The biological and chemical indicators market size is estimated at USD 570.67 million in 2024, growing to USD 600 million in 2025, and is projected to reach approximately USD 942.03 million by 2034. The market is expanding at a CAGR of 5.14% between 2025 and 2034.
The biological and chemical indicators market has been growing in recent periods due to high demand for sterilization in various industries, including healthcare, pharmaceutical, and biopharmaceutical organizations.
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Key Highlights of the Biological and Chemical Indicators Market
➢ By region, North America led the biological and chemical indicators market in 2024, whereas the Asia Pacific is expected to grow in the foreseeable period.
➢ By sterilization type, the thermal sterilization segment led the market for biological and chemical indicators in 2024, whereas the chemical sterilization segment is expected to grow in the foreseen period.
➢ By indicator class, the biological indicators led the biological and chemical indicators market in 2024, whereas the chemical indicators segment is expected to grow in the forecast period.
➢ By packaging form, the self-contained BI segment dominated the market in 2024.
➢ By end-user, the biopharma industry segment dominated the biological and chemical indicators market, whereas the diagnostics lab segment is expected to grow in the foreseeable period.
Market Overview
The biological and chemical indicators market is experiencing a boom in recent periods due to its usage in healthcare, pharmaceutical, and biopharmaceutical organizations. The work of the indicators involves measuring the growth of microorganisms for professionals to take vital actions. The market is also experiencing growth due to dynamic changes in the healthcare industry, high awareness regarding the sterilization procedure, and rising regulatory scrutiny.
Such indicators also have an important role to play in the cosmetic and food processing industry. The increasing need for infection control and maintaining safety standards is also fueling the growth of the market for biological and chemical indicators in recent times.
How has AI impacted the Biological and Chemical Indicators Market?
The use of artificial intelligence (AI) has had a massive impact on the market for biological and chemical indicators by improving efficiency across their various sterilization applications in healthcare, pharmaceuticals, ensuring food and drug safety, and environmental monitoring. AI-powered image recognition, powered by machine learning algorithms, enhances the detection and interpretation of biological and chemical indicators, reducing the risk of human error and enabling faster, more reliable results in critical processes such as sterilization validation and contamination monitoring.
In research and development, AI significantly speeds up the analysis of massive datasets, helping scientists identify patterns in microbial growth, chemical and material interactions, along with environmental changes, which in turn leads to the development of better indicator products. Predictive analytics also allows manufacturers to anticipate performance outcomes under varying conditions, optimizing indicator formulations and reducing trial-and-error in product design.
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New Trends of Biological and Chemical Indicators Market
Increasing demand for maintaining clean, sterile environments in healthcare, pharmaceutical, and food processing industries is helping the growth of the biological and chemical indicators market.
Patient safety and prevention of healthcare-associated infections have also led to the growth of the market in the recent period.
Advanced technology in the form of IoT-enabled indicators to enhance traceability and efficiency is also helping the growth of the market.
Expanding healthcare infrastructure in emerging economies is also creating opportunities for the growth of the biological and chemical indicators market.
Chemical indicators are widely used in tandem with biological indicators since they are inexpensive and indicate that the item has been exposed to the sterilization process. This double method ensures proper sterilization.
Market Dynamics
Driver
Increasing Hospital-Associated Infections Helping the Growth of the Market
Increasing hospital-associated infections are one of the major factors for the growth of the biological and chemical indicators market. Such infections are commonly observed in different types of healthcare facilities, as such infections are damaging for the patients as well as the service providers in such areas if the situation is not handled with proper care.
Some of the common infections observed in such healthcare settings are central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), surgical site infections, and ventilator-associated pneumonia. If the working area is not prepared and sterile enough to handle patients with such healthcare issues, then infection may spread to the people around, worsening the situation. Hence, proper sterilization plays a crucial role under such circumstances, helping the growth of the biological and chemical indicators market.
Restraint
Issues Like Cross-Contamination May Hamper the Growth of the Market for Biological and Chemical Indicators
The biological and chemical indicators useful for sterilization, if they interact with samples to be sterilized mistakenly, then it leads to cross-contamination and degradation of products. Ensuring chemical and material compatibility raises the costs of production, restraining the growth of the biological and chemical indicators market. Under such circumstances, radioactive indicators are preferable as they do not come in contact with the samples physically.
Opportunity
The Expanding Biotechnology Sector Is Helping the Growth of the Market in the Forecasted Period
The rapidly expanding biotechnology sector is helping the biological and chemical indicators market to grow in the foreseeable period. It further leads to the growth of biologics such as monoclonal antibodies, cell and gene therapy products, and vaccines. Such biologics are required to be maintained in stringent sterilization conditions at the time of their manufacturing, aiding the market’s growth in the foreseen period. Manufacturers invest on a huge scale in equipping advanced sterilization technology and building state-of-the-art manufacturing infrastructure.
Regional Insights
North America Led the Biological and Chemical Indicators Market in 2024
An increasing number of surgeries, stringent regulatory policies, and the presence of key players in the region helped the growth of the biological and chemical indicators market in North America in 2024. The US and Canada played a major role in the growth of the market in the region due to the presence of major key players. The government has strict regulations to be followed for sterilization and infection control in various healthcare settings. The region also emphasizes patient safety and the need to prevent healthcare-associated infections, further fueling the growth of the market.
