This Market Spotlight report covers the Atrial Fibrillation market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, key upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were approximately 50.1 million prevalent cases of atrial fibrillation worldwide, and forecasts that number to increase to 56.7 million prevalent cases by 2027.
• The approved drugs in the atrial fibrillation/flutter space focus on targets such as beta adrenergic receptors, alpha adrenergic receptors, potassium channels, sodium channels, and calcium channel. The majority of marketed drugs are administered via the intravenous or oral routes, with only one product being available in a transdermal formulation.
• The approved drugs in the stroke prevention in atrial fibrillation (SPAF) space focus on targets such as coagulation factor X, adenosine diphosphate P2Y12 receptor, and thrombin (coagulation factor IIa). All of the marketed drugs for SPAF are administered via the oral route.
• The majority of industry-sponsored drugs in active clinical development for atrial fibrillation/flutter are in Phase II, with one drug each in Phase III and the NDA/BLA stage.
• Therapies in development for atrial fibrillation/flutter focus on targets such as potassium channels, sodium channels, muscarinic acetylcholine receptor, and beta adrenergic receptors. The greatest proportion of these drugs are administered via the oral route, with the remainder being tested in percutaneous catheter/injection, intravenous, and inhaled formulations.
• There are only two industry-sponsored drugs in active clinical development for SPAF, with one drug each in Phase II and Phase III.
• Therapies in development for SPAF target coagulation factor XI. These therapies are administered via the oral and subcutaneous routes.
• The only high-impact upcoming event for drugs in the atrial fibrillation/flutter space is topline Phase III trial results for InRhythm. The overall likelihood of approval of a Phase I atrial fibrillation/flutter asset is 3.5%, and the average probability a drug advances from Phase III is 60%. Drugs, on average, take 12.0 years from Phase I to approval, compared to 10.5 years in the overall cardiovascular space.
• The overall likelihood of approval of a Phase I SPAF asset is 11.4%, and the average probability a drug advances from Phase III is 85.7%. Drugs, on average, take 6.6 years from Phase I to approval, compared to 9.9 years in the overall hematology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for atrial fibrillation have been in the late phases of development, with 72% of trials in Phase III–IV, and only 28% in Phase I–II.
• The US leads in terms of the number of atrial fibrillation clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the atrial fibrillation space is dominated by completed trials. Bayer has the highest number of completed clinical trials for atrial fibrillation, with 50 trials.
• Bayer leads industry sponsors with the highest overall number of clinical trials for atrial fibrillation.