Biological Indicators Market Expansion Supported by Medical Device Growth

 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. This growth is primarily driven by the increasing focus on sterilization and infection control across healthcare, pharmaceutical, and food industries. The adoption of reliable biological indicators (BIs) is essential to ensure sterilization efficacy and compliance with regulatory standards, thereby supporting safe operations and product quality in critical sectors.

Key Market Trends & Insights

  • North America dominated the global biological indicators market with a revenue share of 42.42% in 2024. This indicates that the region remains the largest contributor to market growth, supported by advanced healthcare infrastructure and stringent sterilization requirements.
  • The U.S. accounted for the largest market revenue share of 90.01% in North America in 2024. High adoption of biological indicators and compliance-driven sterilization practices in medical facilities contribute to this dominance.
  • The self-contained segment led the market with a revenue share of 44.73% in 2024. Self-contained biological indicators offer convenience and reliability, simplifying sterilization validation for healthcare facilities.
  • The steam sterilization segment led the market based on method with a revenue share of 53.26% in 2024. Steam sterilization is widely used due to its proven effectiveness and regulatory acceptance across industries.
  • Hospitals and clinics dominated the end-use segment with a revenue share of 48.92% in 2024. Healthcare facilities are major consumers of biological indicators, driven by infection control initiatives and sterilization compliance needs.

Market Application & Forecast

  • 2024 Market Size: USD 534.80 million
  • 2033 Projected Market Size: USD 1.11 billion
  • CAGR (2025–2033): 8.59%
  • North America: Largest market in 2024
  • Asia Pacific: Fastest growing market

Increasing concerns about hospital-acquired infections (HAIs) and strict regulatory requirements for sterilization validation are boosting demand for rapid and reliable BI solutions. The development of rapid-readout indicators and automation technologies, alongside the adoption of sterilization practices in emerging markets, is further accelerating market growth.

Regulatory compliance plays a pivotal role in driving the industry. Health authorities globally mandate sterilization validation in medical devices, pharmaceuticals, and biotechnology. Biological indicators are considered the gold standard for confirming sterilization efficacy. For example, the U.S. Food and Drug Administration (FDA) requires medical device manufacturers to validate sterilization processes under 21 CFR Part 820, while the European Medicines Agency (EMA) and ISO 11138 provide criteria for BI use. Compliance with Good Manufacturing Practices (GMP) in pharmaceuticals also requires biological indicator-based validation. These regulatory frameworks ensure patient safety and product reliability, driving sustained demand across healthcare and life sciences sectors.

The growing burden of HAIs further fuels market growth. According to the WHO’s Global Report on Infection Prevention and Control 2024, the global prevalence of HAIs was estimated at 14% in 2023. A European survey in 2022/2023 across 28 EU/EEA countries reported an 8% prevalence for patients with at least one HAI. This emphasizes the critical need for reliable sterilization validation, making biological indicators indispensable.

The increasing number of surgical procedures is another key driver. Hospitals and surgical centers face higher volumes of reusable instruments that require validated sterilization. In 2024, approximately 1,585,878 cosmetic surgeries were performed, a 1% increase from 2023, while reconstructive procedures rose by 2%. This surge highlights the importance of biological indicators to ensure patient safety and compliance.

Order a free sample PDF of the Biological Indicators Market Intelligence Study, published by Grand View Research.

Technological advancements enhance market growth by improving efficiency and accuracy in sterilization validation. Rapid-readout indicators now confirm sterilization efficacy within hours rather than days. For instance, Solventum introduced the Attest Super Rapid VH₂O₂ Clear Challenge Pack, integrating a biological indicator and a chemical indicator in a single-use container for simplified and reliable validation.

Key Biological Indicators Company Insights

The market is highly fragmented with numerous major and local players competing for share. Companies are investing in product launches, mergers and acquisitions, and geographic expansion to strengthen their position. This competitive landscape is expected to continue driving market growth.

Leading companies include:

  • STERIS plc.
  • Solventum
  • Getinge
  • Mesa Laboratories, Inc.
  • 3M
  • Terragene S.A.
  • Propper Manufacturing Co., Inc.
  • Tuttnauer
  • Ecolab Inc.
  • W.Andersen Products Ltd.
  • MATACHANA GROUP
  • LISTER BIOMEDICAL CO., LTD
  • Liofilchem S.r.l.
  • Steelco S.p.A
  • Zhejiang Tailin Bioengineering Co., Ltd.
  • Cole-Parmer Instrument Company, LLC (Antylia Scientific)
  • Anhui Tianrun Medical Packaging Materials Co., Ltd.
  • Medline Industries, LP.
  • True Indicating

In conclusion, the biological indicators market is positioned for strong growth due to regulatory mandates, rising surgical procedures, and technological innovations that enable faster and more reliable sterilization validation. The combination of increasing infection control demands, continuous product innovations, and expanding global healthcare infrastructure will ensure the market continues to evolve and expand throughout the forecast period.

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