The Alzheimer’s disease market was valued at approximately USD 3,610 million in 2023 and is expected to expand at a strong CAGR over the 2020 – 2034 study period, with rapid growth projected to drive the market to USD 34,335 million by 2034, supported by an impressive 23.7% CAGR. The United States continues to be the leading contributor to the global Alzheimer’s disease market.
In 2023, the 7MM accounted for nearly 15.84 million diagnosed prevalent cases, underscoring the significant disease burden. Prevalence is forecast to increase steadily, with total cases anticipated to reach 21.5 million by 2034, driven by aging demographics and advancements in diagnostic capabilities. Gender-based analysis indicates that in the US, 4.65 million women and 2.325 million men were living with Alzheimer’s disease in 2023.
Across Europe (EU4 + UK), Germany recorded the highest share of cases at 30%, followed by France with 24%. From an age perspective, individuals aged 75 – 84 years represented the largest patient segment, while those below 65 years accounted for the smallest proportion.
Japan reported approximately 2.47 million cases of Alzheimer’s-related agitation in 2023, a figure expected to rise by 2034. Additionally, Japan strengthened its treatment landscape in 2024 with the approval of KISUNLA (donanemab) for patients with early symptomatic Alzheimer’s disease.
The existing treatment landscape comprises approved therapies such as LEQEMBI (lecanemab) along with multiple off-label options. Market expansion is further reinforced by a strong late-stage pipeline featuring 25+ advanced candidates, including NE3107, Masitinib, Buntanetap, Simufilam, ALZ-801, Remternetug, semaglutide, and other emerging therapies.
DelveInsight’s Alzheimer’s Disease market report delivers an in-depth evaluation of current treatment paradigms, emerging therapeutics, and individual drug market shares, alongside historical and forecast market size estimates for the 7MM from 2020 to 2034. The report also assesses treatment strategies, major growth drivers and challenges, SWOT analysis, reimbursement and access frameworks, and unmet medical needs, offering a comprehensive view of growth opportunities and the overall potential of the Alzheimer’s disease therapeutics market.
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Some facts of the Alzheimer’s Disease Market Report are:
- In 2023, the United States dominated the Alzheimer’s disease market, contributing nearly 54% of the overall market share across the 7MM, surpassing other key regions such as the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- In May 2025, the FDA awarded Breakthrough Device status to Fujirebio Diagnostics’ Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, a blood-based in vitro diagnostic test intended to identify amyloid plaque pathology in adults aged 55 years and older exhibiting symptoms of Alzheimer’s disease.
- In April 2025, the ApoE4 Alzheimer’s Alliance was established as a patient advocacy organization representing individuals who carry the ApoE4 gene. The group aims to address unmet patient needs by working alongside U.S. policymakers and the FDA to promote faster development of novel therapies and supportive healthcare policies.
- DelveInsight estimates that Japan recorded approximately 3.92 million diagnosed prevalent Alzheimer’s disease cases in 2023, highlighting the country’s significant disease burden.
- The United States accounted for roughly 44% of all diagnosed Alzheimer’s disease cases across the 7MM in 2023, corresponding to nearly 6.98 million patients, with prevalence expected to increase further by 2034.
- Major companies actively engaged in the Alzheimer’s disease market include Eisai, Biogen, Changchun Huayang High-tech Co. Ltd., Hoffmann-La Roche, vTv Therapeutics, AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Prilenia Therapeutics, Denali Therapeutics Inc., Stemedica Cell Technologies, Inc., along with numerous other participants.
- In February 2025, Annovis Bio received acceptance of its Phase 3 Alzheimer’s clinical trial protocol, a key step toward accelerating development and supporting a future New Drug Application (NDA) for buntanetap.
- Also in February 2025, Johnson & Johnson’s anti-tau therapy posdinemab was granted Fast Track designation by the FDA, recognizing its potential to target tau pathology and slow cognitive deterioration in Alzheimer’s patients.
