This Market Spotlight report covers the insomnia market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, key upcoming events 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

• Datamonitor Healthcare estimates that in 2017, there were 1.7 billion prevalent cases of insomnia worldwide, and forecasts that number to increase to 1.9 billion prevalent cases by 2026.
• It is estimated that Asia had the largest number of prevalent cases in 2017, despite having the lowest prevalence proportion (675.7 million cases; 15.0%).
• The approved drugs in the insomnia space target type A gamma-aminobutyric acid (GABA-A) receptor, hypocretin/orexin receptor, melatonin receptor, histamine H1 receptor, and potassium channels. The majority of marketed drugs are administered via the oral route, with the remainder being available in sublingual, oral transmucosal, and intravenous formulations.
• The majority of industry-sponsored drugs in active clinical development for insomnia are spread evenly across Phase II and Phase III.
• Therapies in mid-to-late-stage development for insomnia focus on targets such as melatonin receptor, hypocretin/orexin receptor, histamine H1 receptor, serotonin 5-hydroxytryptamine1 (5-HT1) receptor, serotonin 5-hydroxytryptamine receptor 2B (5-HT2B), GABA-A receptor, and GABA receptors. All of the pipeline drugs for insomnia are administered via the oral route.
• Patent expiration for Belsomra is the only high-impact upcoming event in the insomnia space. The overall likelihood of approval of a Phase I insomnia asset is 17.9%, and the average probability a drug advances from Phase III is 61.5%. Drugs, on average, take 6.9 years from Phase I to approval, compared to 9.6 years in the overall neurology space.
• There were 19 licensing and asset acquisition deals involving insomnia drugs during 2013–18. The largest deal during the period was the $150.8m agreement in August 2016 between Shionogi and Lupin’s Japanese subsidiary, Kyowa, for the transfer of marketing rights of Shionogi’s 21 long-listed drugs to Kyowa.
• The clinical trials distribution across Phases I–IV indicates that the majority of trials for insomnia have been in the early and midphases of development, with 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 leads the industry sponsors with the highest number of clinical trials for insomnia, followed by Merck & Co and Pfizer