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Alzheimer's Disease - Market Insight, Epidemiology And Market Forecast - 2032

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    Report

  • 255 Pages
  • August 2023
  • Region: Global
  • DelveInsight
  • ID: 5523957

Key Highlights

  • The diagnosed prevalence of Alzheimer's disease has been increasing in the US due to the increasing geriatric population and disease awareness. Advancements in disease pathophysiology understanding have led to the discovery of novel signaling pathways, due to which various diagnostic tools have evolved that have revolutionized disease diagnosis.
  • The current treatment regime is mostly symptomatic, slows disease progression, and helps improve quality of life. It is not curative and is a mix of non-pharmacological and pharmacological approaches.
  • The major bottleneck in understanding Alzheimer's market is that despite an extremely vibrant pipeline, assessing drugs' potential to enter the market is difficult due to high failure rates. Many therapies like gantenerumab, dabigatran, and verubecestat were unable to move past the trial phase.
  • Approval of disease-modifying novel anti-amyloid biologics, with targeted mechanisms of action, has led to significant improvements from the traditional symptomatic treatment regime. ADUHELM (aducanumab) by Biogen and Eisai, the first available disease-modifying treatment to address Alzheimer's pathology by targeting amyloid ß plaques, has still not received traditional approval in the US and is rejected in Europe and Japan.
  • In July 2023, the US FDA converted Biogen and Eisai's other amyloid beta-protein inhibitor- LEQEMBI's (lecanemab) accelerated approval to a traditional one after a confirmatory trial demonstrated a 27% reduction in cognitive decline. This marks a major milestone and is a forward-looking step in addressing the unmet needs of patients with early Alzheimer's.
  • The approval garners well for Biogen and Eisai, keeping them in a profitable position, ensuring a first-mover advantage in the market, and helping them drive past the ADUHELM stumble. There are hopes that it will be Eisai and Biogen's blockbuster product. This is further supplemented by a CMS go-ahead with Medicare covering the therapy for Alzheimer's appropriate patient segment. This will facilitate reimbursement for and access to LEQEMBI. However, certain Medicare requirements and drug labels' risk warnings and infusion-center bottlenecks could potentially weigh on drug sales, at least in the near term. The testing requirement for a genetic mutation is another hurdle.
  • In 2022, the market size of Alzheimer's disease was highest in the US among the 7MM countries, accounting for approximately USD 1,751.7 million. It is expected to increase by 2032.
  • Acetylcholinesterase inhibitors, donepezil, rivastigmine, and galantamine, have comparable efficacy and are widely used to treat mild-to-advanced stages of Alzheimer's disease, but their benefit-risk ratio is still being debated. NMDA antagonist, memantine, slows symptom progression in individuals with moderate to severe Alzheimer's disease but is also associated with side effects like dizziness, confusion, etc.
  • Emerging therapies by Anavex Life Sciences, Alzheon, Athira Pharma, Annovis Bio, Eli Lilly, BioVie, AB Science, Novo Nordisk, Cassava Sciences, TauRx Therapeutics, KeifeRx, AriBio, Cerecin, Eisai, others are in late stages of development and have the potential to create a positive shift in the Alzheimer's market.
  • Eli Lilly's donanemab (LY3002813), an FDA-designated product, is projected to be the first emerging therapy to enter the market by 2024. It will compete with Biogen and Eisai's LEQEMBI. With the therapy lowering the risk of progression by 39%, it is projected to have a slow-medium uptake. High costs will translate to higher revenue, and despite few safety concerns, the drug is anticipated to perform well during the forecast period.
This “Alzheimer's Disease - Market Insights, Epidemiology, and Market Forecast - 2032” report delivers an in-depth understanding of the Alzheimer's disease historical and forecasted epidemiology as well as the market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Alzheimer's disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Alzheimer's disease market size from 2019 to 2032. The report also covers current Alzheimer's disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan
Study Period: 2019-2032

Alzheimer's Disease Understanding and Treatment Algorithm

Alzheimer's Disease Overview

Alzheimer's disease, the most common type of dementia, is a progressive neurodegenerative disorder with a multifactorial pathogenesis. It is characterized by the gradual decline in cognitive and functional abilities, with individuals eventually losing the ability to undertake everyday tasks and function independently. Symptoms, first appear in their mid-60s, however, early disease may manifest in quadragenarians as well.

The symptoms develop slowly and gradually worsen over time. Early signs include forgetfulness and difficulty with problem-solving or completing familiar tasks, and as the disease progresses, these worsen with an overall decline in cognitive ability. The exact cause is mostly unknown, but research demonstrates that two microscopic features, amyloid plaques, and neurofibrillary agglomerates, characterize the disease. These disrupt normal communication between brain cells, leading to progressive degeneration, memory deterioration, and death.

The disease progresses through several stages with a corresponding increase in severity. The preclinical stage is mostly asymptomatic, while in mild cognitive impairment stage, an individual may experience mild memory problems, but these do not affect daily functioning. Mild, moderate, and severe stages are associated with progressive deterioration of memory that affects language, personality, or cognitive control, with symptoms eventually interfering with daily life.

