Market Spotlight: Insomnia
Market Spotlight: Insomnia
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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- 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, 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 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.
- There have been 19 licensing and asset acquisition deals involving insomnia drugs during 2015–20. 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 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 65 trials.
- Takeda leads the industry sponsors with the highest overall number of clinical trials for insomnia, followed by Merck & Co.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Insomnia subtypes
9 Non-medical treatments
9 Medical treatments
15 MARKETED DRUGS
19 PIPELINE DRUGS
25 RECENT EVENTS AND ANALYST OPINION
25 Hetlioz for Insomnia (August 16, 2019)
26 Seltorexant for Insomnia (June 24, 2019)
28 Dayvigo for Insomnia (October 17, 2018)
30 KEY UPCOMING EVENTS
31 KEY REGULATORY EVENTS
31 Dayvigo Awaits Controlled Substance Scheduling
31 FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices
31 New Zealand Switches Melatonin From Prescription To OTC Status
31 US FDA Converges With Other Regulators On Insomnia Drug Warnings, But Broader Safety Disagreements Persist
32 German Melatonin Denial Is ‘Further Blow’ To PUMA Scheme
33 PROBABILITY OF SUCCESS
34 LICENSING AND ASSET ACQUISITION DEALS
34 Eisai Buys Out Global Rights To Lemborexant
35 PARENT PATENTS
36 REVENUE OPPORTUNITY
37 CLINICAL TRIAL LANDSCAPE
38 Sponsors by status
39 Sponsors by phase
41 Prescription information
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of insomnia, 2017–26
19 Figure 2: Overview of pipeline drugs for insomnia in the US
20 Figure 3: Pipeline drugs for insomnia, by company
20 Figure 4: Pipeline drugs for insomnia, by drug type
20 Figure 5: Pipeline drugs for insomnia, by classification
28 Figure 6: Seltorexant for Insomnia (June 24, 2019): Phase IIb – Dose Finding
29 Figure 7: Dayvigo for Insomnia (October 17, 2018): Phase III – SUNRISE 2
30 Figure 8: Key upcoming events in insomnia
33 Figure 9: Probability of success in the insomnia pipeline
34 Figure 10: Licensing and asset acquisition deals in insomnia, 2015–20
35 Figure 11: Parent patents in insomnia
37 Figure 12: Clinical trials in insomnia
37 Figure 13: Top 10 drugs for clinical trials in insomnia
38 Figure 14: Top 10 companies for clinical trials in insomnia
38 Figure 15: Trial locations in insomnia
39 Figure 16: Insomnia trials status
40 Figure 17: Insomnia trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of insomnia, 2017–26
16 Table 2: Marketed drugs for insomnia
22 Table 3: Pipeline drugs for insomnia in the US
25 Table 4: Hetlioz for Insomnia (August 16, 2019)
26 Table 5: Seltorexant for Insomnia (June 24, 2019)
28 Table 6: Dayvigo for Insomnia (October 17, 2018)
36 Table 7: Historical global sales, by drug ($m), 2014–18
36 Table 8: Forecasted global sales, by drug ($m), 2020–24
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