파이로젠 검사 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pyrogen testing market size is expected to grow from USD 1.57 billion in 2025 to USD 1.73 billion in 2026 and is forecast to reach USD 2.99 billion by 2031 at 11.51% CAGR over 2026-2031.

This report is Segmented by Product & Service (Kits & Reagents, Instruments, Services), Detection Technology (Animal-Based Tests, Recombinant/Cell-Based Tests, Instrument-Integrated Rapid Systems), Sample/Process Stage (Raw Materials & Water, and More), Test Type (LAL, and More), End User (Pharma & Biotech, and More), and Geography (North America, and More). Market Forecasts are Provided in Value (USD).

Global Pyrogen Testing Market Trends and Insights

Biologics & Vaccine Pipeline Expansion

Global regulators cleared 46 novel drugs and 18 biosimilars in 2025, nearly all parenteral, enlarging quality-control sample volumes at every bioprocess stage. Multiple COVID-19 strain-updated mRNA vaccines incorporated new fill-finish lines that demanded fresh component qualifications. Each monoclonal antibody or viral-vector therapy must meet strict +-0.05 EU/mL limits for upstream harvest, downstream pools, and final vials, driving recurring pyrogen testing market demand. Large-scale capital projects by Eli Lilly, AstraZeneca, and Johnson & Johnson are adding sterile capacity that will begin generating validation batches in 2027, locking in sustained testing volumes. Emerging-market producers seeking mutual recognition with ICH jurisdictions are similarly upgrading QC infrastructures, broadening the global footprint of the pyrogen testing market.

Mandatory Endotoxin Limits in New USP 85 and Ph. Eur. 2.6.14

USP's July 2025 update formally recognizes rFC as equivalent to LAL once equivalence is proven, enabling method substitution without full dossier revalidation. In parallel, Europe's deletion of the rabbit-pyrogen method effective July 2025 compels immediate MAT adoption for products headed to the EU. These harmonized policies eliminate historical ambiguity that held back recombinant and cell-based platforms and compress compliance timelines for legacy products. Reagent makers have responded with next-generation MAT kits offering 0.05 EU/mL sensitivity, aligning with new pharmacopeial thresholds. Collectively, the rule changes strengthen the regulatory foundation of the pyrogen testing market.

High Validation Cost for SMEs

Adapting a single biologic line to MAT or rFC can exceed USD 500,000 in qualification and documentation spend, a burden that smaller firms often absorb by outsourcing rather than capitalizing new labs. The cost headwind slows the pyrogen testing market transition in emerging regions where access to low-cost validation support remains limited.

Other drivers and restraints analyzed in the detailed report include:

1. Outsourcing to CROs & CDMOs
2. Automation-Ready Microfluidic Analyzers
3. Horseshoe-Crab Harvest Restrictions

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Kits and reagents supplied 56.67% of 2025 revenue, underscoring the razor-and-blade model that anchors the pyrogen testing market size for consumables. However, instruments are poised for a 13.62% CAGR through 2031 as manufacturers install microfluidic systems to combat labor shortages and compress release timelines. Automated readers integrate seamlessly with LIMS, satisfying data-integrity expectations and supporting continuous bioprocessing workflows. Proprietary cartridges ensure recurring revenue, reinforcing supplier lock-in. Services-chiefly CRO lot-release testing-remain attractive to early-stage biotech clients that lack in-house QC, funneling incremental volumes into the pyrogen testing market.

Labor availability and audit-trail scrutiny accelerate capital outlays for fully integrated analyzers, exemplified by Merck's cartridge-based platform that allows non-specialists to test directly in fill-finish suites. While consumables will continue as the largest revenue pool, hardware adoption raises average selling prices and broadens the pyrogen testing market share of high-margin instrument vendors.

Animal-based assays held 72.52 % of the 2025 pyrogen testing market share, yet recombinant Factor C and MAT platforms are forecast to post a 14.77 % CAGR through 2031. USP Chapter (1085), effective February 2026, now allows rFC substitution once equivalence is proven, removing the last major barrier to animal-free methods. Europe's deletion of the rabbit test mandates MAT for all new and legacy products shipped into the EU, compressing timelines for cell-based validation.

Chinese suppliers sell rFC kits 30-40 % below Western LAL prices, widening adoption across APAC facilities and increasing the pyrogen testing market size for recombinant solutions. LAL retains primacy in legacy BLAs but faces episodic supply shocks whenever horseshoe-crab quotas tighten. Rapid cartridge devices now deliver quantitative results in 30 minutes, demonstrating that speed and regulatory clarity together are tipping the technology mix away from animal lysate.

Complete Report Scope:

• By Product & Service
  • Kits & Reagents
  • Instruments
  • Services
• By Detection Technology
  • Animal-Based Tests
  • Recombinant / Cell-Based Tests
  • Instrument-Integrated Rapid Systems
• By Sample / Process Stage
  • Raw Materials & Water Testing
  • In-Process (Upstream & Downstream)
  • Final Product / Lot-Release
  • Medical Device Surface & Rinse Tests
• By Test Type
  • Limulus Amebocyte Lysate (LAL) Tests
  • Recombinant Factor C (rFC) Assays
  • Monocyte Activation Test (MAT)
  • Rabbit Pyrogen Test
• By End User
  • Pharmaceutical & Biotechnology Companies
  • Medical Device Companies
  • Contract Research Organizations (CROs)
  • Academic & Research Institutes
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 39.14% of 2025 revenue, buoyed by the United States' dense biopharma pipeline and frequent parenteral approvals. USP's formal rFC recognition will likely catalyze method substitutions, enlarging the region's software-integration and equipment opportunities. Canada and Mexico show steady growth as near-shoring of sterile fill-finish expands.

