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The global steam and hydrogen peroxide biological indicators market size was valued at USD 650.4 million in 2022. The market is projected to grow from USD 697.1 million in 2023 to USD 1,178.2 million by 2030, exhibiting a CAGR of 7.8% during the forecast period.
A Biological Indicator (BI) provides a direct measure of lethality and assurance in the efficacy of a sterilization process. Depending on specific type, biological indicators can be used for various sterilization processes using hydrogen peroxide, steam, ethylene oxide, and other gases.
The growing focus on sterilization in healthcare facilities, food and beverage, and biotechnology and pharmaceutical industries is the primary factor in augmenting the global market's growth. Moreover, stringent government regulations to prevent contamination and new product launches by key players favor the global steam and hydrogen peroxide biological indicators market growth during the forecast period.
Outbreak of COVID-19 Favored Growth in Sales of Products
The emergence of COVID-19 has accelerated the demand for sterilization and disinfectant products across pharmaceutical, biotech, and other companies involved in manufacturing healthcare technologies. The outbreak of COVID-19 has led the biotechnology and pharmaceutical companies to focus more on sterilization monitoring steps that have simultaneously increased the demand for steam and hydrogen peroxide biological indicators.
Additionally, the pandemic has exposed the need for sterilization monitoring in hospitals, dental clinics, and other healthcare facilities before loading medical instruments. The pandemic has also highlighted the importance of sterile and infection-free medical instruments during dental practice and invasive surgical procedures to avoid viral or bacterial Hospital-Acquired Infections (HAIs). Therefore, this led to an upsurge in demand and adoption of steam and hydrogen peroxide biological indicators. Thus, the global market witnessed positive growth in the financial year 2020.
Furthermore, the prominent players operating in the market also witnessed a significant increase in their revenue during the pandemic owing to increase in their product sales.
However, the market is expected to grow normally in the post-pandemic period due to various factors such as utilization of already stocked products, rise in surgical procedures, and growing focus to reduce the incidence of surgical site infections, among others.
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Shifting Preference Toward Rapid Biological Indicators is a Prominent Trend in the Market
Pharmaceutical and biotechnology industries are engaged in manufacturing healthcare products and are usually subjected to very strict regulations and standards to ensure the highest levels of sterility. Pharmaceutical industries are launching many parenteral drugs due to the rising prevalence of chronic diseases and the growing demand for them (including heart medications, antibiotics, and analgesics) due to their immediate therapeutic effect. Thus, continuous sterilization and monitoring are essential to facilitate the supply of sterile and safe products.
The increasing demand for rapid biological indicators over conventional products among drug and medical device manufacturers is increasing production efficiency. Conventional biological indicators are primarily self-contained and comprise spore strips, growth media, pH indicators, and others that require at least 72 h to 168 h of incubation for effective results.
However, the lesser result time offered by rapid biological indicators compared to conventional products is anticipated to raise their adoption among consumers. Moreover, the regulatory bodies have also approved rapid biological indicators, further supporting their demand in the coming years.
Growing Focus on Sterilization in Healthcare Facilities to Propel Market Growth
Globally, the chronic diseases’ increasing prevalence, increasing healthcare expenditure, and growing diagnoses have presented a large patient pool undergoing surgical procedures. For instance, according to the article “Action Framework for Safe and Affordable Surgery in the Western Pacific Region (2021–2030), published by the World Health Organization (WHO), there are 313 million surgeries performed every year worldwide.
This creates a huge demand for surgical instruments and reusable devices, such as clamps, scissors, forceps, and others, in healthcare facilities. A major risk of surgical procedures is the inception of pathogenic microbes, leading to a Hospital-Acquired Infection (HAI). To reduce the growing incidence of HAIs, regulatory bodies are focusing on applying various guidelines with an ever-increasing emphasis on sterilization in healthcare settings to ensure the safety of the patients and reduce the costs associated with HAIs. This subsequently leads to higher demand for new and advanced sterilizers by healthcare facilities globally.
The growing demand and adoption of sterilizers drive the demand for monitoring devices, including steam and hydrogen peroxide biological indicators. The factors, combined with innovations in the biological indicators by market players, facilitate the acceptance of these products in the market.
Presence of Alternate Products to Restrict Market Growth
Biological indicators have always been the foremost method of assessing the sterility of any medical or pharmaceutical environment by using the most resistant microorganism strains. However, alternate products, such as enzyme indicators with distinct functional benefits compared to biological and chemical indicators, are anticipated to limit the adoption of biological indicators.
Unlike the traditional biological indicators, enzyme indicators provide instant results, accurate data capture, are simple and easy to use, and are reasonably priced. Moreover, the enzyme indicates a non-toxicological risk and can be used in any part of the process.
