High-Level Disinfection Services Market Size, Share & Trends Analysis Report By Services (In-house, Outsource), By Compound (Formaldehyde, Glutaraldehyde, Peracetic Acid, Hydrogen Peroxide, Ortho-phthalaldehyde, Others), By End-User (Hospitals and Clinics, Diagnostic Laboratories, Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global high-level disinfection services market size was valued at USD 28.05 billion in 2022. It is estimated to reach USD 58.26 billion by 2031, growing at a CAGR of 8.3% during the forecast period (2023–2031).

High-Level Disinfection (HLD) refers to treating medical devices and pathogenic surfaces to inhibit the most viable microorganisms. HLD is reprocessing semi-critical medical devices and dental items that are heat-sensitive or incompatible with conventional sterilizing techniques. Devices that contact intact mucous membranes or non-intact skin are called semi-critical devices. These devices typically do not pierce tissues or enter ordinarily sterile body regions.

Heat sterilization is recommended for critical and semi-critical items; however, if an item is not heat resistant and a single-use option is unavailable, HLD is an acceptable method. In the HLD process, devices undergo a scheduled liquid chemical procedure that includes a high-level disinfection treatment and a water rinse cycle to eliminate any remaining chemical residue. The aesthetics of transport and storage following a thorough rinsing are never to be overlooked.

Highlights

• Outsource dominate the services segment
• Glutaraldehyde dominates the compound segment
• Hospitals and clinics dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market drivers

Rising Prevalence of Hospital-Acquired Infections

Hospital-Acquired Infections (HAIs) are a major global concern for patients and healthcare professionals. With a worldwide increase in hospitalizations &and HAIs, the demand for sterilization of medical equipment and environmental surfaces is growing to minimize the risk of microbial contamination. HAIs primarily occur in patients receiving long-term treatment, mainly surgical treatment. Generally, the geriatric population, children, and patients with low immunity are susceptible to HAIs.

According to a WHO Fact Sheet, healthcare-Associated Infections (HCAIs) affect hundreds of millions of patients annually. Seven patients in affluent nations and ten in underdeveloped countries out of every 100 hospitalized patients have at least one HAI. Thus, increasing the incidence of these infections is expected to boost the demand for high-level disinfectant services in various healthcare facilities to limit the spread of infection.

Increasing Number of Surgical Procedures

The rising number of surgical procedures in hospitals and growing awareness regarding infections and diseases caused due to a nonsterile environment are among the factors expected to propel market development throughout the forecast period. Various factors, such as lack of appropriate hygiene in healthcare settings, usage of catheters, and excessive use of antibiotics, can increase predisposition to HAIs. According to a CDC report in 2018, around 1.7 million cases of HAIs and around 99,000 associated deaths are reported yearly in American hospitals. This may lead to an economic burden in the U.S. as high as USD 45 billion annually.

Additionally, the high prevalence of HAIs is anticipated to increase the need for disinfecting medical equipment and facilities to prevent the possibility of disease transmission from patient to patient and hospital staff. A high prevalence of HAIs can lead to surgical site infections, urinary tract infections (UTIs), hospital and ventilator-acquired pneumonia, clostridium difficile infections, and bloodstream infections. As a result, the market for high-level disinfection services is anticipated to experience significant growth to prevent such infections.

Market restraint

Stringent Regulations Pertaining to the Usage of Disinfectants

Regulations or guidelines for applying high-level disinfectants used in clinics and hospitals may hinder market growth over the forecast period. In the U.S., every disinfectant needs to meet certain FDA regulations, and their use should be based on guidelines by CDC. These guidelines recommend a preferred method for sterilization, disinfection, and cleaning patient-care medical devices and disinfecting and cleaning the healthcare environment.

As per the guidelines, chemical disinfectants for sterilizing patient care equipment include formaldehyde, ortho-phthalaldehyde, glutaraldehyde, hydrogen peroxide, quaternary ammonium compounds, chlorine, and alcohol. The use of any other disinfectant is strictly prohibited. Therefore, workers and surgeons need to be aware of regulatory policies. A lack of knowledge about such policies may decrease the use of approved or recommended disinfectants, hindering market growth over the forecast period.

Market opportunities

Extensive Research and Development Activities

Continuous R&D activities coupled with the launch of novel products by key players operating in the global market are creating tremendous opportunities for the market during the forecast period. For instance, in March 2020, LANXESS, a specialty chemicals company, launched the high-level disinfectant Rely+On Virkon, which is highly effective against coronavirus. Tests have confirmed that Rely+On Virkon inactivates a closely related substitute of the rapidly spreading coronavirus strain.

