The insomnia market across the seven major markets (7MM*) is poised to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032, driven by an increase in the patient share of dual orexin receptor antagonists (DORAs) and the anticipated introduction of four late-stage pipeline products, says GlobalData, a leading data and analytics company.

GlobalData’s report: “Insomnia Market Opportunity Assessment, Epidemiology, Clinical Trials, Unmet Needs and Forecast to 2032” reveals DORAs’ sales growth to continue at a CAGR of 8.6% between 2022 and 2032.

Christie Wong, Pharma Analyst at GlobalData, comments: “Since their launches throughout the 7MM from 2014 to 2023, Merck’s Belsomra (suvorexant), Eisai’s Dayvigo (lemborexant), and Idorsia’s Quviviq (daridorexant) have been stealing patient share from traditional hypnotics, including Z-drugs, benzodiazepines, and low-dose sedating antidepressants.”

Key opinion leaders (KOLs) interviewed by GlobalData agreed that DORAs have transformed insomnia treatment as they offer a new mechanism of action (MOA) that selectively inhibits arousal and promotes sleep without promoting GABA neurotransmission. KOLs believed that DORAs provide additional treatment options for patients who are treatment refractory or have responded partially to older pharmacological treatments.

The introduction of four pipeline products into this market will also have a moderate impact on the treatment landscape. In order of entry, these products will be Vanda Pharmaceuticals’ Hetlioz (tasimelteon), EUSOL’s SM-1 (diphenhydramine + lorazepam + zolpidem), Taisho Pharmaceutical’s vornorexant, and Imbrium Therapeutics’s sunobinop. GlobalData forecasts that the four pipeline products will contribute $330.2 million in sales by 2032.

Wong continues: “Taisho’s vornorexant could be the next DORA to launch in Japan. However, vornorexant may be regarded as a “me-too” drug due to the availability of Belsomra and Dayvigo, and the anticipated launch of Quviviq in Japan.”

The US represents the largest market for insomnia, with 81.3% of the 7MM sales in 2022, increasing to 81.9% in 2032.

Wong adds: “The dominance of the US within the 7MM is due to its larger insomnia population and higher drug prices. Furthermore, during the forecast period, Hetlioz, SM-1, and sunobinop are forecast to launch in the US only.”

While the insomnia market is projected to grow during the forecast period across the 7MM, it may face some challenges that will hinder its growth. Belsomra is set to lose market exclusivity in the US in 2029 and in Japan in 2031. In addition, Dayvigo is set to lose market exclusivity in the US in 2031.

Wong concludes: “The loss of patent exclusivity will allow cheaper generic versions of the DORAs to enter the market and result in sales erosion for the brands. Nonetheless, the launches of pipeline therapies, coupled with the increased uptake of DORAs across the 7MM, will fuel market growth in the insomnia space.”

* 7MM – The US, France, Germany, Italy, Spain, the UK, and Israel