Sterilization Equipment Market to be Worth $26.77 Billion by 2031--Exclusive Report by Meticulous Research®

REDDING, Calif., Oct. 23, 2024 /PRNewswire/ -- According to a new market research report, ' Sterilization Equipment Market Size, Share, Forecast, & Trends Analysis by Offering (Equipment [Heat {Moist (Gravity, High-speed), Dry (Static Air, Forced Air)}, Low-temperature {ETO, Formaldehyde}, Radiation, Filtration] Services—Global Forecast to 2031', published by Meticulous Research^®.

The sterilization equipment market is projected to reach $26.77 billion by 2031, at a CAGR of 8% from 2024 to 2031(View PDF Sample).

Sterilization equipment is a crucial component in the healthcare industry for preventing the spread of infectious diseases. These diseases are caused by pathogenic microorganisms, including bacteria, viruses, parasites, and fungi. They can be transmitted directly or indirectly—from person to person, through the use of infected or non-sterilized medical devices, or within contaminated healthcare environments. To mitigate the incidence of infectious diseases, healthcare facilities are increasingly implementing sterilization methods and programs, enhancing the quality of care and ensuring a safe environment for both patients and staff.

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Supercritical CO2 (scCO2) is carbon dioxide that has been pressurized and heated beyond its critical point, resulting in a fluid with advantageous properties such as low viscosity, high density, and the absence of residual solvents. Initially, scCO2 was utilized in the food industry for extraction, fractionation, and formulation from natural plant materials and food ingredients. Recently, it has emerged as a sustainable and eco-friendly alternative for sterilizing medical devices.

In medical applications, scCO2 was initially used for extracting natural compounds for medicinal purposes, but it is now being employed for the cleaning and terminal sterilization of both synthetic and biological devices. scCO2 is considered a viable alternative to ethylene oxide (EtO), which poses health risks, including an increased cancer risk. According to the U.S. Food and Drug Administration (FDA), around 50% of medical devices are sterilized using EtO. In contrast, scCO2 is cost-effective and compatible with a wide range of devices, including bio-based materials. This shift towards scCO2 sterilization services is expected to drive demand for sterilization equipment and services.

The report also includes an extensive assessment of the product portfolio, geographic analysis, and key growth strategies adopted by leading market players in the last three to four years. In recent years, the sterilization equipment market has witnessed several organic and inorganic strategic developments. The key players profiled in the sterilization equipment market report are STERIS plc (U.S.), 3M Company (U.S.), Getinge AB (Sweden), Cardinal Health, Inc. (U.S.), Advanced Sterilization Products, Inc. (U.S.) (A subsidiary of Fortive Corporation), Fedegari Autoclavi SpA (Italy), Stryker Corporation (U.S.), ANTONIO MATACHANA, S. A. (Spain), SteelcoBelimed AG (Switzerland), Sotera Health Company (U.S.), Benchmark Scientific Inc (U.S.), MMM Münchener Medizin Mechanik GmbH (Germany), Tuttnauer (Netherlands), and Consolidated Sterilizer Systems (U.S.), Andersen Sterilizers, Inc. (U.S.).

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Increasing Use of E-beam Sterilization

There are various types of sterilization methods used in industries like gas-based (ethylene oxide), radiation-based (gamma electron beam, X-ray), filtration, and heat/steam-based sterilization (flaming, incineration, and autoclave steam sterilization) methods. These sterilization methods are determined based on material compatibility, process availability, processing location, physical device attributes, legacy regulatory approval, processing volume, utilization rate for particular devices or supplies, and cost of product to be sterilized. Though ethylene oxide is majorly used for sterilization in medical & pharma industries, the trend is moving towards e-beam sterilization due to its advanced technology and the ability to control the energy level within the beam.

