Pyrogen Testing Market by Product (Instruments, Services, Kits and Reagents) by Test (In Vitro, Lal, and Rabbit) for Pharmaceutical & Biotechnology, Medical Devices and Forecast, 2015 – 2021

By Joseph T Healthcare IT

According to the report, the global pyrogen testing market accounted for USD 564.4 Million in 2015 and is expected to reach USD 1,107.0 Million by 2021, growing at a CAGR of around 12.2% between 2016 and 2021. Pyrogens comprise a diverse group of microbial and nonmicrobial substances which causes fever when directly injected into the human blood. In general, the human body is capable of fighting the bacterial toxins when it is exposed to the external environment through the skin.

According to the report, the global pyrogen testing market accounted for USD 564.4 Million in 2015 and is expected to reach USD 1,107.0 Million by 2021, growing at a CAGR of around 12.2% between 2016 and 2021.

Pyrogen comprises a diverse group of fever-causing substances. It constitutes both microbial and non-microbial substances. The most potent and most widely known pyrogens are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogen, in particular, lipoteichoic acid (LTA), particles from yeasts and viruses. Non-microbial pyrogen often comes from production site of the various manufacturing site. Small particles of packaging materials are a typical example of non-microbial pyrogen. Pyrogen contaminations in pharmaceutical products, bio-therapeutics and on medical devices can bring life-threatening fever, as a result it is mandatory for manufacturers to ensure that the pyrogen concentrations in pharmaceuticals product do not exceed certain limits.

The market for global pyrogen testing has been accelerated by the recent developments of pharmaceutical and biotechnological industry across different parts of the world. Moreover, the rise in a number of the launch of new drugs in the market coupled with the huge investment in research and development of drugs is the driving factor for the growth of pyrogen testing market. Furthermore, growing intervention of government in pharmaceutical industries is expected to fuel the growth of global pyrogen testing market. However, the highly  consolidated pharmaceutical industry can restrict the growth of pyrogen testing market. Nonetheless, untapped market/developing countries market are considered as a major opportunity for upcoming growth of pyrogen testing market.

Global Pyrogen Testing Marke

Based on product, pyrogen testing market is classified into three types: instruments, services, kits, and reagents. In general, all three segments play a very important role in pyrogen testing market. But in 2015, kits and reagent contributed maximum market share in terms of revenue followed by service and instrument. Limulus Amebocyte Lysate test (LAL test) kit is a great example of kits and reagent in pyrogen testing market. Greater demand for LAL test kit is due to ease of handling coupled with accurate result.  The Limulus Amebocyte Lysate test  recommended in international pharmacopoeias as the method for detecting bacterial toxins both in the raw materials used for the production of medicines and for the final products.

Based on the type of test, pyrogen testing market is classified into three types: in vitro test, LAL test and rabbit test. These entire tests play a very keen role in the management of pyrogen testing market. However, in 2015, LAL test dominated the pyrogen testing market due to various advantages over another test. Certain advantage of rabbit test includes:

  • Simple and easy to perform.
  • Results obtained in few hours.
  • Animals (Rabbits) not used in testing.

LAL (Limulus Amebocyte Lysate) method has largely replaced the rabbit test in pyrogen testing market. In rabbit test, rabbits are not only used in the experiments that are conducted in research, but also in the pharmaceutical and food industry as well as other industries. Limulus Amebocyte Lysate test (LAL test) kit is a great example of kits and reagent in pyrogen testing market. Greater demand for LAL test kit is due to ease of handling coupled with accurate result.

Based on application, pyrogen testing market is classified into three types pharmaceutical & biotechnology, medical device and other applications. Application segment was dominated by pharmaceutical and biotechnology in 2015 due to rapidly increasing pharmaceutical and biotechnology industries and an increasing number of new biologics products. In addition, the launching of new biological drugs is considered as the most important growth driver for this segment during the forecast period.

Based on geography, pyrogen testing market is classified into five regions North America, Europe, Asia-Pacific, Latin America and the Middle East and Africa. North America was dominating the regional market for pyrogen testing in 2015, due to the huge investment in research and development of drugs.  In addition, North America holds maximum business centre/headquarters of world premium pharmaceutical industries across the world. Growing business in Asia Pacific serves as a fastest growing regional market for pyrogen testing owing to the huge capital investment in research and manufacturing of medicine. The shift of medical business from west to east, especially in China and India, is a mean cause for the growth in the Asia Pacific region within the forecast period. Moreover, Latin America and the Middle East & Africa are also expected to have good growth due to growth in the medical tourism sector within the forecast period.

