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

Segment by Region

• North America: United States, Canada, and Mexico
• Europe: United Kingdom, Germany, France, Spain, Italy, and Rest of Europe
• Asia Pacific: China, India, Japan, Australia, South Korea, and Rest of Asia Pacific
• Middle East & Africa: Saudi Arabia, South Africa, and Rest of MEA
• Latin America: Brazil, Argentina, and Rest of Latin America

*If you need a regional or country-specific version, or customized segmentation, we can tailor the report to your requirements.