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Pyrogen testing plays a major role in advanced healthcare, as it shows the presence of pyrogen in an organism that causes fever. Pyrogen can be found in lipopolysaccharides and lepoteichoic acid. Contaminated pyrogenic products can cause harmful effects such as fever in human body.

Pyrogen testing is used in detection of pyrogen contamination in pharmaceutical dosage forms and medical devices. Pyrogen contaminated injections post administration can cause temperature dysregulation (fever), bodyache, inflammation, shock, multiorgan failure, and other life threatening problems.

The global pyrogen testing market is estimated to be valued at US$ 979.7 million in 2020 and is expected to exhibit a CAGR of 12.4% over the forecast period (2020-2027).

Figure 1. Global Pyrogen Testing Market Share (%) in Terms of Value, By Region, 2019

Pyrogen Testing  | Coherent Market Insights

Increasing product launches by market players is expected to propel the market growth over the forecast period

Various manufacturers are engaged in launching new testing technologies, which is expected to drive growth of the global pyrogen testing market. For instance, in May 2018, bioMérieux SA, a company focusing on industrial microbiological control, announced the launch of ENDOZYME II GO, an endotoxin test. The company launched ENDOZYME II GO under the range of recombinant horseshoe crab Factor C (rFC) assays, which enables endotoxin testing in pharmaceutical water grades, parenteral drugs, and other pharmaceutical products.

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Pyrogen Testing Market Report Coverage

Report Coverage Details
Base Year: 2019 Market Size in 2020: US$ 979.7 Mn
Historical Data for: 2016 to 2019 Forecast Period: 2020 to 2027
Forecast Period 2020 to 2027 CAGR: 12.4% 2027 Value Projection: US$ 2,220.5 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Test Type: Limulus Amoebocyte Lysate (LAL) Test, TAL Test, Monocyte Activation Test (MAT), Rabbit Pyrogen Test (RPT), Recombinant Factor C Assay (rFC).
  • By Product Type: Instruments, Kits, Reagents.
  • By End User: Pharmaceutical and Biotech Companies, Food and Beverages Companies, Others.
Companies covered:

Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin, Ellab A/S, and Pyrostar

Growth Drivers:
  • Increasing product launches by market players
  • Increasing research and development of therapeutic drugs and medical devices
Restraints & Challenges:
  • Stringent regulations, which control the manufacture, distribution, marketing, and sales of medical devices and drugs

Increasing research & development of therapeutic drugs and medical devices is expected to drive the market growth over the forecast period

Increasing research and development of therapeutic drugs and medical devices is propelling growth of the pyrogen testing market over the forecast period. According to the United Nations Educational, Scientific and Cultural Organization (UNESCO), November 2016, an estimated US$ 1.7 trillion was spent on research and development for various medical applications, globally. Moreover, the U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER) approved around 59 novel drugs in 2018 compared to 46 approvals of new molecule entities in 2017.

Global Pyrogen Testing Market – Impact of Coronavirus (Covid-19) Pandemic

The coronavirus disease (COVID-19) pandemic is the most recent outbreak, which was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared coronavirus disease (COVID-19) as a pandemic on March 11, 2020.

According to the Coronavirus Disease (COVID-19) Weekly Epidemiological Update by the World Health Organization, around 25 million cases and 800,000 deaths due to coronavirus disease (COVID-19) were reported on August 31, 2020 across the globe.

According to the Coronavirus Disease (COVID-19) Weekly Epidemiological Update by the World Health Organization, the coronavirus disease (COVID-19) cases in different regions reported on August 30, 2020 are as follows:

WHO Regions

New cases in last 7 days

Cumulative cases

The Americas

854,959

13,138,912

South-east Asia

539,341

4,073,148

Europe

220,777

4,205,708

Africa

44,134

1,044,513

Eastern Mediterranean

87,340

1,903,547

Western Pacific

36,260

487,571

Such dynamic increase in number of COVID-19 cases across the world has encouraged biotechnology and pharmaceutical companies to develop advanced detection kits and drugs for COVID-19, which is expected to propel growth of the pyrogen testing market over the forecast period.

Pyrogen Testing Market: Restraints

Stringent government regulations, which control the manufacture, distribution, marketing, and sales of medical devices and drugs is expected to hinder growth of the global pyrogen testing market during the forecast period.

Key Players

Major players operating in the global pyrogen testing market include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin,  Ellab A/S, and Pyrostar.

Pyrogen testing is detection of pyrogen in pharmaceutical drugs and devices. The contaminated devices or drugs when introduced in body can cause fever, shock, inflammation, and other problems. Pyrogen testing consists of kits, reagents, and instruments, which enable pyrogen and endotoxins detection by in-vitro methods and minimizes the usage of animal testing.

In June 2012, the U.S. Food and Drug Administration (FDA) provided guidelines for pyrogen and endotoxin testing to industries. Hence, stringent government regulations and rising focus on in-vitro testing for detection of pyrogen are major factors boosting growth of the market.

Market Dynamics

Market players are focusing on development of drugs for the treatment of various diseases such as cancer, which requires pyrogen testing in order to manufacture the drugs. Hence, increasing drug development is expected to boost growth of the global pyrogen testing market. For instance, in April 2019, PharmaCyte Biotech, Inc., a biotechnology company focused on development of cellular therapies for diabetes and cancer, announced that it cleared the pyrogenicity testing of the encapsulation material to manufacture Cell-in-a-Box capsules (CypCaps).

Moreover, according to the Pharma R&D Annual Review, 2019, an estimated number of drugs under pipeline in 2019 was around 16,181, while in 2018, it was around 15,267, resulting in an overall pipeline growth by 6% in 2018.       

Key features of the study:

  • This report provides in-depth analysis of the global pyrogen testing market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2020–2027), considering 2019 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global pyrogen testing market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin, Ellab A/S, and Pyrostar
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global pyrogen testing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global pyrogen testing market.

Detailed Segmentation:

  • Global Pyrogen Testing Market, By Test Type:
    • Limulus Amoebocyte Lysate (LAL) Test
    • TAL Test
    • Monocyte Activation Test (MAT)
    • Rabbit Pyrogen Test (RPT)
    • Recombinant Factor C Assay (rFC)
  • Global Pyrogen Testing Market, By Product Type:
    • Instruments
    • Kits
    • Reagents
  • Global Pyrogen Testing Market, By End User:
    • Pharmaceutical and Biotech Companies
    • Food and Beverages Companies
    • Others
  • Global Pyrogen Testing Market, By Region:
    • North America
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others  
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Product Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Test Type
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Thermo Fisher Scientific*
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Merck KGaA
    • Lonza Group
    • Associates of Cape Cod Inc.
    • Charles River Laboratories Inc.
    • GenScript
    • WuXi PharmaTech (Cayman), Inc.
    • bioMérieux
    • Wako Chemicals USA, Inc.
    • Sanquin
    • Ellab A/S
    • Pyrostar

“*” marked represents similar segmentation in other categories in the respective section.    

Frequently Asked Questions

The global pyrogen testing market size is estimated to surpass US$ 2,220.5 million by 2027.
The global pyrogen testing market is expected to register a CAGR of 12.4% during the forecast period (2020-2027).
The increasing product launches and increasing research and development of therapeutic drugs and medical devices are driving the global pyrogen testing market growth.
The limulus amoebocyte lysate test segment is estimated to hold major market share in 2020, owing to owing to its reliability and reproducibility in detection.
Major factor hampering growth of the market is stringent regulations, which control the manufacture, distribution, marketing, and sales of medical devices and drugs.
Major players operating in the global pyrogen testing market include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin, Ellab A/S, and Pyrostar.

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