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PharmaPoint: Migraine - Global 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.

Highlights

Key Questions Answered

- The migraine market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the migraine market?
- The late-stage migraine pipeline is filled with therapies with diverse formulations and routes of administration. Which drug will have a significant impact on the migraine market. Which of these drugs will have the highest CAGR, and why?
- The migraine market is currently dominated by generic drugs. How will the introduction of combinations of device and drugs, and new classes of therapies change the treatment landscape once reimbursement is not a problem anymore? How will the drug treatment rates change over the next ten years? What are the key drivers and barriers to this change?

Key Findings

- The main driver of the expansion of the migraine market will be the continuous use of Botox for chronic migraine. The introduction of reformulations of mature products as well as new classes of therapies will further increase the market size.
- The biggest barrier for the introduction of new therapies will be patent expirations of the majority of the drugs marketed for migraine, which have resulted in an increase of generics, and which may negatively impact revenue from branded drugs that are expected to launch in the forecast period.
- The concerns of reducing healthcare costs as part of government austerity measures, particularly in Europe, which will impede market growth. To ensure reimbursement companies will have to work closely together with payers and price their drugs competitively.

Scope

- Overview of migraine, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized migraine therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2023.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the migraine therapeutics market.
- Pipeline analysis: focus on the seven late-stage pipeline drugs discussing emerging trends as well as overview of earlier phase drugs.
- Analysis of the current and future market competition in the global migraine therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global migraine therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global migraine therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global migraine therapeutics market from 2012-2017.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

