화학적 인디케이터 시장 규모, 점유율, 성장 및 세계 산업 분석 : 유형별, 용도별, 지역별 인사이트 및 예측(2024-2032년)

Growth Factors of chemical indicators Market

The global chemical indicators market continues to expand as healthcare facilities worldwide increase emphasis on sterilization quality and infection prevention. According to industry data, the market was valued at USD 420.0 million in 2024, driven by the rising volume of surgical procedures, higher hospital admissions, and growing sterilization requirements in pharmaceutical and medical device sectors. In 2025, the market value is projected to reach USD 435.7 million, supported by continued demand for sterility assurance products. By 2032, the chemical indicators market is expected to grow substantially to USD 580.9 million, supported by product innovation, technological advancements, and greater adoption of sterility monitoring systems across healthcare facilities globally.

Market Growth Drivers

One of the key factors driving market growth is the rising number of hospital-acquired infections (HAIs). With hospitalizations increasing, healthcare systems are witnessing a parallel rise in infection-related risks. According to the Australian Institute of Health and Welfare, hospitalizations increased from 11.1 million in 2019 to 12.6 million in 2024, representing a substantial rise in patients requiring safe care environments. In Canada, cases of Clostridioides difficile infections increased from 3,643 in 2021 to 3,846 in 2022, reinforcing the growing need for robust sterilization monitoring practices.

Another major growth contributor is the expanding demand for biologics and biosimilars, which require stringent sterile processing. With the FDA approving 16 biologics in 2024, compared with 14 in 2021, pharmaceutical manufacturing now demands high-performance sterilization validation tools, directly boosting the demand for chemical indicators.

Market Restraints

Despite growth opportunities, the market faces challenges in developing regions. Limited adherence to sterilization protocols, inconsistent regulatory enforcement, and lack of standardized monitoring in low- and middle-income countries restrict the adoption of chemical indicators. For example, NCBI reported in 2023 that 15 out of every 100 hospitalized patients in India acquire a hospital-acquired infection, highlighting gaps in sterilization practices. Many facilities use limited sterility consumables as cost-saving measures, negatively affecting market growth.

Market Opportunities

Strong growth in pharmaceutical and medical device manufacturing in developing regions is generating significant opportunities. Companies are expanding facilities to meet global sterilization standards. In February 2024, Terumo Corporation opened a new device manufacturing plant in Puerto Rico to support rising global healthcare demand. These expansions require robust sterilization monitoring processes, supporting rising demand for chemical indicators.

In addition, increasing awareness among healthcare professionals about sterilization norms and safety practices provides new opportunities for market penetration in Asia Pacific, Latin America, and parts of Europe.

Market Challenges

The availability of alternatives such as biological indicators may limit chemical indicator adoption. Biological indicators, considered the gold standard for sterilization validation, confirm microbial destruction, whereas chemical indicators verify exposure conditions. Companies like STERIS continue to invest in biological validation systems, putting pressure on the chemical indicator segment in certain markets.

Key Market Trends

Market players are focusing heavily on new product launches to strengthen sterilization workflow efficiency. Solventum's 2025 launch of the Attest Super Rapid VH2O2 Challenge Pack, integrating both chemical and biological indicators, reflects the rising demand for rapid sterilization verification technology.

Regional Outlook

North America

North America led the global market in 2024, valued at USD 148.8 million with a 35.42% share. The region's leadership is attributed to advanced healthcare systems, high surgical volume, and strong regulatory frameworks. The U.S. reported 30,100 annual CLABSI cases in 2024, increasing the need for sterilization monitoring.

Europe

Europe held the second-largest market share in 2024, driven by companies actively participating in medical conferences. At ACHEMA 2024, Getinge showcased its chemical indicator solutions, strengthening awareness and adoption.

Asia Pacific

Asia Pacific is expected to grow at the highest rate through 2032. Companies such as STERIS continue expanding sterilization facilities, including the Suzhou, China X-ray processing expansion in 2024, supporting regional growth.

