Pyrogens are a heterogeneous group of microbial and non-microbial substances that cause fever. Most common and potent variants lipopolysaccharides or endotoxins; gram positive bacteria are also some sources of pyrogens. Since contamination from pyrogens in biotherapeutics, medical devices, pharmaceuticals and cosmetics can possibly compromise health and wellbeing, it is mandatory for manufacturers to check on the limit of pyrogen.
The purpose of this research study titled ‘Pyrogen Testing Market - Growth, Future Prospects, and Competitive Analysis, 2017 – 2025’ is to provide investors, developers, company executives and industry participants with in-depth analysis to allow them to take strategic initiatives and decisions related to the prospects in the global pyrogen testing market. This report presents and analyzes the major trends prevalent in the global pyrogen testing market and the market size and forecast.
This report categorizes the global pyrogen testing market in terms of test type, products, applications and geographical distribution. Based on test type, the global pyrogen testing market is categorized into rabbit pyrogen test (RPT), limulus amoebocyte lysate (LAL) assay (chromogenic tests, turbidimetric tests and gel clot tests) and monocyte activation test (MAT) (In-vitro test). Reagents and Kits, Instruments and Systems, and Services are the products/solutions considered for the purpose of this study. Additionally, based on applications, the global pyrogen testing market is categorized into pharmaceutical and biotech manufacturing, medical device manufacturing and others. Market size and forecast for each mentioned segment for the period 2015-2025 is presented in the report along with respective CAGRs for the forecast duration 2017-2025.
Geographically, the global pyrogen testing market is best understood by segmenting the market into five major regions and chief region level markets as follows:
The market size and forecast of each considered geographical market is presented for the period 2015-2025 along with CAGRs for the forecast period 2017-2025 in this study and are further cross-sectional analysis is presented in terms of products, test type, applications and constituent region/country level markets.
This report also includes qualitative assessment factors such as market dynamics (drivers, restraints and opportunities) to have a good understanding of the current and anticipated trends in the global pyrogen testing market. Competition assessment tools such as market attractiveness assessment and competitive landscape analysis by key players are also demonstrated in the study. Furthermore, this report concludes with profiling of key market players currently enjoying prominent position in the pyrogen testing market. The key players profiled in this report are Associates of Cape Cod, Inc., Charles River Laboratories, Inc., Ellab A/S, GenScript, Hyglos GMBH (bioMérieux), Lonza Group, Merck KGaA (Merck Millipore), Sigma-Aldrich Corporation, Thermo Fisher Scientific, Inc., Wako Chemicals USA, Inc. (Pyrostar), and WUXI Pharmatech, Inc.
Chapter 1. Preface
1.1. Report Scope and Description
1.2. Research Methodology
1.2.1. Phase I-Secondary Research
1.2.2. Phase II-Primary Research
1.2.3. Phase III-Expert Panel Review
1.2.4. Assumptions
1.2.5. Approach Adopted
Chapter 2. Executive Summary
2.1. Global Pyrogen Testing Market Portraiture
2.1.1. Global Pyrogen Testing Market, by Test Type, 2016
2.1.2. Global Pyrogen Testing Market, by Product, 2016
2.1.3. Global Pyrogen Testing Market, by Application, 2016
2.1.4. Global Pyrogen Testing Market, by Geography, 2016
Chapter 3. Pyrogen Testing: Market Dynamics and Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.4.1. Attractive Investment Proposition, by Geography
