This Pyrogen Testing report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
The pyrogen testing market size has grown rapidly in recent years. It will grow from $1.68 billion in 2024 to $1.91 billion in 2025 at a compound annual growth rate (CAGR) of 13.8%. The growth in the historic period can be attributed to pharmaceutical and biotechnology industry growth, regulatory requirements for drug safety, advancements in testing methods, increase in infectious disease outbreaks, adoption in medical device manufacturing.
The pyrogen testing market size is expected to see rapid growth in the next few years. It will grow to $3.1 billion in 2029 at a compound annual growth rate (CAGR) of 12.8%. The growth in the forecast period can be attributed to customized pyrogen testing solutions, expansion of rapid and automated testing, innovation in in vitro pyrogen detection, adoption of pyrogen testing in cellTherapy, environmental and sustainable testing practices. Major trends in the forecast period include point-of-care pyrogen testing, regulatory compliance in pyrogen testing, ai-driven pyrogen detection and analysis, personalized and patient-specific pyrogen testing, transparency and traceability in testing processes.
Increasing investments in research and development within the pharmaceutical and biotechnology sectors have fueled the growth of the pyrogen testing market. Pyrogen testing is essential for pharmaceutical, biotech, and various drug manufacturing companies to ensure the safe production and introduction of infection-free products into the market. For example, the Association of the British Pharmaceutical Industry, a trade association based in the UK, reported that in 2022, the innovative pharmaceutical industry contributed approximately £9 billion to UK research and development (R&D), which has the potential to enhance both the nation's health and economy. Consequently, substantial investments in research and development by pharmaceutical companies are driving the pyrogen testing market.
The increasing prevalence of infectious diseases is expected to drive the growth of the pyrogen testing market in the coming years. Infectious diseases are illnesses caused by pathogens that invade the human body. Pyrogen testing plays a vital role in ensuring the safety of pharmaceutical products, as it detects the presence of fever-inducing contaminants in drugs and medical devices. For instance, in April 2024, the European Centre for Disease Prevention and Control, a government health agency based in Sweden, reported 28,855 recorded cases of hepatitis B virus (HBV) infection across 30 EU/EEA Member States in 2022, marking a 78% increase from 16,187 cases in 2021. Furthermore, the 2022 total of 28,420 cases corresponds to a crude rate of 8.5 cases per 100,000 individuals. Thus, the rise in infectious diseases globally is significantly contributing to the growth of the pyrogen testing market.
Companies are actively involved in advancing animal-free pyrogen testing methods, such as the monocyte activation assay (MAT), to overcome limitations associated with traditional methods like the rabbit pyrogen testing method and the Limulus amebocyte lysate (LAL) test. This transition towards animal-free testing is driven by a commitment to ethical treatment of animals. Notably, the MAT method surpasses the LAL test by detecting both endotoxin and non-endotoxin pyrogens. Merck, for instance, has focused on MAT systems, including PyroDetect and PyroMAT.
Innovative product development remains a focal point for major companies operating in the pyrogen testing market. To enhance their business offerings and expand market reach, companies are introducing sustainable monocyte activation test (MAT) systems. Lonza, a Swiss multinational manufacturing company, exemplifies this trend by launching the PyroCell MAT Rapid System and the PyroCell MAT Human Serum (HS) Rapid System. These systems, equipped with the PeliKine Human IL-6 Rapid ELISA Kit, offer efficient MAT testing options for product safety, minimizing hands-on time and reducing time-to-results from two days to two hours. The introduction of such innovative testing options not only aids pharmaceutical manufacturers but also aligns with efforts to reduce reliance on animal testing.
