Sterility Indicators Market

Sterility Indicators Market Analysis By Type (Biological, Chemical), By Sterilization Method (Heat, Low Temperature, Filtration, Liquid, Steam, Radiation), By End User (Hospitals, Pharmaceutical Companies, Medical Device Companies, Others), & By Region - Global Market Insights 2023-2033

Analysis of Sterility Indicators Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Sterility Indicators Market Outlook (2023-2033)

The global sterility indicators market is valued at US$ 1.07 billion in 2023. Worldwide sales of sterility indicators are predicted to increase at an impressive CAGR of 12.5% and reach a market valuation of US$ 3.47 billion in 2033.

Sterility indicators are classified into chemical and biological indicators. Global demand for chemical sterility indicators is expected to rise at a comparatively higher CAGR of 14% from 2023 to 2033.

Chemical sterility indicators are further segmented into class 1 to class 5 indicators. Indicators from classes 1 and 2 are often used in steam and ETO sterilization processes. Due to their expanding use, these indicators are anticipated to continue their dominance in the market over the forecast period. Tapes, strips, and other items are the subcategories of class 1 indicators.

Sales of biological sterility indicators are predicted to progress at a CAGR of 11% during the forecast period. Products including spore ampoules, spore suspensions, self-contained vials, and spore strips are all sub-segments of biological sterility indicators.

In contrast to chemical indicators, biological indicators provide accurate data. These are regarded as the industry's gold standard for evaluating sterilization. Compared to other types, spore ampoules are utilised a lot. They can be used in a variety of sterilization processes, including radiation sterilization, filtration sterilization, low-temperature sterilization, steam sterilization, and liquid sterilization.

Spores and a pH indicator are found in the ampoules. After the sterilization process, these indicators are incubated and examined for the presence of the acid that spores create.

Sterilization procedures are used to eliminate all living organisms as well as other external or biological agents that may be present, such as germs, viruses, fungi, pathogens, spore forms, etc. Different methods of sterilization include the use of heat, chemicals, radiation, high pressure, and filtration.

Global biological indicators incubators are used to eliminate bacterial growth and storage conditions. Lab incubators and microbiological incubators are two separate types of biological indicator incubators that are used for various purposes.

The biological indicator incubator eliminates pollution and offers better or more appropriate conditions for biological and chemical reactions. The biological indicator incubator helps to monitor it while the incubators maintain the ideal humidity, temperature, carbon dioxide, and oxygen contents of the interior atmosphere.

The market is expected to increase rapidly over the coming years due to rising R&D activities and advancements in the medical sector. In addition, it is projected that the demand for medicines and medical devices is likely to rise rapidly due to the increasing prevalence of chronic diseases such as cancer, diabetes, arthritis, and asthma.

Report Attributes


Market Size (2023E)

US$ 1.07 Billion

Forecasted Market Value (2033F)

US$ 3.47 Billion

Global Market Growth Rate (2023-2033)

12.5% CAGR

China Market Growth Rate (2023-2033)

16% CAGR

Japan Market Growth Rate (2023-2033)


Germany Market Growth Rate (2023-2033)

10% CAGR

Key Companies Profiled

  • 3M Company
  • Anderson Products, Inc
  • Cantel Medical Corporation
  • Cardinal Health
  • Getinge Ab
  • GKE-GmbH
  • Hu-Friedy Mfg. Co., LLC
  • Matachana Group
  • Mesa Laboratories
  • Propper Manufacturing Co., Inc
  • Steris Plc

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Why is Demand for Sterility Indicators Increasing across the World?

“Growing Risk of Hospital-acquired Infections”

Nosocomial infections, commonly referred to as hospital-acquired infections (HAIs), are contracted in hospitals, nursing homes, outpatient clinics, rehabilitation centers, or clinical settings. In clinical settings, there are several ways that infection is transmitted to susceptible patients.

