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

The Sterilization Equipment Market was valued at $14.32 billion in 2023. This market is expected to reach $26.77 billion by 2031, from an estimated $15.57 billion in 2024, at a CAGR of 8% during the forecast period 2024-2031.

Sterilization Equipment Market Size & Forecast

The sterilization equipment market's growth is primarily driven by the increasing prevalence of hospital-acquired infections, a rise in surgical procedures, and an enhanced focus on sterilization within the food industry to mitigate food-borne illnesses. Additionally, there is a growing demand for sterilization equipment from the pharmaceutical and biotechnology sectors, alongside a trend toward outsourcing sterilization processes to specialized service providers in non-healthcare industries. However, market growth is being restrained by the adverse effects associated with ethylene oxide and safety concerns regarding the reprocessing of instruments. 

Additionally, the rising adoption of e-beam sterilization, growing demand for sterilization products in emerging markets, rising utilization of CO2 sterilization technology in the medical device industry, and increased focus on infection control in both healthcare and non-healthcare sectors are expected to generate growth opportunities for the players operating in this market. Furthermore, non-compliance with sterilization standards in the healthcare sector and the shift from reusable medical devices to disposable medical devices pose challenges to the growth of the market. 

Click here to: Get a Free Sample Copy of this report

Sterilization Equipment Market Growth Drivers 

Increasing Demand for Sterilization Equipment from the Pharmaceutical and Biotechnology Industries  

Companies in the pharmaceutical and biotechnology industries are key end users of sterilization technologies, as these solutions are essential for maintaining sterile processing environments in pharmaceutical manufacturing facilities. As the pharmaceutical and biotechnology sectors grow, the products being developed, including biologics, gene therapies, and advanced therapeutics, have become increasingly complex. 

Contamination risks present significant challenges for both manufacturers and patients, resulting in the increased demand for effective sterilization solutions. The growing focus on higher quality standards and the increasing prevalence of infections linked to compromised manufacturing environments are driving the demand for advanced sterilization techniques and related equipment in the development and manufacturing processes of pharmaceutical and biopharmaceutical products. 

Furthermore, the demand for biologics is increasing due to their effectiveness in treating various diseases. However, the need for the sterile manufacturing of these sensitive molecules presents significant challenges to manufacturers. Biologics must be produced under aseptic conditions, typically using sterile filtration, as they cannot withstand traditional sterilization methods such as heat, chemical treatments, or radiation. Additionally, unit operations during sterile production, such as pumping, can potentially damage and degrade biologics. Therefore, sterile manufacturing requires skilled professionals with extensive knowledge of sterilization equipment. As a result, many pharmaceutical companies are opting to outsource the sterilization of biologics to specialized providers. 

Growing Incidence of Hospital-acquired Infections 

Hospital-acquired infections (HAIs), also referred to as nosocomial infections, are infections that develop in healthcare settings, typically manifesting 48 hours or more after admission or within 30 days post-discharge. A range of viral, bacterial, and fungal pathogens can cause these infections. The most prevalent types include bloodstream infections (BSIs), pneumonia, urinary tract infections (UTIs), and surgical site infections (SSIs). HAIs pose significant risks to patient health and can lead to extended hospital stays, imposing additional economic burdens on both patients and the healthcare system. They account for approximately 7% of total reported infections in developed countries and around 10% in developing nations. 

In addition to developed regions, hospital-acquired infections (HAIs) represent a significant challenge for healthcare systems in areas where public health infrastructure and infection prevention technologies are still developing. According to the World Health Organization (WHO), as of May 2022, among every 100 patients in acute-care hospitals, seven patients in high-income countries and 15 patients in low- and middle-income countries acquire at least one HAI during their hospital stay. A notable challenge is the delayed response to outbreaks; studies of Ebola, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS) in Asia and West Africa indicate that approximately 50% of these cases experienced such delays. In the Mano River Union countries—Guinea, Sierra Leone, and Liberia—almost all Ebola-related HAI cases were linked to these delayed responses. 

