Market Report Source

Overview

Introduction

Datamonitor estimates that there are over 11 million atrial fibrillation patients in the seven major markets. Despite high unmet needs and limitations of all the current treatment options, achievement of regulatory approval is becoming increasingly difficult. This means that a very limited number of novel treatments are expected to be introduced in the near future.

Scope

*Review of the available epidemiology data to assess the patient population of atrial fibrillation and to segment the patient population by type *Outline of the existing therapy options and current prescribing trends *Assessment of the current status of the rhythm versus rate control debate and the determining factors for each type of treatment strategy *Evaluation of the current usage of cardiac rhythm devices and ablation techniques to determine their future role in atrial fibrillation management

Highlights

The rapid increase in atrial fibrillation prevalence is driven by a number of factors, namely ageing population, the obesity epidemic, better prevention of strokes, and better survival of patients with cardiac disease.

There are numerous unmet needs associated with every treatment option available. The main unmet needs of pharmacological therapy are insufficient efficacy and poor safety. Non-pharmacological therapy has severe limitations, among them the cost of the procedures and the fact that a limited number of patients are eligible for it.

Despite the desperate need for a new efficacious and safe antiarrhythmic, no new drug that would significantly impact atrial fibrillation management is going to appear in the nearest future.

Reasons to Purchase

*Target physicians more effectively, through an understanding of treatment options and their prescription choices *Assess the potential of each treatment option in the management of atrial fibrillation and understand the dynamics of the market *Recognize lucrative target populations, in terms of unmet need and patient potential, in order to successfully position developmental products

