Hemostasis is the process where platelets, blood vessels, and coagulation factors act together to arrest bleeding. Hemostasis occurs by the coagulation process where blood is solidified from liquid to gel state through serial enzymatic steps. During the hemostasis process, thrombin plays the role of key enzyme. Thrombin is an enzyme which is synthesized from precursor glycoprotein called prothrombin. During the clotting process, proteolytic cleavage of prothrombin results in thrombin. Insoluble fibrin is produced from soluble fibrinogen through a series of reactions catalyzed by thrombin. The production of thrombin in the body is highly regulated since the overproduction of thrombin will result in blockage of normal blood flow, a state called thrombosis. Under such conditions, tissue will die due to unavailability of oxygen.

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Recombinant thrombin is a serine protease coagulant, produced in vitro by use of RDT also known as recombinant DNA technology. This recombinant thrombin shares an indistinguishable analogous structure and amino acid sequence with the human protein. Recombinant thrombin is specified for topical use to aid hemostasis in patients undergoing different surgeries, and is a potential hemostatic alternative to bovine and human plasma-derived thrombin. A recombinant thrombin offers a homologous protein that is effective and safe, but without the associated concerns of viral transmission or antibody production. It is used topically to achieve hemostasis at reachable sites of oozing blood and slight bleeding from small venules and capillaries when control of bleeding using standard surgical measures such as ligature, suture, electrocautery, etc. is impractical or ineffective. Recombinant thrombin can be used in combination with an absorbable gelatin sponge in different types of surgeries such as liver resection, spinal surgery, and peripheral arterial bypass surgery. Recombinant thrombin precursor that is secreted to culture medium in the form of single chain. This single chain is proteolytically transformed into a two-chain active form by using a protein derived from snakes. This active form is then purified by a chromatographic process which yields a product with hemostatic properties similar to native human thrombin.

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The usage of bovine thrombin generates antibodies which cross react with human coagulation protein. This has resulted in severe complications and life threatening bleeding. Human thrombin was introduced as an alternative to bovine thrombin; however, it is associated with risk of viral transmission of infection. Nevertheless, recombinant thrombin is expected to gain popularity as it is devoid of risks associated with viral infection and has potential efficacy. Recombinant thrombin is also used in diagnostic centers and clinics in various applications such as clotting factor tests, coagulation assays, and defibrination of blood or plasma. R&D applications of thrombin includes several research activities such as in vitro study, coagulation research, protein-structure analysis, medical research, and biochemical research.

Increase in number of surgeries worldwide, need for perioperative hemostasis, improved educational & awareness programs, rising investments in research & development of proteins as well as hemostasis, and increased demand for recombinant thrombin for research & diagnostic applications are anticipated to drive the growth of the global recombinant thrombin market. However, recombinant thrombin also has certain limitations such as thromboembolic adverse reactions in some patients, and antibody formation in others. These restraints may limit the growth of the market. The global recombinant thrombin market has been segmented based on applications, end-user, and region. Based on applications, the market has been segmented into therapeutic, surgical, and research & diagnostics. Based on end-user, the market has been segmented into hospitals, diagnostic centers, and academic & research institutes.

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Geographically, the global recombinant thrombin market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America holds the largest market share, while Europe holds the second-largest share. High demand for recombinant thrombin due to increased number of surgeries in North America and Europe has put these regions into leading positions.

Recothrom is the only approved brand of recombinant thrombin in the U.S. Recothrom is available in powder form which is used topically by making solution. Recothrom was originally invented and manufactured by ZymoGenetics, and was then owned & marketed by Mallinckrodt Pharmaceuticals in the U.S. Recently Mallinckrodt Pharmaceuticals sold Recothrom to Baxter International Inc.

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