The Market Reports

Synopsis
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 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.

Index