Table of Contents

ABOUT DATAMONITOR HEALTHCARE
About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the AF market
The rapid increase in AF prevalence is driven by a number of factors, namely ageing population, the obesity epidemic, better prevention of strokes, and better survival of patients with cardiac disease.
A change in the definition of AF used by epidemiologists
The growing proportion of ageing population
The current ““obesity epidemic”“
Better prevention and treatment options for patients with heart disease
Stroke prevention and treatment strategies
Advanced technologies driving diagnosis rates
There are numerous unmet needs associated with every treatment option available. The main unmet needs of pharmacological therapy are insufficient efficacy and poor safety. Non-pharmacological therapy has severe limitations, among them the cost of the procedures and the fact that a limited number of patients is eligible for it.
Despite the desperate need for a new efficacious and safe antiarrhythmic, no new drug that would significantly impact the AF management is going to appear in the nearest future.
The unresolved unmet needs put significant pressure on the more widespread use of non-pharmacological treatment options. The usage of electrical cardioversion is steadily growing, despite the guidelines, and due to several advantages of direct current cardioversion over pharmacological cardioversion. Also, pulmonary vein isolation as the only viable curative option, while not very widespread now, is becoming an attractive option for certain patient types, and may gain use, despite being still in development.
Key metrics
CHAPTER 2 INTRODUCTION AND SCOPE
Coverage of the Atrial Fibrillation Stakeholder Insight Survey
CHAPTER 3 COUNTRY TREATMENT TREES
Introduction to the treatment trees
CHAPTER 4 EPIDEMIOLOGY & PATIENT SEGMENTATION
Definition of the disease
Classification of AF
Epidemiology of disease
Methodology
US
Japan
Europe: UK
Europe: France, Germany, Italy and Spain
Lone atrial fibrillation
Co-morbidities, complications and risk factors
Hypertension and AF
Heart failure and atrial fibrillation
Complications
Stroke
CHAPTER 5 DIAGNOSIS & TREATMENT OPTIONS
Diagnosis
Untreated AF patients
Treatment options
Antiarrhythmic drugs
Class I agents
Class Ia
Class Ic
Class II agents – Beta blockers
Class III agents
Sotalol
Amiodarone
Dofetilide
Diltiazem
Verapamil
Digoxin
CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS
Introduction to treatment guidelines
Cardioversion
Pharmacological cardioversion
Electrical cardioversion
Cardioversion: success rates
Antiarrhythmic drug therapy strategies
The rate versus rhythm debate
Drug therapy for sinus rhythm control
Outcome of antiarrhythmic drug therapy for rhythm control
Drug therapy for rate control
Outcome of rate control drugs
Cardiac rhythm management (CRM) devices
Pacemakers
Overdrive atrial pacing
Implantable cardioverter-defibrillators (ICDs)
Shock intolerance issue with ICDs
Pharmacoeconomics
Adjunctive drug therapies used with devices
Catheter ablation
Atrioventricular node or junction ablation
Pulmonary vein isolation/ablation
Success rates of catheter ablation
Success rates: catheter ablation versus drug therapy
Surgical procedures
Overview of AF treatment for all AF types
Recent onset AF
Paroxysmal AF
Persistent and permanent AF
Treatment guidelines for special cases
Heart failure
Coronary artery disease
Hypertensive heart disease
Post-operative therapy
Prevention options
Postoperative treatment options
CHAPTER 7 IMPROVING TREATMENT OUTCOMES
Treatment outcomes
Rhythm versus rate control
Cardioversion
Ablation
Cardiac rhythm devices
Unmet needs in AF
Efficacy
Quality of life
Treatment Options for AF patients with underlying heart disease
Decreased mortality
Safety
New product development – Antiarrhythmics
Dronedarone (Multaq)
Azimilide
RSD1235 (intravenous formulation)
Pulzium (tedisamil) (intravenous formulation)
Future focus
APPENDIX A
Bibliography
Epidemiology
General and clinical trial data
APPENDIX B
QUESTIONNAIRE
1. Presentation And Diagnosis Rates
2. Cardioversion
3. Management Of Atrial Fibrillation
4 Antiarrhythmic Drug Therapy
5 Antiarrhythmic Drug Therapy For Sinus Rhythm Maintenance
6 Antiarrhythmic Drug Therapy For Ventricular Rate Control
7 Implantable Cardiac Rhythm Devices
8 Catheter Ablation Procedures
9 Unmet Needs in the Treatment of Atrial Fibrillation
PHYSICIAN SAMPLE BREAKDOWN
US
Japan
France
Germany
Spain
Italy
UK
Disclaimer
List of Tables
Table1: Prevalenceestimatesforatrialfibrillation,2006-2014
Table 2: Prevalence estimates for Atrial Fibrillation, 2006-2015, 000s
Table 3: Proportion of AF patients with common co-morbidities and risk factors (%)
Table 4: Percentage prevalence of co-morbidity in elderly AF patients
Table 5: Major side effects of antiarrhythmic drugs
Table 6: SAFE-T: median time to AF recurrence in days
Table 7: Percentage of AF patients receiving the following antiarrhythmic classes or drugs for rhythm control
Table 8: Factors effecting choice of first-line therapy for rhythm control (rated on the scale from 1 to 10, where 10 means most influential factor)
Table 9: Percentage of AF patients receiving the following antiarrhythmic drugs for rate control
Table 10: Factors effecting choice of first-line therapy for rate control
Table 11: Average direct costs of care for pacemaker and ICD implantation in Canada, 1997-98
Table 12: The mean success rates for each type of catheter ablation (%)
Table 13: A4: Primary and Secondary Endpoints at 12 Months
Table 14: Treatment outcomes
Table 15: US physician sample breakdown, 2006
Table 16: Japan physician sample breakdown, 2006
Table 17: France physician sample breakdown, 2006
