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Pyrogen Testing Market - By Product and Services (Consumable, Instrument, Service), Test Type (LAL [Chromogenic, Gel Clot], In-vitro Pyrogen, Rabbit Test), End-use (Pharmaceutical, Biotechnology, Medical Device Companies) - Global Forecast (2024 - 2032)

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  • Almac Group
  • bioMérieux SA
  • Charles River Laboratories International, Inc.
  • Eurofins Scientific
  • Fujifilm Holdings Corporation
  • GenScript Biotech Corporation
  • Lonza
  • Merck KGaA
  • STERIS plc
  • Thermo Fisher Scientific Inc.
LSH 24.08.02

Global Pyrogen testing market size will grow over 9.1% CAGR from 2024 to 2032 due to the increasing prevalence of chronic diseases. According to Physiopedia, globally, about 1 in 3 adults suffer from multiple chronic conditions. As diseases such as diabetes, cancer, and cardiovascular diseases become more common, the demand for drugs and medical devices to manage and treat these diseases will increase significantly. This excess requires rigorous safety testing to ensure that these products do not contain pyrogenic contaminants that could adversely affect patients. As a result, pharmaceutical companies and medical device manufacturers are investing more in pyrogen testing to meet strict regulatory standards and ensure the safety and efficacy of their products.

The development of personalized medicine is emerging as a prominent trend in the market. Personalized medicine that adapts treatment to the patient's individual characteristics requires very specific and precise medical products and medical devices. This customization increases the need for rigorous pyrogen testing to ensure the safety and efficacy of these personalized therapies for individual patients. As pharmaceutical companies focus on the development of targeted therapies and biologics, the demand for advanced and reliable pyrogenic testing methods is increasing. This trend underscores the importance of ensuring that personal medical products are free of contaminants to improve patient safety and treatment outcomes.

The pyrogenic testing industry is classified based on products and services, test type, end use, and region.

The instruments segment will grow rapidly through 2032, as endotoxin testing systems and thermal cyclers are critical to performing reliable and reproducible tests. The growing demand for high-throughput screening and the need for automated and efficient testing solutions has led to the development of advanced pyrogen testing equipment. These devices not only improve the accuracy and reliability of test results but also simplify the testing process, reducing the time and effort involved. As pharmaceutical companies and research laboratories strive to meet strict official standards and ensure the safety of their products, further growth is expected.

The medical device segment will grow steadily through 2032, as medical device manufacturers are required to perform pyrogen testing on their products to ensure they are free of pyrogenic contaminants. As the complexity and diversity of medical devices increases, the need for rigorous safety testing has become more prominent. Pyrogen testing is important for many devices, including catheters, implants, and surgical instruments, to prevent pyrogenic reactions in patients.

Europe Pyrogen Testing industry will grow at an unprecedented rate through 2032, driven by strict regulatory frameworks and strong healthcare infrastructure. European countries, including Germany, France, and the UK, have developed comprehensive guidelines for testing pyrogens in the manufacture of medicines and medical devices. The presence of major pharmaceutical and biopharmaceutical companies in the region will help the growth of the market. In addition, the European Union's strict drug and device safety regulations encourage the adoption of advanced pyrogen testing.

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 therapeutic drugs
      • 3.2.1.2 Rising prevalence of chronic diseases
      • 3.2.1.3 Growing investment in R&D
      • 3.2.1.4 Rising awareness about food safety
    • 3.2.2 Industry pitfalls & challenges
      • 3.2.2.1 Stringent government regulations
  • 3.3 Growth potential analysis
  • 3.4 Regulatory landscape
  • 3.5 Technological landscape
  • 3.6 Porter's analysis
  • 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

  • 4.1 Introduction
  • 4.2 Company market share analysis
  • 4.3 Competitive positioning matrix
  • 4.4 Strategy outlook matrix

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

  • 5.1 Key trends
  • 5.2 Consumables
  • 5.3 Instruments
  • 5.4 Services

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

  • 6.1 Key trends
  • 6.2 LAL test
    • 6.2.1 Chromogenic test
    • 6.2.2 Turbidimetric test
    • 6.2.3 Gel clot test
  • 6.3 In-vitro pyrogen test
    • 6.3.1 Monocyte activation test (MAT)
    • 6.3.2 Recombinant factor C assay (rFC)
  • 6.4 Rabbit test

Chapter 7 Market Estimates and Forecast, By End-Use, 2021 - 2032 ($ Mn)

  • 7.1 Key trends
  • 7.2 Pharmaceutical and biotechnology companies
  • 7.3 Medical devices companies
  • 7.4 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

  • 8.1 Key trends
  • 8.2 North America
    • 8.2.1 U.S.
    • 8.2.2 Canada
  • 8.3 Europe
    • 8.3.1 Germany
    • 8.3.2 UK
    • 8.3.3 France
    • 8.3.4 Spain
    • 8.3.5 Italy
    • 8.3.6 Rest of Europe
  • 8.4 Asia Pacific
    • 8.4.1 Japan
    • 8.4.2 China
    • 8.4.3 India
    • 8.4.4 Australia
    • 8.4.5 South Korea
    • 8.4.6 Rest of Asia Pacific
  • 8.5 Latin America
    • 8.5.1 Brazil
    • 8.5.2 Mexico
    • 8.5.3 Argentina
    • 8.5.4 Rest of Latin America
  • 8.6 Middle East and Africa
    • 8.6.1 Saudi Arabia
    • 8.6.2 South Africa
    • 8.6.3 UAE
    • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

  • 9.1 Almac Group
  • 9.2 bioMérieux SA
  • 9.3 Charles River Laboratories International, Inc.
  • 9.4 Eurofins Scientific
  • 9.5 Fujifilm Holdings Corporation
  • 9.6 GenScript Biotech Corporation
  • 9.7 Lonza
  • 9.8 Merck KGaA
  • 9.9 STERIS plc
  • 9.10 Thermo Fisher Scientific Inc.
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