The Anticoagulant market
Anticoagulants have been used for more than 70 years to prevent and treat potentially deadly blood clots. They are prescribed for treatment in a wide variety of cardiovascular conditions where clotting is a risk, including deep venous thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation (AF), unstable angina, as well as myocardial infarction (MI), and stroke. The multi-billion-dollar global anticoagulants market is significantly boosted by an aging population. In addition, anticoagulants have emerged as a critical therapy in the prevention of venous thromboembolism (VTE) following major orthopedic surgeries, such as elective knee or hip replacements.
Older compounds, including heparins and vitamin K antagonists (Warfarin), have long been the mainstays of anticoagulation therapy. These agents, although effective if managed properly, have significant drawbacks. The recent advent of an entirely new class of drugs referred to as Target Specific Oral Anticoagulants (“TSOACs”), has begun to supplant the older drugs in a growing number of conditions. The TSOAC class works by blocking either thrombin directly or factor Xa within the coagulation cascade. There currently is no way to effectively measure a patient’s coagulability (ability to clot) at the point of care (“POC”) when taking a TSOAC drug. As reported by multiple sources, tens of thousands of cases of significant spontaneous bleeding have been recorded over the last few years since this class of drug has come to market. In a study of more than 50,000 anticoagulant users published in the British Medical Journal in 2015, researchers found that Xarelto users had double the risk of gastrointestinal bleeding when compared to warfarin. That same year, clinical trial results claiming that Eliquis reduced the risk of death in patients with atrial fibrillation were questioned by the FDA, due to missing data. With the rapid growth in the prescription of TSOACs by physicians, the need to quickly measure coagulability has become urgent.