Table 18: Germany physician sample breakdown, 2006
Table 19: Spain physician sample breakdown, 2006
Table 20: Italy physician sample breakdown, 2006
Table 21: UK physician sample breakdown, 2006
List of Figures
Figure 1: Total AF population treated with antiarrhythmic drugs
Figure 2: Diagrammatic overview of the coverage of the AF Stakeholder Insight Survey, 2006
Figure 3: A breakdown of AF population in the US by type, and method of diagnosis, 2006
Figure 4: A breakdown of AF population in the US by treatment and success rates, 2006
Figure 5: A breakdown of AF population in the US by treatment and strategy, 2006
Figure 6: A breakdown of AF population in Japan by type, and method of diagnosis, 2006
Figure 7: A breakdown of AF population in Japan by treatment and success rates, 2006
Figure 8: A breakdown of AF population in Japan by treatment and strategy, 2006
Figure 9: A breakdown of AF population France by type, and method of diagnosis, 2006
Figure 10: A breakdown of AF population in France by treatment and success rates, 2006
Figure 11: A breakdown of AF population in France by treatment and strategy, 2006
Figure 12: A breakdown of AF population in Germany by type, and method of diagnosis, 2006
Figure 13: A breakdown of AF population in Germany by treatment and success rates, 2006
Figure 14: A breakdown of AF population in Germany by treatment and strategy, 2006
Figure 15: A breakdown of AF population in Italy by type, and method of diagnosis, 2006
Figure 16: A breakdown of AF population in Italy by treatment and success rates, 2006
Figure 17: A breakdown of AF population in Italy by treatment and strategy, 2006
Figure 18: A breakdown of AF population in Spain by type, and method of diagnosis, 2006
Figure 19: A breakdown of AF population in Spain by treatment and success rates, 2006
Figure 20: A breakdown of AF population in Spain by treatment and strategy, 2006
Figure 21: A breakdown of AF population in the UK by type, and method of diagnosis, 2006
Figure 22: A breakdown of AF population in the UK by treatment and success rates, 2006
Figure 23: A breakdown of AF population in the UK by treatment and strategy, 2006
Figure 24: The structure of the human heart
Figure 25: ECGs of normal heart rhythm and atrial fibrillation
Figure 26: Classification of AF
Figure 27: Prevalence of the different types of AF across the AF population
Figure 28: Percentage of AF population with lone AF
Figure 29: Percentage of severe HF patients within total AF population
Figure 30: Percentage of AF patients diagnosed with each diagnostic method
Figure 31: Percentage of AF population that remain untreated for AF
Figure 32: Overview of treatment guidelines
Figure 33: Antiarrhythmic drug classes and contraindications
Figure 34: Guideline recommendations for drugs for pharmacological cardioversion
Figure 35: Treatment guidelines for cardioversion in AF patients
Figure 36: Percentage of AF patients undergoing each type of cardioversion
Figure 37: Percentage of AF patients undergoing the following number of cardioversions during their arrhythmia lifetime
Figure 38: Percentage of cardioversion patients maintaining sinus rhythm at one year
Figure 39: Percentage of recent onset AF population treated with either rhythm or rate control therapy
Figure 40: Percentage of paroxysmal AF population treated with either rhythm or rate control therapy
Figure 41: Percentage of persistent AF population treated with either rhythm or rate control therapy
Figure 42: Percentage of permanent AF population treated with either rhythm or rate control therapy
Figure 43: Percentage of AF patients with each type of AF that receive rate control therapy
Figure 44: Average ratings of each AF patient population benefiting from sinus rhythm maintenance (ranked from 1 to 13, where 1 means ““great benefit”“)
Figure 45: Average ratings of each AF patient population benefiting from ventricular rate control (ranked from 1 to 14, where 1 means ““great benefit”“)
Figure 46: Percentage of rhythm control patients not treated successfully at first line
Figure 47: Percentage of AF patients treated for sinus rhythm maintenance that change therapy for the following reasons
Figure 48: Percentage of rhythm patients that switch to rate control therapy
Figure 49: Percentage of rate control patients not treated successfully at first line
Figure 50: Percentage of AF patients treated for ventricular rate control that change therapy for the following reasons
Figure 51: Percentage of all patients not treated successfully at first-line
Figure 52: Percentage of AF population receiving CRM devices
Figure 53: Percentage of AF population receiving each type of device
Figure 54: Standard therapies given with Dual Chamber Pacemakers without AF Suppression Algorithms
Figure 55: Standard therapies given with Dual Chamber Pacemakers with AF Suppression Algorithms
Figure 56: Standard therapies given with Dual Chamber Implantable Cardioverter Defibrillator
Figure 57: Standard therapies given with Single Chamber (Ventricular) Pacemakers
Figure 58: Percentage of AF patients that have undergone catheter ablation
Figure 59: Percentage of patients undergoing each type of catheter ablation
Figure 60: Percentage of AF patients undergoing catheter and surgical ablation
Figure 61: Percentage of AF patients receiving the following therapies
Figure 62: Overview of treatment guidelines for recent onset AF
Figure 63: Overview of treatment guidelines for paroxysmal AF
Figure 64: Overview of treatment guidelines for persistent and permanent AF
Figure 65: Treatment guidelines for patients with heart disease
Figure 66: Unmet needs of AF (ranked from 1 to 15, where 1 means ““most important”“)
Figure 67: The most important unmet needs in AF