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米国の滅菌モニタリング市場規模、シェア、動向分析レポート:技術別、製品別、方法別、最終用途別、セグメント別予測、2025年~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
ページ情報
英文 300 Pages
納期
2~10営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=148.50円
米国の滅菌モニタリング市場規模、シェア、動向分析レポート:技術別、製品別、方法別、最終用途別、セグメント別予測、2025年~2033年
出版日: 2025年07月23日
発行: Grand View Research
ページ情報: 英文 300 Pages
納期: 2~10営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

米国の滅菌モニタリング市場概要

米国の滅菌モニタリング市場規模は、2024年に2億3,180万米ドルと推定され、2033年には3億8,230万米ドルに達すると予測され、2025~2033年のCAGRは5.76%で成長します。この成長の原動力は、ヘルスケア関連感染(HAI)の増加、感染管理に対する意識、規制の義務化です。

米国保健社会福祉省次官補健康局疾病予防・健康促進室の推定によると、全国の病院では、常時、入院患者の31人に1人が少なくとも1件の医療関連感染(HAI)を抱えています。米国では年間68万件以上の感染症が発生し、HAIに関連した追加医療費は数十億米ドルにのぼります。

米国の滅菌モニタリング産業は、主に感染管理、患者の安全性、法規制遵守を重視する傾向が強まっていることが背景にあります。ヘルスケア施設が医療関連感染(HAI)の防止に努める中、効果的な滅菌プロセスやモニタリングソリューションに対する需要は著しく高まっています。米国疾病予防センターによると、滅菌モニタリングは、器具や機器が適切に滅菌され、後続の患者に安全に使用できることを確認するために不可欠なプロセスです。さらに、医療機器は湿熱(蒸気)、乾熱、放射線、エチレンオキシド(EtO)ガス、気化過酸化水素、二酸化塩素ガス、気化過酢酸、二酸化窒素などの様々な手法で滅菌されます。したがって、医療機器産業の成長が米国の市場をさらに押し上げています。

この市場には、生物学的インジケーター、化学的インジケーター、滅菌インテグレーター、自動モニタリングシステムなど、滅菌手順の有効性を検証するために設計されたさまざまな製品や技術が含まれます。

市場成長の主要促進要因のひとつは、病院、外科センター、歯科クリニック、バイオ医薬品製造装置などで滅菌モニタリング製品の採用が増加していることです。特に病院は、米国食品医薬品局(FDA)、米国疾病予防管理センター(CDC)、米国医療機器振興協会(AAMI)などの機関が定めた基準を遵守するよう、厳しい規制圧力下にあります。これらの組織は厳格な滅菌プロトコルを義務付けており、機器の無菌性と患者の安全性を確保するためには、正確で信頼性の高いモニタリングが必要です。その結果、ヘルスケアプロバイダは、リアルタイムデータ、自動記録、コンプライアンスレポート機能を提供する先進的滅菌モニタリング技術への投資を増やしています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の滅菌モニタリング市場の変数、動向、範囲

  • 市場系統の展望
    • 補助市場の展望
  • 市場力学
    • 市場促進要因分析
    • 市場抑制要因分析
    • 市場機会分析
    • 市場課題分析
  • 米国の滅菌モニタリング市場分析ツール
    • 産業分析-ポーターのファイブフォース分析
    • PESTEL分析

第4章 米国の滅菌モニタリング市場:技術別、推定・動向分析

  • セグメントダッシュボード
  • 米国の滅菌モニタリング市場の技術変動分析
  • 米国の滅菌モニタリング市場規模と動向分析(技術別、2021~2033年)
  • 生物学的指標
  • 化学的指標

第5章 米国の滅菌モニタリング市場:製品別、推定・動向分析

  • セグメントダッシュボード
  • 米国の滅菌モニタリング市場の製品変動分析
  • 米国の滅菌モニタリング市場規模と動向分析(製品別、2021~2033年)
  • ストリップ
  • インジケーターテープ
  • カード
  • その他

第6章 米国の滅菌モニタリング市場:方法別、推定・動向分析

  • セグメントダッシュボード
  • 米国の滅菌モニタリング市場の方法変動分析
  • 米国の滅菌モニタリング市場規模と動向分析(方法別、2021~2033年)
  • 蒸気滅菌
  • エチレンオキシド滅菌
  • 過酸化水素滅菌
  • その他

第7章 米国の滅菌モニタリング市場:最終用途別、推定・動向分析

  • セグメントダッシュボード
  • 米国の滅菌モニタリング市場の最終用途変動分析
  • 米国の滅菌モニタリング市場規模と動向分析(最終用途別、2021~2033年)
  • 病院とクリニック
  • バイオ医薬品/バイオテクノロジー企業
  • 外来手術センター
  • 研究・学術機関
  • その他

第8章 競合情勢

  • 市場参入企業の分類
  • 主要企業プロファイル
    • 3M
    • ASP
    • STERIS
    • Solventum
    • Getinge
    • Propper Manufacturing Co., Inc.
    • Mesa Labs, Inc.
    • Hu-Friedy Mfg. Co., LLC.
    • Terragene
    • Tuttnauer
    • True Indicating
  • 2024年の企業市場シェア分析
  • その他の主要市場参入企業一覧
図表

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)
目次
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