의약품 신속 미생물 검사 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 기법별, 용도별, 지역별, 부문 예측(2025-2030년)

Pharmaceutical Rapid Microbiology Testing Market Growth & Trends:

The global pharmaceutical rapid microbiology testing market size is anticipated to reach USD 2.80 billion by 2030 and grow at a CAGR of 17.53% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market's growth is attributed to factors such as the increasing demand for biologics and advanced therapies, growing regulatory pressure, and technological advancements such as nucleic acid-based testing, and growing public concern about the safety of pharmaceuticals has pushed manufacturers to adopt advanced quality control measures, including rapid microbiology testing

Expanding manufacturing includes biologics, biosimilars, cell therapies, and vaccines, which are highly sensitive to microbial contamination. Due to their complexity and shorter shelf lives, rapid microbiology testing is critical for these products. The pharmaceutical industry is experiencing rapid growth, especially in emerging markets such as India, China, and Brazil. These regions are investing in manufacturing facilities for generics, biosimilars, vaccines, and biologics. Several biopharmaceutical manufacturers outsource production to CMOs, which often employ advanced rapid microbiology testing technologies to meet diverse client needs and regulatory requirements. For instance, in January 2024, Rapid Micro Biosystems, Inc. announced that Samsung Biologics had selected its Growth Direct platform to enhance microbial quality control processes. This partnership aims to improve efficiency, ensure robust data integrity, and allow for scalable quality control operations within Samsung's manufacturing framework.

Moreover, stringent regulatory compliance is a key driver of the adoption and growth of rapid microbiology testing in the pharmaceutical industry. Regulatory agencies worldwide impose rigorous microbial quality control standards to ensure the safety, efficacy, and quality of pharmaceutical products. Agencies such as the FDA (United States), EMA (Europe), and WHO require strict adherence to pharmacopeial guidelines (e.g., USP, EP, JP) for sterility, microbial limits, and bioburden testing. In addition, regulatory frameworks such as PAT encourage real-time microbial monitoring to ensure process control and compliance. Rapid microbiology methods integrate well with continuous manufacturing systems. Hence, driving the market growth.

Pharmaceutical Rapid Microbiology Testing Market Report Highlights:

• Based on product, reagents and kits segment held the largest market share in 2024. The large share is due to the repetitive usage of reagents and kits for carrying out rapid microbiology tests for biopharmaceuticals.
• Based on technology, the growth-based testing segment dominated the market in 2024. These methods are widely used due to their reliability and acceptance by regulatory agencies.
• Based on application, the sterility testing segment dominated the market in 2024. Rapid microbiology testing ensures that sterile products, such as injectables and implantables, are free from viable microorganisms.
• The North American region dominated the market share of 38.16% in 2024. Accelerated drug and vaccine development timelines, especially during the COVID-19 pandemic, have driven demand for rapid microbiology testing to meet regulatory requirements and market demands faster in this region.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
  • 1.2.1. Product
  • 1.2.2. Technique
  • 1.2.3. Application
• 1.3. Information Analysis
• 1.4. Market Formulation & Data Visualization
• 1.5. Data Validation & Publishing
• 1.6. Information Procurement
  • 1.6.1. Primary Research
• 1.7. Information Or Data Analysis
• 1.8. Market Formulation & Validation
• 1.9. Market Model
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. Pharmaceutical Rapid Microbiology Testing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Technologies Advancements In Rapid Testing
    • 3.2.1.2. Increasing Focus On Quality Control And Rising Microbiology Testing Needs
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Expensive Equipment And Technology Hinder Market Adoption.
    • 3.2.2.2. Complex Regulations Slow Down The Approval And Implementation Process.
• 3.3. Industry Analysis Tools
  • 3.3.1. Porter's Five Forces Analysis
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Pharmaceutical Rapid Microbiology Testing Market: Product Estimates & Trend Analysis

• 4.1. Product Segment Dashboard
• 4.2. Global Pharmaceutical Rapid Microbiology Testing Market Product Movement Analysis
• 4.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Product, 2018 to 2030 (USD Million)
• 4.4. Instruments
  • 4.4.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Reagents & Kits
  • 4.5.1. Reagents & Kits Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Accessories
  • 4.6.1. Accessories Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Pharmaceutical Rapid Microbiology Testing Market: Technique Estimates & Trend Analysis

• 5.1. Technique Segment Dashboard
• 5.2. Global Pharmaceutical Rapid Microbiology Testing Market Technique Movement Analysis
• 5.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Technique, 2018 to 2030 (USD Million)
• 5.4. Growth-based Testing
  • 5.4.1. Growth-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Nucleic Acid-based Testing
  • 5.5.1. Nucleic Acid-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Cellular Component-based Testing
  • 5.6.1. Cellular Component-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Viability-based Testing
  • 5.7.1. Viability-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.8. Other Techniques
  • 5.8.1. Other Techniques Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Pharmaceutical Rapid Microbiology Testing Market: Application Estimates & Trend Analysis

• 6.1. Application Segment Dashboard
• 6.2. Global Pharmaceutical Rapid Microbiology Testing Market Application Movement Analysis
• 6.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 6.4. Raw Material Testing
  • 6.4.1. Raw Material Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Microbial Limit Testing
  • 6.5.1. Microbial Limit Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Bioburden Assessment
  • 6.6.1. Bioburden Assessment Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Sterility Testing
  • 6.7.1. Stability Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. Other Applications
  • 6.8.1. Other Applications Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Pharmaceutical Rapid Microbiology Testing Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, 2018 to 2030
• 7.4. North America
  • 7.4.1. North America Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. UK Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Australia Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.6. Thailand
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Thailand Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.7. South Korea
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. South Korea Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. MEA
  • 7.8.1. MEA Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Participant Categorization
• 8.2. Company Market Position Analysis, 2024
• 8.3. Participant's Overview
  • 8.3.1. Thermo Fisher Scientific Inc.
    • 8.3.1.1. Participant's Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Product Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Merck KGaA
    • 8.3.2.1. Participant's Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Product Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. BD
    • 8.3.3.1. Participant's Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Product Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. bioMerieux
    • 8.3.4.1. Participant's Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Product Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Danaher
    • 8.3.5.1. Participant's Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Product Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Sartorius AG
    • 8.3.6.1. Participant's Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Product Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Abbott
    • 8.3.7.1. Participant's Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Product Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. QuidelOrtho Corporation
    • 8.3.8.1. Participant's Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Product Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Charles River Laboratories
    • 8.3.9.1. Participant's Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Product Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Rapid Micro Biosystems, Inc.
    • 8.3.10.1. Participant's Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Product Benchmarking
    • 8.3.10.4. Strategic Initiatives