Alzheimer's Disease Diagnosis

Continuous discovery of novel signaling pathways and various diagnostic tools have revolutionized disease diagnosis making it more personalized. There is no single test for the diagnosis. In clinical practice, it is typically diagnosed based on patient history, clinical symptoms, and various neuropsychiatric, physical, and functional assessments. Imaging (computed tomography, magnetic resonance imaging, positron emission tomography assessments, and blood tests are particularly important to rule out certain other causes of dementia. Amyloid scans, fluorodeoxyglucose imaging, and tau imaging, besides CSF and blood-biomarker-based diagnosis, have improved the diagnosis manifold.

For cognitive and functional assessment, standardized tests such as the Mini-Mental State Examination or the Montreal Cognitive Assessment are commonly used. National Institute on Aging guideline called the NIA-AA criteria, is the most accepted diagnostic criteria.

Alzheimer's Disease Treatment

There is no cure for Alzheimer's disease, and the available treatments offer relatively small symptomatic benefits but remain palliative. The treatment is divided into pharmaceutical, psychosocial, and caregiving.

Psychosocial interventions are adjuncts to pharmaceutical treatment and are classified within behavior, emotion, cognition, or stimulation-oriented approaches. Environment and lifestyle modifications, diet, and behavioral interventions are also important to improve the quality of life.

The drugs currently available modulate the levels of brain neurotransmitters, such as acetylcholine, serotonin, noradrenaline, glutamate, and dopamine. Therapies for symptomatic treatment like acetylcholinesterase inhibitors (donepezil, rivastigmine transdermal patch, and galantamine), and NMDA receptor antagonist, memantine, have been available for over a decade. Atypical antipsychotics, though not approved, are even commonly used to treat behavioral symptoms. Recently, more specific monoclonal antibodies that target amyloid beta-proteins have entered the Alzheimer's market space. Various therapies like amyloid beta inhibitors have been developed to reduce amyloid accumulation. Therapies by Biogen and Eisai ADUHELM (aducanumab) and LEQEMBI (lecanemab) have received approval from the US FDA. But the former has only accelerated approval while the latter has traditional. Though ADUHELM has been rejected in Europe and Japan, the company has submitted an application for lecanemab in the EU and Japan.

Alzheimer's Disease Epidemiology

As the market is derived using a patient-based model, the Alzheimer's disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of Alzheimer's disease, age-specific cases of Alzheimer's disease, gender-specific cases of Alzheimer's disease, and severity-specific cases of Alzheimer's disease in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
  • In 2022, the total diagnosed prevalent cases of Alzheimer's disease were estimated to be approximately 15,083,370 cases in the 7MM. These cases are projected to increase at a CAGR of 2.4%.
  • In the US, there were approximately 41% diagnosed prevalent cases of Alzheimer's disease in 2022, which is expected to increase during the forecast period.
  • In 2022, among the 7MM, Japan accounted for the second-highest diagnosed prevalent cases of Alzheimer's disease, contributing nearly 26%, while the UK accounted for the least with nearly 4% of the total diagnosed prevalent cases.
  • Japan accounted for 3,954,710 diagnosed prevalent cases of Alzheimer's disease. In 2022 the age-specific distribution of the disease suggests that the age cohort of 75-84 years accounted for the majority, nearly 51% of the cases, followed by =85 (32%), 65-74 (14%), and < 65 years (3%).
  • As per estimates based on this epidemiology model for Alzheimer's disease, the gender distribution of the disease suggests a female predominance across the 7MM, with approximately 5,024,849 male and 10,058,521 female cases in the 7MM in 2022.
  • According to estimates based on this epidemiology model for Alzheimer's, in Japan, in 2022, there were approximately 2,324,183, 826,139, 517,671, and 286,716 cases of MCI, mild, moderate, and severe dementia, which are expected to increase during the study period.

Alzheimer's Disease Drug Chapters

The drug chapter segment of the Alzheimer's disease report encloses a detailed analysis of Alzheimer's disease - currently used drugs and mid-stage (Phase II and Phase I) pipeline drugs. It also helps understand the Alzheimer's disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

ADUHELM (aducanumab): Biogen and Eisai

In June 2021, Biogen and Eisai's ADUHELM (aducanumab) received accelerated approval from the US FDA for the treatment of people living with early Alzheimer's disease, including people with mild cognitive impairment due to Alzheimer's disease, making it the first available disease-modifying treatment to address Alzheimer's disease pathology by targeting amyloid ß plaques. However, the drug is not globally accessible, as it did not receive approval by the EMA or MHLW, and the Alzheimer's community is still awaiting further trial data to support its approval.

It exerts its mechanism of action by crossing the blood-brain barrier and selectively targeting and binding aggregated soluble oligomers and insoluble fibril conformations of Aß plaques in the brain.

