Global Medical Device Sterilization Market Overview
As per MRFR analysis, the Medical Device Sterilization Market Size was estimated at 12.94 (USD Billion) in 2022. The Medical Device Sterilization Market is expected to grow from 14.01 (USD Billion) in 2023 to 28.55 (USD Billion) by 2032. The Medical Device Sterilization Market CAGR (growth rate) is expected to be around 8.23% during the forecast period (2024 - 2032).
Key Medical Device Sterilization Market Trends Highlighted
The Medical Device Sterilization Market is witnessing a surge in demand driven by factors such as the rising prevalence of healthcare-associated infections (HAIs), stringent regulatory mandates, and technological advancements in sterilization techniques.
These trends have created significant opportunities for manufacturers to develop and offer innovative solutions for effective device sterilization.
The growing adoption of minimally invasive procedures, increased awareness of infection control, and the expansion of healthcare infrastructure in emerging markets are further propelling market growth.
With the continuous need for safe and reliable sterilization methods, the medical device sterilization market is expected to remain robust and present numerous opportunities for market players.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Medical Devices Sterilization Market Drivers
Increasing Demand for Sterile Medical Devices
The leading driver of the Medical Device Sterilization Market is the growing demand for sterile medical devices. It is mainly caused by an increasing number of factors, such as the escalation of healthcare-associated infections, the augmentation of surgical procedures, and the spreading of awareness of infection control.
HAIs are a considerable issue for the healthcare system since they may lead to substantial morbidity and mortality for patients, as well as the consumption of additional healthcare resources. Therefore, the sterilization of medical devices is essential to avoid HAIs, and the growing demand for sterile devices will produce an impact on the expansion of the medical device sterilization market.
The second factor of the growth of the Medical Device Sterilization Market is the increasing number of surgical procedures. The population ageing will contribute to the number of surgeries, and this factor will result in growing need for sterile medical devices.
The third driver of the medical device sterilization market is the increasing awareness of the issue of infection control. Healthcare providers are becoming more and more concerned with the problem of healthcare facility-associated infections, and as a result, they employ stricter sterilization practices.
This development will also lead to an increasing demand for sterilization services. The Medical Device Sterilization Market will maintain its growth course in the future.
The multidimensional demand for the growth is caused by the increasing demand for sterile medical devices, the augment of surgical procedures, and spreading awareness of the problem of infection control.
Technological Advancements in Sterilization Techniques
Technological advancements in sterilization techniques are another major driver of the Medical Device Sterilization Market. These advancements are leading to the development of more effective and efficient sterilization methods, which are reducing the cost of sterilization and making it more accessible to healthcare providers.
One of the most significant technological advancements in sterilization techniques is the development of low-temperature sterilization methods.
These methods use lower temperatures to sterilize medical devices, which reduces the risk of damage to the devices. Low-temperature sterilization methods are also more energy-efficient than traditional sterilization methods, which can lead to cost savings for healthcare providers.
Another significant technological advancement in sterilization techniques is the development of plasma sterilization methods. Plasma sterilization methods use plasma to sterilize medical devices.
Plasma is an ionized gas, and it is a very effective sterilizing agent. Plasma sterilization methods are also relatively fast and efficient, which can lead to time savings for healthcare providers.
The development of new sterilization techniques is expected to continue to drive the growth of the Medical Device Sterilization Market. These new techniques are more effective, efficient, and affordable than traditional sterilization methods, which is making them more attractive to healthcare providers.
Stringent Regulatory Requirements
There is also an increasing stringency of regulatory requirements that are helping to drive the global market for medical device sterilization. These requirements are put in place to ensure that medical devices are safe and effective, and they are becoming increasingly stringent in many countries.
The most important of these requirements are those that are imposed by the US Food and Drug Administration. The FDA requires that any medical device that is sold in the US must be sterilized in accordance with its Good Manufacturing Practices.
These GMPs are important in ensuring that devices are produced in such a way as to minimize the risk of contamination and infection. In addition to the FDA GMPs, there are also many other regulatory requirements that apply to medical device sterilization.
These requirements vary from country to country, but they all serve the same purpose as the GMPs. In the future, the range of regulatory requirements may become even more stringent, and this is expected to drive the continued growth of the Medical Device Sterilization Market.
This is because more and more medical devices are being used, and healthcare providers are being increasingly required to use sterile equipment. This will increase the need for medical devices to be sterilized and will drive the growth of the medical device sterilization market.
Medical Device Sterilization Market Segment Insights
Medical Device Sterilization Market Sterilization Technology Insights
The Medical Device Sterilization Market is segmented by sterilization technology, such as the EO Sterilization Market, Gamma Radiation Sterilization Market, E-Beam Sterilization Market, Plasma Sterilization Market, and VHP Sterilization Market.
