Pyrogen Testing Market - Snapshot

The global pyrogen testing market is expanding due to increasing implementation of stringent regulations for manufacturing of pharmaceutical and medical device products, rising number of pharmaceutical and biotechnology companies, and shifting focus of population toward treatment of chronic and lifestyle diseases. The global pyrogen testing market was valued more than US$ 650.0 Mn in 2017. It is projected to surpass a value of US$ 1,700.0 Mn by 2026, expanding at a cumulative annual growth rate (CAGR) of more than 11.0% from 2018 to 2026. The pyrogen testing market in Asia pacific is expanding at a significant pace due to adoption of LAL test in emerging economies, such as China and India, continuous development of innovative products on pyrogen testing by major and emerging players, and rise in importance of conventional research for protection of vital biomolecules and therapeutics.

pyrogen testing industry

Pyrogen are substances that cause fever, post administration of an injection. Occurrence of body ache and increase in body temperature are prominent reactions caused due to injection of harmful pyrogen into the body. Pyrogen testing determines the presence of endotoxin substances.

Key factors that are projected to drive the market during the forecast period include an increase in public and regulatory concerns about product safety, introduction of pyrogen test in different applications, and surge in new innovative drugs and launch of biological products. Increasing focus of key companies on expanding their presence in countries in Asia, in order to cater to the rising demand, is a trend observed in the market. Furthermore, regulations by different regulatory authorities, such as the USFDA, are making it compulsory for every parenteral formulation to perform pyrogen test as a safety measurement and rising government awareness initiatives for healthcare treatment in the region are also boosting the pyrogen testing market.

The global pyrogen testing market has been segmented based on test type, component, end-user, and region. In terms of test type, the global market has been categorized into monocyte activation test (MAT), limulus amoebocyte lysate (LAL) test, rabbit pyrogen test (RPT), and others. The LAL test segment accounted for a key share (in terms of revenue) of the global market in 2017. The MAT test segment is estimated to expand at a rapid pace during the forecast period. It is estimated to gain market share, significantly, by the end of 2026. MAT test offers advantages such as reduced usage of animals for drug testing, which is a major concern raised by PETA. However, MAT test detects pyrogens that cannot be detected by LAL test, making it a more efficient and comprehensive test, which is likely to maintain its high growth rate and gain marginal market share during the forecast period. In terms of component, the global market has been categorized into instruments, kits, and reagents. The reagents segment is estimated to hold a major share of the market due to regular usage of reagents for pyrogen testing. In terms of end-user, the global market has been categorized into pharmaceutical companies, biotechnology companies, medical device companies, and others. In terms of end-user, the pharmaceutical companies segment held a prominent share of the market. The pharmaceutical industry is expanding at a rapid pace, owing to rising importance of these companies not only in the field of conventional research, but also in the development and production of vital biomolecules and therapeutics. Moreover, the biotechnology companies segment is expected to expand at a rapid pace owing to expansion of the biotechnology industry and increasing approval of biological products. Discovery and launch of new products is fueling pharmaceutical companies and biotechnology companies segments. This, in turn, is projected to boost the global pyrogen testing market during the forecast period. The food industry segment is expected to expand at a moderate pace during the forecast period, due to an increased demand for nutrient-added food products in developed countries of Europe and North America. These factors are expected to boost the pyrogen testing market during the forecast period.

Based on region, the global pyrogen testing market has been divided into major five regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America and Europe accounted for a notable share of the global pyrogen testing market, followed by Asia Pacific, Latin America, and Middle East & Africa. The U.S. dominated the pyrogen testing market in North America. The factor that drives the pyrogen testing market in the region includes well-established rules and regulations for pharmaceutical manufacturing processes in the U.S. and rapidly increasing penetration of monocyte activation tests in the country. Europe follows North America in terms of share of the global pyrogen testing market. Germany held a major share of the pyrogen testing market, in terms of revenue, in Europe. The pyrogen testing market in Asia Pacific is expanding rapidly, driven primarily by expansion of the market in developing countries in the region. Increase in focus of key players to expand their presence in the region, large untapped population, and rise in awareness regarding health care are projected to propel the pyrogen testing market in Asia Pacific. However, low penetration of healthcare facilities and lack of availability for advanced pyrogen testing products are key factors restraining the pyrogen testing market in developing and undeveloped regions, such as Latin America and Middle East & Africa.

