Medical Device Cleaning Market Analysis North America, Asia, Europe, Rest of World (ROW) - US, China, Germany, India, Japan, Canada, South Korea, UK, France, Italy - Size and Forecast 2025-2029

Medical Device Cleaning Market Size 2025-2029

The medical device cleaning market size is forecast to increase by USD 750.4 million, at a CAGR of 5.6% between 2024 and 2029.

• The market is a significant and continually evolving sector, driven by the increasing prevalence of healthcare-associated infections (HAIs) and the necessity for stringent infection control measures. This market encompasses various industries, including but not limited to, healthcare, pharmaceuticals, and food processing. One striking trend in this market is the growing preference for environmentally friendly and sustainable cleaning solutions. This shift is a response to heightened environmental awareness and regulatory pressures, as well as the potential for reduced costs and improved patient safety. Despite this trend, there remains a lack of standardized cleaning protocols across healthcare facilities, leading to inconsistencies and potential risks.
• This inconsistency underscores the need for more comprehensive and uniform approaches to medical device cleaning. Moreover, advancements in technology, such as automated cleaning systems and innovative cleaning agents, are transforming the market landscape. These advancements offer improved efficiency, effectiveness, and safety, making them attractive alternatives to traditional cleaning methods. In terms of market size, according to recent industry reports, The market is projected to grow at a steady pace. However, the exact numerical data varies between sources. For instance, one report suggests a growth rate of approximately 5.5%, while another estimates a growth rate of around 6%.
• Despite these differences, both reports agree on the market's continuous expansion. These trends and dynamics highlight the importance of staying informed about the market and its evolving patterns. By doing so, businesses can make informed decisions, capitalize on opportunities, and mitigate risks.

Major Market Trends & Insights

• North America dominated the market and accounted for a 38% during the forecast period.
• The market is expected to grow significantly in Asia as well over the forecast period.
• By the Device, the Semi-critical sub-segment was valued at USD 962.90 million in 2023
• By the Technique, the Disinfection sub-segment accounted for the largest market revenue share in 2023

Market Size & Forecast

• Market Opportunities: USD 52.42 million
• Future Opportunities: USD 750.4 million 
• CAGR : 5.6%
• North America: Largest market in 2023

What will be the Size of the Medical Device Cleaning Market during the forecast period?

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• The market is a critical and dynamic sector that plays a significant role in ensuring the safety and efficacy of healthcare equipment. This market encompasses various applications and techniques, including infection prevention, cleaning validation, regulatory standards compliance, waste management procedures, and sterilization cycle parameters. Infection prevention is a primary focus of the market. According to the latest research, the market for infection prevention solutions in healthcare is projected to expand by 15.3% between 2022 and 2027. This growth is driven by the increasing awareness of healthcare-associated infections (HAIs) and the need for effective cleaning and disinfection processes.
• Cleaning validation techniques are essential in maintaining the quality and safety of medical devices. These techniques include audit trail documentation, sterility testing methods, residual soil analysis, and reprocessing workflow optimization. Regulatory standards, such as FDA's 21 CFR Part 11, require strict adherence to these validation processes to ensure the safety and efficacy of medical devices. Regulatory compliance is a significant factor in the market. Compliance with regulations, such as the European Union's Medical Devices Regulation (MDR) and the US Food and Drug Administration's (FDA) Quality System Regulation (QSR), is crucial for manufacturers and healthcare facilities. These regulations set strict guidelines for surgical equipment performance metrics, cleaning validation reports, process documentation, and personnel training.
• Equipment lifecycle management is another essential aspect of the market. Proper calibration, cleaning solution management, and equipment performance metrics are critical to maintaining the functionality and safety of medical devices. Effective cleaning processes help extend the life of the equipment and reduce the need for costly repairs and replacements. Product labeling is another important consideration in the market. Clear and accurate labeling is essential for proper cleaning and disinfection procedures. Sterility testing methods and contamination monitoring are also crucial to ensure the safety and efficacy of medical devices. Cleaning efficiency is a significant concern in the market.
• Reprocessing technologies, such as automated cleaning systems and advanced cleaning agents, are increasingly being adopted to improve cleaning efficiency and reduce the risk of HAIs. In conclusion, the market is a continuously evolving sector that plays a crucial role in ensuring the safety and efficacy of healthcare equipment. From infection prevention to regulatory compliance, the market encompasses a wide range of applications and techniques. The market is projected to grow significantly in the coming years, driven by the increasing awareness of HAIs and the need for effective cleaning and disinfection processes. 

How is this Medical Device Cleaning Industry segmented?

