Medical Device Cleaning Market

Medical Device Cleaning Market Outlook (2025 to 2035)

The global medical device cleaning market market was valued at USD 1,911.7 million in 2025 and is projected to expand at a noteworthy CAGR of 8.1% to reach USD 4,503.1 million by 2035.

The growing demand for infection control in hospitals drives rapid expansion in medical device cleaning sectors. As surgical procedures increase steadily, hospital-acquired infection prevention and strict regulatory requirements promote substantial market expansion. The market operates on a sustained upward trajectory due to technological innovations, automatic cleaning systems, and global healthcare spending growth.

Across the world, surgical procedures have risen because of increasing chronic diseases that include cardiovascular disease alongside orthopedic complications and cancer. The increasing number of operations performed increases the need for medical device cleaning solutions across the market. The healthcare safety of patients depends on complete cleaning and sterilization procedures for reusable medical equipment, which features endoscopes, surgical instruments, and diagnostic devices.

Healthcare facilities deal with major hospital-acquired infection problems, which lead to longer hospital stays, higher medical costs, worsened health outcomes, and increased fatal outcomes. According to the Centers for Disease Control and Prevention (CDC), HAI affects one out of every thirty-one hospital patients in the USA on any ordinary day. Because of this significant statistic, healthcare facilities have become motivated to establish strict infection control practices, which has led them to implement better medical device cleaning methods.

The WHO report presents the initial worldwide assessment of the IPC program conducted in national healthcare systems at the country and regional levels. It shows healthcare workers' injuries from HAIs and antimicrobial resistance. The report also presents findings on infection prevention and control program influence and cost-effectiveness, as well as available strategic and resource options for countries to strengthen their programs.

Disinfection demand rises because of HAIs, the evolving need for sophisticated cleaning for minimally invasive medical tools, and growing numbers of surgical procedures outside hospitals and in patient homes contribute to industry growth. The compliance requirements for regulations remain in force even though the EU MDR and ISO 17664 need effective sterilization practices to be implemented. Mega developments in medical technology, including ultrasound cleaning for instruments and IoT sterilization oversight with artificial intelligence-enhanced disinfection methods, are transforming the market. The market transition has included the adoption of disposable healthcare tools while outsourcing sterilization services to enhance operational safety and efficiency.

Healthcare-associated infections, along with antimicrobial resistance, create unquantifiable damage to the quality of life of individuals. The annual death rate reaches 24% for patients with healthcare-associated sepsis and 52.3% for sepsis patients undergoing intensive care unit admission. Hospitalized patients with antimicrobial-resistant infections succumb to death more frequently, with mortality being twice or threefold higher.

Metric	Value
Market Size (2020)	USD 1,418.5 million
Market Size (2025)	USD 2,066.6 million
Market Size (2035)	USD 4,503.1 million
Historical CAGR (2020 to 2024)	7.7%
Forecast CAGR (2025 to 2035)	8.1%

Key Trends and Opportunities in the global Medical Device cleaning market

Medical devices must abide by strict cleaning, disinfecting, and sterilization rules issued by health authorities, including the USA Food and Drug Administration (FDA) and the European Medicines Agency (EMA), together with international health organizations. The "Reprocessing of Reusable Medical Device" standard created by the FDA, together with the European Union Medical Device Regulation (EU MDR), establishes cleaning procedures as an essential requirement. Manufacturers of Medical Devices and hospitals need to strictly follow rules to stop legal troubles and create conditions that protect patient safety.

The medical device cleaning sector is transforming automation workflows with robotic systems and artificial intelligence (AI) technologies in cleaning methods. Medical cleaning operations function more effectively now with ultrasonic cleaning, hydrogen peroxide plasma sterilization, and UV disinfection systems, which also reduce human error possibilities. Medical technology has optimized cleaning processes through mechanisms that ensure higher operational effectiveness, better consistency, and safe working conditions for healthcare staff.

The worldwide healthcare sector shows growing financial investment, particularly in emerging countries like China, India, and Brazil, where governments work to develop their medical facilities. Medical device cleaning solutions experience increased demand due to hospital infrastructure expansion and the establishment of surgical centers and diagnostic clinics. Modern sterilization technologies receive support from public-private sector cooperative ventures and collaborative efforts.

Regional outlook of the medical device cleaning industry

The medical device cleaning market will likely have North America as its leader due to its advanced healthcare facilities and government regulations and increasing focus on infection control practices. Regular technological progress by major industry companies together with their market presence drives market expansion.

The priority of patient safety in European health systems requires Medical Device to follow strict mandatory control procedures for cleaning. Advanced sterilization innovation by Germany France and the United Kingdom leads to increased adoption of automated cleaning systems.

