Global Medical Device Ethylene Oxide Sterilization Market, By Type (Services, and Equipment), Material Sterilized (Polymers, Metals and Others), End User (Medical Device Manufacturers, Hospitals, Ambulatory Surgical Centers and Others) - Industry Trends and Forecast to 2031.
Medical Device Ethylene Oxide Sterilization Market Analysis and Insights
According to the article published by AdvaMed in 2023, Ethylene oxide (EtO) sterilization is thepreferred method for approximately 50 percent of all medical device types, with over 20 billion devices sterilized annually. Its effectiveness in sterilizing a wide range of medical devices, including those with complex geometries and heat-sensitive materials, makes it a vital part of modern healthcare. Most surgeries involve at least one device that has been sterilized using Ethylene oxide (EtO), ensuring patient safety and infection control. In compliance with FDA's Quality System regulation and international standards, manufacturers must validate their Ethylene oxide (EtO) sterilization processes to guarantee they meet the highest levels of safety and efficacy, further underscoring Ethylene oxide (EtO) critical role in the medical device industry.
Data Bridge Market Research analyzes that the global medical device ethylene oxide sterilization market is expected to reach USD 3.08 billion by 2031 from USD 2.11 billion in 2023, growing at a CAGR of 5.1% in the forecast period of 2024 to 2031.
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Report Metric
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Details
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Forecast Period
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2024 to 2031
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Base Year
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2023
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Historic Years
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2022 (Customizable to 2016–2021)
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Quantitative Units
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Revenue in USD Million
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Segments Covered
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By Type (Services, and Equipment), Material Sterilized (Polymers, Metals and Others), End User (Medical Device Manufacturers, Hospitals, Ambulatory Surgical Centers and Others)
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Countries Covered
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U.S., Canada, Mexico, Germany, U.K., France, Italy, Netherlands, Spain, Russia, Switzerland, Turkey, Belgium, Poland, Sweden, Denmark, Norway, Finland, Rest of Europe, China, Japan, India, South Korea, Australia, Taiwan, Singapore, Thailand, Indonesia, Malaysia, Philippines, New Zealand, Vietnam, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, Saudi Arabia, U.A.E., Israel, South Africa, Egypt, Qatar, Kuwait, Bahrain, Oman, and Rest of Middle East and Africa
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Market Players Covered
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Sterigenics U.S., LLC – A Sotera Health company, STERIS, 3M , Azbil Telstar, SLU, Getinge AB, Cosmed Group , H.W.Andersen Products Ltd., Ionisos, Labtron Equipment Ltd., ETC , Inox Torres Group S.L. ,RSD ENGINEERING ,Life Science Outsourcing, Inc. ,TEKNOMAR LTD., sterilization-baltics.com., DE LAMA S.P.A ,Hubei CFULL Medical Technology Co., Ltd., INSTECH SYSTEMS, ERNA Ltd. Co., Kaustubh Enterprise, Galbino Technology Inc., SOLSTEO, Steridium, Sterility Equipment India Private Limited, HANGZHOU BOCON MECHANICAL and ELECTRICAL EQUIPMENT CO., LTD., among others
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Market Definition
Medical device ethylene oxide sterilization refers to the process of using ethylene oxide gas to sterilize medical devices and equipment. This method is particularly suitable for items that are heat or moisture sensitive, such as plastic materials, electronic components, and certain types of packaging. Ethylene oxide effectively penetrates packaging and complex geometries, ensuring thorough disinfection without compromising the integrity of the sterilized items. This sterilization technique is widely used across various industries including healthcare, pharmaceuticals, and food production due to its versatility and effectiveness in eliminating microorganisms. It plays a critical role in ensuring the safety and efficacy of medical devices and equipment used in patient care, surgical procedures, and diagnostic applications.
Global Medical Device Ethylene Oxide Sterilization Market Dynamics
This section deals with understanding the market drivers, opportunities, restraints, and challenges. All of this is discussed in detail below:
Driver
- The Essential Role Of Ethylene Oxide In Sterilization Process
Ethylene oxide (EtO) sterilization is essential in the global medical device market due to its compatibility with a wide range of heat-sensitive and delicate devices. This method effectively sterilizes medical instruments such as catheters, pacemakers, and single-use plastics without damaging the materials or compromising their performance. Its ability to penetrate complex devices and treat packaged materials makes it a preferred option for many medical device manufacturers. Ethylene oxide (EtO) sterilization's comprehensive effectiveness against a broad spectrum of microorganisms, including highly resistant bacteria, significantly ensures patient safety and infection control during medical procedures. As the demand for advanced medical devices grows globally, market players benefit from the reliability and versatility of Ethylene oxide (EtO) sterilization, driving market growth and innovation. Ethylene oxide (EtO) ability to thoroughly sterilize complex devices without damaging them has made it an indispensable part of medical device manufacturing. This flexibility, combined with Ethylene oxide (EtO) broad-spectrum antimicrobial effectiveness, drives market growth by meeting healthcare providers' stringent safety and efficacy demands worldwide. As a result, market players continue to invest in Ethylene oxide (EtO) sterilization technologies and services, capitalizing on its proven reliability and safety.
Restraint
- Diverse Sterilization Methods In The Medical Device Industry
The availability of various sterilization methods poses a significant problem for companies in the medical device sterilization market. Different healthcare providers and manufacturers require different sterilization solutions for various medical devices, leading to competition among methods such as ethylene oxide (EtO), steam sterilization, gamma radiation, and electron beam irradiation. Each method has its own advantages and limitations in terms of material compatibility, effectiveness, cost, cycle times, and regulatory compliance. Market players must either invest in multiple sterilization technologies or specialize in one approach to meet diverse customer needs. This can result in higher operational costs and the need for specialized expertise. Furthermore, as the industry changes, there may be shifts in preferences and regulatory requirements, making strategic planning more complex for market players.
