Alzheimer's Disease Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

The Alzheimer's disease market in the 7MM was valued at USD 3,610 million in 2023. The United States accounted for the highest Alzheimer's disease market size approximately 54% of the total Alzheimer's disease market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
Alzheimer's Disease Market Summary

The Alzheimer's disease market in the 7MM was valued at USD 3,610 million in 2023, driven by approved therapies like LEQEMBI (lecanemab) and off-label drugs such as galantamine and memantine. The market is expected to grow further with the launch of emerging therapies during 2024-2034. In 2023, the 7MM reported approximately 15.84 million diagnosed prevalent cases, highlighting a significant disease burden and the need for innovative treatments. Among the EU4 and the UK, Germany had the highest cases (30%), followed by France (24%), while in the US, 2.33 million males and 4.65 million females were affected. The 75-84 age group in the EU4 and UK recorded the most cases (2.3 million), and the under-65 group the fewest (125,000). In Japan, around 2.47 million cases of agitation associated with Alzheimer's were reported in 2023. In September 2024, Japan approved KISUNLA (donanemab-azbt) for adults with early symptomatic Alzheimer's disease and confirmed amyloid pathology.

DelveInsight's, Alzheimer's Disease market report offers a comprehensive analysis of current treatment practices, emerging therapies, and the market share of individual drugs, along with the historical and projected 7MM Alzheimer's disease market size from 2020 to 2034. The report further examines prevailing treatment approaches, key market drivers and barriers, SWOT analysis, reimbursement and market access dynamics, and unmet medical needs, providing a detailed assessment of growth opportunities and the underlying potential within the Alzheimer's disease therapeutics market.

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Some facts of the Alzheimer's Disease Market Report are:

* The Alzheimer's Disease market size was valued ~USD 3,610 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
* In 2023, the United States held the largest share, accounting for around 54% of the total Alzheimer's disease market in the 7MM, compared to other major markets including the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
* In May 2025, the FDA granted Breakthrough Device designation to Fujirebio Diagnostics' Lumipulse G pTau217/Ss-Amyloid 1-42 Plasma Ratio, an in vitro blood test designed to detect amyloid plaques in adults aged 55 and older showing signs of Alzheimer's disease.
* In April 2025, the ApoE4 Alzheimer's Alliance, a new patient advocacy group, was launched to represent individuals carrying the ApoE4 gene. The Alliance seeks to address the unique needs of this community by collaborating with U.S. policymakers and the FDA, aiming to accelerate the development of innovative treatments and supportive policies for those affected by Alzheimer's disease.
* According to DelveInsight, the total diagnosed prevalent cases of Alzheimer's disease in Japan were approximately 3,920 thousand in 2023.
* In 2023, the United States accounted for about 44% of diagnosed Alzheimer's disease cases across the 7MM, totaling around 6,980 thousand cases, with numbers expected to rise by 2034.
* Leading 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.
* In February 2025, Annovis Bio's phase 3 Alzheimer's trial protocol was accepted, aiming to accelerate development and support a New Drug Application for buntanetap.
* In February 2025, Johnson & Johnson's posdinemab, an anti-tau therapy for Alzheimer's, was granted fast track designation, addressing tau pathology to slow cognitive decline.
* In January 2025, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI Registered ) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.
* In October 2024, Annovis Bio Inc. announced that it successfully completed an End-of-Phase 2 meeting with the FDA for its Alzheimer's drug, buntanetap. The FDA has approved the progression to Phase 3 pivotal trials, following data demonstrating symptomatic improvement in patients with early Alzheimer's. Annovis is now poised to file New Drug Applications (NDAs) for both short-term and long-term efficacy in treating early Alzheimer's disease.
* In September 2024, Eli Lilly's Alzheimer's treatment, Kisunla (donanemab), has been approved in Japan, following its U.S. approval in July. Kisunla becomes the second amyloid-targeting therapy approved in Japan, after Eisai and Biogen's Leqembi (lecanemab). It is indicated for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment and mild dementia, who have confirmed amyloid pathology.
* In 2023, the United States represented the largest market for Alzheimer's disease, accounting for approximately 54% of the total market size across the 7MM, compared to other major markets such as the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
* In 2023, Germany had the largest market size for Alzheimer's disease among the EU countries, with USD 267 million, while the UK had the smallest market size, approximately USD 104 million.
* In 2023, the market size for Alzheimer's disease in Japan was estimated to be approximately USD 845 million.
* According to DelveInsight's assessment, the total diagnosed prevalent cases of Alzheimer's disease in Japan were estimated to be approximately 3.92 million in 2023.
* In 2023, the United States accounted for about 44% of the diagnosed Alzheimer's disease cases across the 7MM, with approximately 6.98 million cases. This number is expected to grow by 2034, according to DelveInsight's estimates.
* In Japan, there were approximately 1.39 million diagnosed male cases and 2.53 million diagnosed female cases of Alzheimer's disease in 2023, reflecting the gender distribution within the population.
* In the US, age-specific cases of Alzheimer's disease are divided into four groups: under 65, 65-74, 75-84, and 85+ years. In 2023, the 75-84 age group had the highest prevalence, with approximately 2.79 million cases, while the under-65 group had the lowest, with around 175 thousand cases.
* Key Alzheimer's Disease Therapies: BAN2401, Gantenerumab, ALZT-OP1, Bryostatin-1, ALZT-OP1, Tricaprilin, others.
* The Alzheimer's Disease epidemiology based on gender analyzed that more women than men have Alzheimer's or other dementias

Alzheimer's disease Overview

Alzheimer's disease is a progressive neurodegenerative disorder and the most common cause of dementia, affecting millions globally. It primarily impacts memory, thinking, and behavior, leading to significant impairments in daily functioning. Alzheimer's is characterized by the accumulation of amyloid plaques and tau tangles in the brain, which disrupt neuron communication and lead to cell death.

