Rivaroxaban with the brand name Xarelto is an anticoagulant which is developed by Bayer/ Johnson & Johnson. It is commonly used for dissolving or preventing a type of blood clot that is called deep vein thrombosis (DVT) by blocking the activity of certain clotting substances in the blood.
In September 2008: Rivaroxaban gained marketing authorization from Health Canada to prevent venous thromboembolism (VTE) in people who have undergone elective total hip replacement or total knee replacement surgery. In the same month, the European Commission also granted this authorization.
In July 2011: Rivaroxaban was approved by the U.S. Food and Drug Administration for prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery.
In November 2011: it was approved by the U.S. FDA for stroke prevention in people with common type of abnormal heart rhythm.
XARELTO is a factor Xa inhibitor indicated:
- to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- for the treatment of deep vein thrombosis (DVT)
- for the treatment of pulmonary embolism (PE)
- for the reduction in risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months
- for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
Fator Xa or Eponym Stuart–Prower Factor, is an enzyme of the coagulation cascade and activated form of the coagulation factor thrombokinase. This serine endopeptidase plays a key role at several stages of the coagulation system. It is an active component of the prothrombinase complex that catalyzes the conversion of prothrombin (factor II) to thrombin (factor IIa).
One molecule of factor Xa can generate more than 1000 molecules of thrombin so using selective inhibitors of factor Xa will be effective. Rivaroxaban is one of the competitive reversible antagonists of activated factor X (Xa); it binds directly to factor Xa and effectively blocks the amplification of the coagulation cascade, preventing the formation of thrombus.
Rivaroxaban has been approved for treating Deep Vein Thrombosis that may lead to Pulmonary Embolism and Atrial fibrillation. According to the Bayer’s report, this drug could potentially be used on 30 million patients in its largest national markets nowadays.
In the irregular heartbeat market, Xarelto is competing with its rival pill Eliquis(Pfizer) and Bristol-Myers (Squibb), and also with Boehringer Ingelheim’s Pradaxa; but because of concerns over side effects, none of them have been tested in the atherosclerosis setting. Frank Misselwitz, head of cardiovascular drug development at Bayer believed that by considering the lowered mortality rate and a number of the cases with fatal bleeding you will be noticed that the benefits outweigh the side effect risks by far.
Rivaroxaban was licensed in 130 countries and that more than 23 million patients had been treated in 2016. During this year, revenue of this drug for Bayer, the main medicine supplier for hospitals, was 2.9 billion euros in 2016, up 30 percent from a year earlier and partner J&J who owns the majority of U.S. revenues booked sales of $2.3 billion, up 23 percent. The below diagram shows the revenue of Rivaroxaban during 2016-2017. Its revenue in 2017 was of $1.8 billion compared with $1.7 billion in 2016.
Industry analysts believe that during the slowing down of world economic growth, the market of Rivaroxaban will be affected but still maintained a relatively optimistic growth; for the past four years, Rivaroxaban market size maintains the average annual growth rate of 36.72% from 1980 million $ in 2013 to 5060 million $ in 2016. They also believed that it’s market size will be further expanded; so they expected that the market size of the Rivaroxaban will reach 7890 million $ in 2021.
Rivaroxaban under the trade name of Xarelto has entered the Chinese market in the latter half of 2009 and developed fast with annual sales rising from less than CNY 20 million in 2010 to CNY 140 million in 2014 and CAGR reaching up to over 70% during the period of 2010- 2014. Now, its market in China has been monopolized by Bayer, the main drug seller for hospitals.
Xarelto price is about $1.56 – $6.50 per pill or unit but its import price is relatively high and some Chinese drug enterprises have been developing the generic drugs of Rivaroxaban. Industry analysts estimated that the market size of rivaroxaban in China will keep expanding in the next few years. Dano Health as a pharmaceutical distributor for hospitals can provide Xarelto for all hospitals and clinics.