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

2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 24
2.3 Upcoming Related Reports 24
3 Disease Overview 25
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 28
3.1.3 Prognosis 29
3.2 Symptoms 29
3.2.1 Premonitory Phase 30
3.2.2 Aura Phase 30
3.2.3 Headache Phase 31
3.2.4 Postdrome Phase 31
4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 33
4.2.1 Female sex and family history are interrelated risk factors of migraine 33
4.2.2 People with migraine also suffer from several comorbidities 34
4.3 Global Trends 35
4.3.1 US 36
4.3.2 5EU 37
4.3.3 Japan 38
4.4 Forecast methodology 39
4.4.1 Sources used 41
4.4.2 Sources not used 44
4.4.3 Forecast assumptions and methods 44
4.5 Epidemiological Forecast for Migraine (2013-2023) 49
4.5.1 Total Prevalent Cases of Migraine 49
4.5.2 Age-Specific Total Prevalent Cases of Migraine 50
4.5.3 Sex-Specific Total Prevalent Cases of Migraine 52
4.5.4 Age-Standardized Total Prevalence of Migraine 54
4.5.5 Total Prevalent Cases of Migraine with Aura and Migraine without Aura 55
4.6 Discussion 57
4.6.1 Conclusions on Epidemiological Trends 57
4.6.2 Limitations of the Analysis 58
4.6.3 Strengths of the Analysis 59
5 Disease Management 60
5.1 Treatment Overview 60
5.1.1 Acute Migraine Treatment 63
5.1.2 Preventive Migraine Treatment 64
5.2 US 65
5.2.1 Diagnosis 65
5.2.2 Clinical Practice 65
5.3 France 66
5.3.1 Diagnosis 66
5.3.2 Clinical Practice 66
5.4 Germany 67
5.4.1 Diagnosis 67
5.4.2 Clinical Practice 68
5.5 Italy 69
5.5.1 Diagnosis 69
5.5.2 Clinical Practice 69
5.6 Spain 70
5.6.1 Diagnosis 70
5.6.2 Clinical Practice 70
5.7 UK 71
5.7.1 Diagnosis 71
5.7.2 Clinical Practice 72
5.8 Japan 73
5.8.1 Diagnosis 73
5.8.2 Clinical Practice 73
6 Competitive Assessment 74
6.1 Overview 74
6.2 Strategic Competitor Assessment 75
6.3 Product Profiles- Major Brands 76
6.3.1 Triptans 76
6.3.2 Imitrex (sumatriptan) 78
6.3.3 Zomig (zolmitriptan) 81
6.3.4 Amerge (naratriptan) 84
6.3.5 Maxalt (rizatriptan) 86
6.3.6 Axert (almotriptan) 89
6.3.7 Frova (frovatriptan) 91
6.3.8 Relpax (eletriptan) 93
6.3.9 Sumavel DosePro (sumatriptan) 96
6.3.10 Ergot Alkaloids 99
6.3.11 Beta Blockers 105
6.3.12 Anti-Epileptics 108
6.3.13 Antidepressants 112
6.3.14 Calcium Channel Antagonists 115
6.3.15 Botox (onabotulinum toxin A) 118
7 Opportunity and Unmet Need 122
7.1 Overview 122
7.1.1 A Lack of Acute Therapies for Patients with or at Risk of Cardiovascular Disorders 123
7.1.2 Lack of Acute Therapies for Patients Unresponsive to Triptan Medication 123
7.1.3 Lack of Diagnostic Tools Causes Misdiagnosis 124
7.1.4 Physician Education 124
7.1.5 Effective and Well-Tolerated Prophylactic Therapies 125
7.2 Unmet Needs Gap Analysis 125
7.2.1 Acute Therapies for Patients with or at Risk of Cardiovascular Disorders and for Patients Unresponsive to Triptan Medication 127
7.2.2 Effective and Well-Tolerated (Migraine-Specific) Preventive Therapies 127
7.2.3 Physician Education 128
7.2.4 Diagnostic Tools 128
8 Pipeline Assessment 129
8.1 Overview 129
8.2 Clinical Trial Mapping 130
8.2.1 Clinical Trials by Country 130
8.3 Clinical Trials by Phase and Trial status 131
8.4 Promising drugs in clinical development 132
8.4.1 Zecuity 134
8.4.2 Levadex 139
8.4.3 RHB-103 144
8.4.4 AVP-825 148
8.4.5 Lasmiditan 154
8.4.6 MK-1602 160
8.4.7 SUD-001 165
8.4.8 RT-001 169
8.4.9 NXN-188 171
9 Current and Future Players 174
9.1 Overview 174
9.2 Trends in Corporate Strategy 177
9.3 Company Profiles 178
9.3.1 GlaxoSmithKline 178
9.3.2 AstraZeneca 181
9.3.3 Merck 183
9.3.4 Vernalis 185
9.3.5 Almirall 186
9.3.6 Pfizer 187
9.3.7 Zogenix 188
9.3.8 NuPathe 189
9.3.9 Allergan 191
9.3.10 RedHill Biopharma 192
9.3.11 OptiNose 193
9.3.12 CoLucid Pharmaceuticals 195
9.3.13 SUDA 196
9.3.14 Revance Therapeutics 197
9.3.15 NeurAxon 198
10 Market Outlook 200
10.1 Global Markets 200
10.1.1 Forecast 200
10.1.2 Drivers and Barriers - Global Issues 204
10.2 US 204
10.2.1 Forecast 204
10.2.2 Key Events 209
10.2.3 Drivers and Barriers 209
10.3 France 211
10.3.1 Forecast 211
10.3.2 Key Events 215
10.3.3 Driver and Barriers 215
10.4 Germany 216
10.4.1 Forecast 216
10.4.2 Key Events 220
10.4.3 Driver and Barriers 220
10.5 Italy 221
10.5.1 Forecast 221
10.5.2 Key Events 225
10.5.3 Driver and Barriers 225
10.6 Spain 227
10.6.1 Forecast 227
10.6.2 Key Events 231
10.6.3 Driver and Barriers 231
10.7 United Kingdom 232
10.7.1 Forecast 232
10.7.2 Key Events 236
10.7.3 Driver and Barriers 236
10.8 Japan 238
10.8.1 Forecast 238
10.8.2 Key Events 242
10.8.3 Driver and Barriers 242
11 Appendix 244
11.1 Bibliography 244
11.2 Abbreviations 257
11.3 Methodology 260
11.4 Forecasting Methodology 260
11.4.1 Diagnosed Migraine Patients 260
11.4.2 Percent Drug-treated Patients 260
11.4.3 Drugs Included in Each Therapeutic Class 261
11.4.4 Launch and Patent Expiry Dates 262
11.4.5 General Pricing Assumptions 263
11.4.6 Individual Drug Assumptions 264
11.4.7 Generic Erosion 271
11.4.8 Pricing of Pipeline agents 271
11.5 Physicians and Specialists Included in this Study 273
11.6 Survey of Prescribing Physicians 274
11.7 About the Authors 275
11.7.1 Author 275
11.7.2 Reviewer 275
11.7.3 Epidemiologist 276
11.7.4 Global Head of Healthcare 276
11.8 About GlobalData 277
11.9 Disclaimer 277