Ethylene Oxide Sterilization is one of the most widely used methods, accompanied by its proficiency and adequate material compatibility; this method is extensively adopted and beneficial for sterilizing various medical devices, including heat-sensitive exposure and delicate components.
A substantial enhancement in the Global EO sterilization market is expected to take place due to its efficiency and regulatory reasons.
On the other hand, Gamma Radiation Sterilization can be conducted by using high-energy gamma rays; this sterilization offers excellent penetration; thus, complex medical devices with irregular shapes or internal modules can be treated by such technology.
The global demand for gamma radiation sterilization is projected to increase primarily due to its reliability and credibility in the medical community. E-beam sterilization is a method during with highly controllable and localized for the killing of microorganisms applied; thus, the potential impact on device materials is minimized.
The corresponding E-beam sterilization market is expected to increase due to enhanced capabilities and technological advancements.
Plasma Sterilization uses a low-temperature plasma to destroy all the microorganisms; another reason for this kind of sterilization popularity is the rapid time frames; in addition, it is extremely gentle; thus, plasma is adopted to treat the moisture-sensitive medical devices.
Finally, Vaporized Hydrogen Peroxide sterilization can be applied by using vaporized hydrogen peroxide. The method can achieve the proficiency in the killing of bacteria and viruses; therefore, it is used for sterilizing medical devices with complex geometries or inapprehensible or inaccessible areas.
Trends of the Medical Appliance Sterilization Market are determined by technological advancements, increased pervasiveness of hybrid surgical rooms, and rising demand for minimally invasive operations.
All types of sterilization are placed on the market due to their unique peculiarities, advantages, and distinctive functions, which are adequate for particular kinds of medical devices.
Therefore, the tendency toward research and development and product modifications of the companies will have a positive impact on the Medical Device Sterilization Market in the long term.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Medical Device Sterilization Market Device Type Insights
The Medical Device Sterilization Market Segmentation by Device Type sheds light on the market’s revenues emanating from varied sterilization requirements of different types of medical devices. In 2023, implantable devices continued to have the highest need for sterilization due to their direct exposure to the body, accounting for a considerable share of the market’s revenue.
Non-implantable devices, which are used externally or through minimally invasive procedures, will also require effective sterilization to avoid infections. Surgical instruments are used for making incisions, dissecting tissues, and otherwise piloting the procedure, and their sterility is paramount to reducing the risk of surgical site infections.
Hospital equipment is used on patients and sometimes on staff with a high frequency and must be sterilized to inhibit bioburden in that hospital. Medical consumables are disposable medical items, and they must be cost-effectively sterilized.
Defining the very particular requirements of these different types of devices is vital for manufacturers since they can thus create medical devices through sterilization effectively while responding to the industry's need for increasingly effective and reliable methods.
Medical Device Sterilization Market Application Insights
The Medical Device Sterilization Market is segmented by Application into Terminally Sterilized Products, Aseptically Processed Products, Heat Sensitive Products, Radiations Sensitive Products, and Packaging for Medical Devices.
Among these segments, Terminally Sterilized Products held the largest market share in 2023, accounting for over 40% of the global market revenue.
The growth of this segment is attributed to the increasing demand for terminally sterilized products, such as surgical instruments, implants, and medical devices, due to their ability to withstand high temperatures and harsh chemicals.
Aseptically Processed Products segment is also expected to witness significant growth over the forecast period, owing to the growing adoption of aseptic processing techniques in the pharmaceutical and biotechnology industries.
Medical Device Sterilization Market Regional Insights
Regionally, North America accounted for the largest revenue share in 2023, owing to the presence of major medical device manufacturers, stringent regulatory frameworks, and advanced healthcare infrastructure.
Europe is another significant market driven by government initiatives to promote patient safety and the rising adoption of minimally invasive surgical procedures.
APAC is expected to witness the fastest growth rate due to the increasing demand for medical devices, expanding healthcare facilities, and growing disposable incomes.
South America and MEA are also expected to contribute to the market growth, driven by the rising healthcare expenditure and the increasing prevalence of chronic diseases.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Medical Device Sterilization Market Key Players and Competitive Insights:
An increasing number of companies are investing in the development of innovative medical device sterilization solutions. Leading players in the medical device sterilization market are focusing on expanding their product portfolios and entering into strategic partnerships to maintain their market position.
The development of the medical device sterilization market is primarily driven by the rising demand for medical devices, stringent regulations, and increasing awareness regarding infection control. The medical device sterilization market competitive landscape is anticipated to remain highly competitive, with major players investing heavily in research and development to maintain their product offerings.
Stryker is a key player in the medical device sterilization market. The company offers a wide range of sterilization solutions for medical devices, including steam, ethylene oxide, and hydrogen peroxide sterilization.
Stryker operates a global network of sterilization facilities and offers personalized services tailored to customer-specific requirements. Their high-quality sterilization services have to be met the most stringent regulations.