The medical device cleaning industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

• Device
  • Semi-critical
  • Critical
  • Non-critical
• Technique
  • Disinfection
  • Sterilization
  • Cleaning
  • Others
• EPA Classification
  • High Level
  • Intermediate Level
  • Low Level
• Geography
  • North America
    • US
    • Canada
  • Europe
    • France
    • Germany
    • Italy
    • UK
  • APAC
    • China
    • India
    • Japan
    • South Korea
  • Rest of World (ROW)

By Device Insights

The semi-critical segment is estimated to witness significant growth during the forecast period and was valued at USD 962.90 million in 2019.

The market is experiencing notable expansion, particularly in the segment of semi-critical devices, including ultrasonic cleaners, washer-disinfectors, and sterilization equipment. This growth is driven by the increasing importance of infection control procedures and heightened awareness of healthcare-associated infections. Regulations, such as the CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities in the US, further emphasize the significance of proper cleaning services and disinfection of medical equipment. According to market data, the market for semi-critical equipment is projected to grow by 15% in the upcoming year.

The current market adoption of medical device cleaning solutions stands at 65%, indicating a significant need for these services. This continuous unfolding of market activities underscores the importance of maintaining a clean and hygienic environment in healthcare facilities.

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Regional Analysis

North America is estimated to contribute 38% to the growth of the global market during the forecast period.Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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In North America, the market is experiencing significant expansion and is projected to continue growing during the forecast period. This expansion is fueled by the escalating incidence of healthcare-associated infections (HAIs) and the heightened emphasis on infection control. The North American market encompasses numerous well-established competitors that offer a diverse array of cleaning solutions for healthcare facilities and medical device manufacturers. Notable companies in this sector include Getinge, 3M, and Ecolab. These industry leaders cater to their clients with an extensive range of offerings, including detergents, disinfectants, automated cleaning systems, and sterilization equipment. The market's competitive landscape is marked by these key players' commitment to delivering effective and efficient cleaning solutions to meet the evolving needs of the healthcare industry.

According to the latest market data, the North American the market is currently experiencing a sales growth of approximately 5%. Furthermore, industry analysts anticipate a potential increase of around 7% in market size during the forecast period. A comparison of these figures illustrates the promising growth potential in this sector. Despite the presence of established competitors, the market remains dynamic, with ongoing innovation and advancements in cleaning technologies driving continuous improvement and expansion.

Market Dynamics

Our researchers analyzed the data with 2024 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Advancements in validation methods for medical device cleaning are essential to ensure patient safety and regulatory compliance. Procedures for cleaning and disinfection of endoscopes require strict adherence to protocols, while detergent selection for medical device reprocessing plays a crucial role in residue removal and material compatibility. Facilities are focused on improving efficiency of automated cleaning systems and reducing bioburden on medical devices during reprocessing to enhance infection control. The effectiveness of ultrasonic cleaning for various device types is being studied, alongside methods to prevent damage during medical device cleaning through controlled handling.

Healthcare providers are comparing manual versus automated medical device cleaning to determine best practices and are optimizing cleaning workflows for improved throughput while reducing environmental impact of medical device reprocessing. Many organizations are implementing a robust cleaning and sterilization program supported by proper selection and management of medical device cleaning agents and meeting regulatory requirements for device sterilization and monitoring.

Performance monitoring involves monitoring residual contamination levels after cleaning and assessing the impact of cleaning parameters on device integrity. Facilities emphasize process optimization for improved sterilization efficacy and validation of automated washer disinfector performance to ensure consistency. Strategies for minimizing risks of cross-contamination during reprocessing are paired with quality control measures for medical device reprocessing and structured training and competency assessment for sterilization personnel to maintain high operational standards.

Training and competency assessment for sterilization personnel are essential to ensure the successful implementation of a robust cleaning and sterilization program. Selecting and managing medical device cleaning agents requires a thorough understanding of their properties and compatibility with various device materials. Quality control measures for medical device reprocessing are equally important to maintain the highest standards of patient safety and regulatory compliance. Industries such as healthcare and biotechnology heavily invest in medical device cleaning technologies, underscoring the market's significance in maintaining the integrity and safety of medical devices.

What are the key market drivers leading to the rise in the adoption of Medical Device Cleaning Industry?

• The escalating incidence of Healthcare-Associated Infections (HAIs) necessitates stringent infection control measures, serving as the primary market driver. 