1.1 List of Tables

Table 1: Classification of Migraine Subtypes 26
Table 2: Diagnostic Criteria for Migraine with Aura 30
Table 3: Diagnostic Criteria for Migraine without Aura 31
Table 4: Risk Factors and Comorbidities for Migraine 33
Table 5: Prevalence of the Most Frequent Comorbidities in People with and without Migraine, Ages ?18 Years, Both Sexes 35
Table 6: One-Year Total Prevalence (%) of Migraine in the 5EU 38
Table 7: Lifetime Total Prevalence (%) of Migraine in the 3EU 38
Table 8: Criteria Proposed by the Second Edition of the International Classification of Headache Disorders (ICHD-2) 39
Table 9: Epidemiological Sources of Total Prevalence Data Used in the Analysis for Migraine and its Subtypes (Migraine with Aura and Migraine without Aura) 40
Table 10: 7MM, Total Prevalent Cases of Migraine, Ages ?18 Years, Both Sexes, N, 2013-2023 49
Table 11: 7MM, Total Prevalent Cases of Migraine, by Age, Both Sexes, N, (Row %), 2013 51
Table 12: 7MM, Total Prevalent Cases of Migraine, by Sex, Ages ?18 years, N (Row %), 2013 53
Table 13: 7MM, Total Prevalent Cases of Migraine with Aura and Migraine without Aura, Ages ?18 Years, Both Sexes, N, Row (%), 2013 56
Table 14: Treatment Guidelines for Migraine 61
Table 15: Most Prescribed Drugs for Migraine by Class in the Major Markets, 2013 62
Table 16: Product Profile - Triptans 77
Table 17: Triptans SWOT Analysis, 2013 78
Table 18: Global Sales Forecasts ($m) for Imitrex, 2012-2023 81
Table 19: Global Sales Forecasts ($m) for Zomig, 2012-2023 84
Table 20: Global Sales Forecasts ($m) for Amerge, 2012-2023 86
Table 21: Global Sales Forecasts ($m) for Maxalt, 2012-2023 89
Table 22: Global Sales Forecasts ($m) for Axert, 2012-2023 91
Table 23: Global Sales Forecasts ($m) for Frova, 2012-2023 93
Table 24: Global Sales Forecasts ($m) for Relpax, 2012-2023 95
Table 25: Product Profile - Sumavel DosePro 97
Table 26: Sumavel DosePro SWOT Analysis, 2013 98
Table 27: Global Sales Forecasts ($m) for Sumavel DosePro, 2012-2023 99
Table 28: Product Profile - Ergot Alkaloids 101
Table 29: Ergot Alkaloids SWOT Analysis, 2013 104
Table 30: Global Sales Forecasts ($m) for Ergot Alkaloids, 2012-2023 105
Table 31: Product Profile - Beta Blockers 106
Table 32: Beta Blockers SWOT Analysis, 2013 107
Table 33: Global Sales Forecasts ($m) for Beta Blockers, 2012-2023 108
Table 34: Product Profile - Anti-Epileptics 109
Table 35: Anti-Epileptics SWOT Analysis, 2013 111
Table 36: Global Sales Forecasts ($m) for Anti-Epileptics, 2012-2023 112
Table 37: Product Profile - Antidepressants 113
Table 38: Antidepressants SWOT Analysis, 2013 114
Table 39: Global Sales Forecasts ($m) for Antidepressants, 2012-2023 115
Table 40: Product Profile-Calcium Channel Antagonists 116
Table 41: Calcium Channel Antagonists SWOT Analysis, 2013 117
Table 42: Global Sales Forecasts ($m) for Calcium Channel Antagonists, 2012-2023 118
Table 43: Product Profile - Botox 119
Table 44: Botox SWOT Analysis, 2013 120
Table 45: Global Sales Forecasts ($m) for Botox, 2012-2023 121
Table 46: Overall Unmet Needs - Current Level of Attainment 122
Table 47: Clinical Unmet Needs - Gap Analysis, 2013 126
Table 48: Migraine - Clinical Trials by Phase and Status, 2013 131
Table 49: Migraine - Promising Late-Stage Pipeline, 2013 132
Table 50: Comparison of Therapeutic Classes in Development for Migraine, 2013 134
Table 51: Product Profile - Zecuity 135
Table 52: Zecuity SWOT Analysis, 2013 138
Table 53: Global Sales Forecasts ($m) for Zecuity, 2012-2023 138
Table 54: Product Profile - Levadex 140
Table 55: Levadex SWOT Analysis, 2013 143
Table 56: Global Sales Forecasts ($m) for Levadex, 2012-2023 143
Table 57: Product Profile - RHB-103 145
Table 58: RHB-103 SWOT Analysis, 2013 147
Table 59: Global Sales Forecasts ($m) for RHB-103, 2012-2023 148
Table 60: Product Profile - AVP-825 149
Table 61: AVP-825 SWOT Analysis, 2013 153
Table 62: Global Sales Forecasts ($m) for AVP-825, 2012-2023 154
Table 63: Product Profile - Lasmiditan 155
