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.
- The publisher 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.
- Insomnia Subtypes
- Non-Medical Treatments
- Medical Treatments
RECENT EVENTS AND ANALYST OPINION
- Hetlioz for Insomnia (August 16, 2019)
- Seltorexant for Insomnia (June 24, 2019)
- Dayvigo for Insomnia (October 17, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Dayvigo Awaits Controlled Substance Scheduling
- FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices
- New Zealand Switches Melatonin From Prescription To OTC Status
- US FDA Converges With Other Regulators On Insomnia Drug Warnings, But Broader Safety Disagreements Persist
- German Melatonin Denial Is ‘Further Blow’ To PUMA Scheme
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Eisai Buys Out Global Rights To Lemborexant
CLINICAL TRIAL LANDSCAPE
- Sponsors By Status
- Sponsors By Phase
- Prescription Information
LIST OF FIGURES
Figure 1: Trends In Prevalent Cases Of Insomnia, 2017–26
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 Classification
Figure 6: Seltorexant For Insomnia (June 24, 2019): Phase Iib – Dose Finding
Figure 7: Dayvigo For Insomnia (October 17, 2018): Phase Iii – Sunrise 2
Figure 8: Key Upcoming Events In Insomnia
Figure 9: Probability Of Success In The Insomnia Pipeline
Figure 10: Licensing And Asset Acquisition Deals In Insomnia, 2015–20
Figure 11: Parent Patents In Insomnia
Figure 12: Clinical Trials In Insomnia
Figure 13: Top 10 Drugs For Clinical Trials In Insomnia
Figure 14: Top 10 Companies For Clinical Trials In Insomnia
Figure 15: Trial Locations In Insomnia
Figure 16: Insomnia Trials Status
Figure 17: Insomnia Trials Sponsors, By Phase
List Of Tables
Table 1: Prevalent Cases Of Insomnia, 2017–26
Table 2: Marketed Drugs For Insomnia
Table 3: Pipeline Drugs For Insomnia In The Us
Table 4: Hetlioz For Insomnia (August 16, 2019)
Table 5: Seltorexant For Insomnia (June 24, 2019)
Table 6: Dayvigo For Insomnia (October 17, 2018)
Table 7: Historical Global Sales, By Drug ($m), 2014–18
Table 8: Forecasted Global Sales, By Drug ($m), 2020–24