Sterility Indicators Market Outlook:
Sterility Indicators Market size was valued at USD 1.29 billion in 2025 and is likely to cross USD 3.73 billion by 2035, expanding at more than 11.2% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of sterility indicators is estimated at USD 1.42 billion.
The primary growth driver of the sterility indicators market is the increasing demand for sterilization in the healthcare and pharmaceutical industries. According to the International Atomic Energy Agency, almost 12 million cubic meters of medical equipment are sterilized by radiation annually, while gamma irradiation is used to sterilize almost 40% of all single-use medical equipment manufactured globally.
Regulatory bodies like the Food and Drug Administration (FDA), World Health Organization (WHO), and International Organization for Standardization (ISO) mandate strict sterility assurance protocols in medical devices, pharmaceuticals, and healthcare facilities, driving the adoption of sterility indicators. Moreover, the growing awareness of healthcare-associated infections (HAIs) emphasizes the importance of sterilization, boosting demand for reliable sterility monitoring tools.