Biological & Chemical Indicators Market Outlook 2032
The global biological & chemical indicators market size was USD 523.4 Million in 2023 and is likely to reach USD 978.6 Million by 2032, expanding at a CAGR of 7.2% during 2024–2032. The market growth is attributed to the rising demand for medical devices and pharmaceuticals.
Biological and chemical indicators track sterilization efficacy in hospitals, laboratories, and food processing plants. Biological indicators include heat-resistant microorganism spores, while chemical indicators determine if conditions such as temperature or exposure time have been met using chemical compounds that change color.
Biopharma research outsourcing is prevalent in emerging countries such as India, and clinical trial partnerships between key players and emerging companies are gaining traction in the India market. The biological and chemical indicators industry is gaining momentum, due to the increasing adoption of universal sterilization indicators, advanced product development, parenteral therapeutic commercialization, disease diagnosis, and in-house monitoring solutions.
Biological & Chemical Indicators Market Dynamics
Major Drivers
The rising demand for medical devices and pharmaceuticals is driving the global market. The increasing aging population is propelling the demand for medical procedures and devices. This translates to a high volume of equipment requiring sterilization, driving the demand for indicators. Moreover, the advancements and awareness of new and sophisticated medical technologies for proper sterilization to ensure functionality and patient safety is boosting the market.
Existing Restraints
High cost associated to the indicators is expected to restrain the global market. Biological indicators are generally more expensive than chemical indicators, due to their complex manufacturing and analysis processes. This is a deterrent for some healthcare facilities and small companies.
Emerging Opportunities
Development of multi-parameter indicators for specific temperature and time is presenting an opportunity to the market players. The development of multi-parameter indicators that monitor a combination of factors such as temperature, pressure, and chemical exposure provide a comprehensive picture of sterilization effectiveness, creating a valuable market opportunity.
Scope of the Biological & Chemical Indicators Market Report
The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Biological & Chemical Indicators Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2023
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Historic Data
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2017–2022
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Forecast Period
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2024–2032
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Segmentation
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Type (Biological Indicators and Chemical Indicators), Sterilization Method (Heat, Low Temperature, Filtration, Liquid, Steam, and Radiation), and End-user (Hospitals, Pharmaceutical Companies, and Clinical Laboratories & Research Centers)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast
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Key Players Covered in the Report
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Andersen Products, Inc.; Crosstex International, Inc.; Getinge AB; GKE-GmbH; McKesson Medical-Surgical Inc.; Mesa Labs, Inc.; Propper Manufacturing Co., Inc.; Steris Plc.; Terragene S.A.; The 3M Company; and Thermo Fisher Scientific, Inc.
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Biological & Chemical Indicators Market Segment Insights
Type Segment Analysis
Based on type, the biological & chemical indicators market is divided into biological indicators and chemical indicators. The biological indicators segment held a large share in the global market in 2023 owing to its high precision. The biological indicators are highly used in healthcare institutions, research labs, and fermentation & food industries. These are living organisms such as spores of bacteria or fungi that are used to monitor the effectiveness of sterilization processes. They are killed by the sterilization process, and their absence indicates that the process was successful.
The chemical indicators segment is anticipated to expand at a substantial CAGR during the forecast period. These are chemicals that change color or state in response to a sterilization process. They are a less expensive alternative to biological indicators, although they are not as reliable. The cost-effectiveness and specific applications of these indicators are expected to propel this segment during the forecast period.
Sterilization Method Segment Analysis
On the basis of sterilization method, the global market is segregated into heat, low temperature, filtration, liquid, steam, and radiation. The steam segment is anticipated to register a considerable CAGR in during the forecast period, owing to its wide applications. Steam sterilization is a highly versatile and cost-effective method used extensively in hospitals, pharmaceutical companies, and for medical devices. This widespread adoption drives a high demand for steam sterilization indicators.
The regulatory requirements mandating the use of sterilization is expected to boost the segment significantly during the forecast period. Steam sterilization technology is well-established and widely understood. The supporting indicator technology is also offering reliable and well-tested options.
The radiation segment is projected to register a robust growth rate during the assessment years, due to its increasing adoption and material compatibility. Radiation is effective for sterilizing materials that cannot withstand heat or moisture, such as certain plastics and pharmaceuticals. Growing demand for single-use medical devices is fueling the segment. The increasing use of single-use medical devices, which are often sterilized by radiation, could be driving demand for radiation sterilization indicators.
End-user Segment Analysis
On the basis of End-user, the biological & chemical indicators market is segmented into hospitals, pharmaceutical companies, and clinical laboratories & research centers. The pharmaceutical companies segment registers a robust growth rate in 2023, owing to high regulatory requirements. Both pharmaceuticals and medical devices undergo strict sterilization processes to ensure patient safety. Regulatory bodies mandate the use of biological and chemical indicators to verify sterilization effectiveness, driving high demand in this industry. Additionally, the large production volumes of pharmaceutical companies produce vast quantities, each requiring sterilization, propelling the segment.
The clinical laboratories & research centers segment is expected to expand at a significant growth rate over the projection period, owing to the expansion in research activities. The global research landscape is expanding constantly with growing focus on biotechnology and pharmaceutical manufacturing. Ensuring proper sterilization of equipment to prevent contamination necessitates the use of biological and chemical indicators.
Regional Analysis
In terms of region, the global biological & chemical indicators market is classified as Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa. North America dominates the global market in 2023, owing to increasing R&D activities. Moreover, the stringent regulatory requirements and well-established healthcare system is expected to fuel the regional market during the forecast period. Additionally, the increasing product launch and acquisitions of significant market players is fueling the market in this region. For instance,
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In 2020, QIAGEN N.V. has been acquired by Thermo Fisher Scientific, Inc. for around USD 11.5 Billion.
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In July 2020, The 3M corporation unveiled the Attest Mini Auto-reader 490M, a sterilization monitoring device intended for usage by dental practitioners that lasts for 24 minutes inside the home.
The market in Asia Pacific is projected to grow at a significant pace in the coming years, owing to the increasing community and hospital-acquired infections. The growing population and increasing awareness for sterilization process is driving the regional market. Moreover, the emerging market players and establishment of manufacturing companies for biological and chemical indicators is propelling the regional market.
Segments
The biological & chemical indicators market has been segmented on the basis of
Type
- Biological Indicators
- Chemical Indicators
Sterilization Method
- Heat
- Low Temperature
- Filtration
- Liquid
- Steam
- Radiation
End-user
- Hospitals
- Pharmaceutical Companies
- Medical Devices
- Clinical Laboratories & Research Centers
Region
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
Competitive Landscape
Key players competing in the global biological & chemical indicators market are Andersen Products, Inc.; Crosstex International, Inc.; Getinge AB; GKE-GmbH; McKesson Medical-Surgical Inc.; Mesa Labs, Inc.; Propper Manufacturing Co., Inc.; Steris Plc.; Terragene S.A.; The 3M Company; and Thermo Fisher Scientific, Inc.
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In October 2023, Mesa Laboratories, a global key company in life science equipment, has successfully acquired sterilization indicators business of GKE-GmbH and SAL GmbH, an independent testing lab. The purchase price is EUR 85 million, with the all-cash transactions financed using profits from the company credit facility and cash on hand.
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In October 2022, STEMart is a company that offers biological indicator sterility testing services to the medical device sector. Following the conclusion of the sterilizing load, this testing is carried out in accordance with the exposure of Biological Indicators (BIs). It is a qualitative test designed to provide findings that accurately reflect an organism growth.
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