Rivaroxaban Market Insights – Stop the Clot
Rivaroxaban is a Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) that is marketed as Xarelto. Anticoagulant medicines are potent therapeutic agents used in the prevention or treatment of serious illnesses and potentially life-threatening conditions associated with blood coagulation. Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, LLC.
Xarelto is approved for indications such as stroke prevention in non-valvular atrial fibrillation, pulmonary embolism, deep vein thrombosis, prevention of recurrent venous thromboembolism (VTE), prevention of VTE after elective hip and knee replacement surgery, and secondary prevention after acute coronary syndrome.
In September 2008, the drug received CE approval for venous thromboembolism in adults undergoing knee and hip replacement surgeries and in 2011, it was approved by the U.S. Food and Drug Administration (FDA) for the same indication. Xarelto is approved in over 130 countries by respective regulatory bodies.
Table 1. Timeline of Rivaroxaban Approval
|Year of Approval
||Prevention of venous thromboembolism (VTE) following elective hip or knee-joint replacement surgery
||Canada, Europe, and several other countries
||Stroke prevention in patients with atrial fibrillation, treatment of deep vein thrombosis (DVT) and prevention of recurring DVT and pulmonary embolism
||DVT prophylaxis in adult patients following elective hip or knee joint replacement surgery
||Reducing the risk of stroke in patients with atrial fibrillation
||Prophylaxis of stroke and systemic embolism in patients with non-valvular atrial fibrillation
||Prevention of atherothrombotic events after acute coronary syndrome (ACS) in patients with elevated cardiac biomarkers in combination with standard antiplatelet therapy
||Prevention of stroke and systematic embolism in patients with non atrial fibrillation
||Treatment for recurring deep vein thrombosis
Source: Bayer Annual Report (2008-2017)
The global rivaroxaban market size is estimated to be valued at US$ 5,653 million in 2017 and is expected to witness a CAGR of 1.5% over the forecast period (2018 – 2026) on account of patent expiry during the forecast period.
Figure 1. Global Rivaroxaban Market Share, By Region
Source: Coherent Market Insights Analysis (2018)
Increasing number of hip and knee replacement surgeries are augmenting rivaroxaban market growth
As an anti-coagulant drug is intended to be used for the prevention and treatment of embolism and non-hemorrhagic stroke, increasing incidences of such medical conditions are expected to boost the rivaroxaban market growth over the forecast period.
For instance, according to the Centers for Disease Control and Prevention (CDC) data of 2015, around 900,000 people are expected to be affected by venous thromboembolism each year in the U.S. Furthermore, the number of affected individuals are expected to increase by around 5% to 8% in the U.S., owing to several genetic risk factors such as condition known as inherited thrombophilia.
Moreover, endeavor to use the drug for additional indication is expected to support the market growth. For instance, Swiss Paraplegic Centre Nottwil was investigating the drug for cervical spinal cord injury, which is in phase 4 clinical trial as on December 2017. Furthermore, Onze Lieve Vrouw Hospital and AZ Sint-Jan AV are conducting clinical trial of 10 mg rivaroxaban for the indication of chronic renal failure.
Another major factor negatively affecting the rivaroxaban market growth is patent expiration of the drug Xarelto. Patent expiration leads to the manufacturing of generic drugs, which can be leveraged by the generic manufactures. The availability of generic drugs is expected to lower the treatment cost making it affordable to a wider class of individuals.
Dreadful injuries caused due to Xarelto, has led the company face many legal issues in the U.S. market. For instance, as of January 30, 2018, Bayer Group had been served in the U.S. with around 22,000 claims of Xarelto for personal injuries from the use of Xarelto, which includes cerebral, gastrointestinal or other bleeding and death causes. On clearance of the claims, the market of the product is expected to be affected in terms of revenue.
Rivaroxaban Market Regional Outlook
On the basis of region, the global rivaroxaban market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is holding dominant position in the global rivaroxaban market, owing to high product sales coupled with high cost of the drug. For instance, the treatment cost for rivaroxaban is around US$ 450-500 per month and around 45% of the market revenue generated in 2017 was from the U.S. market.
Moreover, according to an article published in the ‘Journal of The American Heart Association’, 2018, a hospital-based survey suggested the global burden of disability-adjusted life-years from venous thromboembolism to be 7.6 per 100,000 person-years. The high rate of mortality associated with venous thromboembolism increases the demand for drugs such as rivaroxaban.
Key players in the global rivaroxaban market
Major players operating in the global rivaroxaban market include Janssen Pharmaceuticals Inc. and Bayer AG.
Market players strategize to strengthen their foot hold in the market in spite of high cost by implementing cost-effective treatment schemes. For instance, Janssen Pharmaceuticals offer Xarelto manufacturer coupon or patient assistance program to lower the cost of the drug.