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Market Overview

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The global sterilization equipment market was valued at USD 8.2 billion in 2021 and is projected to reach USD 13.7 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 8.95% during the forecast period from 2022 to 2027. Sterilization refers to the complete elimination or destruction of all microbial life forms, achieved through various methods utilizing sterilization equipment. Medical devices undergo sterilization using different techniques such as moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other methods like chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.

Sterilization plays a crucial role in infection control measures within hospitals. Given the significant number of surgeries conducted daily and the increasing complexity of invasive procedures, medical devices or surgical instruments that come into contact with sterile tissue or mucous membranes pose an elevated risk of introducing pathogens into patients’ bodies. Additionally, there is a potential for transmission of infections between patients or between patients and medical staff, as well as through improperly sterilized or disinfected products originating from the patient’s environment. Numerous outbreaks and infections have been reported in hospitals due to inadequately sterilized equipment. Improper sterilization of endoscopes, in particular, has led to the occurrence of infectious diseases worldwide. Hence, proper decontamination techniques for medical and surgical equipment are essential requirements for all healthcare facilities, with healthcare providers being responsible for reducing and eliminating such infections.

The use of sterilization processes extends to various sectors such as pharmaceutical and biotech companies, medical device companies, research laboratories, food and beverage companies, ambulatory settings, and infection control service providers. The healthcare sector’s growing demand for innovative medicines and therapeutic procedures drives research and development activities in laboratories and pharmaceutical and biotech companies, thereby fueling the growth of the sterilization equipment market. Additionally, the consumption of preserved food and beverages continues to rise in modern lifestyles, prompting industry players to adopt sterilization procedures to prevent contamination and ensure extended product shelf life.

Medical devices are utilized for the diagnosis and treatment of multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes, and laryngoscopes. Reusable devices can become contaminated with microbes during patient use, necessitating reprocessing to eliminate the risk of infection from these devices. Reprocessing involves a detailed, multi-step process that includes cleaning, disinfection, and sterilization. When the reprocessing instructions provided by the device’s labeling are strictly followed each time the device is used, it can be safely reused with the same patient. Proper reprocessing of reusable medical devices is critical for ensuring patient safety. The increasing number of surgical procedures leads to the reuse of medical devices on multiple patients. Using unsterilized equipment across different procedures can spread infections or cause adverse reactions in patients. The high risk of infections associated with improper endoscope sterilization has significantly driven the demand for reprocessing equipment. The market for endoscope reprocessing is expected to flourish due to the focus on stringent cleaning standards and mounting pressures for sterilized and disinfected medical devices in hospitals and clinics.

Sterilization is increasingly being employed in hospitals and other healthcare facilities as a powerful technique to prevent the spread of coronavirus and drug-resistant bacteria. Sterile processing has always played a critical role in hospitals, particularly in containing the transmission of harmful pathogens. The COVID-19 pandemic has further emphasized the importance of thorough sterilization of medical instruments between patients, leading to changes in hospital processes and increased awareness of the need for proper sterilization.

An emerging trend in the industry is the exploration of alternatives to ethylene oxide (EO). The FDA supports the development of new approaches to medical device sterilization, with low-temperature technologies like hydrogen peroxide gas plasma, vaporized hydrogen peroxide, ozone, hydrogen peroxide, and nitrogen dioxide emerging as advanced options in the market. This trend presents significant opportunities for sterilization equipment market players to deliver safe and effective methods tailored to end-users’ requirements in the future.

Various national governments and international healthcare agencies are focused on introducing standardized guidelines to reduce healthcare-associated infections (HAI). The growing regulatory framework and stringent measures for reusing and reprocessing medical devices worldwide are driving the sterilization equipment market. Additionally, strict regulations pertaining to the launch of products for medical device sterilization are contributing to the growth of the sterilization equipment market.

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Market Segmentation

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The market is segmented based on various factors, including product type, sterilization method, end-user, and region.

Segmentation by Product Type
Equipment
Consumables

Segmentation by Sterilization Method:
Chemical
Radiation
Thermal
Others

Segmentation by End-User
Hospitals
Pharma & Biotech Companies
Medical Device Companies
Laboratories
Food & Beverage Companies
Others

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey

The market for sterilization equipment is divided into two segments: equipment and consumables. Currently, the equipment segment dominates the market and is expected to experience significant growth in the forecast period. This indicates an increasing demand for sterilization equipment compared to consumables. Key vendors in the market are focusing on introducing new and innovative technologies to meet the requirements of end-users. However, some key vendors are expanding their consumables operations to further their growth in the sterilization equipment market.