The Asia Pacific sector demonstrates rapid development due to increasing healthcare structures and enhancing medical tourism services along with improving healthcare infrastructure spending. China together with India, Japan, and South Korea experience enhanced requirements for efficient cleaning solutions because their healthcare sector performs more operations and implements strengthened infection control methodologies.

Latin American and Middle Eastern emerging economies invest in healthcare modernization through which medical device cleaning solutions are experiencing increased adoption. These markets may experience slower expansion because of the limited availability of complex cleaning equipment together with inconsistent regulations.

What are some of the key factors hampering the market revenue growth of medical device cleaning?

The implementation of advanced cleaning equipment together with recent sterilization technologies incurs high upfront expenses which prevents their use in miniature healthcare institutions.

The combination of cleaning chemicals and sterilization methods might inactivate specific Medical Device as they lead to material degradation.

The lack of proper training and cleaning protocol knowledge, in particular, in developing nations functions as an obstacle to expanding the market.

Smart cleaning technologies integrated with IoT platforms allow real-time monitoring of cleaning operations through which organizations achieve better efficiency levels and maintain regulatory compliance.

The market for biodegradable disinfectants coupled with water-efficient sterilization methods presents an excellent growth possibility.

Shifts in the Medical Device Cleaning Sector: 2020 to 2024 and Future Trends 2025 to 2035

Medical device cleaning has shown rapid market growth from 2020 through 2024 because of strict regulatory mandates and substantial surgical operation volumes together with heightened concerns about infection control measures. New high-tech cleaning products entered the market after COVID-19 exposed the necessity for effective disinfection and sterilization practices. The combination of enzyme detergents along ultrasonic cleaning machines brings better efficiency levels while meeting requirements for healthcare standards. The market will evolve over the coming 10 years through improved automation and AI-based surveillance systems while using environmentally safe cleaning solutions.

Regulatory bodies will enforce strict sterilization guidelines while healthcare units use advanced sterilization technologies to stop patients from developing hospital-acquired infections (HAIs). Market trends will be affected by the rising adoption of single-use medical equipment and developing healthcare facilities in emerging nations.

Market Shift	2020 to 2024
Regulatory Landscape	Stricter infection control regulations (FDA, CDC, and EU MDR) drove demand for compliant cleaning solutions.
Technological Advancements	Enzymatic and biodegradable detergents, ultrasonic cleaning, and manual validation methods were common.
Industry-Specific Demand	High demand from hospitals, ambulatory surgical centers, and diagnostic laboratories due to infection control needs.
Sustainability & Circular Economy	Shift towards biodegradable cleaning agents and reusable device cleaning protocols.
Production & Supply Chain	Reliance on chemical-based disinfectants with global supply chain dependencies.
Market Growth Drivers	Rise in surgical procedures, post-pandemic infection control measures, and regulatory compliance needs.

Market Shift	2025 to 2035
Regulatory Landscape	Regulations will emphasize eco-friendly cleaning agents, automation, and AI-based validation for cleaning processes.
Technological Advancements	AI-driven cleaning validation, automated sterilization, and sensor-based contamination detection will enhance efficiency.
Industry-Specific Demand	Growth in outpatient care facilities and home-based medical care will drive the need for portable and efficient cleaning solutions.
Sustainability & Circular Economy	Expansion of green sterilization methods, water-efficient cleaning systems, and reduced chemical waste disposal.
Production & Supply Chain	Localization of production and increased adoption of sustainable raw materials for disinfectants.
Market Growth Drivers	AI-driven process optimization, sustainability mandates, and expanding healthcare infrastructure in emerging markets.

The medical device cleaning sector will witness a substantial shift because of automation through AI and sustainable practices and the need for rigorous compliance. AI-based monitoring systems have the potential to boost cleaning efficiency together with a reduction of human errors in the process. The main role of sustainability will be crucial as non-toxic and biodegradable cleaning agents will help decrease environmental impact. Asia-Pacific along with Latin America and the Middle East markets will demonstrate robust healthcare sector expansion because of rising medical expenditures and developing foundation infrastructure.

The market will advance through automated processes that combine robotics and AI to achieve both precision and efficiency for sterilization and cleaning operations. Personified Medical Device will need sophisticated cleaning methods in order to preserve patient safety standards. The market will adopt IoT-enabled cleaning devices that use real-time monitoring and compliance tracking systems.

The market growth depends on strict regulations better technology and increasing public understanding of infection prevention practices. Future leadership positions in the market will go to companies that invest in smart sterilization technologies along with sustainable cleaning solutions.

Country-Wise Insights

The USA market accepts regulatory requirements from the FDA and CDC alongside strong hospital and ambulatory surgical facility needs for automated cleaning systems. The market advances due to persistent innovation efforts from leader institutions such as Steris Corporation and Ecolab.

