Low Temperature Sterilization

Global Low Temperature Sterilization Market to Reach US$9.5 Billion by 2030

The global market for Low Temperature Sterilization estimated at US$5.3 Billion in the year 2024, is expected to reach US$9.5 Billion by 2030, growing at a CAGR of 10.2% over the analysis period 2024-2030. Ethylene Oxide Sterilizers, one of the segments analyzed in the report, is expected to record a 10.4% CAGR and reach US$5.6 Billion by the end of the analysis period. Growth in the Hydrogen Peroxide Sterilizers segment is estimated at 10.1% CAGR over the analysis period.

The U.S. Market is Estimated at US$1.4 Billion While China is Forecast to Grow at 14.0% CAGR

The Low Temperature Sterilization market in the U.S. is estimated at US$1.4 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$2.0 Billion by the year 2030 trailing a CAGR of 14.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 7.3% and 9.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 8.1% CAGR.

Global Low Temperature Sterilization Market – Key Trends & Drivers Summarized

What Is Low Temperature Sterilization and Why Is It Crucial in Modern Healthcare?
Low temperature sterilization is a method used to sterilize heat- and moisture-sensitive medical instruments and equipment using chemical agents at temperatures typically below 60°C. Unlike traditional high-temperature steam sterilization (autoclaving), which can damage delicate instruments such as endoscopes, flexible scopes, plastics, and electronics, low temperature sterilization provides effective microbial elimination without compromising the integrity of these materials. Common technologies include hydrogen peroxide gas plasma, ethylene oxide (EtO), vaporized hydrogen peroxide (VHP), and ozone-based systems.

This form of sterilization has become essential in healthcare settings such as hospitals, ambulatory surgical centers, and dental clinics, where the use of minimally invasive surgical tools and advanced medical devices is increasing. It ensures high-level disinfection and sterilization of instruments that cannot tolerate high heat, thereby maintaining patient safety and supporting compliance with infection control standards. With healthcare systems placing greater emphasis on the reuse and longevity of medical equipment, low temperature sterilization plays a vital role in sustainable and cost-effective infection prevention.

What Innovations and Regulatory Trends Are Shaping the Low Temperature Sterilization Market?
The low temperature sterilization market is evolving rapidly due to technological innovations, increased automation, and regulatory enforcement around patient safety and device sterilization standards. Modern systems are becoming more compact, faster, and more energy-efficient while offering improved compatibility with complex instruments. Hydrogen peroxide gas plasma sterilization systems are gaining popularity for their speed, safety, and eco-friendliness, as they leave no toxic residues and require minimal aeration time. Hybrid sterilization systems that combine multiple agents or processes are also emerging to address a broader range of microbial threats and device materials.

Digitization is transforming sterilization processes through IoT-enabled sterilizers that offer real-time performance monitoring, automated cycle documentation, and remote diagnostics. These systems are increasingly integrated into hospital-wide sterile processing departments (SPDs) and centralized reprocessing facilities. Additionally, rising concerns about the safety of ethylene oxide—especially in terms of occupational exposure and environmental impact—are prompting shifts toward safer and faster alternatives like vaporized hydrogen peroxide and ozone-based sterilization.

Regulatory frameworks such as those established by the U.S. FDA, European Medicines Agency (EMA), and ISO standards (e.g., ISO 14937) are influencing equipment design, validation procedures, and compliance protocols. Moreover, third-party accreditation bodies like The Joint Commission are driving hospitals to enhance sterilization traceability and performance documentation. The demand for user-friendly systems that support compliance, reduce human error, and increase throughput is growing, especially in high-volume medical facilities.

What Is Driving the Growth of the Global Low Temperature Sterilization Market?
The growth in the global low temperature sterilization market is driven by several factors, including the rising use of complex, heat-sensitive medical devices, stringent infection control standards, and the global increase in surgical procedures. As minimally invasive and robotic surgeries become more common, healthcare providers require reliable sterilization solutions that protect delicate instruments and ensure patient safety. This is particularly critical in departments such as gastroenterology, cardiology, ophthalmology, and orthopedics, where equipment reuse is standard practice.

Regulatory mandates to reduce hospital-acquired infections (HAIs), combined with accreditation requirements for sterilization validation, are compelling healthcare institutions to invest in advanced low temperature sterilization technologies. Additionally, the rising prevalence of chronic diseases and aging populations in developed and emerging markets alike is increasing demand for surgical interventions and sterile medical environments. Public and private investments in healthcare infrastructure—particularly in Asia-Pacific, the Middle East, and Latin America—are creating new opportunities for sterilizer manufacturers and service providers.

Furthermore, the push toward environmental sustainability and staff safety is encouraging hospitals to replace older EtO-based systems with cleaner, faster, and more eco-friendly alternatives. The growing trend toward centralized sterile supply departments (CSSDs) and outsourcing of reprocessing services is also contributing to market growth, especially in high-volume urban hospitals. Collectively, these trends are ensuring steady and diversified demand for low temperature sterilization technologies across global healthcare systems.

SCOPE OF STUDY:

The report analyzes the Low Temperature Sterilization market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (Ethylene Oxide Sterilizers, Hydrogen Peroxide Sterilizers, Others); Device (Endoscopes, Laparoscopic Kit, Ophthalmology, Otolaryngology, Other Instruments)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 43 Featured) -

• 3M Company
• Advanced Sterilization Products (ASP)
• Belimed AG
• Bioquell (acquired by Ecolab)
• Cantel Medical Corp.
• Eschmann Technologies Ltd.
• Getinge AB
• Hanshin Medical Co., Ltd.
• Johnson & Johnson (Ethicon Inc.)
• Matachana Group
• MMM Group
• Noxilizer
• Olympus Corporation
• Plasmapp Co., Ltd.
• RENOSEM Co., Ltd.
• Shinva Medical Instrument Co., Ltd.
• Steelco S.p.A.
• Sterigenics International LLC
• STERIS Corporation
• Tuttnauer Ltd.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

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INDIA
176 OTHER COUNTRIES.

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