Pyrogen Testing Market To Reach USD 3.17 Billion By 2032, Driven By Shift Toward In Vitro Testing And Regulatory Pressures SNS Insider

(MENAFN- GlobeNewsWire - Nasdaq) SNS Insider Reveals U.S. Pyrogen Testing Market Valued at USD 0.46 Billion in 2023, Poised to Hit USD 0.85 Billion by 2032 Amid Rising Biologics Pipeline, GMP Compliance, and Demand for Endotoxin-Free Pharmaceutical Products.

Austin, July 07, 2025 (GLOBE NEWSWIRE) -- Pyrogen Testing Market Size & Growth Analysis:

According to the latest report by SNS Insider, the Pyrogen Testing Market size was USD 1.60 billion in 2023 and is projected to reach USD 3.17 billion by 2032, expanding at a CAGR of 7.93% during the forecast period of 2024-2032. Growth is fueled by a significant industry shift from animal-based testing to in vitro alternatives, stringent regulatory frameworks for pharmaceutical and biopharmaceutical safety, and increasing biologics production worldwide.

The market is gaining strong momentum due to heightened awareness around drug safety, a growing biopharma manufacturing base, and international moves to adopt more humane and efficient testing methods. Regulatory bodies including the FDA and EMA continue to push for compliance with current Good Manufacturing Practice (cGMP) guidelines, catalyzing widespread adoption of validated in vitro pyrogen testing platforms.

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Market Overview:

Pyrogen testing plays a vital role in the quality assurance of pharmaceutical drugs, medical devices, and biologicals. It ensures products are free of fever-inducing substances that can lead to severe adverse effects. With global pharmacopoeias increasingly endorsing in vitro pyrogen tests such as the Monocyte Activation Test (MAT) and Limulus Amebocyte Lysate (LAL) test, companies are phasing out animal-based methods like the Rabbit Pyrogen Test.

The shift aligns with the pharmaceutical industry's mission to minimize animal usage, reduce time-to-market, and enhance reproducibility in batch testing. The combination of innovation, automation, and ethical testing is creating significant commercial opportunities.

Major Players Analysis Listed in this Report are:

• Associates of Cape Cod Inc.
• Ellab A/S
• Merck KGaA
• GenScript
• bioMérieux SA
• Charles River Laboratories
• Lonza
• FUJIFILM Wako Chemicals U.S.A. Corporation (Pyrostar)
• Thermo Fisher Scientific Inc.
• Hyglos GmbH
• WuXi AppTec

Pyrogen Testing Market Report Scope

Report Attributes	Details
Market Size in 2023	US$ 1.60 billion
Market Size by 2032	US$ 3.17 billion
CAGR (2024–2032)	7.93%
U.S. Market 2023	USD 0.46 billion
U.S. Forecast by 2032	USD 0.85 billion
Base Year	2023
Forecast Period	2024–2032
Key Regional Coverage	North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)

Segment Analysis

Consumables became the leading product segment in 2023 with over 54% market value share. This popularity is due to their reiteration in each testing cycle and extensive reliance on various endotoxin detection protocols, as well as the chronically high demand of QC labs. Whereas the instruments segment is expected to grow fastest during the forecast period due to the growing automation in laboratories for testing and the increasing use of advanced detection systems.

By type of test, the highest share in 2023 was occupied by the LAL test segment (44%), due to the high sensitivity, regulatory acceptance, and use of LAL tests in pharmaceutical, vaccine, and medical device testing. The Monocyte Activation Test (MAT) segment, on the other hand, is projected to witness the highest CAGR driven by growing regulatory acceptance for non-animal test methods, particularly in the EU, coupled with appreciable efficiency on the part of the MAT in non-endotoxin pyrogen detection.

By end-use, the pharmaceutical and biotechnology end-use sector led the market in 2023, attributable to the large-scale R&D operations, high production quantities, and stringent in-house testing procedures. Medical device companies are projected to offer the most rapid growth, owing to growing numbers of device launches and tightening regulatory oversight related to sterility and safety with implantable and invasive products.

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Pyrogen Testing Market Segmentation

By Product

• Consumables
• Instruments
• Services

By Test Type

• LAL test
  • Chromogenic test
  • Turbidimetric test
  • Gel clot test
• In vitro pyrogen test
• Rabbit test

By End-use

• Pharmaceutical and biotechnology companies
• Medical devices companies
• Others

Regional Insights:

North America led the global pyrogen testing market in 2023, accounting for over 38% of total revenue. The U.S. alone contributed USD 0.46 billion, expected to rise to USD 0.85 billion by 2032, fueled by its advanced regulatory environment, expanding biologics pipeline, and high adoption of cutting-edge QC technologies.

Asia Pacific is forecasted to witness the fastest CAGR, underpinned by an expanding base of pharmaceutical manufacturing, increasing investment in biotechnological R&D, and rising awareness about quality standards in nations like China and India.

Recent Developments (Pyrogen Testing Market)

• In March 2024, Merck KGaA introduced a second-generation pyrogen detection platform developed for improved results and aiding in the reduction of batch release turnaround time, along with global pharmacopoeial compliance.
• In October 2023, Wako Chemicals USA, a FUJIFILM company, increased production capacity for its LAL reagents in response to an increasing demand from QC labs.
• Novo Holdings purchased Ellab A/S in June 2023 to expand its position in quality control and pyrogen detection technologies.

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Table of Contents – Major Key Points

1. Introduction

2. Executive Summary

3. Research Methodology

4. Market Dynamics Impact Analysis

5. Statistical Insights and Trends Reporting

5.1 Incidence and Prevalence (2023)

5.2 Prescription Trends, (2023), by Region

5.3 Drug Volume: Production and usage volumes of pharmaceuticals.

5.4 Healthcare Spending: Expenditure data by government, insurers, and out-of-pocket by patients.

6. Competitive Landscape

7. Pyrogen Testing Market by Product

8. Pyrogen Testing Market by Test Type

9. Pyrogen Testing Market by End-use

10. Regional Analysis

11. Company Profiles

12. Use Cases and Best Practices

13. Conclusion

About Us:

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