Sterilization Equipment Market Trends 

Use of Ozone Sterilization 

Ozone is recognized as an oxidizing microbial agent with a strong bactericidal effect that can destroy microorganisms such as bacteria and viruses. Decontamination and disinfection using ozone significantly reduce the microbial load. Ozone is produced naturally when ultraviolet light or sunlight interacts with oxygen, as well as through electrical discharge. However, its use has historically been limited due to its instability. Recent technological advances have made ozone generation easier and more stable, leading to its increased application in sterilization. 

Ozone sterilization is primarily used for medical devices, such as endoscopes, which cannot withstand the high heat and humidity associated with standard steam autoclaving. The advantages of ozone sterilization of ozone sterilization include the requirement of only medical-grade oxygen, which is safe to handle and transport and is readily available in hospitals worldwide, eliminating the need for costly sterilant stocking, shorter cycle time for ozone sterilization as compared to EtO sterilization, and lower costs per cycle as compared to EtO sterilization. 

Enhanced Efficiency and Speed 

In recent years, the demand for faster and more efficient sterilization equipment has been increasing. With advancements in technology, modern sterilizers are now equipped with innovative mechanisms and cutting-edge features that revolutionize the sterilization process. 

These integrations of advanced technologies optimize every aspect of sterilization, from pre-processing to post-processing. Sterilization solutions are equipped with algorithms and automated functions that streamline operations, enhance productivity, and reduce downtime. By leveraging optimized workflows, these sterilizers provide rapid and effective sterilization, meeting the needs of time-sensitive industries.  

The incorporation of intelligent control systems enables monitoring and precise control of critical parameters such as exposure time, temperature, and pressure. This ensures that the sterilization process is conducted efficiently, achieving the desired level of cleanliness while minimizing unnecessary delays. 

Furthermore, advancements in heating technology have significantly contributed to faster sterilization cycles. Modern sterilizers utilize rapid cool-down and heat-up mechanisms, facilitating quicker turnaround times between batches. These technologies have reduced overall processing time without compromising sterilization effectiveness. 

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.  

Sterilization Equipment Market Study: Key Findings 

The Equipment Segment to Account for the Largest Share of this Market in 2024 

Based on offerings, the sterilization equipment market is segmented into equipment, services, and consumables & accessories. In 2024, the equipment segment is expected to account for the largest share of 55.3% of the sterilization equipment market. The substantial market share of this segment is due to the rising incidence of hospital-acquired infections, the high adoption of sterilization equipment in the medical devices and pharmaceutical industries, and the increasing need to ensure the safety of food & beverages. 

The Pharmaceutical and Biotechnology Companies Segment to Account for the Largest Share of this Market in 2024 

Based on end users, the sterilization equipment market is segmented into hospitals & clinics, medical device companies, pharmaceutical companies, food & beverage industry, and other end users. In 2024, the hospitals & clinics segment is expected to account for the largest share of 35.9% of the sterilization equipment market. This segment's substantial market share is due to the high prevalence of HAIs, rising number of surgical procedures, growing demand for clean and quality healthcare facilities among people, and increasing burden of chronic diseases associated with an aging population. According to the World Health Organization (WHO), out of every 100 patients in acute care hospitals, seven patients in high-income countries and 15 patients in low- and middle-income countries will be affected by at least one healthcare-acquired infection (HAI) during their hospital stay. 

Geographical Analysis  

In 2024, North America to Dominate the Sterilization Equipment Market 

Based on geography, the sterilization equipment market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2024, North America is expected to account for the largest share of 46.6% of the sterilization equipment market, followed by Europe and Asia-Pacific. The largest share of the region is attributed to the growing hospital & outpatient visits, rising number of surgical procedures, growing incidence of HAIs, increasing healthcare expenditure, growth in the pharma & biotech industries, and government initiatives to reduce HAIs and implement effective sterilization practices in the region. 

Sterilization Equipment Market: Key Companies  

The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market participants over the past three to four years. The key players profiled in 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.). 

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. 

Sterilization Equipment Market Summary Table: 

Key questions answered in the report: