U.S. 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 Country Forecast, 2023-2030

The U.S. steam and hydrogen peroxide biological indicators market size was worth USD 216.8 million in 2022 and is projected to grow at a CAGR of 7.6% during the forecast period. 

The rising emphasis on sterilization processes in pharmaceutical & medical devices companies to lower the risk of contamination is one of the predominant factors spurring the demand for steam and hydrogen peroxide biological indicators. Furthermore, the rising incidence of hospital-acquired infections and surgical site infections across the globe is compelling healthcare facilities & clinics to adopt proper sterilization methods and monitoring equipment, such as biological indicators, thus contributing to the U.S. steam and hydrogen peroxide biological indicators market growth.

• According to the National and State Healthcare-Associated Infections Data Report published by the Centers for Disease Control and Prevention (CDC) in 2021, an increase of 7% in Central Line Associated Blood Stream Infections (CLABSI) cases were reported among acute care hospitals in the U.S. when compared to 2020.

Thus, rising hospital-acquired infections coupled with stringent government regulations to prevent contamination in healthcare products are bolstering the U.S. steam and hydrogen biological indicators market growth. The COVID-19 pandemic positively impacted the U.S. market as pharmaceutical and medical devices companies focused more on sterilization.

LATEST TRENDS

Gradual Shift Toward Rapid Steam and Hydrogen Biological Indicators 

To facilitate the supply of sterilized products, the sterilization process must be continuously monitored. The use of biological indicators can validate the sterilization process. Although various conventional biological indicators are available in the market, the players and consumers are shifting their focus toward the rapid Biological Indicators (BIs) due to their short result time varying between 15 minutes to less than three hours. The quick turnaround time offered by rapid biological indicators maximizes the efficiency of the sterilization validation process.

Furthermore, to cater to the rising demand for these indicators, the key players are developing and launching rapid biological indicators, thus propelling market growth.

• For instance, in January 2020, the U.S. FDA approved the Sterrad Velocity Biological Indicator, giving results in 15 minutes developed by Advanced Sterilization Products (ASP). According to the company, the product is 38.0% faster than other available products in providing instrument sterility assurance for healthcare professionals. 

DRIVING FACTORS

Rising Incidence of Surgical-Site Infection to Augment Market Growth 

The rising number of surgeries is leading to the increasing usage of surgical instruments, such as scissors, clamps, forceps, and others, in hospitals and other healthcare facilities. However, if improperly sterilized, these reusable instruments might increase the risk of causing surgical site infection.

• For instance, according to the CDC 2021 report, there was a rise of 11% in abdominal hysterectomy Surgical Site Infection (SSI) cases in acute care hospitals in the year 2021 compared to 2020.

Thus, to prevent the increasing burden of surgical site infections, regulatory bodies are implementing various guidelines to emphasize sterilization in healthcare settings to ensure patient safety and reduce the costs associated with SSIs. Growing emphasis on sterilization subsequently leads to a higher demand for sterilizers and monitoring devices such as steam & hydrogen peroxide biological indicators.

According to the American Hospital Association, there are 6,129 hospitals in the U.S., out of which community hospitals are about 84%. The other type of hospitals comprising nonfederal long-term care hospitals and hospital units within an institution was 107 out of the total number of hospitals.

RESTRAINING FACTORS

Rise in Recent Product Recalls to Hamper the Market Growth 

Despite the approval and launch of advanced biological indicators, voluntary recalls of a few biological indicators due to damage and hampered quality are projected to limit steam and hydrogen peroxide biological indicators’ adoption. This further leads to shifting consumer preference toward alternative products available.

• For instance, in December 2022, Steris Corporation initiated a voluntary recall for its self-contained biological indicators, VERIFY Dual Species, as the spores of G. stearothermophilus and B. atrophaeus were inconsistent and gave false-negative results.

Thus, an increase in product recalls will likely impede the market growth in the coming years.

SEGMENTATION

By Product Type Analysis

Based on product type, the market is segmented into self-contained vials, spore strips, and spore suspension. The self-contained vials segment dominated the U.S. steam & hydrogen peroxide biological indicators market share in 2022. The rising demand for self-contained vials among medical device and pharmaceutical companies and the growing number of product approval & launches are a few factors propelling the growth of the market.

• For instance, in April 2022, 3M received the U.S. FDA clearance for 3M Attest super rapid steam biological indicator 1592, a self-contained biological indicator developed for rapid routine monitoring of dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities.

By Application Analysis

Based on application, the market is classified into pharmaceutical & medical devices companies, healthcare facilities, and others. The pharmaceutical & medical devices companies segment is anticipated to grow significantly during the forecast period. The increasing research & development initiatives by the companies and the rising need to comply with stringent government regulations to prevent contamination in product batches also raised the adoption of these indicators.

Moreover, regulatory bodies are implementing stringent safety and efficacy regulations due to rising recalls of drugs and medical devices due to microbial contamination. Such factors are compelling the drug and medical device manufacturers to adopt advanced sterilization processes and indicators, such as steam and hydrogen peroxide biological indicators, for effective monitoring.

• In February 2023, the U.S. FDA voluntarily recalled EzriCare Artificial Tears, developed by Global Pharma, due to potential bacterial contamination. Thus, to prevent such contamination in products, the need for sterilization and its monitoring is increasing.

KEY INDUSTRY PLAYERS

The U.S. market is consolidated with the presence of key players such as 3M, STERIS, ASP, and others. The presence of a strong product portfolio, rising focus of the players to strengthen their geographical presence, increase in investments in inorganic business activities, and the launch of advanced products contribute to their growth.

• For instance, in June 2021, STERIS acquired Cantel Medical, a leading player in biological indicators. Through this acquisition, Steris integrated the Crosstex biological indicator product portfolio into its healthcare and life science segment and strengthened its presence in the overall market.

LIST OF KEY COMPANIES PROFILED:

• 3M (U.S‎.)


• STERIS (U.S.)


• Getinge (Sweden)


• Mesa Labs, Inc. (U.S.)


• Tuttnauer (U.S.)


• ASP (U.S.)


• Bioquell, An Ecolab Solution (U.K.)


• Terragene (Argentina)

KEY INDUSTRY DEVELOPMENTS: 

• June 2022- 3M received commercialization approval for 3M Attest Rapid Readout Biological Indicator 1295. This biological indicator is developed for routine monitoring of vaporized hydrogen peroxide sterilization processes.


• March 2022 - Tuttnauer completed the acquisition of Prestige Medical Limited, a U.K.-based company manufacturing and commercializing sterilization equipment. The former company aimed to expand its distribution network in selected countries through this acquisition.


• June 2021 - STERIS acquired Cantel Medical LLC., a provider of infection prevention products and services. Upon this acquisition, Steris added Crosstex biological indicator products to its healthcare and life science segment, strengthening its position in this market.

REPORT COVERAGE

The U.S. steam & hydrogen peroxide biological indicators market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, competitive landscape, product type, and application. 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 have contributed to the growth of the market in recent years.

Report Scope & Segmentation