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Steam and Hydrogen Peroxide Biological Indicators Market Size, Share & COVID-19 Impact Analysis, By Product Type (Self-contained Vials, Spore Strips, and Spore-suspension); By Application (Pharmaceutical & Medical Device Companies, Healthcare Facilities, and Others), and Regional Forecast, 2021-2028

Region : Global | Format: PDF | Report ID: FBI105204



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The global steam and hydrogen peroxide biological indicators market size was valued at USD 553.1 million in 2020 and is projected to grow from USD 594.4 million in 2021 to USD 1,051.4 million in 2028, exhibiting a CAGR of 8.5% during the 2021-2028 period. Based on our analysis, the global market will exhibit a stellar growth of 16.2% in 2020. The global impact of COVID-19 has been unprecedented and staggering, with steam and hydrogen peroxide biological indicators witnessing a positive demand shock across all regions amid the pandemic. The sudden fall in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

A biological indicator (BI) provides a direct measure of lethality and assurance in the efficacy of a sterilization process. Depending on the 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, pharmaceutical & biotechnology, food and beverage industries is the primary factor in augmenting the global market's growth. Moreover, stringent government regulation to prevent contamination, coupled with new product launches by key players, favors 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 the 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 the medical instruments for the process. 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 the demand and adoption of steam and hydrogen peroxide biological indicators, and thus, the global market witnessed a positive growth in the financial year 2020.


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Increasing Adoption of Biological Indicators in Pharmaceutical Industries is a Prominent Trend

Pharmaceutical and biotech industries are engaged in manufacturing healthcare products and are usually subjected to very strict regulations and standards to ensure the highest levels of sterility assurance. Pharmaceutical industries are launching many parenteral drugs due to the rising prevalence of chronic diseases and the growing demand for these drugs (including heart medications, antibiotics, and analgesics) due to their immediate therapeutic effect. Parenteral drug products are required to be free from viable microorganisms, pyrogenic substances, and visible particulates, thus requiring highly sterile conditions.

These factors and established guidelines and regulations in manufacturing facilities have led to sustained demand for sterilization in the global market. This is subsequently driving the demand for sterilization monitoring devices, including biological indicators.

Additionally, the pharmaceutical and medical devices industry's strong growth is pushing existing leading and domestic companies to expand their geographical presence and manufacturing sites. This is creating a huge demand for sterilization devices, and to seek greater assurance of sterilization, the adoption of biological indicators in these industries is subsequently growing. Hence, the global steam and hydrogen peroxide biological indicators market growth is expected to boom during the forecast period.


Growing Focus on Sterilization in Healthcare Facilities to Propel Growth

Globally, the rising prevalence of chronic diseases, increasing healthcare expenditure, and growing diagnosis present a large patient pool undergoing surgical procedures. For instance, according to a research article published by the Lancet, approximately 313 million surgical procedures are performed globally every year.

This creates a huge demand for surgical instruments and reusable devices such as clamps, forceps, scissors, etc., in healthcare facilities. A major risk of surgical procedures is the introduction of pathogenic microbes, leading to a hospital-acquired infection (HAI). To reduce the growing incidence of HAIs, regulatory bodies are focusing on implementing various guidelines with the ever-increasing emphasis on sterilization in healthcare settings to ensure the safety of the patients and reduce the costs associated with HAIs. This is subsequently leading to higher demand for new and advanced sterilizers by healthcare facilities globally.

The growing demand and adoption of sterilizers are driving the demand for sterilization monitoring devices, including steam and hydrogen peroxide biological indicators. These factors combined with innovations in the biological indicators by market players are facilitating the adoption of these indicators in the market.

  • For instance, in December 2020, STERIS announced the launch of Spordex Self-contained Vials Biological Indicator (SCBI) Ampoules for steam sterilization.


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 through the use of the most resistant microorganism strains. However, alternate sterility indicators 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.

Through strategic collaborations and acquisitions, market players are investing in the research and development of these indicators.

  • For instance, in February 2017, Protak Scientific and Netsteril entered into a partnership to bring the revolutionary alternative to biological indicators, the enzyme indicators, into the market.

Hence, all the above factors and the high cost of these biological indicators restrict their adoption and are expected to further hamper the growth of the market in the forecast period.


By Product Type Analysis

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Self-contained Vials Segment to Hold a Dominant Share of the Global Market

Based on product type, the global market is segmented into self-contained vials, spore strips, and spore-suspension.

