Report Overview

Increased adoption of sterilization processes in healthcare, growing awareness about infection control, regulatory requirements, and advancements in medical technology, which encourage the use of biological indicators to ensure effective sterilization in healthcare facilities, all contribute to the growth of the United States Steam and Hydrogen Peroxide Biological Indicators Market during the forecast period between 2023 and 2029.

United States Steam and Hydrogen Peroxide Biological Indicators Market – Industry Trends & Forecast Report, 2029

United States steam and hydrogen peroxide biological indicators market size was estimated at USD 217.79 million in 2022. During the forecast period between 2023 and 2029, the size of United States steam and hydrogen peroxide biological indicators market is projected to grow at a CAGR of 7.37% reaching a value of USD 333.66 million by 2029. The driving factors of the United States steam and hydrogen peroxide biological indicators market include the increasing demand for sterilization assurance in healthcare facilities, pharmaceutical manufacturing, and life sciences research. Stringent regulatory requirements for sterilization validation and quality control also propel market growth. Technological advancements and a focus on patient safety further stimulate the adoption of biological indicators. Also, the ongoing emphasis on infection prevention and control, as well as the need for reliable sterilization methods, drive the market's expansion. The COVID-19 pandemic has heightened the importance of effective sterilization, contributing to the market's sustained growth in the United States.

Steam and Hydrogen Peroxide Biological Indicators - Overview

Steam and hydrogen peroxide biological indicators are crucial tools in sterilization processes within healthcare and laboratory settings. Steam indicators verify the effectiveness of autoclave sterilization, ensuring that the required temperature and pressure have been reached. Hydrogen peroxide indicators, on the other hand, validate the efficiency of hydrogen peroxide gas sterilization methods. These indicators contain heat-resistant spores of bacteria or enzymes that are highly resistant to the sterilization process. Monitoring their survival or inactivation provides essential quality assurance in healthcare facilities, pharmaceutical manufacturing, and other industries reliant on sterile environments to prevent infection and contamination.

United States Steam and Hydrogen Peroxide Biological Indicators Market

Growth Drivers

Rising Demand for Sterilization Assurance

United States steam and hydrogen peroxide biological indicators market is experiencing robust growth, driven by the increasing demand for sterilization assurance in healthcare facilities and pharmaceutical manufacturing. With a growing emphasis on patient safety and infection control, healthcare providers and pharmaceutical companies are adopting rigorous sterilization processes, thereby fueling the need for reliable biological indicators. These indicators provide a vital means of validating sterilization effectiveness, ensuring compliance with stringent regulatory standards, and mitigating the risk of infection transmission. Therefore, the market for steam and hydrogen peroxide biological indicators in the US is expanding, offering significant growth opportunities for industry stakeholders.

Restraints

Complexity of Sterilization Monitoring

The multifaceted nature of sterilization monitoring in the United States steam and hydrogen peroxide biological indicators market poses a significant challenge. The market demands a delicate balance between precision, automation, and compliance with evolving regulatory standards. The complexity arises from the need to integrate diverse monitoring methods, handle a range of sterilization equipment, and stay updated with ever-evolving industry guidelines. Achieving operational efficiency while maintaining the highest standards of safety and quality assurance is a formidable obstacle, necessitating a holistic approach and innovative solutions in this competitive and demanding marketplace.

Impact of COVID-19 on United States Steam and Hydrogen Peroxide Biological Indicators Market

The COVID-19 pandemic significantly impacted the United States steam and hydrogen peroxide biological indicators market. As healthcare facilities focused on infection control, the demand for sterilization and disinfection products, including biological indicators, surged. Hospitals and laboratories ramped up their sterilization protocols, driving increased adoption of steam and hydrogen peroxide-based indicators to ensure equipment and instruments were effectively disinfected. The market experienced a boost in sales, as healthcare providers prioritized safety measures. Also, research and development efforts in this field accelerated, leading to advancements in sterilization technologies. The market's growth reflected the critical importance of infection control during the pandemic.

United States Steam and Hydrogen Peroxide Biological Indicators Market

Segmental Coverage

United States Steam and Hydrogen Peroxide Biological Indicators Market – By Product Type

Based on product type, United States steam and hydrogen peroxide biological indicators market is divided into Self-contained Vials, Spore Strips, and Spore-suspension segments. The self-contained vials segment is the largest in the United States steam and hydrogen peroxide biological indicators market. This segment outpaces the competition, which includes Spore Strips and Spore-suspension segments. Self-contained vials are the most dominant category, likely due to their ease of use and reliability in monitoring sterilization processes, making them a popular choice in healthcare and other industries where sterilization is crucial.

