Pyrogen Testing Market

Global Market Study on Pyrogen Testing: Animal-free Testing Methods Setting a New Trend

Pyrogen Testing Market Segmented By Recombinant Factor C Assay, Monocyte Activation Assay, Limulus Amebocyte Lysate Test, Rabbit Pyrogen Test Type in form of Injectable Therapeutics, Vaccines, Orally Dosed Pharmaceuticals, Implantable Medical Devices

  • September-2019
  • PMRREP4259
  • 146 Pages
  • Healthcare


Increase in the number of people diagnosed with chronic diseases drives the demand for pyrogen testing. For instance, in 2012, around 220 million people were affected by chronic diseases and approximately 85% of them required monitoring on a regular basis.

Furthermore, it has been estimated that 75% to 80% of the total deaths, in low economies, occur due to chronic conditions and thus, the increasing prevalence of chronic diseases seems to be directly impacting the growth of the global pyrogen testing market. The market for global pyrogen testing is expected to grow at a robust 9% CAGR through 2029, as indicated by a recent forecast study.

Pyrogens, being fever inducing organic substances, play a vital role when dealing with different diseases. Pyrogen testing, especially limulus amebocyte lysate (LAL) testing, is highly recommended, and is an integral part of pharmaceutical microbiology to test bacterial endotoxin.

Rising demand for such in vitro assays to detect the presence and concentration of bacterial endotoxins in biological products and drugs is expected to drive the growth of the market for pyrogen testing.

global pyrogen testing market

Pyrogen testing is an imperative and mandatory process, which is performed in drug and medical device manufacturing units. Pyrogen contamination is usually present in both drugs and medical devices, which can be sometimes responsible for infecting patients with certain life-threating conditions. Pyrogen testing protocol is thus necessary, and continues to drive the market for pyrogen testing globally.

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Company Profiles:

  • Thermo Fisher Scientific, Inc.
  • Merck & Co., Inc.
  • Associates of Cape Cod, Inc.
  • Charles River Laboratories, Inc.
  • GenScript
  • Lonza
  • Hyglos GmbH
  • Wako Chemicals USA, Inc.
  • Microcoat Biotechnologie GmbH


Increasing R&D Investments and Drug Approvals to Aid Pyrogen Testing Market Growth

R&D is a capital intensive sector, owing to long process of development and approval cycles. It has been observed that there is an increase in the number of new drugs entering the market, as approvals by the U.S. FDA has increased in the recent past.

Before a parental drug is launched into a market, it has to undergo pyrogen testing to test for presence of certain endotoxins (pyrogens). Therefore, a number of pyrogen testing assays are available in the market that aid these drug manufacturing companies in making their products safer.

A recent trend among the biopharmaceutical companies observes an increase in the new drug approvals in the areas of high unmet needs. In addition, the regulatory authorities such as FDA has also undertaken number of steps to enhance the first action approval rate. Thus, with the increase in number of drug approvals, the demand for pyrogen testing will grow and will continue to drive the market in the forecast period.

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Rising Healthcare Awareness to Create Lucrative Opportunities

Advancements in the field of medicine, are among other factors leading to an increase in life expectancy, with an average reaching above 50 years. Number of people aged 50 years and above is projected to reach 83 million by the end of 2050. The geriatric population is highly susceptible to various illnesses that require continuous medical interventions.

This in turn is projected to result in higher demand for pyrogen testing in the forecast period. Certain immune response such as rise in body temperature is commonly seen in onset of many chronic and acute diseases. Rise of such diseases in elderly population gives boost to market growth of pyrogen testing.

Moreover, increasing per capita healthcare expenditure is also likely to increase the growth of the pyrogen testing market. For instance, over the past few decades, global per capita healthcare expenditure has almost doubled due to the growing rate of awareness regarding pyrogen testing. Increasing healthcare spending is expected to result in rising demand for better quality pharmaceuticals and medical devices, and in turn will create lucrative growth opportunities for market players in the global pyrogen testing market.

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Preference for Animal-free Pyrogen Testing Methods to Set a New Trend

Companies are focusing on development of various animal-free pyrogen testing methods such as monocyte activation assay (MAT) to overcome limitations of rabbit pyrogen testing method and LAL test, and to propagate humane treatment of animals. MAT provides high level of reliability, and also stimulates fever reaction better than rabbit pyrogen testing method.

However, unlike the LAL test, the MAT pyrogen testing method is not limited exclusively to endotoxin detection, but is highly effective in detecting both endotoxin and non-endotoxin contamination. This change in the pyrogen testing scenario is expected to bring more opportunities for the market and bring a drift in the revenue generation for players in the pyrogen testing market.

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Analysts’ Viewpoint

An extensive analysis on the pyrogen testing market has resulted for our analysts to conclude that the pyrogen testing industry is growing at a notable pace, with North America and Europe dominating the worldwide market demand for pyrogen testing and its applications.

The rising number of drug manufacturing industries and biotechnology companies adds to the increasing need of pyrogen testing and thus anticipated to provide huge growth opportunities for the key players in the pyrogen testing market.

Key Segments of the Pyrogen Testing Market

PMR’s research on the pyrogen testing market provides information organized in four critical segments - test type, application, end user, and region. This report compiles extensive market research information and data on the important business dynamics and development parameters linked with these classifications.

Test type
  • Recombinant Factor C Assay
  • Monocyte Activation Assay (MAT)
  • Limulus Amebocyte Lysate Test (LAL)
  • Rabbit Pyrogen Test
  • Injectable Therapeutics
  • Vaccines
  • Orally Dosed Pharmaceuticals
  • Implantable Medical Devices
  • Others
End user
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Others
  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East & Africa

Key Questions Answered in PMR’s Pyrogen testing Market Report

  • Which variables could alter the demand for pyrogen testing during the evaluated and forecast period?
  • What are the restraints that investors need to be aware of and might tackle while investing in the pyrogen testing market?
  • What are the trends in pyrogen testing sector that will impact the market?
  • Which business approaches are the key companies taking to prosper in the pyrogen testing market?
  • Which regions will stay the most lucrative markets for market participants in pyrogen testing?
  • How businesses in the pyrogen testing market can avail the growth opportunities in developed and emerging sectors?

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