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.
It is estimated 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.
The majority of industry-sponsored drugs in active clinical development for insomnia are in Phase II, with only three drugs in Phase III.
Therapies in development for insomnia focus on targets such as the hypocretin/orexin receptor, melatonin receptor, histamine H1 receptor (HRH1), serotonin 5-hydroxytryptamine (5-HT1) receptor, serotonin 5-hydroxytryptamine receptor 2B (5-HT2B), and GABA-A receptor. All of the pipeline drugs for insomnia are administered via the oral route.
There have been 15 licensing and asset acquisition activities involving insomnia drugs during 2013-18. The largest deal 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.
Rozerem's US parent product patent and Ambien's formulation patent are set to expire in 2019 and 2020, respectively, which will open the door to generic entry.
During 2018-22, Belsomra is forecasted to overtake Ambien to have the highest revenues, peaking in 2021. The distribution of clinical trials across Phases I-IV indicates that the majority of trials for insomnia have been in the early and mid-phases of development, with around 59% of trials in Phase I-II and 41% in Phase III-IV.
Clinical trial activity in the insomnia space is dominated by completed trials. Takeda has the highest number of completed clinical trials for insomnia, with 63 trials. Takeda also leads industry sponsors with the highest number of clinical trials overall for insomnia, followed by Merck & Co, Pfizer, and Sanofi.
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