The global sterilization equipment market was valued at USD 9.00 billion in 2022. It is estimated to reach USD 19.80 billion by 2031, growing at a CAGR of 9.15% during the forecast period (2023–2031).
Sterilization equipment or sterilizers are used to reduce microbial contamination or the presence of pathogenic products in medicinal preparations and on the surfaces of medical devices and instruments. A suitable sterilizer removes or kills all living things and other biological agents that can survive high temperatures. A sterile processing environment is a prerequisite in microbiology and medical laboratories. As a result, effective sterilization methods for laboratories, such as autoclaving (wet heat), flaming and baking (dry heat), filtration, radiation, and gas sterilization, are essential in these settings.
Steam (pressure), dry heat, EO gas, hydrogen peroxide gas plasma, and liquid chemicals are the principal sterilizing agents used in healthcare and research facilities to ensure absolute sterility. Thus, sterilizers are essential for making and keeping an environment clean and safe from microorganisms. Furthermore, the sterilization process in the food and beverage industry entails heat treatments for canned foods to eliminate pathogenic (disease-producing) microorganisms.
|Market Size||USD 19.80 billion by 2031|
|Fastest Growing Market||Europe|
|Largest Market||North Amrica|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
Polylactic acid (PLA) is a promising alternative to traditional biomaterials and non-biodegradable polymers. It offers rapid clinical transmission and is already accepted by the Food and Drug Administration (FDA) in almost all medical disciplines. PLA can be used quickly in clinical settings, and the Food and Drug Administration (FDA) has already approved it for use in almost all medical fields. Due to PLA's suitability for use in cutting-edge technologies like 3D printing, interest in medical devices based on this material has recently increased dramatically. Although there have been significant advances in biomaterials in recent years, there have also been a few changes in sterilization techniques.
Traditional sterilizing methods are limited because they change polymers' shape, structure, and surface properties. Thus, new methods of sterilizing polymeric materials without damaging their structure have been the focus of scientific inquiry for the past few years. Sterilization using supercritical carbon dioxide (scCO2) has emerged as a green and sustainable technology that can reach a very low Sterility Assurance Level (SAL) without altering the original properties. Using scCO2 technology (along with peracetic acid as an additive) to sterilize different allograft tissues has been done successfully in the marketplace. Such advancements in the sterilization method are expected to boost market growth.
Several companies that make medical devices and provide sterilization services have worked together to reduce or get rid of emissions from ethylene oxide (EtO) sterilization. Some promising alternatives to the EtO sterilization method are supercritical carbon dioxide (scCO2) sterilization, nitrogen dioxide sterilization, accelerator-based radiation sterilization, vaporized hydrogen peroxide sterilization, and vaporized hydrogen peroxide-ozone sterilization. The US Food and Drug Administration (FDA) recognized these secure and reliable sterilization techniques as potential substitutions for ethylene oxide (EtO) sterilization for packaged medical devices, fueling market expansion.
Ethylene oxide is considered one of the most hazardous air pollutants. It gets into the air and causes cancer and other serious health problems, like problems with reproduction or congenital disabilities. In 1948, a study found that EtO is a mutagen that can potentially alter the genetic material in cells and make them cancerous. In 2001, the US Environmental Protection Agency (EPA) made a controversial move that allowed companies to disconnect emission controls from their exhaust outlets after explosions at several facilities. A few years after these incidents, the National Institute for Occupational Safety and Health (NIOSH) reported that EtO was found to cause breast cancer and lymphoma. In 2006, the EPA released a scientific report summarizing its findings on the dangers of using EtO and its conclusion that it is a human carcinogen. Several facilities discontinued the use of this sterilization method. Such restrictions due to adverse health effects hamper the market’s growth.
Nitrogen dioxide (NO2) is a fast and effective sterilant, as demonstrated by many microorganisms. For most medical devices, exposure to a NO2 sterilizer for 20–40 minutes can achieve a sterility assurance level (SAL) of 106. For example, Noxilizer has made a way to sterilize medical devices with nitrogen dioxide (NO2) gas that works at room temperature. Currently, medical device manufacturers are provided with industrial sterilizers and contracted sterility services that use NO2 gas for terminal sterilization in the manufacturing process. Therefore, designers of disposable implantable devices and, in the future, reusable devices that will be sterilized in hospitals with NO2 gas sterilizers are more aware of this technology.
NO2 sterilization is consistent with many common syringe materials, such as glass, cyclic olefins, polypropylene, silicones, most rubbers, and thermoplastic elastomers. NO2 can be used to sterilize parts of a syringe after they are made and to clean syringe tabs before they go into the filling line. Furthermore, the advantage of NO2 sterilization for in-house sterilization is that it eliminates the carrying and storage costs associated with contract sterilization. Thus, the increasing adoption of sterilization using NO2 propels market growth.
By region, the global sterilization equipment market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant shareholder in the global market of sterilization equipment and is anticipated to grow at a CAGR of 8.37% during the forecast period. Factors such as a large patient population, high use of ethylene oxide sterilization, stringent government regulations, and the adoption of advanced technologies have contributed to the North American sterilization equipment market growth. The considerable rise in the incidence of HAIs and the necessity to prevent them with the routine use of advanced technologies will drive market growth during the forecast period. In addition, the adoption of advanced sterilization products, such as sound-based sterilization, is high across North America. Furthermore, various regulatory bodies in the region actively monitor sterilization methods in healthcare settings, a significant driver for advanced sterilization methods in the market.