LEQEMBI (lecanemab): Biogen and Eisai

Biogen and Eisai's LEQEMBI (lecanemab) is a humanized IgG1 monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of Aß. In July 2023, the US FDA granted it traditional approval after a confirmatory trial verified the clinical benefit. It is the first amyloid beta-directed antibody, targeting the disease process, to be converted from accelerated to traditional approval for treating people with mild Alzheimer's disease and mild cognitive impairment due to Alzheimer's disease. An application to the European Medicines Agency (EMA) for approval of lecanemab in the EU has been submitted and it is also designated for priority review by the Japanese Ministry of Health, Labour, and Welfare.

Emerging Drugs

NE3107: BioVie

NE3107, being developed by BioVie, is an oral, small molecule, blood-brain permeable, anti-inflammatory, insulin sensitizer that binds to extracellular signal-regulated kinase (ERK) and selectively inhibits inflammation. NE3107 inhibits extracellular ERK/NFkB activation and TNF production stimulated by inflammatory mediators, such as lipopolysaccharide, and inhibits NFkB activation and TNF production. BioVie is also developing a drug for treating Parkinson's disease, multiple myeloma, and prostate cancer. The company is currently conducting Phase III trials to treat mild to moderate Alzheimer's disease.

Donanemab (LY3002813): Eli Lilly

Donanemab (LY3002813), being developed by Eli Lilly and Company, is a humanized IgG1 monoclonal antibody N3pG, developed from mouse mE8-IgG2a that identifies and destroys Aß proteins, excess abnormal proteins that bind together to create brain plaques in Alzheimer's disease patients. The rationale behind donanemab is that targeting deposited plaque itself is necessary to clear existing amyloid burden from the brain rather than merely prevent the deposition of new plaques or the growth of existing plaques.

Given via the IV administration route, its Phase III trial was recently completed. The confirmatory Phase III TRAILBLAZER-ALZ 2 trial is ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

Pharmacological therapies such as acetylcholinesterase inhibitors and NMDA receptor antagonists, and recently, more targeted amyloid beta-proteins inhibitors are the available therapies for Alzheimer's.

The approved acetylcholinesterase inhibitors, donepezil, rivastigmine, and galantamine have comparable therapeutic effects. These are recommended to treat mild-to-advanced stages of Alzheimer's, yet their benefit-risk ratio is still being debated. They work by inhibiting the activity of acetylcholinesterases, thus increasing the levels of acetylcholine in the brain, and improving cognitive symptoms.

The NMDA antagonist, memantine, is recommended for moderate to severe Alzheimer's and slows disease progression. It is not typically used as a first-line treatment for mild Alzheimer's. In Alzheimer's NMDA receptors are activated by the neurotransmitter glutamate. This overstimulation leads to nerve cell damage and cognitive decline. Memantine blocks the excessive activity of glutamate, regulating the neurotransmitter's effect.

Biogen and Eisai's ADUHELM (aducanumab) and LEQEMBI (lecanemab) are two amyloid beta inhibitors that are approved by the US FDA for early Alzheimer's. These are a class of drugs that target and reduce the production, aggregation, or accumulation of amyloid beta protein in the brain. These aim to slow down or potentially halt the progression of Alzheimer's disease.

Though there has been considerable research and development in the area of amyloid beta-protein inhibitors, the results have been mixed. The complex nature of Alzheimer's disease and the involvement of multiple pathological processes make it a challenging condition to target with a single therapy.

Alzheimer's Disease Market Outlook

The current treatment is symptomatic and works by modulating the activity of brain neurotransmitters, such as acetylcholine, serotonin, noradrenaline, glutamate, and dopamine. Due to the associated side effects, personalizing the treatment and considering patients' comorbidities is important.

Acetylcholinesterase inhibitors and NMDA receptor antagonists have been available for over a decade. Their effectiveness is modest, temporary, and needs to be regularly re-evaluated. They have demonstrated symptomatic benefits but are associated with side effects.

With improved understanding, a pathological cascade of amyloid-ß deposition, tau-hyperphosphorylation, neurofibrillary tangle formation, inflammation, and synaptic and cell loss has been well documented. Biogen and Eisai have developed ADUHELM (aducanumab) and LEQEMBI (lecanemab) as anti-amyloid therapies. Of these former could not get traditional approval, but recently LEQEMBI received US FDA approval. Hopefully, it will change the market dynamics and make Biogen and Eisai key players. This approval of a disease-modifying therapy is a ray of hope for many early-stage Alzheimer's patients. But a testing requirement on the drug's prescribing label could be a potential hurdle. The FDA recommends doctors test patients for a genetic mutation known as ApoE4 before starting treatment.

The current market has been covered by the symptomatic treatment that includes different pharmacological agents used across the 7MM, which presents minor variations in the overall prescription pattern. ADUHELM, LEQEMBI, galantamine, rivastigmine, donepezil, memantine, and combination (memantine with acetylcholinesterase inhibitors) are the major drugs considered for symptomatic treatment in the forecast model.

Key players like Anavex Life Sciences, Alzheon, Athira Pharma, Annovis Bio, Eli Lilly, BioVie, AB Science, Novo Nordisk, Cassava Sciences, TauRx Therapeutics, KeifeRx, AriBio, Cerecin, Eisai, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of Alzheimer's Disease.
  • The total market size of Alzheimer's disease in the 7MM was approximately USD 3,460.6 million in 2022 and is projected to increase during the forecast period (2023-2032).
  • According to the publisher's estimates, among the 7MM, the US had the largest market share in Alzheimer's disease, with a revenue of USD 1,751.7 million in 2022. This will increase significantly due to increasing awareness and launch of the emerging therapies.
  • The total market size of Alzheimer's disease in EU4 and the UK was approximately 23.0% of the total market revenue for the 7MM. Among EU4 and the UK countries, Germany accounted for the maximum market size in 2022, while the UK occupied the bottom of the ladder.
  • In the 7MM, cholinesterase inhibitors and NMDA receptor antagonists accounted for USD 3,210.9 million and USD 245.0 million in 2022. Among cholinesterase, donepezil had the highest share (among all the therapies), with nearly 54% of the total revenue in the class, while rivastigmine generated USD 946.1 million in 2022.
  • According to the publisher's estimates, Biogen and Eisai's LEQEMBI, which received approval from the US FDA in July 2023, though may have a humble start, is projected to grow substantially during the forecast period, providing the company a substantial advantage in the biologic pie of the Alzheimer market.
  • Various therapies like Anavex Life Sciences's ANAVEX2-73 (blarcamesine), Alzheon's ALZ-801 (valiltramiprosate), Athira Pharma's fosgonimeton (ATH-1017), Annovis Bio's buntanetap, Eli Lilly's donanemab (LY3002813), BioVie's NE3107, Cassava Sciences' simufilam (PTI-125), and TauRx Therapeutics' hydromethylthionine mesylate (TRx0237) among others are anticipated to enter the market during the forecast period.
  • Eli Lilly's donanemab (LY3002813), an FDA-designated product, is projected to enter the market by 2024. An amyloid ß protein inhibitor, it will compete with Biogen and Eisai's LEQEMBI. With excellent efficacy, wherein the therapy reduced the risk of progression by 39%, it is projected to have a slow- medium uptake. The high costs will translate to high revenue, and it will attain its peak by the seventh year. Despite a few safety concerns, the drug will perform well during the forecast period.
  • NE3107, simufilam (PTI-125), ANAVEX2-73 (blarcamesine), and ALZ-801 (valiltramiprosate) are next in line with projected entry by 2025. Alzheon's ALZ-801, another FDA-designated product, has demonstrated excellent efficacy in its trial, but high doses and long treatment duration may affect its potential. With a slow-medium uptake, it will attain its peak share by the eighth year.

Alzheimer's Disease Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Annovis Bio's buntanetap, a translational inhibitor of neurotoxic aggregating proteins, with an anticipated entry by 2027 in the US, is predicted to have a slow-medium uptake during the forecast period.

Alzheimer's Disease Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase II and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Alzheimer's disease.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the Alzheimer's disease evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like Southern Illinois University School of Medicine, the University of Washington, the University Hospital of Tours, Navarra Institute for Health Research, the University of Tokyo School of Medicine, and the National Center of Neurology and Psychiatry were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Alzheimer's disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

According to the primary research analysis, LEQEMBI's approval will change the treatment regime and market dynamics for Alzheimer's. Though not curative, this first approved disease-modifying therapy garners well for early Alzheimer's patients, as it delays the progression. Though the drug has potential, there are certain hurdles, like testing requirements on the drug's prescribing label and risk warning, which push one to keep caution. The results in delaying disease progression have done well, and awareness needs to be generated to ensure drug usage.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. To analyze the effectiveness, drug-attributed analysis is calculated from scores based upon changes from baseline in ADCS-ADL, ADAS-Cog, and Clinical Dementia Rating, among others.

The therapies' safety is evaluated wherein treatment-related adverse events, serious adverse events were majorly observed, besides the occurrence of amyloid-related imaging abnormalities. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

In April 2022, CMS released its final national coverage determination decision memorandum on Medicare coverage for approved mAbs as a treatment for Alzheimer's. CMS issued a two-track decision that differentiates Medicare coverage for mAbs based on whether they receive from the US FDA: Accelerated approval based on surrogate endpoints or traditional approval based on clinical endpoints.

In July 2023, the US FDA approved the sBLA supporting the traditional approval of LEQEMBI 100 mg/mL injection for IV use. Following FDA's traditional approval Medicare will cover the therapy for appropriate patients. This will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the US.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

  • The report covers a segment of key events, an executive summary, descriptive overview of Alzheimer's disease, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the Alzheimer's disease market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Alzheimer's disease market.

