Pyrogen Testing Market

Global Pyrogen Testing Market Size, Share & Trends Analysis Report by Product &Services (Assays, Kits & Reagents, Instruments, and Services), By Test Type (LAL, Monocyte Activation, Chromogenic, Turbidimetric, Gel Clot, In Vitro, Rabbit, and Others), By End-User (Pharmaceutical companies, Biotechnology Companies, Medical Device Companies and, Others), Forecast Period (2022-2028)
    Update Available - Forecast 2024-2030   

Published: Jul 2023 | Report Code: OMR2026359 | Category : Healthcare Information Technology | Delivery Format: /

The global pyrogen testing market is anticipated to grow at a significant CAGR of around 8.5% during the forecast period. Pyrogen testing helps in determining the presence or absence of pyrogen in parenteral medicines, and it is governed by several organizations that include, the United States Pharmacopeia (USP), the Food and Drug Administration (FDA), and European Pharmacopoeia (EP). The rising R&D expenditure is propelling the market growth. As per the information provided by the European Federation of Pharmaceutical Industries and Associations (EFPIA) report in 2019, alone in Europe, the pharmaceutical industry invested around $4.2billion in R&D and on life science in 2018. The steadily growing pharmaceutical and biotechnology industries are anticipated to drive the growth of the pyrogen testing market studied. Pyrogen testing is mostly used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and release of infection-free products. As per the data revealed by European Pharmacopoeia's general chapter 2.6.30, the rabbit pyrogen test is gradually replaced by other pyrogen tests, that is a significant step forward in terms of animal welfare. 

Impact Of COVID-19 Pandemic On Global Pyrogen Testing Market

The demand for pyrogen testing techniques has obtained steady growth during the emergence of COVID-19 due to the rising prevalence of infectious diseases. The COVID-19 economic and social burden has prompted various government bodies across the globe to increase support for vaccine development, that in turn led to the growing adoption of pyrogen testing products for COVID-19 research and developments. As vaccine manufacturing was increased due to COVID-19, bacterial endotoxin testing was an important quality assurance measure to ensure patient safety and that is a factor that pyrogen testing in COVID-19 was impacted positively and that in turn created the pyrogen testing market to grow.

Segmental Outlook 

The global pyrogen testing market is segmented based on the product & services, test type, and end-user. On the basis of product and services, the market is segmented into assays, kits & reagents, instruments, and services. Based on the test type the market is sub-divided into LAL, monocyte activation, chromogenic, turbidimetric, gel clot, vitro, rabbit, and others. On the basis of end-user, the market is sub-segmented into pharmaceutical companies, biotechnology companies, medical device companies, and others. Among the end-user segment, the pharmaceutical sub-segment dominated owing to the rising demand for biologics to develop therapeutically advanced drugs on a large scale. 

Global Pyrogen Testing Market Share By Type, 2021 (%)

Global Pyrogen Testing Market Share By Type

The Monocyte Activation Is Dominating In The Global Pyrogen Testing Market

Among the test type segment, the monocyte activation test sub-divided segment dominates in the market. It is used to detect substances that activate human monocytes or monocytic cells to release endogenous mediators, that act or have a role in the human fever response throughout the body. The monocyte activation test provides a more relevant prediction of pyrogenic activity than the RPT tests, it can also detect endotoxin and non-endotoxin pyrogens and it applies to a greater variety of products than the RPT tests held. This test is more accurate as well as more cost- and time-effective than the RPT test and thus driving the growth of the MAT segment. As per the report published by the Brazilian Journal of Pharmaceutical Science, the monocyte activation test is getting more attention across the pharmaceutical industry, that is propelling the growth of the pyrogen testing market. 

