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Market Spotlight: Migraine

  • ID: 4421392
  • Report
  • 73 Pages
  • Datamonitor Healthcare
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This Market Spotlight report covers the migraine market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • It is estimated that in 2017, there were 579.6 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 649.2 million prevalent cases by 2026.
  • Latin America and the Caribbean is estimated to have the highest disease prevalence (16.4%), while Northern America has the lowest prevalence (9.7%).
  • The majority of approved drugs in the migraine space target the serotonin 5-HT1 receptor or GABA receptors. These are commonly administered via the oral route, with a smaller number of products being available in intravenous, intranasal, intramuscular, intradermal, intraarticular, intravesical, rectal, sublingual, oral transmucosal, and subcutaneous formulations.
  • The largest proportion of industry-sponsored drugs in active clinical development for migraine are in Phase III, with six drugs in the NDA/BLA phase.
  • Drugs in development for migraine focus on a wide variety of targets. Approximately half of the drugs in development for migraine are administered via the oral route, with the remainder being intranasal, inhaled, subcutaneous, intravenous, topical, transdermal, sublingual, oral transmucosal, and intramuscular formulations.
  • High-impact upcoming events for drugs in the migraine space comprise topline Phase II/III and Phase III trial results, an expected supplemental CHMP opinion, and FDA decisions on NDAs and BLAs.
  • The overall likelihood of approval of a Phase I migraine and other headaches asset is 15.7%, and the average probability a drug advances from Phase III is 93.8%. Drugs, on average, take 7.6 years from Phase I to approval, compared to 9.8 years in the overall neurology space.
  • There have been 29 licensing and asset acquisition deals involving migraine drugs during 2014–19. The largest deal was the $573.5m exclusive agreement between Bristol-Myers Squibb and Biohaven in 2016 to develop and commercialize rimegepant and BHV-3500, as well as for rights to other CGRP-related intellectual property.
  • The distribution of clinical trials across Phase I–IV indicates that the majority of trials for migraine have been in the early and mid-phases of development, with 55% of trials in Phase I–II, and 45% in Phase III–IV.
  • The US has a substantial lead in the number of migraine clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
  • Clinical trial activity in the migraine space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for migraine, with 95 trials.
  • GlaxoSmithKline leads the industry sponsors with by far the highest overall number of clinical trials for migraine, followed by Eli Lilly and Merck & Co.
Note: Product cover images may vary from those shown
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OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

Migraine without aura
Migraine with aura

TREATMENT
Analgesics
NSAIDs
Serotonergic drugs
Prophylactic agents for migraine

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION
Emgality for Migraine (August 5, 2019)
Multiple Drugs for Migraine (June 25, 2019)
Emgality for Migraine (May 8, 2019)
Eptinezumab for Migraine (May 8, 2019)
Ubrogepant for Migraine (May 8, 2019)
Rimegepant for Migraine (May 7, 2019)
Atogepant for Migraine (May 6, 2019)
Emgality for Migraine (May 6, 2019)
Eptinezumab for Migraine (May 6, 2019)
Ajovy for Migraine (April 23, 2019)
Emgality for Migraine (April 1, 2019)
SpringTMS for Migraine (February 27, 2019)
Ajovy for Migraine (December 17, 2018)
Rimegepant for Migraine (December 10, 2018)
Rimegepant for Migraine (December 3, 2018)
Cefaly Device for Migraine (November 17, 2018)
Nerivio Migra for Migraine (November 15, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS
Global Device Approvals Snapshot: 9-15 July 2019
CGRP Inhibitor Review Pipeline Grows With Biohaven’s Rimegepant Submission
Theranica’s Smartphone-Controlled Migraine Device Earns FDA De Novo
CMC Issues Derail Rizaport. Again.
Biohaven Pays $105m For Turbo Boost In Migraine Drug Review Race
Allergan Aims To Broaden CGRP Class With First Oral Candidate For Acute Migraine
Alder Bids To Join Anti-CGRP Fray With Promise Of Rapid Onset, Infusion Delivery
Teva’s Ajovy Gets EU Thumbs Up From CHMP
Promius’ Tosymra Is First Approval Using Neurelis’ Intravail Technology

