PUBLISHER: DelveInsight | PRODUCT CODE: 1705108
PUBLISHER: DelveInsight | PRODUCT CODE: 1705108
DelveInsight's "Alzheimer's Disease - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Alzheimer's disease, historical and forecasted epidemiology as well as the Alzheimer's disease market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.
The Alzheimer's Disease market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Alzheimer's disease market size from 2020 to 2034. The Report also covers current Alzheimer's disease treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Study Period: 2020-2034
Alzheimer's Disease Overview
Alzheimer's disease is a progressive, irreversible neurological disorder, primarily impacting memory, reasoning, and cognitive abilities. It is the leading cause of dementia, responsible for roughly 60-80% of all cases. Though often emerging in the mid-60s, early-onset Alzheimer's can affect individuals as young as their 40s or 50s, albeit rarely. Initial symptoms commonly include memory loss that significantly interferes with daily life, followed by confusion, language difficulties, impaired judgment, and behavioral changes. The disease's exact cause remains unknown, but it is associated with abnormal accumulations of Amyloid Beta protein plaques and tau protein tangles in the brain, which disrupt cellular communication and lead to cell death. Increasing age and family history are recognized as key risk factors for Alzheimer's disease.
Alzheimer's Disease Diagnosis
Diagnosing Alzheimer's disease remains challenging due to its gradual onset and overlapping symptoms with other cognitive disorders. The diagnosis primarily relies on clinical assessments, including a detailed medical history, cognitive tests, and evaluations of memory, reasoning, and language skills. Neuroimaging techniques, like MRI and PET scans, help detect structural brain changes, while biomarkers in cerebrospinal fluid can reveal amyloid and tau protein abnormalities. However, definitive diagnosis often occurs post-mortem through brain tissue examination.
The complexity of Alzheimer's disease diagnosis is compounded by variability in symptom progression and the absence of a single diagnostic test. Additionally, the need for specialized tools and resources makes early diagnosis difficult, especially in low-resource settings. Misdiagnosis risks are high, which can delay appropriate interventions and add stress for patients and caregivers. Improved diagnostic accuracy through advancements in biomarker research and neuroimaging is critical to enabling timely, targeted treatments and addressing these diagnostic challenges in Alzheimer's disease.
Alzheimer's Disease Treatment
The treatment landscape for Alzheimer's disease centers around managing symptoms rather than halting disease progression. Current FDA-approved treatments, including cholinesterase inhibitors and the NMDA receptor antagonist memantine, temporarily aid cognitive functions but do not reverse the underlying pathology. Recently, anti-amyloid monoclonal antibodies, like aducanumab, have targeted amyloid plaques to potentially slow cognitive decline, though these options have faced scrutiny regarding efficacy and safety. Additionally, non-pharmacological interventions-such as cognitive therapy, physical exercise, and lifestyle modifications-are vital components of patient care to support mental and physical health.
However, treatment challenges persist. The progressive nature of Alzheimer's disease, coupled with an incomplete understanding of its causes, limits therapeutic advancements. Effective treatment is further hindered by high costs, potential adverse effects, and the variability of patient responses. Consequently, addressing these challenges requires ongoing research to develop therapies that effectively target Alzheimer's disease's complex pathology and enhance patients' quality of life.
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, Gender-specific Diagnosed Prevalent Cases of Alzheimer's Disease, Age-specific Diagnosed Prevalent Cases of Alzheimer's Disease, Severity-specific Diagnosed Prevalent Cases of Alzheimer's Disease, Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease, and Diagnosed Prevalent Cases of Psychosis in Alzheimer's Disease in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the Alzheimer's disease report encloses a detailed analysis of Alzheimer's disease off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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
LEQEMBI (lecanemab): Biogen Inc./Eisai Co., Ltd.
LEQEMBI, an FDA-approved treatment for Alzheimer's, specifically targets patients in the Alzheimer's disease or mild dementia stages. Developed as a humanized IgG1 monoclonal antibody, LEQEMBI addresses amyloid B (AB) pathology by reducing both soluble and insoluble forms of AB to slow disease progression.