Furthermore, Solvay offers a peracetic acid-based liquid solution, PROXITANE, effective against fungus, bacteria, and viruses, including SAR-CoV-2, on clean and soiled surfaces. Similarly, in February 2020, 3M released a catalog of products that help stop the spread of the COVID-19 outbreak. It is working with federal, state, and local health agencies by providing a list of over 100 biocidal and ready-to-use products that effectively kill coronavirus. These products are authorized by the U.S. Environmental Protection Agency (EPA). Such products are anticipated to increase the demand for high-level disinfectant services globally, fueling market growth during the forecast period.

Regional Analysis

North america dominates the global market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global high-level disinfection services market shareholder and is estimated to exhibit a CAGR of 8.91% over the forecast period. North America's leading market share can be attributed to the COVID-19 pandemic, which significantly increased demand for high-level disinfectants. In 2020, the Environmental Protection Agency (EPA) released an updated list of EPA-registered disinfectant services authorized for use against SARS-CoV-2. The list included approximately 200 additional services and 40 new services. In addition, stringent regulatory policies regarding the delivery of safe and quality healthcare services, such as the presence of the Patient Protection and Affordable Care Act, mandate the use of high-level disinfection solutions and services in hospitals and clinics. These aspects are anticipated to fuel market growth over the forecast period.

Additionally, the increasing incidence of Hospital-acquired Infections (HAIs) and the rising number of surgeries are among the significant factors anticipated to propel the demand for HLD services. As per the Massachusetts Health & Hospital Association, Inc., in U.S. hospitals, the CDC predicted that HAIs constitute about 1.7 million infections and 99,000 related deaths yearly. Therefore, increasing in-patient hospital admissions due to HAIs contribute to regional market growth.

Europe is predicted to exhibit a CAGR of 8.9% over the forecast period. Europe's high-level disinfection services market is driven by the increasing prevalence of HAIs, rising incidence of chronic diseases, technological advancements, well-established healthcare infrastructure, and the strong presence of key market players. Moreover, the COVID-19 pandemic has mandated implementing preventative measures to minimize the spread of infection. Key players in the global market continually launch novel products and solutions to combat disease transmission. For instance, in April 2020, Solvay (Belgium) offered PROXITANE, a Peracetic Acid (PAA)-based liquid solution that is influential against a wide range of fungi, bacteria, and viruses, including SAR-CoV-2, on clean and unclean surfaces. As a result, the market for high-level disinfection services in Europe is expected to expand rapidly over the coming years.

Asia-Pacific comprises developing and rapidly emergent markets, such as Japan, China, Australia, and India. Its global market is expected to expand considerably because of the increasing need for controlling HAIs, growing demand for non-disposable medical devices, and rising awareness about hygiene in hospitals and clinics. Moreover, the growing incidence of chronic diseases, the rising number of surgeries, and the surging prevalence of SSIs and HAIs contribute to the demand for HLD services, leading to regional market growth. A significant upsurge in the elderly population, susceptible to severe HAIs, is expected to propel the regional market. According to UNFPA statistics, the number of elderly in Asia Pacific will triple, reaching 1.3 billion by 2050.

Latin America's high-level disinfection services market is anticipated to grow significantly during the forecast period. The presence of developing economies, like Brazil and Mexico, is expected to drive the overall Latin American market primarily. Increasing healthcare expenditure is providing ample growth opportunities to the players operating in the market. According to WHO's Global Health Expenditure Database 2018, Latin American and Caribbean healthcare spending was 7.97% of GDP. Thus, increasing healthcare spending and incremental acceptance of advanced healthcare facilities are expected to boost market growth.

The Middle East and Africa market is expected to grow considerably over the forecast period. The higher spending capacity of Middle Eastern nations, like the UAE and Saudi Arabia, is creating demand for HLD services. Factors that determine the expansion of the Middle East and Africa high-level disinfection services market are an increase in nosocomial infections and a rising need for improved hygiene practices under government guidelines. Moreover, increased government support for new disinfection techniques and increased expenditure on healthcare in this region is further driving market growth.

Segmental Analysis

The global market is bifurcated into services, compound, and end-user.

Based on services, the global market is segmented into in-house and outsourced. 

