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Patent expiration, low-cost generics will contribute to the decrease.
September 19, 2023
By: Michael Barbella
Managing Editor
The steady beat of the atrial fibrillation (AF) market is about to slow. GlobalData forecasts the market to decline 1.3% annually over the next nine years, going from $14.53 billion in 2022 to $12.8 billion in 2032 across eight major markets due to the patent expiration of novel oral anticoagulants (NOACs) and the rise of low-cost generics. “The patent expiration and subsequent generic erosion of the NOACs will have a significant effect on the AF market, especially as this drug class is the current standard of care for stroke prevention in AF,” GlobalData Healthcare Analyst Amy Murray said. GlobalData’s report, “Atrial Fibrillation: Eight Market Drug Forecast and Market Analysis,” reveals that five late-stage pipeline therapies are expected to enter the market during the forecast period, including four anticoagulants and one cardioversion agent. The most significant driver of growth will be the launch of the Factor XI (FXI) and FXIa inhibitors: abelacimab, asundexian and milvexian. Murray notes: “The FXI/FXIa inhibitors have huge commercial potential. As an anticoagulant that can suppress pathological thrombus formation without a corresponding increase in bleeding risk, FXI/FXIa inhibitors have the potential to provide a novel anticoagulant option for the many patients who until now did not have an option to be treated with an anticoagulant due to bleeding concerns—accounting for approximately 40% of AF patients.” In addition to the FXI/FXIa inhibitors, Cadrenal Therapeutics’ vitamin K antagonist (VKA) tecarfarin and InCarda Therapeutics’ cardioversion agent, InRhythm (flecainide acetate), are also expected to launch over the forecast period. However, these agents are not expected to be key drivers of growth during the forecast period. “Tecarfarin and InRhythm have both been developed to overcome some of the most pressing unmet needs in the AF space, including the development of an anticoagulant for AF patients with chronic kidney failure and a non-invasive rapid-acting pharmacological agent for cardioversion, respectively,” Murray noted. “Despite their novelty, both drugs will experience limited market uptake owing to their high annual cost of therapy, the lack of data demonstrating their superiority in terms of efficacy and safety compared to the current SoC, and their small target patient populations.” While some important unmet needs may be addressed during the 10-year forecast period, especially due to the anticipated launch of the FXI/FXIa inhibitors across the 8MM, certain challenges remain. One of the biggest unmet needs lies in the development of safer antiarrhythmic agents for the maintenance of sinus rhythm. “Currently, the antiarrhythmic drugs available for rhythm control in AF patients have modest efficacy, unfavorable safety profiles, and often fail to keep patients in sinus rhythm over the long term. According to key opinion leaders (KOLs) interviewed by GlobalData, the inadequacy of many current antiarrhythmic drugs lies in the fact that they rarely impact the causal mechanisms of disease,” Murray concluded. “They agreed that an important unmet need in the management of AF will be the development of safer and more effective rhythm-control drugs that directly interdict the primary underlying drivers of AF progression, such as atrial remodeling—an area of drug development that remains largely untouched.” * 8MM: The United States, 5EU (France, Germany, Italy, Spain, and the U.K.), Canada, and Japan
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