Bivalirudin Drug Market Challenging Health Concerns 2025 | The Medicines Company, Pfizer
Bivalirudin is a synthetic residue peptide and it is direct thrombin inhibitor (DTI). It is an anticoagulant that helps to prevent the formation of blood clots, especially in people with severe chest pain or ones who are undergoing angioplasty. Bivalirudin is for IV use only and it is supplied as a sterile, lyophilized product, and glass vials. Moreover, Bivalirudin is also used conjuction with other medicines.
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Bivalirudin drugs are finding wide application in patients undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA) and percutaneous coronary intervention (PCI) procedures. Bivalirudin is not given to patients with active major bleeding. The most common adverse health effects of Bivalirudin are pain, nausea, back pain, hypotension, and headache. Meanwhile, Bivalirudin is also approved for cardiac patients undergoing PCI. Bivalirudin is also partly cleared by renal mechanism, hence, the dose administration needs to be managed for patients with severe renal impairment.
Bivalirudin Drug Market: Notable Developments
Accord Healthcare has entered into the license agreement with Foresee Pharma. Under the agreement, Foresee will receive combination of regulatory, sales and upfront milestone, in addition to the significant share of the product revenue as Accord Healthcare will cover overall cost of commercialization in the global market with exception of Japan, mainland China, the US, and Taiwan, along with previously partnered territories including various countries in the Middle East, Turkey, and Israel.
Aurobindo Pharma has acquired Apotex’s commercial operations in five European countries including the Netherlands, Belgium, Poland, Spain, and the Czech Republic.
Beximo Pharmaceuticals Limited plans to buy eight ANDAs in the US from Sandoz Inc., a division of Novartis. Following this deal, Beximo Pharma will have 14 approved ANDAs in its product portfolio in the US.
Some of the leading players operating in the Bivalirudin drug market are Sandoz, Dr. Reddys Laboratories, Fresenius Kabi, Apotex, The Medicines Company, Pfizer, Aurobindo Pharma, Mylan, Accord Healthcare, Sun Pharmaceuticals Industries Limited, and Ferring Pharmaceuticals.
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Bivalirudin Drug Market Dynamics
Bivalirudin Drug as Alternative to Heparin for Anticoagulation in Children and Infants
Bivalirudin has emerged as an alternative for heparin for infants and children in anticoagulation. Moreover, Bivalirudin, unlike heparin, does not require antithrombin to be effective, thus providing more consistent anticoagulation. The use of DTI among children and infants has been uncommon. However, the primary reason for use of DTI is the development of thrombus or HIT extension during the heparin therapy.
Although the use of Bivalirudin is not common in pediatrics, the use of DTI is slowly increasing owing to the rise in diagnosis of HIT. Meanwhile, in various studies, researchers have found a significant reduction in the rate of bleeding after using DTI with Bivalirudin as compared to argatroban. Meanwhile, the first pilot study on use of Bivalirudin to treat thrombosis in infants was presented in 2007. After this more research has been done resulting in the successful use of Bivalirudin in various cases including children undergoing cardiac catheterization.
Increasing Use of Bivalirudin Drug in Patients Undergoing PCI
The acute coronary syndrome is emerging as the most common cause of death globally. This is driving the demand for Percutaneous Coronary Intervention (PCI) to manage acute coronary syndrome. In order to reduce the risk of thrombotic complications, the use of anticoagulation therapy is increasing during PCI, thereby, driving the demand for Bivalirudin drug as the anticoagulant drug as it reduces the risk of bleeding during the procedure. Moreover, Bivalirudin drug has also been licensed as an alternative to Heparin for the patients undergoing PCI and also for the patients with HIT who go for PCI.
The sale of Bivalirudin drug is also increasing as anticoagulant drug owing to the advantages as compared to similar drugs in the market. Moreover, Bivalirudin does not present complications including hemorrhagic and ischemic that are often caused by other anticoagulant drugs.
High Cost of Bivalirudin Drug to Restrain its Growth
Despite increasing use of Bivalirudin drug as a substitute for Heparin and other anticoagulant drugs, the high cost of Bivalirudin drug is restricting its use among patients with low or moderate risk of bleeding. Although, Bivalirudin has shown better results in patients undergoing PCI, its high cost may restrict its use among patients. Moreover, expenditure review by various healthcare institutions have also noted a significant increase in the contribution of Bivalirudin drug on the overall drug budget.
Various organizations and governments are focusing on cost saving initiatives to reduce the cost of Bivalirudin and also reduce its wastage by providing the dosage as required depending on the patient’s condition.
Bivalirudin Drug Market Segmentation
Based on the types, the Bivalirudin drug market is segmented into
Powder for reconstitution
On the basis of application, the Bivalirudin drug market is segmented into
By end use the Bivalirudin drug market is segmented into
Percutaneous Coronary Intervention (PCI) Procedures
Percutaneous Transluminal Coronary Angioplasty (PTCA) Procedures
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