무균 시험 시장 : 제품별, 검사별, 유형별, 용도별, 최종 사용자별 - 세계 예측

The Sterility Testing Market is poised to record a CAGR of 10.6% during 2024-2032, driven by the rising prevalence of chronic diseases. According to WHO, if current trends persist, non-communicable diseases (NCDs) like cardiovascular diseases, cancer, diabetes, and respiratory illnesses could constitute 86% of the projected 90 million annual deaths by 2050, marking a 90% increase from 2019. As the global burden of chronic illnesses continues to escalate, there is an increasing demand for effective pharmaceutical treatments and biologics. The rigorous sterility testing to ensure the safety and efficacy of these medical products.

Chronic disease management often involves the use of injectable drugs, implants, and other sterile medical devices, all of which require stringent sterility testing. Consequently, the growing need for safe and reliable medical solutions to address chronic diseases is driving market expansion.

Further, there is focus on reducing testing turnaround times. Rapid microbiological methods and automated testing systems are increasingly being adopted to streamline the sterility testing process, enabling quicker detection of contaminants and faster commercialization of products. This will bolster the market outlook in the coming years.

The sterility testing market is classified based on test, type, application, end-use, product, and region.

The services segment will grow rapidly over the forecast period, as many pharmaceutical and biotechnology companies outsource their sterility testing requirements to specialized service providers. These providers offer a range of testing services, including routine sterility testing, method development & validation, environmental monitoring, and microbiological testing. Outsourcing these services allows companies to leverage the expertise and advanced facilities of specialized laboratories, ensuring compliance with regulatory standards while reducing operational costs and turnaround times.

The direct inoculation test segment will gain traction through 2032, owing to its simplicity and ability to test a variety of products, including injectable drugs, ophthalmic solutions, and other parenteral preparations. The method is highly effective for detecting both aerobic and anaerobic microorganisms, ensuring comprehensive sterility assessment. Its application is critical in scenarios where membrane filtration is not feasible, such as with viscous or particulate-containing samples. The adoption of direct inoculation is driven by its reliability, ease of use, and compliance with regulatory guidelines.

Asia Pacific sterility testing industry will grow at a decent pace through 2032, driven by the rapid growth of the pharmaceutical and biotechnology sectors in countries like China, India, Japan, and South Korea. The region's increasing investment in healthcare infrastructure, coupled with the rising demand for high-quality medical products, is propelling the need for rigorous sterility testing. Moreover, favorable government initiatives and policies supporting the development of the life sciences sector are creating a conducive environment for market growth.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing demand for biopharmaceuticals
    • 3.2.1.2 Increasing outsourcing of sterility testing services
    • 3.2.1.3 Technological advancements in sterility testing
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Time-consuming testing process
    • 3.2.2.2 Complex regulatory framework
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Competitive analysis of major market players
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 - 2032 ($ Million)

• 5.1 Key trends
• 5.2 Kits & reagents
• 5.3 Services
• 5.4 Instruments

Chapter 6 Market Estimates and Forecast, By Test, 2021 - 2032 ($ Million)

• 6.1 Key trends
• 6.2 Membrane filtration
• 6.3 Direct inoculation
• 6.4 Rapid microbial method
  • 6.4.1 ATP bioluminescence
  • 6.4.2 Fluorescent -based
  • 6.4.3 Solid-phase cytometry
  • 6.4.4 Other rapid microbial methods
• 6.5 Other tests

Chapter 7 Market Estimates and Forecast, By Type, 2021 - 2032 ($ Million)

• 7.1 Key trends
• 7.2 In-house
• 7.3 Outsourced

Chapter 8 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Million)

• 8.1 Key trends
• 8.2 Pharmaceutical and biological manufacturing
• 8.3 Medical devices manufacturing
• 8.4 Other applications

Chapter 9 Market Estimates and Forecast, By End-User, 2021 - 2032 ($ Million)

• 9.1 Key trends
• 9.2 Pharmaceutical & biotechnology companies
• 9.3 Medical device companies
• 9.4 CROs and contract testing laboratories
• 9.5 Other end-users

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 China
  • 10.4.2 Japan
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 Rest of Asia Pacific
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Rest of Latin America
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 Rest of Middle East and Africa

Chapter 11 Company Profiles

• 11.1 bioMerieux SA
• 11.2 Charles River Laboratories International Inc.
• 11.3 Merck KGaA
• 11.4 Nelson Laboratories, LLC
• 11.5 Pacific Biolabs
• 11.6 Rapid Micro Biosystems Inc.
• 11.7 Sartorius AG
• 11.8 SGS SA
• 11.9 Thermo Fisher Scientific Inc.
• 11.10 WuXi AppTec