The Alzheimer’s disease (AD) market is expected to grow at a compound annual growth rate (CAGR) of 20.0% over the course of the forecast period (2020–2030), reaching $13.7bn across the eight major markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and China), according to GlobalData’s recent report, Alzheimer’s Disease: Eight-Market Drug Forecast and Market Analysis. Major driving factors of this growth include an ageing global population leading to an increase in prevalent cases, the launch of novel symptomatic therapies, including the first therapies for the treatment of agitation associated with AD, and the entry of disease-modifying therapies (DMTs) into the market.

AD is a progressive neurodegenerative disease that is characterised by memory loss, cognitive impairment, and functional decline. In 2020, the competitive landscape in AD offered medications such as acetylcholinesterase inhibitors and N-methyl-D-aspartate (NMDA) receptor antagonists, which are aimed at treating the symptoms of the disease. These drugs are modestly effective and primarily off-patent, thus creating a significant opportunity for new entrants into the AD market.

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A major focus of R&D in the AD therapeutic space is preventing the accumulation of amyloid beta (Aβ). Despite many historical failures, the industry continues to demonstrate its commitment to the amyloid cascade hypothesis of AD. Drug developers have finally begun to see some success with this strategy, first with the FDA approval of Biogen’s anti-Aβ monoclonal antibody (mAb) Aduhelm (aducanumab) in 2021, followed by the FDA approval of Eisai/Biogen’s anti-Aβ mAb Leqembi (lecanemab) in January 2023. The launch of these products and of two other anti-Aβ mAbs, Lilly’s donanemab and remternetug, during the forecast period will be a significant driver of growth within the AD market, as these are the first DMTs to launch and, as biologics, they will have high costs of therapy.

Although the approval of Aduhelm was a major milestone for the AD community, the drug’s launch was marred by controversy surrounding the FDA’s decision, which conflicted with its advisory board’s opinion that there was not enough evidence to show that Aduhelm could effectively slow cognitive decline. Thus, despite being the first DMT to enter the AD market, sales are expected to be low for Aduhelm. In contrast, Leqembi and donanemab have both demonstrated that they can reduce cognitive decline in Phase III clinical trials. As such, they are expected to become the top-selling AD drugs by 2030. GlobalData forecasts that Leqembi and donanemab could generate global (8MM) sales of approximately $3.5bn and $2.0bn in 2030, respectively.

While the AD market is projected to experience strong growth throughout the forecast period across the 8MM, challenges still remain. The rates of diagnosis and treatment are low across all stages of the disease, so there is an unmet need for accurate, easy-to-use diagnostic tests, and biomarkers that can be used for patient classification and the assessment of treatment response. As trial designs and the incorporation of biomarkers in trials improve, and testing in the pre-symptomatic AD population becomes accessible, opportunities will increase for players looking to enter the AD market in the future. Key opinion leaders (KOLs) interviewed by GlobalData did not believe there will ever be one product that can cure AD. Rather, they consistently expressed that the future of AD treatment will entail the combinatory use of preventative, symptomatic, and disease-modifying products.

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