Insights Into the Global Alzheimer's Disease Market, 2023-2032 - Eli Lilly's Donanemab Poised as Front-Runner for 2024 Market Debut, Set to Rival Biogen and Eisai's LEQEMBI in Emerging Therapy Arena

DUBLIN, Aug. 18, 2023 /PRNewswire/ -- The "Alzheimer's Disease - Market Insight, Epidemiology And Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

This 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 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.

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 ? 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.

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 <_5 years="years" />
• 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 ? 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 A? 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 A?. 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 A? 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.

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-? 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 ? 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.

Pipeline Activities

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

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.

Key Topics Covered

1. Key Insights
2. Report Introduction
3. Alzheimer's Disease Market Overview at a Glance
4. Methodology of Alzheimer's Disease Epidemiology and Market
5. Executive Summary of Alzheimer's Disease
6. Key events
7. Disease Background and Overview
8. Patient Journey of Alzheimer's Disease
9. Epidemiology and Patient Population
10. Marketed Drugs
11. Emerging Therapies
12. Alzheimer's Disease: The Seven Major Market Analysis
13. KOL views
14. SWOT Analysis
15. Unmet Needs
16. Market Access and Reimbursement
17. Appendix

A selection of companies mentioned in this report includes:

• 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

For more information about this report visit https://www.researchandmarkets.com/r/vhv3sp

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected] 
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg

SOURCE Research and Markets