化学指标

第五章美国灭菌监测市场：产品、估计与趋势分析

  • 细分仪表板
  • 美国灭菌监测市场的产品差异分析
  • 2021 年至 2033 年美国灭菌监测市场规模及趋势分析（依产品）
  • 条
  • 指示带
  • 卡片
  • 其他的

第六章美国灭菌监测市场：依方法、估计和趋势分析

  • 细分仪表板
  • 美国灭菌监测市场方法论变化分析
  • 美国灭菌监测市场规模及趋势分析（依方法，2021-2033）
  • 蒸气灭菌
  • 环氧乙烷灭菌
  • 过氧化氢灭菌
  • 其他的

第七章美国灭菌监测市场：依最终用途的估计和趋势分析

  • 细分仪表板
  • 美国灭菌监测市场最终用途变化分析
  • 美国灭菌监测市场规模及趋势分析（依最终用途），2021-2033
  • 医院和诊所
  • 生物製药/生技公司
  • 门诊手术中心
  • 研究和学术机构
  • 其他的

第八章 竞争态势

  • 市场参与企业分类
  • 主要企业简介
    • 3M
    • ASP
    • STERIS
    • Solventum
    • Getinge
    • Propper Manufacturing Co., Inc.
    • Mesa Labs, Inc.
    • Hu-Friedy Mfg. Co., LLC.
    • Terragene
    • Tuttnauer
    • True Indicating
  • 2024年公司市场占有率分析
  • 其他主要市场参与企业名单
Product Code: GVR-4-68040-685-8

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
  • 3.3. 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

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
  • 8.3. 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)