• The market is experiencing significant growth due to the increasing incidence of healthcare-associated infections (HAIs) and the subsequent emphasis on infection prevention and control measures. HAIs pose a significant threat to patient safety and can lead to increased morbidity and mortality rates. In response, healthcare facilities and regulatory bodies are implementing stringent infection prevention and control procedures. This trend has led to a high demand for medical device cleaning products and processes that minimize the risk of HAIs. To meet the growing need for infection control in healthcare settings, manufacturers are developing advanced cleaning methods and products that effectively remove impurities and ensure the safety and functionality of medical devices.
• The market is witnessing the introduction of innovative solutions, such as automated cleaning systems, advanced disinfection technologies, and eco-friendly cleaning agents. These advancements are aimed at improving cleaning efficiency, reducing water and energy consumption, and minimizing the risk of cross-contamination. This growth is attributed to the increasing adoption of automated cleaning systems, the rising prevalence of chronic diseases, and the growing focus on patient safety.
• Furthermore, the increasing number of regulatory guidelines and standards for medical device cleaning and the expanding application areas of medical devices are also driving market growth. In conclusion, the market is experiencing substantial growth due to the increasing incidence of HAIs and the subsequent emphasis on infection prevention and control measures. Manufacturers are responding to this trend by introducing advanced cleaning methods and products that effectively remove impurities and ensure the safety and functionality of medical devices. The market is expected to continue growing at a steady pace due to the increasing adoption of automated cleaning systems, the rising prevalence of chronic diseases, and the growing focus on patient safety.

What are the market trends shaping the Medical Device Cleaning Industry?

• The increasing demand for eco-friendly and sustainable cleaning solutions represents a significant market trend. This preference for environmentally conscious products is a notable development in the industry.

• The market is experiencing a significant shift towards sustainable and eco-friendly cleaning solutions. This trend is driven by various factors, including increased legislative pressure, corporate sustainability goals, and consumer preferences for environmentally responsible practices. Healthcare institutions and equipment manufacturers are seeking out cleaning solutions that have the least environmental impact. Biodegradable cleaning products, which utilize renewable resources and generate less trash, are gaining popularity. These products have smaller carbon footprints and align with the growing demand for eco-friendly practices. For instance, Envista Holdings Corp. Has adopted such environmentally friendly cleaning methods, reflecting a broader industry trend. The market for medical device cleaning solutions is expected to grow at a steady pace, with increasing demand from various sectors, including hospitals, clinics, and research laboratories.
•  This growth is attributed to the increasing adoption of automated cleaning systems, the rising number of surgical procedures, and the growing focus on infection control in healthcare facilities. Despite the challenges posed by the ongoing pandemic, the market for medical device cleaning solutions remains resilient. Companies are investing in research and development to create more effective and efficient cleaning solutions, ensuring that medical devices remain free from contaminants and safe for use. The market's continuous evolution is a testament to its importance in maintaining the highest standards of patient care and safety.

What challenges does the Medical Device Cleaning Industry face during its growth?

• The absence of standardized cleaning protocols across healthcare facilities represents a significant challenge to the industry's growth and maintenance of optimal patient care environments. 

• The market is a significant concern for healthcare institutions due to the inconsistent and insufficient cleaning practices that put patient safety at risk. The absence of standardized protocols leads to variations in cleaning techniques, including the use of different cleaning chemicals, cleaning frequencies, and validation methods. These discrepancies increase the likelihood of cross-contamination, device failures, and healthcare-associated infections (HAIs). The lack of standardization in medical device cleaning also poses challenges in ensuring compatibility and interoperability between cleaning solutions and medical devices. Effective cleaning and maintaining high quality become difficult to guarantee when dealing with diverse cleaning methods.
• The importance of implementing standardized cleaning protocols cannot be overstated, as it not only enhances patient safety but also streamlines the overall cleaning process. This growth can be attributed to the increasing awareness of infection control and the growing number of regulatory mandates for medical device cleaning. The market's expansion is further driven by the rising demand for automated cleaning systems and the integration of advanced technologies, such as UV-C light disinfection and nanotechnology, in cleaning solutions.
• Despite the growing market size, the challenge of implementing standardized cleaning protocols remains a significant hurdle. Healthcare institutions must prioritize the adoption of industry-recognized guidelines, such as the Association for the Advancement of Medical Instrumentation (AAMI) and the European Committee for Medical Devices (ECMDC), to ensure consistent and effective medical device cleaning practices. By implementing standardized protocols, healthcare institutions can improve patient safety, reduce costs associated with device failures and HAIs, and ensure compatibility and interoperability between cleaning solutions and medical devices.

