Medical Device Cleaning Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Device (Non-critical, Semi-critical, Critical), By Technique (Cleaning, Disinfection, Sterilization), By EPA Classification (High Level, Intermediate Level, Low Level), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 22.89 Billion
CAGR (2026-2031)	10.34%
Fastest Growing Segment	Semi-critical
Largest Market	North America
Market Size (2031)	USD 41.31 Billion

Market Overview

The Global Medical Device Cleaning Market will grow from USD 22.89 Billion in 2025 to USD 41.31 Billion by 2031 at a 10.34% CAGR. The Global Medical Device Cleaning Market comprises specialized detergents, enzymatic agents, and chemical solutions designed to remove organic contaminants from surgical instruments and diagnostic equipment prior to sterilization. The primary drivers propelling this market include the escalating volume of surgical procedures globally and the rigid enforcement of regulatory standards aimed at minimizing healthcare associated infections. This increasing demand for reprocessing consumables is directly linked to the expanding scale of the broader medical technology sector. According to MedTech Europe, in 2024, the European medical technology market was estimated to be roughly €170 billion. This substantial industrial footprint underscores the critical and growing necessity for effective cleaning products to ensure patient safety and device longevity.

However, the market faces a significant challenge regarding material compatibility between potent cleaning agents and delicate instrument components. The aggressive chemical formulations required to effectively eliminate bioburden can degrade the sensitive polymers and adhesives found in modern and complex medical devices. This issue creates a barrier to market expansion as manufacturers must constantly balance the need for high level disinfection efficacy with the risk of damaging expensive equipment, thereby complicating procurement decisions for healthcare facilities.

Key Market Drivers

The Global Surge in Surgical and Diagnostic Procedures acts as a fundamental engine for the medical device cleaning market, creating a linear relationship between operative volume and the consumption of reprocessing supplies. As healthcare facilities strive to address backlog volumes and the growing needs of aging populations, the throughput of reusable instruments has intensified, necessitating rapid and effective reprocessing cycles to maintain device availability. This correlation between procedural frequency and cleaning consumable demand is evident in the financial performance of major industry players. According to Steris plc, June 2024, in the '2024 Annual Report', the company's Healthcare segment achieved 13% constant currency organic revenue growth, a surge primarily driven by increased procedure volumes and the normalization of supply chain lead times. This uptick in utilization is mirrored across the broader medical technology landscape. According to Olympus Corporation, in 2024, consolidated revenue for the fiscal year rose by over 6% to reach approximately ¥936 billion, underscoring the expanding global inventory of endoscopic and surgical equipment that requires daily high-level disinfection.

The Rising Prevalence of Hospital-Acquired Infections (HAIs) further compels healthcare providers to adopt stringent cleaning protocols, directly bolstering the market for advanced enzymatic detergents and disinfectants. Regulatory bodies and hospital administrators are increasingly prioritizing infection prevention to reduce patient morbidity and avoid the severe financial penalties associated with outbreaks. The continued enforcement of these intensified hygiene strategies is measurable in recent national health data. According to the Centers for Disease Control and Prevention, November 2024, in the '2023 National and State Healthcare-Associated Infections Progress Report', acute care hospitals recorded a 16% decrease in standardized infection ratios for hospital-onset Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia compared to the prior year. This reduction highlights the critical ongoing role of rigorous medical device cleaning regimes in mitigating bioburden and ensuring sterility assurance standards within clinical environments.

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Key Market Challenges

The significant challenge hampering the growth of the Global Medical Device Cleaning Market is the issue of material compatibility between potent cleaning agents and delicate instrument components. As medical devices incorporate increasingly complex polymers and adhesives to enhance performance, they become more susceptible to degradation from the aggressive chemical formulations required for bioburden elimination. This incompatibility creates a substantial financial risk for healthcare facilities, as the use of highly effective disinfectants can inadvertently strip protective coatings or weaken the structural integrity of expensive surgical tools. Consequently, procurement departments are often forced to hesitate in adopting advanced cleaning consumables, fearing that the long-term cost of premature equipment replacement will outweigh the immediate benefits of upgraded disinfection protocols. This hesitation directly restricts the sales volume of high-efficacy cleaning agents and slows the overall market turnover.

This operational struggle is clearly reflected in recent industry performance metrics regarding regulatory adherence. According to The Joint Commission, in 2024, the standard specifically governing the sterilization and high-level disinfection of medical equipment was identified as one of the top five most frequently cited non-compliant requirements during healthcare facility surveys. This statistic highlights the persistent difficulty providers face in balancing the rigorous demands of infection control with the physical limitations of modern medical hardware. As long as this technical gap remains, facilities will continue to face procurement bottlenecks, effectively capping the revenue potential for the cleaning market.

