#sterilizationmonitoring

The biological indicators (BIs) market is growing fast, especially as healthcare and pharmaceutical industries focus more on safety and sterilization. According to Global Data Stats, The global Biological Indicators Market size accounted for USD 787.3 Million in 2024 and is predicted to increase from USD 829.1 Million in 2025 to approximately USD 1157.3 Million by 2032, expanding at a CAGR of 4.8% from 2025 to 2032.

So, what is behind this growth, and where is the market headed?

Why Are Biological Indicators So Important?

Biological indicators are considered the gold standard for sterilization monitoring. Unlike chemical or physical indicators that only check for temperature, pressure, or time, BIs use resilient bacterial spores to test whether sterilization processes are truly effective. If no growth occurs after incubation, it confirms that sterilization worked as intended — a critical assurance for patient safety.

Who Are the Major Players Leading the Market?

Some of the leading companies in this space include:

Mesa Labs, Inc. (U.S.)

Terragene (Argentina)

Tuttnauer (Netherlands)

Solventum (U.S.)

ASP (Fortive) (U.S.)

Getinge (Sweden)

STERIS (U.S.)

LISTER Biomedical Co., Ltd (China)

BEYA Medical Machine Equipments Co. (Turkey)

Propper Manufacturing Co., Inc. (U.S.)

These companies are driving market growth through product innovation, acquisitions, and increasing their regional footprint.

How Is the Market Segmented?

The biological indicators market can be understood through several lenses:

By Product

Steam Biological Indicators

Hydrogen Peroxide Biological Indicators

Others

By Form

Self-Contained Vials

Indicator Strips

Others

By Type

Traditional Biological Indicators

Rapid Biological Indicators

By Sterilization Method

Steam Sterilization

Hydrogen Peroxide Sterilization

Ethylene Oxide Sterilization

Others

By End‑User

Hospitals & Clinics

Pharmaceutical & Medical Device Manufacturers

Others

By Geography

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

What Trends Are Emerging in This Market?

Rise of Rapid-Readout Indicators — Faster results are pushing more adoption of rapid biological indicators.

Preference for Self‑Contained Vials — Their ease of use and reliability make them increasingly popular.

Sterilization Outsourcing — More hospitals and manufacturers are delegating sterilization to specialist labs.

Regulatory Pressure & Safety Focus — Increased awareness and regulation around sterilization are driving BI usage.

Sustainable Innovations — There’s growing demand for eco‑friendly BIs and greener packaging.

What Challenges Could Hold Back Growth?

Cost Constraints: Advanced BIs and rapid-readout systems can be expensive, particularly for smaller clinics.

Regulatory Hurdles: Compliance with global sterilization standards can be complex.

Adoption Barriers in Emerging Markets: Awareness and budgets may limit uptake in some regions.

What Opportunities Lie Ahead?

Digital & Connected Solutions: IoT-enabled BIs and real-time tracking are opening new business models.

Biopharma Boom: Growth in biologics and biosimilars is raising the need for strict sterility validation.

Green Innovation: A market for biodegradable and eco‑friendly BIs is emerging.

Emerging Market Expansion: Developing regions are improving healthcare infrastructure, boosting demand.

Recent Developments

May 2025 — STERIS opened a new ethylene oxide (EO) processing facility in Batu Kawan, Malaysia to support growing regional sterilization needs.

November 2024 — Terragene participated in the 25th WFHSS Congress in Santiago, Chile, where it showcased sterilization consumables to increase product awareness among healthcare professionals.

November 2023 — STERIS announced that its Applied Sterilization Technologies (AST) business took part in the U.S. FDA Radiation Sterilization Master File Pilot Program to help improve radiation sterilization practices.

October 2023 — Mesa Labs, Inc., a producer of life science tools and quality control solutions, acquired GKE-GmbH’s sterilization indicators business and its independent accredited testing lab, SAL GmbH.

October 2020 — Propper Manufacturing Co., Inc. entered a new partnership with Medical Supply Company to expand its sterilization product portfolio and strengthen its presence in the European market.

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How Can Businesses Leverage This Market Growth?

Validate Sterilization Better: Use BIs to ensure sterilization cycles are truly effective.

Adopt Rapid & Digital Tools: Scale faster by using connected, rapid-readout indicators.

Partner for Sterilization Services: Work with specialist labs to reduce testing burdens.

Benchmark with Leaders: Learn from top companies like STERIS, Mesa Labs, and Terragene.

Invest in Training: Build internal expertise in sterility validation and regulatory compliance.

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