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
Key Takeaways
- The publisher 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
OverviewKey TakeawaysEpidemiologyMarketed DrugsPipeline DrugsKey Upcoming EventsProbability of SuccessRevenue OpportunityAppendix
Disease Background
Treatment
Recent Events and Analyst Opinion
Key Regulatory Events
Licensing and Asset Acquisition Deals
Clinical Trial Landscape
Bibliography
List of Figures
List of Tables