Market players invest in R&D through strategic collaborations and acquisitions and seek approval for steam and hydrogen peroxide biological indicators.
All the above factors and the high cost of the steam and hydrogen peroxide biological indicators are restricting their adoption, further hampering the market growth in the forecast period.
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Self-contained Vials Segment to Hold a Dominant Share due to Growing Adoption Rate of Biological Indicators
Based on product type, the market is segmented into self-contained vials, spore strips, and spore-suspension.
The self-contained vials segment dominated the market share of global steam and hydrogen peroxide biological indicators. The dominance is driven by a higher adoption rate in both developed and developing economies due to the various benefits. Self-contained Biological Indicators (SCBIs) provide fast, visible, consistent, and reliable results that assure an effective sterilization process. This coupled with various novel and innovative product launches will boost market growth during the forecast period.
The spore strips segment will hold the second-largest market share during the forecast period. The comparatively lower cost of spore strips leads to higher demand for these products in sterilization monitoring for process challenge devices in small clinics and healthcare facilities.
Growing Focus on Sterilization in Healthcare Facilities Enabled Dominance of the Segment
Based on application, the market is segmented into pharmaceutical & medical device companies, healthcare facilities, and others.
The healthcare facilities segment dominated the global market in 2022. The segment's dominance is due to the rising number of healthcare facilities emphasizing the sterilization process due to the increasing prevalence of hospital-acquired infections.
The pharmaceutical & medical device companies segment accounted for the second-largest market share. Stringent government regulations to prevent contamination and undergo sterilization due to increased product recalls favor market growth in pharmaceutical & medical device companies during the forecast period.
North America Steam and Hydrogen Peroxide Biological Indicators Market Size, 2022 (USD Million)
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The North America market stood at USD 228.6 million in 2022. North America is expected to dominate the global steam and hydrogen peroxide biological indicators market share during the forecast period. The higher emphasis of healthcare facilities, pharmaceutical, and medical device companies on sterilization is primarily responsible for the region's dominance.
Additionally, the constant focus of market players on introducing innovative steam and hydrogen peroxide biological indicators is another major factor responsible for the dominance of North America in the forthcoming years.
Europe is anticipated to register a significant CAGR during the forecast period. A large pool of geriatric patients suffering from chronic disorders associated with longer hospital stays leads to increasing hospital-acquired infections in the region. Therefore, this contributes to the growing emphasis on the sterilization process in healthcare facilities and boosts the demand for sterilization monitoring devices/products, including steam & hydrogen peroxide biological indicators.
Asia Pacific is expected to register the highest CAGR during the forecast period. The rapid growth of pharmaceutical and medical device manufacturing in China, India, and other countries is driving the demand for sterilization in these countries. This simultaneously augments the need for biological indicators and favors market growth during the forecast period.
Latin America and the Middle East & Africa accounted for a comparatively lower market share attributable to less awareness among the population about steam & hydrogen peroxide biological indicators.
Strong Portfolio of Mesa Labs, Inc. and 3M to Help Them Lead the Global Market
The global market is consolidated with major players, including 3M, STERIS, ASP, Getinge, and Mesa Labs, Inc., comprising the largest global market share. 3M is the leading player in the global market, with the highest market share in 2022. The company’s dominant position in the global market is attributed to its robust distribution network, a strong portfolio of biological indicators, and a strong brand presence.
Other leading players, such as Steris and Getinge, are engaging in various strategic business activities to expand their product portfolio and geographical presence, contributing to their high market share.
Other players such as Tuttnauer, Bioquell, An Ecolab Solution, Terragene, and others continuously engage in strategic expansion initiatives to establish their footprints in emerging regions.
An Infographic Representation of Steam and Hydrogen Peroxide Biological Indicators Market
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The market research report provides a detailed market analysis. It focuses on key aspects such as leading companies, product type, and applications. Besides this, it offers insights into market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that contributed to the growth of the market in recent years.
CAGR of 7.8 % from 2023-2030
Value (USD million)
By Product Type, By Application, and By Geography
By Product Type
Fortune Business Insights says that the global market stood at USD 650.4 million in 2022 and is projected to reach USD 1,178.2 million by 2030.
In 2022, the market size in North America was USD 228.6 million.
The market will exhibit steady growth at a CAGR of 7.8% during the forecast period (2023-2030).
By product type, the self-contained vials segment will lead the market.
The growing focus of healthcare facilities & pharmaceutical companies on sterilization and the increasing product launches are the key drivers of the market.
3M, STERIS, ASP, Getinge, and others are the top players in the market.
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