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  • Published In : Nov 2020
  • Code : CMI243
  • Pages :170
  • Formats :
      Excel and PDF
  • Industry : Clinical Diagnostic

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 MARKET

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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.

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.

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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