Pyrogens are lipopolysaccharides, in which the lipid part is pyrogenic in nature and the polysaccharide part increases the solubility of the pyrogen. Pyrogens are fever-inducing substances and are the products of metabolism of bacteria and viruses. However, it is the gram-negative bacteria that produce the most potent pyrogen. Pyrogen contamination can occur due to environmental factors, and through contaminated solute, solvent, apparatus, and container. The human body is capable of fighting the bacterial toxins it is exposed to in the environment through the skin. However, when contaminated drugs are injected into the bloodstream, the toxins bypass normal defense mechanisms. In such a situation, the white blood cells present in the body start releasing another form of pyrogen that causes high fever, which in certain cases may lead to shock and death. Rise in body temperature, chills, body aches, rise in arterial blood pressure, and cutaneous vasoconstriction are some of the reactions caused in the human body following the injection of harmful pyrogens. Pharmaceutical companies use pyrogen testing to determine the presence of bacterial toxins in medical and veterinary products. This process helps to detect the presence of microbes or their metabolites in intravenous solutions during manufacturing operations. The most common and oldest form of pyrogen testing is injecting drugs into rabbits. During this process, the substance is injected into the rabbit’s ear to determine if the fever occurs. The rabbit pyrogen test is commonly conducted to detect the possibility of pyrogen contamination in injectable pharmaceuticals. However, the rabbit pyrogen test has some limitations. Limulus Amebocyte Lysate (LAL) test, a bacterial endotoxin test, is also used to detect pyrogens. This test is carried out on pharmaceutical products used in parenteral dosage form, blood products and plasma fractions, vaccines, nebulizers used in respiratory therapy, and for the validation of dry heat sterilization. However, LAL test is more advantageous than the rabbit pyrogen test as it is less time consuming, more sensitive, less expensive, and easier to perform.
North America dominates the global market for pyrogen testing due to an increasing number of new biologics or biological products in the region. Asia is expected to witness high growth rates in the next five years in the global pyrogen testing market, with China and India being the fastest-growing markets in Asia Pacific. The key driving forces for the pyrogen testing market in developing countries are the large pool of patients, and increasing government support for pharmaceutical and biotechnology industries in the region.
Growing number of new drug launches, rapid growth in pharmaceutical and biotechnology industries, increasing R&D investments in life sciences, and increasing government support for pharmaceutical and biotechnology industries are some of the key factors driving the growth of the global pyrogen testing market. However, high degree of constraints in pharmaceutical industry is major restraint on the growth of the global pyrogen testing market.
Increasing pharmaceutical outsourcing activities in the pharmaceutical industry would provide more opportunities for the global pyrogen testing market. Transition from animal-based testing to in-vitro testing is the trend in the global pyrogen testing market. The major companies operating in the global pyrogen testing market are Associates of Cape Cod, Inc., Lonza Group, Charles River Laboratories International, Inc., Merck & Co., Inc., Wako Chemicals USA, Inc., Ellab A/S, Genscript USA Inc., Thermo Fisher Scientific, Inc., Sigma-Aldrich Corporation, and Hyglos Gmbh.
Key geographies evaluated in this report are:
Key features of this report