Market Spotlight: Insomnia
This Market Spotlight report covers the insomnia market, comprising key pipeline and
marketed drugs, clinical trials, regulatory events, patent information, a 10-year disease
prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific
revenue forecasts.
Key Takeaways
Datamonitor Healthcare estimates that in 2016, there were 1.7 billion prevalent cases of
insomnia worldwide, and forecasts that number to increase to 1.8 billion prevalent cases by
2025.
It is estimated that Asia had the largest number of prevalent cases in 2016, despite having
the lowest prevalence proportion (665 million cases; 15.0%).
The approved drugs in the insomnia space target type A gamma-aminobutyric acid (GABA-
A) receptor, potassium channels, hypocretin/orexin receptor, melatonin receptor, and
histamine 1 receptor. The majority of marketed drugs are administered via the oral route,
with the remainder being sublingual, intravenous, and oral transmucosal formulations.
A majority of industry-sponsored drugs in active clinical development for insomnia are in
Phase II, with only three drugs in Phase III.
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Therapies in development for insomnia focus on targets such as hypocretin/orexin receptor,
melatonin receptor, serotonin 5- hydroxytryptamine (HT1) receptor, serotonin 5-HT2B
receptor, and GABA-A receptor. All the pipeline drugs for insomnia are administered via the
oral route.
There were 17 licensing and asset acquisition activities involving insomnia drugs during
2012–17. The largest deal during that time was the $150.8m agreement in August 2016
between Shionogi and Lupin’s Japanese subsidiary, Kyowa, for the transfer of marketing
rights to 21 of Shionogi’s long-listed drugs to Kyowa.
During 2017–22, Belsomra is forecasted to have the highest revenues, peaking in 2022. The
clinical trials distribution across Phases I–IV indicates that the majority of trials for insomnia
have been in early and midphases of development, with 58.5% of trials in Phase I–II and
41.5% in Phase III–IV.
The US has a substantial lead in the number of insomnia clinical trials globally. Germany
leads the five major EU markets (France, Germany, Italy, Spain, and the UK), while Japan
has the top spot in Asia.
Clinical trial activity in the insomnia space is dominated by completed trials. Takeda has the
highest number of completed clinical trials for insomnia, with 62. Takeda also leads industry
sponsors with the highest number of clinical trials overall for insomnia, followed by Merck
& Co, Pfizer, and Sanofi.
Major Table of Content