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Market Spotlight: Atrial Fibrillation

  • Report

  • 48 Pages
  • April 2021
  • Region: Global
  • Citeline
  • ID: 4895484
This Market Spotlight report covers the Atrial Fibrillation market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • The publisher estimates that in 2018, there were approximately 47.2 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 in the NDA/BLA phase.
  • Therapies in development for atrial fibrillation/flutter focus on targets such as potassium channels, sodium channels, and beta adrenergic receptors. The majority of these drugs are administered via the oral route, with the remainder being tested in intravenous and inhaled formulations.
  • The only industry-sponsored drug in active clinical development for SPAF is in Phase II.
  • The only therapy in development for SPAF targets coagulation factor XI. It is administered via the subcutaneous route. The overall likelihood of approval of a Phase I atrial fibrillation/flutter asset is 2.5%, and the average probability a drug advances from Phase III is 60%. Drugs, on average, take 12.1 years from Phase I to approval, compared to 10.1 years in the overall cardiovascular space.
  • The overall likelihood of approval of a Phase I SPAF asset is 9.8%, and the average probability a drug advances from Phase III is 85.7%. Drugs, on average, take 6.2 years from Phase I to approval, compared to 9.7 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 75% of trials in Phase III–IV, and only 25% 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 South Korea 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 44 trials.
  • Bayer leads industry sponsors with the highest overall number of clinical trials for atrial fibrillation, followed by Johnson & Johnson.

Table of Contents

OVERVIEWKEY TAKEAWAYS
DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Diagnosis
  • Patient segmentation

TREATMENT
  • Rate control strategy
  • Rhythm control strategy
  • Medications to prevent thromboembolism

EPIDEMIOLOGY
MARKETED DRUGS
  • Atrial fibrillation/flutter

SPAF
PIPELINE DRUGS
  • Atrial fibrillation/flutter

SPAF
RECENT EVENTS AND ANALYST OPINION
  • Brinavess for Atrial Fibrillation/Flutter (December 24, 2019)
  • Brinavess for Atrial Fibrillation/Flutter (December 10, 2019)
  • Brinavess for Atrial Fibrillation/Flutter (December 6, 2019)

KEY REGULATORY EVENTS
  • Biotronik Adds Temperature Sensing To Biomonitor IIIm Injectable Cardiac Monitor
  • UK’s NICE Backs Interim Funding For 14-Day Ambulatory Heart Monitoring Tech
  • Accord Gets First EU-Wide Nod For Xarelto Rival
  • Fitbit Receives FDA Clearance, CE Mark For ECG App To Rival Apple
  • LifeSignals Receives US FDA Clearance To Market ECG Remote Monitoring Platform
  • FDA Clears Medtronic's And Boston Scientific's Remote Cardiac Monitors, Approves Abbott’s Bluetooth-Compatible ICDs

PROBABILITY OF SUCCESS
  • Atrial fibrillation/flutter

SPAFREVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of atrial fibrillation, 2018–27
Figure 2: Overview of pipeline drugs for atrial fibrillation/flutter in the US
Figure 3: Pipeline drugs for atrial fibrillation/flutter, by company
Figure 4: Pipeline drugs for atrial fibrillation/flutter, by drug type
Figure 5: Pipeline drugs for atrial fibrillation/flutter, by classification
Figure 6: Overview of pipeline drugs for SPAF in the US
Figure 7: Pipeline drugs for SPAF, by company
Figure 8: Pipeline drugs for SPAF, by drug type
Figure 9: Pipeline drugs for SPAF, by classification
Figure 10: Probability of success in the atrial fibrillation/flutter pipeline
Figure 11: Probability of success in the SPAF pipeline
Figure 12: Clinical trials in atrial fibrillation
Figure 13: Top 10 drugs for clinical trials in atrial fibrillation
Figure 14: Top 10 companies for clinical trials in atrial fibrillation
Figure 15: Trial locations in atrial fibrillation
Figure 16: Atrial fibrillation trials status
Figure 17: Atrial fibrillation trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of atrial fibrillation, 2018–27
Table 2: Marketed drugs for atrial fibrillation/flutter
Table 3: Marketed drugs for SPAF
Table 4: Pipeline drugs for atrial fibrillation/flutter in the US
Table 5: Pipeline drugs for SPAF in the US
Table 6: Brinavess for Atrial Fibrillation/Flutter (December 24, 2019)
Table 7: Brinavess for Atrial Fibrillation/Flutter (December 10, 2019)
Table 8: Brinavess for Atrial Fibrillation/Flutter (December 6, 2019)
Table 9: Historical global sales, by drug ($m), 2016–20
Table 10: Forecasted global sales, by drug ($m), 2021–25