The outsourcing segment is the largest contributor to the market and is projected to grow at a CAGR of 9.2% over the forecast period. Key end-users such as hospitals, clinics, and diagnostics facilities prefer outsourcing high-level disinfection services. Outsourcing has several advantages, including cost savings, specialized cleaning services, and sophisticated technologies. Moreover, outsourced service providers are compliant and offer staff education. These services also eliminate additional expenses. In addition, outsourcing eradicates the necessity for recruiting, interviewing, hiring, training, and staffing. As global healthcare practices have advanced, hospitals have outsourced disinfection and sterilizing services. This has created growth opportunities for high-level disinfection equipment manufacturers.

The in-house segment is anticipated witness a sluggish growth rate over the forecast period. In-house disinfection enables total control over the movement of disinfection services and reduces extra handling costs associated with transporting loads to and from the facility. Furthermore, high-level disinfectants are costly, and most facilities that use in-house services might not even be able to afford them. In addition, the additional cost associated with storage cabinets and maintenance may restrict the adoption of advanced high-level disinfection systems and automated probe reprocessors among end users with limited budgets. Thus, overall in-house services are expensive as compared to outsourcing.

Based on the compound, the global market is segmented into formaldehyde, glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peracetic acid, and others. 

The glutaraldehyde segment is the highest contributor to the market and is projected to grow at a CAGR of 9.2% over the forecast period. Glutaraldehyde is a commonly used aldehyde for disinfecting surgical equipment. Its broad spectrum, covering sporicidal, virucidal, bactericidal, and fungicidal activity, makes it an ideal chemical compound for low-temperature disinfection and sterilization of critical and semi-critical equipment. The rising number of surgical procedures worldwide is also expected to boost the demand for these products. For instance, according to Plastic Surgery Statistics Report, in 2017, around 17.5 million cosmetic surgical procedures were performed in the U.S., accounting for an increase of nearly 2.0% from 2016. Furthermore, the increasing incidence of hospital-acquired infections due to improper reprocessing of surgical units is expected to propel the demand for these products, which is anticipated to result in lucrative segment growth over the forecast period.

Formaldehyde is used as a high-level disinfectant and sterilant and is primarily available as a water-based solution called formalin, which contains 37% formaldehyde by weight. Formaldehyde solutions destroy many microorganisms in the aqueous state and in combination with low-temperature steam. Traditionally, formaldehyde has been used to sterilize surgical instruments and hemodialyzers with alcohol. Currently, paraformaldehyde, a solid polymer of formaldehyde, is used with low-temperature steam to disinfect heat-sensitive medical equipment. Therefore, the rising incidence of hospital-acquired infections globally will likely impact segment growth positively.

Based on end-user, the global market is bifurcated into hospitals and clinics, diagnostic laboratories, pharmaceutical and biotechnology companies, academic and research institutes, and others. 

The hospitals and clinics segment dominates the global market and is predicted to exhibit a CAGR of 9.2% during the forecast period. The increasing prevalence of hospital-acquired infections leads to high demand for high-level disinfection services in hospitals and other healthcare settings. Moreover, the COVID-19 pandemic in numerous countries has led to a significant increase in the usage of high-level hospital disinfection services as part of broader virus-control measures. Furthermore, increased surgical procedures, stringent safety guidelines for staff and patients, and medical waste disposal drive hospitals' adoption of disinfection services.

In pharmaceutical companies, an increase in R&D and the introduction of complex equipment and devices are boosting demand for disinfection procedures. Complex medical devices require effective disinfection techniques, as existing traditional methods may not assure complete disinfection, which is expected to propel the demand for high-level disinfection services. The rise in the need for disinfection of manufacturing equipment and packages has led to advancements in disinfection techniques for pharmaceutical companies. Moreover, pharmaceutical and medical device manufacturing firms' rising adoption of bio-decontamination products and services to follow stringent regulations contributes to market growth.

Recent Developments

• June 2023- Infection prevention specialist Tristel received regulatory sanction in the United States to market its proprietary chlorine dioxide technology as a high-level disinfectant in non-invasive ultrasound scans, sending the stock up 15% to 416.8p.
• June 2023- Parker Laboratories Inc., a global leader in ultrasound supplies and accessories, announced that the US Food and Drug Administration (FDA) had approved Tristel ULT as a high-level disinfectant for ultrasound probes utilized within body cavities and skin-surface transducers.