With ongoing prescription expansion, the focus includes customized facility information on the drug, reimbursement support, and system efficiency enhancements. Approved by regulatory bodies in Great Britain (August 2024) and Japan (September 2023), LEQEMBI marks a significant milestone as the first approved therapy in Europe to target an Alzheimer's-related pathology directly.
In May 2023, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted lecanemab designation under the Innovative Licensing and Access Pathway (ILAP). The MHRA, which oversees the regulation of medicines and medical devices in the UK, recognized lecanemab for this accelerated pathway to enhance patient access.
KISUNLA (Donanemab): Eli Lilly and Company
KISUNLA (donanemab-azbt), developed by Eli Lilly, targets amyloid plaques in patients with Alzheimer's disease or early symptomatic Alzheimer's disease confirmed by amyloid pathology. This humanized IgG1 monoclonal antibody addresses amyloid B accumulation-a key contributor to Alzheimer's by focusing on insoluble N-truncated pyroglutamate amyloid beta plaques.
Administered intravenously every four weeks, KISUNLA's structured dosing regimen was informed by Phase III TRAILBLAZER-ALZ 2 trial data, supporting approvals in the US (July 2024) and Japan (September 2024). Unique to KISUNLA is the potential to halt treatment once plaques clear, which may optimize efficacy and lower treatment costs.
In June 2021, Eli Lilly's donanemab received the US FDA's breakthrough therapy designation (BTD) for treating Alzheimer's disease
Emerging Drugs
Masitinib (AB1010): AB Science
Masitinib, an orally administered tyrosine kinase inhibitor, targets neuro-immune cells such as mast cells and microglia that accumulate in the Central Nervous System (CNS) at effective concentrations. Evidence increasingly links these cells to Alzheimer's disease pathology. In preclinical studies, masitinib demonstrated synaptic protection by inhibiting mast cells, which contributed to improved spatial learning and recovery of synaptic markers in Alzheimer's disease models. The drug is currently in Phase III clinical trial and development for the disease.
Clinically, masitinib showed promise in treating mild to moderate Alzheimer's disease, with a Phase II trial confirming potential benefits. Additionally, a Phase IIb/III study found that masitinib significantly slowed cognitive decline. A confirmatory Phase III trial is currently underway.
Valiltramiprosate (ALZ-801): Alzheon, Inc.
ALZ-801 is an oral small-molecule prodrug that effectively blocks the formation of neurotoxic amyloid oligomers in the brain. Structurally, it is a valine-conjugated version of tramiprosate, metabolizing into homotaurine in the body, which enhances absorption and extends blood retention compared to tramiprosate. Both ALZ-801 and tramiprosate are metabolized to 3-sulfopropanoic acid (3-SPA), a natural brain compound that prevents AB42 aggregation.
ALZ-801 was specifically designed to improve tramiprosate's gastrointestinal tolerance and pharmacokinetics, allowing for efficient gut absorption and conversion to active tramiprosate in the bloodstream. Phase I studies indicate improved gastrointestinal tolerance and stable plasma levels.
Currently in Phase III, ALZ-801 is being evaluated as a potential disease-modifying treatment for early-stage Alzheimer's disease.
Tricaprilin (CER-0001): Cerecin
Cerecin's tricaprilin (CER-0001) (also known as AC-1204) is an innovative oral formulation of caprylic triglyceride, designed to induce a mild state of chronic ketosis that enhances mitochondrial metabolism. Early in the progression of Alzheimer's disease, there is a notable decline in cerebral glucose utilization. Tricaprilin aims to counteract this by providing an alternative energy source for cells, thus boosting metabolic activity in Alzheimer's disease. Caprylic acid is converted into ketone bodies, including acetoacetic acid and B-hydroxybutyric acid, which can then be transformed into acetyl-CoA, facilitating energy production through the citric acid cycle.
Clinical studies indicate that CER-0001 is a promising ketogenic agent that demonstrates cognitive improvement in subjects with mild to moderate Alzheimer's disease, particularly among those who are APOE4-negative.
