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PharmaPoint: Migraine - US Drug 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.

The US migraine market is the largest given its population size and high drug prices. The main growth driver during this period will be Allergan’s Botox, in addition to the launch of new combinations of drug and device and new classes of acute therapy. Historically the triptans have dominated the acute migraine segment and although the gold standard, GSK’s Imitrex, expired in 2008, it has remained as one of the most popular triptans among physicians. A recent trend in this segment is the development of devices that can deliver drugs in a more effective way, such as Sumavel DosePro, a needle-free injection of sumatriptan.

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 the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Migraine market.

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 drug performance
- Obtain sales forecast for drugs from 2012-2023 in the US

Table Of Contents

PharmaPoint: Migraine - US Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.1.3 Prognosis 19
3.2 Symptoms 19
3.2.1 Premonitory Phase 20
3.2.2 Aura Phase 20
3.2.3 Headache Phase 21
3.2.4 Postdrome Phase 21
4 Disease Management 22
4.1 Treatment Overview 22
4.1.1 Acute Migraine Treatment 25
4.1.2 Preventive Migraine Treatment 26
4.2 US 27
4.2.1 Diagnosis 27
4.2.2 Clinical Practice 27
5 Competitive Assessment 29
5.1 Overview 29
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles- Major Brands 31
5.3.1 Triptans 31
5.3.2 Imitrex (sumatriptan) 33
5.3.3 Zomig (zolmitriptan) 35
5.3.4 Amerge (naratriptan) 37
5.3.5 Maxalt (rizatriptan) 38
5.3.6 Axert (almotriptan) 40
5.3.7 Frova (frovatriptan) 41
5.3.8 Relpax (eletriptan) 43
5.3.9 Sumavel DosePro (sumatriptan) 44
5.3.10 Ergot Alkaloids 47
5.3.11 Beta Blockers 52
5.3.12 Anti-Epileptics 54
5.3.13 Antidepressants 57
5.3.14 Calcium Channel Antagonists 60
5.3.15 Botox (onabotulinum toxin A) 62
6 Opportunity and Unmet Need 66
6.1 Overview 66
6.1.1 A Lack of Acute Therapies for Patients with or at Risk of Cardiovascular Disorders 67
6.1.2 Lack of Acute Therapies for Patients Unresponsive to Triptan Medication 67
6.1.3 Lack of Diagnostic Tools Causes Misdiagnosis 68
6.1.4 Physician Education 68
6.1.5 Effective and Well-Tolerated Prophylactic Therapies 69
6.2 Unmet Needs Gap Analysis 69
6.2.1 Acute Therapies for Patients with or at Risk of Cardiovascular Disorders and for Patients Unresponsive to Triptan Medication 70
6.2.2 Effective and Well-Tolerated (Migraine-Specific) Preventive Therapies 71
6.2.3 Physician Education 71
6.2.4 Diagnostic Tools 72
7 Pipeline Assessment 73
7.1 Overview 73
7.2 Promising drugs in clinical development 74
7.2.1 Zecuity 76
7.2.2 Levadex 80
7.2.3 RHB-103 84
7.2.4 AVP-825 87
7.2.5 Lasmiditan 93
7.2.6 MK-1602 98
7.2.7 SUD-001 102
7.2.8 RT-001 106
7.2.9 NXN-188 108
8 Market Outlook 110
8.1 US 110
8.1.1 Forecast 110
8.1.2 Key Events 115
8.1.3 Drivers and Barriers 115
9 Appendix 118
9.1 Bibliography 118
9.2 Abbreviations 126
9.3 Methodology 128
9.4 Forecasting Methodology 128
9.4.1 Diagnosed Migraine Patients 128
9.4.2 Percent Drug-treated Patients 128
9.4.3 Drugs Included in Each Therapeutic Class 129
9.4.4 Launch and Patent Expiry Dates 130
9.4.5 General Pricing Assumptions 131
9.4.6 Individual Drug Assumptions 131
9.4.7 Generic Erosion 137
9.4.8 Pricing of Pipeline agents 137
9.5 Physicians and Specialists Included in this Study 138
9.6 Survey of Prescribing Physicians 139
9.7 About the Authors 140
9.7.1 Author 140
9.7.2 Reviewer 140
9.7.3 Global Head of Healthcare 141
9.8 About GlobalData 142
9.9 Disclaimer 142

1.1 List of Tables

Table 1: Classification of Migraine Subtypes 16
Table 2: Diagnostic Criteria for Migraine with Aura 20
Table 3: Diagnostic Criteria for Migraine without Aura 21
Table 4: Treatment Guidelines for Migraine 23
Table 5: Most Prescribed Drugs for Migraine by Class in the Major Markets, 2013 24
Table 6: Product Profile - Triptans 32
Table 7: Triptans SWOT Analysis, 2013 33
Table 8: Product Profile - Sumavel DosePro 45
Table 9: Sumavel DosePro SWOT Analysis, 2013 46
Table 10: Product Profile - Ergot Alkaloids 48
Table 11: Ergot Alkaloids SWOT Analysis, 2013 51
Table 12: Product Profile - Beta Blockers 53
Table 13: Beta Blockers SWOT Analysis, 2013 54
Table 14: Product Profile - Anti-Epileptics 55
Table 15: Anti-Epileptics SWOT Analysis, 2013 57
Table 16: Product Profile - Antidepressants 59
Table 17: Antidepressants SWOT Analysis, 2013 60
Table 18: Product Profile-Calcium Channel Antagonists 61
Table 19: Calcium Channel Antagonists SWOT Analysis, 2013 62
Table 20: Product Profile - Botox 63
Table 21: Botox SWOT Analysis, 2013 65
Table 22: Overall Unmet Needs - Current Level of Attainment 66
Table 23: Clinical Unmet Needs - Gap Analysis, 2013 70
Table 24: Migraine - Promising Late-Stage Pipeline, 2013 74
Table 25: Comparison of Therapeutic Classes in Development for Migraine, 2013 76
Table 26: Product Profile - Zecuity 77
Table 27: Zecuity SWOT Analysis, 2013 80
Table 28: Product Profile - Levadex 81
Table 29: Levadex SWOT Analysis, 2013 84
Table 30: Product Profile - RHB-103 85
Table 31: RHB-103 SWOT Analysis, 2013 87
Table 32: Product Profile - AVP-825 89
Table 33: AVP-825 SWOT Analysis, 2013 93
Table 34: Product Profile - Lasmiditan 94
Table 35: Lasmiditan SWOT Analysis, 2013 98
Table 36: Product Profile - MK-1602 99
Table 37: MK-1602 SWOT Analysis, 2013 102
Table 38: Product Profile - SUD-001 103
Table 39: SUD-001 SWOT Analysis, 2013 105
Table 40: Product Profile - RT-001 107
Table 41: RT-001 SWOT Analysis, 2013 107
Table 42: Product Profile - NXN-188 108
Table 43: NXN-188 SWOT Analysis, 2013 109
Table 44: Sales Forecasts ($m) for Migraine in the US, 2012-2023 112
Table 45: Key Events Impacting Sales for Migraine in the US, 2012-2023 115
Table 46: US Migraine Market - Drivers and Barriers, 2012-2023 115
Table 47: Key Launch or Approval Dates 130
Table 48: Key Patent Expiries 130
Table 49: Physicians Surveyed, By Country 139

1.2 List of Figures

Figure 1: Migraine Treatment Algorithm in the 7MM 24
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Migraine, 2012-2023 75
Figure 3: Sales for Migraine in the US by Drug Class, 2012-2023 114

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