생물학적 지시제 시장 규모, 점유율, 동향 분석 : 제품별, 방법별, 최종 용도별, 지역별, 부문별 예측(2026-2033년)

Biological Indicators Market Summary

The global biological indicators market size was estimated at USD 572.28 million in 2025 and is projected to reach USD 1,106.24 million by 2033, growing at a CAGR of 8.78% from 2026 to 2033. This growth is attributed to the growing emphasis on sterilization and infection control across healthcare, pharmaceutical, and food industries.

Increasing concerns over hospital-acquired infections (HAIs) and stringent regulatory requirements for validating sterilization processes are boosting demand for reliable and rapid BI solutions. In addition, advancements in rapid-readout and automation technologies, coupled with the rising adoption of sterilization methods in emerging markets, are further accelerating the growth of the market. Stringent regulatory requirements play a pivotal role in driving the biological indicators industry, as global health authorities mandate the validation of sterilization processes across industries such as medical devices, pharmaceuticals, and biotechnology. Biological indicators are the gold standard for confirming sterilization efficacy, making them a necessity for compliance. For instance, the U.S. Food and Drug Administration (FDA) requires medical device manufacturers to demonstrate sterilization validation under 21 CFR Part 820 (Quality System Regulation), while the European Medicines Agency (EMA) and the ISO 11138 standard outline specific criteria for biological indicator use in sterilization assurance. Similarly, compliance with Good Manufacturing Practices (GMP) in pharmaceuticals necessitates biological indicator-based validation for sterilized drug products and equipment. These strict regulatory frameworks ensure patient safety and product reliability, fueling consistent demand for biological indicators across critical healthcare and life sciences sectors.

The rising burden of hospital-acquired infections (HAIs) is a key factor driving the growth of the biological indicators industry, as healthcare facilities are increasingly focusing on strengthening infection control and sterilization practices. According to the WHO's Global Report on Infection Prevention and Control 2024, a large-scale systematic review of nearly 400 studies estimated the global prevalence of HAIs at around 14% in 2023. Furthermore, a European point prevalence survey conducted in 2022/2023 across 28 EU/EEA countries and three Western Balkan nations/territories reported an adjusted prevalence of 8% for patients with at least one HAI. This growing incidence of HAIs underscores the critical need for reliable sterilization validation, fueling the demand for biological indicators to ensure the effectiveness of sterilization processes over the forecast period.

Global Biological Indicators Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biological indicators market report based on product, method, end use, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Self-Contained (Vials/Ampoules)
• Strips
• Cards / Rapid Readout BIs
• Others
• Method Outlook (Revenue, USD Million, 2021 - 2033)
• Steam Sterilization
• Ethylene Oxide Sterilization
• Hydrogen Peroxide Sterilization
• Irradiation Sterilization (Gamma, E-beam)
• Dry Heat Sterilization
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics (CSSD / Infection Control Units)
• Ambulatory Surgery Centers (ASCs) & Dental Clinics
• Biopharma & Biotech Companies
• Medical Device Manufacturers
• Contract Sterilization Service Providers
• Research & Academic Institutes
• Other End Uses
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Thailand
  • South Korea
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Research Methodology
• 1.3. Information Procurement
  • 1.3.1. Purchased database.
  • 1.3.2. GVR's internal database
  • 1.3.3. Secondary sources
  • 1.3.4. Third Party Perspective
  • 1.3.5. Primary research
  • 1.3.6. Details of primary research
• 1.4. Information or Data Analysis
  • 1.4.1. Data analysis models
• 1.5. Market Formulation & Validation
• 1.6. Model Details
  • 1.6.1. Commodity flow analysis (Model 1)
• 1.7. Approach 1: Commodity flow approach
  • 1.7.1 Volume price analysis (Model 2)
• 1.8. Approach 2: Volume price analysis
• 1.9. List of Secondary Sources
• 1.10. List of Primary Sources
• 1.11. List of Abbreviations

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Biological Indicators Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Increasing Prevalence of Healthcare-Associated Infections (HAIs)
    • 3.2.1.2. Stringent Regulatory Requirements and Standards
    • 3.2.1.3. Growth in Surgical Procedures and Healthcare Infrastructure
    • 3.2.1.4. Technological Innovation
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. High Cost of Advanced Indicators and Supporting Systems
  • 3.2.3. Market Opportunities Analysis
    • 3.2.3.1. Integration with Digital/IoT & Automation
    • 3.2.3.2. Emerging Market Expansion
  • 3.2.4. Market Challenges Analysis
    • 3.2.4.1. Competition from Alternative & Less Expensive Technologies
• 3.3. Biological Indicators Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Bargaining Power of Suppliers
    • 3.3.1.2. Bargaining Power of Buyers
    • 3.3.1.3. Threat of Substitutes
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political & Legal Landscape
    • 3.3.2.2. Economic and Social Landscape
    • 3.3.2.3. Technological Landscape

Chapter 4. Biological Indicators Market: Product Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Biological Indicators Market: Product Movement Analysis & Market Share, 2025 & 2033
• 4.3. Self-Contained
  • 4.3.1. Self-Contained Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.4. Strips
  • 4.4.1. Strips Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Cards / Rapid Readout BIs
  • 4.5.1. Cards / Rapid Readout BIs Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Others
  • 4.6.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Biological Indicators Market: Method Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Biological Indicators Market: Method Movement Analysis & Market Share, 2025 & 2033
• 5.3. Steam Sterilization
  • 5.3.1. Steam Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Ethylene Oxide Sterilization
  • 5.4.1. Ethylene Oxide Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Hydrogen Peroxide Sterilization
  • 5.5.1. Hydrogen Peroxide Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Irradiation Sterilization
  • 5.6.1. Irradiation Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Dry Heat Sterilization
  • 5.7.1. Dry Heat Sterilization Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Biological Indicators Market: End Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Biological Indicators Market: End Use Movement Analysis & Market Share, 2025 & 2033
• 6.3. Hospitals & Clinics
  • 6.3.1. Hospitals & Clinics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. Ambulatory Surgery Centers (ASCs) & Dental Clinics
  • 6.4.1. Ambulatory Surgery Centers (ASCs) & Dental Clinics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Biopharma & Biotech Companies
  • 6.5.1. Biopharma & Biotech Companies Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Medical Device Manufacturers
  • 6.6.1. Medical Device Manufacturers Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Contract Sterilization Service Providers
  • 6.7.1. Contract Sterilization Service Providers Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Research & Academic Institutes
  • 6.8.1. Research & Academic Institutes Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.9. Other End Uses
  • 6.9.1. Other End Uses Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Biological Indicators Market: Regional Estimates & Trend Analysis by Product, Method, End Use