United States Steam and Hydrogen Peroxide Biological Indicators Market – By Application

By application, United States steam and hydrogen peroxide biological indicators market is divided into Pharmaceutical & Medical Device Companies and Healthcare Facilities segments. The pharmaceutical & medical device companies segment holds a larger share. These companies rely on biological indicators to ensure the effectiveness of sterilization processes for their products, such as medical devices and pharmaceuticals. Robust sterilization is crucial to maintaining quality and safety standards. While healthcare facilities also use biological indicators, the pharmaceutical and medical device sector's broader scope and higher demand for sterilization validation contribute to this segment's dominance in the market.

Competitive Landscape

Major players in the United States steam and hydrogen peroxide biological indicators market include 3M, STERIS, ASP, Mesa Labs, Inc., Tuttnauer, and Cantel Medical. To enhance their market share and expand their reach, these companies are also focusing on investing in innovations, collaborations, and expansions.

Recent Developments

• In April 2022 - 3M received the US 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.

Scope of the Report

Attributes	Details
Years Considered	Historical Data – 2019–2022
	Base Year – 2022
	Estimated Year – 2023
	Forecast Period – 2023–2029
Facts Covered	Revenue in USD Million
Market Coverage	United States
Product/Service Segmentation	Product Type, Application
Key Players	3M, STERIS, ASP, Mesa Labs, Inc., Tuttnauer, Cantel Medical

 

 

By Product Type

• Self-contained Vials

• Spore Strips

• Spore-suspension

By Application

• Pharmaceutical & Medical Device Companies

• Healthcare Facilities

1. Research Framework
   1. Research Objective
   2. Product Type Overview
   3. Market Segmentation
2. Executive Summary
3.  United States Steam and Hydrogen Peroxide Biological Indicators Market Insights
   1. Industry Value Chain Analysis
   2. DROC Analysis
      1. Growth Drivers
         1. Increasing demand for sterilization
         2. Increasing Healthcare-Associated Infections (HAIs)
      2. Restraints
         1. Limited awareness
         2. Complexity of sterilization monitoring
      3. Opportunities
         1. The expansion of healthcare infrastructure in the United States
         2. Rise in ambulatory surgery centers
      4. Challenges
         1. Regulatory compliance complexity
         2. Competition from other sterilization monitoring methods
   3. Technology Advancements/Recent Developments
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of New Entrants
      4. Threat of Substitutes
      5. Intensity of Rivalry
4.  United States Steam and Hydrogen Peroxide Biological Indicators Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share and Forecast
      1. By Product Type
         1. Self-contained Vials
         2. Spore Strips
         3. Spore-suspension
      2. By Application
         1. Pharmaceutical & Medical Device Companies
         2. Healthcare Facilities
         3. Others
5. Competitive Landscape
   1. List of Key Players and Their Offerings
   2. United States Steam and Hydrogen Peroxide Biological Indicators Market Share Analysis, 2022
   3. Competitive Benchmarking, By Operating Parameters
   4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)
6. Impact of COVID-19 on United States Steam and Hydrogen Peroxide Biological Indicators Market
7. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)
   1. 3M
   2. STERIS
   3. ASP
   4. Mesa Labs, Inc.
   5. Tuttnauer
   6. Cantel Medical
   7. Other Prominent Players
8. Key Strategic Recommendations
9. Research Methodology
   1.    Qualitative Research
      1.  Primary & Secondary Research
   2.    Quantitative Research
   3.    Market Breakdown & Data Triangulation
      1.  Secondary Research
      2.  Primary Research
   4.    Breakdown of Primary Research Respondents, By Region
   5.    Assumptions & Limitations

*Financial information in case of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable

 

List of Figures

 

Figure 1       United States Steam and Hydrogen Peroxide Biological Indicators  Segmentation

Figure 2       United States Steam and Hydrogen Peroxide Biological Indicators Market Value Chain Analysis

Figure 3       Company Market Share Analysis, 2022

Figure 4       United States Steam and Hydrogen Peroxide Biological Indicators Market Size, By Value (USD Million), 2019-2029

Figure 5       United States Steam and Hydrogen Peroxide Biological Indicators Market Share, By Product Type, By Value, 2019-2029

Figure 6       United States Steam and Hydrogen Peroxide Biological Indicators Market Share, By Application, By Value, 2019-2029

 

List of Tables

 

Table 1        United States Steam and Hydrogen Peroxide Biological Indicators Market Size, By Value (USD Million), 2019-2029

Table 2         United States Steam and Hydrogen Peroxide Biological Indicators Market Size, By Product Type, By Value, 2019-2029

Table 3         United States Steam and Hydrogen Peroxide Biological Indicators Market Size, By Application, By Value, 2019-2029

Table 4        3M Company Overview

Table 5        3M Financial Overview

Table 6        STERIS Company Overview

Table 7        STERIS Financial Overview

Table 8        ASP Company Overview

Table 9        ASP Financial Overview

Table 10      Mesa Labs, Inc. Company Overview

Table 11      Mesa Labs, Inc. Financial Overview

Table 12      Tuttnauer Company Overview

Table 13      Tuttnauer Financial Overview

Table 14      Cantel Medical Company Overview

Table 15      Cantel Medical Financial Overview