Alzheimer's Disease Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Alzheimer's Disease Pipeline Analysis
  • Alzheimer's Disease Market Size and Trends
  • Existing and Future Market Opportunity

Alzheimer's Disease Report Key Strengths

  • Ten Years Forecast
  • The 7MM Coverage
  • Alzheimer's Disease Epidemiology Segmentation
  • Key Cross Competition
  • Conjoint analysis
  • Drugs Uptake and Key Market Forecast Assumptions

Alzheimer's Disease Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market Insights

  • What was the total market size of Alzheimer's disease, the market size of Alzheimer's disease by therapies, market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
  • How will donanemab (LY3002813), and others affect the treatment paradigm of Alzheimer's disease?
  • How will LEQEMBI (lecanemab) compete with other off-label symptomatic treatments?
  • Which drug is going to be the largest contributor by 2032?
  • What are the pricing variations among different geographies for off-label therapies?
  • How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

  • What are the disease risk, burdens, and unmet needs of Alzheimer's disease? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Alzheimer's disease?
  • What is the historical and forecasted patient pool of Alzheimer's disease in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
  • Out of the countries mentioned above, which country would have the highest diagnosed Alzheimer's disease diagnosed prevalent population during the forecast period (2023-2032)?
  • What factors are contributing to the growth of Alzheimer's disease cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for the treatment of Alzheimer's disease?
  • How many companies are developing therapies for the treatment of Alzheimer's disease?
  • How many emerging therapies are in the mid-stage and early stage of development for treating Alzheimer's disease?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What is the cost burden of current treatment on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the accessibility issues of approved therapy in the US?
  • What is the 7MM historical and forecasted market of Alzheimer's disease?

Reasons to Buy

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Alzheimer's disease market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunity in varying geographies and the growth potential over the coming years.
  • The distribution of historical and current patient share based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy

Table of Contents

1. Key Insights2. Report Introduction
3. Alzheimer’s Disease Market Overview at a Glance
3.1. Total Market Share (%) Distribution of Alzheimer’s Disease in 2019
3.2. Total Market Share (%) Distribution of Alzheimer’s Disease in 2032
4. Methodology of Alzheimer’s Disease Epidemiology and Market5. Executive Summary of Alzheimer’s Disease6. Key events
7. Disease Background and Overview
7.1. Introduction
7.2. Signs and Symptoms
7.3. Classification of Alzheimer’s Disease
7.4. Risk Factors
7.5. The severity of Alzheimer’s Disease
7.6. Pathophysiology
7.7. Diagnosis
7.7.1. NIA-AA Criteria
7.7.2. DSM-5 Criteria for Diagnosing Alzheimer’s Disease
7.7.3. IWG-2 Criteria for Alzheimer’s Disease
7.7.4. Mini-mental State Examination (MMSE)
7.8. Treatment
7.9. Treatment Algorithm
7.9.1. Italian Association of Psychogeriatric Guidelines for Alzheimer’s Disease
7.9.2. NICE guideline for Alzheimer’s Disease
7.9.3. European Federation of the Neurological Societies Guidelines for the Diagnosis and Management of Alzheimer’s Disease
7.9.4. American Psychiatric Association (APA) Guidelines for Alzheimer’s Disease
8. Patient Journey of Alzheimer’s Disease
9. Epidemiology and Patient Population
9.1. Epidemiology Key Findings
9.2. Assumptions and Rationale: The 7MM
9.2.1. Diagnosed Prevalent Cases of Alzheimer’s Disease
9.2.2. Gender-specific Cases of Alzheimer’s Disease
9.2.3. Age-specific Cases of Alzheimer’s Disease
9.2.4. Severity-specific Cases of Alzheimer’s Disease
9.3. Epidemiology Scenario: The 7MM
9.4. Total Diagnosed Prevalent Cases of Alzheimer’s Disease in the 7MM
9.5. The United States Epidemiology
9.5.1. Diagnosed Prevalent Cases of Alzheimer’s Disease in the US
9.5.2. Gender-specific Cases of Alzheimer’s Disease in the US
9.5.3. Age-specific Cases of Alzheimer’s Disease in the US
9.5.4. Severity-specific Cases of Alzheimer’s Disease in the US
9.6. EU4 and the UK Epidemiology
9.6.1. Diagnosed Prevalent Cases of Alzheimer’s Disease in EU4 and the UK
9.6.2. Gender-specific Cases of Alzheimer’s Disease in EU4 and the UK
9.6.3. Age-specific Cases of Alzheimer’s Disease in EU4 and the UK
9.6.4. Severity-specific Cases of Alzheimer’s Disease in EU4 and the UK
9.7. Japan Epidemiology
9.7.1. Diagnosed Prevalent Cases of Alzheimer’s Disease in Japan
9.7.2. Gender-specific Cases of Alzheimer’s Disease in Japan
9.7.3. Age-specific Cases of Alzheimer’s Disease in Japan
9.7.4. Severity-specific Cases of Alzheimer’s Disease in Japan
10. Marketed Drugs
10.1. Key Cross Competition
10.2. ADUHELM (aducanumab): Biogen/Eisai
10.2.1. Product Description
10.2.2. Regulatory Milestone
10.2.3. Other Development Activities
10.2.4. Clinical Development
10.2.5. Clinical Trial Information
10.2.6. Safety and Efficacy
10.2.7. Product Profile
10.3. LEQEMBI (lecanemab): Biogen/Eisai
10.3.1. Product Description
10.3.2. Regulatory Milestone
10.3.3. Other Development Activities
10.3.4. Clinical Development
10.3.5. Clinical Trial Information
10.3.6. Safety and Efficacy
10.3.7. Product Profile
11. Emerging Therapies
11.1. Key Cross Competition
11.2. NE3107: BioVie
11.2.1. Product Description
11.2.2. Other Developmental Activities
11.2.3. Clinical Development
11.2.4. Clinical Trial Information
11.2.5. Safety and Efficacy
11.2.6. Product Profile
11.2.7. Analyst Views
11.3. Masitinib (AB1010): AB Science
11.3.1. Product Description
11.3.2. Other Developmental Activities
11.3.3. Clinical Development
11.3.4. Clinical Trial Information
11.3.5. Safety and Efficacy
11.3.6. Product Profile
11.3.7. Analyst Views
11.4. Simufilam (PTI-125): Cassava Sciences
11.4.1. Product Description
11.4.2. Other Developmental Activities
11.4.3. Clinical Development
11.4.4. Clinical Trial Information
11.4.5. Safety and Efficacy
11.4.6. Product Profile
11.4.7. Analyst Views
11.5. Donanemab: Eli Lilly
11.5.1. Product Description
11.5.2. Other Developmental Activities
11.5.3. Clinical Development
11.5.4. Clinical Trial Information
11.5.5. Safety and Efficacy
11.5.6. Product Profile
11.5.7. Analyst Views
11.6. Hydromethylthionine mesylate (TRx0237): TauRx Therapeutics
11.6.1. Product Description
11.6.2. Other Developmental Activities
11.6.3. Clinical Development
11.6.4. Clinical Trial Information
11.6.5. Safety and Efficacy
11.6.6. Product Profile
11.6.7. Analyst Views
11.7. Semaglutide (NN6535): Novo Nordisk
11.7.1. Product Description
11.7.2. Other Developmental Activities
11.7.3. Clinical Development
11.7.4. Clinical Trial Information
11.7.5. Safety and Efficacy
11.7.6. Product Profile
11.7.7. Analyst Views
11.8. KFRX01 (nilotinib BE): KeifeRx
11.8.1. Product Description
11.8.2. Other Developmental Activities
11.8.3. Clinical Development
11.8.4. Clinical Trial Information
11.8.5. Safety and Efficacy
11.8.6. Product Profile
11.8.7. Analyst Views
11.9. Remternetug (LY3372993): Eli Lilly
11.9.1. Product Description
11.9.2. Other Developmental Activities
11.9.3. Clinical Development
11.9.4. Clinical Trial Information
11.9.5. Safety and Efficacy
11.9.6. Product Profile
11.9.7. Analyst Views
11.10. AR1001: AriBio
11.10.1. Product Description
11.10.2. Other Developmental Activities
11.10.3. Clinical Development
11.10.4. Clinical Trial Information
11.10.5. Safety and Efficacy
11.10.6. Product Profile
11.10.7. Analyst Views
11.11. Tricaprilin (CER-0001): Cerecin
11.11.1. Product Description
11.11.2. Other Developmental Activities
