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PharmaPoint: Migraine - 5EU 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.

Each of the countries included in this report provide guidelines for the treatment of migraine. According to GlobalData’s high-prescriber survey, the US, UK and Japan strongly adhere to their own national guidelines; however, the majority of the physicians from other EU countries (France, Germany, Italy and Spain) follow European guidelines such as the European Headache Federation (EHF) and European Federation of Neurological Societies (EFNS) guidelines.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU (the UK, France, Italy, Spain, Germany) 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 5EU (the UK, France, Italy, Spain, Germany).

Table Of Contents

PharmaPoint: Migraine - 5EU Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 19
3.1.3 Prognosis 20
3.2 Symptoms 20
3.2.1 Premonitory Phase 21
3.2.2 Aura Phase 21
3.2.3 Headache Phase 22
3.2.4 Postdrome Phase 22
4 Disease Management 23
4.1 Treatment Overview 23
4.1.1 Acute Migraine Treatment 26
4.1.2 Preventive Migraine Treatment 27
4.2 France 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 28
4.3 Germany 29
4.3.1 Diagnosis 29
4.3.2 Clinical Practice 29
4.4 Italy 30
4.4.1 Diagnosis 30
4.4.2 Clinical Practice 30
4.5 Spain 31
4.5.1 Diagnosis 31
4.5.2 Clinical Practice 32
4.6 UK 33
4.6.1 Diagnosis 33
4.6.2 Clinical Practice 33
5 Competitive Assessment 35
5.1 Overview 35
5.2 Strategic Competitor Assessment 36
5.3 Product Profiles- Major Brands 37
5.3.1 Triptans 37
5.3.2 Imitrex (sumatriptan) 39
5.3.3 Zomig (zolmitriptan) 41
5.3.4 Amerge (naratriptan) 43
5.3.5 Maxalt (rizatriptan) 44
5.3.6 Axert (almotriptan) 46
5.3.7 Frova (frovatriptan) 47
5.3.8 Relpax (eletriptan) 49
5.3.9 Ergot Alkaloids 50
5.3.10 Beta Blockers 55
5.3.11 Anti-Epileptics 57
5.3.12 Antidepressants 60
5.3.13 Calcium Channel Antagonists 63
5.3.14 Botox (onabotulinum toxin A) 65
6 Opportunity and Unmet Need 69
6.1 Overview 69
6.1.1 A Lack of Acute Therapies for Patients with or at Risk of Cardiovascular Disorders 70
6.1.2 Lack of Acute Therapies for Patients Unresponsive to Triptan Medication 70
6.1.3 Lack of Diagnostic Tools Causes Misdiagnosis 71
6.1.4 Physician Education 71
6.1.5 Effective and Well-Tolerated Prophylactic Therapies 72
6.2 Unmet Needs Gap Analysis 72
6.2.1 Acute Therapies for Patients with or at Risk of Cardiovascular Disorders and for Patients Unresponsive to Triptan Medication 73
6.2.2 Effective and Well-Tolerated (Migraine-Specific) Preventive Therapies 74
6.2.3 Physician Education 74
6.2.4 Diagnostic Tools 75
7 Pipeline Assessment 76
7.1 Overview 76
7.2 Promising drugs in clinical development 77
7.2.1 RHB-103 79
7.2.2 Lasmiditan 82
7.2.3 MK-1602 87
7.2.4 RT-001 91
7.2.5 NXN-188 93
8 Market Outlook 96
8.1 France 96
8.1.1 Forecast 96
8.1.2 Key Events 100
8.1.3 Driver and Barriers 100
8.2 Germany 101
8.2.1 Forecast 101
8.2.2 Key Events 105
8.2.3 Driver and Barriers 105
8.3 Italy 106
8.3.1 Forecast 106
8.3.2 Key Events 111
8.3.3 Driver and Barriers 111
8.4 Spain 113
8.4.1 Forecast 113
8.4.2 Key Events 116
8.4.3 Driver and Barriers 116
8.5 United Kingdom 117
8.5.1 Forecast 117
8.5.2 Key Events 121
8.5.3 Driver and Barriers 121
9 Appendix 123
9.1 Bibliography 123
9.2 Abbreviations 131
9.3 Methodology 133
9.4 Forecasting Methodology 133
9.4.1 Diagnosed Migraine Patients 133
9.4.2 Percent Drug-treated Patients 134
9.4.3 Drugs Included in Each Therapeutic Class 134
9.4.4 Launch and Patent Expiry Dates 135
9.4.5 General Pricing Assumptions 136
9.4.6 Individual Drug Assumptions 136
9.4.7 Generic Erosion 143
9.4.8 Pricing of Pipeline agents 143
9.5 Physicians and Specialists Included in this Study 144
9.6 Survey of Prescribing Physicians 145
9.7 About the Authors 146
9.7.1 Author 146
9.7.2 Reviewer 146
9.7.3 Global Head of Healthcare 147
9.8 About GlobalData 148
9.9 Disclaimer 148

