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AVP-825 (Migraine) - Forecast and Market Analysis to 2023

Summary

The migraine market is saturated with generic drugs, and the remaining branded products already on the market are expected to lose exclusivity during the next few years, with the exception of Botox for chronic migraine, which is expected to maintain its leading position in terms of sales. However, reformulations of mature products as well as new classes of therapies are anticipated to launch during the forecast period and these will contribute to the market growth. By 2023, the migraine market will grow to $3.7 billion at a compound annual growth rate (CAGR) of 3.6%, with the US continuing to dominate the market as a result of higher drug prices and a large migraine population. Some of the new treatments are expected to target the key unmet needs but opportunities will remain for further treatment choices especially drugs that will offer an improved safety and side-effects profile.

OptiNose, a private medical device company, is developing a low-dose sumatriptan powder formulation to be delivered intranasally using its breath-powered nasal delivery technology. The technology has been designed to deliver drugs efficiently and reliably to the targeted, hard-to-reach areas. Avanir will hold responsibilities for regulatory, manufacturing, supply-chain and commercialization activities for AVP-825.

Scope

- Overview of Migraine, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on AVP-825 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for AVP-825 for the US from 2012 to 2023.
- Sales information covered for the US.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Migraine
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of AVP-825 performance
- Obtain sales forecast for AVP-825 from 2012-2023 in the US.

Table Of Contents

AVP-825 (Migraine) - Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 15
3.1.3 Prognosis 16
3.2 Symptoms 16
3.2.1 Premonitory Phase 16
3.2.2 Aura Phase 17
3.2.3 Headache Phase 17
3.2.4 Postdrome Phase 18
4 Disease Management 19
4.1 Treatment Overview 19
4.1.1 Acute Migraine Treatment 22
4.1.2 Preventive Migraine Treatment 23
5 Competitive Assessment 24
5.1 Overview 24
5.2 Strategic Competitor Assessment 25
6 Opportunity and Unmet Need 26
6.1 Overview 26
6.1.1 A Lack of Acute Therapies for Patients with or at Risk of Cardiovascular Disorders 27
6.1.2 Lack of Acute Therapies for Patients Unresponsive to Triptan Medication 27
6.1.3 Lack of Diagnostic Tools Causes Misdiagnosis 28
6.1.4 Physician Education 28
6.1.5 Effective and Well-Tolerated Prophylactic Therapies 29
6.2 Unmet Needs Gap Analysis 29
6.2.1 Acute Therapies for Patients with or at Risk of Cardiovascular Disorders and for Patients Unresponsive to Triptan Medication 30
6.2.2 Effective and Well-Tolerated (Migraine-Specific) Preventive Therapies 31
6.2.3 Physician Education 31
6.2.4 Diagnostic Tools 32
7 Pipeline Assessment 33
7.1 Overview 33
7.2 Promising drugs in clinical development 34
8 AVP-825 37
8.1 Overview 37
8.2 Efficacy 38
8.3 Safety 39
8.4 Dosing and Formulation 39
8.5 Potential Clinical Positioning 40
8.6 Potential Commercial Positioning 41
8.7 Pricing and Reimbursement 41
8.8 SWOT Analysis 42
8.9 Forecast 43
9 Appendix 44
9.1 Bibliography 44
9.2 Abbreviations 47
9.3 Methodology 48
9.4 Forecasting Methodology 48
9.4.1 Diagnosed Migraine Patients 49
9.4.2 Percent Drug-treated Patients 49
9.4.3 General Pricing Assumptions 49
9.4.4 Generic Erosion 50
9.4.5 Pricing of Pipeline agents 50
9.5 Physicians and Specialists Included in this Study 51
9.6 Survey of Prescribing Physicians 52
9.7 About the Authors 53
9.7.1 Author 53
9.7.2 Reviewer 53
9.7.3 Global Head of Healthcare 53
9.8 About GlobalData 55
9.9 Disclaimer 55

1.1 List of Tables

Table 1: Classification of Migraine Subtypes 13
Table 2: Diagnostic Criteria for Migraine with Aura 17
Table 3: Diagnostic Criteria for Migraine without Aura 18
Table 4: Treatment Guidelines for Migraine 20
Table 5: Most Prescribed Drugs for Migraine by Class in the Major Markets, 2013 21
Table 6: Overall Unmet Needs - Current Level of Attainment 26
Table 7: Clinical Unmet Needs - Gap Analysis, 2013 30
Table 8: Migraine - Promising Late-Stage Pipeline, 2013 34
Table 9: Comparison of Therapeutic Classes in Development for Migraine, 2013 36
Table 10: Product Profile - AVP-825 38
Table 11: AVP-825 SWOT Analysis, 2013 42
Table 12: Global Sales Forecasts ($m) for AVP-825, 2012-2023 43
Table 13: Physicians Surveyed, By Country 52

1.2 List of Figures

Figure 1: Migraine Treatment Algorithm in the 7MM 21
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Migraine, 2012-2023 35

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