Alzheimer's disease market to reach $17bn across 8MM by 2033
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 US Food and Drug Administration (FDA)-approved therapies for the treatment of agitation and psychosis associated with Alzheimer's.
A major focus of research and development 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 to the 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. In April 2025, after multiple delays, the European Medicines Agency approved Leqembi in a restricted population compared with the US, preventing it from being prescribed to patients who are APOE4 homozygotes [individuals who have inherited two copies of the APOE4 gene variant, one from each parent, increasing their likelihood of developing the disease].
Although the approval of the first DMTs for the treatment of Alzheimer's 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 in which the drug can be administered, and access to positron emission tomography 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 genericised symptomatic treatments used in the management of Alzheimer's, providing a further access challenge in the form of reimbursement/payer restrictions. Indeed, the Japanese Central Social Insurance Medical Council (Chuikyo) recently approved the cost-effectiveness assessment results for Leqembi, recommending a 15% price reduction, with the price change expected to come into effect from 1 November 2025. The final reimbursement guidance for Leqembi and Kisunla in the UK, published in June 2025 following two previous rejections, is that neither drug is recommended for use on the NHS.
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 for patients. In clinical trials, these oral products have not been associated with amyloid-related imaging abnormalities, the key side effect associated with the anti-Aβ mAbs that requires MRI monitoring, which would further improve access to these drugs.
Overall, DMTs are expected to dominate the global Alzheimer's market, contributing 69.2% of the market by 2033, with drugs targeting Aβ making up the majority of this. GlobalData forecasts that Leqembi and Kisunla could generate global sales of approximately $2.9 billion and $2.3 billion, respectively, by 2033.
While the 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 for 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, although advances are being made with the first FDA approval of a blood test for diagnosis, Fujirebio's Lumipulse G pTau 217/ß-Amyloid 1-42 Plasma Ratio, in May 2025. Additionally, the new DMTs are only considered to be moderately effective, so a significant opportunity remains for more effective DMTs that do not just slow progression but also stop the disease, with prevention 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 an opportunity for developers.
Key opinion leaders interviewed by GlobalData did not believe there will ever be one product that could cure Alzheimer's. Rather, they consistently noted that the future of treatment will entail the combinatory use of preventative, symptomatic and disease-modifying products. Despite the significant anticipated growth of the market, activity remains high and there will be many opportunities for developers.
"Alzheimer's disease market to reach $17bn across 8MM by 2033" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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