Terminal Sterilization Services Market

Market Overview

The global terminal sterilization services market was valued at USD 9 billion in 2021 and is estimated to reach an expected value of 22 billion by 2030 at a CAGR of 10.5% during the forecast period (2022-2030).

Terminal sterilization is the method of sterilizing a product in its final container. It is an essential procedure because it assures that the product remains sterile. All parenteral, ophthalmic, and medical equipment is usually sterilized using heat in batches. An alternative method, such as filtration, is used, which reduces the risk of a product becoming contaminated because the heat may cause damage to the products. The increasing prominence of chronic diseases like diabetes and cancer, the increasing prevalence of hospital-acquired infections, and new product launches by the key market players are factors driving the terminal sterilization services market growth.

Market Dynamics

Global Terminal Sterilization Services Market Drivers

Increasing Prevalence of Hospital-Acquired Infections

Hospital-acquired Infections (HAIs) are a significant concern for patients and healthcare professionals globally. With a worldwide increase in hospitalizations and HAIs, the demand for sterilization of medical equipment is rising as it can help minimize the risk of microbial contamination. HAIs primarily occur in patients receiving long-term treatment, mainly surgical treatment. They can occur in hospitals, clinics, surgical centers, ambulatory surgery centers, and long-term care facilities such as rehabilitation centers & nursing homes. Generally, the senior population, children, and patients with low immunity are susceptible to HAIs. Various factors, such as lack of appropriate hygiene in healthcare settings, use of catheters, and excessive use of antibiotics, can increase predisposition to HAIs. According to the WHO Fact Sheet, hundreds of millions of patients are affected by HAIs globally each year. Out of every 100 hospitalized patients, 7 in developed and 10 in developing economies acquire at least one HAI. Thus, the increasing incidence of HAIs is expected to fuel the demand for advanced sterilization techniques to limit disease transmission.

A growing number of surgical procedures in hospitals and increasing awareness about infections & diseases caused due to nonsterile environments are factors expected to propel the market over the forecast period further. According to a CDC report in 2018, around 1.7 million HAI cases and around 99,000 associated deaths are reported yearly in U.S. hospitals. This has led to an economic burden for the U.S., as high as USD 45 billion per year. Similarly, per a report published by European Centre for Disease Prevention and Control (ECDC), in 2018, the prevalence of HAIs in European countries was around 7.1%, and about 4,131,000 patients suffer from HAIs every year. Such a high prevalence of infections is expected to increase the demand for sterilizing medical instruments and devices to avoid the possibility of disease transmission between patients and hospital staff.

Increase in Prevalence of Chronic Diseases

An increase in chronic diseases, such as cancer, diabetes, cardiovascular illness, and other autoimmune diseases, is anticipated to boost the demand for terminal sterilization equipment in healthcare facilities. Increased adoption of unhealthy & sedentary lifestyles, smoking & alcohol consumption, and antimicrobial resistance are some significant factors contributing to the growing prevalence of chronic diseases. According to the IDF Diabetes Statistic Report 2019, approximately 463 million adults (aged 20-79 years) were living with diabetes globally, and by 2045, this is expected to increase to 700 million. In addition, cancer has been a global healthcare burden.

According to estimates by WHO, cancer is the leading cause of death globally; nearly 1 in 6 deaths can be attributed to this ailment. It was also reported that more than 70% of cancer-related fatalities occur in middle- and low-income countries. The increasing prevalence of chronic conditions has significantly boosted the hospital admission rate. Blankets, sterile fluids, and surgical instruments are some of the essential requirements in hospitals & clinics. In such cases, terminal sterilization techniques can efficiently serve the purpose, as they can help reduce the risk of infection transmission among patients & improve care delivery. Thus, the increasing prevalence of chronic diseases is expected to impact the market during the forecast period positively.

Global Terminal Sterilization Services Market Restraint

Paradigm Shift From Reusable Medical Devices To Disposable Medical Devices

The trend of using disposable medical devices has increased in hospitals to minimize the spread of infections. These devices are cost-effective, which may decrease the usage of sterilization equipment in the long run. The availability of affordable disposable devices that are cheaper and easier to manage than the cost incurred in sterilization and cleaning & preparing reusable devices may restrain the market growth. Moreover, used devices must go through an extensive reprocessing cycle to become fully sterile, resulting in extra administrative costs in the delivery of patient care. The growing use of disposable devices to reduce HAIs and increase cost-effectiveness may decrease the usage of sterilization equipment in the long run. These factors may restrain the market during the forecast period.

Global Terminal Sterilization Services Market Opportunities

Increasing Application of Terminal Sterilization in the Pharmaceutical and Biotechnology Industry

An increase in R&D activities can propel the demand for various sterilization processes in the pharmaceutical and biotechnology industry. Sterilization of pharmaceutical manufacturing equipment and packaging is essential to kill all forms of microbial life. Terminal sterilization is tailored to pharmaceutical requirements & it is currently the most commonly used method for sterilization in these industries.

Furthermore, heat sterilization is performed to ensure products remain sterile, which is the process of sterilizing a product in its final container. For instance, Tuttnauer is involved in manufacturing custom-built pharmaceutical autoclaves that can meet the requirements of pharmaceutical companies. Such pharmaceutical autoclaves have typical applications, such as sterilization of sealed liquid, sealed ampoules/vials, sealed IV bags/bottles, prefilled syringes, and sealed contact lenses. These factors are anticipated to increase the application of sterilization equipment, thus fueling the market during the forecast period.

Regional Analysis

By region, the global terminal sterilization services market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East & Africa.

