Medical Device Cleaning Market Size, Share & Trends Analysis Report By Device (Semi-critical, Critical), By Technique (Sterilization, Disinfection), By EPA Classification (High, Intermediate Levels), And Segment Forecasts, 2021 - 2028

Report Overview

The global medical device cleaning market size was valued at USD 16.24 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 10.2% from 2021 to 2028. The rising prevalence of hospital-acquired infections is expected to be a major factor responsible for the steady growth of the overall market during the forecast period. Diseases, such as pneumonia, bloodstream infection, Urinary Tract Infections (UTIs), surgical site infections, and Methicillin-Resistant Staphylococcus Aureus (MRSA) infections, are some of the most common Hospital-Acquired Infections (HAIs). Other major HAIs include catheter-associated UTIs, ventilator-associated pneumonia, and catheter-related bloodstream infections.

Hospital-acquired infections are believed to be one of the major health concerns affecting patient recovery, which has a major impact on mortality rates globally. According to the practical guide published by the WHO on the prevention of HAIs, the increase in the duration of hospitalization of persons suffering from HAIs was found to be approximately 8 days. Thus, prolonged stays are a significant contributor to the overall costs incurred during hospitalization, thus raising clinical urgency to adopt measures for the prevention of infections. Prolonged hospital stays are also not economical for hospitals and healthcare payers due to excessive usage of resources to treat the acquired infections.

These additional costs are mostly a result of increased usage of drugs, additional diagnostic studies, and laboratory equipment, thus creating an imbalance in resource allocation. High risk of infection from bloodborne pathogens, drug-resistant pathogens, and other infectious agents in operating rooms is one of the major concerns for hospitals. For instance, frequent usage of urinary catheters creates a high risk of UTIs and may result in Catheter-Associated (CA) UTIs. According to research published in NCBI, UTIs account for 25% of all bacterial infections. As per the National Nosocomial Infection Surveillance (NNIS) system report, most hospital-acquired UTIs are associated with catheterization, and CA-bacteriuria is the most frequently occurring infection globally, accounting for up to 40% of HAIs in the U.S. each year.

Diabetic patients often develop severe UTIs requiring efficient as well as consistent treatment regimens, thus widening the future growth prospects of the infection control market. These factors exemplify the high clinical urgency to prevent surgical site infection and adopt Personal Protective Equipment (PPE), such as surgical gloves, resulting in a significant increase in the growth of the medical device cleaning market.

Moreover, the rise in the prevalence of surgical site infections is anticipated to boost the market growth. It has been observed that consistent implementation of infection control and prevention measures has resulted in a significant decline in the number of HAI cases, and the scenario is likely to improve over the coming years if these measures are implemented at the same pace. As per the National and State Healthcare-Associated Infections Progress Report (CDC) published in 2016, there has been a significant decrease in central line-associated bloodstream infections between 2008 and 2016. In addition, it was observed that there has been a 17.00% decline in surgical site infections

Device Insights

The semi-critical segment held the largest revenue share of 46.07% in 2020. Semi-critical devices include those that are exposed to the mucus membranes, such as dental equipment, endoscopes, and other surgical instruments. These equipment are required to be sterilized before use, mostly using heat or chemical methods as the frequency of sterilization required is high. When these types of sterilization methods cannot be employed, disinfectants approved by and registered with the U.S. Environmental Protection Agency (EPA) are used. These disinfectants include peracetic acid, ortho-phthalaldehyde, glutaraldehyde, and hydrogen peroxide.

The critical segment is anticipated to witness the fastest growth rate over the forecast period. This category includes devices that penetrate body tissues. These equipment are sterilized before packaging and the majority of them are single-use products. Heat sterilization and Ethylene Oxide (EtO) are the most widely used methods in hospital settings. Most of the commercially available single-use surgical equipment are sterilized by the radiation method. However, the process is not performed within hospital settings and thus has not been considered in the scope of this report. Similar to semi-critical devices, the increase in adoption of single-use products has reduced the need for cleaning, disinfecting, and sterilizing critical devices, which is anticipated to hinder the market growth.

Technique Insights

The disinfection segment held the largest revenue share of 52.47% in 2020. Disinfection is an important step in reprocessing of semi-critical and critical medical devices. The disinfectants used in this stage are generally categorized as bactericidal, fungicidal, and virucidal. The selection of these materials generally depends on the type of medical equipment. However, the selection of such materials for the processing of devices, such as endoscopes, is difficult. Disinfectants in combination with detergents are also considered in this segment. The sterilization segment is anticipated to witness the fastest growth rate over the forecast period.