For instance, in June 2020, Lonza Sales AG and Sanquin Reagents B.V. partnered with innovative new technologies that can facilitate accurate, reliable detection of pyrogenic contamination in their products to safeguard patient health. The partnership will facilitate global access to the sustainable, highly sensitive methodology for in vitro pyrogen testing essential for the safety of parenteral pharmaceuticals during development, manufacture, and release to market. In the agreement, Sanquin's cryopreserved pooled human Peripheral Blood Mononuclear Cell-based Monocyte Activation Test (MAT) will be added to Lonza's extensive portfolio of pyrogen testing products.

Regional Outlooks

The global pyrogen testing market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East &Africa, and Latin America. North America is dominating due to the well-established healthcare infrastructure, better regulatory framework, and government support. Moreover, rise in the awareness initiatives for healthcare further supports the growth of the pyrogen testing market. 

Global Pyrogen Testing Market Growth, By Region 2022-2028

Global Pyrogen Testing Market Growth, By Region

The Asia-Pacific  Region is Predicated to be the Fastest Growing in the Global Pyrogen Testing Market

The growing demand for endotoxin testing products in pharmaceutical and biotechnology companies is propelling the growth of the market in the Asia-Pacific region. The technological advancements for the development and production of new endotoxin testing methods such as complete automation systems are for testing are anticipated to boost the growth of the market. Additionally, with the growing importance of healthcare and rising awareness regarding toxicity in drugs and medical devices there is an increase in demand for pyrogen testing in pharmaceutical and biological products industries.

Market Players Outlook

The major companies serving the global Pyrogen Testing market include BIOMÉRIEUX SA, Charles River Laboratories International, Inc., Ellab A/S, GenScript Biotech Corp., Lonza Group Ltd., MAT BioTech B.V., Merck KGaA, and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers & acquisitions, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in April 2021, Associates of Cape Cod, Inc., launched its new innovative, sustainable recombinant LAL reagent namer PyroSmart NextGen for bacterial endotoxin testing (BET), that utilize a raw material found in crab blood. The New  LAL reagent is sustainably produced using recombinant technology, based on raw materials from animals, unlike traditional LAL reagents that are manufactured using the blood harvested from horseshoe crabs. It will deliver consistent and reliable quantitation in all BET applications requiring LAL reagents such as testing of water, injectable drugs, vaccines, and medical devices.

The Report Covers

  • Market value data analysis of 2021 and forecast to 2028.
  • Annualized market revenues ($ million) for each market segment.
  • Country-wise analysis of major geographical regions.
  • Key companies operating in the global Pyrogen Testing market. Based on the availability of data, information related to new product launches, and relevant news is also available in the report.
  • Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
  • Analysis of market entry and market expansion strategies.
  • Competitive strategies by identifying ‘who-stands-where’ in the market.