Sterilization can be achieved through various methods such as heat, chemicals, irradiation, high pressure, and filtration. Effective sterilization techniques are crucial as negligence can have serious consequences, even life-threatening. Chemical, radiation, thermal, and filtration methods are commonly used for sterilization. The chemical sterilization method integrated with low temperature is highly adopted by end-users in the market, with ethylene oxide playing a significant role. However, alternatives to reduce ethylene oxide emissions are emerging, leading to the growth of radiation sterilization as a competitive method, which is expected to drive the sterilization equipment market.

The importance of large-scale sterilization equipment in hospitals has been highlighted by recent epidemics of infectious diseases. As a result, the rise in healthcare-associated infections (HAI) encourages the adoption of innovative and advanced technologies by the hospital segment, contributing to market growth. Pharma and biotech companies also contribute to the market as different sterilization methods are applied to materials, equipment, and products with varying compositions and characteristics. Sterilization processes are being increasingly adopted in the food and beverage industries to prevent contamination and extend the preservation of food items. The medical devices companies’ segment is growing significantly due to the demand for sterile medical devices to control HAI.

North America is the leading market for sterilization equipment, with key players operating in the region. Factors driving the market in North America include a growing patient population, an increase in surgical procedures, stringent regulations mandating sterilization procedures, and the rise of offsite sterilization services due to the COVID-19 pandemic. Europe is the second-largest market, with countries like Germany, France, Italy, the UK, and Spain contributing significantly. Prominent market players, effective preventive measures, and high healthcare expenditure contribute to Europe’s significant market share. The region is experiencing significant growth due to stringent regulatory actions regarding the (re)use of medical devices to prevent HAI. Players in Europe are focused on delivering innovative and cost-effective sterilization equipment.

In the Asia-Pacific (APAC) region, factors fueling the growth of the sterilization equipment market include increased use of antimicrobial drugs/antibiotics, inappropriate sterilization practices, growing geriatric population, and R&D activities in research laboratories, pharma, and biotech companies. Most of the revenue in this region comes from developing countries. APAC is expected to grow at the highest compound annual growth rate (CAGR) during the forecast period.

Latin America and the Middle East and Africa represent low and middle-income countries. In these regions, stimulating factors for the sterilization equipment market include a large undertreated patient population, growing awareness of advanced management procedures, and non-compliance with government guidelines in Latin America and the Middle East and Africa.

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Competitive Landscape

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The global market for sterilization equipment exhibits a moderate level of competition. In recent years, there have been a few notable product innovations introduced to the market. One such innovation is sound-based sterilization, which offers an alternative to traditional sterilization techniques involving EtO and nitrogen oxide. Additionally, several start-ups have emerged, developing and launching new sterilization methods, particularly in the realm of low-temperature sterilization for medical implants and devices.

Market vendors are primarily focused on ensuring compliance with regulatory guidelines across different countries. For instance, in Austria, Germany, and various other European countries, sterilization processes are limited to dried herbs, spices, and condiments. Conversely, in Brazil, sterilization is permitted for all types of food products. Some developed countries have adopted a strategy of outsourcing sterilization services, as this proves to be more financially advantageous. Consequently, sterilization service providers in these countries are making significant investments in advanced sterilization equipment to enhance their service offerings to end users.

Key companies profiled in this report include 3M, Cardinal Health, Getinge, Steelco, STERIS, Acmas Technologies, Andersen Sterilizers, Belimed, B.M. S.r.l. Medical Equipment, ClorDisys Solutions, Cosmed Group, DE LAMA, Fortive, GPC Medical, Hubei CFULL Medical Technology, MATACHANA GROUP, MELAG Medizintechnik, Midmark, MMM Group, NovaSterilis, SCHLUMBOHM Medizin-Labor-Technologie, Sotera Health, Sterile Technologies, Stryker, Systec, Tuttnauer.

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Key Questions Answered

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HOW BIG IS THE STERILIZATION EQUIPMENT MARKET?

The sterilization equipment market is expected to reach USD 13.7 billion by 2027.

WHAT IS THE GROWTH RATE OF THE GLOBAL STERILIZATION EQUIPMENT MARKET?

The global sterilization equipment market is expected to grow at a CAGR of 8.95%.

WHO ARE THE KEY PLAYERS IN THE STERILIZATION EQUIPMENT MARKET?

3M, Cardinal Health, Getinge, Steelco, and STERIS.

WHICH REGION IS EXPECTED TO HOLD THE LARGEST SHARE IN THE STERILIZATION EQUIPMENT MARKET BY 2027?

North America will hold the largest share in the market by 2027.

WHAT ARE THE LATEST TRENDS IN THE STERILIZATION EQUIPMENT MARKET?

Upcoming sterilization methods for sensitive biomaterials, potential alternatives to ethylene oxide sterilization, and increasing adoption of sterilization using NO2 are the latest trends in the market.