Opportunity
- Technological Advancements Contribute To The Efficiency And Safety In Sterilization
The continuous development of technology for sterilization in the Ethylene Oxide (EO) sterilization market has created numerous opportunities for the industry. These technologies have enabled the development of more efficient and productive ethylene oxide sterilization systems, which can process a larger volume of products in a shorter time frame. This increased efficiency has led to cost savings and reduced production times, making it more attractive for manufacturers to use ethylene oxide sterilization. Advancements in technology have enhanced safety and containment measures, including improved ventilation systems, automated monitoring, and advanced control systems. These features have reduced the risk of accidents and exposure to hazardous chemicals, making ethylene oxide sterilization a more viable option for companies.
Challenge
- High Initial Investment In Ethylene Oxide Sterilization Facilities
Building and installing an ETO sterilization facility requires a significant investment. The cost of equipment, building design, and ventilation systems can be substantial, making it a barrier to entry for new players. ETO sterilization facility is also expensive due to the costs of energy, labor, and maintenance. The high cost of ETO itself and the need for complex ventilation systems add to the overall operating expenses. Moreover, operating an ETO sterilization facility requires specialized expertise and training. This includes understanding the chemistry of ETO, the proper handling and storage of the gas, and the safe operation of the equipment. The high cost of training and retaining qualified personnel can be a significant challenge for companies.
Recent Developments
- In February 2021, 3M has launched 3M Clean & Protect Certified Badge Program. It is a new comprehensive system for cleaning, monitoring and protecting facilities. This strategy anticipated to strengthen the company footprints in the market and accelerate its growth trajectory particularly in the long term.
- In January 2021, STERIS announced that it has completed the acquisition of Cantel Medical. Through this acquisition, STERIS complement and extend its product and service offerings, global reach and customers. This acquisition has increased the sales and demands of the product and boosted the growth.
- In November 2020, Solsteo launched a new ethylene oxide sterilizer. This launch integrated pre-conditioning, sterilization and aeration in one cycle, reduces EO exposure risks, and makes it easier to operate.
- In October 2020, Getinge AB announced the launch of cost-efficient sterilization with Getinge’s new steam sterilizer Solsus 66. The new sterilizer is easy to use and install and is energy efficient. This product launch has broadened the product portfolio of the company and boosted the market growth.
Global Medical Device Ethylene Oxide Sterilization Market Scope
The global medical device ethylene oxide sterilization market is segmented into three notable segments based on type, material sterilized and end user. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the differences in your target markets.
Type
- Services
- Equipment
On the basis of type, the market is segmented into services and equipment.
Material Sterilized
- Polymers
- Metals
- Others
On the basis of material sterilized, the market is segmented into polymers, metals and others.
End User
- Medical Device Manufacturers
- Hospitals
- Ambulatory Surgical Centers
- Others
On the basis of end user, the market is segmented into medical device manufacturers, hospitals, ambulatory surgical centers and others.
Global Medical Device Ethylene Oxide Sterilization Market Regional Analysis/Insights
The global medical device ethylene oxide sterilization market is segmented into three notable segments based on type, material, and end user.
The countries covered in this market report are U.S., Canada, Mexico, Germany, U.K., France, Italy, Netherlands, Spain, Russia, Switzerland, Belgium, Turkey, rest of Europe, China, Japan, India, South Korea, Australia, Singapore, Thailand, Indonesia, Malaysia, Philippines, rest of Asia-Pacific, Brazil, Argentina, rest of South America, Saudi Arabia, U.A.E., Israel, South Africa, Egypt, and rest of Middle East and Africa.
North America is expected to dominate the global medical device ethylene oxide sterilization market expected to dominate the market its advanced healthcare infrastructure, robust regulatory framework, and significant investment in research and development. U.S. is expected to dominate the North America market due to its advanced healthcare infrastructure, extensive medical device manufacturing industry, and stringent regulatory standards ensuring high-quality sterilization processes. China is expected to dominate in the Asia-Pacific region due to its large-scale manufacturing capabilities, expanding healthcare sector, and growing medical device industry. Gemany is expected to dominate in the Europe region due to its its advanced healthcare infrastructure, strong medical device industry, and technological innovations in sterilization processes.
The country section of the report also provides individual market-impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands and the impact of sales channels are considered while providing forecast analysis of the country data.
Competitive Landscape and Global Medical Device Ethylene Oxide Sterilization Market Share Analysis
The global medical device ethylene oxide sterilization market competitive landscape provides details of competitors. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product approvals, product width and breadth, application dominance, and product type lifeline curve. The above data points provided are only related to the company’s focus on the market.
Some of the major market players operating in the market are Sterigenics U.S., LLC – A Sotera Health company, STERIS, 3M , Azbil Telstar, SLU, Getinge AB, Cosmed Group , H.W.Andersen Products Ltd., Ionisos, Labtron Equipment Ltd., ETC , Inox Torres Group S.L. ,RSD ENGINEERING ,Life Science Outsourcing, Inc. ,TEKNOMAR LTD., sterilization-baltics.com., DE LAMA S.P.A ,Hubei CFULL Medical Technology Co., Ltd., INSTECH SYSTEMS, ERNA Ltd. Co., Kaustubh Enterprise, Galbino Technology Inc., SOLSTEO, Steridium, Sterility Equipment India Private Limited, HANGZHOU BOCON MECHANICAL and ELECTRICAL EQUIPMENT CO., LTD., among others.
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