- In January 2025, Eisai and Biogen announced FDA approval of the Supplemental Biologics License Application (sBLA) for once-monthly intravenous maintenance dosing of LEQEMBI® (lecanemab-irmb). The therapy is indicated for patients with early Alzheimer’s disease, including those with mild cognitive impairment or mild dementia, following an initial bi-weekly dosing phase.
- In October 2024, Annovis Bio confirmed successful completion of an End-of-Phase 2 FDA meeting for buntanetap, clearing the path for Phase 3 pivotal trials after clinical data showed symptomatic improvement in early Alzheimer’s disease patients. The company is preparing to submit NDAs addressing both short- and long-term efficacy.
- In September 2024, Eli Lilly’s Kisunla (donanemab) received regulatory approval in Japan, following its U.S. approval earlier in July. Kisunla became Japan’s second approved amyloid-targeting therapy, indicated for adults with early symptomatic Alzheimer’s disease and confirmed amyloid pathology.
- The United States remained the largest Alzheimer’s disease market in 2023, accounting for approximately 54% of total market revenue across the 7MM, ahead of the EU4 countries, the United Kingdom, and Japan.
- Among European markets, Germany recorded the highest Alzheimer’s disease market value in 2023, reaching approximately USD 267 million, while the UK represented the smallest market, estimated at around USD 104 million.
- Japan’s Alzheimer’s disease market was valued at approximately USD 845 million in 2023, reflecting high prevalence and expanding therapeutic adoption.
- DelveInsight further estimates that Japan had around 3.92 million diagnosed Alzheimer’s disease cases in 2023, underscoring the growing healthcare challenge in the region.
- In 2023, the U.S. contributed nearly 44% of all diagnosed Alzheimer’s disease cases across the 7MM, totaling about 6.98 million patients, with case numbers projected to rise through 2034.
- Gender-specific analysis in Japan showed approximately 1.39 million diagnosed male patients and 2.53 million diagnosed female patients in 2023, indicating a higher disease burden among women.
- In the United States, Alzheimer’s disease prevalence is segmented into four age groups—under 65, 65–74, 75–84, and 85+ years. In 2023, individuals aged 75–84 years represented the largest patient group with around 2.79 million cases, while those under 65 accounted for the fewest cases at approximately 175,000.
- Notable Alzheimer’s disease therapies under development or evaluation include BAN2401, gantenerumab, ALZT-OP1, bryostatin-1, tricaprilin, and other emerging candidates.
- Gender-based epidemiological analysis indicates that women are more likely than men to develop Alzheimer’s disease or other forms of dementia, consistent with global prevalence trends.
Alzheimer’s disease Overview
Alzheimer’s disease is a progressive neurodegenerative disorder and the leading cause of dementia, primarily affecting older adults. It is characterized by memory loss, cognitive decline, and behavioral changes that gradually impair daily functioning. The disease is driven by the accumulation of amyloid-beta plaques and tau protein tangles in the brain, resulting in neuronal damage and brain atrophy. Early symptoms include forgetfulness and difficulty with planning or problem-solving, which worsen over time. While current treatments mainly provide symptomatic relief, emerging disease-modifying therapies targeting underlying pathology are reshaping the future of Alzheimer’s care.
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Alzheimer’s Disease Market Outlook
Existing Alzheimer’s disease treatments are largely aimed at relieving symptoms by influencing key neurotransmitters, including acetylcholine, serotonin, and noradrenaline, while also modulating glutamate and dopamine pathways.
However, these therapies are often associated with adverse effects, underscoring the importance of personalized treatment strategies that consider patient comorbidities and possible drug–drug interactions.
Recent regulatory approvals of LEQEMBI (lecanemab) from Biogen and Eisai, KISUNLA (donanemab-azbt) from Eli Lilly, and Brexpiprazole (REXULTI) highlight a transition toward more precise, targeted, and patient-centric approaches in Alzheimer’s disease care.
