1 Global Medical Device Sterilization Market Insight Analysis
In 2025, the global medical device sterilization market size will reach US$14,519.83 million, with a CAGR of 7.05% from 2025 to 2033.
Medical devices are sterilized in a variety of ways, including the use of damp heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide and other sterilization methods (e.g., chlorine dioxide gas, vaporized peracetic acid and nitrogen dioxide).
Figure Global Medical Device Sterilization Market Size (M USD) and CAGR (2025-2033)
2 Medical Device Sterilization Market Growth Drivers and Restraints
Improved public health awareness and growing medical demand
The aging of the global population is accelerating (for example, the proportion of people over 65 years old in Europe and the United States exceeds 20%), and the number of patients with chronic diseases has increased, driving the demand for medical devices in hospitals, clinics and other institutions. At the same time, the COVID-19 pandemic has significantly increased the public and medical institutions’ attention to infection control, and the frequency of hospital disinfection and the use of sterilization consumables have increased significantly. For example, during the pandemic, the demand for sterilization of reusable instruments in hospitals increased by more than 15%, driving the expansion of the sterilization service and consumables market.
Advances in medical technology and the popularization of disposable devices
The widespread use of minimally invasive surgery and implantable devices (such as heart stents and artificial joints) requires higher standards of sterilization technology. The popularization of disposable medical devices (reducing the risk of cross-infection) has also driven the demand for technologies such as ethylene oxide (EO) and radiation sterilization. In addition, the development of the pharmaceutical and biotechnology industries (such as vaccine production) has increased the demand for sterile production environments, further driving the sterilization equipment and service market.
Policies, regulations and industry standards promote
Countries have strengthened medical device supervision, such as the strict certification of sterilization processes by the US FDA and the implementation of China’s “Medical Device Unique Identification System Rules”, requiring companies to adopt more efficient sterilization technology and traceability systems. Compliance requirements have prompted hospitals and companies to upgrade sterilization equipment, driving market growth.
Rapid expansion of emerging markets
The improvement of medical infrastructure in the Asia-Pacific region (especially China and India) and the growing demand for high-quality medical care among the middle class have become the main driving forces of the market. For example, the scale of China’s medical device sterilization market reached US$8.56 billion in 2021, with a compound growth rate of more than 11% from 2016 to 2021, far exceeding the global average.
Corporate innovation and market diversification
Heading companies such as Steris and 3M continue to invest in research and development, and launch efficient sterilization technologies (such as low-temperature plasma sterilization and electron beam sterilization) to meet the needs of different scenarios. At the same time, the service model has transformed from single equipment sales to an integrated “equipment + consumables + service” to enhance customer stickiness.
Risks of technological substitution and environmental pressure
Traditional sterilization technologies (such as ethylene oxide) face regulatory restrictions due to their carcinogenicity. The US EPA has listed them as high-risk pollutants and requires companies to adopt alternative technologies (such as hydrogen peroxide plasma). However, alternative technologies are costly (equipment investment increases by 30-50%) and have limited applicability (such as the inability to handle complex geometric instruments), which restricts the upgrading of small and medium-sized enterprises.
Supply chain fluctuations and cost pressures
The epidemic has led to rising prices of raw materials (such as stainless steel and plastics) and increased production costs of sterilization consumables. At the same time, global logistics disruptions have affected the supply of equipment parts, and some companies have been forced to adjust their production plans. For example, in 2021, European sterilization equipment manufacturers extended their delivery cycles by 20-30% due to chip shortages.
Unbalanced regional market development
Medical resources are scarce in the Middle East, Africa and other regions, the penetration rate of sterilization equipment is low, and they rely on imports and are highly price sensitive. At the same time, the market in developed countries is approaching saturation and competition is fierce. Companies need to invest more resources to develop emerging markets, but face challenges in localized operations and regulatory adaptation.