Europe follows as the second-largest region. The July 2025 rabbit-test sunset forces continent-wide MAT adoption, triggering equipment and kit purchases. Germany, the United Kingdom, and France continue to anchor demand, while Eastern Europe gains share through biosimilar outsourcing.

Asia-Pacific is projected to lead growth at 13.63% CAGR through 2031, fueled by China's domestic rFC capacity and India's rising sterile-drug export ambitions. Japan and South Korea complement the regional picture with automation upgrades to offset aging technical workforces. The Middle East and Africa plus South America remain nascent but attractive targets as multinational firms and local governments collaborate on GMP facility build-outs, planting future seeds for the pyrogen testing market.

1. Accugen Laboratories Inc.
2. Associates of Cape Cod Inc.
3. bioMerieux
4. Charles River
5. Ellab
6. Eurofins
7. FUJIFILM Wako Pure Chemical Corporation
8. Genscript
9. Hyglos GmbH
10. InvivoGen
11. Lonza Group
12. Merck KGaA (MilliporeSigma)
13. Microcoat Biotechnologie
14. Minerva Analytix GmbH
15. Nelson Laboratories LLC
16. Pacific BioLabs
17. Sanquin Reagents B.V.
18. Sartorius
19. Thermo Fisher Scientific
20. WuXi AppTec Co., Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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 Biologics & Vaccine Pipeline Expansion
  • 4.2.2 Mandatory Endotoxin Limits in New USP <85> / Ph. Eur. 2.6.14 Revisions
  • 4.2.3 Outsourcing To CROs & CDMOs For Lot-Release Testing
  • 4.2.4 Automation-Ready Microfluidic/LAL Analyzers Adopted by Big Pharma
  • 4.2.5 EU Phase-Out of Rabbit Tests Accelerating MAT Procurement Budgets
  • 4.2.6 Chinese RFC Reagent Start-Ups Lowering Cost Floor, Spurring APAC Demand
• 4.3 Market Restraints
  • 4.3.1 High Capital Cost of MAT & RFC Validation for SME Manufacturers
  • 4.3.2 Horseshoe-Crab Harvest Restrictions Causing Supply Bottlenecks For LAL
  • 4.3.3 Persistent Low Endotoxin Recovery (LER) Events Delaying Biosimilar Launches
  • 4.3.4 Divergent Data-Integrity Rules (E.G., China GxP) Complicate Lab Automation ROI
• 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 Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product & Service
  • 5.1.1 Kits & Reagents
  • 5.1.2 Instruments
  • 5.1.3 Services
• 5.2 By Detection Technology
  • 5.2.1 Animal-Based Tests
  • 5.2.2 Recombinant / Cell-Based Tests
  • 5.2.3 Instrument-Integrated Rapid Systems
• 5.3 By Sample / Process Stage
  • 5.3.1 Raw Materials & Water Testing
  • 5.3.2 In-Process (Upstream & Downstream)
  • 5.3.3 Final Product / Lot-Release
  • 5.3.4 Medical Device Surface & Rinse Tests
• 5.4 By Test Type
  • 5.4.1 Limulus Amebocyte Lysate (LAL) Tests
  • 5.4.2 Recombinant Factor C (rFC) Assays
  • 5.4.3 Monocyte Activation Test (MAT)
  • 5.4.4 Rabbit Pyrogen Test
• 5.5 By End User
  • 5.5.1 Pharmaceutical & Biotechnology Companies
  • 5.5.2 Medical Device Companies
  • 5.5.3 Contract Research Organizations (CROs)
  • 5.5.4 Academic & Research Institutes
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 France
    • 5.6.2.3 United Kingdom
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 Accugen Laboratories Inc.
  • 6.3.2 Associates of Cape Cod Inc.
  • 6.3.3 bioMerieux SA
  • 6.3.4 Charles River Laboratories International Inc.
  • 6.3.5 Ellab A/S
  • 6.3.6 Eurofins Scientific SE
  • 6.3.7 FUJIFILM Wako Pure Chemical Corporation
  • 6.3.8 GenScript Biotech Corporation
  • 6.3.9 Hyglos GmbH
  • 6.3.10 InvivoGen
  • 6.3.11 Lonza Group AG
  • 6.3.12 Merck KGaA (MilliporeSigma)
  • 6.3.13 Microcoat Biotechnologie GmbH
  • 6.3.14 Minerva Analytix GmbH
  • 6.3.15 Nelson Laboratories LLC
  • 6.3.16 Pacific BioLabs
  • 6.3.17 Sanquin Reagents B.V.
  • 6.3.18 Sartorius AG
  • 6.3.19 Thermo Fisher Scientific Inc.
  • 6.3.20 WuXi AppTec Co., Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment