Increase in Number of Hospital-acquired Infections to Augment Market
Within the healthcare sector, reprocessing of ‘single-use’ devices has become mainstream across hospitals and clinics as a measure to reduce costs. However, while reprocessing enables healthcare providers to reduce costs, there is a downside to it– the risk of cross-contamination and pathogen infection. The number of hospital-acquired infections (HAI) has increased at a steady pace across the global healthcare sector and thus, medical device cleaning processes have garnered significant attention from regulatory bodies. At present, medical device manufacturers are increasingly focusing on providing robust guidelines and manuals that offer insights regarding sterilization, disinfection, and cleaning of ‘single-use’ medical devices. Thus, medical device cleaning validations have become an integral part of the reprocessing validation cycle. Moreover, it also assures that medical devices can be cleaned and sterilized by adhering to the medical device manufacturer’s instruction for use (IFU).
While the prevalence of hospital acquired infections continues to grow across ambulatory clinics, surgical centers, hospitals, etc., the medical device cleaning market has also gained notable momentum. In the current scenario, in the U.S., guidelines provided by The American Society of Testing and Materials (ASTM) related to medical device cleaning are applicable, which predominantly focus on equipment design, documentation, sampling, analytical techniques, procedures, etc. Owing to these developments in the healthcare sector concerning medical device cleaning, the medical device cleaning market is projected to reach a value of ~US$ 3.2 Bn by the end of 2020.
Automatic Cleaning Process Gains Popularity
Scientific advancements in therapeutic and diagnostic medicine have triggered the production of cutting-edge reusable medical devices. However, due to the risk of cross-contamination and a range of other infections, medical device manufacturers have the responsibility to validate their product label claims as far as reusability is concerned. Label guidelines require approval from the Food and Drug Association (FDA) to ensure the overall efficacy and safety of the provided guidelines. The efficacy of the guidelines primarily depends on the markers utilized to soil the devices prior to cleaning. Some of the most commonly used markers include hemoglobin and protein.
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Medical device cleaning techniques have evolved over the years and are one of the most critical stages in the reprocessing of reusable medical devices. Cleaning techniques are primarily segregated into manual and automatic processes. Manual medical device cleaning processes are largely deployed to clean highly complex and delicate medical devices, such as lensed instruments, microsurgical devices, and flexible endoscopes among others. Automated cleaning techniques are predominantly used when other cleaning techniques prove to be ineffective, to prevent soiling of crevices, joints, lumens, and other parts of a medical device. Within the medical device cleaning market, the automatic cleaning process segment is estimated to reach a value of ~US$ 2 Bn and account for ~63% share of the medical device cleaning market by the end of 2020. The automatic cleaning process segment is also projected to expand at a higher CAGR than manual cleaning process segment during the forecast period (2019-2027).
Focus on Guide Approvals and Product Launches Gain Momentum in Medical Device Cleaning Market
The American Society of Testing and Material is an important regulatory body that is responsible for the approval of new standards for medical device cleaning. Testing laboratories, regulatory agencies, and medical device manufacturers are required to comply with these standards. In the medical device cleaning market, attaining approval from the ASTM for new standards has gained significant momentum in recent times. For instance, in November 2019, the ASTM approved a list of new standards wherein the effectiveness of new medical device cleaning procedures is thoroughly evaluated. Additionally, the newly curated guide will largely focus on the extraction process of test soils to verify new cleaning methods. According to a member of the ATSM, approval of new standards is a crucial step in the overall process of validating cleaning instructions.
Stakeholders in the medical device cleaning market are also focusing their efforts on the launch of new medical device cleaning products. For instance, in April 2019, DuPont launched a medical device cleaning bio-based enzyme – OPTIMASE. The product, which is part of the company’s new product range is primarily developed to provide optimum cleaning efficiency in medical devices.
The medical device cleaning market is estimated to grow at a CAGR of 5.2% during the forecast period. A significant rise in the number of hospital-acquired infections is a leading factor that has increased brought medical device cleaning at the forefront in the past couple of decades. Moreover, as medical device manufacturers are required to provide guidelines and standards for cleaning, sterilization, etc., the market for medical device cleaning is expected to witness significant growth in the coming years. Automatic cleaning processes will remain popular during the forecast period despite steady adoption of manual cleaning processes. Product launches and mergers & acquisitions are likely to become common in the medical device cleaning market landscape.
