Sterilization Equipment Market (2025-2035)

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.

Sterilization of medical devices using ethylene oxide (EtO) is commonly preferred by healthcare organizations for instruments that cannot withstand heat sterilization or that contain electrical components sensitive to other sterilization methods. However, concerns about the safety of EtO as a sterilizing agent have grown, particularly following statements from the CDC indicating that repeated exposure to EtO may lead to skin and mucous membrane irritation, central nervous system abnormalities, and an increased risk of cancer in some cases.

Acute exposure to EtO is associated with symptoms such as headache, nausea, vomiting, cyanosis, and shortness of breath. These health concerns have led to a growing reluctance among healthcare organizations and other users to utilize the EtO sterilization method. In the U.S., the Environmental Protection Agency (EPA) has classified ethylene oxide as a potential human carcinogen and has restricted its use in specific sterilization applications.

Furthermore, the European Union has banned the use of ethylene oxide (EtO) in the food and beverage industry due to safety and environmental concerns. The demand for both EtO sterilization equipment and contract sterilization services is expected to decline in the coming years as regulatory authorities in various countries continue to tighten policies regarding the use of EtO for sterilization purposes.

EtO sterilization usage is declining, especially in the U.S., due to stricter environmental regulations. The U.S. EPA finalized emission control standards in April 2024 mandating 80% reduction in EtO emissions at sterilization plants. In the EU, REACH legislation classifies EtO as a “Substance of Very High Concern” (SVHC) under review for total phase-down by 2026.

These actions are pushing hospitals and contract sterilizers to transition toward vaporized hydrogen peroxide (VHP) and ozone technologies. Companies like Sterigenics and Sotera Health have invested in retrofitting EtO facilities with hybrid or alternative sterilization systems to maintain compliance.

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.

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.
• ScCO2 operates at low temperatures (around 35°C), making it suitable for heat-sensitive materials.
• Unlike other methods, scCO2 does not require a lengthy outgassing period, enabling faster processing times.

Furthermore, Supercritical CO2 (scCO2) sterilization remains one of the fastest-growing segments, advancing at an estimated CAGR of 9% between 2025 and 2032. The method’s low toxicity, absence of residue, and shorter cycle times make it attractive for implantable and biocompatible medical devices.

Since 2023, medical device manufacturers such as STERIS plc and 3M Company have launched scCO2-based prototype systems for shielding polymer-based materials and electronics-sensitive devices. The development of CO2-compatible packaging films by French and Japanese material technology firms is aiding adoption, particularly in reusable instrument processing.

Additionally, according to Qarboon, a France-based machine manufacturer, scCO2 is well-suited for the treatment of various medical devices, including textiles, silicone, plastics, bi-materials, and intelligent medical devices. ScCO2 has a strong impact on the biological load present on these devices and can be used to pre-sterilize both implantable and non-implantable, single-use/reusable medical devices. The growth of the medical device industry is expected to drive demand for scCO2 sterilization, creating opportunities for market growth.