Asia Pacific Is Expected to Grow at the Fastest Rate in the Forecasted Period
Asia Pacific is expected to grow in the foreseeable period, aiding the growth of the biological and chemical indicators market. The growth of advanced technology and the development of research centers in the region are also helping the growth of the market. The enhancing biotechnology sector and the increasing number of biotech startups are also helping the growth of the market. Countries such as India and China have a major role in the growth of the market in the region due to the presence of major key players in the region.
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Segmental Insights
Sterilization Type Insights
The thermal sterilization segment led the biological and chemical indicators market in 2024, as the procedure involves sterilizing products using high heat or steam, which is helpful to access specific parameters of sterilization. Various other known parameters, such as temperature, time, and sterilant, are required to be monitored and maintained during the whole procedure. Such a form of sterilization is especially cost-effective in quickly ensuring results for the product, and hence, the segment led the market in 2024.
The chemical sterilization segment is expected to grow the most significantly in the forecasted period, as it involves sterilizing a product with ethylene oxide, hydrogen peroxide, and formaldehyde. The procedure is helpful for procedures such as thermosensitive samples, objects, and surfaces. The sterilization method is useful to kill various types of bacteria, microorganisms, viruses, and spores. Hence, the segment is helpful for the growth of the market in the foreseeable period.
Indicator Class Insights
The biology segment led the biological and chemical indicators market in 2024 due to the presence of viable microorganism and their versatility. The commonly observed biological indicators are endospores or bacterial spores. Such biological indicators depend on their resistance to the sterilization process. They provide vital information, such as necessary conditions that must be observed to kill microorganisms or not for a given sterilization process. Hence, the segment led the market in 2024.
The chemical indicators segment is set to grow with the highest CAGR in the forecasted period, as they immediately change their physical appearance if appropriate sterilization parameters are not maintained. They are highly preferred compared to biological indicators in the current scenarios, as they immediately indicate errors and help prevent the use of improperly processed medical instruments for any medical procedure. They are also helpful to identify the proper functioning of the sterilizer, which is further helpful for the growth of the market in the foreseeable period. Identifying steam penetration and temperature fluctuations related to the sterilizer is also indicated immediately with the help of chemical indicators.
Packaging Form Insights
The self-contained BI segment led the biological and chemical indicators market in 2024, as it consists of a durable PC vial with a cap, a crushable glass ampoule, and a disc inoculated with any BI. The segment is useful for confirmation of the sterilization of liquids in the steam autoclave cycle. The self-contaminated BI is also useful for testing the worst-case locations in liquids or within the steam sterilizer. The complete procedure involves combining a microbial spore population with a growth medium in a sealed container, eliminating the need for aseptic transfer. Hence, the segment led the market as it lowers the risk of contamination by providing faster results.
End-User Insights
The biopharma industry segment led the biological and chemical indicators market in 2024, as the segment was attributed to favorable infrastructure and suitable capital investments, helping the growth of the market. Such advancing activities help encourage biopharma companies to adopt advanced sterilization tools essential for biological and chemical indicators. Enhancing demand for biologics is also helping the manufacturing process. The segment is also observing growth due to an increasing number of biotech startups and rising preferences for contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs).
The diagnostic labs segment is expected to grow in the foreseen period due to prevailing chronic disorders, leading patients to visit diagnostic labs for getting different types of tests done to identify the root cause of the disorder. Such labs have different types of medical instruments and medical devices for diagnostic purposes. Biological and chemical indicators are used repeatedly in diagnostic labs to sterilize the medical equipment to lower the infection risk, further boosting the growth of the market.
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Recent Developments in the Biological and Chemical Indicators Market
In June 2025, Solventum, a global MedTech leader, launched its Attest™ Super Rapid Vaporized Hydrogen Peroxide (VH2O2) Clear Challenge Pack for verifying proper sterilizer function.
In November 2024, a study conducted by researchers at the University of Saskatchewan found that steam sterilizers are exceptionally effective with low failure rates, while human errors continue to remain one of the main causes of failures.
Top Biological and Chemical Indicators Market Companies
• 3M
• Aayur Lifesciences
• Anderson Products, Inc.
• Cantel Medical Corp.
• Etigam BV
• Medzell
• Mesa Labs
• Sigmaxis Innovations Pvt. Ltd.
• Solventum
• SSI Diagnostica A/S
• STERIS Life Sciences
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The global spine biologics market is forecast to grow from USD 4.65 billion in 2025 to USD 7.34 billion by 2034, at a CAGR of 5.20%.
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Segments Covered in the Report
By Sterilization Type
• Thermal Sterilization
Steam Heat
Dry Heat
• Chemical Sterilization
Ethylene Oxide
Hydrogen Peroxide
Formaldehyde
• Radiation Sterilization
By Indicator Class
• Biological Indicators
○ Geobacillus stearothermophilus (GS) Spores
○ Bacillus atrophaeus (BA) Spores
○ Others
• Chemical Indicators
○ Class 1 (Process)
○ Class 4 (Multi-Variable)
○ Class 2 (Specific-Use)
○ Class 3 (Single-Variable)
○ Class 5 (Integrating)
○ Class 6 (Cycle Verification)
• Enzyme Indicators
By Packaging Form
• Self-Contained BI
• Spore Suspension BI
• Strip and Disc BI
• Strip and Disc CI
• Others
By End-User
• Biopharma Industry
• Diagnostic Labs
• Hospitals
• Clinics
• Ambulatory Surgical Centers
• Research Lab
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa
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