1. Report Summary

Current Industry Analysis and Growth Potential Outlook

Impact of COVID-19 on the Global Pyrogen Testing Market

Recovery Scenario of Global Pyrogen Testing Market

1.1. Research Methods and Tools

1.2. Market Breakdown

1.2.1. By Segments

1.2.2. BY Region

2. Market Overview and Insights

2.1. Scope of the Report

2.2. Analyst Insight & Current Market Trends

2.2.1. Key Findings

2.2.2. Recommendations

2.2.3. Conclusion

3. Competitive Landscape

3.1. BIOMÉRIEUX SA

3.1.1. Overview

3.1.2. Financial Analysis 

3.1.3. SWOT Analysis

3.1.4. Recent Developments

3.2. Ellab A/S

3.2.1. Overview

3.2.2. Financial Analysis 

3.2.3. SWOT Analysis

3.2.4. Recent Developments

3.3. GenScript Biotech Corp.

3.3.1. Overview

3.3.2. Financial Analysis 

3.3.3. SWOT Analysis

3.3.4. Recent Developments

3.4. Lonza Group Ltd.

3.4.1. Overview

3.4.2. Financial Analysis 

3.4.3. SWOT Analysis

3.4.4. Recent Developments

3.5. Merck KGaA

3.5.1. Overview

3.5.2. Financial Analysis 

3.5.3. SWOT Analysis

3.5.4. Recent Developments

3.6. Key Strategy Analysis

3.7. Impact of Covid-19 on Key Players

4. Market Segmentation

4.1. Global Pyrogen Testing Market by Product & Service

4.1.1. Assays

4.1.2. Kits & Reagents

4.1.3. Instruments

4.1.4. Services

4.2. Global Pyrogen Testing Market by Test Type

4.2.1. LAL

4.2.2. Monocyte Activation

4.2.3. Chromogenic

4.2.4. Turbidimetric

4.2.5. Gel Clot

4.2.6. In Vitro 

4.2.7. Rabbit

4.2.8. Others

4.3. Global Pyrogen Testing Market by End-User 

4.3.1. Pharmaceutical Companies

4.3.2. Biotechnology Companies

4.3.3. Medical Device Companies

4.3.4. Others

5. Regional Analysis

5.1. North America

5.1.1. US

5.1.2. Canada

5.2. Europe

5.2.1. UK

5.2.2. Germany

5.2.3. Italy

5.2.4. Spain

5.2.5. France

5.2.6. Rest of Europe 

5.3. Asia-Pacific

5.3.1. China

5.3.2. India

5.3.3. Japan

5.3.4. South Korea

5.3.5. Rest of Asia-Pacific 

5.4. Rest of the World

6. Company Profiles

6.1. Accugen Laboratories, Inc. 

6.2. Almac Group Eurofins Scientific

6.3. Associates Of Cape Cod, Inc. 

6.4. Charles River Laboratories International, Inc. 

6.5. Eurofins Advinus Ltd.

6.6. Fujifilm Holdings Corp.

6.7. Hycult Biotech Inc.

6.8. INDOOR Biotechnologies, Inc.

6.9. InvivoGen 

6.10. Labcorp

6.11. MAT BioTech B.V. 

6.12. Microcoat Biotechnologie GmbH

6.13. Minerva Analytix

6.14. Nelson Laboratories, LLC

6.15. Promega Corp

6.16. Sanquin Diagnostics BV 

6.17. Solvias AG

6.18. STERIS

6.19. WuXi AppTec 

6.20. Xiamen Bioendo Technology Co., Ltd

1. GLOBAL PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY PRODUCT & SERVICES, 2021-2028 ($ MILLION)

2. GLOBAL ASSAYS IN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

3. GLOBAL KITS & REAGENTS IN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($MILLION) 

4. GLOBAL INSTRUMENTAL IN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($MILLION)

5. GLOBAL SERVICES IN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($MILLION)

6. GLOBAL PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY TEST TYPE, 2021-2028 ($ MILLION)

7. GLOBAL LAL PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

8. GLOBAL MONOCYTE ACTIVATION PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

9. GLOBAL CHROMOGENIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

10. GLOBAL TURBIDMETRIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

11. GLOBAL GEL CLOT PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

12. GLOBAL VITRO PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

13. GLOBAL RABBIT PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

14. GLOBAL OTHERS PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

15. GLOBAL PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)

16. GLOBAL PYROGEN TESTING FOR PHARMACEUTICAL COMPANIES MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

17. GLOBAL PYROGEN TESTING FOR BIOTECHNOLOGY COMPANIES MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

18. GLOBAL PYROGEN TESTING FOR MEDICAL DEVICE COMPANIES MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

19. GLOBAL PYROGEN TESTING FOR OTHER END-USERS MARKET RESEARCH AND ANALYSIS BY REGION, 2021-2028 ($ MILLION)

20. NORTH AMERICAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)