Latin America & Middle East/Africa

These regions show steady growth due to emerging healthcare capabilities, new sterilization centers, and increased presence of manufacturers at events like Arab Health 2025, where LISTER BIOMEDICAL showcased sterilization consumables.

Conclusion

With market value increasing from USD 420.0 million in 2024 to an estimated USD 580.9 million by 2032, the chemical indicators market is underpinned by rising sterilization needs, growth in biologics manufacturing, and rising global healthcare workloads. Product innovation, new manufacturing facilities, and strong regulatory initiatives will continue to fuel market expansion.

Segmentation

By Product

• Steam Chemical Indicators
• Hydrogen Peroxide Chemical Indicators
• Others

By Parameter

• Single-Variable Indicators
• Multi-Variable Indicators

By Sterilization Method

• Steam Sterilization
• Hydrogen Peroxide Sterilization
• Ethylene Oxide Sterilization
• Others

By End-user

• Hospital & Clinics
• Pharmaceutical & Medical Device Manufacturers
• Others

By Region

• North America (by Product, by Parameter, by Sterilization Method, by End-user, and by Country)
  • U.S.
  • Canada
• Europe (by Product, by Parameter, by Sterilization Method, by End-user, and by Country/Sub-Region)
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Scandinavia
  • Rest of Europe
• Asia Pacific (by Product, by Parameter, by Sterilization Method, by End-user, and by Country/Sub-Region)
  • China
  • Japan
  • India
  • Australia
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (by Product, by Parameter, by Sterilization Method, by End-user, and by Country/Sub-Region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (by Product, by Parameter, by Sterilization Method, by End-user, and by Country/Sub-Region)
  • GCC
  • South Africa
• Rest of Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Incidence of Hospital Acquired Infections - by Key Countries/Sub-regions, - 2024
• 4.2. New Product Launches - by Key Players
• 4.3. Key Industry Developments (Mergers, Acquisitions, and Partnerships)

5. Global Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 5.1. Market Analysis, Insights and Forecast - By Product
  • 5.1.1. Steam Chemical Indicators
  • 5.1.2. Hydrogen Peroxide Chemical Indicators
  • 5.1.3. Others
• 5.2. Market Analysis, Insights and Forecast - By Parameter
  • 5.2.1. Single-Variable Indicators
  • 5.2.2. Multi-Variable Indicators
  • 5.2.3. Biological Indicators
• 5.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 5.3.1. Steam Sterilization
  • 5.3.2. Hydrogen Peroxide Sterilization
  • 5.3.3. Ethylene Oxide Sterilization
  • 5.3.4. Others
• 5.4. Market Analysis, Insights and Forecast - By End-user
  • 5.4.1. Hospital & Clinics
  • 5.4.2. Pharmaceutical & Medical Device Manufacturers
  • 5.4.3. Others
• 5.5. Market Analysis, Insights and Forecast - By Region
  • 5.5.1. North America
  • 5.5.2. Europe
  • 5.5.3. Asia Pacific
  • 5.5.4. Latin America
  • 5.5.5. Middle East & Africa

6. North America Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 6.1. Market Analysis, Insights and Forecast - By Product
  • 6.1.1. Steam Chemical Indicators
  • 6.1.2. Hydrogen Peroxide Chemical Indicators
  • 6.1.3. Others
• 6.2. Market Analysis, Insights and Forecast - By Parameter
  • 6.2.1. Single-Variable Indicators
  • 6.2.2. Multi-Variable Indicators
  • 6.2.3. Biological Indicators
• 6.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 6.3.1. Steam Sterilization
  • 6.3.2. Hydrogen Peroxide Sterilization
  • 6.3.3. Ethylene Oxide Sterilization
  • 6.3.4. Others
• 6.4. Market Analysis, Insights and Forecast - By End-user
  • 6.4.1. Hospital & Clinics
  • 6.4.2. Pharmaceutical & Medical Device Manufacturers
  • 6.4.3. Others
• 6.5. Market Analysis, Insights and Forecast - By Country
  • 6.5.1. U.S.
  • 6.5.2. Canada