Apart from this, increasing complexity, including combination products that incorporate sensitive materials, such as drugs or bioresorbables, and the miniaturization of medical devices, leads to more difficulty sterilizing these products with standard methods, such as gamma irradiation (Cobalt 60 radiation) and ethylene oxide (EtO). As a result, accelerator-based technologies such as electron beams and X-rays are seeing continued focus and investment as a complement to cobalt-based processing. This provides high growth opportunities for e-beam-based sterilization products in the coming years.

The sterilization equipment market is segmented by Offering (Equipment [Heat/Steam Sterilization Equipment {Moist Heat Sterilizers (Gravity Displacement Autoclaves, High-speed Prevacuum Sterilizers), Dry Heat Sterilizers (Static Air Sterilizers, Forced Air Sterilizers)}, Low-Temperature Sterilization Equipment {Hydrogen Peroxide/Gas Plasma Sterilizers, Ethylene Oxide Sterilizers, Ozone-based Sterilizers, Formaldehyde Sterilizers, Othe Low-temperature Sterilization Equipment}, Radiation Sterilization Equipment, Filtration Sterilization Equipment], Services [Ethylene Oxide Sterilization Services, Gamma Sterilization Services, E-beam Sterilization Services, Steam Sterilization Services, Other Sterilization Services], Consumables & Accessories [Sterilization Indicators {Biological Indicators, Chemical Indicators}, Sterilants, Instruments Packaging & Pouches, Other Consumables & Accessories]), End User (Hospitals & Clinics, Medical Device Companies, Pharmaceutical Companies, Food & Beverage Industry, Other End Users). The report also provides a comprehensive analysis of the sterilization equipment market in North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

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By offering, the consumables & accessories segment is slated to register the highest CAGR of 9% during the forecast period. Sterilization consumables and accessories play a vital role in measuring, controlling, and preventing infections, as well as in tracking healthcare-associated infections (HAIs). Factors expected to drive significant growth in this segment include the rising utilization of sterilization equipment, increasing availability of sterilization products, cost-effectiveness, user-friendliness, and their effectiveness in providing barriers against contamination.

By end user, the hospitals & clinics segment is slated to register the highest CAGR of 8.9% during the forecast period. Hospitals & clinics have experienced substantial growth in recent years, driven by improved hospital infrastructure in developing countries, an increasing number of hospitalizations, a rise in the total number of hospitals, and enhanced collaborations between private and public hospitals aimed at delivering quality care. Additionally, the growing volume of surgical procedures has contributed to this expansion. For example, the Rural Health Statistics (RHS) report for 2021–2022 indicates that as of March 2022, India had 1,275 operational hospitals, along with 767 district hospitals. The National Health Policy of India aims to establish a minimum of two beds per 1,000 people and construct between 3,000 to 5,000 new hospitals, each with approximately 200 beds, by 2025.

By geography, Asia-Pacific is slated to register the highest CAGR of 9.6% during the forecast period. Emerging infectious diseases linked to multidrug-resistant organisms (MDROs) and pathogens with pandemic potential, coupled with the rising number of surgical procedures and heightened efforts by pharmaceutical and biotechnology companies in developing biologics, are key factors anticipated to drive significant growth in this segment. Moreover, increasing government investments in the healthcare sector are expected to further support the rapid growth of this segment.

Sterilization Equipment Market Opportunity 

Increasing Use of CO2 Sterilization in the Medical Device Industry 

The demand for carbon dioxide (CO2) sterilization is expected to rise due to increasing concerns and restrictions regarding the use of ethylene oxide (EtO). CO2 is utilized in the form of supercritical carbon dioxide (scCO2), a state in which CO2 exhibits both gas and liquid-like properties. The supercritical state is achieved when pressure exceeds approximately 1,070 psi (73 atm) and temperature is above ~31°C. ScCO2 sterilization effectively inactivates bacterial, viral, fungal, and yeast pathogens. The benefits of using scCO2 sterilization for medical devices include: 

• ScCO2 is a non-reactive molecule, offering a safer alternative to EtO in terms of chemical reactivity. 