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
Lundbeck CEO: Alder Buy Will Boost Pipeline
Upsher-Smith Completes Acquisition Of Dr Reddy’s Two Migraine Treatments
Kurve, Seurat Collaborate On Nasal Spray For Migraines
Upsher-Smith Snaps Up Migraine Assets As Dr Reddy’s Hones Focus
No More Deal? Novartis, Amgen Trade Lawsuits Over Aimovig Agreements

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
Recent events

BIBLIOGRAPHY
Prescription information

APPENDIX

LIST OF FIGURES

Figure 1: Trends in prevalent cases of migraine, 2017–26
Figure 2: Overview of pipeline drugs for migraine in the US
Figure 3: Pipeline drugs for migraine, by company
Figure 4: Pipeline drugs for migraine, by drug type
Figure 5: Pipeline drugs for migraine, by classification
Figure 6: Emgality for Migraine (August 5, 2019): Phase III – CONQUER
Figure 7: Eptinezumab for Migraine (May 8, 2019): Phase III – PROMISE 1 (High Frequency; IV)
Figure 8: Ubrogepant for Migraine (May 8, 2019): Phase III – ACHIEVE II (UBR-MD-02)
Figure 9: Rimegepant for Migraine (May 7, 2019): Phase III – BHV3000-303 (ODT Formulation)
Figure 10: Emgality for Migraine (May 6, 2019): Phase III – EVOLVE-1 (Episodic Migraine), Phase III – EVOLVE-2 (Episodic Migraine)
Figure 11: Eptinezumab for Migraine (May 6, 2019): Phase III – PROMISE 2 (Chronic; IV)
Figure 12: Ajovy for Migraine (December 17, 2018): Phase IIIb – FOCUS (Migraine Prophylaxis)
Figure 13: Rimegepant for Migraine (December 3, 2018): Phase III – BHV3000-303 (ODT Formulation)
Figure 14: Cefaly Device for Migraine (November 17, 2018): ACME (US)
Figure 15: Nerivio Migra for Migraine (November 15, 2018): TCH-003 (US & Israel)
Figure 16: Key upcoming events in migraine
Figure 17: Probability of success in the migraine pipeline
Figure 18: Licensing and asset acquisition deals in migraine, 2014–19
Figure 19: Parent patents in migraine, 2019–27
Figure 20: Parent patents in migraine, 2028–37
Figure 21: Clinical trials in migraine
Figure 22: Top 10 drugs for clinical trials in migraine
Figure 23: Top 10 companies for clinical trials in migraine
Figure 24: Trial locations in migraine
Figure 25: Migraine trials status
Figure 26: Migraine trials sponsors, by phase

LIST OF TABLES

Table 1: Prevalent cases of migraine, 2017–26
Table 2: Prevalence proportions, 2017–26
Table 3: Marketed drugs for migraine
Table 4: Pipeline drugs for migraine in the US
Table 5: Emgality for Migraine (August 5, 2019)
Table 6: Multiple Drugs for Migraine (June 25, 2019)
Table 7: Emgality for Migraine (May 8, 2019)
Table 8: Eptinezumab for Migraine (May 8, 2019)
Table 9: Ubrogepant for Migraine (May 8, 2019)
Table 10: Rimegepant for Migraine (May 7, 2019)
Table 11: Atogepant for Migraine (May 6, 2019)
Table 12: Emgality for Migraine (May 6, 2019)
Table 13: Eptinezumab for Migraine (May 6, 2019)
Table 14: Ajovy for Migraine (April 23, 2019)
Table 15: Emgality for Migraine (April 1, 2019)
Table 16: SpringTMS for Migraine (February 27, 2019)
Table 17: Ajovy for Migraine (December 17, 2018)
Table 18: Rimegepant for Migraine (December 10, 2018)
Table 19: Rimegepant for Migraine (December 3, 2018)
Table 20: Cefaly Device for Migraine (November 17, 2018)
Table 21: Nerivio Migra for Migraine (November 15, 2018)
Table 22: Historical global sales, by drug ($m), 2014–18
Table 23: Forecasted global sales, by drug ($m), 2019–23

Note: Product cover images may vary from those shown
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