3M is one of the leaders in the medical device sterilization market. It supplies a broad range of sterilizers and related products and services for medical devices. 3M’s sterilization solutions include steam sterilizers, ethylene oxide sterilizers, and hydrogen peroxide sterilizers.
3M sterilization products and accessories, such as wraps, pouches, and indicators. 3M is a global company that supplies and provides sterilization services in more than 100 countries. The company’s offerings are in line with the ongoing trends in sterilizers, which favor energy-efficient, lightweight, and low-maintenance products.
Key Companies in the Medical Device Sterilization Market Include:
Medical Device Sterilization Market Developments
The Medical Device Sterilization Market is poised to experience substantial growth in the coming years, driven by increasing demand for sterile medical devices and the rising prevalence of healthcare-associated infections.
Key factors contributing to this growth include stringent regulatory requirements for medical device sterilization, technological advancements in sterilization methods, and the expansion of the healthcare industry in emerging economies.
Notable recent developments in the market include the increasing adoption of low-temperature sterilization techniques such as ethylene oxide (EO) sterilization and the growing popularity of contract sterilization services.
Furthermore, the COVID-19 pandemic has highlighted the critical importance of effective medical device sterilization to prevent the spread of infections.
Medical Device Sterilization Market Segmentation Insights
Medical Device Sterilization Market Sterilization Technology Outlook
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Ethylene Oxide (EO) Sterilization
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Gamma Radiation Sterilization
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Electron Beam (E-Beam) Sterilization
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Plasma Sterilization
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Vaporized Hydrogen Peroxide (VHP) Sterilization
Medical Device Sterilization Market Device Type Outlook
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Implantable Devices
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Non-Implantable Devices
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Surgical Instruments
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Hospital Equipment
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Medical Consumables
Medical Device Sterilization Market Application Outlook
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Terminally Sterilized Products
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Aseptically Processed Products
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Heat Sensitive Products
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Radiations Sensitive Products
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Packaging for Medical Devices
Medical Devices Sterilization Market Regional Outlook
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North America
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Europe
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South America
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Asia Pacific
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Middle East and Africa
| Report Attribute/Metric |
Details |
| Market Size 2022 |
12.94(USD Billion) |
| Market Size 2023 |
14.01(USD Billion) |
| Market Size 2032 |
28.55(USD Billion) |
| Compound Annual Growth Rate (CAGR) |
8.23% (2024 - 2032) |
| Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Base Year |
2023 |
| Market Forecast Period |
2024 - 2032 |
| Historical Data |
2019 - 2023 |
| Market Forecast Units |
USD Billion |
| Key Companies Profiled |
STERIS Corporation, Cantel Medical, Advanced Sterilization Products, Johnson Johnson, Sotera Health, Thermo Fisher Scientific, Boston Scientific, STERIS, Allmed Healthcare, Cardinal Health, Medtronic, Stryker, Stericycle, Getinge, Sterigenics |
| Segments Covered |
Sterilization Technology, Device Type, Application, Regional |
| Key Market Opportunities |
Growth in Minimally Invasive Surgeries Technological Advancements Increasing Medical Device Reusability Rising Healthcare Expenditure in Emerging Economies Growing Geriatric Population |
| Key Market Dynamics |
Rising demand for minimally invasive procedures, increasing prevalence of healthcare-associated infections, technological advancements, stringent regulatory requirements, and the growing adoption of single-use medical devices |
| Countries Covered |
North America, Europe, APAC, South America, MEA |
Frequently Asked Questions (FAQ) :
The Global Medical Device Sterilization Market was valued at 14.01 billion USD in 2023 and is projected to reach 28.55 billion USD by 2032, exhibiting a CAGR of 8.23% during the forecast period.
North America held the largest market share, accounting for over 40% of the global revenue in 2023.
The single-use medical devices segment is anticipated to register the highest growth rate, owing to the increasing adoption of disposable medical devices to prevent cross-contamination.
Key competitors include Sterrad, Getinge, 3M, Ethylene Oxide Sterilization Services, and Sotera Health.
Rising prevalence of healthcare-associated infections, growing demand for sterile medical devices, and stringent regulatory requirements are driving the market growth.
Environmental concerns associated with ethylene oxide sterilization, high capital investment requirements, and potential device damage during sterilization pose challenges to the market.
Advanced sterilization technologies such as hydrogen peroxide gas plasma and electron beam sterilization are gaining traction due to their effectiveness and environmental friendliness.
Technological advancements are driving innovation in sterilization methods, leading to improved efficiency, reduced costs, and enhanced patient safety.
The Asia-Pacific region is projected to witness significant growth due to rising healthcare expenditure, increasing healthcare infrastructure, and a growing population in need of medical devices.
Stringent regulatory requirements, such as ISO 13485 and FDA guidelines, ensure the safety and efficacy of medical device sterilization processes.
