Biological and Chemical Indicators Market Size to Hit USD 851.4 Million by 2032 with CAGR of 6.5% | Coherent Market Insights
Burlingame, CA, Nov. 11, 2025 (GLOBE NEWSWIRE) — The Global Biological and Chemical Indicators Market is estimated to be valued at USD 547.9 Mn in 2025 and is expected to reach USD 851.4 Mn by 2032, exhibiting a compound annual growth rate (CAGR) of 6.5% from 2025 to 2032. This consistent growth is propelled by growing awareness of sterilization validation processes and the enforcement of strict regulatory standards across the healthcare and pharmaceutical sectors, driving the need for reliable and effective quality assurance indicators.
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Global Biological and Chemical Indicators Market Key Takeaways
Biological indicators segment is set to dominate the market, capturing 58.2% of the market share in 2025.
Biological test kits are slated to remain a highly sought-after product form, accounting for nearly one-third of the global biological and chemical indicators share by 2025.
Based on sterilization method, the steam sterilization category is likely to hold a market share of 31.7% in 2025.
North America is forecast to account for 36.8% of the global biological and chemical indicators industry share by 2025.
Asia Pacific, with an estimated share of 25.4% in 2025, is slated to become a hotbed for companies during the forecast period.
Stringent Regulatory Requirements Fueling Market Growth
Coherent Market Insights’ new biological and chemical indicators market analysis outlines key factors driving growth. Implementation of strict regulatory requirements is one such prominent growth factor.
Regulatory bodies like the FDA, EMA, and ISO are imposing stricter sterilization, hygiene, and disinfection protocols across healthcare, pharmaceutical, and medical device industries. These standards mandate validation of sterilization processes, often requiring use of both biological and chemical indicators.
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High Cost and Alternative Methods Hampering Market Growth
The global biological and chemical indicators market outlook remains positive. However, high cost of advanced indicators and rising adoption of alternative sterilization validation methods might limit market growth to some extent during the forthcoming period.
Advanced biological and chemical indicators are quite expensive, increasing the overall cost of sterilization validation. This can limit adoption among small and medium-sized healthcare facilities and laboratories.
Furthermore, technological advances in digital sterilization monitoring systems and automated sterilizers with built-in validation reduce dependence on external indicators. This substitution is expected to lower overall biological and chemical indicators market demand in the coming years.
Rising Incidence of Hospital-Acquired Infections Unlocking Growth Opportunities
Hospital-acquired infections (HAIs) are on the rise globally. According to the WHO, hundreds of millions of patients are affected by HAIs each year. This increase is prompting healthcare facilities to strengthen sterilization and infection control measures, which, in turn, is boosting demand for biological and chemical indicators.
Emerging Biological and Chemical Indicators Market Trends
Growing emphasis on quality assurance and patient safety is a key growth-shaping trend in the biological and chemical indicators market. Medical devices and pharmaceutical products need validated sterility to ensure safety and quality. This, in turn, is driving demand for biological and chemical indicators.
Expanding applications in non-pharmaceutical industries is expected to boost sales of biological and chemical indicators. Industries like food & beverage, environmental monitoring, cosmetics, and research laboratories are increasingly using sterilization validation. As a result, there is a rising demand for biological and chemical indicators across these sectors.
Technological advancements are providing an additional boost to the biological and chemical indicators market growth. Companies are developing faster biological indicators (rapid readout), self‐contained vials, spore strips, and other products that reduce cycle time. Similarly, there is a rising trend of using digital solutions like AI and IoT to streamline validation workflows and improve result reliability.
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Analyst’s View
“The global biological and chemical indicators industry is set to expand steadily, owing to implementation of stringent regulations and compliance standards, rising incidence of hospital-acquired infections, expanding pharmaceutical and healthcare sectors, and ongoing technological advancements,” said a senior analyst at CMI.
Current Events and Their Impact on the Biological and Chemical Indicators Market
| Event | Description and Impact |
| Post-Pandemic Healthcare Infrastructure Transformation |
|
| Climate Change and Environmental Monitoring Regulations |
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| Artificial Intelligence and Automation Integration |
|
Competitor Insights
Key companies in the biological and chemical indicators market report:
- STERIS
- 3M
- Mesa Laboratories
- Terragene
- gke GmbH
- Getinge
- SteriTec Products Inc.
- Propper Manufacturing Company
- PMS Medikal
- 4A Medical
- Etigam BV
- Liofilchem S.r.l.
- Advanced Sterilization Products (ASP)
- Tuttnauer
- Propper Manufacturing Co., Inc.
- Andersen Sterilizers
Key Developments
In September 2025, Nelson Laboratories launched RapidCert Biological Indicator Sterility Testing to speed up the process of confirming product sterility. This new method reduces testing time from seven days to about two days. According to Nelson Labs, they are the first to offer this kind of rapid BI sterility testing for pharmaceutical products and medical devices.
In June 2025, Solventum launched the Attest Super Rapid Vaporized Hydrogen Peroxide (VH₂O₂) Clear Challenge Pack, a preassembled, see-through test pack for low-temperature medical instrument sterilization. Each unit integrates both a biological indicator (BI) and a chemical (tri-metric) indicator (CI) in a ready-to-use design intended to support every-load monitoring across various sterilizer models.
Market Segmentation
Type Insights (Revenue, USD Mn, 2020 – 2032)
- Biological Indicators
- Chemical Indicators
Product Form Insights (Revenue, USD Mn, 2020 – 2032)
- Biological Test Kits
- Self-contained biological indicators vials
- Indicator Strips
- Integrators/Emulators
- Single-Use Indicators
- Reusable Indicators
- Reference Materials and Calibration Standards
- Others (Tapes, Discs)
Sterilization Method Insights (Revenue, USD Mn, 2020 – 2032)
- Steam sterilization
- Dry Heat Sterilization
- Ethylene Oxide (ETO) Sterilization
- Hydrogen Peroxide (H₂O₂) Sterilization
- Formaldehyde Sterilization
- Others (Plasma, Radiation, Filtration etc.)
Technology Insights (Revenue, USD Mn, 2020 – 2032)
- Enzyme-Based Technology
- Colorimetric Technology
- Fluorometric Technology
- Nucleic Acid-Based Technology
- Digital and IoT-Enabled Indicators
End User Insights (Revenue, USD Mn, 2020 – 2032)
- Pharmaceutical and Biotech Companies
- Hospitals and Clinics
- Medical Device Manufacturers
- Contract Research Organizations (CROs)
- Others (Academic and Research Institutes, etc.)
Regional Insights (Revenue, USD Mn, 2020 – 2032)
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
Related Reports:
Sterilization Equipment Market Analysis & Forecast for 2025-2032
Biological Indicator Market Size, Share, Trends & Opportunities for 2025-2032
Biological Safety Cabinets Market Outlook for 2025-2032
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