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.

 Key Takeaways

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 target type A gamma-aminobutyric acid (GABA-A) receptor, potassium channels, hypocretin/orexin receptor, melatonin receptor, and histamine 1 receptor. The majority of marketed drugs are administered via the oral route, with the remainder being sublingual, intravenous, and oral transmucosal formulations.

A majority of industry-sponsored drugs in active clinical development for insomnia are in Phase II, with only three drugs in Phase III.

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Therapies in development for insomnia focus on targets such as hypocretin/orexin receptor, melatonin receptor, serotonin 5- hydroxytryptamine (HT1) receptor, serotonin 5-HT2B receptor, and GABA-A receptor. All the pipeline drugs for insomnia are administered via the oral route.

There were 17 licensing and asset acquisition activities involving insomnia drugs during 2012–17. The largest deal during that time 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 2017–22, Belsomra is forecasted to have the highest revenues, peaking in 2022. The clinical trials distribution across Phases I–IV indicates that the majority of trials for insomnia have been in early and midphases of development, with 58.5% of trials in Phase I–II and 41.5% in Phase III–IV.

The US has a substantial lead in the number of insomnia clinical trials globally. Germany leads the five major EU markets (France, Germany, Italy, Spain, and the UK), 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 62. Takeda also leads industry sponsors with the highest number of clinical trials overall for insomnia, followed by Merck & Co, Pfizer, and Sanofi.

Major Table of Content

1 KEY TAKEAWAYS

2 DISEASE BACKGROUND
3 Insomnia subtypes

4 TREATMENT
5 Non-medical treatments
6 Medical treatments

7 EPIDEMIOLOGY

8 MARKETED DRUGS
9 Approvals by country

10 PIPELINE DRUGS

11 KEY REGULATORY EVENTS
12 First FDA-Cleared Anti-Insomnia Device To Hit Market In 2017

13 LICENSING AND ASSET ACQUISITION DEALS

14 PARENT PATENTS

15 REVENUE OPPORTUNITY

16 CLINICAL TRIAL LANDSCAPE
17 Sponsors by status
18 Sponsors by phase

19 BIBLIOGRAPHY
20 Prescription information:

21 APPENDIX

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, 2012–17
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 ($m), 2012–16
Table 7: Forecasted global sales, by drug ($m), 2017–22

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