Market Spotlight: Insomnia
Market Spotlight: Insomnia
This Market Spotlight report covers the insomnia market, comprising key pipeline and marketed drugs, clinical trials, regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
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.
- 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.
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
7 Insomnia subtypes
8 Non-medical treatments
8 Medical treatments
15 MARKETED DRUGS
18 Approvals by country
21 PIPELINE DRUGS
25 KEY UPCOMING EVENTS
26 KEY REGULATORY EVENTS
26 First FDA-Cleared Anti-Insomnia Device To Hit Market In 2017
27 LICENSING AND ASSET ACQUISITION DEALS
28 PARENT PATENTS
29 REVENUE OPPORTUNITY
30 CLINICAL TRIAL LANDSCAPE
31 Sponsors by status
32 Sponsors by phase
34 Prescription information
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of insomnia, 2016–25
21 Figure 2: Overview of pipeline drugs for insomnia in the US
21 Figure 3: Pipeline drugs for insomnia, by company
22 Figure 4: Pipeline drugs for insomnia, by drug type
22 Figure 5: Pipeline drugs for insomnia, by classifications
25 Figure 6: Key upcoming events in insomnia
27 Figure 7: Licensing and asset acquisition deals in insomnia, 2013–18
28 Figure 8: Parent patents in insomnia
30 Figure 9: Clinical trials in insomnia
30 Figure 10: Top 10 drugs for clinical trials in insomnia
31 Figure 11: Top 10 companies for clinical trials in insomnia
31 Figure 12: Trial locations in insomnia
32 Figure 13: Insomnia trials status
33 Figure 14: Insomnia trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of insomnia, 2016–25
14 Table 2: Prevalence proportions of insomnia, 2016–25
16 Table 3: Marketed drugs for insomnia
19 Table 4: Approvals by country for insomnia
23 Table 5: Pipeline drugs for insomnia in the US
29 Table 6: Historical global sales, by drug ($m), 2012–17
29 Table 7: Forecasted global sales, by drug ($m), 2018–22
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