Major companies operating in the pyrogen testing market include Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories Inc., Lonza Group Ltd., Ellab A/S, Nelson Laboratories LLC, Associates of Cape Cod Inc., GenScript Biotech Corporation, bioMérieux SA, Hyglos GmbH, Sanquin Blood Supply Foundation, Wako Chemicals USA Inc., Pyrostar International Inc., Eurofins Scientific SE, SGS SA, WuXi AppTec Group, Sigma-Aldrich Co. LLC, Bio-Rad Laboratories Inc., Microcoat Biotechnologie GmbH, Sartorius AG, Pacific Biolabs Inc., Toxikon Corporation, STERIS Corporation, Avance Biosciences Inc., BioReliance Corporation, Microbiological Consulting LLC, Microbac Laboratories Inc., North American Science Associates Inc., Pace Analytical Life Sciences LLC.
North America was the largest region in the pyrogen testing market in 2024. Asia-Pacific is expected to continue to be the fastest growing region in the pyrogen testing market share during the forecast period. The regions covered in the pyrogen testing market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the pyrogen testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
The pyrogen testing market includes revenues earned by entities by endotoxin testing and monocyte activation testing (MAT). The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The pyrogen testing provides testing services to check the presence or absence of pyrogens in all aqueous parenteral products. Pyrogen testing determines the presence of bacterial toxins in vaccines, biotechnological products, and drugs, which induce fever in humans. It also identifies the presence of microbes and their metabolites in drugs during the manufacturing process.
The main types of pyrogen tests are the Limulus Amebocyte Lysate (LAL) test, in vitro test, and rabbit test. The LAL test is a method for determining bacterial endotoxins, utilizing the amebocyte lysate of the Limulus crab. The rabbit pyrogen test involves injecting a small amount of batched test material into a rabbit's bloodstream, and the rabbit's body temperature is monitored. The products used for pyrogen tests include assays, kits, and reagents, as well as instruments and related services. Pyrogen testing is applied in pharmaceutical and biologics, medical devices, and other industries.
The pyrogen testing market research report is one of a series of new reports that provides pyrogen testing market statistics, including pyrogen testing industry global market size, regional shares, competitors with a pyrogen testing market share, detailed pyrogen testing market segments, market trends and opportunities, and any further data you may need to thrive in the pyrogen testing industry. This pyrogen testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
The pyrogen testing market size has grown rapidly in recent years. It will grow from $1.68 billion in 2024 to $1.91 billion in 2025 at a compound annual growth rate (CAGR) of 13.8%. The growth in the historic period can be attributed to pharmaceutical and biotechnology industry growth, regulatory requirements for drug safety, advancements in testing methods, increase in infectious disease outbreaks, adoption in medical device manufacturing.
The pyrogen testing market size is expected to see rapid growth in the next few years. It will grow to $3.1 billion in 2029 at a compound annual growth rate (CAGR) of 12.8%. The growth in the forecast period can be attributed to customized pyrogen testing solutions, expansion of rapid and automated testing, innovation in in vitro pyrogen detection, adoption of pyrogen testing in cellTherapy, environmental and sustainable testing practices. Major trends in the forecast period include point-of-care pyrogen testing, regulatory compliance in pyrogen testing, ai-driven pyrogen detection and analysis, personalized and patient-specific pyrogen testing, transparency and traceability in testing processes.
Increasing investments in research and development within the pharmaceutical and biotechnology sectors have fueled the growth of the pyrogen testing market. Pyrogen testing is essential for pharmaceutical, biotech, and various drug manufacturing companies to ensure the safe production and introduction of infection-free products into the market. For example, the Association of the British Pharmaceutical Industry, a trade association based in the UK, reported that in 2022, the innovative pharmaceutical industry contributed approximately £9 billion to UK research and development (R&D), which has the potential to enhance both the nation's health and economy. Consequently, substantial investments in research and development by pharmaceutical companies are driving the pyrogen testing market.
The increasing prevalence of infectious diseases is expected to drive the growth of the pyrogen testing market in the coming years. Infectious diseases are illnesses caused by pathogens that invade the human body. Pyrogen testing plays a vital role in ensuring the safety of pharmaceutical products, as it detects the presence of fever-inducing contaminants in drugs and medical devices. For instance, in April 2024, the European Centre for Disease Prevention and Control, a government health agency based in Sweden, reported 28,855 recorded cases of hepatitis B virus (HBV) infection across 30 EU/EEA Member States in 2022, marking a 78% increase from 16,187 cases in 2021. Furthermore, the 2022 total of 28,420 cases corresponds to a crude rate of 8.5 cases per 100,000 individuals. Thus, the rise in infectious diseases globally is significantly contributing to the growth of the pyrogen testing market.
