Low Temperature Sterilization Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Product (Ethylene Oxide Sterilizers, Hydrogen Peroxide Sterilizers, Others), By Device (Endoscopes, Laparoscopic Kit, Ophthalmology, Otolaryngology (ORL), Others), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.39 Billion
CAGR (2026-2031)	10.32%
Fastest Growing Segment	Ethylene Oxide Sterilizers
Largest Market	North America
Market Size (2031)	USD 6.11 Billion

Market Overview

The Global Low Temperature Sterilization Market will grow from USD 3.39 Billion in 2025 to USD 6.11 Billion by 2031 at a 10.32% CAGR. Low temperature sterilization involves utilizing chemical agents such as ethylene oxide or hydrogen peroxide gas plasma to eliminate microbial life from medical devices sensitive to heat and moisture. The primary driver supporting market growth is the rising prevalence of complex surgical instruments and endoscopes that require effective reprocessing without sustaining thermal damage. Furthermore, the intensifying focus on infection control protocols to minimize infections acquired in hospital settings creates a sustained demand for these specialized sterilization technologies across global medical facilities.

According to AdvaMed, in 2024, ethylene oxide sterilization was employed for approximately 50 percent of all sterile medical devices in the United States, accounting for 20 billion devices annually. Despite this substantial usage volume, the market encounters a significant challenge arising from stringent environmental regulations concerning the emissions of toxic sterilizing agents. These regulatory pressures force facilities to implement costly emission control systems and may restrict the operational capacity of established sterilization centers, thereby impeding broader market expansion.

Key Market Drivers

Growing adoption of minimally invasive surgical procedures propels the Global Low Temperature Sterilization Market by necessitating the reprocessing of delicate instrumentation. Unlike traditional stainless-steel tools, the robotic arms and fiber-optic endoscopes used in these operations contain intricate electronics and heat-labile polymers that degrade under steam autoclaving, forcing facilities to rely on low-temperature modalities like vaporized hydrogen peroxide. This surge in surgical volume directly amplifies the daily operational demand for compatible sterilization cycles to maintain high throughput. According to Intuitive Surgical, January 2025, in the 'Preliminary Fourth Quarter and Full Year 2024 Financial Results', worldwide da Vinci procedures increased by approximately 17% in 2024 compared to the previous year, underscoring the expanding inventory of complex devices requiring specialized processing.

Increasing demand for sterilization of heat-sensitive and moisture-sensitive medical devices further drives market expansion as safety organizations intensify scrutiny on reprocessing standards. The intricate design of reusable instruments often harbors organic residue, making effective low-temperature sterilization critical to preventing infections without damaging the equipment. Highlighting this urgency, according to ECRI, February 2024, in the 'Top 10 Health Technology Hazards for 2024' report, inadequate or onerous device cleaning instructions for reusable medical devices was ranked as the second highest technology hazard facing healthcare organizations. To meet these rigorous safety standards, providers are actively maintaining service capacities; according to Sotera Health, in 2025, the company's Sterigenics segment reported full-year 2024 net revenues of $698 million, reflecting sustained industrial demand for critical sterilization services.

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Key Market Challenges

The stringent regulatory environment governing the emissions of toxic sterilizing agents, particularly ethylene oxide, stands as a formidable barrier to the expansion of the Global Low Temperature Sterilization Market. As environmental agencies enforce rigorous air quality standards to protect public health, sterilization facilities are compelled to implement expensive emission control systems and continuous monitoring technologies. These compliance requirements impose significant capital and operational burdens on service providers, diverting financial resources that could otherwise fund capacity expansion or technological innovation. Consequently, the high cost of compliance restricts the ability of smaller facilities to compete and limits the overall operational flexibility of the market.

Beyond financial constraints, these regulations directly threaten the existing supply chain capacity. The enforcement of stricter emission limits often necessitates facility retrofitting, leading to extended operational downtime or the permanent closure of centers unable to meet new standards. This reduction in operational availability creates severe bottlenecks, preventing the market from adequately servicing the rising volume of medical devices. According to the Advanced Medical Technology Association (AdvaMed), in 2024, the implementation of finalized environmental proposals was projected to potentially reduce nationwide ethylene oxide sterilization capacity by 30 to 50 percent, underscoring the substantial impact of regulatory pressures on market availability.

Key Market Trends

The market is witnessing a distinct shift toward the strategic outsourcing of sterilization services, driven by the escalating complexity of regulatory compliance for in-house departments. Rather than investing capital in retrofitting facilities to meet stringent emission controls for agents like ethylene oxide, hospitals and device manufacturers are increasingly contracting third-party vendors who possess the specialized infrastructure to manage hazardous chemistries safely. This operational model allows organizations to convert fixed regulatory expenses into variable costs while leveraging external expertise to handle diverse sterilization modalities. Highlighting this growth in contract processing, according to STERIS plc, February 2025, in the 'STERIS Announces Financial Results for Fiscal 2025 Third Quarter' report, revenue for the Applied Sterilization Technologies segment increased 10 percent to $258.1 million, reflecting the expanding industrial reliance on outsourced sterilization partners.

Simultaneously, the emergence of nitrogen dioxide sterilization technology is gaining traction as a sustainable alternative for temperature-sensitive combination products. This modality is particularly effective for pre-filled syringes and bio-absorbable implants, as it operates at ultra-low temperatures that preserve drug integrity, a critical requirement where traditional vaporized hydrogen peroxide may face penetration limitations. The adoption of this technology is further accelerated by its rapid cycle times and minimal aeration requirements, offering a solution that aligns with the industry's push for low-emission and efficient sterilants. According to Noxilizer, Inc., September 2025, in the 'Noxilizer Expands Access to Commercial-Scale Nitrogen Dioxide Terminal Sterilization Capacity' press release, the company secured $30 million in growth capital to scale its operations and support the increasing global adoption of this terminal sterilization alternative.

Segmental Insights

The Ethylene Oxide Sterilizers segment is currently identified as the fastest-growing category within the Global Low Temperature Sterilization Market. This rapid expansion is primarily driven by the critical necessity of processing heat-sensitive and moisture-sensitive medical devices, such as complex catheters and integrated electronics, which cannot withstand high-temperature steam. Industry analysis indicates that the surging demand for disposable surgical instruments and the unique ability of ethylene oxide to penetrate intricate device geometries are key factors fueling this trajectory. Consequently, this method remains indispensable for manufacturers ensuring sterility in advanced medical equipment, securing its leading growth position.

Regional Insights

North America dominates the Global Low Temperature Sterilization Market due to its established healthcare infrastructure and the high volume of minimally invasive surgeries performed across the region. These procedures rely on delicate, heat-sensitive instruments, such as endoscopes, which require specialized low-temperature processing to maintain functionality. The region's leadership is reinforced by strict regulatory oversight from the U.S. Food and Drug Administration (FDA), which mandates rigorous infection control protocols to prevent hospital-acquired infections. Furthermore, the concentration of key industry players within the United States ensures widespread accessibility to innovative sterilization systems, sustaining the region's competitive advantage.

Recent Developments

• In September 2025, Andersen Sterilizers launched the EOGas 4PLUS, a next-generation ethylene oxide sterilization system engineered to minimize emissions while maximizing efficiency. The company reported that the system featured a flexible chamber technology that significantly reduced gas consumption compared to traditional methods. This platform was cleared by regulatory authorities to sterilize complex instruments with long lumens, addressing specific needs in the reprocessing of endoscopes. The CEO of Andersen Sterilizers indicated that the product was developed in response to customer demand for a solution that ensured deep sterilization of intricate medical devices while maintaining strict environmental and safety compliance.
• In August 2024, Advanced Sterilization Products received FDA clearance for the ULTRA GI Cycle, a new sterilization cycle for its STERRAD 100NX Sterilizer with ALLClear Technology. Developed in collaboration with PENTAX Medical, this innovation utilized hydrogen peroxide gas plasma to process duodenoscopes, a category of devices historically associated with complex reprocessing challenges. The Chief Medical & Scientific Officer at Advanced Sterilization Products noted that this method aimed to establish a higher standard of sterility assurance for these instruments. The approval marked a transition from high-level disinfection to terminal sterilization for compatible gastrointestinal scopes, significantly enhancing patient safety protocols.
• In July 2024, STERIS announced the opening of a new ethylene oxide processing facility in Singapore to support the medical device manufacturing sector in the region. This expansion was executed through a strategic partnership with TOMOE SHOKAI CO., Ltd., a move intended to enhance global supply chain resilience. The facility was established to provide critical low-temperature sterilization services, ensuring that manufacturers had access to reliable processing capabilities for sensitive products. The company emphasized that this development aligned with its long-term commitment to safeguarding patient health by increasing the availability of essential sterilization modalities in key international markets.
• In June 2024, Getinge launched the Poladus 150, a new vaporized hydrogen peroxide low-temperature sterilizer designed to process heat-sensitive surgical instruments such as endoscopes. The company described the system as operating at gentle temperatures of up to 55°C, making it suitable for a wide range of devices including those with lumens. A key feature highlighted was the Cross-Contamination Barrier, which separated airflows between zones to enhance infection control. The President of Surgical Workflows at Getinge stated that the launch represented a significant expansion of their portfolio for central sterile supply departments, addressing the growing need for advanced reprocessing solutions.

Key Market Players

• STERIS Corporation
• Getinge AB
• 3M Company
• Advanced Sterilization Products
• Belimed AG
• Tuttnauer Ltd.
• Steelco S.p.A.
• Matachana Group
• Shinva Medical Instrument Co., Ltd.
• Andersen Products, Inc.

By Product	By Device	By Region
Ethylene Oxide Sterilizers Hydrogen Peroxide Sterilizers Others	Endoscopes Laparoscopic Kit Ophthalmology Otolaryngology (ORL) Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Low Temperature Sterilization Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Low Temperature Sterilization Market, By Product:

• Ethylene Oxide Sterilizers
• Hydrogen Peroxide Sterilizers
• Others

• Low Temperature Sterilization Market, By Device:

• Endoscopes
• Laparoscopic Kit
• Ophthalmology
• Otolaryngology (ORL)
• Others

• Low Temperature Sterilization Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE