Global Medical Device Cleaning Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Device;
Non-critical, Semi-critical, and Critical.By Technique;
Cleaning, and Disinfection.By Process;
Precleaning, Automatic, Manual Cleaning, Disinfection, Type Non-Enzymatic, Enzymatic.By Application;
Surgical, Endoscope, Ultrasound, Dental Instruments.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Medical Device Cleaning Market (USD Million), 2021 - 2031
In the year 2023, the Global Medical Device Cleaning Market was valued at USD 1,698.26 million. The size of this market is expected to increase to USD 2,413.62 million by the year 2030, while growing at a Compounded Annual Growth Rate (CAGR) of 5.2%.
Medical device cleaning is a foundational practice that helps prevent healthcare-associated infections (HAIs), ensuring that medical devices are free from contaminants, pathogens, and organic matter before they are reused or sterilized. The importance of this market is underscored by stringent regulatory standards and guidelines enforced by health authorities, such as the FDA, CDC, and WHO, which mandate rigorous cleaning protocols to safeguard patient health and maintain the integrity of medical procedures.
Enzymatic detergents are particularly effective in breaking down organic materials, including blood and tissue, while non-enzymatic detergents are used for general cleaning purposes. Disinfectants are essential for eliminating microbial contaminants, and the use of automated washers and ultrasonic cleaners enhances the efficiency and consistency of the cleaning process, reducing the risk of human error. The growth of the Global Medical Device Cleaning Market is driven by several factors, including the rising prevalence of HAIs, increasing healthcare expenditures, and the growing volume of surgical procedures worldwide. The expanding elderly population, which is more susceptible to infections and requires frequent medical interventions, further fuels the demand for effective medical device cleaning solutions. Additionally, advancements in medical device technology and the introduction of complex, reusable devices necessitate sophisticated cleaning methods to ensure comprehensive decontamination.
Geographically, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America and Europe dominate the market due to well-established healthcare infrastructure, stringent regulatory frameworks, and high adoption rates of advanced cleaning technologies. However, emerging markets in Asia-Pacific and Latin America present significant growth opportunities, driven by increasing healthcare investments, improving healthcare infrastructure, and rising awareness about infection control practices.
Global Medical Device Cleaning Market Recent Developments
-
In January 2023, PAMA launched its new ethylene oxide sterilization solution for the eco-efficient, cost-effective, and safe sterilization of medical devices.
-
In May 2022, GOJO Industries, the makers of Purell products, expanded its surface hygiene portfolio with the launch of Purell Healthcare Surface Disinfecting Wipes. The new offering delivers unprecedented potent efficacy and peace of mind. Purell Healthcare Surface Disinfecting Wipes offer powerful germ-kill in one-step, hospital-grade surface disinfecting wipes.
Segment Analysis
The global medical device cleaning market is segmented based on device type into non-critical, semi-critical, and critical categories. Non-critical devices, which include items that come into contact with intact skin but do not penetrate the body, are typically cleaned using low-level disinfection methods. Semi-critical devices, such as endoscopes and dental instruments, require higher levels of cleaning and disinfection due to their exposure to mucous membranes. Critical devices, which include surgical instruments that come into contact with sterile tissues or the bloodstream, demand the highest levels of cleaning and sterilization to prevent infections and ensure patient safety.
In terms of cleaning technique, the market is divided into cleaning and disinfection. Cleaning refers to the removal of dirt, organic material, and debris from medical devices, often using detergents and other cleaning agents. Disinfection involves the use of chemical agents or heat to kill or inactivate harmful microorganisms. Both processes are essential in maintaining the functionality and safety of medical devices. The market also segments based on the cleaning process, which includes precleaning, automatic cleaning, manual cleaning, and disinfection. Precleaning typically involves the initial removal of debris before more advanced cleaning techniques are applied. Automatic cleaning systems are gaining popularity due to their efficiency, while manual cleaning still plays a role in certain situations. Disinfection, which follows cleaning, is essential in reducing the microbial load on medical devices.