North America accounted for the largest market share and is estimated to grow at a CAGR of 10.4% during the forecast period. North America dominated the terminal sterilization services market with the largest share owing to government initiatives and increasing surgeries. Furthermore, the increase in chronic disease prevalence and disposable income contribute to the terminal sterilization services market growth in the region. The growing incidence of HAIs and the increasing number of surgeries are anticipated to boost the demand for terminal sterilization services in the U.S. For instance, as per Healthcare Information and Management Systems Society, each day, 1 out of 25 patients in the U.S. is affected by HAIs. Proper and regular usage of antiseptics, disinfectants, terminal sterilization of devices, and surgical equipment in hospitals & clinics generally helps prevent such infections, as these steps reduce or kill harmful microbes & bacteria, creating an aseptic environment. Thus, the increasing prevalence of HAIs is expected to boost the demand for terminal sterilization. In addition, the rising number of surgeries in the U.S. is expected to boost the market, as terminal sterilization plays an essential role in reprocessing surgical units. For instance, per the American Society for Aesthetic Plastic Surgery, surgical procedures accounted for 77% of total expenditure in 2017 in the U.S. These factors are expected to impact the market over the forecast period positively.

The Europe terminal sterilization services market is the second largest and is estimated to reach an expected value of USD 5470 million at a CAGR of 10.5% during the forecast period. A growing number of surgeries and increasing incidence of HAIs are expected to fuel the market over the forecast period. For instance, as per ECDC estimates, around 3.1-4.6 million people acquire HAIs in Europe every year. Major market players are undertaking various initiatives for the sterilization of equipment & medical devices, and recommendations by doctors for using such solutions are also anticipated to propel the market. In addition, the increasing number of surgical procedures being performed is likely to impact the market growth positively, as usage of terminal sterilization is necessary for reprocessing the surgical devices & equipment before surgeries. Furthermore, the COVID-19 pandemic has increased the regional demand for terminal sterilization services.

Asia Pacific exhibited the highest CAGR during the forecast period due to the increased number of hospitals and healthcare spending. The increasing incidence of HAIs and chronic diseases is a significant factor driving the market over the forecast period. In addition, growing awareness about new technologies for sterilizing medical devices, equipment, and other products will likely impact the market positively. Furthermore, major players are undertaking efforts to enter untapped markets in the Asia Pacific, thereby expanding the market scope.

Segmental Analysis

The global terminal sterilization services market is segmented by product, end-user, and region.

Based on product, the global market has been segmented into ethylene oxide, irradiation, moist heat terminal sterilization, and others. Among these, the ethylene oxide segment accounted for the largest market share and is estimated to grow at a CAGR of 10.5% during the forecast period. This sterilization technique is used as an alternative to steam/dry heat for sterilizing moisture-intolerant or heat-sensitive surgical equipment & supplies in healthcare facilities. Items and devices, such as electrical devices, plastics wares, & corrosion-susceptible instruments that cannot endure extreme temperature and humidity, can be treated by this technique, as this technique is compatible with most medical devices and materials. Therefore, the increasing need for sterilization of heat- and moisture-sensitive medical equipment with complex designs is propelling the need for ETO sterilization, contributing to the growth of this segment over the forecast period.

The moist heat terminal sterilization segment is expected to grow at the highest CAGR during the forecast period. Steam/moist heat sterilization is carried out in an autoclave that produces pressurized steam. The intense heat causes coagulation & hydrolysis of proteins, killing microbes, viruses, and spores. Autoclaves usually expose the product to steam at a temperature of 121–134°C (250–273°F) for 15–30 minutes. As the pressure and temperature increase, the time required to sterilize items reduces. This method is widely used in heat sterilization to achieve sterility of medical equipment and devices. It does not involve toxic fumes or liquids, and it is quick & effective in killing & eliminating infectious bacteria, viruses, & spores. Moist heat sterilization is widely used in all hospitals to disinfect medical equipment, such as surgical scalpels. Dentists frequently use this technique to sterilize dental equipment. Thus, the abovementioned factors are expected to boost the market over the forecast period.

Based on the end user, the global market is segmented into hospitals & clinics, pharma, and others. The hospitals and clinic segment accounted for the largest market share and is estimated to grow at a CAGR of 10.5% during the forecast period. Increases in R&D and the introduction of complex equipment & devices are boosting demand for sterilization procedures in pharmaceutical companies. Complex medical devices require effective sterilization techniques, as traditional methods might not assure complete sterility, propelling demand for advanced equipment. The increased need for sterilization of manufacturing equipment and packages has led to advancements in terminal sterilization techniques for pharmaceutical companies. In addition, FDA regulations and guidelines for pharmaceutical preparations are other significant factors boosting the adoption of advanced & effective sterilization methods, such as sterilization through X-rays & gamma rays. Moreover, the growing focus on developing vaccines to tackle the pandemic by pharma & biotech companies has increased the demand for sterilization equipment. These factors are responsible for the growth of this segment in the market.

The hospitals and clinics segment is expected to grow at the highest CAGR during the forecast period. The increasing burden of HAIs primarily boosts the demand for sterilization in hospitals and other healthcare settings. In addition, a growing number of surgical procedures and stringent safety guidelines for staff & patients in terms of medical waste disposal are likely to drive the adoption of sterilization in hospitals. Using suitable disinfectants and sterilization methods is essential, as they can help prevent the transmission of infections. In addition, a rise in healthcare expenditure in developing economies is likely to boost the number of hospitals, owing to which demand for sterilization services is expected to increase over the forecast period. For instance, according to WHO, in Brazil, total healthcare expenditure was 9.1% of its GDP in 2016. Furthermore, according to the World Bank estimates, in 2016, public & private healthcare spending accounted for 8.5% of the total GDP in Brazil. Such factors are expected to propel the segment over the forecast period.

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