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
It is estimated 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%).
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
The Annual General Meeting of Bioretec Ltd was held on 26 April 2024 in Tampere, Finland.
The Annual General Meeting approved the financial statements for the financial year 1 January?31 December 2023 and resolved to discharge the members of the...
IDEAYA Biosciences, Inc. , a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on April 25, 2024, the Compensation Committee of IDEAYA's Board of Directors granted...
-- Diluted EPS of $2.16; Adjusted Diluted EPS of $2.26 ---- Increases 2024 Full Year Guidance --
2024 adjusted diluted EPS of $2.26, up over 7% from $2.11 in the first quarter of 2023.Increases 2024 full year adjusted diluted EPS guidance by $0.10 to...
Avantor, Inc. , a leading global provider of mission-critical products and services to customers in the life sciences and advanced technology industries, today reported financial results for its first...
Swedish Orphan Biovitrum AB (publ) (Sobi®) has established a medium term note programme with a framework amount of SEK 10 billion or the equivalent thereof in EUR (the "MTN Programme").
For this purpose, Sobi has prepared a base prospectus, which...
OMRON Healthcare Co., Ltd. based in Muko, Kyoto Prefecture, Japan, announces to be the official sponsor of May Measurement Month (MMM,) a global campaign to raise awareness of blood pressure screening and promote hypertension prevention, detection,...