11.11.3. Clinical Development
11.11.4. Clinical Trial Information
11.11.5. Safety and Efficacy
11.11.6. Product Profile
11.11.7. Analyst Views
11.12. ALZ-801 (valiltramiprosate): Alzheon
11.12.1. Product Description
11.12.2. Other Developmental Activities
11.12.3. Clinical Development
11.12.4. Clinical Trial Information
11.12.5. Safety and Efficacy
11.12.6. Product Profile
11.12.7. Analyst Views
11.13. Piromelatine (neu-P11): Neurim Pharmaceuticals/Syneos Health
11.13.1. Product Description
11.13.2. Other Developmental Activities
11.13.3. Clinical Development
11.13.4. Clinical Trial Information
11.13.5. Safety and Efficacy
11.13.6. Product Profile
11.13.7. Analyst Views
11.14. Fosgonimeton (ATH-1017): Athira Pharma
11.14.1. Product Description
11.14.2. Other Developmental Activities
11.14.3. Clinical Development
11.14.4. Clinical Trial Information
11.14.5. Safety and Efficacy
11.14.6. Product Profile
11.14.7. Analyst Views
11.15. Buntanetap: Annovis Bio
11.15.1. Product Description
11.15.2. Other Developmental Activities
11.15.3. Clinical Development
11.15.4. Clinical Trial Information
11.15.5. Safety and Efficacy
11.15.6. Product Profile
11.15.7. Analyst Views
11.16. ANAVEX2-73 (blarcamesine): Anavex Life Sciences
11.16.1. Product Description
11.16.2. Other Developmental Activities
11.16.3. Clinical Development
11.16.4. Clinical Trial Information
11.16.5. Safety and Efficacy
11.16.6. Product Profile
11.16.7. Analyst Views
11.17. AGB101 (extended-release formulation of levetiracetam): AgeneBio
11.17.1. Product Description
11.17.2. Other Developmental Activities
11.17.3. Clinical Development
11.17.4. Clinical Trial Information
11.17.5. Safety and Efficacy
11.17.6. Product Profile
11.17.7. Analyst Views
11.18. E2814: Eisai
11.18.1. Product Description
11.18.2. Other Developmental Activities
11.18.3. Clinical Development
11.18.4. Clinical Trial Information
11.18.5. Safety and Efficacy
11.18.6. Product Profile
11.18.7. Analyst Views
12. Alzheimer’s Disease: The Seven Major Market Analysis
12.1. Key Findings
12.2. Market Outlook: The 7MM
12.3. Key Forecast Assumption
12.4. Conjoint Analysis
12.5. The 7MM Market Size
12.5.1. Total Market Size of Alzheimer’s Disease in the 7MM
12.5.2. Total Market Size of Alzheimer’s Disease by Therapies in the 7MM
12.6. The United States Market Size
12.6.1. Total Market Size of Alzheimer’s Disease in the United States
12.6.2. Total Market Size of Alzheimer’s Disease by Therapies in the United States
12.7. EU4 and the UK Market Size
12.7.1. Total Market Size of Alzheimer’s Disease in EU4 and the UK
12.7.2. Total Market Size of Alzheimer’s Disease by Therapies in EU4 and the UK
12.8. Japan Market Size
12.8.1. Total Market Size of Alzheimer’s Disease in Japan
12.8.2. Total Market Size of Alzheimer’s Disease by Therapies in Japan
13. KOL views14. SWOT Analysis15. Unmet Needs
16. Market Access and Reimbursement
16.1. The US
16.1.1. CMS
16.2. EU4 and the UK
16.2.1. Germany
16.2.2. France
16.2.3. Italy
16.2.4. Spain
16.2.5. The UK
16.3. Japan
16.3.1. MHLW
17. Appendix
17.1. Bibliography
17.2. Acronyms and Abbreviations
17.3. Report Methodology
18. Publisher Capabilities19. Disclaimer20. About the Publisher
List of Tables
Table 1: Summary of Alzheimer’s Disease Market, Epidemiology, and Key Events (2019-2032)
Table 2: DSM-5 Diagnostic Criteria for Diagnosing Alzheimer’s Disease
Table 3: IWG-2 Criteria for Alzheimer’s Disease
Table 4: Interpreting the Results Using MMSE Scoring Chart
Table 5: Guidelines for the Use of AChE Inhibitors and Other Pharmacotherapies in the Management of Alzheimer’s Disease
Table 6: NICE Guideline for Alzheimer’s Disease
Table 7: EFNS Guideline for Alzheimer’s Disease
Table 8: Total Diagnosed Prevalent Cases of Alzheimer’s Disease in the 7MM (2019-2032)
Table 9: Diagnosed Prevalent Cases of Alzheimer’s Disease in the US (2019-2032)
Table 10: Gender-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Table 11: Age-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Table 12: Severity-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Table 13: Diagnosed Prevalent Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Table 14: Gender-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Table 15: Age-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Table 16: Severity-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Table 17: Diagnosed Prevalent Cases of Alzheimer’s Disease in Japan (2019-2032)
Table 18: Gender-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Table 19: Age-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Table 20: Severity-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Table 21: Key Cross of Marketed Drugs
Table 22: ADUHELM (aducanumab), Clinical Trial Description, 2023
Table 23: LEQEMBI (lecanemab), Clinical Trial Description, 2023
Table 24: Key Cross of Emerging Drugs
Table 25: NE3107, Clinical Trial Description, 2023
Table 26: Masitinib (AB1010), Clinical Trial Description, 2023
Table 27: Donanemab (LY3002813), Clinical Trial Description, 2023
Table 28: Simufilam (PTI-125), Clinical Trial Description, 2023
Table 29: Hydromethylthionine Mesylate (TRx0237), Clinical Trial Description, 2023
Table 30: Semaglutide (NN6535), Clinical Trial Description, 2023
Table 31: KFRX01 (nilotinib BE), Clinical Trial Description, 2023
Table 32: Remternetug (LY3372993), Clinical Trial Description, 2023