Applications of medical device cleaning span various fields such as surgical, endoscope, ultrasound, and dental instruments. Surgical instruments require meticulous cleaning due to their direct contact with sterile body areas during procedures. Endoscopes, which are prone to contamination, require specialized cleaning and disinfection to prevent cross-contamination between patients. Ultrasound probes, which may come into contact with mucous membranes, are cleaned and disinfected to prevent the spread of infection. Dental instruments are similarly cleaned to maintain hygiene standards and prevent transmission of diseases. The diverse needs in these applications drive the demand for tailored cleaning solutions, ensuring both safety and compliance with healthcare regulations.
Global Medical Device Cleaning Segment Analysis
In this report, the Global Medical Device Cleaning Market has been segmented by Device, Technique, Process, Application and Geography.
Global Medical Device Cleaning Market, Segmentation by Device
The Global Medical Device Cleaning Market has been segmented by Device into Non-critical, Semi-critical, and Critical.
Non-critical devices, such as stethoscopes, blood pressure cuffs, and hospital beds, come into contact with intact skin and pose a relatively low risk of infection. These devices typically require low-level disinfection or thorough cleaning with detergents to ensure they are free from contaminants. Despite the lower risk, maintaining cleanliness for non-critical devices is essential to prevent cross-contamination and ensure a safe healthcare environment.
Semi-critical devices, including endoscopes, respiratory therapy equipment, and ultrasound probes, contact mucous membranes or non-intact skin and therefore require a higher level of disinfection. High-level disinfection methods, often involving chemical disinfectants, are necessary to eliminate all microorganisms except for high levels of bacterial spores. The complexity of these devices, especially endoscopes with their intricate channels, necessitates specialized cleaning and disinfection protocols to ensure all surfaces are adequately treated and safe for reuse. The market for cleaning semi-critical devices is driven by the increasing use of minimally invasive diagnostic and therapeutic procedures, which rely heavily on these types of instruments.
Critical devices, such as surgical instruments, implants, and needles, enter sterile body areas or the vascular system, presenting the highest risk of infection transmission. These devices must undergo rigorous cleaning followed by sterilization to ensure they are completely free of all microorganisms, including bacterial spores. The cleaning process for critical devices often involves multiple steps, including pre-cleaning, ultrasonic cleaning, and automated washing, to ensure thorough decontamination before sterilization. The stringent regulatory requirements for sterilizing critical devices and the potential consequences of inadequate cleaning drive significant demand for advanced cleaning technologies and solutions in this market segment.
Global Medical Device Cleaning Market, Segmentation by Technique
The Global Medical Device Cleaning Market has been segmented by Technique into Cleaning, and Disinfection.
Cleaning refers to the physical removal of visible soil, organic material, and other debris from medical devices. This initial step is crucial because the presence of organic matter can interfere with the effectiveness of subsequent disinfection or sterilization processes. Cleaning can be performed manually or using automated systems. Manual cleaning involves the use of brushes, detergents, and water to scrub the device surfaces, ensuring that all visible contaminants are removed. Automated cleaning, often utilizing washer-disinfectors or ultrasonic cleaners, enhances efficiency and consistency by using mechanical action, detergents, and sometimes high-frequency sound waves to clean the devices thoroughly.
Disinfection, the next crucial step, involves using chemical agents to destroy microorganisms on the surface of medical devices. This process is particularly important for semi-critical and non-critical devices that do not require sterilization but still need to be free from potentially harmful pathogens. High-level disinfection is necessary for semi-critical devices such as endoscopes and respiratory therapy equipment, which come into contact with mucous membranes or non-intact skin. Low-level disinfection is typically sufficient for non-critical devices like blood pressure cuffs and stethoscopes that come into contact with intact skin. The effectiveness of disinfection depends on the choice of disinfectant, the duration of exposure, and the device's material compatibility.