1.1 List of Tables

Table 1: Classification of Migraine Subtypes 17
Table 2: Diagnostic Criteria for Migraine with Aura 21
Table 3: Diagnostic Criteria for Migraine without Aura 22
Table 4: Treatment Guidelines for Migraine 24
Table 5: Most Prescribed Drugs for Migraine by Class in the Major Markets, 2013 25
Table 6: Product Profile - Triptans 38
Table 7: Triptans SWOT Analysis, 2013 39
Table 8: Product Profile - Ergot Alkaloids 52
Table 9: Ergot Alkaloids SWOT Analysis, 2013 55
Table 10: Product Profile - Beta Blockers 56
Table 11: Beta Blockers SWOT Analysis, 2013 57
Table 12: Product Profile - Anti-Epileptics 58
Table 13: Anti-Epileptics SWOT Analysis, 2013 60
Table 14: Product Profile - Antidepressants 62
Table 15: Antidepressants SWOT Analysis, 2013 63
Table 16: Product Profile-Calcium Channel Antagonists 64
Table 17: Calcium Channel Antagonists SWOT Analysis, 2013 65
Table 18: Product Profile - Botox 66
Table 19: Botox SWOT Analysis, 2013 68
Table 20: Overall Unmet Needs - Current Level of Attainment 69
Table 21: Clinical Unmet Needs - Gap Analysis, 2013 73
Table 22: Migraine - Promising Late-Stage Pipeline, 2013 77
Table 23: Comparison of Therapeutic Classes in Development for Migraine, 2013 79
Table 24: Product Profile - RHB-103 80
Table 25: RHB-103 SWOT Analysis, 2013 82
Table 26: Product Profile - Lasmiditan 84
Table 27: Lasmiditan SWOT Analysis, 2013 87
Table 28: Product Profile - MK-1602 88
Table 29: MK-1602 SWOT Analysis, 2013 91
Table 30: Product Profile - RT-001 93
Table 31: RT-001 SWOT Analysis, 2013 93
Table 32: Product Profile - NXN-188 94
Table 33: NXN-188 SWOT Analysis, 2013 95
Table 34: Sales Forecasts ($m) for Migraine in France, 2012-2023 97
Table 35: Key Events Impacting Sales for Migraine in France, 2012-2023 100
Table 36: Migraine Market - Drivers and Barriers, 2012-2023 100
Table 37: Sales Forecasts ($m) for Migraine in Germany, 2012-2023 103
Table 38: Key Events Impacting Sales for Migraine in Germany, 2012-2023 105
Table 39: German Migraine Market - Drivers and Barriers, 2012-2023 105
Table 40: Sales Forecasts ($m) for Migraine in Italy, 2012-2023 108
Table 41: Key Events Impacting Sales for Migraine in Italy, 2012-2023 111
Table 42: Italian Migraine Market - Drivers and Barriers, 2012-2023 111
Table 43: Sales Forecasts ($m) for Migraine in Spain, 2012-2023 113
Table 44: Key Events Impacting Sales for Migraine in Spain, 2012-2023 116
Table 45: Spanish Migraine Market - Drivers and Barriers, 2012-2023 116
Table 46: Sales Forecasts ($m) for Migraine in the UK, 2012-2023 118
Table 47: Key Events Impacting Sales for Migraine in the UK, 2012-2023 121
Table 48: UK Migraine Market - Drivers and Barriers, 2012-2023 121
Table 49: Key Launch or Approval Dates 135
Table 50: Key Patent Expiries 135
Table 51: Physicians Surveyed, By Country 145

1.2 List of Figures

Figure 1: Migraine Treatment Algorithm in the 7MM 25
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Migraine, 2012-2023 78
Figure 3: Sales for Migraine in France by Drug Class, 2012-2023 99
Figure 4: Sales for Migraine in Germany by Drug Class, 2012-2023 104
Figure 5: Sales for Migraine in Italy by Drug Class, 2012-2023 110
Figure 6: Sales for Migraine in Spain by Drug Class, 2012-2023 115
Figure 7: Sales for Migraine in the UK by Drug Class, 2012-2023 120

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