Companies are actively involved in advancing animal-free pyrogen testing methods, such as the monocyte activation assay (MAT), to overcome limitations associated with traditional methods like the rabbit pyrogen testing method and the Limulus amebocyte lysate (LAL) test. This transition towards animal-free testing is driven by a commitment to ethical treatment of animals. Notably, the MAT method surpasses the LAL test by detecting both endotoxin and non-endotoxin pyrogens. Merck, for instance, has focused on MAT systems, including PyroDetect and PyroMAT.
Innovative product development remains a focal point for major companies operating in the pyrogen testing market. To enhance their business offerings and expand market reach, companies are introducing sustainable monocyte activation test (MAT) systems. Lonza, a Swiss multinational manufacturing company, exemplifies this trend by launching the PyroCell MAT Rapid System and the PyroCell MAT Human Serum (HS) Rapid System. These systems, equipped with the PeliKine Human IL-6 Rapid ELISA Kit, offer efficient MAT testing options for product safety, minimizing hands-on time and reducing time-to-results from two days to two hours. The introduction of such innovative testing options not only aids pharmaceutical manufacturers but also aligns with efforts to reduce reliance on animal testing.
Major companies operating in the pyrogen testing market include Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories Inc., Lonza Group Ltd., Ellab A/S, Nelson Laboratories LLC, Associates of Cape Cod Inc., GenScript Biotech Corporation, bioMérieux SA, Hyglos GmbH, Sanquin Blood Supply Foundation, Wako Chemicals USA Inc., Pyrostar International Inc., Eurofins Scientific SE, SGS SA, WuXi AppTec Group, Sigma-Aldrich Co. LLC, Bio-Rad Laboratories Inc., Microcoat Biotechnologie GmbH, Sartorius AG, Pacific Biolabs Inc., Toxikon Corporation, STERIS Corporation, Avance Biosciences Inc., BioReliance Corporation, Microbiological Consulting LLC, Microbac Laboratories Inc., North American Science Associates Inc., Pace Analytical Life Sciences LLC.
North America was the largest region in the pyrogen testing market in 2024. Asia-Pacific is expected to continue to be the fastest growing region in the pyrogen testing market share during the forecast period. The regions covered in the pyrogen testing market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the pyrogen testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
The pyrogen testing market includes revenues earned by entities by endotoxin testing and monocyte activation testing (MAT). The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The pyrogen testing provides testing services to check the presence or absence of pyrogens in all aqueous parenteral products. Pyrogen testing determines the presence of bacterial toxins in vaccines, biotechnological products, and drugs, which induce fever in humans. It also identifies the presence of microbes and their metabolites in drugs during the manufacturing process.
The main types of pyrogen tests are the Limulus Amebocyte Lysate (LAL) test, in vitro test, and rabbit test. The LAL test is a method for determining bacterial endotoxins, utilizing the amebocyte lysate of the Limulus crab. The rabbit pyrogen test involves injecting a small amount of batched test material into a rabbit's bloodstream, and the rabbit's body temperature is monitored. The products used for pyrogen tests include assays, kits, and reagents, as well as instruments and related services. Pyrogen testing is applied in pharmaceutical and biologics, medical devices, and other industries.
