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Report Overview

The global market size for pyrogen testing reached a value of more than USD 1.51 Billion in 2025. The global pyrogen testing market is expected to grow at a CAGR of 11.70% between 2026 and 2035, reaching a value of USD 4.57 Billion by 2035.

2025

Base Year

2019-2025

Historical Period

2026-2035

Forecast Period

Compound Annual Growth Rate

11.7%

Value in USD Billion

2026-2035


*this image is indicative*

Key Trends in the Market

Pyrogens are substances known to cause fever and pyrogen testing is a method that is used to test the presence or absence of pyrogens in medical devices and parenteral pharmaceutical products. It is an important step to avoid the life-threatening reactions of fever caused by the pyrogenic substances. Pyrogen testing is carried out in cool atmospheres or in air-conditioned spaces. 

  • Chronic diseases are on the rise, as well as infectious diseases that are spreading rapidly among people, increasing the need for medical devices and parenteral medication. This has largely contributed to the growth of the market for pyrogen testing.
  • Developments such as the monocyte activation test among other tests and technological advancements in pyrogen testing have greatly contributed to the growth of the market. Such tests are helping replace tests such as rabbit pyrogen testing, which face criticism due to their use of animals.
  • With increased competition amongst pharmaceutical and biotechnology companies, particularly for the manufacturing of new devices and drugs for treatment, pyrogen testing is a crucial step to develop new treatment. The pyrogen testing market is expected to grow in the coming years, fuelled by growing demand from manufacturers and developers of new devices and pharmaceuticals.

pyrogen testing market

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Market Analysis

Based on product type, the pyrogen testing market can be divided into kits and reagents, services, and instruments. By test type, the market is categorised into LAL test, rabbit pyrogen tests, and monocyte activation test, among others. The LAL Test segment is subdivided into chromogenic tests, turbidimetric tests, and gel clot tests. On the basis of end use, the market is segmented into medical devices, pharmaceutical companies, and biotechnology companies, among others. Based on region, the market is divided into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa.

The comprehensive EMR report provides an in-depth assessment of the market based on the Porter's five forces model along with giving a SWOT analysis. The report gives a detailed analysis of the following key players in the global pyrogen testing market covering their competitive landscape and latest developments like mergers, acquisitions, investments, and expansion plans.

  • Charles River Laboratories International Inc.
  • Merck KGaA
  • Microcoat Biotechnologie GmbH
  • Ellab A/S
  • Lonza Group
  • Others

pyrogen testing market by segments

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Market Share by Test Type

The LAL test type is expected to hold the largest share in the pyrogen testing market owing to its sensitivity that is 3 to 300 times more than the rabbit pyrogen tests and its ability to procure results using less amount of sample. Results are given in not more than an hour and is cost saving, encouraging its increased demand thereby contributing to the growth of the LAL test segment in the market. 

Rabbit pyrogen test lacks robustness owing to the difference in reaction between a human and an animal. Growing concerns regarding animal abuse are also resulting in lowered popularity of rabbit pyrogen tests. 

Market Share by Region

North America has held a leading share in the market for pyrogen testing because of the prevalence of chronic as well as infectious diseases that require pyrogen testing. Other factors such as increase in the number of pharmaceutical companies and presence of key players have also helped the growth of the market in the North America region. 

Countries in North America such as the United States have developed healthcare infrastructure and streamlined regulatory systems governing healthcare, supporting the pyrogen testing market. With a growing geriatric population and increase in healthcare complications, the need for medical devices and parenteral pharmaceuticals will expand in coming years. 

Meanwhile, developments in healthcare systems in the Asia Pacific are likely to lead to a heightened demand for pyrogen testing in the region. 

Competitive Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

Charles River Laboratories International Inc.

Charles River Laboratories International Inc. is an international pharmaceutical company that has its headquarter in Massachusetts, United States. It was founded in 1947 and provides cell therapy, clinical and preclinical laboratory, and gene therapy services to pharmaceutical, biotechnology, and medical device companies.

Merck KGaA

Merck KGaA founded in 1668 is headquartered in Darmstadt in Germany. It is a multinational pharmaceutical and science and technology company that aims at improving the quality of life worldwide of every individual by carrying out innovations based on life sciences.

Microcoat Biotechnologie GmbH

Microcoat Biotechnologie GmbH was founded in 1992 and is based out of Bavaria in Germany. It is a biotechnology company that provides services such as kit manufacturing, solid phase coating, and diagnostic testing. 

*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*

Other market players include Ellab A/S, and Lonza Group, among others.

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The global market size for pyrogen testing reached a value of more than USD 1.51 Billion in 2025.

The market is expected to grow at a CAGR of 11.70% between 2026 and 2035.

The major market drivers include increasing demand from pharmaceutical industry, development of data and expert driven methods, and rising prevalence of chronic and infectious diseases.

The global market size for pyrogen testing is expected to reach a value of more than USD 4.57 Billion by 2035.

The key trends of the market are technological advancements in pyrogen testing, improved accuracy and cost-effective testing, and use of alternatives to animal-based testing methods.

Key market players include Charles River Laboratories International Inc., Merck KGaA, Microcoat Biotechnologie GmbH, Ellab A/S, and Lonza Group, among others.

Pyrogen testing is a method that is used to test the presence or absence of pyrogens in medical devices and parenteral pharmaceutical products.

It is an important step to prevent possibly life-threatening fever complications caused by pyrogenic substances.

The global pyrogen testing market is segmented based on product type, test type, end use, and region.

Pyrogen testing is always carried out in cool atmosphere or in an air-conditioned space.

Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2025
Historical Period 2019-2025
Forecast Period 2026-2035
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product Type
  • Test Type
  • End Use
  • Region
Breakup by Product Type
  • Kits and Reagents
  • Services
  • Instruments
Breakup by Test Type
  • LAL Test
  • Rabbit Pyrogen Tests
  • Monocyte Activation Test
  • Others
Breakup by End Use
  • Medical Devices
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Others
Breakup by Region
  • North America
    • United States of America 
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • PESTEL Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Company News and Developments
    • Certifications
Companies Covered
  • Charles River Laboratories International, Inc.
  • Merck KGaA
  • Microcoat Biotechnologie GmbH
  • Ellab A/S
  • Lonza Group
  • Others

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