Drug sales for Alzheimer’s disease (AD) and mild cognitive impairment (MCI) collectively reached $2.2bn in 2018 across the eight major markets (8MM*). By the end of the forecast period in 2028, these sales are forecast to increase to $12.9bn at a compound annual growth rate (CAGR) of 19.3%, according to GlobalData, a leading data and analytics company.

The company’s report, ‘Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2028’, states that this growth will be driven by the increasing prevalence of the two conditions worldwide and the introduction of DMTs such as Biogen’s aducanumab, Eisai’s BAN-2401 and Roche’s gantenerumab.

The current competitive landscape in AD consists only of symptomatic treatments, of which there are currently six approved medications: three ChEIs (donepezil, rivastigmine and galantamine), one NMDA-R antagonist (memantine), one combination therapy (memantine/donepezil) and one Aβ A4 protein inhibitor (sodium oligomannate). Improvements to the approved therapies such as easier routes of administration and reduced dosing frequencies, along with the developments that are expected to occur within the next decade, could have a significant effect on the way the disease is managed. However, earlier disease detection may render the currently available therapies more useful, but until disease-modifying agents are introduced, the landscape will not change significantly.

Alessio Brunello, Senior Pharma Analyst at GlobalData, comments: “Due to their additional cost, GlobalData believes that the uptake of biologics will initially be low compared with other medications, especially in the more advanced stages of the disease where these therapies are believed to have less of an effect. In addition, regulatory agencies and healthcare institutions will be forced to revise their protocols to allow for these therapies to be reimbursed and administered on a large scale. Given that the clinical data in support of this drug class have not been conclusive, these changes are expected to be slow and the therapies will still be subjected to intense scrutiny in order to justify their high costs.”

The late-stage pipeline in AD includes several strong candidates and a diverse range of novel mechanisms of action. The Phase II/III and III pipeline in the 8MM comprises five immunotherapies (Roche’s gantenerumab, Biogen’s aducanumab, Eisai’s BAN-2401, Grifols’ Albutein, and Eli Lilly’s solanezumab) and 14 small molecules. According to GlobalData, Biogen’s Aβ-targeting immunotherapy aducanumab is forecast to see the highest sales at the end of the forecast period.

Brunello adds: “Biogen currently expects to complete the US filing for aducanumab in the third quarter of 2020. However, the company has raised skepticism and criticism about how the data from ENGAGE and EMERGE studies were analyzed and for the decision to seek Food and Drug Administration (FDA) approval of the drug; the company was supposed to proceed with an NDA for the drug in early 2020, but due to the COVID-19 pandemic this is expected to take more time than was originally estimated. Although safety concerns remain for aducanumab, regulators are likely to overlook some levels of adverse effects given the difficulties associated with AD drug development.”

*8MM: US, France, Germany, Italy, Spain, UK, Japan and China