의료기기 세척 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the medical device cleaning market size was valued at USD 2.48 billion in 2025 and estimated to grow from USD 2.61 billion in 2026 to reach USD 3.36 billion by 2031, at a CAGR of 5.18% during the forecast period (2026-2031).

This report is Segmented by Product Type (Enzymatic Detergents, Non-Enzymatic Detergents and More), by Cleaning Process (Manual Cleaning, Automated Washer-Disinfectors and More), by Application (Surgical Instruments, Endoscopes and More), by End User (Hospitals, Ambulatory Surgical Centers and More) and Geography (North America and More). The Report Offers the Value (in USD) for the Above Segments.

Global Medical Device Cleaning Market Trends and Insights

Rising Prevalence of Hospital-Acquired Infections (HAIs)

HAIs add an estimated USD 25 billion-USD 45 billion to U.S. healthcare costs yearly. Although 2023 CDC data show double-digit declines in several device-associated infections, persistent bloodstream and endoscope-linked outbreaks have kept pressure on facilities to upgrade cleaning protocols. European surveillance recorded 7.1% HAI prevalence across 28 member states, equal to 4.3 million affected patients each year . Multidrug-resistant organisms such as carbapenem-resistant Klebsiella pneumoniae require extended contact times and multi-enzyme detergents that break down protective biofilms. This epidemiological environment is accelerating demand for validated chemistries and automated washer-disinfectors that deliver repeatable, trackable cycles.

Stringent Global Reprocessing Regulations (FDA, MDR, ISO 17664)

The U.S. FDA now demands full cleaning validation data for high-risk reusable devices, including bronchoscopes and laparoscopic instruments. MDR 2017/745 classifies standalone cleaning systems as medical devices and mandates Unique Device Identification to guarantee traceability across the cleaning life-cycle. ISO 17664 requires manufacturers to describe exact detergent type, temperature and contact time, pushing hospitals toward branded chemistries aligned with device instructions. Automated systems that reduce operator variability have become the preferred route to regulatory confidence, particularly in high-volume surgical centers.

High Capex & Opex of Automated Reprocessors

State-of-the-art washer-disinfectors cost USD 100,000-USD 300,000, while annual service contracts add 8%-12% of purchase price. Smaller hospitals and ASCs often struggle to justify this outlay, especially when staffing shortages already stretch operating budgets. Component inflation and freight surcharges have pushed supply-chain expenses close to 20% of revenue for many equipment makers, translating into higher list prices for buyers. As a workaround, vendors are rolling out subscription and leasing models that bundle chemistry, service and analytics in a per-cycle fee, but acceptance in price-sensitive markets remains limited.

Other drivers and restraints analyzed in the detailed report include:

1. Growth in Surgical & Endoscopic Procedure Volumes
2. IoT-Enabled Washer-Disinfectors for Real-Time Compliance Analytics
3. Rising Adoption of Disposable Single-Use Devices

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

High-Level Disinfectants captured 37.10% of the medical device cleaning market in 2025 as they deliver proven sporicidal activity for semi-critical devices. Enzymatic Detergents, however, are forecast to record a 6.63% CAGR, the fastest within the category, because multi-enzyme blends dissolve protein, lipid and carbohydrate soils lodged in intricate lumens. Chlorine-dioxide formulations are also expanding due to broad-spectrum efficacy with lower material corrosion, while non-enzymatic detergents remain the low-cost staple for routine trays. Manufacturers are introducing pH-neutral blends that maintain potency across variable water quality, improving compatibility with delicate polymer-based instruments.

The medical device cleaning market size for Enzymatic Detergents is projected to advance steadily as facilities retire legacy alkaline agents that cannot break down resilient biofilms formed by carbapenem-resistant organisms. Uptake is particularly strong in ophthalmology, orthopedics and robotic surgery suites where instrument longevity is critical. User-friendly dosing pumps and color-changing test strips ensure correct concentration, reducing technician training burden. Despite ocular-procedure concerns over toxic anterior segment syndrome, recent peer-review findings indicate that thorough rinsing mitigates risk, supporting broader adoption in outpatient surgical centers.

Automated Washer-Disinfectors led the 2025 revenues with 40.85% share, reflecting industry confidence in repeatable thermal and chemical parameters. UV/Ozone/Emerging Technologies are expected to clock 7.42% CAGR as facilities seek low-temperature methods that sidestep ethylene oxide bottlenecks. Far-UVC 222 nm ceiling fixtures now operate continuously in occupied spaces, trimming downtime between cases. Plasma and vaporized-hydrogen-peroxide units are capturing demand for heat-sensitive plastics.

The medical device cleaning market size tied to automated platforms is expanding as internet-connected units verify each load against ISO 17664-specified cycles. Conversely, manual cleaning persists in low-resource environments but shows declining share as audit failures highlight variability risks. New ductless ethylene oxide scrubbers that achieve 99% destruction efficiency are reopening sterilization lines idled by emission limits, ensuring that washer-disinfectors remain the upstream workhorse.