Medical Device Cleaning Market: Overview
The global medical device cleaning market for the historical period 2017–2018 and forecast period from 2019 to 2027, a surge in the number of surgeries is projected to be a major driver of the global medical device cleaning market during the forecast period
The global medical device cleaning market was valued at US$ 2.8 Bn in 2018. It is expected to expand at a CAGR of 5.2% from 2019 to 2027.
This report analyzes the current and future scenario of the global medical device cleaning market
The global medical device cleaning market report comprises an elaborate executive summary, which includes a snapshot that provides information about various segments of the market. It also provides information and data analysis of the global medical device cleaning market with respect to the segments based on product, process, application and region.
A detailed qualitative analysis of drivers, restraints, and opportunities of the global medical device cleaning market has been provided in the overview section. Additionally, the section comprises competitive matrix and company profiles along with business overview to understand the competitive landscape in the global medical device cleaning market.
This section of the report also provides market attractiveness analysis by region and market share analysis by key players, thereby presenting a thorough analysis of the overall competitive scenario in the global medical device cleaning market
Medical Device Cleaning Market: Key Drivers
Surge in number of surgeries
According to the latest data from the Centers for Disease Control and Prevention, around 51 million inpatient surgical procedures were performed in the U.S., alone, in 2017, followed closely by outpatient surgeries
According to the annual plastic surgery procedural statistics, 17.5 million surgical and minimally invasive cosmetic procedures were performed in the U.S. in 2017, a 2% increase over that in 2016
Minimally invasive cosmetic procedures increased at a slightly higher rate than surgical procedures in 2017
Increase in the number of surgeries, globally, is anticipated to boost the demand for medical devices cleaning agents, such as detergents and disinfectants, during the forecast period, as various chemical disinfectants such as aldehydes, hydrogen peroxide, alcohol, chlorine-based disinfectants, peracetic acid, and quaternary ammonium compounds are used extensively in the disinfection of medical devices.
Increase in incidence of hospital-acquired/associated infections (HAI)
Healthcare-associated infections (also termed as nosocomial infections) are defined as infections (fungal and bacterial) that patients acquire during the course of their stay in hospitals
Hospital-acquired infection (HAIs) is a significant cause of mortality across the world. According to the U.S. Department of Health and Human Services, one in every 20 infections is HAI in the U.S.
Post-operative sepsis, catheter-associated urinary tract infection, pneumonia, and blood stream infections are major types of HAIs in adults
According to a report published by WHO, of every 100 hospitalized patients at any given time, 7 in developed and 10 in developing countries will acquire at least one health care-associated infection
Increase in incidence of various HAIs is projected to propel the utilization of medical device cleaning and disinfection agents across the globe
Medical Device Cleaning Market: Key Segments
In terms of product, the global medical device cleaning market has been categorized into chemicals and detergents. Furthermore, the chemicals segment has been sub-segmented into aldehydes, hydrogen peroxide, alcohol, chlorine based disinfectant, peracetic acid, quaternary ammonium compounds, and others.
In terms of process, the global market for medical device cleaning has been classified into manual cleaning and automatic cleaning
Based on application, the global market for medical devices cleaning has been split into surgical instruments, ultrasound probes, endoscopes, and others.
The market size and forecast for each of the segments have been provided in terms of US$ Mn from 2017 to 2027, along with their respective CAGRs for the forecast period from 2019 to 2027, considering 2018 as the base year
Medical Device Cleaning Market: Regional Outlook
In terms of geography, the global medical device cleaning market has been segmented into four major regions: North America (the U.S. and Canada), Europe (the U.K., Germany, France, Spain, Italy, and Rest of Europe), Japan, Rest of the world (India, China, Australia & New Zealand, Brazil, Rest of Latin America, and Middle East & Africa)
The market size and forecast for each of these regions and the mentioned countries/sub-regions have been provided for the period from 2017 to 2027, along with their respective CAGRs for the forecast period from 2019 to 2027, considering 2018 as the base year. The research study also covers the competitive scenario in these regions.
Companies Mentioned in Report
The report also profiles following mentioned major players in the global medical device cleaning market based on various attributes such as company overview, financial overview, treatment types, business strategies, and recent developments. Key companies include:
Key Questions Answered in Medical Device Cleaning Market Report
Medical Device Cleaning Market – Segmentation