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Global Pyrogen Testing Market Size 2025, Forecast To 2034

27 Feb, 2025

What Has Been the Growth Trajectory of the Pyrogen Testing Market?

The pyrogen testing market has seen considerable growth due to a variety of factors.
• The market size for pyrogen testing has experienced swift growth recently. The market will rise from a size of $1.68 billion in 2024, to $1.91 billion in 2025, boasting a compound annual growth rate (CAGR) of 13.8%.
The historic period's growth can be pinned down to factors such as increased growth in the pharmaceutical and biotechnology sector, stringent regulatory guidelines for drug safety, improved testing procedures, the surge in outbreaks of infectious diseases, and application in manufacturing of medical devices.

What Does the Future Hold for the Pyrogen Testing Market?

The pyrogen testing market is expected to maintain its strong growth trajectory in upcoming years.
• The pyrogen testing market is poised for rapid expansion in the upcoming years, anticipated to reach a valuation of $3.1 billion by 2029, with a compound annual growth rate (CAGR) of 12.8%.
The significant growth in the forthcoming period is attributable to the implementation of custom pyrogen testing solutions, the broadening of swift and automated testing, and advancements in in vitro pyrogen detection. It can also be attributed to the adoption of pyrogen testing in cell therapy, environmental, and sustainable testing practices. Some prominent trends during the forecast period are set to be point-of-care pyrogen testing, regulatory compliance in pyrogen testing, AI-assisted pyrogen detection and analysis, and personalized pyrogen testing specific to the patient. The demand for transparency and traceability in testing processes is another contributing factor.

What Main Forces Are Fueling Expansion In The Pyrogen Testing Market?

The augmentation of the pyrogen testing market is largely attributable to increasing investments in research and development activities within the spheres of pharmaceuticals and biotechnology. Employed by entities such as biotech, pharmaceuticals, and assorted drug manufacturing companies, pyrogen testing plays a pivotal role in assuring the safe production and release of products devoid of infections into the marketplace. To underscore the impact of such investments, the Association of the British Pharmaceutical Industry, a trade organization based in the UK, highlighted that approximately £9 billion was contributed towards UK research and development (R&D) by the innovative pharmaceutical industry in 2022. This crucial investment not only bolsters the country's health sector but also contributes towards economic growth. As such, it is clear that intensified R&D initiatives by pharmaceutical firms serve as a significant propellant for the pyrogen testing market.

What Are The Primary Segments In The Global Pyrogen Testing Market?

The pyrogen testing market covered in this report is segmented –
1) By Test Type: LAL Test, In Vitro Test, Rabbit Test
2) By Product And Service: Assays, Kits, And Reagents, Instruments, Services
3) By Application: Pharmaceutical And Biologics, Medical Devices, Other Applications Subsegments:
1) By Test Limulus Amebocyte Lysate (LAL) Test: Gel Clot LAL Test, Chromogenic LAL Test, Turbidimetric LAL Test
2) By In Vitro Test: Monocyte Activation Test (MAT), Recombinant Factor C (rFC) Assay, Other In Vitro Tests
3) By Rabbit Test: Pyrogen Test in Rabbits, Other Animal-Based Tests

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Which Key Trends Are Driving Changes In The Pyrogen Testing Market?

A key focus for businesses is the development of alternative pyrogen testing methods such as monocyte activation assay (MAT) that don't use animals. This approach aims to resolve the restrictions associated with the rabbit pyrogen testing approach and LAL test, and to manufacturer a treatment for humans without the use of animals. MAT offers promising results in predicting pyrogenic activity and is more effective in triggering a fever response than either RPT or BET/LAL. MAT pyrogen testing method is effective in detecting both endotoxin and non-endotoxin pyrogens, in contrast to the LAL test which only detects endotoxin pyrogens. An example of this is Merck, that has focused on two different MAT systems for pyrogens detection, called PyroDetect and PyroMAT.

Who Are the Key Players in the Pyrogen Testing Market?

Major companies operating in the pyrogen testing market include:
• Thermo Fisher Scientific Inc.
• Merck KGaA
• Charles River Laboratories Inc.
• Lonza Group Ltd.
• Ellab A/S
• Nelson Laboratories LLC
• Associates of Cape Cod Inc.
• GenScript Biotech Corporation
• bioMérieux SA
• Hyglos GmbH
• Sanquin Blood Supply Foundation
• Wako Chemicals USA Inc.
• Pyrostar International Inc.
• Eurofins Scientific SE
• SGS SA
• WuXi AppTec Group
• Sigma-Aldrich Co. LLC
• Bio-Rad Laboratories Inc.
• Microcoat Biotechnologie GmbH
• Sartorius AG
• Pacific Biolabs Inc.
• Toxikon Corporation
• STERIS Corporation
• Avance Biosciences Inc.
• BioReliance Corporation
• Microbiological Consulting LLC
• Microbac Laboratories Inc.
• North American Science Associates Inc.
• Pace Analytical Life Sciences LLC

What Is The Most Dominant Region In The Pyrogen Testing Market?

North America was the largest region in the pyrogen testing market in 2024. Asia-Pacific is expected to continue to be the fastest growing region in the pyrogen testing market share during the forecast period. The regions covered in the pyrogen testing market report include Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.