jarun011/iStock via Getty Images
Although many branded drugs have a large portion of the atrial fibrillation (Afib) market, the loss of patent exclusivity and the introduction of generics will cause this market to decline between now and 2032.
drugs such as PfizerNew York Stock Exchange: PFE) And Bristol Myers Squibb (New York Stock Exchange: BMY) Eliquis (apixaban) and Bayer (OTCPK: Paysafe) and Johnson & Johnson (New York Stock Exchange: JNJ) Xarelto (rivaroxaban) is the blockbuster medication used to treat Afib. In 2022, Eliquis brought in approximately $18.3 billion, while Xarelto earned approximately $7.5 billion.
However, the Afib market is expected to decline at a compound annual growth rate of 1.3% from 2022 to 2032 across the eight major markets, according to a new report from consulting and analytics firm GlobalData.
Given that these new oral anticoagulants are the standard of care for AFib stroke prevention, the introduction of generics will significantly impact the AFib drug market, GlobalData noted.
As it currently stands, the earliest generic Eliquis that could be available to patients in the United States is April 2028 following the September 2021 court ruling. For Xarelto, the date is December 2024, according to DrugPatentWatch.com.
the GlobalData report Note that between now and 2032, several new therapies for AFib are slated to enter the market. The company has highlighted three factor XI inhibitors (“FXI”) and FXIa that will be the biggest growth drivers: abelacimab, asundexian, and milvexian. They are all in stage 3.
The attraction of these newer drugs is their ability to prevent thromboembolic events without increasing the risk of bleeding.
Abelacimab is under development by privately owned Anthos Therapeutics. Asundexian is from Bayer (OTCPK: BAYRY), while milvexian is being developed by Bristol (BMY) and J&J (JNJ).
In May, the FDA granted fast-track designation to asundexian for preventing stroke and systemic embolism in people with AFib. Milvexian also received Fast Track status in the same month.
These new drugs may appeal to a large proportion of AFib patients — about 40%, according to GlobalData, who don’t take anticoagulants because of bleeding concerns.
“According to key opinion leaders interviewed by GlobalData, the inadequacy of many current anti-arrhythmic medications lies in the fact that they rarely affect the causal mechanisms of disease,” Murray said.
“They agreed that a significant unmet need in the management of AFib would be the development of safer and more effective heart rhythm control drugs that directly counteract the basic drivers underlying AFib progression, such as atrial remodeling — an area of drug development in which It’s still pretty much the same.”
More about AFib treatments
Bristol-Myers, Janssen launch Librexia late-stage program for milvexian assessment
Bristol-Myers is down 5%, most in two years, after mid-stage data for its blood broth
Bayer has been granted a patent extension in the European Union for its best-selling drug, Xarelto
An AbbVie candidate for postoperative atrial fibrillation failed mid-trial