The pyrogen testing market research report is one of a series of new reports that provides pyrogen testing market statistics, including pyrogen testing industry global market size, regional shares, competitors with a pyrogen testing market share, detailed pyrogen testing market segments, market trends and opportunities, and any further data you may need to thrive in the pyrogen testing industry. This pyrogen testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
Table of Contents
1. Executive Summary2. Pyrogen Testing Market Characteristics3. Pyrogen Testing Market Trends and Strategies4. Pyrogen Testing Market - Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market32. Global Pyrogen Testing Market Competitive Benchmarking and Dashboard33. Key Mergers and Acquisitions in the Pyrogen Testing Market34. Recent Developments in the Pyrogen Testing Market
5. Global Pyrogen Testing Growth Analysis and Strategic Analysis Framework
6. Pyrogen Testing Market Segmentation
7. Pyrogen Testing Market Regional and Country Analysis
8. Asia-Pacific Pyrogen Testing Market
9. China Pyrogen Testing Market
10. India Pyrogen Testing Market
11. Japan Pyrogen Testing Market
12. Australia Pyrogen Testing Market
13. Indonesia Pyrogen Testing Market
14. South Korea Pyrogen Testing Market
15. Western Europe Pyrogen Testing Market
16. UK Pyrogen Testing Market
17. Germany Pyrogen Testing Market
18. France Pyrogen Testing Market
19. Italy Pyrogen Testing Market
20. Spain Pyrogen Testing Market
21. Eastern Europe Pyrogen Testing Market
22. Russia Pyrogen Testing Market
23. North America Pyrogen Testing Market
24. USA Pyrogen Testing Market
25. Canada Pyrogen Testing Market
26. South America Pyrogen Testing Market
27. Brazil Pyrogen Testing Market
28. Middle East Pyrogen Testing Market
29. Africa Pyrogen Testing Market
30. Pyrogen Testing Market Competitive Landscape and Company Profiles
31. Pyrogen Testing Market Other Major and Innovative Companies
35. Pyrogen Testing Market High Potential Countries, Segments and Strategies
36. Appendix
Executive Summary
Pyrogen Testing Global Market Report 2025 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses on pyrogen testing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for pyrogen testing? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The pyrogen testing market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include:
- The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:
1) by Test Type: LAL Test; in Vitro Test; Rabbit Test2) by Product and Service: Assays, Kits, and Reagents; Instruments; Services
3) by Application: Pharmaceutical and Biologics; Medical Devices; Other Applications
Subsegments:
1) by Test Limulus Amebocyte Lysate (LAL) Test: Gel Clot LAL Test; Chromogenic LAL Test; Turbidimetric LAL Test2) by in Vitro Test: Monocyte Activation Test (MAT); Recombinant Factor C (rFC) Assay; Other in Vitro Tests
3) by Rabbit Test: Pyrogen Test in Rabbits; Other Animal-Based Tests
Key Companies Mentioned: Thermo Fisher Scientific Inc.; Merck KGaA; Charles River Laboratories Inc.; Lonza Group Ltd.; Ellab a/S
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: PDF, Word and Excel Data Dashboard.
Companies Mentioned
Some of the major companies featured in this Pyrogen Testing market report include:- Thermo Fisher Scientific Inc.
- Merck KGaA
- Charles River Laboratories Inc.
- Lonza Group Ltd.
- Ellab A/S
- Nelson Laboratories LLC
- Associates of Cape Cod Inc.
- GenScript Biotech Corporation
- bioMérieux SA
- Hyglos GmbH
- Sanquin Blood Supply Foundation
- Wako Chemicals USA Inc.
- Pyrostar International Inc.
- Eurofins Scientific SE
- SGS SA
- WuXi AppTec Group
- Sigma-Aldrich Co. LLC
- Bio-Rad Laboratories Inc.
- Microcoat Biotechnologie GmbH
- Sartorius AG
- Pacific Biolabs Inc.
- Toxikon Corporation
- STERIS Corporation
- Avance Biosciences Inc.
- BioReliance Corporation
- Microbiological Consulting LLC
- Microbac Laboratories Inc.
- North American Science Associates Inc.
- Pace Analytical Life Sciences LLC
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | February 2025 |
| Forecast Period | 2025 - 2029 |
| Estimated Market Value ( USD | $ 1.91 Billion |
| Forecasted Market Value ( USD | $ 3.1 Billion |
| Compound Annual Growth Rate | 12.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 30 |