Sterilization includes the removal of any microorganism present on medical equipment. Steam and EtO sterilization are the most commonly employed sterilization methods in hospital settings. The introduction of surgical devices made of materials other than stainless steel has led to the need for finding alternatives for heat sterilization. Trends of forming a central sterile services department (Sterile Processing Department) is increasing the demand for advanced sterilization equipment to optimize the time and money required in the process.

EPA Classification Insights

The intermediate level segment held the largest share of over 50% in 2020. Intermediate level disinfectants are the chemical agents that are tuberculocidal and kill the disease-producing microbes. Some of the most common types of intermediate-level disinfectants are water-based phenolics, quat and alcohol blends, bleach, and hydrogen peroxide blends. The increasing prevalence of HAIs and the spread of infectious diseases are contributing to the segment growth.

The high level segment is expected to register the fastest CAGR during the forecast period. High-level disinfection refers to the treatment of dental instruments and medical equipment for inhibiting the microorganisms. It includes the reprocessing of the heat-sensitive semi-critical medical equipment and dental instruments. Some of the most commonly used high-level disinfectants are glutaraldehydes, special hydrogen peroxide, and special peracetic acid products.

Regional Insights

North America dominated the market and accounted for over 33.73% share of the global revenue in 2020. A consistent number of strategic collaborations adopted by the key market players to widen their product portfolio and infection control capabilities are expected to be responsible for the greater share captured by the region. In addition, favorable reimbursement policies and stringent government regulations regarding the disinfection and cleaning of medical equipment are expected to fuel the regional market over the forecast period.

Asia Pacific is expected to be the fastest-growing regional market during the forecast period owing to the strong presence of outsourcing organizations, increasing healthcare expenditure, and unprecedented evolution of the healthcare standards and infrastructure across the region. In addition, the outbreak of Covid-19 and the spread of infectious disease are further fueling the market growth in this region. The presence of various voluntary and government organizations focused on improving infection control standards is also one of the major factors contributing to the market growth.

Key Companies & Market Share Insights

Major companies are focusing on R&D to develop technologically advanced products to gain a competitive edge. For instance, in April 2020, the U.S. FDA approved the use of Steris V-PRO 1 Plus, maX2, & maX low-temperature sterilization systems for decontamination of around 750,000 N95 respirators and similar masks each day in hospitals used for treating Covid-19 patients. This may increase the goodwill of the company.

Companies are also engaging in partnerships, mergers, and acquisitions, aiming to strengthen their product portfolio, manufacturing capacities, and provide competitive differentiation. For instance, in April 2019, Fortive completed the acquisition of the Advanced Sterilization Products business segment from Johnson & Johnson, which also includes the STERRAD Sterilization System. Thus, infection prevention-related product portfolio would be marketed under Fortive. This initiative is anticipated to boost the growth of the company. Some prominent players in the global medical device cleaning market include:

• Steris plc.

• GetingeAB

• Advanced Sterilization Products

• The Ruhof Corp.

• Sklar Surgical Instruments

• Sterigenics International LLC

• Biotrol

• Metrex Research, LLC

• Oro Clean Chemie AG

• Cantel Medical Corp. 

Medical Device Cleaning Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global medical device cleaning market report on the basis of device, technique, EPA classification, and region:

• Device Outlook (Revenue, USD Million, 2016 - 2028)

  • Non-critical

  • Semi-critical

  • Critical

• Technique Outlook (Revenue, USD Million, 2016 - 2028)

  • Cleaning

    • Detergents

    • Buffers

    • Chelators

    • Enzymes

    • Others

  • Disinfection

    • Chemical

      • Alcohol

      • Chlorine & Chorine Compounds

      • Aldehydes

      • Phenolics

    • Metal

    • Ultraviolet

    • Others

  • Sterilization

    • Heat Sterilization

    • Ethylene Dioxide (ETO) Sterilization

    • Radiation Sterilization

• EPA Classification Outlook (Revenue, USD Million, 2016 - 2028)

  • High Level

  • Intermediate Level

  • Low Level

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • Greece

    • Denmark

    • Spain

    • Norway

    • Belgium

    • Austria

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • Australia

    • Singapore

    • Malaysia

    • Indonesia

    • Philippines

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • UAE

    • Saudi Arabia

    • South Africa

    • Qatar

    • Kuwait