Changing Treatment Landscape Expands Patient Population
The treatment landscape for conditions requiring anticoagulation, such as atrial fibrillation (AF), venous thromboembolism (VTE), and stroke prevention, has evolved dramatically in recent years. Once limited largely to warfarin, an anticoagulant drug first approved in the 1950s, clinicians now have several newer drug classes to choose from that do not require routine monitoring of international normalized ratios (INRs). These novel oral anticoagulants (NOACs) include direct thrombin inhibitors such as dabigatran and factor Xa inhibitors like rivaroxaban, apixaban, edoxaban, and betrixaban.
The approval of NOACs has changed the profile of patients eligible for anticoagulation. Whereas warfarin treatment requires frequent INR monitoring and dietary restrictions that limit its use, the NOACs have simplified drug regimens without these constraints. This expansion of the treatable population represents an enormous market opportunity for Anticoagulant manufacturers. Additionally, lifelong management is required for chronic conditions such as AF, mitigating concerns over a limited treatment duration.
New Indications Widen the Patient Population
The NOACs were initially approved for preventing stroke and systemic embolism in nonvalvular AF, representing a huge patient population of over 33 million individuals worldwide projected to grow to over 43 million by 2030. However, additional approvals for VTE treatment and prevention have further increased the patient pool eligible for these drugs.
Areas of continuing expansion include extended VTE treatment beyond the initial 6 months, as evidenced by approval of rivaroxaban and apixaban for reducing VTE recurrence. Betrixaban became the first oral anticoagulant approval specifically for VTE prophylaxis in acutely ill medical patients. Edoxaban is now also indicated for VTE treatment, as well as reducing the risk of recurrent VTE in patients who have been previously treated.
Perhaps the greatest potential market growth lies in new primary prevention indications for cardiovascular disease more broadly. In November 2021, the FDA approved rivaroxaban for reducing the risk of major cardiovascular events in certain patients with chronic coronary or peripheral artery disease. Industry analysts project this new indication could expand rivaroxaban's eligible patient pool in the United States to over 15 million individuals.
Continued Evolution of Treatment Options
Even as the currently approved NOACs remain blockbuster sellers, pharmaceutical companies continue developing next-generation anticoagulants. One goal has been to identify alternatives for patients who cannot tolerate or are not appropriate candidates for the existing NOACs and warfarin. Another aim is to design drugs with even broader therapeutic windows and fewer drug-drug interactions than first-generation agents.
For example, andexanet alfa was approved in 2018 for reversing the anticoagulant effects of factor Xa inhibitors like apixaban and rivaroxaban in major bleeding episodes. Another reversal agent, ciraparantag, completed phase III trials in 2021 and may offer broader reversal of multiple anticoagulant classes including unfractionated and low molecular weight heparins.
On the development front, investor attention has turned to several NOACs in late-stage clinical testing. inclacumab is a direct factor IXa inhibitor in phase III trials as RVT prophylaxis in orthopedic surgeries. Another direct factor IXa inhibitor, recarisiban, finished phase II testing for VTE prevention. Anumodakin alfa, a synthetic analogue of human anisopleura isoquinoline alkaloid, is in phase III as an anticoagulant and antiplatelet medication.
The anticoagulant drug market has undergone radical change in the past decade with the development of NOACs that simplified treatment for millions of patients. Expanding indications will continue driving volume growth by broadening the eligible patient population for many years. Additionally, the need remains for improved reversal agents and novel anticoagulant mechanisms, representing ongoing research and business opportunities. Overall, factors suggest steady growth ahead for manufacturers participating in the revolutionized anticoagulation space.
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The major players in the anticoagulant market include Bayer AG, Aspen Holdings, Boehringer Ingelheim GmbH, Daiichi Sankyo Company, Limited, Bristol-Myers Squibb Company, GlaxoSmithKline, Pfizer, Inc., Sanofi S.A., Johnson & Johnson, and Portola Pharmaceuticals, Inc., among others.
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Moreover, the growing adoption of new oral anticoagulants, and maturing awareness of new techniques is boosting the market growth.
