The global ethylene oxide sterilization services market is estimated to be USD 5.47 billion in 2024 and is expected to reach USD 16.78 billion by 2035, with a CAGR of 10.73% during the forecast period 2025-2035. The market will grow due to factors such the growing demand for medical devices, the expansion of the healthcare industry in emerging markets, stricter regulations requiring sterilization, technological advancements in EO sterilization, and an increase in the outsourcing of sterilization services.
Regulatory bodies such as the U.S. FDA and EU MDR impose stringent sterilization protocols to prevent healthcare-associated infections (HAIs), which underscores the critical need for effective sterilization methods in the healthcare sector. Ethylene oxide (EO) sterilization is recognized for its exceptional efficacy in eliminating microorganisms and has become a widely accepted solution to comply with these regulations. Addressing the pressing safety concerns of hospital employees using EO for medical device sterilization, the Association for the Advancement of Medical Instrumentation (AAMI) issued an updated guidance in November 2024. This guidance not only addresses regulatory and safety issues but also reinforces best practices for chemical sterilization and high-level disinfection in healthcare facilities. Consequently, the growing reliance on EO sterilization services is expected to drive significant market expansion as institutions seek compliance and enhanced patient safety.
By type, the contract sterilization services segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the increasing preference among medical device manufacturers and healthcare facilities to outsource sterilization processes to reduce operational costs and ensure regulatory compliance. For instance, Sterigenics U.S., LLC (Sterigenics), a medical sterilizing company with facilities in Vernon and Ontario, recently reached a settlement with the South Coast Air Quality Management District (South Coast AQMD) in August 2024 for permit and other regulation violations. Additionally, the sterilization validation services segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising focus on quality assurance and compliance with stringent sterilization standards set by regulatory authorities.
By mode of delivery, the off-site sterilization services segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the cost-effectiveness and ability to handle large-scale sterilization processes, making it suitable for bulk medical devices and supplies. For instance, ClorDiSys Solutions, Inc. ("ClorDiSys" or the "Company") was acquired by Allentown, LLC ("Allentown"), a portfolio business of Aterian Investment Partners ("Aterian"), in January 2024. Additionally, the on-site sterilization services segment is predicted to grow at the fastest CAGR during the forecast period owing to its convenience in reducing turnaround times and providing sterilization solutions tailored to specific healthcare or manufacturing facility needs.
By end-user, the hospitals segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the high volume of surgical instruments and medical devices requiring sterilization to ensure infection control in healthcare settings. For instance, the American Chemistry Council (ACC) released the following statement in April 2023 in response to draft proposals from the Environmental Protection Agency about the use of ethylene oxide in commercial sterilizing and pesticide registration applications. Additionally, the ambulatory surgical centers segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing number of outpatient procedures and the rising need for sterilized medical instruments in these cost-effective healthcare facilities.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of a well-established healthcare infrastructure, high adoption of advanced sterilization technologies, and stringent regulatory requirements for sterilized medical products. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the expansion of healthcare facilities, increasing demand for medical devices, and rising awareness about infection prevention and control in emerging economies like China and India. For instance, in March 2023, Picarro, Inc. and LESNI A/S announced a collaborative agreement to provide medical device and contract sterilization facilities worldwide with industry-leading Ethylene Oxide (EtO or EO) monitoring solutions. The all-inclusive solutions will integrate Picarro's cutting-edge Continuous Emission Monitoring Systems (CEMS) with LESNI's thirty-five years of experience in emissions control and abatement. Increased safety, regulatory risk reduction, decreased source and fugitive emissions, and enhanced operational efficiency are just a few of the major advantages that the medical device and contract sterilization industries will experience from the final goods and services.
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
Regulatory bodies such as the U.S. FDA and EU MDR impose stringent sterilization protocols to prevent healthcare-associated infections (HAIs), which underscores the critical need for effective sterilization methods in the healthcare sector. Ethylene oxide (EO) sterilization is recognized for its exceptional efficacy in eliminating microorganisms and has become a widely accepted solution to comply with these regulations. Addressing the pressing safety concerns of hospital employees using EO for medical device sterilization, the Association for the Advancement of Medical Instrumentation (AAMI) issued an updated guidance in November 2024. This guidance not only addresses regulatory and safety issues but also reinforces best practices for chemical sterilization and high-level disinfection in healthcare facilities. Consequently, the growing reliance on EO sterilization services is expected to drive significant market expansion as institutions seek compliance and enhanced patient safety.