Other sick patients, staff members, or environmental factors might all be the source of the infection. Nosocomial infections can commonly be caused by opportunistic bacteria that are the result of surgeries or any other medical procedures.

  • The World Health Organization (WHO) estimates that, out of every 100 hospitalised patients, seven patients in industrialised countries and ten patients in developing countries would develop at least one hospital-acquired infection annually.
  • According to the Healthcare Associated Infection Progress Report 2020 from the Centers for Disease Control and Prevention, there were roughly 18,416 surgical site infections recorded in the United States in 2020. In addition, it said that 2,173 of these infections occurred during hip arthroplasty and 6,094 occurred during colon surgery.
  • According to the same source, in American hospitals, at least one in every 25 patients receives a diagnosis of HAI every year.

The market is expanding quickly due to the rising occurrence of surgical site infections and the consequent demand for HAI prevention solutions. The sales growth is increasing as awareness of sterility indicators' capacity to prevent infections in hospitals has improved. Therefore, biological indicators (BI) are crucial for sterilization quality control in hospitals because they can accurately determine whether the sterilizing conditions are ideal for eliminating the most resistant germs.

“Rising Prevalence of Infectious Diseases”

The prevalence of infectious diseases is increasing rapidly, recent COVID-19 pandemic has shown very adverse effects on society. Rising awareness by public and private organizations about infectious diseases, increasing investments in R&D activities, and advancements in medicines are boosting the demand for medical products for target infections.

  • For instance, the World Health Organization's (WHO) Global Tuberculosis Report 2021 data shows that the majority of tuberculosis cases were found in South-East Asia (43%), Africa (25%), and the Western Pacific (18%), while the Eastern Mediterranean (8.3%), the Americas (3.0%), and Europe (2.3%) saw fewer rises in cases.
  • According to the same source, Sub-Saharan Africa was estimated to continue to bear the brunt of malaria, which accounted for 96% of deaths of overall cases in 2021.

Over the past few years, the terminal sterilization market has drawn attention due to growing awareness of diseases and infections brought on by unsterile environments.

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What is Negatively Influencing the Sales of Sterility Indicators?

“Increasing Risks Associated with Ethylene Oxide Sterilization Process”

Sales of sterility indicators could be hampered due to the increasing awareness of the side effects associated with the use of ethylene oxide. In particular, exposure to ethylene oxide has negative consequences on human health. It can irritate the eyes, nose, throat, lungs, and skin.

It is well known that acute exposure can cause a headache, nausea, vomiting, lung injuries, diarrhoea, breathing difficulties, and cyanosis. While prolonged exposure to ethylene oxide causes neurotoxicity, cancer, mutagenic alterations, and reproductive problems. These health hazards connected to using ethylene oxide for sterilization may restrain the market growth.

Additionally, flaws in sterility indicator equipment such as the inability to recognize procedural issues, challenging package configuration in the load, defective sterilization equipment, non-compliance with sterilization standards, high device costs, and chemical exposure hamper the demand for sterility indicators.

Sterility Indicators Market Forecast by Fact.MR

Country-wise Analysis

Why is the North American Market Performing So Well?

“Presence of Key Market Players and Rising Cases of Chronic Disorders”

North America currently dominates the global market. U.S. and Canada both are expected to be profitable marketplaces for sterility indicator producers. Demand for sterility indicators is expected to increase at a high CAGR of 11% in Canada.

Standard product launches of pharmaceuticals, medical equipment, and biologics as well as positive reimbursement policies are booting the sales of sterility indicators in the region. The rapidly growing rate of the ageing target patient population, increasing cases of chronic diseases, and the presence of leading companies are driving regional market growth.

Will Europe be a Lucrative Market for Sterility Indicators?

“Presence of Advanced Healthcare Facilities and Rapid Development of Effective Solutions”

The Europe sterility indicators market is predicted to grow at a rapid pace during the forecast period. The U.K., Germany, France, and Italy are very beneficial countries for the medical tourism industry. Sales of sterility indicators are anticipated to rise at a CAGR of 10% during the next 10 years.

