Published Date : 2022-09-03
Published Date : 2022-09-03
Updated On : 2023-07-05
Pages : 159
Thelansis’s “Paroxysmal Atrial Fibrillation (PAF) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Paroxysmal Atrial Fibrillation treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Paroxysmal atrial fibrillation (PAF) constitutes a form of cardiac arrhythmia distinguished by irregular and frequently rapid atrial contractions. Atrial fibrillation (AF) entails the disruption of coherent electrical signaling that orchestrates the heart's rhythmicity, culminating in an accelerated and erratic heart rate. The "paroxysmal" descriptor pertains to the sporadic manifestation of this ailment, denoting the abrupt onset and cessation of episodes of irregular cardiac activity. The clinical manifestations of PAF exhibit notable variability. While certain individuals might remain asymptomatic, others may encounter sensations of palpitations, rapid or erratic heartbeat, vertigo, dyspnea, fatigue, and thoracic discomfort. In certain instances, untreated PAF might give rise to severe complications such as stroke, particularly if the condition is not subjected to intervention. Predisposing Factors:
AF's fundamental mechanism is predicated upon a multifaceted interplay between inciting factors and a conducive substrate. Inciting factors are accountable for initiating the arrhythmic episode, while the substrate sustains the ongoing arrhythmia. Inciting factors emerge when the action potential triggers after-depolarizations of sufficient magnitude to override the recuperating repolarization process. This after-depolarization may induce additional systolic contractions but is inadequate to uphold persistent arrhythmia. However, the impulses arising from such extra contractions are discharged at a heightened frequency. Upon impinging on myocardial tissue characterized by varying excitability or refractory periods, these impulses give rise to functionally obstructive electrical barriers. Consequently, re-entry circuits manifest, subsequently engendering fresh impulse waves that propagate additional re-entry circuits, thereby perpetuating the persistence of the arrhythmia by surmounting these barriers. The prevalent locus for ectopic foci and initiation of inciting factors is the muscular sleeve of the left atrium extending into the pulmonary vein. Myocardial cells within this region exhibit a diminished refractory period relative to neighboring myocardium in patients free from AF. Pulmonary vein isolation (PVI) carried out during catheter ablation procedures for AF seeks to insulate this region from the contiguous myocardium, thus thwarting further propagation of AF. The diagnostic approach for PAF conventionally entails electrocardiographic (ECG or EKG) recordings, capturing the heart's electric patterns. Therapeutic strategies for PAF are oriented toward heart rate regulation, restoration of normal rhythm, and mitigation of underlying risk factors. The absence of appropriate intervention could subject paroxysmal atrial fibrillation to the risk of complications, notably an elevated susceptibility to stroke. This peril emanates from the potential for clot formation within the atria, subsequent embolization to the cerebral vasculature, precipitating a stroke.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | M201-A Injection | Aetas Pharma Co. Ltd. | Phase 2 |
2 | Flecainide Acetate | InCarda Therapeutics, Inc. | Phase 2 |
3 | Ranolazine and Dronedarone | Gilead Sciences | Phase 2 |
4 | Flecainide | Pharmassist Ltd | Phase 3 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Paroxysmal Atrial Fibrillation (PAF) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Paroxysmal Atrial Fibrillation (PAF) market scenario 2022 |
1.2.2. Paroxysmal Atrial Fibrillation (PAF) market scenario 2025 |
1.2.3. Paroxysmal Atrial Fibrillation (PAF) market scenario 2032 |
2. Paroxysmal Atrial Fibrillation (PAF) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Paroxysmal Atrial Fibrillation (PAF) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Paroxysmal Atrial Fibrillation (PAF) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Paroxysmal Atrial Fibrillation (PAF) management |
2.16. Market Opportunity for Paroxysmal Atrial Fibrillation (PAF) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Paroxysmal Atrial Fibrillation (PAF) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Paroxysmal Atrial Fibrillation (PAF) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Paroxysmal Atrial Fibrillation (PAF) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Paroxysmal Atrial Fibrillation (PAF) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Paroxysmal Atrial Fibrillation (PAF) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Paroxysmal Atrial Fibrillation (PAF) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Paroxysmal Atrial Fibrillation (PAF) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Paroxysmal Atrial Fibrillation (PAF) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Paroxysmal Atrial Fibrillation (PAF) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Paroxysmal Atrial Fibrillation (PAF) Market Forecast 2022-2032 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Paroxysmal Atrial Fibrillation (PAF) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Paroxysmal Atrial Fibrillation (PAF) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Paroxysmal Atrial Fibrillation (PAF) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Paroxysmal Atrial Fibrillation (PAF) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |