Medical Device Cleaning Market Size, Share & Trends Analysis Report By Device Type (Non-critical, Semi-critical, Critical), By Technique (Cleaning, Disinfection, Sterilization), By EPA Classification (High level, Intermediate level, Low level) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global medical device cleaning market size was valued at USD 19,650.21 million in 2022. It is estimated to reach USD 46,335.31 million, growing at a CAGR of 10.01% over the forecast period (2023–2031). One of the expected driving forces behind the growth of the medical device cleaning market is the expected rise in government initiatives aimed at achieving the highest level of infection prevention.

Medical equipment must be sterile in order to safeguard patients and stop infections at the sites of cuts and wounds. Medical equipment must always be cleaned after surgery. The majority of medical devices, including forceps, endoscopes, retractors, scissors, and scalpels, are used in medical procedures. The surgical tool must be carefully sterilized and cleaned before further use to reduce the possibility of infection to patients and healthcare workers.

In medical device cleaning, disinfectants and detergents are used to clean and sanitize medical equipment. Different chemicals and detergents are used to clean different types of medical equipment. All medical equipment—disposable, implanted, or reusable—should be cleaned throughout the manufacturing process to eliminate oil, grease, fingerprints, and other manufacturing dirt. Reusable items must be thoroughly cleaned and sterilized between uses to prevent disease transmission or patient infection.

Market Dynamics

Global medical device cleaning market drivers

Growing incidence of hospital-acquired infections

Pneumonia, bloodstream infections, surgical site infections (SSIs), urinary tract infections (UTIs), and methicillin-resistant Staphylococcus aureus (MRSA) infections are a few of the most typical hospital-acquired infections. Other major hospital-acquired infections include Catheter-Associated (CA) UTIs, ventilator-associated pneumonia, and catheter-related bloodstream infections. Hospital-acquired infections are among the major health concerns affecting patient recovery, impacting mortality rates globally. According to the practical guide published by WHO on the prevention of hospital-acquired infections, the increase in the hospitalization time of persons suffering from hospital-acquired infections was approximately eight days. As a result, lengthier stays contribute significantly to the overall hospitalization costs, emphasizing the clinical need for taking infection prevention measures.

Furthermore, it is anticipated that a significant contributor to the overall market's continued expansion throughout the projection period will be the rising incidence of hospital-acquired illnesses. One of the main issues for hospitals is the increased risk of infection from bloodborne pathogens, drug-resistant infections, and other infectious agents in operating rooms. For instance, urinary catheter use frequently increases the incidence of UTIs, including CA ones. According to research from the National Nosocomial Illness Surveillance (NNIS) System, catheterization is the most common cause of hospital-acquired urinary tract infections (UTIs), and CA-bacteriuria is the most common healthcare-associated illness worldwide, accounting for up to 40% of hospital-acquired infections worldwide. These factors boost clinical urgency to prevent SSI and adopt personal protective equipment, such as surgical gloves, resulting in significant medical device cleaning market growth.

Rising number of government initiatives to curb infection‌

The increase in government activities to ensure the highest degree of infection prevention is anticipated to be a key factor in the market expansion for medical device cleaning. For instance, the 2030 Sustainable Development Agenda was approved by world leaders in 2015 during a historic UN Summit in New York and went into effect on January 2016, according to the Forum of International Respiratory Societies in 2017. The 2030 Agenda also includes 169 and 17 Sustainable Development Goals (SDGs), which cover sustainable development's economic, social, and environmental aspects. This should accelerate market expansion.

Furthermore, the development of the medical device cleaning market is anticipated to be aided by the increased involvement of government organizations in issuing recommendations to promote awareness about effective infection prevention measures being employed internationally. For instance, the WHO has created recommendations for the healthcare industry on preventing and managing pandemic and epidemic-prone acute respiratory diseases. The topics of sterilization and disinfection are covered, as well as common safety measures like maintaining good hand hygiene and donning protective clothes.

Global medical device cleaning market restraint

Safety concerns related to ethylene oxide sterilization

Ethylene Oxide (EtO) is a low-temperature sterilant frequently used for sterilizing heat- or moisture-sensitive medical devices. It is toxic in nature due to its capability to kill microorganisms. According to EOSA, the U.S. produces around 4 billion pounds of EtO annually. Sterilization uses a negligible fraction of EtO compared to its widespread usage in the production of commonplace goods like detergents, antifreeze, polyester, and cosmetics. EtO is highly reactive and flammable, which increases the risk of chemical accidents among hospital employees and patients. This may restrain the growth of the medical device cleaning market during the forecast period.

Furthermore, EtO, a typical gas sterilization method, became a catch-all due to its recent use for sterilizing testing swabs during the COVID-19 epidemic. As a result, in September 2021, the International Standards Organization (ISO) technical committee 194 revised ISO 10993-7, which specifies allowable limits for Ethylene Chlorohydrin (ECH) and residual EtO in individual EtO-sterilized medical equipment, which is expected to restrain market growth in the near future.

Global medical device cleaning market opportunities

Changing regulations

Manual cleaning and disinfection methods are insufficient to control hospital-acquired infections. Only 40% to 50% of the surfaces that need to be cleaned to keep a space hygienic are cleaned by housekeepers. This may be the consequence of hospitals failing to follow rules issued by regulatory agencies or because the MDR microbiota is resistant to severe cleaning and sterilization practices. As a result, the Asia-Pacific Society of Infection Control (APSIC) updated its disinfection and sterilization guidelines for medical devices in February 2017. This was aimed at emphasizing practical advice in a succinct way, which would help healthcare institutions meet high sterilization and disinfection standards.

