Pyrogen Testing Market By Test Type (Attractive Investment Proposition, Rabbit Pyrogen Test (RPT), Limulus Amoebocyte Lysate (LAL) Assay, Chromogenic Tests, Turbidimetric Tests, Gel Clot Tests), By Product, By Application – Growth, Future Prospects, And Competitive Analysis, 2017 – 2025

Market Insights

Pyrogens are a heterogeneous group of microbial and non-microbial substances that cause fever. Lipopolysaccharides and endotoxins are the most common and potent variants; gram-positive bacteria are also a source of pyrogens. Since contamination from pyrogens in biotherapeutics, medical devices, pharmaceuticals, and cosmetics can possibly compromise health and well-being, 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 analyses the major trends prevalent in the global pyrogen testing market and provides 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 testing (RPT), Limulus amoebocyte lysate (LAL) assay (chromogenic tests, turbidimetric tests, and gel clot tests), and monocyte activation testing (MAT) (in vitro test). Reagents and kits, instruments and systems, and services are the products and 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. The market size and forecast for each mentioned segment for the period 2015–2025 are presented in the report, along with respective CAGRs for the forecast duration of 2017–2025.

Geographically, the global pyrogen testing market is best understood by categorizing it into five major regions and five major region-level markets, as follows:

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• Rest of Europe

Asia Pacific

• China
• Japan
• Rest of Asia Pacific

Latin America

• Brazil
• Mexico
• rest of Latin America

Middle East and Africa

• GCC
• Rest of the Middle East and Africa

The market size and forecast of each considered geographical market are presented for the perioad 2015–2025, along with CAGRs for the forecast period 2017–2025, and further cross-sectional analysis is presented in terms of products, test types, 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 a profile of key market players currently enjoying prominent positions 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.

The global pyrogen testing market is studied for the following test types:

• Rabbit Pyrogen Test (RPT)
• Limulus Amoebocyte Lysate (LAL) Assay
• Chromogenic Tests
• Turbidimetric Tests
• Gel-Clot Tests
• Monocyte Activation Test (MAT) (in vitro test)

Among the considered test types, the rabbit pyrogen test and LAL tests are the most widely known. Monocyte activation testing is an in vitro method that is newer to the industry. Because this method is based on human fever reactions, the results are very similar to human situations. The protocol for RPT was first introduced in 1942; however, recent concerns around animal welfare and the risk of result variability are urging 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, in reported cases such as testing for the 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
• Instruments and systems
• Services

Reagents and kits form the largest revenue-generating segment for pyrogen testing, followed by instruments. The extensive requirement of consumables for research, supported by large-scale research and development and drug discovery activities 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, increasing pressure to ensure good manufacturing practices and continuous technological innovation has pushed the need to replace obsolete instruments, supporting the demand for new pyrogen testing instruments. Additionally, growing CRO activities have led to the rise of several new testing establishments, which further support the demand for instruments and equipment, along with testing services.

For the purpose of this study, the global pyrogen testing market is studied for its application in the following applications:

• Manufacturing of pharmaceuticals and biotech products
• Medical Device Manufacturing
• Others

Pharmaceutical and biotechnology manufacturing is the largest revenue-generating application segment in the global pyrogen testing market. Since the R&D activities of the pharma and biotech industries have plummeted, several new trends in these industries are being observed. With the incidence of chronic diseases increasing, there is increasing pressure on pharmaceutical manufacturers to come up with novel drugs. The demand for medicines is rapidly growing in emerging countries and economies that are witnessing rapid industrialization. As treatments become more sophisticated, there is an emerging need for creating new treatment models that are safe as well as effective for critical patients. Furthermore, stringent regulations in terms of operation, production, and commercialization have further ensured compliance with safety measures, thus driving the demand for pyrogen testing in these markets.

Geographically, the global pyrogen testing market is cumulative for North America, Europe, Asia Pacific, the Middle East, Africa, and Latin America.

North America, followed by Europe, was 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 of 2017–2025. Being large and diversified, the U.S. is the largest and most critical market for pyrogen testing. The country houses several occupations, ranging from scientific research to manufacturing. The pharmaceuticals sector in the U.S. has consistently been the most research-intensive industry. 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:

• North America (U.S. and Canada)
• Europe (U.K., Germany, and the Rest of Europe)
• Asia Pacific (China, Japan, and the Rest of Asia Pacific)
• Latin America (Brazil, Mexico, and the Rest of Latin America)
• Middle East and Africa (GCC plus the rest of the Middle East and Africa)

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 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)

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)