The availability of advanced healthcare facilities, the rising healthcare spending power of the population, and rising sterilization awareness are driving the growth of the regional market. The presence of numerous industry players who are committed to creating innovative, efficient solutions to enhance sterilization control in hospitals and pharmaceutical firms would improve the outlook for the regional market.

Where is Demand for Sterility Indicators Higher?

“Rapidly Advancing Medical Sector”

Asia Pacific is expected to be the fastest emerging market for sterility indicators. Local manufacturers are widely spread in China, South Korea, Japan, and India, and are providing affordable alternatives and escalating rivalry. The rapidly developing medical industry is attracting several target patients, availability of effective treatment at an effective cost boosts the regional market growth.

New biologics and sensitive goods are actively being developed by the biopharmaceutical industry. The bulk of treatments in newly commercialized biologics is designed in parenteral dose forms. It is anticipated that the rise in parenteral dosage manufacturing throughout the biopharmaceutical sector will generate new opportunities in the sterility indicators market in the Asia Pacific.

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Category-wise Analysis

Which End User Accounts for High Sales of Sterility Indicators?

“Growing Levels of R&D Activities Performed in Pharmaceutical Companies”

Based on end users, the sterility indicators market is segmented into hospitals, pharmaceutical companies, medical device companies, and clinical laboratories/research centers.

Pharmaceutical companies currently hold more than 24% of revenue share as a result of the increasing rate of sterility testing as part of quality control during product manufacturing using sterility indicators.

Pharmaceutical businesses can test a wide range of applications using chemical and biological indicators. For instance, they use biological indicators in process challenge devices (PCD) for traditional autoclave sterilization testing, and the successful results demonstrate an efficient sterilization cycle. Pharmaceutical businesses are driving up demand for these products due to the rising level of R&D activities.

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Competitive Landscape

Some of the key players in the sterility indicators market are 3M Company, Anderson Products, Inc, Cantel Medical Corporation, Cardinal Health, Getinge Ab, GKE-GmbH, Hu-Friedy Mfg. Co., LLC, Matachana Group, and Mesa Laboratories.

To enter emerging markets including those in the Asia Pacific, the Middle East, and Africa, leading companies are working arduously to develop sophisticated, affordable indicators. Top market players are constantly utilizing new technologies to provide improved healthcare services through the introduction of smart indicators which follows the respective government’s norms.

  • The Attest Mini Auto-reader 490M, a 24-minute in-house sterilization monitoring system, was introduced by the 3M company in July 2020. This technology is useful for the dental sterilization process.

Key Segments of Sterility Indicators Industry Research

  • By Type :

    • Biological
    • Chemical
  • By Sterilization Method :

    • Heat
    • Low Temperature
    • Filtration
    • Liquid
    • Steam
    • Radiation
  • By End User :

    • Hospitals
    • Pharmaceutical Companies
    • Medical Device Companies
    • Clinical Laboratories / Research Centers
  • By Region :

    • North America
    • Latin America
    • Europe
    • East Asia
    • South Asia & Oceania
    • MEA

- FAQs -

What is the market value of sterility indicators in 2023?

The global sterility indicators market is valued at US$ 1.07 billion in 2023.

What is the estimated growth rate for the sterility indicators market?

Global demand for sterility indicators is predicted to increase at an impressive CAGR of 12.5% through 2033.

What valuation is the sterility indicators market expected to reach by 2033?

Global sales of sterility indicators are projected to reach US$ 3.47 billion by 2033.

How will North America emerge as a lucrative avenue for the sterility indicators market?

Rapidly growing rate of the senior population and increasing cases of chronic disorders are boosting regional market growth.

Which companies form the competitive landscape of the sterility indicators industry?

3M Company, Anderson Products, Inc, Cantel Medical Corporation, and Cardinal Health are some of the leading companies in the market.

Sterility Indicators Market

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