Pyrogen Testing Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Pyrogen Testing Market Report Segments the Industry Into by Product (Kits and Reagents, Services, Instruments), by Test Type (LAL Tests, Rabbit Pyrogen Test, Monocyte Activation Test, Other Test Types), by End User (Pharmaceutical and Biotechnology Companies, Medical Device Companies, Other End Users), and Geography. The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Global Pyrogen Testing Market Size and Share

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Global Pyrogen Testing Market Analysis by Mordor Intelligence

The pyrogen testing market is valued at USD 1.59 billion in 2025 and is forecast to reach USD 2.24 billion by 2030, advancing at a 7.13% CAGR. Sustained growth is shaped by rising biologics production, strong regulatory backing for recombinant assays, and a broad move toward outsourcing quality-control (QC) services. Companies adopt automation to cut manual intervention, reduce errors, and release products faster. Regulatory agencies are approving animal-free tests to protect horseshoe crab populations while securing supply continuity. Asia-Pacific manufacturers add high-throughput capacity, creating new demand pockets even as North America maintains the largest installed base of QC laboratories. Sustained vaccine funding, expanding cell- and gene-therapy pipelines, and cost-efficient microfluidic kits all reinforce the long-term expansion of the pyrogen testing market.

Key Report Takeaways

  • By product, Kits & Reagents led with 44.51% revenue share in 2024; Instruments are projected to post the fastest 8.21% CAGR to 2030.
  • By test type, LAL Tests accounted for 63.12% of the pyrogen testing market share in 2024, while the Monocyte Activation Test segment is set to grow at an 8.04% CAGR through 2030.
  • By end user, Pharmaceutical & Biotechnology Companies held 62.34% of the pyrogen testing market size in 2024; Medical Device Companies are expanding at a 7.85% CAGR to 2030.
  • By geography, North America commanded 42.45% of the pyrogen testing market in 2024; Asia-Pacific is forecast to register the highest 8.54% CAGR to 2030. 

Segment Analysis

By Product: Automation Drives Instrument Growth

Instruments captured are on track to log an 8.21% CAGR to 2030, the fastest among all product lines. Their rise rests on pharma’s push for data integrity and lean staffing, which favors closed-system readers that generate automatic audit trails. Cartridge-based units integrate reagent packs, alleviating dilution errors and trimming analyst time by 85%. Kits & Reagents still contributed 44.51% of 2024 revenues, underscoring the recurring consumables model that underwrites vendor profitability. The services slice grows steadily as CDMOs add fee-for-service endotoxin panels to turnkey offerings. 

Portable spectrophotometers with barcode tracking now enable on-floor release, allowing facilities to shorten lot disposition by as much as six hours. Microfluidic kits use 95% less lysate than traditional tubes, a material efficiency welcomed by sustainability teams. End-users cite easier validation and higher sample throughput as core reasons to budget for new readers despite elevated capital prices. Combined, these preferences reinforce the upgrade cycle and widen adoption, sustaining momentum in the pyrogen testing market.

Market Share
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Note: Segment shares of all individual segments available upon report purchase

By Test Type: MAT Gains Ground Against LAL Dominance

LAL Tests maintained 63.12% of the pyrogen testing market share in 2024, reflecting deep regulatory lineage since the 1970s. However, MAT is forecast to rise at an 8.04% CAGR as regulators demand coverage of non-endotoxin pyrogens. European authorities already require MAT in cases where LAL interference occurs, creating a pull effect on global pharma that operates harmonized QC protocols. Recombinant portfolios widen, and rFC options further erode traditional gel-clot volumes. 

MAT’s sensitivity down to 0.004 EU/mL supports advanced biologic release specs, and new rapid formats finish in under two hours. Training programs and reference labs, such as the Sanquin–Lonza hub, boost technician confidence and method adoption. Rabbit tests continue to decline amid welfare campaigns and higher housing costs. Over the forecast horizon, alternative assays carve share yet coexist with LAL in legacy pipelines, gradually rebalancing the pyrogen testing market.

