- The author 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.
- 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.
- 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
Approvals by country
KEY REGULATORY EVENTS
First FDA-Cleared Anti-Insomnia Device To Hit Market In 2017
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in prevalent cases of insomnia, 2016-25
Figure 2: Overview of pipeline drugs for insomnia in the US
Figure 3: Pipeline drugs for insomnia, by company
Figure 4: Pipeline drugs for insomnia, by drug type
Figure 5: Pipeline drugs for insomnia, by classifications
Figure 6: Licensing and asset acquisition deals in insomnia, 2013-18
Figure 7: Parent patents in insomnia
Figure 8: Clinical trials in insomnia
Figure 9: Top 10 drugs for clinical trials in insomnia
Figure 10: Top 10 companies for clinical trials in insomnia
Figure 11: Trial locations in insomnia
Figure 12: Insomnia trials status
Figure 13: Insomnia trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of insomnia, 2016-25
Table 2: Prevalence proportions of insomnia, 2016-25
Table 3: Marketed drugs for insomnia
Table 4: Approvals by country for insomnia
Table 5: Pipeline drugs for insomnia in the US
Table 6: Historical global sales, by drug ($m), 2012-17
Table 7: Forecasted global sales, by drug ($m), 2018-22