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
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.
| 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: |
|
||
| Segments covered: |
|
||
| 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: |
|
||
| Restraints & Challenges: |
|
||
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:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
Joining thousands of companies around the world committed to making the Excellent Business Solutions.
View All Our Clients