The Alzheimer’s disease market is expected to grow at a high compound annual growth rate (CAGR) of 20.0% from $2.4 billion in 2023 to $14.7 billion by 2033 across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China), according to GlobalData’s recent report, Alzheimer’s Disease: Eight-Market Drug Forecast and Market Analysis – Update (2026).
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 therapies for the treatment of agitation and psychosis associated with Alzheimer’s disease.
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A major focus of R&D in the Alzheimer’s disease 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 Alzheimer’s disease 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 across the other 8MM.
Although the approval of the first DMTs for the treatment of Alzheimer’s disease 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 disease, providing a further access challenge in the form of reimbursement/payer restrictions. Indeed, in Japan, a 15% price reduction for Leqembi took effect in November 2025 following the Central Social Insurance Medical Council (Chuikyo) cost-effectiveness assessment, and across Europe Leqembi and Kisunla are facing reimbursement challenges due to cost-benefit analyses.
Developers are investigating alternative routes of administration so that patients will not require multiple lengthy IV infusions to be treated. In the US, the FDA approved Leqembi Iqlik, a subcutaneous autoinjector formulation of lecanemab, for weekly maintenance dosing in August 2025 and for treatment initiation in July 2026, making Leqembi Iqlik the first DMT with at-home dosing from the start of treatment. 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 more widely accessible for patients. Furthermore, in clinical trials, these oral products have not been associated with amyloid-related imaging abnormalities (ARIA), the key side effect associated with 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 disease market, contributing 63.7% 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 $2.8 billion and $2.9 billion, respectively, by 2033.
GlobalData considers AriBio’s AR1001 (mirodenafil), Annovis Bio’s buntanetap, and Bristol Myers Squibb’s Cobenfy (xanomeline + trospium) to be some of the most promising late-stage pipeline drugs in Alzheimer’s disease as oral drugs with novel mechanisms of action. AR1001 and buntanetap have convenient once-daily dosing that could be easily integrated into clinical practice and Bristol Myers Squibb’s Cobenfy is targeting psychosis associated with Alzheimer’s disease, an indication with no approved therapeutics. If these drugs deliver in their ongoing Phase III trials, they are expected to make a meaningful contribution to market growth and to broaden the treatment options available beyond the anti-Aβ mAbs.
While the Alzheimer’s disease 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 clearance of a blood test for diagnosing Alzheimer’s disease, Fujirebio’s Lumipulse G pTau 217/ß-Amyloid 1-42 Plasma Ratio, in May 2025. Additionally, the current 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 opportunity for developers. Key opinion leaders (KOLs) interviewed by GlobalData did not believe there will ever be one product that can cure Alzheimer’s disease. Rather, they consistently noted that the future of Alzheimer’s disease treatment will entail the combined use of preventative, symptomatic, and disease-modifying products. Despite the significant growth anticipated for the Alzheimer’s disease market, many opportunities will remain for developers in this highly active market.