3.5. Competitive Landscape
3.5.1. Competitive Landscape, by Key Players, 2016
Chapter 4. Global Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
4.1. Overview
4.2. Attractive Investment Proposition, by Test Type
4.3. Rabbit Pyrogen Test (RPT)
4.4. Limulus Amoebocyte Lysate (LAL) Assay
4.4.1. Chromogenic Tests
4.4.2. Turbidimetric Tests
4.4.3. Gel Clot Tests
4.5. Monocyte Activation Test (MAT) (In-vitro test)
Chapter 5. Global Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
5.1. Overview
5.2. Attractive Investment Proposition, by Product
5.3. Reagents and Kits
5.4. Instruments and Systems
5.5. Services
Chapter 6. Global Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
6.1. Overview
6.2. Attractive Investment Proposition, by Application
6.3. Pharmaceutical and Biotech Manufacturing
6.4. Medical Device Manufacturing
6.5. Others
Chapter 7. Global Pyrogen Testing Market, by Geography, 2015 – 2025
7.1. Overview
7.2. North America Pyrogen Testing Market Analysis, 2015 – 2025
7.2.1. North America Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
7.2.2. North America Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
7.2.3. North America Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
7.2.4. North America Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
7.2.4.1. U.S.
7.2.4.2. Canada
7.3. Europe Pyrogen Testing Market Analysis, 2015 – 2025
7.3.1. Europe Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
7.3.2. Europe Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
7.3.3. Europe Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
7.3.4. Europe Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
7.3.4.1. U.K.
7.3.4.2. Germany
7.3.4.3. Rest of Europe
7.4. Asia Pacific Pyrogen Testing Market Analysis , 2015 – 2025
7.4.1. Asia Pacific Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
7.4.2. Asia Pacific Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
7.4.3. Asia Pacific Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
7.4.4. Asia Pacific Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
7.4.4.1. China
7.4.4.2. Japan
7.4.4.3. Rest of APAC
7.5. Latin America Pyrogen Testing Market Analysis , 2015 – 2025
7.5.1. Latin America Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
7.5.2. Latin America Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
7.5.3. Latin America Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
7.5.4. Latin America Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
7.5.4.1. Brazil
7.5.4.2. Mexico
7.5.4.3. Rest of Latin America
7.6. Middle East & Africa (MEA) Pyrogen Testing Market Analysis, 2015 – 2025
7.6.1. MEA Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
7.6.2. MEA Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
7.6.3. MEA Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
7.6.4. MEA Pyrogen Testing Market, by Region, 2015 – 2025 (US$ Mn)
7.6.4.1. GCC
7.6.4.2. Rest of MEA
Chapter 8. Company Profiles
8.1. Associates of Cape Cod, Inc.
8.1.1. Business Description
8.1.2. Financial Information (Subject to data availability)
8.1.3. Product Portfolio
8.1.4. Key Developments
8.2. Charles River Laboratories, Inc.
8.3. Ellab A/S
8.4. GenScript
8.5. Hyglos GMBH (bioMérieux)
8.6. Lonza Group
8.7. Merck KGaA (Merck Millipore)
8.8. Sigma-Aldrich Corporation
8.9. Thermo Fisher Scientific, Inc.
8.10. Wako Chemicals USA, Inc. (Pyrostar)
8.11. WUXI Pharmatech, Inc.
8.12. Other Notable Players
List of Tables :
TABLE 1 Global Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 2 Global Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 3 Global Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 4 North America Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 5 North America Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 6 North America Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 7 North America Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 8 Europe Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 9 Europe Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 10 Europe Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 11 Europe Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 12 Asia Pacific Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 13 Asia Pacific Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 14 Asia Pacific Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 15 Asia Pacific Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 16 Latin America Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 17 Latin America Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 18 Latin America Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 19 Latin America Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 20 Middle East and Africa Pyrogen Testing Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 21 Middle East and Africa Pyrogen Testing Market, by Product, 2015 – 2025 (US$ Mn)
TABLE 22 Middle East and Africa Pyrogen Testing Market, by Application, 2015 – 2025 (US$ Mn)
TABLE 23 Middle East and Africa Pyrogen Testing Market, by Country, 2015 – 2025 (US$ Mn)
List of Figures :
FIG. 1 Pyrogen Testing: Market Segmentation
FIG. 2 Global Pyrogen Testing Market, by Test Type, 2016 (US$ Mn)
FIG. 3 Global Pyrogen Testing Market, by Product, 2016 (US$ Mn)
FIG. 4 Global Pyrogen Testing Market, by Application, 2016 (US$ Mn)
FIG. 5 Global Pyrogen Testing Market, by Geography, 2016 (Value %)
FIG. 6 Attractive Investment Proposition, by Geography
FIG. 7 Market Competition Landscape, by Key Players, 2016
FIG. 8 Global Rabbit Pyrogen Test (RPT) Market, 2015 – 2025 (US$ Mn)
FIG. 9 Global Limulus Amoebocyte Lysate (LAL) Assay Market, 2015 – 2025 (US$ Mn)
FIG. 10 Global Chromogenic Tests Market, 2015 – 2025 (US$ Mn)
FIG. 11 Global Turbidimetric Tests Market, 2015 – 2025 (US$ Mn)
FIG. 12 Global Gel Clot Tests Market, 2015 – 2025 (US$ Mn)
FIG. 13 Global Monocyte Activation Test (MAT) (In-vitro Test) Market, 2015 – 2025 (US$ Mn)
FIG. 14 Global Pyrogen Testing Reagents and Kits Market, 2015 – 2025 (US$ Mn)
FIG. 15 Global Pyrogen Testing Instruments and Systems Market, 2015 – 2025 (US$ Mn)
FIG. 16 Global Other Pyrogen Testing Products Market, 2015 – 2025 (US$ Mn)
FIG. 17 Global Pyrogen Testing Market for Pharmaceutical and Biotech Manufacturing, 2015 – 2025 (US$ Mn)
FIG. 18 Global Pyrogen Testing Market for Medical Device Manufacturing, 2015 – 2025 (US$ Mn)
FIG. 19 Global Pyrogen Testing Market for Other Applications, 2015 – 2025 (US$ Mn)
FIG. 20 U.S. Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 21 Canada Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 22 U.K. Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 23 Germany Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 24 Rest of Europe Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 25 China Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 26 Japan Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 27 Rest of Asia Pacific Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 28 Brazil Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 29 Mexico Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 30 Rest of Latin America Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 31 GCC Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
FIG. 32 Rest of Middle East and Africa Pyrogen Testing Market, 2015 – 2025 (US$ Mn)
The global pyrogen testing market is studied for the following test types:
Among the considered test types, rabbit pyrogen test and LAL tests are the most widely known. Monocyte activation test is an in-vitro method and is newer to the industry. Since this method is based on human fever reaction, its results are aligned closely to human situation. The protocol for RPT was first introduced in 1942; however the recent concern around animal welfare and the risk of result variability is urging the users to consider other alternatives. It is observed that LAL tests are continuously replacing RBTs and are being recommended by pharma companies and international bodies. However, reported cases such as testing for Hepatitis B vaccine the use of RBT is still recommended. It is also suggested that the use of RBT is justified only when other test types cannot be validated.
The global pyrogen testing market is studied for the following product types:
Reagents and kits form the largest revenue generating segment for pyrogen testing, followed by instruments. Extensive requirement of consumables for research supported by large scale research and development and, drug discovery activities being taking place in the market due to the growing need for breakthrough drugs and medical devices is the main growth driver of this segment. On the other hand, growing pressure for ensuring good manufacturing practices, and constant technological innovation has urged the need for replacing obsolete instruments and thus support the demand for new pyrogen testing instruments. Additionally, growing CRO activities has led to rise of several new testing establishments, which further supports the demand for instruments and equipment, along with testing services.
For the purpose of this study, global pyrogen testing market is studied for their application in following applications:
Pharmaceutical and biotechnology manufacturing is the largest revenue generating application segment in the global pyrogen testing market. Since the R&D activities of pharma and biotech industries has plummeted, several new trends in these industries are being observed. With the incidence of chronic diseases increasing, there is an increasing pressure on pharmaceuticals manufacturers to come up with novel drugs. The demand for medicines is rapidly growing in the emerging countries and economies witnessing rapid industrialization. As treatments are becoming more sophisticated there is an emerging need for creating new treatment models that are safe as well as effective to critical patients. Furthermore, stringent regulations in terms of operation, production and commercialization has further ensured compliance to safety measures, thus driving the demand for pyrogen testing in these markets.
Geographically, the global pyrogen testing market is cumulative to North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
North America, followed by Europe is the largest market for pyrogen testing in 2016, and it is expected that the region will continue to retain its dominance through the forecast period 2017-2025. Being large and diversified, the U.S. is the largest and the most critical market for pyrogen testing. The country houses several occupations ranging between scientific research to manufacturing. The pharmaceuticals sector in the U.S. has consistently been the most research intensive industries. However, the research and development activities performed in the U.S. are consistently being outsourced to Asian countries such as China, Singapore and India, mainly due to increasing R&D expenses.
The detailed regional classification of the global pyrogen testing market is as follows:
