Steam and Hydrogen Peroxide Biological Indicators Market

Report Description

Steam and Hydrogen Peroxide Biological Indicators Market Outlook 2032

The global steam and hydrogen peroxide biological indicators market size was USD 680.7 Million in 2023 and is likely to reach USD 1349.4 Million by 2032, expanding at a CAGR of 7.9% during 2024–2032. The market growth is attributed to the increased emphasis on sterilization in the food & beverage, biotechnology, and pharmaceutical industries as well as healthcare institutions.

The global market expansion for steam and hydrogen peroxide biological indicators is expected to be supported by strict government regulations aimed at preventing pollution and by the introduction of new products by major players during the forecast period.

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Biological indicators (BIs) are crucial in sterilization processes, ensuring the complete elimination of microorganisms. Steam and hydrogen peroxide BIs are two widely used types. Steam BIs are composed of highly resistant bacterial spores, such as Geobacillus stearothermophilus, and are commonly used in healthcare settings to validate autoclave sterilization of surgical instruments, medical devices, and other materials. They are reliable, cost-effective, and widely available, although require long incubation times for results.

Hydrogen peroxide BIs, contain Bacillus subtilis spores and are used in the pharmaceutical, cosmetics, and food industries to validate hydrogen peroxide vapor sterilization of cleanrooms, isolators, and packaging materials. They offer fast incubation times, although expected to be expensive and require careful consideration of compatibility with specific materials or products.

The choice between steam and hydrogen peroxide BIs depends on factors such as sterilization process type, validation speed, cost considerations, and material compatibility. Understanding these indicators allows for informed selection and optimal sterilization practices across various industries.

The market for steam and hydrogen peroxide biological indicators (BIs) is experiencing steady growth, due to increasing sterility concerns in various industries. Rising demand for sterile products, increasing adoption of hydrogen peroxide sterilization, technological advancements, and increasing awareness & training drive the market.

Impact of Artificial Intelligence (AI) in the Steam and Hydrogen Peroxide Biological Indicators Market

Integration of Artificial Intelligence (AI) has significantly impacted the steam and hydrogen peroxide biological indicators market by enhancing efficiency and accuracy in monitoring sterilization processes. AI algorithms are employed to analyze vast datasets generated during sterilization cycles, allowing for real-time tracking and validation of biological indicators. This expedites the decision-making process as well as ensures a higher level of precision in assessing the effectiveness of steam and hydrogen peroxide-based sterilization methods.

Predictive capabilities of AI contribute to proactive maintenance, minimizing downtime, and optimizing resource utilization. Moreover, AI facilitates the development of intelligent and adaptive systems that continuously improve sterilization protocols based on evolving trends and data patterns. Therefore, the adoption of AI in the steam and hydrogen peroxide biological indicators market is fostering advancements in sterilization technologies, ultimately boosting the overall quality and safety standards in healthcare and life sciences industries.

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Major Drivers

Growing need for sterilization services is driving the market revenue for steam and hydrogen peroxide biological indicators market. Moreover, increasing number of hospitals & clinics and  rise in surgical operations is boosting the market growth substantially. Additionally, rising microbial load in the environment and realization of the need for sterilizing are propelling the global steam and hydrogen peroxide biological indicators market. There is a significant need for surgical and reusable equipment, due to the rising incidence of chronic diseases and the increased emphasis on improving healthcare infrastructures across the globe.

• In January 2020, Advanced Sterilization Products (ASP) developed the Sterrad Velocity Biological Indicator, a quick biological indicator with a 15-minute result time, which was approved by the U.S. FDA.

Existing Restraints

High cost of the advanced indicators and the lack of affordability of small-scale healthcare laboratories restrain the market. The lack of awareness in remote cities, the availability of an alternate sterilization method and other environmental conditions related to the side effects of hydrogen peroxides are expected to hinder the market during the forecast period.

