Fibrinogen also called as factor I is a protein produced by liver which helps in blood clotting. The soluble fibrinogen in blood plasma is broken down in fibrins by thrombin enzyme which results in blood clot. Lower fibrinogen concentration leads to excessive bleeding, and may cause thrombosis. Thrombosis involves formation of blood clots inside the blood vessel which obstructs blood flow. Thrombosis may have serious complications if blockage is found in critical areas and leads to heart attack or stroke. Decreased level of fibrinogen is observed in chronic liver disease, large-volume blood transfusion and severe malnutrition; while elevated levels are observed in inflammation, tissue damage, certain cancers, stroke, and severe infections and thus the test has a wide application in disease diagnosis. Fibrinogen deficiency may also arise as a result of genetic inheritance of a defective gene. These genetic disorders include afibrinogenemia which is associated with absence of fibrinogen, hypofibrinogenemia associated with lower than normal level, dysfibrinogenemia which involves improper functioning of the protein.
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Various methods are used to determine concentration of fibrinogen in blood plasma. These include heat precipitation test, clotting method and immunoassays. DNA tests are also used in case of hereditary hemophilia disorder. Currently immunoassays are widely used for their accuracy and instant results. In immunoassay based methods, immunoprecipitation, enzyme linked immunosorbent assay (ELISA), and chemilumeniscence assay are prominent methods. The market growth is mainly attributed to development of various point-of-care diagnostic tests being developed for fibrinogen testing. These point-of-care diagnostic tests have helped in delivering quick and accurate medication to the patient. Accuracy and easy procedure of chemiluminescence assay is gradually cannibalizing the ELISA fibrinogen testing market. But due to long standing position of ELISA method, the market for ELISA based tests for fibrinogen testing will continue to account for a larger share. Advent of automation and decentralized testing has facilitated fibrinogen testing. The market will also be driven by increasing incidences where fibrinogen tests are advised; these include stroke, liver diseases, hemophilia, inflammatory diseases and others. According to National Hemophilia Foundation, New York, U.S., factor I deficiency which includes afibrinogenemia, dysfibrinogenemia, or hypofibrinogenemia has prevalence of 2 individuals per million in the U.S. Liver cancer also increases the risk of hemostasis disorders, as it produces most of the clotting factors and inhibitors; moreover it also produces various proteins involved in fibrinoysis. In 2012, it has been estimated that around 120,000 people were suffering from liver cancer and is expected to grow exponentially. This exponential growth of liver cancer will also leverage the growth of fibrinogen testing market.
Overall diagnostics industry is driven by an excellent supplier and distributor network across the globe. This has helped in greater market penetration of fibrinogen tests, especially in developing and under developed countries where the prevalence of several diseases such as cancer and some others is high. The fibrinogen test is expected to become more cost effective in the light of developing technology, and increasing number of local players in the diagnostics market.
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The market is highly competitive with many global players operating in similar geographies, with little product differentiation. Also the global players have to compete with local players who offer similar products at cheaper rates. The local players also have access to a strong distribution channel which helps them compete with global players. Key players in the fibrinogen testing market include Abbott, Roche, Siemens, Sysmex, Thermo Fisher Scientific, Beckman Coulter, and Avocet Medical.
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