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Pyrogen Testing Market Size, Methods, and Growth Trends | Global Forecast to 2031
Pyrogen Testing Market Size
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United States: Recent Industry Developments
✅ December 2025: Charles River Laboratories launched an advanced endotoxin detection platform to improve testing accuracy and reduce turnaround times.
✅ November 2025: FDA updated guidelines emphasizing alternative pyrogen testing methods to reduce animal testing in pharmaceuticals.
✅ October 2025: Increased adoption of recombinant Factor C (rFC) assays gained traction for safer and more sensitive pyrogen detection.
Japan: Recent Industry Developments
✅ December 2025: Sysmex Corporation introduced automated pyrogen testing solutions optimized for biopharmaceutical manufacturing.
✅ November 2025: Japanese regulatory bodies encouraged adoption of in vitro pyrogen testing to align with global standards.
✅ October 2025: Collaborative efforts between universities and industry advanced next-generation pyrogen detection technologies.
List of Top Key Player:
Merck KGaA, Lonza Group, Ellab A/S, Electronics India, Charles River Laboratories, BioNordika AS, Eurofins Biolab Srl, Charles River Laboratories, CellMade Laboratories, and Environmental & Scientific Instruments Co.
Industry Developments:
January 2026
• Introduction of rapid endotoxin detection kits accelerates pharmaceutical quality control.
• Regulatory agencies in North America propose updated guidelines to enhance testing accuracy.
• Expansion of automated pyrogen testing systems reduces manual error and increases throughput.
December 2025
• Major industry players collaborate to develop sustainable testing reagents minimizing environmental impact.
• Asia-Pacific market experiences significant growth driven by rising biopharmaceutical manufacturing.
• New portable pyrogen testing devices launched, improving on-site testing flexibility.
November 2025
• Advances in recombinant factor C (rFC) assays gain regulatory approvals across Europe.
• Emerging trends in in vitro pyrogen testing reduce reliance on animal models.
• Increased investment in R&D fosters innovations in endotoxin detection technologies.
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Forecast Projection:
The Global Pyrogen Testing Market is poised for significant growth between 2025 and 2032. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.
Market Key Segmentations:
By Product & Service
• Assays and Kits hold the largest share, driven by demand for rapid, accurate pyrogen detection solutions.
• Reagents and Instruments show steady growth, supported by technological advancements and automation.
• Services segment is expanding, fueled by outsourcing trends and regulatory compliance needs.
• Others contribute with specialized consumables and support products.
By Test Type
• LAL Tests dominate the market, owing to their high sensitivity and widespread regulatory acceptance.
• Rabbit Pyrogen Test remains relevant, especially for specific biologics and medical device testing.
• Monocyte Activation Test is gaining traction due to ethical concerns and predictive accuracy.
• Other test types maintain niche applications in research and specialized testing.
By End-User
• Pharmaceutical Companies represent the largest user base, driven by stringent safety requirements.
• Biotechnology Companies are rapidly adopting advanced pyrogen testing to support novel therapies.
• Medical Device Companies focus on pyrogen testing for device safety and regulatory clearance.
• Others include contract research organizations and academic institutions leveraging testing services.
Regional Growth Analysis:
⇥ North America - 43.7%
Dominates due to advanced biopharmaceutical manufacturing and stringent regulatory standards.
⇥ Europe - 27.5%
Strong presence driven by established pharmaceutical industries and regulatory compliance focus.
⇥ Asia-Pacific - 18.0%
Growing market supported by expanding biopharma production and increasing healthcare investments.
⇥ Middle East & Africa - 6.3%
Emerging adoption fueled by rising biotech startups and increasing healthcare infrastructure.
⇥ South America - 4.5%
Gradual growth driven by expanding pharma manufacturing and regulatory improvements.
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Related Deals
✦ Novo Holdings acquired Ellab A/S in June 2024 (2025 operational impact), gaining the world's leading pyrogen testing provider with rFC, MAT, and LAL platforms serving 90%+ of top pharma firms.
✦ Ellab (pre-acquisition) bought PharmaProcess (Italy/Switzerland) in December 2024, enhancing validation services for pyrogen-free sterile manufacturing.
✦ Cormica acquired Zwisler Laboratorium in January 2025, expanding European lab testing including endotoxin/pyrogen assays for injectable
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