Emerging Opportunities

Rapid expansion of healthcare infrastructure in emerging economies offer growth opportunities in the market. Continuous R&D activities are leading to technological advancements and developing rapid, accurate, and user-friendly indicators that are creating new opportunities for the market players. Moreover, the collaborations and strategic partnerships among the key market players are leading to the discovery of new prospects, fostering the market growth. 

• In April 2022, the cessation of hydrogen peroxide biological indicators was announced by Etigam BV. The business is to concentrate more on steam biological indicators among other things and become well-known in the industry for the ongoing divisions.

• In December 2020, STERIS announced the availability of Spordex Self-contained Vials Biological Indicator (SCBI) Ampoules for steam sterilization.

Scope of the Steam and Hydrogen Peroxide Biological Indicators Market Report

The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have been included in the report.

Steam and Hydrogen Peroxide Biological Indicators Market Segment Insights

Product Segment Analysis

Based on product, the steam and hydrogen peroxide biological indicators market are sub segmented into spore suspension, self-contained vials, and spore strips. The self-contained vials segment is expected to dominate the  market during the forecast period. Its widespread acceptance in both developed and emerging nations boosts the segment. Self-contained vials are quick to use, providing dependable and regular results that guarantee efficient sterilization.

The spore strips segment is expected to expand with a growing revenue share during the forecast period. These strips are  preferred for sterilization monitoring in small clinics and healthcare facilities, due to their inexpensive cost, driving the segment.

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Application Segment Analysis

On the basis of application, the global steam and hydrogen peroxide biological indicators market is segmented into healthcare facilities, pharmaceutical & medical device companies, and others. The healthcare facilities segment dominated with a large market revenue share in 2023. High hospital patient traffic and rising infections lead to the increasing demand for advanced sterilization products across the globe. Healthcare facilities emphasize on sterilization, driving the segment.

The pharmaceutical and medical device companies segment is expected to register a high CAGR during the forecast period. These companies are expected to grow rapidly in the coming years, due to stringent sterilization laws enforced by governments.

End User Segment Analysis

On the basis of end users, the steam and hydrogen peroxide biological indicators market are segmented into hospitals & clinics, pharmaceuticals & biotechnology companies, research laboratories, and others. The hospitals and clinics segment was attributed to a high market revenue in 2023. This significant share of revenue is attributed to increasing number of patients and the need for reusable & surgical instruments globally. Additionally, there is a large prevalence of nosocomial infections and safety concerns regarding hazardous germs. 

The research laboratories segment is expected to register a significant CAGR in the coming years, due to the rising need for a sterile environment for performing contamination-free experiments. Researchers need to keep the environment contamination-free and avoid the cross-contaminations with other microbes, due to the large number of experiments conducted in research laboratories in which various microbes are used. Therefore, for eliminating the cross-contamination, the steam and hydrogen peroxides are needed in a large quantity in research laboratories, boosting the market.  

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Regional Outlook

In terms of region, the global steam and hydrogen peroxide biological indicators market is classified as Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa. North America dominates the global market with a large revenue share in 2023. This is attributed to the increased emphasis on sterilization placed by medical device, pharmaceutical, and healthcare facilities. The ongoing emphasis by the market players on developing novel biological indicators, such as steam and hydrogen peroxide, drive the market in the region.

• According to a 2021 Journal of the Canadian Dental Association article, in majority of the North America-based jurisdictions, testing at least once a week is advised when employing Biological Indicators (BIs) in general dentistry practices.

The market in Europe is expected to expand at a substantial growth rate in terms of revenue share during the forecast period. A significant number of elderly patients with chronic illnesses that require prolonged hospital stays contribute to the rising rate of hospital-acquired infection, and ultimately, increasing demand for hospital-acquired infections therapeutic  . Therefore, this increases the need for sterilization monitoring tools and supplies, such as steam and hydrogen peroxide biological indicators, and adds to the increased emphasis on the sterilization process in healthcare institutions.

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