Alzheimer’s Disease Market Dynamics: Drivers and barriers
Alzheimer’s Disease Market Drivers:
- Rising prevalence of Alzheimer’s disease globally, driven by aging populations.
- Increasing awareness and early diagnosis initiatives improving patient identification.
- Advancements in disease-modifying therapies and targeted treatments.
- Growing investment in research and development of novel therapeutics.
- Expanding healthcare infrastructure and reimbursement policies facilitating treatment access.
- Rising demand for personalized medicine approaches in managing Alzheimer’s disease.
Alzheimer’s Disease Market Barriers:
- High treatment costs limiting patient access, especially in emerging markets.
- Complex disease pathology and limited understanding of etiology hindering therapeutic development.
- Potential side effects associated with current therapies affecting adherence.
- Regulatory challenges and lengthy approval processes for novel drugs.
- Limited availability of specialized healthcare providers in certain regions.
- Diagnostic challenges and delayed disease recognition impacting early intervention.
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Alzheimer’s Disease Epidemiology
DelveInsight estimates indicate that Japan had approximately 3.92 million diagnosed Alzheimer’s disease patients in 2023, comprising about 1.39 million males and 2.53 million females. In the United States, Alzheimer’s disease accounted for nearly 44% of all diagnosed cases across the 7MM, translating to approximately 6.98 million patients, with prevalence anticipated to rise through 2034.
Age-based analysis in the U.S. shows that individuals aged 75–84 years experienced the highest disease burden, with nearly 2.79 million cases, whereas people under 65 years represented the smallest affected group at roughly 175,000 cases.
Within the EU4 countries and the United Kingdom, mild cognitive impairment (MCI) emerged as the most prevalent disease stage, accounting for approximately 2.56 million cases, while severe dementia remained the least frequent stage with around 645,000 cases.
Neuropsychiatric manifestations significantly add to the overall disease burden, as in 2023 the United States reported about 5.23 million cases of agitation, while Japan recorded nearly 2.03 million cases of psychosis, both expected to increase over the forecast period.
Alzheimer’s Disease Epidemiology Segmentation
- Total Diagnosed Prevalent Cases of Alzheimer’s Disease in the 7MM
- Age-specific Cases of Alzheimer’s Disease in the 7MM
- Gender-specific Cases of Alzheimer’s Disease in the 7MM
- Severity-specific Cases of Alzheimer’s Disease in the 7MM
Understand the current and future burden of the disease across the 7MM and uncover opportunities for research and market growth. @ Alzheimer’s Disease Patient Forecasting
Alzheimer’s Disease Drugs Analysis: Competitive Landscape
Masitinib (AB1010) – AB Science
Masitinib is an orally administered tyrosine kinase inhibitor that targets neuro-immune cells such as mast cells and microglia, which accumulate in the central nervous system and play a role in Alzheimer’s disease pathology. Preclinical research indicates that masitinib preserves synaptic integrity by suppressing mast cell activity, leading to improved spatial learning and recovery of synaptic markers. In clinical development, Phase II studies showed therapeutic benefits in patients with mild to moderate Alzheimer’s disease, while Phase IIb/III trials reported a meaningful reduction in the rate of cognitive decline. The drug is currently being evaluated in confirmatory Phase III trials.
Valiltramiprosate (ALZ-801) – Alzheon, Inc.
ALZ-801 is an orally available small-molecule prodrug developed to prevent the formation of neurotoxic amyloid oligomers in the brain. It is a valine-linked derivative of tramiprosate that is metabolized into homotaurine, improving bioavailability and extending systemic exposure. Both ALZ-801 and tramiprosate are further metabolized into 3-sulfopropanoic acid (3-SPA), an active metabolite that inhibits Aβ42 aggregation. Engineered to enhance gastrointestinal tolerability and pharmacokinetic properties, ALZ-801 demonstrated consistent plasma concentrations in Phase I studies. It is currently undergoing Phase III clinical evaluation as a potential disease-modifying therapy for early Alzheimer’s disease.
