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According to a recent industry report by market research and competitive intelligence source Fact.MR, the global sterility indicators market is expected to grow at a compound annual growth rate (CAGR) of 12.5% from 2023 to 2033, from its estimated US$ 1.07 billion in 2023.
Sterility indicators are used to explain how the sterilization process operates. The steam sterilization process is routinely qualified, load-monitored, and monitored using both biological and chemical sterility indicators. They also demonstrate whether the parameters of a steam autoclave cycle were appropriate for reaching a particular degree of microbial inactivation.
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'Biological indicators' are test systems that contain live bacteria that are known to be resistant to a specific sterilizing technique. They help determine whether the necessary number of germs was killed during the sterilizing process.
Why Is Demand for Sterility Indicators Rising Globally?
Hospital-acquired infections (HAIs), also known as nosocomial infections, occur in healthcare settings such as hospitals, nursing homes, and outpatient clinics. These infections are often transmitted through other patients, staff, or environmental factors, with surgical procedures being a common source due to opportunistic bacteria.
According to the World Health Organization (WHO), annually, 7 out of 100 hospitalized patients in industrialized nations and 10 in developing countries contract at least one HAI. The CDC's Healthcare-Associated Infection Progress Report 2020 reported 18,416 surgical site infections in the U.S., including 2,173 from hip arthroplasty and 6,094 from colon surgeries. Additionally, 1 in 25 hospitalized patients in the U.S. is diagnosed with an HAI each year.
The growing prevalence of surgical site infections and heightened awareness of sterility indicators' role in preventing HAIs are driving market growth. Biological indicators (BIs) are especially critical for sterilization quality control, ensuring optimal conditions to eliminate resistant germs.
What Is Hindering Sales of Sterility Indicators?
The use of ethylene oxide for sterilization poses significant health risks, which could limit sterility indicator sales. Exposure to this chemical can irritate the eyes, skin, and respiratory system, while acute exposure may lead to headaches, nausea, lung injuries, and breathing difficulties. Prolonged exposure is linked to serious conditions such as neurotoxicity, cancer, reproductive issues, and genetic mutations, raising concerns about its safety.
Moreover, technical issues with sterility indicators—such as difficulty detecting procedural errors, faulty equipment, non-compliance with standards, and high costs—also restrict market growth. These challenges, coupled with concerns over chemical exposure, impact the adoption of sterility indicators.
Why Is the North American Market Thriving?
North America leads the global sterility indicator market, with the U.S. and Canada emerging as lucrative regions. In Canada, demand is projected to grow at an 11% CAGR.
Factors driving growth include frequent launches of pharmaceuticals, medical devices, and biologics, along with favorable reimbursement policies. Additionally, the aging population, increasing prevalence of chronic diseases, and the presence of major industry players are boosting market performance.
Key Segments of Sterility Indicators Industry Research
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By Type :
- Biological
- Chemical
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By Sterilization Method :
- Heat
- Low Temperature
- Filtration
- Liquid
- Steam
- Radiation
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By End User :
- Hospitals
- Pharmaceutical Companies
- Medical Device Companies
- Clinical Laboratories / Research Centers
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By Region :
- North America
- Latin America
- Europe
- East Asia
- South Asia & Oceania
- MEA
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