21. NORTH AMERICAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY PRODUCT & SERVICES, 2021-2028 ($ MILLION)

22. NORTH AMERICAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY TEST TYPE, 2021-2028 ($ MILLION)

23. NORTH AMERICAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)

24. EUROPEAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)

25. EUROPEAN TRANSGENIC SEED MARKET RESEARCH AND ANALYSIS BY PRODUCTS & SERVICES, 2021-2028 ($ MILLION)

26. EUROPEAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY TEST TYPES, 2021-2028 ($ MILLION)

27. EUROPEAN PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)

28. ASIA-PACIFIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)

29. ASIA-PACIFIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY PRODUCTS & SERVICES, 2021-2028 ($ MILLION)

30. ASIA-PACIFIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY TEST TYPE, 2021-2028 ($ MILLION)

31. ASIA-PACIFIC PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)

32. REST OF THE WORLD PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY COUNTRY, 2021-2028 ($ MILLION)

33. REST OF THE WORLD PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY PRODUCTS & SERVICES, 2021-2028 ($ MILLION)

34. REST OF THE WORLD PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY TEST TYPE, 2021-2028 ($ MILLION)

35. REST OF THE WORLD PYROGEN TESTING MARKET RESEARCH AND ANALYSIS BY END-USER, 2021-2028 ($ MILLION)

1. IMPACT OF COVID-19 ON GLOBAL PYROGEN TESTING MARKET, 2021-2028 ($ MILLION)

2. IMPACT OF COVID-19 ON GLOBAL PYROGEN TESTING MARKET BY SEGMENT, 2021-2028 ($ MILLION)

3. RECOVERY OF GLOBAL PYROGEN TESTING  MARKET, 2021-2028 (%)

4. GLOBAL PYROGEN TESTING MARKET SHARE BY PRODCUTS & SERVICES, 2021 VS 2028 (%)

5. GLOBAL ASSAYS  IN PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

6. GLOBAL KITS & REAGENTS IN PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%

7. GLOBAL INSTRUMENTS IN PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

8. GLOBAL SERVICES IN PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

9. GLOBAL PYROGEN TESTING MARKET SHARE BY TEST TYPE, 2021 VS 2028 (%)

10. GLOBAL LAL  PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

11. GLOBAL MONOCYTE ACTIVATION PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

12. GLOBAL CHROMOGENIC PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

13. GLOBAL TURBIDIMETRIC PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

14. GLOBAL GEL CLOT PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

15. GLOBAL VITRO PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

16. GLOBAL RABBIT PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

17. GLOBAL OTHERS  PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%

18. GLOBAL PYROGEN TESTING MARKET SHARE BY END-USER, 2021 VS 2028 (%)

19. GLOBAL PYROGEN TESTING FOR PHARMACEUTICAL COMPANIES MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

20. GLOBAL PYROGEN TESTING FOR BIOTECHNOLOGY COMPANIES MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

21. GLOBAL PYROGEN TESTING FOR MEDICAL DEVICE COMPANIES MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

22. GLOBAL PYROGEN TESTING FOR OTHERS MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

23. GLOBAL PYROGEN TESTING MARKET SHARE BY GEOGRAPHY, 2021 VS 2028 (%)

24. US PYROGEN TESTING MARKET SIZE, 2021-2028 ($ MILLION)

25. CANADA PYROGEN TESTING MARKET SIZE, 2021-2028 ($ MILLION)

26. UK PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

27. FRANCE PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

28. GERMANY PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

29. ITALY PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

30. SPAIN TRANSGENIC SEED  MARKET SIZE, 2021-2028 ($ MILLION)

31. REST OF EUROPE PYROGEN TESTING  MARKET SIZE, 2021-2028 ($ MILLION)

32. INDIA PYROGEN TESTING MARKET SIZE, 2021-2028 ($ MILLION)

33. CHINA PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

34. JAPAN PYROGEN TESTING MARKET SIZE, 2021-2028 ($ MILLION)

35. SOUTH KOREA PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)

36. REST OF ASIA-PACIFIC PYROGEN TESTING MARKET SIZE, 2021-2028 ($ MILLION)

37. REST OF THE WORLD PYROGEN TESTINGMARKET SIZE, 2021-2028 ($ MILLION)