Sterility Indicators Market Size To Reach $2.10 Billion By 2030

January 2025 | Report Format: Electronic (PDF)

Sterility Indicators Market Growth & Trends

The global sterility indicators market size is expected to reach USD 2.10 billion in 2030 and is projected to grow at a CAGR of 10.9% from 2024 to 2030. Strict regulations regarding healthcare products and high emphasis on sterility parameters and measures for the prevention of Hospital Acquired Infections (HAIs) are projected to drive the market growth.

Increasing number of geriatric population prone to chronic conditions is primarily driving the demand for drugs and medical devices globally.Governments in developing economies like India and China are focusing on providing cost-effective, high quality medications. The Union Cabinet of India has provided USD 13.16 billion to the National Health Mission (NHM) from April 2017 to March 2020. Currently, India has the highest U.S. Food and Drug Administration (FDA)-approved manufacturing facilities outside U.S. It also accounts for 22.0% of the overall approved U.S. FDA plants. Thus, demand for sterility testing services and products is anticipated to rise over the forecast period.

Standardized manufacturing protocols, introduction of novel products, and adoption of new technologies has led to harmonization of quality and sterility testing standards in the healthcare industry. This has created a need for not only aseptic manufacturing techniques but also for efficient and reliable sterilization monitoring processes. Furthermore, organizations such as the Agency for Healthcare Research and Quality and Centers for Medicare and Medicaid Services are also raising awareness about the need for stringent regulations for safety and quality testing services of healthcare products. Such steps are anticipated to bode well for expansion of the sterility indicators market over the forecast period.


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Sterility Indicators Market Report Highlights

  • Biological indicators dominated the market and accounted for the largest revenue share of 65.2% in 2023. Extensive usage as compared to chemical indicators owing to their reliability is anticipated to propel the segment growth

  • The heat sterilization segment accounted for the largest market revenue share in 2023

  • North America is expected to maintain its dominance with the largest market share over the forecast period owing to the presence of a large number of major companies and a high adoption of advanced technologies

  • Asia Pacific is expected to exhibit a lucrative CAGR during the forecast period. Presence of a large untapped market and availability of supportive government regulations are expected to attract global players

Sterility Indicators Market Segmentation

Grand View Research has segmented the global sterility indicators market report based on type, technique, end use, and region

Sterility Indicators Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Chemical Indicators

    • Class 1

    • Class 2

    • Class 3

    • Class 4

    • Class 5

  • Biological Indicators

    • Spore Ampoules

    • Spore Suspensions

    • Self-contained vials

    • Spore Strips

Sterility Indicators Technique Outlook (Revenue, USD Million, 2018 - 2030)

  • Heat sterilization

  • Low-temperature sterilization

  • Filtration sterilization

  • Radiation sterilization

  • Liquid sterilization

Sterility Indicators End-Use Outlook (Revenue, USD Million, 2018 – 2030)

  • Hospitals

  • Pharmaceutical companies

  • Medical device companies

  • Clinical laboratories/ Research centers

  • Others

Sterility Indicators Regional Outlook (Revenue, USD Million; 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

List of Key Players in Sterility Indicators Market

  • Getinge

  • STERIS

  • 3M

  • Cardinal Health

  • MATACHANA group

  • Mesa Labs, Inc.

  • Andersen Sterilizers

  • PMS Healthcare Technologies.

  • Propper Manufacturing Co., Inc.

  • Liofilchem S.r.l.

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