Tricaprilin (CER-0001) – Cerecin
Tricaprilin (CER-0001), also referred to as AC-1204, is an oral caprylic triglyceride formulation designed to induce sustained mild ketosis and support mitochondrial energy metabolism. Since Alzheimer’s disease is associated with impaired brain glucose utilization, CER-0001 supplies ketone bodies as an alternative fuel source to enhance neuronal metabolism. Caprylic acid is metabolized into acetoacetic acid and β-hydroxybutyric acid, which are converted into acetyl-CoA for energy generation through the citric acid cycle. Clinical data suggest that CER-0001 may improve cognitive outcomes in patients with mild to moderate Alzheimer’s disease, particularly among those who are APOE4-negative.
Bezisterim (NE3107) – BioVie
NE3107 is an oral, brain-penetrant small molecule with combined anti-inflammatory and insulin-sensitizing properties. It selectively modulates the ERK/NF-κB signaling pathway, leading to reduced TNF production and regulated microglial activity without disrupting essential immune functions. Through this dual mechanism, NE3107 may alleviate central nervous system inflammation and insulin resistance, potentially slowing disease progression in Alzheimer’s patients. Formerly known as HE3286, the compound is also being studied in Parkinson’s disease, multiple myeloma, and prostate cancer. Phase III trials in mild to moderate Alzheimer’s disease have been completed, with data presented at AD/PD 2024 in Lisbon, highlighting its potential to reduce neurocognitive decline.
Alzheimer’s Disease Therapeutic Assessment
Alzheimer’s Disease companies working in the market are Eisai, Biogen, Changchun Huayang High-tech Co. Ltd., Hoffmann-La Roche, vTv Therapeutics, AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Prilenia Therapeutics, Denali Therapeutics Inc., Stemedica Cell Technologies, Inc. and many others.
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Scope of the Alzheimer’s Disease market report:
- Geography: The US, EU4 (Germany, France, Italy, and Spain) and UK, and Japan
- Study period: 2020 to 2034
- Forecast period: 2024 to 2034
- Market Size: ~USD 5,048 million in 2025
- Companies: Eli Lilly and Company, BioVie, AB Science, Cassava Sciences, Eli Lilly, TauRx Therapeutics, Novo Nordisk, KeifeRx, Eli Lilly, AriBio, Cerecin, Alzheon, Neurim Pharmaceuticals/Syneos Health, Athira Pharma, Annovis Bio, Anavex Life Sciences, AgeneBio, Eisai, and others.
- Therapies: LEQEMBI (lecanemab) – Biogen Inc./Eisai Co., Ltd., KISUNLA (donanemab-azbt) – Eli Lilly and Company, Masitinib (AB1010) – AB Science, Valiltramiprosate (ALZ-801) – Alzheon, Inc., Tricaprilin (CER-0001) – Cerecin, Bezisterim (NE3107) – BioVie.
Table of Contents
1. Key Insights
2. Executive Summary
3. Alzheimer’s Disease Competitive Intelligence Analysis
4. Alzheimer’s Disease Market Overview at a Glance
5. Alzheimer’s Disease Disease Background and Overview
6. Alzheimer’s Disease Patient Journey
7. Alzheimer’s Disease Epidemiology and Patient Population
8. Alzheimer’s Disease Treatment Algorithm, Current Treatment, and Medical Practices
9. Alzheimer’s Disease Unmet Needs
10. Key Endpoints of Alzheimer’s Disease Treatment
11. Alzheimer’s Disease Marketed Products
12. Alzheimer’s Disease Emerging Therapies
13. Alzheimer’s Disease Seven Major Market Analysis
14. Attribute Analysis
15. Alzheimer’s Disease Market Outlook (7 major markets)
16. Alzheimer’s Disease Access and Reimbursement Overview
17. KOL Views on the Alzheimer’s Disease Market
18. Alzheimer’s Disease Market Drivers
19. Alzheimer’s Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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