The distinction between cleaning and disinfection techniques is critical in the context of regulatory standards and infection control protocols. Effective cleaning is a prerequisite for successful disinfection; without thorough cleaning, organic residues can shield microorganisms from disinfectants, reducing their efficacy. The market for these techniques is driven by the increasing incidence of healthcare-associated infections (HAIs), which necessitates stringent infection control measures in healthcare settings.
Global Medical Device Cleaning Market, Segmentation by Process
The Global Medical Device Cleaning Market has been segmented by Process into Precleaning, Automatic, Manual Cleaning, Disinfection, Type Non-Enzymatic, Enzymatic.
The global medical device cleaning market is categorized based on various processes that ensure the proper cleaning and disinfection of medical devices. One of the key segments is precleaning, which involves initial cleaning steps to remove gross contaminants from medical instruments before they undergo further cleaning procedures. This step is crucial in reducing the potential for infection and ensuring that the device is ready for more intensive cleaning processes.
Another important segment is automatic cleaning, which utilizes specialized machines to perform the cleaning and disinfection of medical devices. This process is highly efficient and reduces human error, providing a standardized and thorough cleaning. Manual cleaning, on the other hand, relies on healthcare professionals to scrub and wash medical devices, typically in cases where automatic cleaning is not feasible. While manual cleaning may require more time and attention, it is essential for delicate or complex devices that need more careful handling.
Additionally, disinfection is a vital part of the medical device cleaning market, where various agents are used to eliminate harmful microorganisms from the surfaces of medical devices. The types of disinfectants can include both non-enzymatic and enzymatic solutions. Non-enzymatic disinfectants are typically broad-spectrum chemicals that are effective in killing bacteria and viruses, while enzymatic cleaners are used to break down organic matter and facilitate the removal of contaminants from medical instruments. Each cleaning type and method plays a pivotal role in maintaining high standards of hygiene and preventing healthcare-associated infections.
Global Medical Device Cleaning Market, Segmentation by Device
The Global Medical Device Cleaning Market has been segmented by Application into Surgical, Endoscope, Ultrasound, Dental Instruments.
The Global Medical Device Cleaning Market is diverse, with several key applications driving its growth. One of the primary segments is surgical instruments cleaning, which requires rigorous and specialized processes to ensure the safety and sterility of devices used in surgical procedures. These cleaning methods typically include manual, automated, or a combination of both, and are essential in preventing infections and maintaining high standards of hygiene in operating rooms.
Another significant segment is endoscope cleaning. Endoscopes are delicate and complex devices used for minimally invasive surgeries and diagnostic procedures. The cleaning process for endoscopes is particularly challenging due to their intricate design and the need to thoroughly disinfect them without damaging sensitive components. This segment is expanding due to the increasing number of diagnostic and therapeutic procedures involving endoscopy, which drives the demand for effective and efficient cleaning solutions.
Ultrasound and dental instrument cleaning are also important market segments. Ultrasound cleaning requires specialized equipment and techniques to ensure the integrity and function of the transducers, which are critical for accurate imaging. Dental instruments, such as scalers, drills, and forceps, must be cleaned and disinfected to the highest standards to prevent cross-contamination between patients. As the demand for high-quality, safe medical procedures continues to rise globally, the market for cleaning solutions in these applications is expected to grow.
Global Medical Device Cleaning Market, Segmentation by Geography
In this report, the Global Medical Device Cleaning Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Medical Device Cleaning Market Share (%), by Geographical Region, 2024
North America, comprising the United States and Canada, leads the global market due to its well-established healthcare infrastructure, stringent regulatory standards, and high awareness of infection control practices. The presence of leading market players and substantial investments in healthcare facilities further drive the adoption of advanced cleaning and disinfection technologies. Regulatory bodies like the FDA enforce rigorous guidelines that mandate effective cleaning protocols, thereby boosting the demand for high-quality cleaning agents and equipment.
