Market outlook to 2032: future trends across the seven major markets

The treatment markets for two key diseases areas: insomnia and the rare metabolic disorder, Gaucher disease, are predicted to flourish in the seven major markets (7MM - France, Germany, Italy, Spain, UK, US, and Israel) in 2032, data and analytics company GlobalData suggests.

Insomnia market

Dual orexin receptor antagonists (DORAs)

[dual orexin receptor antagonists (DORAs)]... offer a new mechanism of action [in treating insomnia]"

Across the seven major markets, the insomnia market is anticipated to grow at a compound annual growth rate (CAGR) of 2.6 percent from $3.2 billion in 2022 to $4.1 billion in 2032. The company predicted this will be “driven by an increase in the patient share of dual orexin receptor antagonists (DORAs)”.

In its report on the insomnia market published last month, GlobalData expected that sales for DORAs, which offer a new mechanism of action for the condition, will continue to grow at a CAGR of 8.6 percent between 2022 and 2032.

Importantly, by “selectively inhibiting arousal and promoting sleep without promoting GABA neurotransmission”, the research by GlobalData noted that DORAs are another treatment option for those who are "treatment refractory or have responded partially to older pharmacological treatments".

In 2015, GlobalData forecasted that the insomnia treatment market will reach $1.8 billion by 2023, driven by the launch of Merck's Belsomra and Eisai’s lemborexant (E-2006). GlobalData’s Analyst covering Neurology and Ophthalmology, Thomas Parker, MPharmacol, predicted that Belsomra would lead the market by 2023.

“Since their launches throughout the seven major markets 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,” Pharma Analyst at GlobalData, Christie Wong commented.

More recently, GlobalData considered that four late-stage pipeline products, Vanda Pharmaceuticals’ Hetlioz (tasimelteon), EUSOL’s SM-1 (diphenhydramine + lorazepam + zolpidem), Taisho Pharmaceutical’s vornorexant, and Imbrium Therapeutics’s sunobinop, will contribute $330.2 million in sales by 2032.

Market projections

Leading treatments in the insomnia treatment market

“The loss of patent exclusivity will allow cheaper generic versions of the DORAs to enter the [insomnia treatment] market"

The company emphasised that at present, the US represents the largest insomnia market, with 81.9 percent sales expected in 2032 within the seven major markets. “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,” Wong explained.

However, across these major markets, the insomnia market is predicted to experience growth challenges up to 2023 too. GlobalData considered drug pricing and market exclusivity to be two major obstacles. In the US in 2029 and in Japan in 2031, Belsomra is set to lose market exclusivity. In addition, Dayvigo is set to lose market exclusivity in the US in 2031, the research suggested.

“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,” Wong asserted.

Gaucher disease market

On the other hand, treatments for Gaucher disease, another key market, is expected to reach $1.3 billion across the 7MM up to 2032, GlobalData’s predicted in a report published in December 2023.

Comparatively, in 2015, GlobalData’s research expected that sales of therapies for Gaucher disease will reach $1.16 billion by 2024.

With the treatment landscape for Gaucher disease historically led by enzyme replacement therapy (ERT), GlobalData’s forecast suggested that substrate reduction therapy (SRT) will increase market share in the upcoming decade.

Potential market driver for Gaucher disease

The research anticipated that the launch of venglustat malate will be the main drivers of steady market growth over the forecast period. GlobalData anticipated it will launch in the US and 5EU (France, Germany, Italy, Spain, and the UK) markets during the forecast period, Sulayman Patel, MSci, Pharma Analyst at GlobalData noted.

“As the first brain-penetrant substrate reduction therapy (SRT), venglustat malate holds the potential to provide relief for neuropathic symptoms... the most significant unmet need [in Gaucher disease]"

“As the first brain-penetrant SRT, venglustat malate holds the potential to provide relief for neuropathic symptoms. In turn, this will address the most significant unmet need highlighted by key opinion leaders, the lack of effective therapies for neuropathic symptoms,” Patel added.

Challenges in the Gaucher disease treatment landscape

Moreover, like for the insomnia market, up to 2023, GlobalData shared that several barriers are anticipated to hinder growth of the treatment market for Gaucher disease.

When considering the expense of ERTs and SRTs, where biosimilars face difficult market penetration due to strict regulations, this will slow market growth. Although the research noted that younger patients are increasingly switching from ERT to SRT, the current “familiarity” of existing therapies are expected to play a part in impeding the market’s expansion. In turn, this will hinder the growth of potential new players to the market, according to GlobalData.

Therefore, Patel explained that ERT is expected to produce sales of “approximately $793 million, followed closely by SRTs with combined sales of $524 million in the 7MM.”

Conclusion

While there are expected challenges, such as navigating drug exclusivity and meeting increasing patient demand alongside the vast unmet need in rare conditions like Gaucher disease, these markets are expected to witness continued growth in the seven major markets up to 2032.