Intensified industry competition and compressed profit margins
The market has a high concentration of leading companies (the top five companies account for more than 40% of the global market share) and fierce price competition. Small and medium-sized enterprises are at a disadvantage in technology and cost, and their profit margins continue to shrink. For example, the gross profit margin of the global sterilization service market in 2021 fell by 2-3 percentage points compared with 2019.
Technical barriers and long certification cycles
High-end sterilization equipment (such as gamma ray sterilizers) has high technical barriers, a research and development cycle of up to 5-8 years, and needs to pass multiple certifications such as FDA and CE, making it difficult for new entrants to quickly deploy. At the same time, the patent layout of existing companies (such as Steris holding more than 300 sterilization technology patents) further consolidates its market position.
3 Technological Innovations in the Medical Device Sterilization Market
Popularization of low-temperature sterilization technology
Hydrogen peroxide plasma sterilization: represented by Advanced Sterilization Products’ STERAD NX system, which uses low-temperature plasma to decompose hydrogen peroxide, has no residue and a short sterilization cycle (<1 hour), and is suitable for electronic instruments and endoscopes.
Nitrogen dioxide (NO₂) sterilization: Sterigenics’ low-temperature sterilization technology is suitable for heat-sensitive materials. The sterilization time only takes a few minutes, but the equipment cost is high and it is mainly used for high-value-added equipment.
Intelligentization and automation upgrade
Heading companies are accelerating the development of intelligent sterilization systems, integrating the Internet of Things (IoT) and data analysis functions. For example, 3M’s Attest™ system automatically generates compliance reports by real-time monitoring of sterilization parameters (temperature, pressure) to reduce manual errors. Steris’ i-Pack™ intelligent packaging system can trace the sterilization status and improve the efficiency of hospital supply chain management.
Environmentally friendly sterilization technology research and development
In response to environmental restrictions on ethylene oxide, companies are turning to biodegradable consumables and green sterilization processes. For example, Beta Star’s EnviroVac® vacuum system reduces water consumption by 90%, and MATACHANA GROUP’s steam sterilizer adopts an energy-saving design, reducing energy consumption by 40%.
Exploration of emerging sterilization technologies
Pulsed electric field sterilization: It destroys microbial cell membranes through high-voltage pulses and is suitable for liquid and semi-solid sterilization. It is currently in the laboratory stage and may subvert traditional moist heat sterilization in the future.
Photocatalytic sterilization: It uses ultraviolet light (UV-C) and nanomaterials for combined sterilization. It has been used in some dental and ophthalmic instruments and has the advantage of no chemical residues.
Horizontal expansion of leading companies
Multinational companies quickly acquire technology and market share through mergers and acquisitions. For example:
In 2020, Fortive acquired Johnson & Johnson’s Advanced Sterilization Products business to enhance its competitiveness in hydrogen peroxide sterilization.
In 2021, Sotera Health (Sterigenics’ parent company) acquired Iotron Industries to expand the global layout of electron beam sterilization, especially in the Canadian and European markets.
Regional market integration is accelerating
In emerging markets, companies are filling technology gaps through mergers and acquisitions. For example:
China’s Mindray Medical invested in a local sterilization service provider to improve the “equipment + service” ecosystem.
India’s Ajanta Pharma acquired a local sterilization consumables company to cope with the surge in local medical demand.
Vertical integration of the industry chain
Companies are transforming from single equipment suppliers to solution service providers. For example:
Belimed acquired an endoscope cleaning equipment company and launched an integrated “cleaning-sterilization-storage” solution to increase hospital purchasing stickiness.
Getinge integrates its sterilization equipment and life science businesses to provide pharmaceutical companies with customized aseptic production processes.
4 Global Medical Device Sterilization Market Size by Type
Sterilization instruments are essential tools used to sterilize medical devices through various methods such as steam, ethylene oxide, and hydrogen peroxide plasma. In 2025, the market value for sterilization instruments is forecasted to be $6,523.77 million USD. This segment holds a significant market share of approximately 44.93%, reflecting its importance in the overall sterilization process. The growth in this segment is driven by the increasing demand for advanced and efficient sterilization technologies, particularly in hospitals and medical device manufacturing facilities.