The disease typically manifests in individuals over the age of 65, with early symptoms including memory loss, confusion, and difficulty with language. As it advances, symptoms exacerbate to severe cognitive decline, loss of independence, and inability to perform basic tasks.

While the exact cause of Alzheimer's remains unknown, risk factors include age, genetics, family history, and lifestyle factors such as cardiovascular health. Diagnosis involves a combination of medical history, cognitive tests, and brain imaging.

Currently, there is no cure for Alzheimer's, but treatments are available to manage symptoms and improve quality of life. Medications like cholinesterase inhibitors and memantine can help, alongside lifestyle interventions and supportive care. Ongoing research aims to better understand the disease and develop effective treatments, with hopes of finding a cure in the future.

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Alzheimer's Disease Market Outlook

Current Alzheimer's disease therapies primarily focus on symptomatic management by modulating neurotransmitters such as acetylcholine, serotonin, and noradrenaline, while regulating glutamate and dopamine activity. These treatments, however, can cause side effects, emphasizing the need for personalized approaches that account for patient comorbidities and potential drug interactions. The recent approvals of LEQEMBI (lecanemab) by Biogen and Eisai, KISUNLA (donanemab-azbt) by Eli Lilly, and Brexpiprazole (REXULTI) reflect a shift toward more targeted and individualized therapeutic strategies in Alzheimer's disease management.

Alzheimer's Disease Market 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

According to DelveInsight's analysis, the total diagnosed prevalent cases of Alzheimer's disease in Japan were estimated at nearly 3.92 million in 2023, with a gender distribution of approximately 1.39 million males and 2.53 million females. In the United States, Alzheimer's accounted for around 44% of diagnosed cases across the 7MM, totaling 6.98 million, a figure projected to increase by 2034. Age-specific prevalence in the US shows the 75-84 age group as the most affected, with nearly 2.79 million cases, while the under-65 group had the lowest prevalence at 175 thousand. Alzheimer's disease severity across EU4 and the UK indicates that mild cognitive impairment (MCI) is the most prevalent stage (2.56 million cases), whereas severe dementia has the fewest cases (645 thousand). Behavioral and psychiatric complications are also significant, with the US reporting nearly 5.23 million cases of agitation and Japan documenting 2.03 million cases of psychosis in 2023, both anticipated to rise 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

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Alzheimer's Disease Drugs Uptake and Pipeline Activities

* Masitinib (AB1010) - AB Science Masitinib is an oral tyrosine kinase inhibitor targeting neuro-immune cells, including mast cells and microglia, which accumulate in the central nervous system (CNS) and are implicated in Alzheimer's disease pathology. Preclinical studies have shown that masitinib protects synapses by inhibiting mast cells, improving spatial learning and restoring synaptic markers. Clinically, Phase II trials demonstrated benefits in mild to moderate Alzheimer's disease, while Phase IIb/III studies indicated a significant slowing of cognitive decline. Masitinib is currently under confirmatory Phase III evaluation.
* Valiltramiprosate (ALZ-801) - Alzheon, Inc. ALZ-801 is an oral small-molecule prodrug designed to block the formation of neurotoxic amyloid oligomers in the brain. It is a valine-conjugated form of tramiprosate, metabolizing into homotaurine for enhanced absorption and prolonged blood retention. Both ALZ-801 and tramiprosate metabolize to 3-sulfopropanoic acid (3-SPA), which inhibits ASs42 aggregation. Designed to improve gastrointestinal tolerance and pharmacokinetics, ALZ-801 has shown stable plasma levels in Phase I studies. It is currently in Phase III clinical trials for early-stage Alzheimer's disease as a potential disease-modifying therapy.
* Tricaprilin (CER-0001) - Cerecin Tricaprilin (CER-0001), also known as AC-1204, is an oral formulation of caprylic triglyceride that induces mild chronic ketosis to enhance mitochondrial metabolism. Alzheimer's disease is associated with reduced cerebral glucose utilization, and CER-0001 provides ketone bodies as an alternative energy source, boosting cellular metabolism. Caprylic acid is converted to acetoacetic acid and Ss-hydroxybutyric acid, which form acetyl-CoA for energy production via the citric acid cycle. Clinical studies suggest cognitive improvements in mild to moderate Alzheimer's disease, particularly in APOE4-negative patients.
* Bezisterim (NE3107) - BioVie NE3107 is an oral small molecule that crosses the blood-brain barrier and acts as both an anti-inflammatory agent and an insulin sensitizer. It selectively inhibits the ERK/NF-B pathway, reducing TNF production and modulating microglial activity without impairing essential functions. This dual action may reduce CNS inflammation and insulin resistance, potentially slowing Alzheimer's progression. Previously known as HE3286, NE3107 is also under investigation for Parkinson's disease, multiple myeloma, and prostate cancer. Phase III trials in mild to moderate Alzheimer's disease have been completed, with results presented at AD/PD 2024 in Lisbon, demonstrating potential to mitigate 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 3,460 Million in 2022
* 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.

Alzheimer's Disease Report Key Insights

1. Alzheimer's Disease Patient Population

2. Alzheimer's Disease Market Size and Trends

3. Key Cross Competition in the Alzheimer's Disease Market

4. Alzheimer's Disease Market Dynamics (Key Drivers and Barriers)

5. Alzheimer's Disease Market Opportunities

6. Alzheimer's Disease Therapeutic Approaches

7. Alzheimer's Disease Pipeline Analysis

8. Alzheimer's Disease Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Alzheimer's Disease Market

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

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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