7. Europe Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 7.1. Market Analysis, Insights and Forecast - By Product
  • 7.1.1. Steam Chemical Indicators
  • 7.1.2. Hydrogen Peroxide Chemical Indicators
  • 7.1.3. Others
• 7.2. Market Analysis, Insights and Forecast - By Parameter
  • 7.2.1. Single-Variable Indicators
  • 7.2.2. Multi-Variable Indicators
  • 7.2.3. Biological Indicators
• 7.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 7.3.1. Steam Sterilization
  • 7.3.2. Hydrogen Peroxide Sterilization
  • 7.3.3. Ethylene Oxide Sterilization
  • 7.3.4. Others
• 7.4. Market Analysis, Insights and Forecast - By End-user
  • 7.4.1. Hospital & Clinics
  • 7.4.2. Pharmaceutical & Medical Device Manufacturers
  • 7.4.3. Others
• 7.5. Market Analysis, Insights and Forecast - By County/ Sub-region
  • 7.5.1. Germany
  • 7.5.2. U.K.
  • 7.5.3. France
  • 7.5.4. Italy
  • 7.5.5. Spain
  • 7.5.6. Scandinavia
  • 7.5.7. Rest of Europe

8. Asia Pacific Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 8.1. Market Analysis, Insights and Forecast - By Product
  • 8.1.1. Steam Chemical Indicators
  • 8.1.2. Hydrogen Peroxide Chemical Indicators
  • 8.1.3. Others
• 8.2. Market Analysis, Insights and Forecast - By Parameter
  • 8.2.1. Single-Variable Indicators
  • 8.2.2. Multi-Variable Indicators
  • 8.2.3. Biological Indicators
• 8.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 8.3.1. Steam Sterilization
  • 8.3.2. Hydrogen Peroxide Sterilization
  • 8.3.3. Ethylene Oxide Sterilization
  • 8.3.4. Others
• 8.4. Market Analysis, Insights and Forecast - By End-user
  • 8.4.1. Hospital & Clinics
  • 8.4.2. Pharmaceutical & Medical Device Manufacturers
  • 8.4.3. Others
• 8.5. Market Analysis, Insights and Forecast - By Country/ Sub-region
  • 8.5.1. China
  • 8.5.2. India
  • 8.5.3. Japan
  • 8.5.4. Australia
  • 8.5.5. Southeast Asia
  • 8.5.6. Rest of Asia Pacific

9. Latin America Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 9.1. Market Analysis, Insights and Forecast - By Product
  • 9.1.1. Steam Chemical Indicators
  • 9.1.2. Hydrogen Peroxide Chemical Indicators
  • 9.1.3. Others
• 9.2. Market Analysis, Insights and Forecast - By Parameter
  • 9.2.1. Single-Variable Indicators
  • 9.2.2. Multi-Variable Indicators
  • 9.2.3. Biological Indicators
• 9.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 9.3.1. Steam Sterilization
  • 9.3.2. Hydrogen Peroxide Sterilization
  • 9.3.3. Ethylene Oxide Sterilization
  • 9.3.4. Others
• 9.4. Market Analysis, Insights and Forecast - By End-user
  • 9.4.1. Hospital & Clinics
  • 9.4.2. Pharmaceutical & Medical Device Manufacturers
  • 9.4.3. Others
• 9.5. Market Analysis, Insights and Forecast - By Country/ Sub-region
  • 9.5.1. Brazil
  • 9.5.2. Mexico
  • 9.5.3. Rest of Latin America

10. Middle East & Africa Chemical Indicators Market Analysis, Insights and Forecast, 2019-2032

• 10.1. Market Analysis, Insights and Forecast - By Product
  • 10.1.1. Steam Chemical Indicators
  • 10.1.2. Hydrogen Peroxide Chemical Indicators
  • 10.1.3. Others
• 10.2. Market Analysis, Insights and Forecast - By Parameter
  • 10.2.1. Single-Variable Indicators
  • 10.2.2. Multi-Variable Indicators
  • 10.2.3. Biological Indicators
• 10.3. Market Analysis, Insights and Forecast - By Sterilization Method
  • 10.3.1. Steam Sterilization
  • 10.3.2. Hydrogen Peroxide Sterilization
  • 10.3.3. Ethylene Oxide Sterilization
  • 10.3.4. Others
• 10.4. Market Analysis, Insights and Forecast - By End-user
  • 10.4.1. Hospital & Clinics
  • 10.4.2. Pharmaceutical & Medical Device Manufacturers
  • 10.4.3. Others
• 10.5. Market Analysis, Insights and Forecast - By Country/ Sub-region
  • 10.5.1. South Africa
  • 10.5.2. GCC
  • 10.5.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2024)
• 11.2. Company Profiles
  • 11.2.1. STERIS
    • 11.2.1.1. Overview
    • 11.2.1.2. Products
    • 11.2.1.3. SWOT Analysis
    • 11.2.1.4. Recent Developments
    • 11.2.1.5. Strategies
    • 11.2.1.6. Financials (Based on Availability)
  • 11.2.2. Getinge
    • 11.2.2.1. Overview
    • 11.2.2.2. Products
    • 11.2.2.3. SWOT Analysis
    • 11.2.2.4. Recent Developments
    • 11.2.2.5. Strategies
    • 11.2.2.6. Financials (Based on Availability)
  • 11.2.3. ASP (Fortive)
    • 11.2.3.1. Overview
    • 11.2.3.2. Products
    • 11.2.3.3. SWOT Analysis
    • 11.2.3.4. Recent Developments
    • 11.2.3.5. Strategies
    • 11.2.3.6. Financials (Based on Availability)
  • 11.2.4. Solventum
    • 11.2.4.1. Overview
    • 11.2.4.2. Products
    • 11.2.4.3. SWOT Analysis
    • 11.2.4.4. Recent Developments
    • 11.2.4.5. Strategies
    • 11.2.4.6. Financials (Based on Availability)
  • 11.2.5. Terragene
    • 11.2.5.1. Overview
    • 11.2.5.2. Products
    • 11.2.5.3. SWOT Analysis
    • 11.2.5.4. Recent Developments
    • 11.2.5.5. Strategies
    • 11.2.5.6. Financials (Based on Availability)
  • 11.2.6. BiomatiQ Scientific Pvt. Ltd.
    • 11.2.6.1. Overview
    • 11.2.6.2. Products
    • 11.2.6.3. SWOT Analysis
    • 11.2.6.4. Recent Developments
    • 11.2.6.5. Strategies
    • 11.2.6.6. Financials (Based on Availability)
  • 11.2.7. Tuttnauer
    • 11.2.7.1. Overview
    • 11.2.7.2. Products
    • 11.2.7.3. SWOT Analysis
    • 11.2.7.4. Recent Developments
    • 11.2.7.5. Strategies
    • 11.2.7.6. Financials (Based on Availability)
  • 11.2.8. LISTER BIOMEDICAL CO., LTD
    • 11.2.8.1. Overview
    • 11.2.8.2. Products
    • 11.2.8.3. SWOT Analysis
    • 11.2.8.4. Recent Developments
    • 11.2.8.5. Strategies
    • 11.2.8.6. Financials (Based on Availability)
  • 11.2.9. BEYA Medical Machinery Equipments CO.
    • 11.2.9.1. Overview
    • 11.2.9.2. Products
    • 11.2.9.3. SWOT Analysis
    • 11.2.9.4. Recent Developments
    • 11.2.9.5. Strategies
    • 11.2.9.6. Financials (Based on Availability)
  • 11.2.10. Propper Manufacturing Co., Inc.
    • 11.2.10.1. Overview
    • 11.2.10.2. Products
    • 11.2.10.3. SWOT Analysis
    • 11.2.10.4. Recent Developments
    • 11.2.10.5. Strategies
    • 11.2.10.6. Financials (Based on Availability)