Companies such as Thermo Fisher Scientific, Inc., Merck KGaA, Charles River Laboratories International, Inc., GenScript, Lonza Group, Sanquin, and WuXi AppTec, were major players operating in the global pyrogen testing market in 2017. Thermo Fisher Scientific, Inc. emphasizes on acquisition of related companies in the industry in order to strengthen customer offerings and strategic position in the highly competitive environment. For instance, in 2017, the company invested around US$ 7.8 Bn for acquisitions. In April 2016, the company entered into a partnership with Siemens in order to offer a new type of molecular testing. The new product is likely to be integrated with Thermo Fisher Scientific's real-time PCR system and Siemens’ VERSANT kPCR molecular solution. Other global players operating in the market include Associates of Cape Cod, Inc., Hyglos GmbH - a bioMérieux Company, and Wako Chemicals USA, Inc. Market players are adopting the strategy of acquisitions and collaborations with parallel companies in order to improve and strengthen their geographic presence in the global market.

Pyrogen Testing Market - Overview

This report on pyrogen testing market studies the current as well as future prospects of the market globally. The stakeholders of this report include companies and intermediaries engaged in the manufacture, commercialization, providing pyrogen testing products as well as new entrants planning to enter this market. This report comprises an elaborate executive summary along with a market snapshot providing overall information of various segments and sub-segments considered in the scope of the study. This section also provides the overall information and data analysis of the global pyrogen testing market with respect to the leading market segments based on test type, component, end-user, and region.

A detailed qualitative analysis of drivers and restraints of the market and opportunities has been provided in the market overview section. Additionally, the section comprises major players’ product portfolio based on brands, and products in order to understand the competitive landscape in the market. This section of the report also provides market attractiveness analysis, by region and market share analysis, by key players, thus presenting a thorough analysis of the overall competitive scenario in the global pyrogen testing market.

Based on test type, the market has been segmented into MAT test, LAL test, rabbit pyrogen test, and others. The test type segments have been analyzed based on available approved products, cost-effectiveness, and preference for technologies by physicians and patients. The market size and forecast for each of these segments have been provided for the period from 2016 to 2026, along with their respective CAGRs for the forecast period from 2018 to 2026, considering 2017 as the base year.

Based on end-user, the pyrogen testing market has been classified into pharmaceutical companies, biotechnology companies, medical device companies, and others. The market size and forecast in terms of US$ Mn for each segment have been provided for the period from 2016 to 2026. The report also provides the compound annual growth rate (CAGR %) for each market segment for the forecast period from 2018 to 2026, considering 2017 as the base year.

In terms of region, the global pyrogen testing market has been categorized into five major regions and the key countries in the respective regions are: North America (the U.S. and Canada), Europe (the U.K., Germany, France, Spain, Italy, and Rest of Europe), Asia Pacific (Japan, India, China, Australia & New Zealand, and Rest of Asia Pacific), Latin America (Brazil, Mexico, and Rest of Latin America) and Middle East & Africa (South Africa, GCC countries, and Rest of Middle East & Africa). The market size and forecast for each of these regions and the mentioned countries have been provided for the period from 2016 to 2026, along with their respective CAGRs for the forecast period from 2018 to 2026, considering 2017 as the base year. Market size of each country with respect to application segment has been provided for the period from 2016 to 2026, along with their respective CAGRs for the forecast period from 2018 to 2026, considering 2017 as the base year. The research study also covers the competitive scenario in these regions.

The report also profiles major players in the global pyrogen testing market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments. Major players profiled in this report include Thermo Fisher Scientific, Inc., Merck KGaA, Associates of Cape Cod, Inc., Charles River Laboratories International, Inc., GenScript, Lonza Group, Hyglos GmbH - a bioMérieux Company, Wako Chemicals USA, Inc., Sanquin, and WuXi AppTec.

The global pyrogen testing market has been segmented as given below:

Global Pyrogen Testing Market, by Test Type

  • Monocyte Activation Test (MAT)
  • Limulus Amoebocyte Lysate (LAL) Test
  • Rabbit Pyrogen Test
  • Others

Global Pyrogen Testing Market, by Component

  • Instruments
  • Kits
  • Reagents

Global Pyrogen Testing Market, by End-user

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Others

Global Pyrogen Testing Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Rest of Middle East & Africa
.