Sterilization services involve third-party providers offering specialized sterilization solutions to healthcare facilities and medical device companies. In 2025, the market value for sterilization services is expected to reach $3,640.34 million USD, accounting for about 25.07% of the total market share. The growth in this segment is attributed to the outsourcing trend among smaller healthcare providers and the need for specialized expertise in sterilization processes. These services are particularly important for ensuring compliance with regulatory standards and maintaining the sterility of medical devices.
Sterilization consumables include items such as sterilization wraps, indicators, and other disposable products used during the sterilization process. In 2025, the market value for sterilization consumables is projected to be $3,036.50 million USD, representing approximately 20.91% of the total market share. The demand for these consumables is driven by the need for single-use, disposable products that ensure the highest level of sterility and reduce the risk of contamination. This segment is expected to grow steadily as healthcare providers continue to prioritize infection control and patient safety.
Accessories encompass a range of products that support the sterilization process, such as racks, trays, and other equipment used in sterilization chambers. In 2025, the market value for accessories is forecasted to be $1,319.22 million USD, accounting for about 9.09% of the total market share. While this segment has a relatively smaller market share compared to others, it is essential for the efficient operation of sterilization processes. The growth in this segment is driven by the need for high-quality, durable accessories that enhance the effectiveness and reliability of sterilization systems.
Table Global Medical Device Sterilization Market Size and Share by Type in 2025
Type | Market Size (M USD) 2025 | Market Share 2025 |
|---|---|---|
Sterilization Instruments | 6523.77 | 44.93% |
Sterilization Services | 3640.34 | 25.07% |
Sterilization Consumables | 3036.50 | 20.91% |
Accessories | 1319.22 | 9.09% |
5 Global Medical Device Sterilization Market Size by Application
Hospitals and clinics are the major contributors to the medical device sterilization market. In 2025, their market revenue is projected to be 5494.03 million USD. This accounts for a significant share of 37.84% of the total market. The high demand in this sector is mainly due to the large – scale use of medical devices in daily patient care, surgeries, and diagnostic procedures. With the increasing number of patients seeking medical treatment globally, especially in the context of an aging population and the rising prevalence of chronic diseases, hospitals and clinics require a continuous supply of sterile medical devices. For example, surgical instruments, syringes, and catheters all need to be sterilized to prevent infections and ensure patient safety.
Medical device companies also play a crucial role in the sterilization market. In 2025, their market revenue is estimated to be 4784.84 million USD, with a market share of 32.95%. These companies are responsible for manufacturing a wide range of medical devices, from simple band – aids to complex imaging equipment. They need to ensure that their products are sterile before they reach the market. Many medical device companies have their own in – house sterilization facilities or outsource the sterilization process to specialized service providers. The development of new medical devices and the increasing quality control requirements also drive the demand for sterilization services in this sector.
Pharmaceutical companies have a notable share in the medical device sterilization market as well. In 2025, their market revenue is forecasted to be 2713.73 million USD, accounting for 18.69% of the total market. Pharmaceutical companies often need to sterilize equipment used in the production of drugs, such as vials, containers, and manufacturing machinery. Sterilization is essential to maintain the integrity and sterility of pharmaceutical products, ensuring that they are safe for human consumption. With the continuous growth of the pharmaceutical industry, especially in the development of biologics and vaccines, the demand for sterilization services in this area is also on the rise.
Table Global Medical Device Sterilization Market Size and Share by Application in 2025
Application | Market Size (M USD) 2025 | Market Share 2025 |
|---|---|---|
Hospitals & Clinics | 5494.03 | 37.84% |
Medical Device Companies | 4784.84 | 32.95% |
Pharmaceutical Companies | 2713.73 | 18.69% |
Others | 1527.23 | 10.52% |
6 Global Medical Device Sterilization Market Size by Region
North America is projected to lead the global medical device sterilization market in 2025, with a market size of $5,857.62 million USD. This region has a well-established healthcare infrastructure and stringent regulatory standards, which drive the demand for high-quality sterilization solutions. The presence of major medical device manufacturers and a high focus on research and development contribute to the region’s dominance in the market. The growth in North America is also supported by increasing healthcare expenditure and a growing awareness of the importance of sterilization in preventing healthcare-associated infections.