Table 64: Lasmiditan SWOT Analysis, 2013 159
Table 65: Global Sales Forecasts ($m) for lasmiditan, 2012-2023 160
Table 66: Product Profile - MK-1602 161
Table 67: MK-1602 SWOT Analysis, 2013 164
Table 68: Global Sales Forecasts ($m) for MK-1602, 2012-2023 165
Table 69: Product Profile - SUD-001 166
Table 70: SUD-001 SWOT Analysis, 2013 168
Table 71: Global Sales Forecasts ($m) for SUD-001, 2012-2023 169
Table 72: Product Profile - RT-001 170
Table 73: RT-001 SWOT Analysis, 2013 171
Table 74: Product Profile - NXN-188 172
Table 75: NXN-188 SWOT Analysis, 2013 173
Table 76: Key Companies in the Migraine Market, 2013 176
Table 77: GSK's Migraine Portfolio Assessment, 2013 180
Table 78: GSK SWOT Analysis, 2013 181
Table 79: AstraZeneca's Migraine Portfolio Assessment, 2013 182
Table 80: AstraZeneca SWOT Analysis, 2013 182
Table 81: Merck's Migraine Portfolio Assessment, 2013 184
Table 82: Merck SWOT Analysis, 2013 184
Table 83: Vernalis' Migraine Portfolio Assessment, 2013 185
Table 84: Vernalis SWOT Analysis, 2013 185
Table 85: Almirall's Migraine Portfolio Assessment, 2013 186
Table 86: Almirall SWOT Analysis, 2013 186
Table 87: Pfizer's Migraine Portfolio Assessment, 2013 187
Table 88: Pfizer SWOT Analysis, 2013 188
Table 89: Zogenix's Migraine Portfolio Assessment, 2013 189
Table 90: Zogenix SWOT Analysis, 2013 189
Table 91: NuPathe's Migraine Portfolio Assessment, 2013 190
Table 92: NuPathe SWOT Analysis, 2013 190
Table 93: Allergan's Migraine Portfolio Assessment, 2013 192
Table 94: Allergan SWOT Analysis, 2013 192
Table 95: RedHill's Migraine Portfolio Assessment, 2013 193
Table 96: RedHill SWOT Analysis, 2013 193
Table 97: OptiNose's Migraine Portfolio Assessment, 2013 194
Table 98: OptiNose SWOT Analysis, 2013 194
Table 99: CoLucid Pharmaceuticals' Migraine Portfolio Assessment, 2013 195
Table 100: CoLucid Pharmaceuticals SWOT Analysis, 2013 196
Table 101: SUDA's Migraine Portfolio Assessment, 2013 197
Table 102: SUDA SWOT Analysis, 2013 197
Table 103: Revance Therapeutics' Migraine Portfolio Assessment, 2013 198
Table 104: Revance Therapeutics SWOT Analysis, 2013 198
Table 105: NeurAxon's Migraine Portfolio Assessment, 2013 199
Table 106: NeurAxon SWOT Analysis, 2013 199
Table 107: Global Sales Forecasts ($m) for Migraine, 2012-2023 201
Table 108: Migraine Market - Drivers and Barriers, 2012-2023 204
Table 109: Sales Forecasts ($m) for Migraine in the US, 2012-2023 206
Table 110: Key Events Impacting Sales for Migraine in the US, 2012-2023 209
Table 111: US Migraine Market - Drivers and Barriers, 2012-2023 209
Table 112: Sales Forecasts ($m) for Migraine in France, 2012-2023 212
Table 113: Key Events Impacting Sales for Migraine in France, 2012-2023 215
Table 114: Migraine Market - Drivers and Barriers, 2012-2023 215
Table 115: Sales Forecasts ($m) for Migraine in Germany, 2012-2023 218
Table 116: Key Events Impacting Sales for Migraine in Germany, 2012-2023 220
Table 117: German Migraine Market - Drivers and Barriers, 2012-2023 220
Table 118: Sales Forecasts ($m) for Migraine in Italy, 2012-2023 222
Table 119: Key Events Impacting Sales for Migraine in Italy, 2012-2023 225
Table 120: Italian Migraine Market - Drivers and Barriers, 2012-2023 225
Table 121: Sales Forecasts ($m) for Migraine in Spain, 2012-2023 228
Table 122: Key Events Impacting Sales for Migraine in Spain, 2012-2023 231
Table 123: Spanish Migraine Market - Drivers and Barriers, 2012-2023 231
Table 124: Sales Forecasts ($m) for Migraine in the UK, 2012-2023 233
Table 125: Key Events Impacting Sales for Migraine in the UK, 2012-2023 236
Table 126: UK Migraine Market - Drivers and Barriers, 2012-2023 236
Table 127: Sales Forecasts ($m) for Migraine in Japan, 2012-2023 239
Table 128: Key Events Impacting Sales for Migraine in Japan, 2012-2023 242
Table 129: Japanese Migraine Market - Drivers and Barriers, 2012-2023 242
Table 130: Key Launch or Approval Dates 262
Table 131: Key Patent Expiries 262
Table 132: Physicians Surveyed, By Country 27

