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 (675.7 million cases). The approved drugs in the insomnia space target 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, or intravenous formulations.
• The largest proportion of industry-sponsored drugs in active clinical development for insomnia are in Phase III, with two drugs in the NDA/BLA phase.
• Therapies in mid-to-late-stage development for insomnia focus on targets such as melatonin receptor, hypocretin/orexin receptor, GABA-A receptor, GABA receptors, histamine H1 receptor, serotonin 5-HT1 receptor, and serotonin 5-HT2B receptor. All of the pipeline drugs for insomnia are administered via the oral route.
• High-impact upcoming events in the insomnia space comprise an expected PDUFA date for lemborexant, an expected approval decision for ZolpiMist, topline Phase III trial results for daridorexant, and an estimated patent expiration for Belsomra.
• The overall likelihood of approval of a Phase I insomnia asset is 17.6%, and the average probability a drug advances from Phase III is 66.7%. Drugs, on average, take 8.0 years from Phase I to approval, compared to 9.8 years in the overall neurology space.
• There have been 22 licensing and asset acquisition deals involving insomnia drugs during 2014–19. 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 of Shionogi’s 21 long-listed drugs to Kyowa.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for insomnia have been in the early and mid-phases 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 65 trials.
• Takeda leads the industry sponsors with the highest overall number of clinical trials for insomnia, followed by Merck & Co.