Europe follows closely, with countries such as Germany, France, and the UK spearheading the market. The region's strong focus on healthcare quality and patient safety, along with stringent regulatory frameworks, ensures robust demand for medical device cleaning solutions. The European Union's medical device regulations (MDR) impose strict requirements on cleaning and sterilization, compelling healthcare providers to adopt reliable and efficient cleaning processes.
The Asia Pacific region is witnessing rapid growth, driven by expanding healthcare infrastructure, increasing healthcare expenditures, and rising awareness about infection control. Countries like China, India, and Japan are investing heavily in modernizing their healthcare systems, which includes the adoption of advanced medical device cleaning technologies. The growing incidence of healthcare-associated infections (HAIs) in this region further underscores the need for effective cleaning and disinfection practices.
In the Middle East and Africa, the market is gradually developing, supported by improving healthcare infrastructure and increasing government initiatives to enhance healthcare quality. Countries such as Saudi Arabia, the UAE, and South Africa are focusing on upgrading their healthcare systems, which includes adopting better infection control measures. However, challenges such as limited access to advanced technologies and financial constraints may hinder market growth to some extent.
Latin America, including countries like Brazil, Mexico, and Argentina, presents significant growth opportunities due to the ongoing improvements in healthcare infrastructure and rising awareness about the importance of infection control. Government initiatives and increasing investments in healthcare are driving the demand for effective medical device cleaning solutions in this region.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Medical Device Cleaning Market. These factors include; Market Drivers, Restraints and Opportunities.
Drivers:
- Rising HAI Incidence
- Increasing Surgeries
-
Regulatory Compliance - Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health agencies have established stringent guidelines and standards for the cleaning and disinfection of medical devices. These regulations are designed to ensure patient safety by preventing healthcare-associated infections (HAIs) and maintaining the efficacy of medical procedures. Compliance with these regulations is mandatory for healthcare providers and medical device manufacturers, creating a substantial impetus for the adoption of robust cleaning protocols and technologies.
The regulations specify detailed requirements for the cleaning, disinfection, and sterilization processes that must be followed for different categories of medical devices. For instance, critical devices that enter sterile body areas or the vascular system must undergo rigorous cleaning followed by sterilization to eliminate all microorganisms, including bacterial spores. Semi-critical devices, which contact mucous membranes or non-intact skin, require high-level disinfection to ensure they are free from potential pathogens. Non-critical devices, which contact intact skin, must also be adequately cleaned and disinfected to prevent cross-contamination and ensure overall hygiene in healthcare settings.
Compliance with these regulatory standards necessitates the use of advanced cleaning agents, automated washers, ultrasonic cleaners, and high-level disinfectants. Medical device manufacturers are required to validate their cleaning and disinfection processes, demonstrating that their devices can be effectively decontaminated according to the regulatory guidelines. This has led to increased investments in research and development to create innovative cleaning solutions that meet these stringent standards.
Regulatory compliance drives the need for thorough documentation and traceability of the cleaning and disinfection processes. Healthcare facilities must maintain detailed records to prove compliance during inspections and audits. This requirement has spurred the adoption of sophisticated tracking and monitoring systems that ensure every step of the cleaning process is accurately documented and can be reviewed if necessary.
Restraints:
- High Costs
- Complex Procedures
-
Equipment Limitations - Medical devices such as endoscopes, catheters, and other instruments with intricate designs and narrow lumens require specialized cleaning techniques to ensure all surfaces are adequately decontaminated. However, existing cleaning equipment may not always reach or effectively clean these complex areas, leaving residual bioburden that could potentially lead to healthcare-associated infections (HAIs). This inadequacy necessitates manual intervention, which is time-consuming and prone to human error, further complicating the cleaning process.
The limitations in cleaning equipment technology can hinder the adoption of automated systems. Automated washers and ultrasonic cleaners, while efficient for many types of devices, may not be universally applicable to all instruments due to variations in design, materials, and usage. Some medical devices may require customized cleaning protocols that standard equipment cannot provide, leading to inconsistencies in the decontamination process. This variability can result in insufficiently cleaned devices being used in medical procedures, increasing the risk of cross-contamination and infection.