The major players in the pyrogen testing market include Associates of Cape Cod, Inc., Charles River Laboratories, Inc., Ellab A/S, Genscript, Hyglos GmbH, Lonza Group, Merck Kgaa, Thermo Fisher Scientific, Inc., WUXI Pharmatech (Cayman) Inc. and Wako Chemicals Usa, Inc.

  • Chapter 1. Introduction
    • 1.1. Report Description And Scope
    • 1.2. Research Scope
    • 1.3. Research Methodology
      • 1.3.1. Market Research Process
      • 1.3.2. Market Research Methodology
  • Chapter 2. Executive Summary
    • 2.1. Global Pyrogen Testing Market, 2015 – 2021 (USD Million)
    • 2.2. Global Pyrogen Testing Market: Snapshot
  • Chapter 3. Pyrogen Testing – Market Dynamics
    • 3.1. Introduction
    • 3.2. Value Chain Analysis
    • 3.3. Market Drivers
      • 3.3.1. Global Pyrogen Testing Market Drivers: Impact Analysis
      • 3.3.2. Growing Number Of New Drug Launches
      • 3.3.3. Increasing Government Support For Pharmaceutical And Biotechnology Industries
    • 3.4. Market Restraints
      • 3.4.1. Global Pyrogen Testing Market Restraints: Impact Analysis
      • 3.4.2. High Degree of Constraints
    • 3.5. Opportunities
      • 3.5.1. Untapped Market.
    • 3.6. Porter’s Five Forces Analysis
      • 3.6.1. Bargaining Power Of Suppliers
      • 3.6.2. Bargaining Power Of Buyers
      • 3.6.3. Threat From New Entrants
      • 3.6.4. Threat From New Substitutes
      • 3.6.5. Degree Of Competition
    • 3.7. Market Attractiveness Analysis
      • 3.7.1. Market Attractiveness Analysis, By Product Segment
      • 3.7.2. Market Attractiveness Analysis, By Test Segment
      • 3.7.3. Market Attractiveness Analysis, By Application Segment
      • 3.7.4. Market Attractiveness Analysis, By Regional Segment
  • Chapter 4. Global Pyrogen Testing Market – Competitive Landscape
    • 4.1. Company Market Share, 2015 (Subject To Data Availability)
    • 4.2. Strategic Development
      • 4.2.1. Acquisitions & Mergers
      • 4.2.2. New Source Launch
      • 4.2.3. Agreements, Partnerships, Collaborations And Joint Ventures
      • 4.2.4. Research And Development, Product And Regional Expansion
    • 4.3. Product Portfolio
    • 4.4. Patent Analysis (2011-2016)
      • 4.4.1. Patent Trend
      • 4.4.2. Patent Share By Company
      • 4.4.3. By Region
  • Chapter 5. Global Pyrogen Testing Market – Product Segment Analysis
    • 5.1. Global Pyrogen Testing Market: Product Segment Overview
      • 5.1.1. Global Pyrogen Testing Market Revenue Share, By Product Segment, 2015 And 2021
    • 5.2. Instrument
      • 5.2.1. Global Pyrogen Testing Market For Instrument , 2015 – 2021 (USD Million)
    • 5.3. Service
      • 5.3.1. Global Pyrogen Testing Market For Service, 2015 – 2021 (USD Million)
    • 5.4. Kit and Reagent
      • 5.4.1. Global Pyrogen Testing Market For Kit and Reagent, 2015 – 2021 (USD Million)
  • Chapter 6. Global Pyrogen Testing Market –Tests Analysis
    • 6.1. Global Pyrogen Testing Market: Tests Overview
      • 6.1.1. Global Pyrogen Testing Market Revenue Share, By Tests, 2015 And 2021
    • 6.2. In Vitro Test
      • 6.2.1. Global Pyrogen Testing Market For In Vitro Test , 2015 – 2021 (USD Million)
    • 6.3. LAL Test
      • 6.3.1. Global Pyrogen Testing Market For LAL Test, 2015 – 2021 (USD Million)
    • 6.4. Rabbit Test
      • 6.4.1. Global Pyrogen Testing Market For Rabbit Test, 2015 – 2021 (USD Million)
  • Chapter 7. Global Pyrogen Testing Market – Application Segment Analysis
    • 7.1. Global Pyrogen Testing Market: Application Segment Overview
      • 7.1.1. Global Pyrogen Testing Market Revenue Share, By Application Segment, 2015 And 2021
    • 7.2. Pharmaceutical & Biotechnology
      • 7.2.1. Global Pyrogen Testing Market For Pharmaceutical & Biotechnology, 2015 – 2021 (USD Million)
