Product Code: DMKC0178453
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.
Datamonitor Healthcare estimates that in 2019, there were 554.6 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 619.8 million prevalent cases by 2028.
Latin America and the Caribbean is estimated to have the highest disease prevalence (16.4%), while the Northern America region has the lowest prevalence (9.7%).
The majority of approved drugs in the migraine space target the serotonin 5-HT1 receptor or calcitonin gene-related peptide/receptor. 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.
There are equal proportions of industry-sponsored drugs in active clinical development for migraine in Phase II and Phase III, with three drugs in the NDA/BLA stage.
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, topical, transdermal, sublingual, and oral transmucosal formulations.
High-impact upcoming events for drugs in the migraine space comprise topline Phase III trial results for atogepant, STS101, and Vyepti; topline Phase IIIb trial results for Vyepti; topline Phase II trial results for TRV250; an estimated PDUFA date for Qtrypta; and a response to a complete response letter for Rizaport.
The overall likelihood of approval of a Phase I migraine and other headaches asset is 16.9%, and the average probability a drug advances from Phase III is 94.4%. Drugs, on average, take 7.7 years from Phase I to approval, compared to 9.8 years in the overall neurology space.
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 54% of trials in Phase I-II, and 46% in Phase III-IV.
The US has a substantial lead in the number of migraine clinical trials globally. Germany leads the major European 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 AbbVie and Eli Lilly.
TABLE OF CONTENTS
- Migraine without aura
- Migraine with aura
- Serotonergic drugs
- CGRP inhibitors
- Prophylactic agents for migraine
RECENT EVENTS AND ANALYST OPINION
- INP-104 for Migraine (June 10, 2020)
- AXS-07 for Migraine (April 6, 2020)
- NURTEC ODT for Migraine (March 30, 2020)
- AXS-07 for Migraine (December 30, 2019)
- Vazegepant for Migraine (December 17, 2019)
- Emgality for Migraine (August 5, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Cipla Gets CGT Nod For US Migranal Rival
- Biohaven Goes All In On ODT With Nurtec
- Dr Reddy's Elyxyb Receives US Approval For Its NDA
- FDA Issues Response Letter For Rizaport
- Relief For Migraine as England's NICE Reverses Ajovy Knockback
- Yes For Shionogi But No For Lilly In Latest EMA Recommendations
- Biohaven's Oral CGRP Inhibitor Nurtec ODT Approved In The US For Acute Migraine
- Pricing Could Help Lundbeck's Vyepti In Slow-Growing CGRP Market
- Triptan Switches Offer Hope For Australia's OTC Market
- Allergan's Oral CGRP Inhibitor Ubrelvy Approved For Migraine Attacks
- Lilly Expands Migraine Franchise With Reyvow Approval
- IntelGenx Takes A Fourth Try At Rizaport Approval
- Global Device Approvals Snapshot: 9-15 July 2019
- CGRP Inhibitor Review Pipeline Grows With Biohaven's Rimegepant Submission
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Currax Gains NA License To Optinose's Onzetra Xsail Migraine Treatment
- Deals Shaping The Medical Industry, October 2019
- 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
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in prevalent cases of migraine, 2019-28
- 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: INP-104 for Migraine (June 10, 2020): Phase III - STOP-301
- Figure 7: AXS-07 for Migraine (April 6, 2020): Phase III - INTERCEPT (Early)
- Figure 8: NURTEC ODT for Migraine (March 30, 2020): Phase II/III - BHV3000-305 (Migraine Prevention)
- Figure 9: AXS-07 for Migraine (December 30, 2019): Phase III - MOMENTUM (Acute)
- Figure 10: Vazegepant for Migraine (December 17, 2019): Phase II/III - 201
- Figure 11: Emgality for Migraine (August 5, 2019): Phase III - CONQUER
- Figure 12: Key upcoming events in migraine
- Figure 13: Probability of success in the migraine pipeline
- Figure 14: Clinical trials in migraine
- Figure 15: Top 10 drugs for clinical trials in migraine
- Figure 16: Top 10 companies for clinical trials in migraine
- Figure 17: Trial locations in migraine
- Figure 18: Migraine trials status
- Figure 19: Migraine trials sponsors, by phase
LIST OF TABLES
- Table 1: Prevalent cases of migraine, 2019-28
- Table 2: Prevalence proportions of migraine, 2019-28
- Table 3: Marketed drugs for migraine
- Table 4: Pipeline drugs for migraine in the US
- Table 5: INP-104 for Migraine (June 10, 2020)
- Table 6: AXS-07 for Migraine (April 6, 2020)
- Table 7: NURTEC ODT for Migraine (March 30, 2020)
- Table 8: AXS-07 for Migraine (December 30, 2019)
- Table 9: Vazegepant for Migraine (December 17, 2019)
- Table 10: Emgality for Migraine (August 5, 2019)
- Table 11: Historical global sales, by drug ($m), 2015-19
- Table 12: Forecasted global sales, by drug ($m), 2020-24