Sterility Indicators Market Report 2024

This Sterility Indicators market report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The sterility indicators market size has grown rapidly in recent years. It will grow from $1.08 billion in 2023 to $1.23 billion in 2024 at a compound annual growth rate (CAGR) of 13.6%. The growth during the historical period can be attributed to increasing regulatory requirements for sterilization processes, a rise in the number of healthcare facilities, growing demand for advanced sterilization techniques, an increase in global healthcare expenditures, and a heightened demand for sterile packaging solutions.

The sterility indicators market size is expected to see rapid growth in the next few years. It will grow to $2.06 billion in 2028 at a compound annual growth rate (CAGR) of 13.8%. The anticipated growth during the forecast period can be attributed to the rising incidence of hospital-acquired infections, increased spending on research and development, a growing number of drug launches, a high prevalence of chronic diseases, and an increasing prevalence of infectious diseases. Key trends expected during this period include technological advancements, integration with automated systems, innovations in biological indicators, the development of fast monitoring technologies, and the use of spore strips.

The growing prevalence of infectious diseases is projected to drive the expansion of the sterility indicators market in the future. Infectious diseases are conditions caused by harmful microorganisms such as bacteria, viruses, fungi, or parasites, which can be transmitted from one person to another, either directly or indirectly. Common infectious diseases include tuberculosis (TB), urinary tract infections, influenza (flu), and others. The increase in infectious diseases can be attributed to various factors, including heightened global travel, urbanization, and increased population density, all of which facilitate the spread of pathogens. Sterility indicators play a critical role in ensuring the effectiveness of sterilization processes, particularly in managing and preventing infectious diseases, by providing a dependable method to confirm the complete elimination of pathogens. These indicators uphold the highest safety standards within healthcare settings, minimizing the risk of contamination and the transmission of diseases. For instance, in March 2022, the Centers for Disease Control and Prevention, a US-based national public health agency, reported 8,331 tuberculosis cases in the United States, reflecting an incidence rate of 2.5 cases per 100,000 people in 2022. This represented a 5.9% rise in case numbers and a 5.5% increase in the incidence rate compared to 2021. Thus, the rising prevalence of infectious diseases is contributing to the growth of the sterility indicators market.

Key companies in the sterility indicators market are concentrating on the development of advanced products, such as steam monitoring tools, which assist healthcare facilities in identifying trends, analyzing performance, and making informed decisions. Steam monitoring products are essential devices used to ensure the efficacy of steam sterilization processes across various environments, particularly in healthcare, laboratories, and industries where sterilization is vital. These tools are crucial for maintaining sterility and minimizing contamination risks, especially in settings that handle infectious materials or critical medical devices. For example, in October 2023, Advanced Sterilization Products, a US-based healthcare company, announced an expansion of its Sterilization Monitoring portfolio by introducing new Steam Monitoring products, which include BIOTRACE Readers, BIOTRACE Biological Indicator, VERISURE Chemical Indicator, and SEALSURE Steam Indicator Tape. These products provide quick results and enhance compliance by improving workflow and connectivity in sterilization monitoring. The BIOTRACE Biological Indicator simplifies the tracking of steam sterilization processes with an integrated traceability solution. The VERISURE Chemical Indicator facilitates easy and rapid monitoring of sterilization procedures, streamlining operations. Meanwhile, the SEALSURE Steam Indicator Tape offers a visual method to differentiate between processed and unprocessed steam items, aiding in the tracking and identification of sterilized equipment.

In October 2023, Mesa Laboratories Inc., a US-based manufacturer of medical devices, acquired the sterilization indicators business from GKE-GmbH for an undisclosed amount. This acquisition is intended to bolster Mesa Laboratories’ capabilities in sterilization indicators, thereby enhancing its presence and strengthening its portfolio within the healthcare and life sciences sectors. GKE-GmbH is a Germany-based manufacturer specializing in cleaning process indicators and monitoring for cleaning and sterilization.

Major companies operating in the sterility indicators market are Cardinal Health Inc., Thermo Fisher Scientific Inc., 3M Company, Propper Manufacturing Co. Inc., Andersen Products Inc., Ecolab Inc., Medline Industries Inc., VWR International LLC, STERIS PLC, Getinge AB, Sigma-Aldrich Corporation, Halyard Health Inc., Aesculap Inc., Hu-Friedy Mfg. Co. LLC, Mesa Laboratories Inc., Nelson Laboratories LLC, Crosstex International Inc., Tuttnauer, Matachana Group, Etigam B.V.

North America was the largest region in the sterility indicators market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the sterility indicators market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the sterility indicators market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Sterility indicators are tools or devices utilized to verify the effectiveness of sterilization processes in medical, pharmaceutical, and laboratory environments. They ensure that equipment, instruments, and materials have been properly sterilized and are free from viable microorganisms that could lead to contamination or infection. These indicators are crucial for quality control and patient safety within the healthcare sector and related industries.

The main types of sterility indicators are chemical and biological. Chemical indicators are substances that change color or appearance when subjected to specific sterilization conditions, such as temperature or pressure. The techniques involved include heat sterilization, low-temperature sterilization, filtration sterilization, radiation sterilization, and liquid sterilization. The primary end users of these indicators include hospitals, pharmaceutical companies, medical device manufacturers, and clinical laboratories or research centers.

The sterility indicators market research report is one of a series of new reports that provides sterility indicators market statistics, including sterility indicators industry global market size, regional shares, competitors with a sterility indicators market share, detailed sterility indicators market segments, market trends and opportunities, and any further data you may need to thrive in the sterility indicators industry. This sterility indicators market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The sterility indicators market consists of sales of autoclave tape, chemical indicator strips, and spore test kits. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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