• 7.1. Regional Outlook
• 7.2. Biological Indicators Market: Regional Movement Analysis & Market Share, 2025 & 2033
• 7.3. North America
  • 7.3.1. North America Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.3.2. U.S.
    • 7.3.2.1. Key Country Dynamics
    • 7.3.2.2. Competitive Scenario
    • 7.3.2.3. Regulatory Scenario
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. U.S. Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.3.3. Canada
    • 7.3.3.1. Key Country Dynamics
    • 7.3.3.2. Competitive Scenario
    • 7.3.3.3. Regulatory Scenario
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Canada Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.3.4. Mexico
    • 7.3.4.1. Key Country Dynamics
    • 7.3.4.2. Competitive Scenario
    • 7.3.4.3. Regulatory Scenario
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Mexico Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.4. Europe
  • 7.4.1. Europe Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.2. UK
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Scenario
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. UK Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. Germany
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Scenario
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Germany Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. France
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Scenario
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. France Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.5. Italy
    • 7.4.5.1. Key Country Dynamics
    • 7.4.5.2. Competitive Scenario
    • 7.4.5.3. Regulatory Scenario
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Italy Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.6. Spain
    • 7.4.6.1. Key Country Dynamics
    • 7.4.6.2. Competitive Scenario
    • 7.4.6.3. Regulatory Scenario
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Spain Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.7. Denmark
    • 7.4.7.1. Key Country Dynamics
    • 7.4.7.2. Competitive Scenario
    • 7.4.7.3. Regulatory Scenario
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Denmark Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.8. Sweden
    • 7.4.8.1. Key Country Dynamics
    • 7.4.8.2. Competitive Scenario
    • 7.4.8.3. Regulatory Scenario
    • 7.4.8.4. Reimbursement Scenario
    • 7.4.8.5. Sweden Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.9. Norway
    • 7.4.9.1. Key Country Dynamics
    • 7.4.9.2. Competitive Scenario
    • 7.4.9.3. Regulatory Scenario
    • 7.4.9.4. Reimbursement Scenario
    • 7.4.9.5. Norway Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Asia Pacific
  • 7.5.1. Asia Pacific Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. Japan
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Scenario
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Japan Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. China
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Scenario
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. China Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. India
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Scenario
    • 7.5.4.4. Reimbursement Scenario
    • 7.5.4.5. India Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. South Korea
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Scenario
    • 7.5.5.4. Reimbursement Scenario
    • 7.5.5.5. South Korea Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Australia
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Scenario
    • 7.5.6.4. Reimbursement Scenario
    • 7.5.6.5. Australia Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Thailand
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Scenario
    • 7.5.7.4. Reimbursement Scenario
    • 7.5.7.5. Thailand Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Latin America
  • 7.6.1. Latin America Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Brazil
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Scenario
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Brazil Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. Argentina
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Scenario
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Argentina Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Middle East & Africa
  • 7.7.1. Middle East & Africa Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. South Africa
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Scenario
    • 7.7.2.4. Reimbursement Scenario
    • 7.7.2.5. South Africa Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Saudi Arabia
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Scenario
    • 7.7.3.4. Reimbursement Scenario
    • 7.7.3.5. Saudi Arabia Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.4. UAE
    • 7.7.4.1. Key Country Dynamics
    • 7.7.4.2. Competitive Scenario
    • 7.7.4.3. Regulatory Scenario
    • 7.7.4.4. Reimbursement Scenario
    • 7.7.4.5. UAE Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.5. Kuwait
    • 7.7.5.1. Key Country Dynamics
    • 7.7.5.2. Competitive Scenario
    • 7.7.5.3. Regulatory Scenario
    • 7.7.5.4. Reimbursement Scenario
    • 7.7.5.5. Kuwait Biological Indicators Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
• 8.2. Key Company Profiles
  • 8.2.1. STERIS plc.
    • 8.2.1.1. Company Overview
    • 8.2.1.2. Financial Performance
    • 8.2.1.3. Product Benchmarking
    • 8.2.1.4. Strategic Initiatives
  • 8.2.2. Solventum
    • 8.2.2.1. Company Overview
    • 8.2.2.2. Financial Performance
    • 8.2.2.3. Product Benchmarking
    • 8.2.2.4. Strategic Initiatives
  • 8.2.3. Getinge
    • 8.2.3.1. Company Overview
    • 8.2.3.2. Financial Performance
    • 8.2.3.3. Product Benchmarking
    • 8.2.3.4. Strategic Initiatives
  • 8.2.4. Mesa Laboratories, Inc.
    • 8.2.4.1. Company Overview
    • 8.2.4.2. Financial Performance
    • 8.2.4.3. Product Benchmarking
    • 8.2.4.4. Strategic Initiatives
  • 8.2.5. 3M
    • 8.2.5.1. Company Overview
    • 8.2.5.2. Financial Performance
    • 8.2.5.3. Product Benchmarking
    • 8.2.5.4. Strategic Initiatives
  • 8.2.6. Terragene S.A.
    • 8.2.6.1. Company Overview
    • 8.2.6.2. Financial Performance
    • 8.2.6.3. Product Benchmarking
    • 8.2.6.4. Strategic Initiatives
  • 8.2.7. Propper Manufacturing Co., Inc.
    • 8.2.7.1. Company Overview
    • 8.2.7.2. Financial Performance
    • 8.2.7.3. Product Benchmarking
    • 8.2.7.4. Strategic Initiatives
  • 8.2.8. Tuttnauer
    • 8.2.8.1. Company Overview
    • 8.2.8.2. Financial Performance
    • 8.2.8.3. Product Benchmarking
    • 8.2.8.4. Strategic Initiatives
  • 8.2.9. Ecolab Inc.
    • 8.2.9.1. Company Overview
    • 8.2.9.2. Financial Performance
    • 8.2.9.3. Product Benchmarking
    • 8.2.9.4. Strategic Initiatives
  • 8.2.10. H.W.Andersen Products Ltd.
    • 8.2.10.1. Company Overview
    • 8.2.10.2. Financial Performance
    • 8.2.10.3. Product Benchmarking
    • 8.2.10.4. Strategic Initiatives
  • 8.2.11. MATACHANA GROUP
    • 8.2.11.1. Company Overview
    • 8.2.11.2. Financial Performance
    • 8.2.11.3. Product Benchmarking
    • 8.2.11.4. Strategic Initiatives
  • 8.2.12. LISTER BIOMEDICAL CO.,LTD
    • 8.2.12.1. Company Overview
    • 8.2.12.2. Financial Performance
    • 8.2.12.3. Product Benchmarking
    • 8.2.12.4. Strategic Initiatives
  • 8.2.13. Liofilchem S.r.l.
    • 8.2.13.1. Company Overview
    • 8.2.13.2. Financial Performance
    • 8.2.13.3. Product Benchmarking
    • 8.2.13.4. Strategic Initiatives
  • 8.2.14. Steelco S.p.A.
    • 8.2.14.1. Company Overview
    • 8.2.14.2. Financial Performance
    • 8.2.14.3. Product Benchmarking
    • 8.2.14.4. Strategic Initiatives
  • 8.2.15. Zhejiang Tailin Bioengineering Co., Ltd.
    • 8.2.15.1. Company Overview
    • 8.2.15.2. Financial Performance
    • 8.2.15.3. Product Benchmarking
    • 8.2.15.4. Strategic Initiatives
  • 8.2.16. Cole-Parmer Instrument Company, LLC (Antylia Scientific)
    • 8.2.16.1. Company Overview
    • 8.2.16.2. Financial Performance
    • 8.2.16.3. Product Benchmarking
    • 8.2.16.4. Strategic Initiatives
  • 8.2.17. Anhui Tianrun Medical Packaging Materials Co., Ltd.
    • 8.2.17.1. Company Overview
    • 8.2.17.2. Financial Performance
    • 8.2.17.3. Product Benchmarking
    • 8.2.17.4. Strategic Initiatives
  • 8.2.18. Medline Industries, LP.
    • 8.2.18.1. Company Overview
    • 8.2.18.2. Financial Performance
    • 8.2.18.3. Product Benchmarking
    • 8.2.18.4. Strategic Initiatives
  • 8.2.19. True Indicating
    • 8.2.19.1. Company Overview
    • 8.2.19.2. Financial Performance
    • 8.2.19.3. Product Benchmarking
    • 8.2.19.4. Strategic Initiatives