Bezisterim (NE3107): BioVie
NE3107 is an oral small molecule designed to effectively penetrate the blood-brain barrier, serving as both an anti-inflammatory agent and an insulin sensitizer. It selectively targets Extracellular Signal-regulated Kinase (ERK) to inhibit inflammatory pathways by blocking ERK/NF?B activation and decreasing tumor necrosis factor (TNF) production, particularly in response to inflammatory stimuli such as lipopolysaccharides. This mechanism holds promise for reducing pathological inflammatory signaling in peripheral tissues and the Central Nervous System (CNS), potentially alleviating insulin resistance, diminishing inflammatory cell infiltration in the CNS, and modulating microglial activation without impairing their critical functions.
NE3107's dual action may disrupt this detrimental cycle, presenting a novel therapeutic strategy for Alzheimer's disease. Previously known as HE3286, NE3107 is a synthetic analog of the adrenal hormone dehydroepiandrosterone (DHEA) metabolite and is also being explored for treating conditions such as Parkinson's disease, multiple myeloma, and prostate cancer. BioVie has completed Phase III trials for NE3107 as a treatment for mild to moderate Alzheimer's disease.
In March 2024, BioVie showcased findings at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD 2024) held in Lisbon, Portugal. The data presented from a Phase III trial of NE3107 in patients with mild to moderate Alzheimer's disease suggest its potential to realign physiological processes, which may lead to a reduction in neurocognitive decline associated with aging.
Currently, available therapies for Alzheimer's disease primarily target symptom management by modulating key neurotransmitters, including acetylcholine, serotonin, and noradrenaline, while aiming to reduce the activity of glutamate and dopamine. However, these approaches often lead to potential side effects, highlighting the necessity for personalized treatment strategies that consider patient comorbidities and potential drug interactions. Recent approvals, such as LEQEMBI (lecanemab) by Biogen and Eisai, Eli Lilly's KISUNLA (donanemab-azbt), and Brexpiprazole (REXULTI), signify a shift toward more tailored therapeutic options.
Pharmacological treatments, including acetylcholinesterase inhibitors (AChEIs) and the NMDA receptor antagonist memantine, have been in use in the U.S. for over a decade. The US FDA and EMA have approved three AChEIs donepezil, rivastigmine, and galantamine Administered in over 60 countries for various stages of Alzheimer's disease. Despite demonstrating modest symptomatic benefits in clinical trials, the effectiveness of these therapies is temporary, necessitating regular re-evaluation.
Additionally, the benefit-risk ratio of these medications remains a topic of debate, influencing reimbursement decisions in some countries, such as France. Memantine, effective as monotherapy or in combination with AChEIs, serves to slow symptom progression in moderate to severe cases, further diversifying treatment options available for this challenging condition.
With a growing focus on advanced treatment options, the market for Alzheimer's disease is expanding, highlighting opportunities for innovation and investment in new therapies and technologies.
The Alzheimer's disease market has a rich pipeline and is poised for transformation with the anticipated introduction of therapies like Masitinib, Valiltramiprosate/ ALZ-801, Tricaprilin (CER0001), Bezisterim (NE3107) and others. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.
This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Masitinib in the US is expected to be launched by 2027 with a peak share of 1.20%. Bezisterim is anticipated to take 7 years to peak with a slow medium uptake.
Alzheimer's Disease Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 Alzheimer's disease emerging therapies.
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 the secondary research. Industry Experts were contacted for insights on 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 KOL from Washington University School of Medicine, St. Louis, US; University of Nevada, US; Hannover Medical School, Germany; Universite Paris Saclay, France; Universita di Palermo, Italy; Hospital Virgen De La Salud, Spain; University College London, the UK; and Kyoto University, Japan.
Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, 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.
Qualitative Analysis
We perform 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 approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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
The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
The Alzheimer's Disease Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.
The Alzheimer's Disease market is quite robust. The major layers are Alzheon Inc., Cerecin, BioVie Inc, AbbVie, and others which are currently developing drugs for the treatment of Alzheimer's disease.
The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as prevalent cases, treatment costs, revenue generated, and market trends.
The increase in diagnosed prevalent cases of Alzheimer's Disease and the launch of emerging therapies are attributed to be the key drivers for increasing the Alzheimer's disease market.
Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Alzheimer's disease treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.
The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Alzheimer's Disease market.