Europe is expected to grow at a CAGR of 9.37% over the forecast period. The presence of prominent market players, better preventive measures/practices, and high expenditure on healthcare are the primary growth drivers for the regional market. Europe has some of the strictest environmental laws worldwide. In response to environmental problems, the European Union's (EU) environmental standards have changed over time and become stricter. Countries like Germany, France, and the UK have passed laws to reduce the amount of ethylene oxide that goes into the air. There is a high demand for alternatives to ethylene oxide (EO) sterilizers in the region. Furthermore, large hospitals in the market are increasingly outsourcing their sterilization processes, which is expected to result in a considerable surge in the presence of sterilization service providers. These sterilization service providers mainly invest in advanced equipment to provide better customer service.
In Asia-Pacific, countries such as China, Japan, India, South Korea, and Australia are major revenue contributors to the Asia-Pacific sterilization equipment market size. Factors such as the surge in the adoption of antimicrobial drugs/antibiotics and the inadequate/inappropriate sterilization of medical devices, ICUs, and drainage tubes are expected to drive market growth. Furthermore, the expanding geriatric population in the region will propel the market growth during the forecast period. Countries such as India are emerging as the best destinations for medical tourism, as most hospitals in Asia-Pacific strictly follow sterilization methods. Thus, all these factors are expected to drive market growth during the forecast period.
The sterilization equipment market share in Latin America generates the most revenue in Brazil, Mexico, and Argentina. The Middle East and Africa accounted for a revenue share of 4.00% in the global market. Factors such as the presence of a large, undertreated patient population, the surge in awareness of advanced management procedures, and noncompliance with regulatory guidelines across Latin America and the Middle East and Africa are expected to drive the growth of these regional markets.
The global sterilization equipment market is segmented by product type, sterilization method, and end-users.
By product type, the global market is divided into equipment and consumables.
The equipment segment is the highest contributor to the market and is anticipated to grow at a CAGR of 9.25% over the forecast period. Sterilization tools are crucial to modern medical care because most patients require surgical instruments, syringes, and bandages. Medical devices must be used safely to keep patients, doctors, and the environment healthy. Thus, medical devices must be routinely sterilized and disinfected between patients. This vital equipment must be cleaned thoroughly and effectively if patient-to-patient disease transmissions are to be avoided. The demand for sterilization equipment will increase with the increase in surgical procedures.
Consumables include a predominant range of products to ensure sterile processing in a safe and closed cycle. The consumables used in the market include sterilization indicators, pouches, lubricants, and accessories. Sterilization indicators are helpful tools that help in routine monitoring, load monitoring, and qualification of the steam sterilization procedure. Sterilization indicators show whether the conditions in the sterilization process were sufficient to achieve a specific state of microbial inactivation. The sterilization pouch is a disposable, peel-open pouch designed to hold items during sterilization. Sterilized pouches are recommended for small, lightweight, and thin items. In the medical field, a sterilization lubricant keeps the moving parts of dental, medical, or surgical instruments from sticking.
By sterilization method, the global market is divided into chemical sterilization, radiation sterilization, thermal sterilization, and other methods.
Chemical sterilization owns the highest market share and is anticipated to expand at a CAGR of 8.80% over the forecast period. Chemical sterilizers are substances that are characterized by their bactericidal properties. Several new ways to sterilize things are being made and studied, like using supercritical carbon dioxide and nitrogen dioxide. Instruments used in hospitals and labs must be heated or treated with chemicals to be sterilized. Chemical sterilization can get the job done without heating. However, because some components can react violently with chemicals, not all instruments and devices can be sterilized using chemical methods. Chemical sterilization is emerging as the most highly recommended method of sterilization. Many hospitals and labs are starting to use fewer instruments and devices that only need to be used once and then thrown away.
Radiation sterilization is done with the help of ionizing radiation. Ionizing radiation has the energy to break molecular bonds and ionize atoms. The ionizing radiation changes the physical, chemical, and biological characteristics of the material exposed to it. The sterilization of pharmaceuticals used in healthcare, as well as the irradiation of food and agricultural products with a variety of end goals, including disinfection, shelf-life extension, germination inhibition, pest control, sterilization, and material modification, are currently the leading industrial uses of radiation (chain scission and polymer cross-linking). UV, X-rays, and gamma rays are different types of electromagnetic radiation that have incredibly damaging effects on DNA, making sterilization an excellent tool. The main difference between them in terms of their effectiveness is their penetration.
By end-users, the global market is divided into hospitals, pharmaceutical and biotechnology companies, medical devices companies, laboratories, food and beverage companies, and others.
The hospital segment is the highest contributor to the market and is anticipated to grow at a CAGR of 7.35% over the forecast period. In order to prevent the spread of pathogens, hospitals and clinics constantly use disinfectants and sterilants due to the high number of patients with both short- and long-term illnesses. For example, the rise in HAIs among patients and medical staff in hospitals and clinics has been caused partly by hospitals and clinics that do not follow standard infection control guidelines to keep the environment clean and free of pathogens. The reuse of disposable medical equipment and the disregard for infection control standards displayed by hospitals and clinics are two additional factors contributing to the rise in HAIs. Therefore, all of these factors drive the demand for HAI control products like sterilization equipment to stop the spread of infections.
In the pharmaceutical and biotechnology industries, different ways are used to sterilize equipment, materials, and products with different chemical and physical properties. Currently, sterilization processes in industrial practice include thermal, radiation, chemical, and sterile filtration processes. In pharmaceutical and biotechnology companies, thermal sterilization is the most commonly used method. Radiation in industrial sterilization processes utilizes electron beams, gamma rays, or X-rays. Chemical sterilization is usually used for things that cannot be sterilized any other way. The depth and microbial filters are used as prefilters in sterile filtration processes to eliminate high-particle and microbial contaminants in the fluid.
The global sterilization equipment market’s major key players are