1.2 List of Figures
Figure 1: 7MM, Total Prevalent Cases of Migraine, Ages ?18 Years, Both Sexes, N, 2013-2023 50
Figure 2: 7MM, Total Prevalent Cases of Migraine, by Age, Both Sexes, N, 2013 52
Figure 3: 7MM, Total Prevalent Cases of Migraine, by Sex, Ages ?18 Years, N, 2013 54
Figure 4: 7MM, Age-Standardized Total Prevalence of Migraine, Ages ?18 Years, 2013 55
Figure 5: 7MM, Total Prevalent Cases of Migraine with Aura and Migraine without Aura, Ages ?18 Years, Both Sexes, N, Row (%), 2013 57
Figure 6: Migraine Treatment Algorithm in the 7MM 62
Figure 7: Migraine Therapeutics - Clinical Trials by Country, 2012 130
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in Migraine, 2012-2023 133
Figure 9: Company Portfolio Gap Analysis in Migraine, 2012-2023 177
Figure 10: Global Sales for Migraine by Region, 2012-2023 203
Figure 11: Sales for Migraine in the US by Drug Class, 2012-2023 208
Figure 12: Sales for Migraine in France by Drug Class, 2012-2023 214
Figure 13: Sales for Migraine in Germany by Drug Class, 2012-2023 219
Figure 14: Sales for Migraine in Italy by Drug Class, 2012-2023 224
Figure 15: Sales for Migraine in Spain by Drug Class, 2012-2023 230
Figure 16: Sales for Migraine in the UK by Drug Class, 2012-2023 235
Figure 17: Sales for Migraine in Japan by Drug Class, 2012-2023 241

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