    • 7.3. Medical Devices
      • 7.3.1. Global Pyrogen Testing Market For Medical Device, 2015 – 2021 (USD Million)
    • 7.4. Others
      • 7.4.1. Global Pyrogen Testing Market For Others, 2015 – 2021 (USD Million)
  • Chapter 8. Global Pyrogen Testing Market – Regional Segment Analysis
    • 8.1. Global Pyrogen Testing Market: Regional Overview
      • 8.1.1. Global Pyrogen Testing Market Revenue Share, By Region, 2015 And 2021
    • 8.2. North America
      • 8.2.1. North America Pyrogen Testing Market Revenue, By Product, 2015 – 2021 , (USD Million)
      • 8.2.2. North America Pyrogen Testing Market Revenue, By Test, 2015 – 2021 , (USD Million
      • 8.2.3. North America Pyrogen Testing Market Revenue, By Application, 2015 – 2021 , (USD Million)
    • 8.3. Europe
      • 8.3.1. Europe Pyrogen Testing Market Revenue, By Product, 2015 – 2021 (USD Million)
      • 8.3.2. Europe Pyrogen Testing Market Revenue, By Test, 2015 – 2021 (USD Million)
      • 8.3.3. Europe Pyrogen Testing Market Revenue, By Application, 2015 – 2021 (USD Million)
    • 8.4. Asia Pacific
      • 8.4.1. Asia Pacific Pyrogen Testing Market Revenue, By Product, 2015 – 2021 (USD Million)
      • 8.4.2. Asia Pacific Pyrogen Testing Market Revenue, By Test, 2015 – 2021 (USD Million)
      • 8.4.3. Asia Pacific Pyrogen Testing Market Revenue, By Application, 2015 – 2021 (USD Million)
    • 8.5. Latin America
      • 8.5.1. Latin America Pyrogen Testing Market Revenue, By Product, 2015 – 2021 (USD Million)
      • 8.5.2. Latin America Pyrogen Testing Market Revenue, By Test, 2015 – 2021 (USD Million)
      • 8.5.3. Latin America Pyrogen Testing Market Revenue, By Application, 2015 – 2021 (USD Million)
    • 8.6. Middle East And Africa
      • 8.6.1. Middle East And Africa Pyrogen Testing Market Revenue, By Product, 2015 – 2021 (USD Million)
      • 8.6.2. Middle East And Africa Pyrogen Testing Market Revenue, By Test, 2015 – 2021 (USD Million)
      • 8.6.3. Middle East And Africa Pyrogen Testing Market Revenue, By Application, 2015 – 2021 (USD Million)
  • Chapter 9. Company Profile
    • 9.1. Associates of Cape Cod, Inc.
      • 9.1.1. Overview
      • 9.1.2. Financials
      • 9.1.3. Product Portfolio
      • 9.1.4. Business Strategy
      • 9.1.5. Recent Developments
    • 9.2. Charles River Laboratories Inc.
      • 9.2.1. Overview
      • 9.2.2. Financials
      • 9.2.3. Product Portfolio
      • 9.2.4. Business Strategy
      • 9.2.5. Recent Developments
    • 9.3. Ellab A/S
      • 9.3.1. Overview
      • 9.3.2. Financials
      • 9.3.3. Product Portfolio
      • 9.3.4. Business Strategy
      • 9.3.5. Recent Developments
    • 9.4. Genscript, Hyglos GmbH
      • 9.4.1. Overview
      • 9.4.2. Financials
      • 9.4.3. Product Portfolio
      • 9.4.4. Business Strategy
      • 9.4.5. Recent Developments
    • 9.5. Lonza Group
      • 9.5.1. Overview
      • 9.5.2. Financials
      • 9.5.3. Product Portfolio
      • 9.5.4. Business Strategy
      • 9.5.5. Recent Developments
    • 9.6. Merck KGaA
      • 9.6.1. Overview
      • 9.6.2. Financials
      • 9.6.3. Product Portfolio
      • 9.6.4. Business Strategy
      • 9.6.5. Recent Developments
    • 9.7. Thermo Fisher Scientific, Inc.
      • 9.7.1. Overview
      • 9.7.2. Financials
      • 9.7.3. Product Portfolio
      • 9.7.4. Business Strategy
      • 9.7.5. Recent Developments
    • 9.8. Wako Chemicals USA Inc.
      • 9.8.1. Overview
      • 9.8.2. Financials
      • 9.8.3. Product Portfolio
      • 9.8.4. Business Strategy
      • 9.8.5. Recent Developments
    • 9.9. Wuxi PharmaTech Inc
      • 9.9.1. Overview
      • 9.9.2. Financials
      • 9.9.3. Product Portfolio
      • 9.9.4. Business Strategy
      • 9.9.5. Recent Developments