Complete Report Scope:

• By Product Type
  • Enzymatic Detergents
  • Non-enzymatic Detergents
  • High-Level Disinfectants
  • Lubricants & Rust Inhibitors
  • Other Cleaning Chemicals
• By Cleaning Process
  • Manual Cleaning
  • Automated Washer-Disinfectors
  • Automated Endoscope Reprocessors (AERs)
  • UV / Ozone / Emerging Technologies
• By Application / Device Type
  • Surgical Instruments
  • Endoscopes
  • Dental Instruments
  • Ultrasound & Probes
  • Others
• By End-User
  • Hospitals
  • Ambulatory Surgical Centers
  • Specialty Clinics & Dental Practices
  • Diagnostic & Research Laboratories
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa

Geography Analysis

The medical device cleaning market is moderately consolidated as strategic acquisitions reshape competitive dynamics. STERIS, Getinge and Ecolab remain the reference suppliers due to broad portfolios spanning chemistries, washer-disinfectors and service contracts. Medline's USD 950 million purchase of Ecolab's surgical solutions business in 2024 instantly broadened its consumables range and expanded access to European operating rooms. Thermo Fisher's USD 4.1 billion acquisition of Solventum's purification and filtration division in 2025 extends its reach into validated chemistries and membrane-based cleaning adjuncts.

Competition centers on automation, sensor integration and regulatory documentation. Getinge is rolling out vision-guided loading robots that cut operator touches by 30%, while Tristel leverages chlorine-dioxide chemistry registered in 38 countries to offer wipe-based high-level disinfection for niche scopes. Smaller innovators such as Sonata Scientific target emission-control niches with ductless EtO destruction units, easing pressure on sterilization capacity. Because no single customer accounts for more than 10% of STERIS revenue, demand remains fragmented and open to specialized entrants that address robotic instruments, ophthalmic scopes or plasma sterilization accessories.

Price competition is limited at the premium end, but mid-tier Asian suppliers are moving up-market with washer-disinfectors featuring basic IoT dashboards. Global service footprints, rapid part availability and operator training packages therefore differentiate incumbents. Partnerships between detergent formulators and equipment OEMs are tightening as hospitals prefer one-stop procurement that simplifies validation paperwork and warranty liability.

1. STERIS
2. Getinge
3. Ecolab
4. 3M
5. Advanced Sterilization Products (Fortive)
6. Cantel Medical (Steris subsidiary)
7. Olympus
8. Medivators Inc.
9. Tristel
10. Schulke & Mayr GmbH
11. Ruhof
12. Metrex Research
13. Hartmann Group
14. Belimed
15. Oro Clean Chemie AG
16. Medline Industries ReNewal
17. Sklar Instruments
18. Stryker Corporation (Renu)
19. Johnson & Johnson (ASP Ethicon)
20. Tuttnauer

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising prevalence of hospital-acquired infections (HAIs)
  • 4.2.2 Stringent global reprocessing regulations (FDA, MDR, ISO-17664)
  • 4.2.3 Growth in surgical & endoscopic procedure volumes
  • 4.2.4 IoT-enabled washer-disinfectors for real-time compliance analytics
  • 4.2.5 Shift to enzyme-based, low-temperature detergents extending device life
• 4.3 Market Restraints
  • 4.3.1 High capex & opex of automated reprocessors
  • 4.3.2 Rising adoption of disposable single-use devices
  • 4.3.3 Supply-chain bottlenecks for specialty enzymes & surfactants
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product Type
  • 5.1.1 Enzymatic Detergents
  • 5.1.2 Non-enzymatic Detergents
  • 5.1.3 High-Level Disinfectants
  • 5.1.4 Lubricants & Rust Inhibitors
  • 5.1.5 Other Cleaning Chemicals
• 5.2 By Cleaning Process
  • 5.2.1 Manual Cleaning
  • 5.2.2 Automated Washer-Disinfectors
  • 5.2.3 Automated Endoscope Reprocessors (AERs)
  • 5.2.4 UV / Ozone / Emerging Technologies
• 5.3 By Application / Device Type
  • 5.3.1 Surgical Instruments
  • 5.3.2 Endoscopes
  • 5.3.3 Dental Instruments
  • 5.3.4 Ultrasound & Probes
  • 5.3.5 Others
• 5.4 By End-User
  • 5.4.1 Hospitals
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Specialty Clinics & Dental Practices
  • 5.4.4 Diagnostic & Research Laboratories
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 France
    • 5.5.2.3 United Kingdom
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 South America
    • 5.5.4.1 Brazil
    • 5.5.4.2 Argentina
    • 5.5.4.3 Rest of South America
  • 5.5.5 Middle East and Africa
    • 5.5.5.1 GCC
    • 5.5.5.2 South Africa
    • 5.5.5.3 Rest of Middle East and Africa

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 STERIS plc
  • 6.3.2 Getinge AB
  • 6.3.3 Ecolab Inc.
  • 6.3.4 3M Company
  • 6.3.5 Advanced Sterilization Products (Fortive)
  • 6.3.6 Cantel Medical (Steris subsidiary)
  • 6.3.7 Olympus Corporation
  • 6.3.8 Medivators Inc.
  • 6.3.9 Tristel plc
  • 6.3.10 Schulke & Mayr GmbH
  • 6.3.11 Ruhof Corporation
  • 6.3.12 Metrex Research
  • 6.3.13 Hartmann Group
  • 6.3.14 Belimed AG
  • 6.3.15 Oro Clean Chemie AG
  • 6.3.16 Medline Industries ReNewal
  • 6.3.17 Sklar Instruments
  • 6.3.18 Stryker Corporation (Renu)
  • 6.3.19 Johnson & Johnson (ASP Ethicon)
  • 6.3.20 Tuttnauer

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment