Global Rivaroxaban Market Is Estimated to Witness High Growth Owing to Increasing Incidences of Deep Vein Thrombosis and Growing Geriatric Population
The Global Rivaroxaban Market is estimated to be valued at USD 16.72 Mn in 2024 and exhibit a CAGR of 6.6% over the forecast period 2024-2031. Furthermore, rising healthcare expenditure and increasing approvals and launches of generic versions of rivaroxaban are also fueling the market growth.
Market Dynamics:
Increasing incidences of deep vein thrombosis (DVT) and pulmonary embolism (PE) across the globe remain a key driver for the global rivaroxaban market growth over the forecast period. According to the Center for Disease Control and Prevention (CDC), around 900,000 Americans suffer from DVT annually resulting in as many as 100,000 deaths. Rivaroxaban has emerged as the drug of choice for treating and preventing recurrent DVT and PE.
Growing geriatric population prone to developing cardiovascular diseases and blood clots is another major factor accelerating demand for rivaroxaban. As per the UN’s World Population Ageing report, the population aged 65 years or over is projected to grow from 703 million in 2019 to 1.5 billion in 2050. Older people tend to have a higher risk of DVT, thereby augmenting sales opportunities for rivaroxaban manufacturers.
Increasing Prevalence of Deep Vein Thrombosis and Pulmonary Embolism is Driving the Market Growth
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are common and potentially fatal conditions. The risk factors for developing these conditions include older age, cancer, recent surgery, immobility, and genetic predisposition. Rivaroxaban is an anticoagulant commonly prescribed to treat and prevent DVT and PE. It offers convenience of oral administration compared to traditional injectable anticoagulants. This ease of use has increased rivaroxaban's adoption rate among patients and doctors. The rising incidence of conditions requiring anticoagulation therapy is expected to continue driving market growth for rivaroxaban in the coming years.
Increasing Use of Rivaroxaban in Stroke Prevention is Augmenting the Market Demand
Atrial fibrillation is a heart condition that increases the risk of blood clots and stroke. An estimated 33.5 million people globally suffer from atrial fibrillation. Rivaroxaban is approved for reducing the risk of stroke in non-valvular atrial fibrillation patients. It has shown comparable efficacy and better safety profile than warfarin in clinical trials. With aging population and lifestyle changes, the prevalence of atrial fibrillation is increasing rapidly. This has prompted physicians to widely prescribe rivaroxaban for long-term stroke prevention therapy. Favorable clinical data and growing patient pool indicate that rivaroxaban usage for stroke prevention will help boost market revenues.
Availability of Generics and Biosimilars Poses Significant Challenge
The patent for rivaroxaban expired in major markets in 2021-2022, allowing the approval of generic versions called biosimilars. The introduction of these low-cost generics is expected to severely impact the sales of branded rivaroxaban. Patients and healthcare providers may switch to cheaper generics for cost savings. This poses a serious restraint on the parent molecule revenues. Similarly, other novel oral anticoagulants gaining market share can erode rivaroxaban's patient base over time. To counter generic competition, companies need to devise innovative pricing and marketing strategies to retain existing customers.
Emerging Economies Present Lucrative Untapped Opportunities
While developed nations dominate the current rivaroxaban sales, emerging Asian, African and Latin American countries offer huge future growth prospects. Rapid economic development, rising healthcare expenditures and growing medical needs in these regions are driving the anticoagulant market transformation. Although affordability and awareness remain key challenges, sales are expected to surge with increasing diagnosis rates, insurance coverage and accessibility of treatment options. Market players could benefit from these opportunities by participating in collaborations, establishing local production facilities and tweaking drug prices suitably. Penetrating developing countries early would help gain first-mover advantage.
Stringent Regulatory Approval Process Hinders Market Growth
Approval of new drugs or new indications involves lengthy clinical trials to prove efficacy and safety profiles. Regulatory agencies like the USFDA and EMA impose rigorous guidelines on study protocols, manufacturing practices and post-marketing surveillance. While protecting public health, this strenuous approval paradigm causes treatment delays and increases development costs substantially for companies. From concept to commercialization, it takes an average of 10-15 years and over $2.6 billion expense for innovative drugs reaching the market. Strict regulations thus pose a restraint by creating entry barriers and discouraging smaller firms with limited budgets. Streamlining procedures can help accelerate patient access.
To conclude, the global rivaroxaban market exhibits positive long-term outlook driven by increasing disease prevalence, expanding therapeutic applications and coverage in emerging nations. Meanwhile, generics threat, stringent regulations and other competitive dynamics require strategic interventions from industry participants to maximize market potential over the forecast period.
Link: https://www.coherentmarketinsights.com/market-insight/rivaroxaban-market-1962
Key Developments:
- On April 2024, Johnson & Johnson announced new data from the PIONEER AF-PCI clinical trial, showing that XARELTO® (rivaroxaban) reduced the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) compared to warfarin in both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). These findings were presented at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia.
- On January 2024, Lupin has secured tentative approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg doses. This approval allows Lupin to market a generic version of Xarelto Tablets, in the same strengths, originally developed by Janssen Pharmaceuticals. The product will be manufactured at Lupin’s Pithampur facility in India.
- On February 2024, Roche has launched three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban, and rivaroxaban in countries accepting the CE mark. These tests, aimed at improving clinical decision-making for patients treated with these anticoagulants, are crucial for conditions like non-valvular atrial fibrillation, CAD, PAD, and VTE.
Key Player:
Bayer AG, Janssen Pharmaceuticals, Inc., Interquim SA, Natco Pharma, Mylan N.V., Sandoz (a Novartis division), Teva Pharmaceutical Industries Ltd., Aurobindo Pharma, Zydus Cadila, Apotex Inc., Hetero Labs Limited, Fresenius Kabi AG, Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Dr. Reddy's Laboratories, Bristol-Myers Squibb, Merck & Co., Inc., Pfizer Inc., Eisai Co., Ltd., and Amgen Inc.