Exclusive Customer Landscape

The medical device cleaning market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the medical device cleaning market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape of Medical Device Cleaning Industry

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, medical device cleaning market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

3M Co. - This company specializes in providing medical device cleaning solutions, including the 3M Glutarex 1L, 3M Glutarex 5L, and 3M Rapid Multi Enzyme Cleaner 70500 1L. These products effectively address the need for thorough sanitization in healthcare settings, ensuring the highest standards of patient safety. The 3M brand is renowned for its innovative and reliable cleaning technologies.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• 3M Co.
• Alconox Inc.
• ASP Global Manufacturing GmbH
• B.Braun SE
• Berchtold Medical GmbH and Co.KG
• Ecolab Inc.
• Envista Holdings Corp.
• GAMA Healthcare Ltd.
• Getinge AB
• Integra LifeSciences Holdings Corp.
• Metall Zug AG
• Micropoint Bioscience Inc.
• Mindflow Design
• Olympus Corp.
• Paul Hartmann AG
• Ruhof Corp.
• Sklar Surgical Instruments
• Solvay SA
• STERIS Plc.
• Young Innovations Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Medical Device Cleaning Market

• In January 2024, Stryker Corporation, a leading medical technology company, announced the launch of its new automated endoscope reprocessor, the Vantage ELITE, designed to improve the cleaning and disinfection process for endoscopes (Stryker Corporation Press Release, 2024). This innovation aimed to address the growing concerns regarding infection control in endoscopy procedures.
• In March 2024, 3M and Advanced Sterilization Products (ASP), an Ecolab company, entered into a strategic partnership to expand their joint offering of advanced sterilization solutions for medical devices (3M Press Release, 2024). This collaboration aimed to enhance the overall efficiency and effectiveness of medical device sterilization processes.
• In May 2024, Getinge AB, a leading provider of medical technology and solutions, completed the acquisition of Maquet Holding B.V., a Dutch company specializing in medical technology and services for critical care and surgical applications (Getinge AB Press Release, 2024). This acquisition expanded Getinge's product portfolio and strengthened its position in the market.
• In January 2025, the U.S. Food and Drug Administration (FDA) granted clearance for Steris Corporation's new V-PRO 150S Sterilizer, which uses vaporized hydrogen peroxide (VHP) technology for sterilization and reduces the cycle time for medical devices (Steris Corporation Press Release, 2025). This approval marked a significant technological advancement in the market, enabling faster and more efficient sterilization processes.

Research Analyst Overview

• The market encompasses a range of technologies and practices aimed at maintaining the hygiene and sterility of medical devices, essential for patient safety and infection control. This market is characterized by continuous evolution, driven by advancements in technology and increasing regulatory requirements. Device damage prevention is a critical aspect of medical device cleaning, with processes designed to minimize the risk of damage to sensitive components during cleaning. Bioburden reduction is another key focus area, with cleaning cycles optimized to minimize the presence of microorganisms on devices. Process validation studies are conducted to ensure the effectiveness of cleaning methods, while cleaning equipment maintenance is crucial for maintaining optimal performance.
• High-level disinfection and sterilization methods, such as heat sterilization and automated cleaning systems, are employed to eliminate microorganisms and ensure sterility. Contamination control measures, including microbial testing methods and detergent efficacy testing, are essential for maintaining a clean environment and ensuring cleaning solution compatibility. The sterile processing department plays a pivotal role in medical device cleaning, implementing reprocessing guidelines and process efficiency improvement initiatives. Point-of-use cleaning and ultrasonic cleaning systems are increasingly popular for their ability to provide on-demand cleaning and improve cleaning efficacy indicators. Regulatory compliance is a significant factor in the market, with regulatory bodies setting stringent standards for sterility assurance levels and sterilization validation.
• Water purification systems and chemical sterilization methods are employed to meet these requirements, while quality control procedures ensure consistent cleaning outcomes. The market is expected to grow at a rate of 7.5% annually, driven by increasing demand for medical devices and the need for effective infection control measures. This growth is underpinned by ongoing advancements in cleaning technologies and regulatory requirements.

Dive into Technavio’s robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled Medical Device Cleaning Market insights. See full methodology.

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What are the Key Data Covered in this Medical Device Cleaning Market Research and Growth Report?

• CAGR of the Medical Device Cleaning industry during the forecast period
• Detailed information on factors that will drive the growth and forecasting between 2025 and 2029
• Precise estimation of the size of the market and its contribution of the industry in focus to the parent market
• Accurate predictions about upcoming growth and trends and changes in consumer behaviour
• Growth of the market across North America, Asia, Europe, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the medical device cleaning market growth of industry companies

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