The self-contained vials segment generated the highest revenue worldwide. The dominance is driven by a higher rate of adoption in both developed and developing economies due to the various benefits. Self-contained biological indicators (SCBIs) provide fast, visible, consistent, and reliable results offering assurance of an effective sterilization process. This, along with the various novel and innovative product launches, is projected to boost the market growth rate during the forecast period.

On the other hand, the spore strips segment held 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.

By Application Analysis

Growing Focus of Sterilization in Healthcare Facilities Enabled Dominance of Segment

Based on application, the global market is segmented into pharmaceutical & medical device companies, healthcare facilities, and others.

The healthcare facilities segment dominated the global market in 2020. 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.

  • For instance, according to the National Nosocomial Infections Surveillance (NNIS) system estimates, around 5%-10% of patients contract at least one hospital-acquired infection due to contaminated instruments, objects, and various other causes.

Stringent government regulations to prevent contamination and undergo sterilization favor market growth in pharmaceutical and medical device companies during the forecast period.


North America Steam and Hydrogen Peroxide Biological Indicators Market Size, 2020 (USD Million)

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North America stood at USD 195.4 million in 2020 and is expected to dominate the global steam and hydrogen peroxide biological indicators market during the forecast period. Higher emphasis of healthcare facilities, pharmaceutical, and medical device companies on sterilization is primarily responsible for the dominance of the region. Additionally, constant focus of market players towards the introduction of innovative biological indicators is another major factor responsible for the dominance of North America in 2020.

  • For instance, Advanced Sterilization Products (ASP) received the USFDA approval for STERRAD VELOCITY Biological Indicator (BI), the fastest biological indicator for hydrogen peroxide sterilization.

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 the increasing number of hospital-acquired infections in the region. Therefore, this contributes to the growing emphasis on the sterilization process in healthcare facilities and boosting the demand for sterilization monitoring devices/products, including 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 hence favors the market growth during the forecast period.

South America and the Middle East & Africa accounted for a comparatively lower market share attributable to the less awareness among the population about the steam and hydrogen peroxide biological indicators.


Strong Portfolio of Mesa Labs, Inc., 3M to Help Them Lead Global Market

The global market is consolidated with major players, including 3M, STERIS, ASP, Getinge AB, SHINVA MEDICAL INSTRUMENT CO.LTD. Cantel Medical, and Mesa Labs, Inc., comprising large market share. 3M is the leading player in the global market, with the highest market share in 2020. The company’s dominant position in the global market is attributed to its robust distribution network, a strong portfolio of biological indicators, and strong brand presence

Other players like Tuttnauer, Bioquell, An Ecolab Solution, Terragene, and others are continuously engaged in strategic expansion initiatives to establish their footprints in emerging regions.


  • 3M (Minnesota, U.S‎.)

  • STERIS (Ohio, United States)

  • Getinge AB (Sweden)

  • Cantel Medical (New Jersey, U.S.)

  • Mesa Labs, Inc. (Colorado, United States)

  • Tuttnauer (Hauppauge, U.S.)

  • Bioquell, An Ecolab Solution (Hampshire, U.K.)

  • Terragene (Rosario, Argentina)

  • Other Prominent Players


  • January 2021– STERIS announced the acquisition of Cantel Medical through its U.S. subsidiary.

  • December 2020 - STERIS announced the global launch of spordex self-contained biological indicator (SCBI) ampoules to confirm sterilization of liquids in steam autoclave cycles


An Infographic Representation of Steam and Hydrogen Peroxide Biological Indicators Market

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The global steam and hydrogen peroxide biological indicators market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, product type, and application. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation



Study Period


Base Year


Forecast Period


Historical Period



  Value (USD Million) Volume (Thousand Units)


By Product Type

  • Self-contained Vials

  • Spore Strips

  • Spore-suspension

By Application

  • Pharmaceutical & Medical Device Companies

  • Healthcare Facilities

  • Others


By Region

  • North America (the U.S. and Canada)

  • Europe (U.K., Germany, France, Italy, Russia, and Rest of Europe)

  • Asia-Pacific (Japan, China, India, Korea, Southeast Asia, and Rest of Asia- Pacific)

  • Latin America (Brazil, Mexico, Argentina, and Rest of Latin America)

  • The Middle East & Africa (Turkey, Saudi Arabia, U.A.E., and Rest of the Middle East & Africa)

Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 553.1 million in 2020 and is projected to reach USD 1,051.4 million by 2028.

The market will exhibit steady growth at a CAGR of 8.5% during the forecast period (2021-2028).

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 AB, and SHINVA MEDICAL INSTRUMENT CO.LTD. are the top players in the market.

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