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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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
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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