Europe is expected to have a market size of $4,609.1 million USD in 2025. The European market is characterized by a strong emphasis on quality and safety, leading to a high demand for advanced sterilization technologies. Countries in Europe are known for their robust healthcare systems and investment in medical research, which fosters the development of innovative sterilization methods. The European market is also influenced by the need to comply with European Union regulations, which mandate high standards for medical device sterilization.
The Asia-Pacific region is projected to have a market size of $3,519.03 million USD in 2025. This region is experiencing rapid growth due to factors such as increasing healthcare expenditure, growing awareness about the importance of sterilization, and the expansion of healthcare facilities. Countries like China and India are investing heavily in healthcare infrastructure, which is driving the demand for medical device sterilization services. Additionally, the Asia-Pacific region is becoming a hub for medical device manufacturing, further boosting the market for sterilization solutions.
Figure Global Medical Device Sterilization Market Size (M USD) by Region in 2025
7 Global Medical Device Sterilization Market Analysis by Major Players
Steris PLC
Company Profile: Steris PLC, established in 1985, is headquartered in Mentor, Ohio, USA. The company has a strong global presence and is renowned for its infection prevention solutions and procedural products.
Business Overview: STERIS is a leading provider of innovative capital equipment products such as sterilizers, washers, surgical tables, lights, and equipment management systems. They also offer connectivity solutions like operating room integration and a range of consumable products including detergents and gastrointestinal endoscopy accessories. Additionally, STERIS provides services such as equipment installation and maintenance, microbial reduction of medical devices, instrument and scope repair solutions, laboratory services, and off-site reprocessing.
Product Offered: Steris offers a variety of sterilization products including the AMSCO 400 SMALL STEAM STERILIZERS, which are designed for quick turnaround in operating rooms or sterile processing departments (SPDs). These sterilizers can process up to three, 25 lb trays at once and accommodate larger bariatric and orthopedic devices, making them ideal for various healthcare settings.
Advanced Sterilization Products Services Inc.
Company Profile: Advanced Sterilization Products Services Inc. (ASP) was founded in 1987 and is based in Irvine, California, USA. The company has core sites in Everett, Washington, and Schaffhausen, Switzerland, with additional offices worldwide.
Business Overview: ASP is a global leader in infection prevention solutions for healthcare. They specialize in advanced products, technologies, and workflows for medical sterilization and disinfection. ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities by ensuring the safety and sterility of medical devices.
Product Offered: One of ASP’s key products is the STERRAD NX® System with ALLClear® Technology, which utilizes hydrogen peroxide gas plasma sterilization technology. This system enhances patient and staff safety by actively breaking down hydrogen peroxide, reducing emissions exposure. It includes two sterilization cycles – STANDARD and ADVANCED – designed to sterilize a variety of medical devices, supported by device validations in collaboration with medical device manufacturers.
3M Company
Company Profile: The 3M Company, established in 1902, is an American multinational conglomerate based in Maplewood, Minnesota. The company operates in various fields including industry, worker safety, healthcare, and consumer goods.
Business Overview: 3M produces over 60,000 products under several brands. Their products range from adhesives and abrasives to personal protective equipment and medical products. The company is known for its innovation and diversity in product offerings across multiple sectors.
Product Offered: 3M offers the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496VF, which provides biological indicator (BI) results in just 24 minutes using 3M Attest 490/490H Auto-readers with software version 4.2.7 or greater. This product is designed to ensure the effectiveness of sterilization processes, meeting ISO and FDA performance requirements for biological indicators.