List of Figures

1. Market Research Process
2. Market Research Methodology
3. Global Pyrogen Testing Market Revenue, 2015 – 2021 (USD Million)
4. Porter’s Five Forces Analysis
5. Pyrogen Testing : Market Attractiveness Analysis, By Product Segment
6. Pyrogen Testing : Market Attractiveness Analysis, By Test Segment
7. Pyrogen Testing : Market Attractiveness Analysis, By Application Segment
8. Pyrogen Testing : Market Attractiveness Analysis, By Regional Segment
9. Company Market Share Analysis, 2015 And 2021
10. Global Pyrogen Testing Market Revenue Share By Product, 2015 And 2021
11. Instrument Pyrogen Testing Market, 2015 – 2021, (USD Million)
12. Service Pyrogen Testing Market 2015 – 2021, (USD Million)
13. Kit and Reagent Pyrogen Testing Market, 2015 – 2021, (USD Million)
14. Global Pyrogen Testing Market Revenue Share By Test, 2015 And 2021
15. Pyrogen Testing Market For, In Vitro Test, 2015 – 2021, (USD Million)
16. Pyrogen Testing Market For, LaL Test, 2015 – 2021, (USD Million)
17. Pyrogen Testing Market For, Rabbit Test, 2015 – 2021, (USD Million)
18. Global Pyrogen Testing Market Revenue Share By Application, 2015 And 2021
19. Pyrogen Testing Market For Pharmaceutical & Biotechnology, 2015 – 2021, (USD Million)
20. Pyrogen Testing Market For Medical Device, 2015 – 2021, (USD Million)
21. Pyrogen Testing Market For Others, 2015 – 2021, (USD Million)
22. Global Pyrogen Testing Market Share, By Region, 2015 – 2021
23. North America Pyrogen Testing Market, 2015 – 2021, (USD Million)
24. Europe Pyrogen Testing Market, 2015 – 2021, (USD Million)
25. Asia Pacific Pyrogen Testing Market, 2015 – 2021, (USD Million)
26. Latin America Pyrogen Testing Market, 2015-2021, (USD Million)
27. Middle East & Africa Pyrogen Testing Market, 2015 – 2021, (USD Million)

List of Tables

1. Pyrogen Testing Market: Market Snapshot
2. Drivers Of Global Pyrogen Testing Market: Impact Analysis
3. Restraints Of Global Pyrogen Testing Market: Impact Analysis
4. North America Pyrogen Testing Market Revenue, By Product, 2015 – 2021(USD Million)
5. North America Pyrogen Testing Market Revenue, By Test, 2015 – 2021(USD Million)
6. North America Pyrogen Testing Market Revenue, By Application, 2015 – 2021(USD Million)
7. Europe Pyrogen Testing Market Revenue, By Product, 2015 – 2021(USD Million)
8. Europe Pyrogen Testing Market Revenue, By Tests, 2015 – 2021(USD Million)
9. Europe Pyrogen Testing Market Revenue, By Application, 2015 – 2021(USD Million)
10. Asia Pacific Pyrogen Testing Market Revenue, By Product, 2015 – 2021(USD  Million)
11. Asia Pacific Pyrogen Testing Market Revenue, By Test, 2015 – 2021(USD Million)
12. Asia Pacific Pyrogen Testing Market Revenue, By Application, 2015 – 2021(USD Million)
13. Latin America Pyrogen Testing Market Revenue, By Product, 2015- 2021 (USD Million)
14. Latin America Pyrogen Testing Market Revenue, By Test, 2015- 2021 (USD Million)
15. Latin America Pyrogen Testing Market Revenue, By Application, 2015- 2021 (USD Million)
16. Middle East And Africa Pyrogen Testing Market Revenue, By Product, 2015- 2021 (USD Million)
17. Middle East And Africa Pyrogen Testing Market Revenue, By Test, 2015- 2021 (USD Million)
18. Middle East And Africa Pyrogen Testing Market Revenue, By Application, 2015- 2021 (USD Million)

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