By type, the contract sterilization services segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the increasing preference among medical device manufacturers and healthcare facilities to outsource sterilization processes to reduce operational costs and ensure regulatory compliance. For instance, Sterigenics U.S., LLC (Sterigenics), a medical sterilizing company with facilities in Vernon and Ontario, recently reached a settlement with the South Coast Air Quality Management District (South Coast AQMD) in August 2024 for permit and other regulation violations. Additionally, the sterilization validation services segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising focus on quality assurance and compliance with stringent sterilization standards set by regulatory authorities.
By mode of delivery, the off-site sterilization services segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the cost-effectiveness and ability to handle large-scale sterilization processes, making it suitable for bulk medical devices and supplies. For instance, ClorDiSys Solutions, Inc. ("ClorDiSys" or the "Company") was acquired by Allentown, LLC ("Allentown"), a portfolio business of Aterian Investment Partners ("Aterian"), in January 2024. Additionally, the on-site sterilization services segment is predicted to grow at the fastest CAGR during the forecast period owing to its convenience in reducing turnaround times and providing sterilization solutions tailored to specific healthcare or manufacturing facility needs.
By end-user, the hospitals segment accounted for the highest revenue-grossing segment in the global ethylene oxide sterilization services market in 2024 owing to the high volume of surgical instruments and medical devices requiring sterilization to ensure infection control in healthcare settings. For instance, the American Chemistry Council (ACC) released the following statement in April 2023 in response to draft proposals from the Environmental Protection Agency about the use of ethylene oxide in commercial sterilizing and pesticide registration applications. Additionally, the ambulatory surgical centers segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing number of outpatient procedures and the rising need for sterilized medical instruments in these cost-effective healthcare facilities.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of a well-established healthcare infrastructure, high adoption of advanced sterilization technologies, and stringent regulatory requirements for sterilized medical products. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the expansion of healthcare facilities, increasing demand for medical devices, and rising awareness about infection prevention and control in emerging economies like China and India. For instance, in March 2023, Picarro, Inc. and LESNI A/S announced a collaborative agreement to provide medical device and contract sterilization facilities worldwide with industry-leading Ethylene Oxide (EtO or EO) monitoring solutions. The all-inclusive solutions will integrate Picarro's cutting-edge Continuous Emission Monitoring Systems (CEMS) with LESNI's thirty-five years of experience in emissions control and abatement. Increased safety, regulatory risk reduction, decreased source and fugitive emissions, and enhanced operational efficiency are just a few of the major advantages that the medical device and contract sterilization industries will experience from the final goods and services.
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
Report Scope:
- Base Year: 2024
- Forecast Period: 2025-2035
- Study Coverage
- Market Forecast by Type, Mode of Delivery, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: Ethylene Oxide Sterilization Services Market Report 2024 - 2035
Ethylene Oxide Sterilization Services Market Analysis & Forecast by Type 2024 - 2035 (Revenue USD Bn)
- Contract Sterilization Services
- Sterilization Validation Services
Ethylene Oxide Sterilization Services Market Analysis & Forecast by Mode of Delivery 2024 - 2035 (Revenue USD Bn)
- On-Site Sterilization Services
- Off-Site Sterilization Services
Ethylene Oxide Sterilization Services Market Analysis & Forecast by End-User 2024 - 2035 (Revenue USD Bn)
- Hospitals
- Specialty Clinics
- Ambulatory Surgical Centers
- Diagnostic Labs
- Academic Research Institutes
- Others
Ethylene Oxide Sterilization Services Market Analysis & Forecast by Region 2024 - 2035 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Ethylene Oxide Sterilization Services Market: Type Estimates & Trend Analysis
8. Ethylene Oxide Sterilization Services Market: Mode of Delivery Estimates & Trend Analysis
9. Ethylene Oxide Sterilization Services Market: End-User Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Ethylene Oxide Sterilization Services Market
12. Europe Global Ethylene Oxide Sterilization Services Market
13. Asia Pacific Global Ethylene Oxide Sterilization Services Market
14. Latin America Global Ethylene Oxide Sterilization Services Market
15. MEA Global Ethylene Oxide Sterilization Services Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Steris Corporation
- Advanced Sterilization Products (ASP)
- 3M Company
- Medline Industries, Inc.
- Ecolab Inc.
- Cantel Medical Corporation (A STERIS Company)
- Sterigenics International LLC (A Sotera Health Company)
- NELCO Worldwide
- Andersen Sterilizers, Inc.
- Scantibodies Laboratory, Inc.
- Belimed AG
- Tuttnauer Ltd.
- Getinge AB
- Cosmed Group, Inc.
- Matachana Group
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | December 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 5.47 Billion |
| Forecasted Market Value ( USD | $ 16.78 Billion |
| Compound Annual Growth Rate | 10.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
