Antithrombin is a protein present in the blood which acts as a natural anticoagulant through the regulation of thrombin. Thrombin plays a key role in the formation of blood clots and it becomes necessary in some cases to prevent clotting. Antithrombin comes to rescue in such conditions and blocks the blood clotting mechanism by inactivating the major blood clotting protein – thrombin. A low level of antithrombin may lead to unnecessary clotting while high levels of this protein may induce bleeding. The major causes of thrombosis are inactivity, blood vessel damage, medical and genetic conditions, pregnancy, obesity, and smoking. Antithrombotic drugs help in reduction of thrombus formation. Different antithrombotics affect different blood clotting processes like antiplatelet drugs, anticoagulants, and thrombolytic drugs. However, recombinant antithrombin has been developed and is commercially available that mimics the role of natural antithrombin in the body.
There are two conditions in which antithrombin deficiency is observed, an inherited deficiency and an acquired deficiency. An inherited deficiency is due to a genetic abnormality while an acquired deficiency is due to some other unknown reasons. Inherited antithrombin is a rare genetic disorder but is equally common in men as well as women. The prevalence rate of this disease ranges from 0.02 to 0.2% of the general population. It is estimated that 60,000 to 600,000 people in the U.S. are affected by this genetic disorder. However, low levels of antithrombin are more common and can also be found in patients with conditions such as liver failure, nephritic syndrome, metastatic tumors, severe trauma, burns, and also in people with heparin therapy and chemotherapy with Asparaginase.
In 2009, ATryn – a recombinant antithrombin developed by GTC Biotherapeutics, Inc. received an approval from the U.S. FDA for use in the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. However, the product is not indicated for the treatment of thromboembolic events in patients with hereditary antithrombin therapy. This product is a recombinant anticoagulant produced by a genetically engineered (GE) animal – a goat. ATryn has been proven beneficial for patients with antithrombin deficiency who are at a greater risk of clotting during surgery and childbirth. Earlier, in 2008, the U.S. FDA had assigned Priority Review status to GTC Biotherapeutics’ Biologics License Application (BLA) for ATryn. Subsequently, in 2009, the Blood Products Advisory committee cleared recombinant antithrombin as safe and efficacious for the treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures which paved the way for its approval in the same year.
On the basis of geography, the global recombinant antithrombin market can be segmented into four major regions, namely, North America, Europe, Asia Pacific and Rest of the World. The increasing number of cardiovascular diseases across the globe is expected to raise the demand for recombinant antithrombin. The recombinant antithrombin market has been dominated by North America followed by Europe due to early adoption of the product in these regions.
However, strongest growth in demand is likely to be witnessed in the Asia Pacific region owing to the ever increasing population in large nations such as China and India. Some of the key companies in the global antithrombin (recombinant) market include GTC Biotherapeutics, Inc., Ovation Pharmaceuticals, Inc., and rEVO Biologics Inc. (a subsidiary of LFB SA). As increasing number of large pharmaceutical companies are stepping into the biopharmaceuticals market, it is more likely that the competition in the global antithrombin (recombinant) market will be intensified in the near future.
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