The wear and tear on cleaning equipment is another critical issue. Over time, the performance of cleaning devices can degrade due to constant use, leading to decreased efficacy. Regular maintenance and replacement of parts are necessary to ensure optimal performance, but this can be costly and time-consuming for healthcare facilities. Additionally, outdated equipment may not be compatible with newer, more complex medical devices, necessitating expensive upgrades or replacements.
Opportunities:
- Emerging Markets
- Technological Advancements
-
Green Cleaning Solutions - The push towards green cleaning solutions in the medical device cleaning market is driven by several factors. Regulatory bodies and health organizations worldwide are implementing stricter guidelines and policies to reduce the environmental footprint of healthcare operations. Hospitals and healthcare facilities are under increasing pressure to comply with these regulations, which promotes the adoption of green cleaning practices. Additionally, there is a growing awareness among healthcare providers about the long-term benefits of using environmentally friendly products, such as improved indoor air quality and reduced chemical residues on medical devices.
Technological advancements are also playing a crucial role in the development and adoption of green cleaning solutions. Innovations in cleaning formulations and equipment are enabling more effective and efficient cleaning processes that are less reliant on traditional chemical disinfectants. For example, the use of enzymatic cleaners, which utilize natural enzymes to break down organic matter, offers a powerful yet eco-friendly alternative to conventional cleaning agents. Moreover, the integration of automated cleaning systems that optimize the use of green cleaning agents further enhances the efficiency and sustainability of the cleaning process.
The market potential for green cleaning solutions is particularly strong in regions with stringent environmental regulations and high environmental consciousness, such as North America and Europe. However, emerging markets in Asia-Pacific and Latin America are also beginning to recognize the importance of sustainable healthcare practices, providing additional growth opportunities. As healthcare infrastructure in these regions continues to develop, the adoption of green cleaning solutions is expected to rise.
Competitive Landscape Analysis
Key players in Global Medical Device Cleaning Market include:
- GetingeAB
- Advanced Sterilization Products
- The Ruhof Corp.
- Sklar Surgical Instruments
- Sterigenics International LLC
- Biotrol
- Metrex Research, LLC
- Oro Clean Chemie AG
- Cantel Medical Corp.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Deivce
- Market Snapshot, By Technique Process
- Market Snapshot, By Process
- Market Snapshot, By Application
- Market Snapshot, By Region
- Global Medical Device Cleaning Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
-
Rising HAI Incidence
-
Increasing Surgeries
-
Regulatory Compliance
-
- Restraints
-
High Costs
-
Complex Procedures
-
Equipment Limitations
-
- Opportunities
-
Emerging Markets
-
Technological Advancements
-
Green Cleaning Solutions
-
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Medical Device Cleaning Market, By Device, 2021 - 2031 (USD Million)
-
Non-critical
-
Semi-critical
-
Critical
-
- Global Medical Device Cleaning Market, By Technique, 2021 - 2031 (USD Million)
-
Cleaning
-
Disinfection
-
- Global Medical Device Cleaning Market, By Process, 2021 - 2031 (USD Million)
- Precleaning
- Automatic
- Manual Cleaning
- Disinfection
- Type Non-Enzymatic
- Enzymatic
- Global Medical Device Cleaning Market, By Application, 2021 - 2031 (USD Million)
- Surgical
- Endoscope
- Ultrasound
- Dental Instruments
- Global Medical Device Cleaning Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Medical Device Cleaning Market, By Device, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- GetingeAB
- Advanced Sterilization Products
- The Ruhof corporation
- Sklar Surgical Instruments
- Sterigenics International LLC
- Biotrol
- Metrex Research, LLC
- Oro Clean Chemie AG
- Cantel Medical corporation
- Company Profiles
- Analyst Views
- Future Outlook of the Market