Moreover, several manufacturers are providing terminally sterile versions of significant or intricate medical devices due to regulatory changes. This strategy is expected to improve patient safety and minimize hospital costs; manufacturers will benefit from terminal sterilization while increasing the efficacy of medical devices, which is predicted to propel market growth in the near future.

Regional Analysis

Region-wise, the global medical device cleaning market is segmented into North America, Europe, Asia-Pacific, and LAMEA.

North america dominates the global market

North America is the most significant global medical device cleaning market shareholder and is estimated to exhibit a CAGR of 9.61% during the forecast period. Leading market players are expected to increase their product range and infection control capabilities through a steady stream of strategic collaborations, which is expected to lead to the region capturing a larger share. Authorities in the region have implemented stringent regulations regarding the cleaning and disinfection of medical equipment, which is expected to drive the market in the coming years. Due to the local presence of key market participants and ongoing global expansion efforts, the U.S. market has expanded over the past several years.

Moreover, the region's leading market players are implementing tactics including intense R&D and facility expansion in Europe and Asia for manufacturing and R&D. Factors such as knowledge of sterilization and the availability of resources enable the successful implementation of sterilization procedures in hospitals, surgical centers, and other healthcare facilities. Some primary factors contributing to the increasing adoption of sterile practices are the growing usage of non-disposable medical devices and the rising demand to reduce costs related to hospital-acquired infections.

Europe is estimated to exhibit a CAGR of 9.8% during the forecast period. This can be due to the increasing number of government initiatives to promote awareness about infection control issues. For instance, the European Biological Safety Association identifies and defines the best biosecurity practices. It encourages and promotes infection control tools through certain projects, including Infection Control Professional Competence, Biorisk Laboratory Management Standard, etc., which is expected to boost the market's growth in this region.

Germany is a significant contributor to the European sterilization equipment market. The local presence of key medical device manufacturers and technological advancements are predicted to propel market growth. A few outputs of successful R&D in liquid sterilization are hydrogen peroxide and ethylene oxide sterilization procedures. Therefore, it is anticipated that the adoption of cutting-edge medical technology and the availability of improved procedures will fuel the expansion of the German medical device cleaning market.

Asia-Pacific is expected to experience significant regional market growth over the projection period because of the significant presence of outsourcing companies, rising healthcare expenditures, and the amazing evolution of healthcare standards and infrastructure throughout the region. The COVID-19 epidemic and the proliferation of infectious diseases are boosting the expansion of this region's market. An increasing number of governmental and nonprofit organizations committed to raising infection control standards are among the main forces behind market expansion.

Japan has an 83.9-year life expectancy, which suggests that the nation has good access to healthcare. Maintaining good health is aided by having easy access to health services. In Japan, Shakai Hoken is a unique insurance system under which the employer and employee pay premiums for insurance coverage. With growing age, the burden of premiums gradually reduces, and the government aids in getting insurance coverage. The senior population is prone to diseases like osteoporosis, diabetes, and arthritis, which drives the demand for medical devices and subsequently helps grow the medical device-cleaning market.

Segmental Analysis

The global medical device cleaning market is segmented by device type, technique, and EPA classification. 

Based on device type, the global medical device cleaning market is segmented into non-critical, semi-critical, and critical. 

The semi-critical segment dominates the global market and is estimated to exhibit a CAGR of 9.9% during the forecast period. Semi-critical devices are those that come in touch with mucosal membranes. These devices include, among others, dental tools, endoscopes, and some surgical instruments. Due to the high frequency of sterilization, these devices must be sanitized before use, typically using heat or chemicals. When these sterilization methods cannot be employed, disinfectants are approved by and registered with the U.S. Environmental Protection Agency (EPA). These disinfectants include peracetic acid, ortho-phthalaldehyde, glutaraldehyde, and hydrogen peroxide. Although the availability and use of products for cleaning, disinfectant, and sterilization are high, the market is expected to exhibit slow growth over the forecast period. Increased disposable device use, intense pricing rivalry, and strict regulatory standards from the Centers for Disease Control and Prevention (CDC) affect market growth.

Based on technique, the global medical device cleaning market is segmented into cleaning, disinfection, and sterilization. 

The disinfection segment owns the highest market share and is estimated to exhibit a CAGR of 9.8% during the forecast period. Reprocessing semi-critical and critical medical devices involves several steps, including disinfection. Bactericidal, fungicidal, and virucidal are the three major categories of disinfectants employed in this stage. Generally speaking, the kind of medical equipment determines which of these materials are used. However, selecting materials for processing devices, such as endoscopes, is difficult. For instance, choosing between sterilization and high-level disinfection is one such decision. This section also considers the use of disinfectants in conjunction with detergents. The segment is expected to exhibit lucrative growth due to factors such as developing novel products to counter resistant strains.

Based on EPA classification, the global medical device cleaning market is segmented into high-level, intermediate-level, and low-level.

The high-level segment dominates the global market and is estimated to grow at a CAGR of 10.8% during the forecast period. High-level disinfection is the process of treating dental instruments and medical equipment to prevent the growth of microorganisms. It involves the sterilization of heat-sensitive medical equipment and dental instruments that are moderately critical. Glutaraldehydes, specialized hydrogen peroxide, and specialized peracetic acid products are frequently utilized as high-level disinfectants.

Recent Developments

• January 2024- MD&M West 2024, to be held at the Anaheim Convention Center in Anaheim, CA, from February 6th to the 8th, 2024, will feature an exhibit by KYZEN, a world leader in innovative, eco-friendly cleaning chemicals. At Booth 3085, the KYZEN clean team will review the benefits of METALNOX M6093 and M6386, two great products for cleaning medical devices.