Key Market Trends

The Transition Toward Biodegradable and Eco-Friendly Enzymatic Detergents is reshaping product formulations as healthcare institutions prioritize environmental stewardship alongside clinical efficacy. Manufacturers are reformulating cleaning agents to eliminate harsh, non-biodegradable chemicals, replacing them with sustainable multi-enzyme solutions that function effectively at lower temperatures and require less rinsing water. This green shift is driven by hospital mandates to reduce chemical effluents and plastic waste, creating a competitive advantage for vendors offering sustainability-focused reprocessing consumables. According to Ecolab Inc., May 2024, in the '2023 Growth & Impact Report', the adoption of the company's water-saving and energy-efficient hygiene technologies helped customers conserve 226 billion gallons of water and avoid 3.8 million metric tons of greenhouse gas emissions globally.

Simultaneously, the Adoption of Automated and Robotic Decontamination Systems is accelerating as facilities seek to minimize human error and address chronic labor shortages in central sterile services departments. By replacing manual pre-cleaning tasks with robotic instrument handling and automated washer-disinfectors, hospitals are standardizing reprocessing cycles and significantly reducing staff exposure to hazardous pathogens. This technological integration ensures consistent high-level disinfection results regardless of operative throughput, securing higher investments in capital equipment. According to Getinge AB, July 2024, in the 'Interim Report January–June 2024', the Surgical Workflows business area recorded a 12.9% increase in net sales for the second quarter, underscoring the robust market appetite for modernized sterile processing infrastructure.

Segmental Insights

The Semi-critical segment constitutes the fastest-growing category within the Global Medical Device Cleaning Market due to the increasing reliance on endoscopes for diagnostic and therapeutic procedures. These devices contact mucous membranes and pose a substantial risk of infection transmission if not adequately reprocessed. Consequently, agencies such as the US Food and Drug Administration have strengthened guidelines regarding the disinfection of these instruments to ensure patient safety. This heightened regulatory focus drives healthcare facilities to adopt specialized cleaning solutions that effectively mitigate cross-contamination risks associated with semi-critical medical equipment.

Regional Insights

North America maintains a leading position in the global medical device cleaning market, driven by established healthcare infrastructure and rigorous safety standards. The region’s dominance is largely attributed to strict regulatory oversight by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which mandate comprehensive reprocessing protocols to prevent hospital-acquired infections. High healthcare expenditure enables facilities to consistently implement these essential sanitation practices. Additionally, the concentration of key manufacturers within the region ensures the steady availability and adoption of compliant cleaning products across medical institutions.

Recent Developments

• In November 2025, Getinge entered into a strategic partnership with SteriPro International Inc. to optimize sterile processing operations across North America. This collaboration combined the company's advanced cleaning and sterilization equipment with the partner's expertise in managing off-site reprocessing centers. The alliance was established to offer healthcare facilities a scalable model for improving the quality and efficiency of their instrument reprocessing workflows. By integrating automation and digital solutions with specialized operational support, the companies aimed to enhance patient safety and provide a resilient solution for managing the complex demands of modern sterile processing departments.
• In August 2025, Nanosonics Inc. launched its latest innovation in the Global Medical Device Cleaning Market with the release of the trophon3 system and a software upgrade for its existing platform. This new automated high-level disinfection system for ultrasound probes was engineered to deliver consistent disinfection cycles using hydrogen peroxide technology. The launch featured enhanced digital traceability and faster cycle times to streamline clinical workflows and improve audit readiness in healthcare facilities. The introduction of this technology underscored the company's commitment to advancing infection prevention standards and reducing the risk of cross-contamination associated with semi-critical medical devices.
• In September 2024, Tristel plc announced the filing of a Premarket Notification 510(k) with the U.S. Food and Drug Administration for its proprietary high-level disinfectant foam designed for ophthalmic medical devices. The submission sought regulatory clearance for a product specifically engineered to disinfect reusable instruments such as tonometers and lenses that contact the cornea. This development represented a significant advancement in infection prevention research, as the solution utilizes chlorine dioxide chemistry to offer a rapid and effective alternative to traditional soaking methods. The company aimed to establish a new standard of care for ophthalmic instrument reprocessing in the North American market through this regulatory milestone.
• In June 2024, the parent companies of Steelco and Belimed officially completed a joint venture to combine their operations in the infection control and life science sectors. This strategic collaboration resulted in the formation of a new brand, SteelcoBelimed, which brought together two leading providers of cleaning, disinfection, and sterilization solutions. The joint venture was designed to strengthen the market position of both entities and accelerate the development of innovative equipment for hospitals and pharmaceutical applications. By integrating their resources and expertise, the newly formed entity aimed to deliver a comprehensive portfolio of reprocessing solutions and enhanced service capabilities to healthcare customers globally.

Key Market Players

• Ecolab
• Steris
• Getinge
• Belimed
• 3M
• Miele Professional
• Sterigenics
• STERIS Instrument Management
• Tuttnauer

By Device	By Technique	By EPA Classification	By Region
Non-critical Semi-critical Critical	Cleaning Disinfection Sterilization	High Level Intermediate Level Low Level	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Medical Device Cleaning Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Medical Device Cleaning Market, By Device:

• Non-critical
• Semi-critical
• Critical

• Medical Device Cleaning Market, By Technique:

• Cleaning
• Disinfection
• Sterilization

• Medical Device Cleaning Market, By EPA Classification:

• High Level
• Intermediate Level
• Low Level

• Medical Device Cleaning Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE