This Market Spotlight report covers the Migraine market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
The author estimates that in 2016, there were 569.8 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 638.4 million prevalent cases by 2025.
Latin America and the Caribbean is estimated to have the highest disease prevalence (16.40%), while Northern America has the lowest prevalence (9.70%).
A large number of industry-sponsored drugs in active clinical development for migraine are in Phase III. Mid- and late-stage drugs in development for migraine are predominantly focusing on targets such as the serotonin 5-HT1 receptor, CGRP receptor, and nitric oxide synthase. Among these classes, the CGRP antagonists hold considerable promise owing to their specific targeting of migraine mechanisms, contrary to conventional treatments, and prophylactic efficacy. In particular, Aimovig is the most clinically advanced monoclonal antibody against CGRP, and has been demonstrated to significantly reduce the number of migraine days per month in episodic migraine patients. Approximately half of the drugs in mid- to late-stage development for migraine are administered via the oral route, with the remainder being intranasal, inhaled, subcutaneous, intravenous, and intramuscular formulations.
The majority of approved drugs in the migraine space target serotonin 5-HT1 receptors or GABA receptors. These are commonly administered via the oral route, with a few select products being available in intranasal, intramuscular, and subcutaneous formulations.
High-impact upcoming events for drugs in the migraine space include topline Phase II and Phase III trial results, as well as FDA decisions on BLAs.
Licensing and asset acquisition activity involving migraine drugs has been weak during 2012-17, although 2016 witnessed the highest number of licensing deals during this period. The exclusive agreement between Bristol-Myers Squibb and Biohaven in 2016 to develop and commercialize rimegepant and BHV-3500, as well as rights to other CGRP-related intellectual property for $523.5m, was the largest deal during 2012-17.
During 2017-21, formulation patent expiries of Depakote (2019) and Zomig (2021), and device patent expiry of Onzetra (2020) are expected to open the door to generic entry.
Botox's sales during 2012-16 were the highest of any approved migraine drug, and are forecast to grow through 2022, reaching $4.4bn in 2022. However, only a portion of Botox's revenues derive from its therapeutic use in migraine prophylaxis.
The number of clinical trials at each of Phase I-IV indicates an even distribution of trials across the phases. The US has a substantial lead in the number of migraine clinical trials globally, yet forecasted prevalent cases of migraine are lower in North America as compared to Asia and Europe. Germany leads the major EU markets, while Asia is forecasted to have the largest number of prevalent cases of migraine.
Relatively few clinical trials are ongoing, compared to the vast body of evidence among completed studies. GlaxoSmithKline has the highest number of completed migraine trials, while Eli Lilly has the most ongoing trials. Pharma giants are the main sponsors of migraine clinical trials, such as GlaxoSmithKline, Merck & Co, Allergan, Eli Lilly, Johnson & Johnson, Pfizer, and Teva.
Many of the main industry sponsors have more Phase III trials than any other stage. GlaxoSmithKline, Merck & Co, and Johnson & Johnson in particular appear to be top-heavy, with most of their trials in Phase III-IV.
Key Topics Covered:
1 KEY TAKEAWAYS
2 DISEASE BACKGROUND
Prophylactic agents for migraine
6 PIPELINE DRUGS
7 MARKETED DRUGS
Approvals by country
8 KEY UPCOMING EVENTS
9 LICENSING AND ASSET ACQUISITION DEALS
Eli Lilly Pays Nearly $1bn To Regain Migraine Candidate It Once Sold For $1m