• When used with an entrainer, such as a peracetic acid-based additive, scCO2 demonstrates a synergistic effect, allowing for a minimal amount of scCO2 to achieve a sterility assurance level. 

• ScCO2 is highly effective in penetrating medical devices for thorough sterilization. 

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Sterilization Equipment Market Industry Overview: Latest Developments from Key Industry Players 

• In June 2024, Getinge AB (Sweden) launched Poladus 150, a low-temperature sterilizer designed for heat-sensitive surgical instruments. The new instrument is equipped with advanced cross-contamination barrier technology, which helps prevent healthcare-acquired infections (HAIs). 

• In March 2024, STERIS plc (U.S.) launched the Verafit Sterilization Bags and Covers to Support EU GMP Annex 1 Compliance. The design enables biopharmaceutical companies to comply with the most recent EU GMP Annex 1 standards for dryness confirmation for sterilization cycle acceptance. 

• In October 2023, Advanced Sterilization Products, Inc. (U.S.) launched new Steam Monitoring products, including BIOTRACE Readers, BIOTRACE Biological Indicator, VERISURE Chemical Indicator, and SEALSURE Steam Indicator Tape. These products are specifically designed to assist sterile processing departments in healthcare facilities, enhancing their ability to achieve sterility with improved efficiency and increased confidence in outcomes. 

• In May 2022, Sterigenics U.S., LLC (U.S.), a subsidiary of the Sotera Health Company (U.S.), launched a new sterilization technology utilizing nitrogen dioxide gas at its facility in Petit-Rechain, Belgium. This innovation expands the company's service portfolio. 

Scope of the Report:

Sterilization Equipment Market—by Offering

• Equipment
• Heat/Steam Sterilization Equipment
• Moist Heat Sterilizers
• Gravity Displacement Autoclaves
• High-speed Prevacuum Sterilizers
• Dry Heat Sterilizers
• Static Air Sterilizers
• Forced Air Sterilizers
• Low-Temperature Sterilization Equipment
• Hydrogen Peroxide/Gas Plasma Sterilizers
• Ethylene Oxide Sterilizers
• Ozone-Based Sterilizers
• Formaldehyde Sterilizers
• Other Low-Temperature Sterilization Equipment

(Other low-temperature sterilization equipment primarily includes nitrogen dioxide sterilization and vaporized peracetic acid (VPA)-based sterilizers)

• Radiation Sterilization Equipment
• Filtration Sterilization Equipment
• Services
• Ethylene Oxide Sterilization Services
• Gamma Sterilization Services
• E-Beam Sterilization Services
• Steam Sterilization Services
• Other Sterilization Services

(Other sterilization services include primarily include services of the following technologies: vaporized hydrogen peroxide, hydrogen peroxide, hydrogen peroxide gas plasma sterilization, X-ray sterilization, NO₂, peracetic acid, and dry heat sterilization)

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• Consumables & Accessories
• Sterilization Indicators
• Biological Indicators
• Chemical Indicators
• Sterilants
• Instrument Packaging & Pouches
• Other Consumables & Accessories

(Other consumables & accessories include incubators, trolleys, carts, baskets, containers, trays, and racks)

Sterilization Equipment Market—by End User

• Hospitals & Clinics
• Medical Device Companies
• Pharmaceutical Companies
• Food & Beverage Industry
• Other End Users

(Other end users primarily include diagnostic laboratories, academic & research institutes, veterinary hospitals & clinics, and blood banks)

Sterilization Equipment Market—by Geography

• North America
• U.S.
• Canada
• Europe
• Germany
• France
• U.K.
• Italy
• Spain
• Switzerland
• Belgium
• Rest of Europe
• Asia-Pacific
• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific
• Latin America
• Brazil
• Mexico
• Rest of Latin America
• Middle East & Africa
• Saudi Arabia
• U.A.E.
• South Africa
• Rest of Middle East & Africa

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