Table 33: AR1001, Clinical Trial Description, 2023
Table 34: Tricaprilin (CER-0001), Clinical Trial Description, 2023
Table 35: ALZ-801 (valiltramiprosate), Clinical Trial Description, 2023
Table 36: Piromelatine (neu-P11), Clinical Trial Description, 2023
Table 37: Fosgonimeton (ATH-1017), Clinical Trial Description, 2023
Table 38: Buntanetap, Clinical Trial Description, 2023
Table 39: ANAVEX2-73 (blarcamesine), Clinical Trial Description, 2023
Table 40: AGB101 (extended-release formulation of levetiracetam), Clinical Trial Description, 2023
Table 41: E2814, Clinical Trial Description, 2023
Table 42: Key Market Forecast Assumptions for NE3107
Table 43: Key Market Forecast Assumptions for Masitinib (AB1010)
Table 44: Key Market Forecast Assumptions for Donanemab (LY3002813)
Table 45: Key Market Forecast Assumptions for Simufilam (PTI-125)
Table 46: Key Market Forecast Assumptions for Hydromethylthionine Mesylate (TRx0237)
Table 47: Key Market Forecast Assumptions for Semaglutide (NN6535)
Table 48: Key Market Forecast Assumptions for KFRX01 (nilotinib BE)
Table 49: Key Market Forecast Assumptions for Remternetug (LY3372993)
Table 50: Key Market Forecast Assumptions for AR1001
Table 51: Key Market Forecast Assumptions for Tricaprilin (CER-0001)
Table 52: Key Market Forecast Assumptions for ALZ-801 (valiltramiprosate)
Table 53: Key Market Forecast Assumptions for Piromelatine (neu-P11)
Table 54: Key Market Forecast Assumptions for Fosgonimeton (ATH-1017)
Table 55: Key Market Forecast Assumptions for Buntanetap (previously known as ANVS401 or posiphen)
Table 56: Key Market Forecast Assumptions for ANAVEX2-73 (blarcamesine)
Table 57: Key Market Forecast Assumptions for AGB101 (extended-release formulation of levetiracetam)
Table 58: Key Market Forecast Assumptions for E2814
Table 59: Market Size of Alzheimer’s Disease in the 7MM in USD million (2019-2032)
Table 60: Market Size of Alzheimer’s Disease by Therapies in the 7MM in USD million (2019-2032)
Table 61: Market Size of Alzheimer’s Disease in the US, in USD million (2019-2032)
Table 62: Market Size of Alzheimer’s Disease by Therapies in the US, in USD million (2019-2032)
Table 63: Market Size of Alzheimer’s Disease in EU4 and the UK, in USD million (2019-2032)
Table 64: Market Size of Alzheimer’s Disease by Therapies in EU4 and the UK, in USD million (2019-2032)
Table 65: Market Size of Alzheimer’s Disease in Japan, in USD million (2019-2032)
Table 66: Market Size of Alzheimer’s Disease by Therapies in Japan, in USD million (2019-2032)
List of Figures
Figure 1: Symptoms of Alzheimer’s Disease
Figure 2: Classification of Alzheimer’s Disease
Figure 3: Risk Factors of Alzheimer’s Disease
Figure 4: Stages of Alzheimer’s Disease
Figure 5: Pathophysiology of Alzheimer’s Disease
Figure 6: Treatment of Alzheimer’s disease
Figure 7: Flow Chart for Treating Alzheimer’s Disease
Figure 8: Treatment Algorithm of Alzheimer’s Disease
Figure 9: Patient Journey of Alzheimer’s Disease
Figure 10: Total Diagnosed Prevalent Cases of Alzheimer’s Disease in the 7MM (2019-2032)
Figure 11: Diagnosed Prevalent Cases of Alzheimer’s Disease in the US (2019-2032)
Figure 12: Gender-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Figure 13: Age-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Figure 14: Severity-specific Cases of Alzheimer’s Disease in the US (2019-2032)
Figure 15: Diagnosed Prevalent Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Figure 16: Gender-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Figure 17: Age-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Figure 18: Severity-specific Cases of Alzheimer’s Disease in EU4 and the UK (2019-2032)
Figure 19: Diagnosed Prevalent Cases of Alzheimer’s Disease in Japan (2019-2032)
Figure 20: Gender-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Figure 21: Age-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Figure 22: Severity-specific Cases of Alzheimer’s Disease in Japan (2019-2032)
Figure 23: Market Size of Alzheimer’s Disease in the 7MM, in USD million (2019-2032)
Figure 24: Market Size of Alzheimer’s Disease by Therapies in the 7MM, in USD million (2019-2032)
Figure 25: Market Size of Alzheimer’s Disease in the US, in USD million (2019-2032)
Figure 26: Market Size of Alzheimer’s Disease by Therapies in the US, in USD million (2019-2032)
Figure 27: Market Size of Alzheimer’s Disease in EU4 and the UK, in USD million (2019-2032)
Figure 28: Market Size of Alzheimer’s Disease by Therapies in EU4 and the UK, in USD million (2019-2032)
Figure 29: Market Size of Alzheimer’s Disease in Japan, in USD million (2019-2032)
Figure 30: Market Size of Alzheimer’s Disease by Therapies in Japan, in USD million (2019-2032)
Figure 31: SWOT Analysis
Figure 32: Unmet Needs
Figure 33: Health Technology Assessment
Figure 34: Reimbursement Process in Germany
Figure 35: Reimbursement Process in France
Figure 36: Reimbursement Process in Italy
Figure 37: Reimbursement Process in Spain
Figure 38: Reimbursement Process in the United Kingdom
Figure 39: Reimbursement Process in Japan

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AB Science
  • AgeneBio
  • Alzheon
  • Anavex Life Sciences
  • Annovis Bio
  • AriBio
  • Athira Pharma
  • BioVie
  • Cassava Sciences
  • Cerecin
  • Eisai
  • Eli Lilly
  • KeifeRx
  • Neurim Pharmaceuticals/Syneos Health
  • Novo Nordisk
  • TauRx Therapeutics