This Market Spotlight report covers the insomnia market, comprising key marketed and pipeline drugs, clinical trials, key upcoming events and 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 focus on targets such as the type A gamma-aminobutyric acid (GABA-A) receptor, hypocretin/orexin receptor, melatonin receptor, histamine H1 receptor (HRH1), and potassium channels. The majority of marketed drugs are oral formulations, with the remainder being sublingual, intravenous, and oral transmucosal formulations.
• The majority of industry-sponsored drugs in active clinical development for insomnia are in Phase II. 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 were 17 licensing and asset acquisition deals 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.
• 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.
• The US has a substantial lead in the number of insomnia clinical trials globally. Germany leads the major EU markets, 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 63 trials. Takeda also leads industry sponsors with the highest number of clinical trials overall for insomnia, followed by Merck & Co, Pfizer, and Sanofi.