This Market Spotlight report covers the Insomnia market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming 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 2019, there were 1.4 billion prevalent cases of insomnia worldwide, and forecasts that number to increase to 1.5 billion prevalent cases by 2028.
• It is estimated that Asia had the largest number of prevalent cases in 2019, despite having the lowest prevalence proportion (690.2 million cases; 15.0%).
• The approved drugs in the insomnia space target GABA-A receptor, hypocretin/orexin receptor, chloride channel 2, chloride, 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 only one drug 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 for drugs in the insomnia space comprise an expected approval decision for ZolpiMist, topline Phase II and 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 18.1%, 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.
• 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 European 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 67 trials.
• Takeda leads the industry sponsors with the highest overall number of clinical trials for insomnia, followed by Merck & Co.