Biological Indicators Market Share, Share & Trends Analysis Report By Product (Self-Contained, Strips, Cards / Rapid Readout BIs), By Method (Steam Sterilization, Ethylene Oxide Sterilization), By End Use, By Region, And Segment Forecasts, 2025 - 2033

Biological Indicators Market Summary

The global biological indicators market size was estimated at USD 534.80 million in 2024 and is projected to reach USD 1.11 billion by 2033, growing at a CAGR of 8.59% from 2025 to 2033. The growth of the market is attributed due to the growing emphasis on sterilization and infection control across healthcare, pharmaceutical, and food industries.

Increasing concerns over hospital-acquired infections (HAIs) and stringent regulatory requirements for validating sterilization processes are boosting demand for reliable and rapid BI solutions. In addition, advancements in rapid-readout and automation technologies, coupled with rising adoption of sterilization methods in emerging markets, are further accelerating the growth of the market.

Stringent regulatory requirements play a pivotal role in driving the biological indicators industry, as global health authorities mandate the validation of sterilization processes across industries such as medical devices, pharmaceuticals, and biotechnology. Biological indicators are the gold standard for confirming sterilization efficacy, making them a necessity for compliance. For instance, the U.S. Food and Drug Administration (FDA) requires medical device manufacturers to demonstrate sterilization validation under 21 CFR Part 820 (Quality System Regulation), while the European Medicines Agency (EMA) and the ISO 11138 standard outline specific criteria for biological indicator use in sterilization assurance. Similarly, compliance with Good Manufacturing Practices (GMP) in pharmaceuticals necessitates biological indicator-based validation for sterilized drug products and equipment. These strict regulatory frameworks ensure patient safety and product reliability, fueling consistent demand for biological indicators across critical healthcare and life sciences sectors.

The rising burden of hospital-acquired infections (HAIs) is a key factor driving the growth of the biological indicators industry, as healthcare facilities are increasingly focusing on strengthening infection control and sterilization practices. According to the WHO’s Global Report on Infection Prevention and Control 2024, a large-scale systematic review of nearly 400 studies estimated the global prevalence of HAIs at around 14% in 2023. Furthermore, a European point prevalence survey conducted in 2022/2023 across 28 EU/EEA countries and three Western Balkan nations/territories reported an adjusted prevalence of 8% for patients with at least one HAI. This growing incidence of HAIs underscores the critical need for reliable sterilization validation, fueling the demand for biological indicators to ensure the effectiveness of sterilization processes over the forecast period.

The global rise in surgical procedures, ranging from elective operations to complex organ transplants, is significantly driving demand in the biological indicators industry. The growing procedural load in hospitals and surgical centers has led to a sharp increase in the daily use of reusable instruments that must undergo validated sterilization. This surge creates volume pressures and raises the bar for quality and compliance, pushing healthcare facilities to adopt stringent sterilization validation practices. According to the 2024 Procedural Statistics Release, approximately 1,585,878 cosmetic surgeries were performed in 2024, marking a 1% increase from 2023, while reconstructive procedures rose by 2% over the same period. The steady growth in surgical interventions highlights the critical need for biological indicators to ensure the effectiveness of sterilization processes and safeguard patient safety.

Technological advancements significantly shape the market by improving efficiency, accuracy, and compliance in sterilization validation. Innovations such as rapid-readout indicators have reduced the time required to confirm sterilization efficacy from several days to a few hours, accelerating instrument turnaround in busy healthcare facilities. For instance, in June 2025, Solventum introduced its Attest Super Rapid Vaporized Hydrogen Peroxide (VH₂O₂) Clear Challenge Pack, a ready-to-use solution that combines two previously FDA-cleared indicators into one test system. The pack integrates a biological indicator (BI) to confirm microbial inactivation and a chemical indicator (CI) to verify sterilizer performance, all within a transparent, single-use container for simplified and reliable sterilization validation.
"Innovations that make every load monitoring easier to adopt, more reliable, and faster across sterilization modalities empower healthcare facilities to consistently uphold the highest patient safety standards while supporting the increasing productivity demand of modern sterile processing departments," said Sharon Greene-Golden, past president of the Healthcare Sterile Processing Association (HSPA).
"In the high-stakes environment of sterile processing where patients' lives are at stake, both speed and accuracy are non-negotiable," said Doug Bartlett, senior vice president of the company's Infection Prevention & Surgical Solutions business. "Solventum innovations equip dedicated professionals with intuitive, cutting-edge resources that help them to safeguard patient health, reflecting our drive to continually support elevated standards of care in critical settings."

Global Biological Indicators Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biological indicators market report based on product, method, end use, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Self-Contained (Vials/Ampoules)
• Strips
• Cards / Rapid Readout BIs
• Others
• Method Outlook (Revenue, USD Million, 2021 - 2033)
• Steam Sterilization
• Ethylene Oxide Sterilization
• Hydrogen Peroxide Sterilization
• Irradiation Sterilization (Gamma, E-beam)
• Dry Heat Sterilization
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics (CSSD / Infection Control Units)
• Ambulatory Surgery Centers (ASCs) & Dental Clinics
• Biopharma & Biotech Companies
• Medical Device Manufacturers
• Contract Sterilization Service Providers
• Research & Academic Institutes
• Other End Uses
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
• U.S.
• Canada
• Mexico
• Europe
• UK
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway
• Asia Pacific
• Japan
• China
• India
• Australia
• Thailand
• South Korea
• Latin America
• Brazil
• Argentina
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE
• Kuwait

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