Migraine (Event Driven)

Decision Resources, Inc, January 2012, Pages: 193

The bulk of the $3.4 billion migraine market in 2010 was triptan drugs, prescribed for the acute treatment of migraine. The rapid genericization of this class over the 2010-2020 study period will force new acute therapies to demonstrate significant benefits over generic options in order to compete. New prophylactic therapies face similar pressure: only one branded therapy (onabotulinumtoxinA [Allergan’s Botox]) remains on the market.

Despite the dominance of generic options for both acute and prophylactic therapies, weaknesses in current products’ efficacy and side effects present significant opportunity for new therapies to treat both episodic and chronic migraineurs. Moreover, we forecast increases in diagnosis and drug treatment rates across the major markets during our forecast period. As such, we forecast that sales of emerging acute therapies and continued uptake of onabotulinumtoxinA will overcome losses to triptan generic erosion, leading to a $4.4 billion market in 2020.

Executive Summary
What are the key parameters of the migraine market?
What factors are driving the market for migraine therapies?
What factors are constraining the market for migraine therapies?
What are the drug development activities of note in migraine?
What do the experts say?
What key challenges and opportunities remain?

1 . Etiology and Pathophysiology
Overview
Etiology
Genetic Factors
Environmental Factors: Migraine Triggers
Pathways and Drug Targets
The Vasculature in Migraine
Wolff’s Theory
Spreading Oligemia
Substances Involved in Neurotransmission in Migraine
Serotonin
Dopamine
Glutamate
Gamma-Aminobutyric Acid
Calcitonin Gene-Related Peptide
Nitric Oxide
Hormones
Magnesium
Neurogenic Inflammation
Spreading Nerve Cell Depression in Migraine Aura
Role of the Trigeminovascular System
Central Sensitization
The Brain Stem as Migraine Generator
Targets of Prophylactic Migraine Therapies
The Chronification of Migraine

2 . Epidemiology and Patient Populations
Overview
Disease Definition
Methods
Episodic Migraine Prevalence
Episodic Migraine Attack Frequency
Chronic Migraine Prevalence
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated
Acute Migraine Treatment
Migraine Prophylaxis

3 . Current Therapies and Medical Practice
Treatment Providers
Goals of Treatment
Currently Marketed Products
Acute Treatment
Prophylactic Treatment
Treatment Guidelines and Factors Influencing Drug Selection
Treatment Algorithm
Acute Treatment
Prophylactic Treatment
Menstrual Migraine
Country-Specific Prescribing Practices
Country-Specific Reimbursement Issues

4 . Unmet Needs
Overview
Acute Treatment
Greater Efficacy than the Oral Triptans
Nontriptan Migraine-Specific Alternatives
Better Tolerability than the Triptans
Prophylactic Treatment
More-Efficacious Drugs
More Drugs with Acceptable Tolerability
Agents Approved for the Prevention of Chronic Migraine

5 . Emerging Therapies
Overview
Future Positioning of Key Competitors
Drug Development and Regulatory Hurdles

5-HT

1B/1D

Receptor Agonists

Overview
Mechanism of Action
NP-101 (Sumatriptan Iontophoretic Transdermal Patch)
INT-008 (Rizatriptan Oral Film)
Zolmitriptan Oral Dispersible Film (ODF)
NVD-201 (Sumatriptan Oral Spray)
Sumatriptan Intranasal Powder
Ergot Derivatives
Mechanism of Action
Orally Inhaled Dihydroergotamine (Levadex, MAP-004)
Other Serotonergic Agents
Mechanism of Action
Lasmiditan (COL-144)
Nitric Oxide Synthase Inhibitors
Overview
Mechanism of Action
NXN-188
MTR-106
Dopamine Antagonists
Overview
Mechanism of Action
AZ-104
Antiepileptic Drugs
Overview
Mechanism of Action
DP-VPA

6 . Market Outlook
Overview
Drug-Class-Specific Trends

1B/1D

Receptor Agonists

Ergot Derivatives

5-HT

Receptor Agonists

Other Acute Therapies
Prophylactic Therapies
Segment-Specific Trends
Acute Migraine Treatment
Migraine Prophylaxis
Episodic and Chronic Migraine

Appendix A . Bibliography—Migraine

Appendix B . Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Agents Included in Our Market Analysis
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy and Compliance
Acute Treatments
Prophylactic Treatments
Generic Erosion
Emerging Therapy Prices
Sumatriptan Pre-Filled Autoinjector
Orally Inhaled Dihydroergotamine (Levadex [MAP-0004])
NP-101 (Sumatriptan Iontophoretic Patch)
Zolmitriptan Oral Dispersible Film
INT-008
Sumatriptan Intranasal Powder
Lasmiditan

Appendix C . Experts Interviewed—Migraine

Appendix D . Supplemental Epidemiology Bibliography

Tables and Figures

Table 1-1. Role of 5-HT Receptor Subtypes in Migraine

Table 2-1. Number of Total, Diagnosed, and Acutely Drug-Treated Prevalent Cases of Episodic Migraine in the Major Pharmaceutical Markets, 2010-2020

Table 2-2. Number of Total, Diagnosed, and Acutely Drug-Treated Prevalent Cases of Chronic Migraine in the Major Pharmaceutical Markets, 2010-2020

Table 2-3. Number of Total, Diagnosed, and Prophylactically Drug-Treated Prevalent Cases of Episodic Mi- graine in the Major Pharmaceutical Markets, 2010-2020

Table 2-4. Number of Total, Diagnosed, and Prophylactically Drug-Treated Prevalent Cases of Chronic Mi- graine in the Major Pharmaceutical Markets, 2010-2020

Table 2-5. Number of Total Episodic Migraine Events in the Major Pharmaceutical Markets, 2010-2020

Table 2-6. Key Sources for Migraine Epidemiology and Model Parameters

Table 3-1. Migraine Treatment Providers and Referral Patterns, by Market

Table 3-2. End Points Used in Clinical Trials for Migraine

Table 3-3. Current Drug Classes Used for Treatment of Migraine—Mechanism of Action

Table 3-4. Key Current Therapies Used for the Acute Treatment of Migraine

Table 3-5. Main Efficacy Outcomes for Key Therapies Approved for the Acute Treatment of Migraine

Table 3-6. Main Efficacy Outcomes for Key Therapies Approved for Migraine Prophylaxis

Table 3-7. Comparison of Key Current Therapies for the Acute Treatment of Migraine Attacks

Table 3-8. Expert Insight: Leading Drugs for the Acute Treatment of Migraine Attacks

Table 3-9. Key Current Therapies Used for Migraine Prophylaxis

Table 3-10. Comparison of Key Current Therapies for Migraine Prophylaxis

Table 3-11. Expert Insight: Leading Drugs in Migraine Prophylaxis

Table 3-12. Migraine Treatment Guidelines, by Market

Table 3-13. Factors Influencing Drug Selection in Migraine

Table 3-14. Expert Insight on Prescribing Trends in Migraine Treatment, by Market

Table 3-15. Reimbursement Trends, by Market

Table 5-1. Emerging Therapies in Development for the Acute Treatment of Migraine

Table 5-2. Emerging Therapies in Development for Migraine Prophylaxis

Table 5-3. Estimated Launch Dates for Key Emerging Therapies for the Treatment of Migraine

Table 5-4. Early-Stage Emerging Therapies in Development for the Acute and Prophylactic Treatment of Migraine

Table 5-5. Expert Insight: Leading Emerging Drugs for the Acute Treatment of Migraine

Table 5-6. Expert Insight: Leading Emerging Drugs for Migraine Prophylaxis

Table 5-7. Drug Classes in Development for Treatment of Migraine—Mechanism of Action

Table 5-8. Phase III Efficacy Results for NP-101

Table 5-9. Post-Hoc Analysis of Phase III Efficacy Results for NP-101

Table 5-10. 12 Month Open-Label Extension Studies for NP-101

Table 5-11. Phase II Safety and Efficacy Results for NVD-201 (sumatriptan oral spray)

Table 5-12. Phase II Safety and Efficacy Results for OptiNose Sumatriptan Intranasal Powder

Table 5-13. Phase III Efficacy Results for Orally Inhaled Dihydroergotamine (DHE; Levadex)

Table 5-14. Post-Hoc Analysis of Phase III Efficacy Results for Orally Inhaled Dihydroergotamine (DHE)

Table 5-15. Phase II Safety and Efficacy Results for Lasmiditan

Table 5-16. Phase II Safety and Efficacy Results for NXN-188

Table 5-17. Phase II Pharmacokinetics and Pharmacodynamics Results for MTR-106

Table 5-18. Phase II Safety and Efficacy Results for AZ-104

Table 6-1. Sales of Drugs to Treat Migraine (All Populations) in the Major Pharmaceutical Markets, 2010-2020

Table 6-2. Timeline of Key Market Events for Migraine

Table B-1. Sources for Drug Prices

Table B-2. Dosing Assumptions for Current Acute Therapies

Table B-3. Dosing Assumptions for Current Prophylactic Therapies

Figure 1-1. Anatomy of the Brain

Figure 1-2. Select Precipitating (Trigger) Factors Associated with Migraine

Figure 1-3. Neurogenic Inflammation in Migraine Headache

Figure 1-4. Progression of Spreading Depression and Oligemia Believed to Be Associated with Migraine Aura

Figure 2-1. Prevalent Cases of Episodic and Chronic Migraine in the Major Pharmaceutical Markets, 2010

Figure 2-2. Episodic Migraine Prevalence by Age in the Major Pharmaceutical Markes, 2010

Figure 2-3. Chronic Migraine Prevalence by Age in the Major Pharmaceutical Markets, 2010

Figure 3-1. Stepped vs. Stratified Care for Migraine

Figure 4-1. Unmet Needs: Attainment and Remaining Opportunity in the Acute Treatment of Migraine

Figure 4-2. Unmet Needs: Attainment and Remaining Opportunity in Migraine Prophylaxis

Figure 6-1. Market Share of Leading Prescription Drugs Used for the Acute Treatment of Migraine, 2010 and 2020

Figure 6-2. Market Share of Leading Prescription Drugs Used for Migraine Prophylaxis, 2010 and 2020

Figure 6-3. Sales of Acute and Prophylactic Treatments in the Episodic and Chronic Migraine Markets, 2010 and 2020

Figure 6-4. Timeline of Near-Term Events in Migraine

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