The Alzheimer’s disease market is expected to grow at a high compound annual growth rate (CAGR) of 23.4% from $2.4bn in 2023 to $19.3bn by 2033 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‘. The major driving factors of this growth include the ageing global population, which will lead to an increase in prevalent cases; the entry of expensive disease-modifying therapies (DMTs) into the market, which will likely result in increased treatment rates as more options become available; and the launch of novel symptomatic therapies including the first FDA-approved therapies for the treatment of agitation and psychosis associated with Alzheimer’s.
A major focus of R&D in the Alzheimer’s therapeutic space is preventing the accumulation of amyloid beta (Aβ). Despite many historical failures, this strategy has come to fruition for drug developers in recent years with the entry of the first DMTs into the Alzheimer’s market. The FDA approved Eisai / Biogen’s Leqembi (lecanemab) in January 2023 and Lilly’s Kisunla (donanemab) in July 2024, and both drugs have since been approved in Japan, China, and the UK. The launch of these products and two other anti-Aβ targeting drugs, Eli Lilly’s remternetug and Alzheon’s ALZ-801 (valiltramiprosate), during the forecast period will be a significant driver of growth within the Alzheimer’s market. GlobalData forecasts that Leqembi and Kisunla could generate global sales of approximately $3.6bn and $3.8bn, respectively, by 2033. Overall, DMTs are expected to dominate the global Alzheimer’s market, contributing 73.5% of the market by 2033, with drugs targeting Aβ making up the majority of this.
Although the approval of the first DMTs for the treatment of the illness is a significant step forward, a key limiting factor in their uptake has been their integration into clinical practice so that they can be widely available for patients. Frequent intravenous (IV) administration places a high burden on care settings where the drug can be administered, and access to positron emission tomography (PET) and magnetic resonance imaging (MRI) scans is a key economic and operational limiting factor for access to these drugs. In addition to logistical factors, these new DMTs are significantly more expensive than the current highly genericized symptomatic treatments used in the management of Alzheimer’s, providing a further access challenge in the form of reimbursement/payer restrictions.
Developers are investigating alternative routes of administration so that patients will not require multiple lengthy IV infusions to be treated. Eisai and Biogen are currently evaluating a subcutaneous formulation of Leqembi, and Eli Lilly is developing a second anti-Aβ monoclonal antibody (mAb), remternetug, which can also be administered subcutaneously. Additionally, there are several oral late-stage pipeline products with a variety of mechanisms of action that, if approved, should be easier to integrate into clinical practice and therefore be more widely accessible to patients. Furthermore, in clinical trials, these oral products have not been associated with amyloid-related imaging abnormalities (ARIA), the key side effect associated with the anti-Aβ mAbs that require MRI monitoring, which would further improve access to these drugs.
While the Alzheimer’s market is projected to experience strong growth throughout the forecast period across the 8MM, unmet needs beyond access to treatment will 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. While blood-based biomarkers are now being used fairly routinely in clinical trials and research, they have not yet entered routine clinical practice. Additionally, the new DMTs are only considered to be moderately effective, so significant opportunity remains for more effective DMTs that do not just slow progression but also stop the disease, with prevention being the end goal. Beyond DMTS, drugs that can effectively improve cognition in the late stages of disease, as well as more effective options for secondary symptoms such as agitation and psychosis, also provide opportunities for developers. Key opinion leaders (KOLs) interviewed by GlobalData did not believe there would ever be one product that can cure the disease. Rather, they consistently noted that the future of Alzheimer’s treatment will entail the combinatory use of preventative, symptomatic, and disease-modifying products. Despite the significant anticipated growth for the Alzheimer’s market, many opportunities will remain for developers.
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By GlobalData