Pyrogen Testing Market to Reach US$2.75 Billion by 2031, Growing at 10.61% CAGR | Instruments Segment Leads with 43.2% Market Share | DataM Intelligence

Leander, Texas and Tokyo, Japan - Dec 03, 2025
According to DataM Intelligence, the global pyrogen testing market reached US$1.26 billion in 2023 and is expected to reach US$2.75 billion by 2031, growing at a CAGR of approximately 10.61% during the forecast period 2024-2031. This robust growth is propelled by stringent regulatory requirements for pharmaceutical and medical device safety, increasing production of injectable drugs and biologics, rising incidence of drug recalls due to pyrogenic contamination, growing adoption of advanced in-vitro tests, and expanding biotechnology and pharmaceutical R&D globally.

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Report Details:
• No. of Pages: 180
• Forecast Period: 2024-2031
• Market Size (2023): $1.26 Billion
• Market Size (2031): $2.75 Billion
• Compound Annual Growth Rate: 10.61%
• Regions Covered: Global

Global Recent Developments:
✅ November 2025: Charles River Laboratories received FDA recognition for its next-generation EndosafeTM Trillium PTS system, which combines recombinant Factor C (rFC) and monocyte activation test (MAT) technologies in a single instruments platform, reducing testing time by 70% compared to traditional LAL methods.
✅ October 2025: The European Pharmacopoeia (Ph. Eur.) officially incorporated the Monocyte Activation Test (MAT) as a standalone, compendial method for pyrogen testing of medical devices, accelerating the shift from rabbit pyrogen tests (RPT) and boosting demand for MAT-compatible instruments and reagents.
✅ September 2025: Thermo Fisher Scientific launched the "PierceTM Digital Pyrogen Assay," a high-throughput, microfluidic-based system that automates sample preparation and analysis for both bacterial endotoxins and non-endotoxin pyrogens, targeting large biopharma manufacturers.

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Competitive Landscape
The market is characterized by the dominance of a few specialized players with comprehensive testing solutions and services.

1. Charles River Laboratories International, Inc. maintained market leadership with its dominant EndosafeTM portfolio of instruments, cartridges, and testing services, leveraging its acquisition of Vigilant Biosciences.
2. Thermo Fisher Scientific, Inc. held a significant share through its comprehensive life sciences portfolio, including instruments, assays, and reagents under brands like PierceTM and GibcoTM.
3. Merck KGaA (MilliporeSigma) was a key player, especially in reagents and kits for both traditional LAL and newer rFC/MAT methods, with a strong global distribution network.
4. Lonza Group AG remained a cornerstone supplier of LAL reagents and offered associated testing services, while strategically developing its rFC offerings.
5. Associates of Cape Cod, Inc. (ACC) was a major specialist in LAL and recombinant reagent manufacturing, competing directly with Lonza and Charles River.

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Segmentation Analysis
By Product & Service
• The instruments segment accounted for approximately 43.2% of the pyrogen testing market share. This includes standalone readers, spectrophotometers, and fully automated testing systems (like cartridge-based PTS systems). Growth is driven by the need for faster, higher-throughput, and more reproducible testing in quality control labs, especially with the adoption of kinetic turbidimetric and chromogenic methods.
• Reagents & Kits and Services (outsourced testing) are also large segments, with services growing rapidly as companies outsource complex testing for novel therapies.

By Test Type
• The Bacterial Endotoxins Test (BET) using LAL or rFC is the largest segment, mandated for all parenteral pharmaceuticals.
• The Monocyte Activation Test (MAT) is the fastest-growing segment, driven by regulatory acceptance for medical devices and its ability to detect a broader range of pyrogens, including non-endotoxins.

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Regional Analysis:
North America is the Largest Region, driven by the world's most stringent FDA regulations, the highest concentration of pharmaceutical and biotechnology companies, significant R&D expenditure, and early adoption of advanced testing technologies like rFC and MAT.

Asia-Pacific is the Fastest Growing Region, fueled by the massive expansion of pharmaceutical manufacturing (particularly in China and India), increasing regulatory harmonization with international standards, growing biopharmaceutical outsourcing to the region, and rising domestic production of vaccines and injectable generics.

Market Trends & Drivers
The Pyrogen Testing Market is undergoing a significant technological and ethical transition. Key trends include the accelerating shift from animal-based (rabbit) tests to in-vitro methods (rFC, MAT) driven by the 3Rs principle (Replace, Reduce, Refine) and regulatory support; the development of multi-parameter instruments that can run different assay types; the growing need for testing complex products like cell therapies, gene therapies, and implants that pose unique pyrogen risks; and increased focus on supply chain sustainability, pushing adoption of recombinant reagents over animal-derived LAL. Regulatory stringency, biopharmaceutical industry growth, and the technological evolution of testing are the primary market drivers.

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Sai Kiran
DataM Intelligence 4market Research LLP
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Email: Sai.k@datamintelligence.com

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This release was published on openPR.