By End User: Medical Device Growth Outpaces Pharma

Pharmaceutical & Biotechnology Companies delivered 62.34% of 2024 revenues, anchored by dense lot-release schedules across global sterile plants. Still, Medical Device Companies are projected to notch a 7.85% CAGR to 2030 as regulators tighten ISO 10993 enforcement. Cardiovascular and implantable devices now undergo material-mediated pyrogen checks, a gap only MAT can reliably fill. Cosmetic injectable makers also join the user base, expanding addressable volumes. 

Combination products merge device and drug regulations, lifting complexity and test counts for contract test houses with both competencies. Hospitals increasingly request vendor certificates listing rFC use, signaling end-user pull toward animal-free validation. QC outsourcing remains highest among mid-tier device firms lacking internal sterile suites, reinforcing service demand within the broader pyrogen testing market.

Market Share
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Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America generated 42.45% of 2024 revenues, helped by the FDA’s speedy acceptance of rFC and a dense cluster of biotech HQs. The region benefits from mature automation penetration and entrenched test culture but faces slower percentage growth due to its high base. Asia-Pacific, by contrast, is set to expand at an 8.54% CAGR, underpinned by Chinese and Indian build-outs of biologics mega-plants. Generous incentives from India’s Production Linked scheme and China’s provincial grants fund state-of-the-art QC labs, lifting reagent pull-through. 

Europe holds steady growth, supported by early alternative-assay adoption and cross-border standards from EDQM. Stringent animal-welfare laws push firms to validate MAT and rFC earlier than peers elsewhere. Brexit added administrative filings but did not materially deter trade, with UK-EU assay producers retaining reciprocal certifications. Collectively, geographic diversification balances global demand and cements resilience across the pyrogen testing market.

Pyrogen Testing Market
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Competitive Landscape

The pyrogen testing market is moderately consolidated, with the top five suppliers controlling a sizable slice of reagent and instrument sales. Charles River Laboratories generated USD 4.1 billion revenue in 2023 and leverages its Endosafe cartridge franchise and global testing network to defend share. Thermo Fisher fortified its portfolio through the USD 4.1 billion takeover of Solventum’s purification and filtration business in 2024, adding complementary endotoxin-removal technologies that bundle smoothly with rFC kits. bioMérieux advances reagent innovation, commercializing rFC formulations with extended stability that simplify global cold-chain logistics. 

Lonza upgrades Walkersville facilities to triple MAT cartridge output, underscoring long-term faith in monocyte-based adoption curves. Associates of Cape Cod retains a loyal gel-clot customer base, especially in smaller sterile plants that still run legacy LAL. Across the field, incremental R&D focuses on microfluidic chips, AI-enabled reader analytics, and cloud-connected compliance dashboards. Patent filings for integrated rFC microchips doubled between 2023 and 2024, hinting at disruptive prospects that could shift shares further. 

Vendors court emerging-market manufacturers with leasing models and reagent subscription bundles that lower upfront barriers. Partnerships with CDMOs secure predictable reagent pull-through, while training alliances with academic labs foster early-career familiarity among QC scientists. Competitive intensity is tempered by demanding regulatory validation cycles that insulate incumbents, but cost-driven buyers in Asia still invite price competition, especially for commoditized LAL consumables. Overall, technology leadership, regulatory fluency, and sustainability credentials define success factors within the pyrogen testing market.

Global Pyrogen Testing Industry Leaders

  1. Merck KGaA

  2. GenScript

  3. Lonza Group

  4. BioMérieux

  5. Ellab A/S

  6. *Disclaimer: Major Players sorted in no particular order
Pyrogen Testing Market Concentration
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Recent Industry Developments

  • December 2024: Ellab acquired PharmaProcess in Italy and Switzerland, integrating regulatory consultancy with compliance mapping solutions for life-science clients.
  • September 2024: Lonza Walkersville began an 18,000 ft² expansion to boost endotoxin assay cartridge production capacity.
  • June 2024: FUJIFILM Wako Pure Chemicals debuted the LumiMAT Pyrogen Detection Kit and PYROSTAR Neo+ recombinant protein reagent, slated for global shipment in Jul 2024.
  • October 2023: Lonza launched the PyroCell MAT Human Serum Rapid System and PyroCell MAT Rapid System, advancing 3Rs-aligned testing options.

