The Alzheimer’s disease (AD) market is projected to experience robust growth at a compound annual growth rate of 20.0% from $2.2 billion in 2020 to $13.7 billion in 2030 across the eight major markets (8MM*). This expansion is primarily attributed to the introduction of pioneering therapies aimed at addressing the challenges posed by AD, says GlobalData, a leading data and analytics company.

GlobalData’s latest report, “Alzheimer’s Disease: Eight-Market Drug Forecast and Market Analysis – Update,” reveals that the main driver of growth will be the launch of 23 new pipeline products, including novel symptomatic therapies for the treatment of agitation associated with AD and the entry of disease-modifying therapies (DMTs) to the market.

Philippa Salter, Neurology Analyst at GlobalData, comments: “In 2020, the competitive landscape in AD only offered medications such as acetylcholinesterase inhibitors, which are aimed at treating the symptoms of the disease. These drugs are modestly effective and primarily off patent, thus creating significant opportunity for new entrants into the AD market.”

A major focus of R&D in the AD therapeutic space is preventing the accumulation of amyloid beta (Aβ) and formation of Aβ plaques in the brain. 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 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.

Salter continues: “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 support whether 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 $3.5 billion and $2.0 billion in 2030, respectively.”

While the AD market is projected to experience strong growth throughout the forecast period across the 8MM, challenges 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 for biomarkers that can be used for patient classification and the assessment of treatment response.

Salter concludes: “As trial designs and the incorporation of biomarkers in trials improve, and testing in the pre-symptomatic AD population becomes accessible, opportunity will increase for players looking to enter the AD market in the future. Key opinion leaders (KOLs) interviewed by GlobalData do not believe there will ever be one product that can cure AD. Rather, they consistently expressed that the future of AD treatment will entail combinatory use of preventative, symptomatic, and disease-modifying products.”

*8MM = The US, France, Germany, Italy, Spain, the UK, Japan, and China.