The European Union market follows rigorous MDR (Medical Device Regulation) compliance and ISO sterilization standards whereas Germany and France and the United Kingdom comprise the largest contribution due to their extensive healthcare facility development. Growing interest in sustainable practices drives the market demand for products which break down naturally.

The Asia-Pacific market consisting of Japan and South Korea and China and India continues to experience fast growth because Asian governments implement infection control policies during rapid healthcare expansion. The adoption of enzymatic and ultrasonic cleaning technology has been rising in this region because it improves disinfection effectiveness.

Year	USA Attributes
Market Value (2025)	USD 661.3 Million
CAGR (2025 to 2035)	8.7%
Market value (2035)	USD 1,516.6 Million

Year	China Attributes
Market Value (2025)	USD 224.3 Million
CAGR (2025 to illio2035)	8.0%
Market value (2035)	USD 485.2 Million

Year	Japan Attributes
Market Value (2025)	USD 68.6 Million
CAGR (2025 to illio2035)	6.9%
Market value (2035)	USD 134.0 Million

The medical device cleaning sector will demonstrate consistent compound annual growth rate between 2025 and 2035 because healthcare institutions maintain both infection prevention standards and regulatory compliance. The market demonstrates favorable growth prospects because emerging cleansing technologies and increased attention to sustainable practices direct its long-term direction.

Category-wise Insights

Enzymatic Cleaners Dominate Owing to Better Biodegradability and Efficiency

Enzymatic cleaners lead the market through their ability to decompose blood and tissue with no adverse effects on medical tools. The use of enzymatic cleaners extends to surgical instruments that are minimally invasive as well as flexible endoscopes and robotic-assisted surgical instruments. FDA together with CDC and European Medical Device Regulation (MDR) ensured the increasing use of these environmentally friendly cleaning agents. Strict hospital infection control requirements make the European and North American markets lead this segment.

The market demand for non-enzymatic cleaning agents persists regardless of implementation restrictions.

General medical equipment receives vast non-enzymatic cleaning using alkaline and neutral detergents which remain common throughout all types of medical settings. The benefits of low-cost operation limit their use in delicate medical environments because biofilm breakdown efficiency remains poor. Strong market demand exists in developing nations because cost efficiencies determine which cleaning agents doctors select. Non-Invasive Prenatal Testing (NIPT) Remains on the Rise despite Issues.

Surgical Instruments Cleaning Dominates Owing to Sterilization Needs

The surgical instruments section maintains its position as the leading segment within medical device cleaning markets because robot-assisted and laparoscopic procedures have been on the rise. Medical facilities strengthen their disinfection standards because of elevated hospital-acquired infection rates. The market demand in North America as well as Europe and Asia-Pacific continues to rise because hospitals invest in modern reprocessing facilities.

Ultrasound Probe Cleaning Picks Up Pace with Increasing Demand for Diagnostic Imaging

Hospital demand for high-level disinfection and cleaning of ultrasound probes has increased because of improved ultrasound-guided procedure protocols. Ultrasonic probe cleaning needs fundamental improvement according to regulations established by CDC, FDA, and ECRI Institute. Research indicates that diagnostic imaging services growth rate in Asia-Pacific and Latin America will drive market expansion across these regions.

Hospitals and Clinics Fuel Market Expansion with Rising Patient Admissions

Hospitals holds largest market share % in the year 2025 because of the high number of medical procedures with stringent infection control requirements. As hospital acquired infections (HAIs) are of immense concern during recent times as growing awareness of antimicrobial resistance (AMR) has spurred greater investment in automated cleaning and sterilization systems. The USA, China, Germany, and Japan, dominate the market, with hospitals adopting advanced disinfection methods, the rate of hospital acquired infections is low.

Ambulatory Surgical Centers (ASCs) Increase Market Opportunities

The trend toward outpatient procedures has increased the need for effective and rapid medical device cleaning solutions. ASCs demand small, economical cleaning systems that meet regulatory requirements while providing fast turnaround times. Expansion is being seen in North America and Europe, where minimally invasive procedures (MIS) are increasingly being done outside of conventional hospital facilities.

Competitive Landscape

Key players in the medical device cleaning industry are Steris plc, Getinge AB, Advanced Sterilization Products, Ecolab Inc., 3M Company, Ecolab Inc., Getinge AB, MMM Group, Belimed AG, Sakura Global Holding Company Ltd., Tuttnauer Company Ltd., Ruhof Corporation, Borer Chemie AG, Fortive Corporation, Cardinal Health, Inc., Olympus Corporation, and PAUL HARTMANN AG among others.