Table of Contents for Global Pyrogen Testing Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rapid growth of biologics & biosimilars pipeline
    • 4.2.2 Expansion of contract research & manufacturing outsourcing
    • 4.2.3 Regulatory endorsement of recombinant Factor C (rFC) assays
    • 4.2.4 Conservation-driven shift to animal-free endotoxin detection
    • 4.2.5 Microfluidic-based rapid pyrogen detection platforms
    • 4.2.6 Surge in vaccine & cell-/gene-therapy manufacturing volumes
  • 4.3 Market Restraints
    • 4.3.1 Horseshoe-crab lysate supply volatility
    • 4.3.2 Uncertainty during rFC transition for legacy QC protocols
    • 4.3.3 Inter-lab variability of Monocyte Activation Test results
    • 4.3.4 High upfront cost of automated endotoxin analyzers
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces Analysis
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD mn)

  • 5.1 By Product
    • 5.1.1 Kits and Reagents
    • 5.1.2 Services
    • 5.1.3 Instruments
  • 5.2 By Test Type
    • 5.2.1 LAL Tests
    • 5.2.2 Rabbit Pyrogen Test
    • 5.2.3 Monocyte Activation Test
    • 5.2.4 Other Test Types
  • 5.3 By End User
    • 5.3.1 Pharmaceutical & Biotechnology Companies
    • 5.3.2 Medical Device Companies
    • 5.3.3 Other End Users
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Share Analysis
  • 6.2 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.2.1 Associates of Cape Cod Inc.
    • 6.2.2 bioMérieux SA
    • 6.2.3 Charles River Laboratories Inc.
    • 6.2.4 Ellab A/S
    • 6.2.5 GenScript Biotech
    • 6.2.6 Lonza Group
    • 6.2.7 Merck KGaA
    • 6.2.8 Thermo Fisher Scientific Inc.
    • 6.2.9 Fujifilm Wako Pure Chemical Corp.
    • 6.2.10 WuXi AppTec
    • 6.2.11 Eurofins Scientific
    • 6.2.12 Microcoat Biotechnologie GmbH
    • 6.2.13 Sotera Health (Nelson Labs)
    • 6.2.14 Sanquin
    • 6.2.15 Seikagaku Corporation
    • 6.2.16 Hyglos GmbH
    • 6.2.17 Toxin Technology Inc.
    • 6.2.18 Labor Dr. Merk & Kollegen
    • 6.2.19 Endosafe (Charles River)

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Pyrogen Testing Market Report Scope

As per the scope of the report, pyrogen testing refers to the process of determining microbes or the presence of their metabolites in drugs and intravenous solutions during their manufacture. A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal's body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen-free according to regulatory requirements of 21CFR, USP, and EP. The pyrogen testing market is segmented by product, test type (LAL Tests, rabbit pyrogen test, monocyte activation test, and other test types), end user (pharmaceutical and biotechnology companies, medical device companies, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

By Product Kits and Reagents
Services
Instruments
By Test Type LAL Tests
Rabbit Pyrogen Test
Monocyte Activation Test
Other Test Types
By End User Pharmaceutical & Biotechnology Companies
Medical Device Companies
Other End Users
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Product
Kits and Reagents
Services
Instruments
By Test Type
LAL Tests
Rabbit Pyrogen Test
Monocyte Activation Test
Other Test Types
By End User
Pharmaceutical & Biotechnology Companies
Medical Device Companies
Other End Users
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

How big is the Global Pyrogen Testing Market?

The Global Pyrogen Testing Market size is expected to reach USD 1.59 billion in 2025 and grow at a CAGR of 7.13% to reach USD 2.24 billion by 2030.

Why are CDMOs important to market expansion?

Outsourcing concentrates high-volume testing in specialized facilities, enabling investment in automated systems that lower per-test costs and drive wider adoption.

Who are the key players in Global Pyrogen Testing Market?

Merck KGaA, GenScript, Lonza Group, BioMérieux and Ellab A/S are the major companies operating in the Global Pyrogen Testing Market.

Which is the fastest growing region in Global Pyrogen Testing Market?

Asia-Pacific leads with an anticipated 8.54% CAGR through 2030, driven by expanding biologics manufacturing in China and India.

Which region has the biggest share in Global Pyrogen Testing Market?

In 2025, the North America accounts for the largest market share in Global Pyrogen Testing Market.

Global Pyrogen Testing Market Report Snapshots