The insomnia market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is poised to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2bn in 2022 to $4.1bn in 2032, according to GlobalData’s report, Insomnia: Opportunity Assessment and Forecast.

This modest growth will be driven by an increase in the patient share of dual orexin receptor antagonists (DORAs) and the anticipated introduction of four late-stage pipeline products.

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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 the 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 gamma-aminobutyric acid neurotransmission.

KOLs believe that DORAs provide additional treatment options for patients who are treatment refractory or responded partially to older pharmacological treatments.

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In addition, KOLs were enthusiastic about Quviviq as it is the first and only DORA approved in the five major European markets (France, Germany, Italy, Spain, and the UK) and has demonstrated improvements in nighttime symptoms, as well as daytime functioning. 

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GlobalData expects DORAs’ sales growth to continue at a CAGR of 8.6% to 2032.

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’ sunobinop.

GlobalData forecasts that these four pipeline products will contribute $330.2m in sales by 2032.

Hetlioz is anticipated to be used in patients with insomnia, characterised by difficulty with sleep onset, and is anticipated to generate $235.8m in sales for the treatment of insomnia by 2032. This is attributed to its high annual cost of therapy.

Notably, sunobinop will see good initial uptake as it is projected to be the first product targeting insomnia associated with substance use disorder. As such, it is anticipated to generate $79.2m in sales by 2032.

In addition, 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.

This dominance of the US within the 7MM is due to its larger population of those with insomnia, as well as higher drug prices.

Furthermore, during the forecast period, Hetlioz, SM-1, and sunobinop are forecast to launch in the US exclusively.

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 Japan in 2031. In addition, Dayvigo is set to lose market exclusivity in the US in 2031.

This will allow cheaper generic versions of the DORAs to enter the market and result in sales erosion of the aforementioned 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.