The competition in the medical device cleaning industry intensifies because healthcare institutions need better infection control alongside regulatory compliance and technological solutions. Healthcare-associated infections have pushed the demand for efficient cleaning products into its highest market position. This industry focuses its competitive strategy on product differentiation and research and development, as well as sustainability. The market is controlled by Steris plc, Getinge AB, Advanced Sterilization Products (ASP), Ecolab Inc., and 3M Company because of their extensive product ranges and international business footprint through which they built their market positions.

Market Share Analysis by Company

Company Name	Estimated Market Share (%)
Top 5 Companies	~40-50%
Getinge AB	~20-30%
Advanced Sterilization Products	~20-40%

Steris plc

The company supplies diverse infection prevention products and solutions that include sterilizers along with disinfectants and cleaning chemistries. Through its global presence and innovative strategies with acquisition-based growth, the company has enhanced its market leadership position.

Getinge AB

Getinge AB position among the product competitors but establishes excellence in disinfectors and contains expertise in sterilisation equipment and environmentally friendly cleaning solutions. The company makes large investments to maintain regulatory compliance & sustainability standards which helps it sustain competition with North American & Europe markets.

Advanced Sterilization Products (ASP)

The company focuses on high-level disinfection & medical device sterilization technologies. The subsidiary business of Fortive Corporation, known as ASP, delivers efficient, sustainable cleaning solutions for hospitals, surgical centers, and laboratories.

Global Expansion and Market Penetration

The competitive market is also shaped by market consolidation, technological changes, and compliance requirements. Big players are acquiring smaller firms to increase their offerings and consolidate market positions. Those firms that make investments in automation, AI-powered cleaning procedures, and green disinfectants lead the way in industry innovation. Compliance continues to be a high priority, with companies following FDA, EPA, and EU MDR regulations in order to have credibility in the market. Sustainability is another key motivator, and large players emphasize biodegradable and non-toxic cleaning products to support healthcare providers' green objectives.

Apart from the incumbent players, the market is also driven by a number of regional and emerging players. The Asia-Pacific region, specifically, is experiencing a pick-up in demand for medical device cleaning solutions with the growth in healthcare infrastructure in the region. Those companies that lay down robust distribution channels & their strategic alliances in these high-growth markets are poised to excel in the coming years. With the medical device cleaning industry continues to grow, market competition will be driven by continued technological innovation and advancement, sustainability efforts, and the capacity to comply with stringent regulatory standards, creating a fast-paced and constantly growing industry environment.

Key Market Players and Competitive Positioning

The competitive landscape is defined by a combination of incumbent companies and new biotechnology companies.

Key Attributes and Offerings by Company

Company Name	Key Offerings/Activities
Steris plc	Provides a comprehensive range of infection prevention solutions, including sterilizers and cleaning chemistries. Focuses on innovation and global reach.
Getinge AB	Specializes in disinfectors and sterilization equipment. Invests in eco-friendly solutions and adheres to regulatory compliance.
Advanced Sterilization Products	Develops advanced sterilization and disinfection technologies. Emphasizes sustainability and efficient resource utilization.
Ecolab Inc.	Offers cleaning and disinfection products tailored for healthcare settings. Focuses on sustainability and innovation.
3M Company	Provides a wide array of cleaning and sterilization products. Invests in research and development for cutting-edge solutions.

Market Outlook

Medical Device Cleaning sector is growing strongly driven by the high incidence of infection, increased regulatory requirements, and greater use of Medical Device within healthcare facilities. Enzyme-based cleaners and surgical instrument cleaning are the major segments, whereas Asia-Pacific has the greatest potential for growth. As hospitals and ASCs persist in investing in advanced cleaning solutions, the market is likely to grow, where sustainability and automation are going to be the core drivers of future developments.

Fact.MR has provided detailed information about the price points of key manufacturers of Medical Device cleaning positioned across regions, sales growth, production capacity, and speculative technological expansion, in the recently published report.

Segmentation of Medical Device Cleaning Industry Research

• By Method:

  • Automated Cleaning
  • Manual Cleaning

• By Process:

  • Disinfection
    • High-level Disinfectants
    • Intermediate-level Disinfectant
    • Low-level Disinfectant
  • Automatic Cleaning
    • Enzymatic Detergents
    • Non-Enzymatic Detergents
  • Manual Cleaning
    • Enzymatic
    • Non-Enzymatic
  • Precleaning
    • Enzymatic
    • Non-Enzymatic

• By Applications:

  • Surgical Instruments
  • Endoscopes
  • Ultrasound Probes
  • Dental Instruments
  • Other Instruments

• By End User:

  • Hospitals
  • Specialty Clinics
  • Diagnostic Centers
  • Dental Clinics and Hospitals
  • Academic & Research Institutes
  • Others

• By Region:

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa