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Market Spotlight: Migraine, Pharma Intelligence

Market Spotlight: Migraine, Pharma Intelligence

  • October 2019
  • 73 pages
  • ID: 5780095
  • Format: PDF
  • By Pharma Intelligence


Table of Contents

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
The analyst estimates 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 and Co.

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