Global Biological Indicators Market Growth (Status and Outlook) 2025-2031

The global Biological Indicators market size is predicted to grow from US$ 423 million in 2025 to US$ 604 million in 2031; it is expected to grow at a CAGR of 6.1% from 2025 to 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.

LPI (LP Information)' newest research report, the “Biological Indicators Industry Forecast” looks at past sales and reviews total world Biological Indicators sales in 2024, providing a comprehensive analysis by region and market sector of projected Biological Indicators sales for 2025 through 2031. With Biological Indicators sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Biological Indicators industry.

This Insight Report provides a comprehensive analysis of the global Biological Indicators landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Biological Indicators portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Biological Indicators market.

This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Biological Indicators and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Biological Indicators.

This report presents a comprehensive overview, market shares, and growth opportunities of Biological Indicators market by product type, application, key players and key regions and countries.

Segmentation by Type:
Self-Contained Biological Indicator
Biological Indicator Strip
Others

Segmentation by Application:
Hospital
Pharma Companies
Others

This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
3M
Getinge Group
Cantel Medical
Mesa Laboratories
Steris
Fuze Medical
Matachana
Hu-Friedy
Advanced Sterilization
Bag Health Care
Terragene
Andersen
GKE

Please note: The report will take approximately 2 business days to prepare and deliver.