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 Biological Indicators - Global Market Share and Ranking, Overall Sales and Demand Forecast 2025-2031
The global market for Biological Indicators was estimated to be worth US$ 411 million in 2024 and is forecast to a readjusted size of US$ 610 million by 2031 with a CAGR of 5.9% during the forecast... もっと見る
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SummaryThe global market for Biological Indicators was estimated to be worth US$ 411 million in 2024 and is forecast to a readjusted size of US$ 610 million by 2031 with a CAGR of 5.9% during the forecast period 2025-2031.Biological indicators (BIs), as defined by ANSI/AAMI and ISO, are test systems containing viable microorganisms providing a defined resistance to a specific sterilization process. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, providing a level of confidence in the process. Biological Indicators (BIs) play a critical role in sterilization validation and infection control, widely used in medical devices, pharmaceuticals, food processing, and life sciences laboratories. They assess the effectiveness of steam, dry heat, ethylene oxide (EO), hydrogen peroxide, and other sterilization methods, ensuring compliance with ISO 11138, USP, and FDA regulations. Based on form factor, BIs can be categorized into Self-Contained Biological Indicators (SCBIs), BI Strips, and BI Suspensions. Among them, SCBIs are widely used due to their convenience, reduced contamination risk, and enhanced validation efficiency. In terms of application, the medical sector dominates the market, as hospitals and medical device manufacturers must routinely validate sterilization equipment like autoclaves and plasma sterilizers. The pharmaceutical industry also has stringent requirements for sterilization, especially in injectable drugs, vaccines, and sterile drug production. Additionally, the food and beverage sector is increasingly adopting BIs to monitor sterilization efficiency in processing equipment, ensuring food safety and regulatory compliance. Regionally, North America is the largest market, with a share nearly 55%. North America and Europe lead the market due to stringent medical regulations and high industry standards. The Asia-Pacific region (especially China and India) is experiencing rapid growth in the BI market, driven by expanding healthcare and pharmaceutical industries and evolving regulatory frameworks. Latin America and the Middle East are also emerging markets, benefiting from improvements in healthcare infrastructure. Looking ahead, the BI industry is shifting toward more efficient, intelligent, and automated solutions. Rapid-read BIs, electronic BIs (E-BIs), and smart monitoring systems are gradually replacing traditional methods, reducing manual intervention, accelerating sterilization validation, and improving quality control. As pharmaceutical regulations tighten and medical device standards advance, the demand for BIs is expected to rise, ensuring a more reliable approach to sterilization validation and infection control worldwide. This report aims to provide a comprehensive presentation of the global market for Biological Indicators, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of Biological Indicators by region & country, by Type, and by Application. The Biological Indicators market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Biological Indicators. Market Segmentation By Company 3M Getinge Group Cantel Medical Mesa Laboratories Steris Fuze Medical Matachana Hu-Friedy Advanced Sterilization Bag Health Care Terragene Andersen GKE Segment by Type Self-Contained Biological Indicator Biological Indicator Strip Others Segment by Application Hospital Pharma Companies Others By Region North America United States Canada Asia-Pacific China Japan South Korea Southeast Asia India Australia Rest of Asia-Pacific Europe Germany France U.K. Italy Netherlands Nordic Countries Rest of Europe Latin America Mexico Brazil Rest of Latin America Middle East & Africa Turkey Saudi Arabia UAE Rest of MEA Chapter Outline Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry. Chapter 2: Detailed analysis of Biological Indicators company competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc. Chapter 3: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments. Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets. Chapter 5: Revenue of Biological Indicators in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world. Chapter 6: Revenue of Biological Indicators in country level. It provides sigmate data by Type, and by Application for each country/region. Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc. Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry. Chapter 9: Conclusion. Table of Contents1 Market Overview1.1 Biological Indicators Product Introduction 1.2 Global Biological Indicators Market Size Forecast (2020-2031) 1.3 Biological Indicators Market Trends & Drivers 1.3.1 Biological Indicators Industry Trends 1.3.2 Biological Indicators Market Drivers & Opportunity 1.3.3 Biological Indicators Market Challenges 1.3.4 Biological Indicators Market Restraints 1.4 Assumptions and Limitations 1.5 Study Objectives 1.6 Years Considered 2 Competitive Analysis by Company 2.1 Global Biological Indicators Players Revenue Ranking (2024) 2.2 Global Biological Indicators Revenue by Company (2020-2025) 2.3 Key Companies Biological Indicators Manufacturing Base Distribution and Headquarters 2.4 Key Companies Biological Indicators Product Offered 2.5 Key Companies Time to Begin Mass Production of Biological Indicators 2.6 Biological Indicators Market Competitive Analysis 2.6.1 Biological Indicators Market Concentration Rate (2020-2025) 2.6.2 Global 5 and 10 Largest Companies by Biological Indicators Revenue in 2024 2.6.3 Global Top Companies by Company Type (Tier 1, Tier 2, and Tier 3) & (based on the Revenue in Biological Indicators as of 2024) 2.7 Mergers & Acquisitions, Expansion 3 Segmentation by Type 3.1 Introduction by Type 3.1.1 Self-Contained Biological Indicator 3.1.2 Biological Indicator Strip 3.1.3 Others 3.2 Global Biological Indicators Sales Value by Type 3.2.1 Global Biological Indicators Sales Value by Type (2020 VS 2024 VS 2031) 3.2.2 Global Biological Indicators Sales Value, by Type (2020-2031) 3.2.3 Global Biological Indicators Sales Value, by Type (%) (2020-2031) 4 Segmentation by Application 4.1 Introduction by Application 4.1.1 Hospital 4.1.2 Pharma Companies 4.1.3 Others 4.2 Global Biological Indicators Sales Value by Application 4.2.1 Global Biological Indicators Sales Value by Application (2020 VS 2024 VS 2031) 4.2.2 Global Biological Indicators Sales Value, by Application (2020-2031) 4.2.3 Global Biological Indicators Sales Value, by Application (%) (2020-2031) 5 Segmentation by Region 5.1 Global Biological Indicators Sales Value by Region 5.1.1 Global Biological Indicators Sales Value by Region: 2020 VS 2024 VS 2031 5.1.2 Global Biological Indicators Sales Value by Region (2020-2025) 5.1.3 Global Biological Indicators Sales Value by Region (2026-2031) 5.1.4 Global Biological Indicators Sales Value by Region (%), (2020-2031) 5.2 North America 5.2.1 North America Biological Indicators Sales Value, 2020-2031 5.2.2 North America Biological Indicators Sales Value by Country (%), 2024 VS 2031 5.3 Europe 5.3.1 Europe Biological Indicators Sales Value, 2020-2031 5.3.2 Europe Biological Indicators Sales Value by Country (%), 2024 VS 2031 5.4 Asia Pacific 5.4.1 Asia Pacific Biological Indicators Sales Value, 2020-2031 5.4.2 Asia Pacific Biological Indicators Sales Value by Region (%), 2024 VS 2031 5.5 South America 5.5.1 South America Biological Indicators Sales Value, 2020-2031 5.5.2 South America Biological Indicators Sales Value by Country (%), 2024 VS 2031 5.6 Middle East & Africa 5.6.1 Middle East & Africa Biological Indicators Sales Value, 2020-2031 5.6.2 Middle East & Africa Biological Indicators Sales Value by Country (%), 2024 VS 2031 6 Segmentation by Key Countries/Regions 6.1 Key Countries/Regions Biological Indicators Sales Value Growth Trends, 2020 VS 2024 VS 2031 6.2 Key Countries/Regions Biological Indicators Sales Value, 2020-2031 6.3 United States 6.3.1 United States Biological Indicators Sales Value, 2020-2031 6.3.2 United States Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.3.3 United States Biological Indicators Sales Value by Application, 2024 VS 2031 6.4 Europe 6.4.1 Europe Biological Indicators Sales Value, 2020-2031 6.4.2 Europe Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.4.3 Europe Biological Indicators Sales Value by Application, 2024 VS 2031 6.5 China 6.5.1 China Biological Indicators Sales Value, 2020-2031 6.5.2 China Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.5.3 China Biological Indicators Sales Value by Application, 2024 VS 2031 6.6 Japan 6.6.1 Japan Biological Indicators Sales Value, 2020-2031 6.6.2 Japan Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.6.3 Japan Biological Indicators Sales Value by Application, 2024 VS 2031 6.7 South Korea 6.7.1 South Korea Biological Indicators Sales Value, 2020-2031 6.7.2 South Korea Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.7.3 South Korea Biological Indicators Sales Value by Application, 2024 VS 2031 6.8 Southeast Asia 6.8.1 Southeast Asia Biological Indicators Sales Value, 2020-2031 6.8.2 Southeast Asia Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.8.3 Southeast Asia Biological Indicators Sales Value by Application, 2024 VS 2031 6.9 India 6.9.1 India Biological Indicators Sales Value, 2020-2031 6.9.2 India Biological Indicators Sales Value by Type (%), 2024 VS 2031 6.9.3 India Biological Indicators Sales Value by Application, 2024 VS 2031 7 Company Profiles 7.1 3M 7.1.1 3M Profile 7.1.2 3M Main Business 7.1.3 3M Biological Indicators Products, Services and Solutions 7.1.4 3M Biological Indicators Revenue (US$ Million) & (2020-2025) 7.1.5 3M Recent Developments 7.2 Getinge Group 7.2.1 Getinge Group Profile 7.2.2 Getinge Group Main Business 7.2.3 Getinge Group Biological Indicators Products, Services and Solutions 7.2.4 Getinge Group Biological Indicators Revenue (US$ Million) & (2020-2025) 7.2.5 Getinge Group Recent Developments 7.3 Cantel Medical 7.3.1 Cantel Medical Profile 7.3.2 Cantel Medical Main Business 7.3.3 Cantel Medical Biological Indicators Products, Services and Solutions 7.3.4 Cantel Medical Biological Indicators Revenue (US$ Million) & (2020-2025) 7.3.5 Cantel Medical Recent Developments 7.4 Mesa Laboratories 7.4.1 Mesa Laboratories Profile 7.4.2 Mesa Laboratories Main Business 7.4.3 Mesa Laboratories Biological Indicators Products, Services and Solutions 7.4.4 Mesa Laboratories Biological Indicators Revenue (US$ Million) & (2020-2025) 7.4.5 Mesa Laboratories Recent Developments 7.5 Steris 7.5.1 Steris Profile 7.5.2 Steris Main Business 7.5.3 Steris Biological Indicators Products, Services and Solutions 7.5.4 Steris Biological Indicators Revenue (US$ Million) & (2020-2025) 7.5.5 Steris Recent Developments 7.6 Fuze Medical 7.6.1 Fuze Medical Profile 7.6.2 Fuze Medical Main Business 7.6.3 Fuze Medical Biological Indicators Products, Services and Solutions 7.6.4 Fuze Medical Biological Indicators Revenue (US$ Million) & (2020-2025) 7.6.5 Fuze Medical Recent Developments 7.7 Matachana 7.7.1 Matachana Profile 7.7.2 Matachana Main Business 7.7.3 Matachana Biological Indicators Products, Services and Solutions 7.7.4 Matachana Biological Indicators Revenue (US$ Million) & (2020-2025) 7.7.5 Matachana Recent Developments 7.8 Hu-Friedy 7.8.1 Hu-Friedy Profile 7.8.2 Hu-Friedy Main Business 7.8.3 Hu-Friedy Biological Indicators Products, Services and Solutions 7.8.4 Hu-Friedy Biological Indicators Revenue (US$ Million) & (2020-2025) 7.8.5 Hu-Friedy Recent Developments 7.9 Advanced Sterilization 7.9.1 Advanced Sterilization Profile 7.9.2 Advanced Sterilization Main Business 7.9.3 Advanced Sterilization Biological Indicators Products, Services and Solutions 7.9.4 Advanced Sterilization Biological Indicators Revenue (US$ Million) & (2020-2025) 7.9.5 Advanced Sterilization Recent Developments 7.10 Bag Health Care 7.10.1 Bag Health Care Profile 7.10.2 Bag Health Care Main Business 7.10.3 Bag Health Care Biological Indicators Products, Services and Solutions 7.10.4 Bag Health Care Biological Indicators Revenue (US$ Million) & (2020-2025) 7.10.5 Bag Health Care Recent Developments 7.11 Terragene 7.11.1 Terragene Profile 7.11.2 Terragene Main Business 7.11.3 Terragene Biological Indicators Products, Services and Solutions 7.11.4 Terragene Biological Indicators Revenue (US$ Million) & (2020-2025) 7.11.5 Terragene Recent Developments 7.12 Andersen 7.12.1 Andersen Profile 7.12.2 Andersen Main Business 7.12.3 Andersen Biological Indicators Products, Services and Solutions 7.12.4 Andersen Biological Indicators Revenue (US$ Million) & (2020-2025) 7.12.5 Andersen Recent Developments 7.13 GKE 7.13.1 GKE Profile 7.13.2 GKE Main Business 7.13.3 GKE Biological Indicators Products, Services and Solutions 7.13.4 GKE Biological Indicators Revenue (US$ Million) & (2020-2025) 7.13.5 GKE Recent Developments 8 Industry Chain Analysis 8.1 Biological Indicators Industrial Chain 8.2 Biological Indicators Upstream Analysis 8.2.1 Key Raw Materials 8.2.2 Raw Materials Key Suppliers 8.2.3 Manufacturing Cost Structure 8.3 Midstream Analysis 8.4 Downstream Analysis (Customers Analysis) 8.5 Sales Model and Sales Channels 8.5.1 Biological Indicators Sales Model 8.5.2 Sales Channel 8.5.3 Biological Indicators Distributors 9 Research Findings and Conclusion 10 Appendix 10.1 Research Methodology 10.1.1 Methodology/Research Approach 10.1.1.1 Research Programs/Design 10.1.1.2 Market Size Estimation 10.1.1.3 Market Breakdown and Data Triangulation 10.1.2 Data Source 10.1.2.1 Secondary Sources 10.1.2.2 Primary Sources 10.2 Author Details 10.3 Disclaimer
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