Alzheimer's Disease Market Soars with FDA Approval of LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer's Treatment | DelveInsight

The Alzheimer's disease market has achieved a groundbreaking milestone with the FDA approval of LEQEMBI IQLIK (lecanemab-irmb) subcutaneous injection for maintenance dosing in early Alzheimer's disease treatment on August 15, 2025.
Developed by Eisai Co., Ltd. and Biogen Inc., LEQEMBI represents a transformative advancement in Alzheimer's therapies, becoming the first approved therapy for maintenance dosing to slow disease progression in patients with early Alzheimer's disease. This approval marks a pivotal moment in the Alzheimer's treatment market, addressing a critical unmet need for disease-modifying Alzheimer's drugs in the early stages of this neurodegenerative condition.

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LEQEMBI IQLIK: A Breakthrough in Alzheimer's Treatment

LEQEMBI, an anti-amyloid beta protofibril antibody, targets amyloid-beta (A) protofibrils, a key driver in Alzheimer's pathology, reducing amyloid plaques and slowing cognitive decline. The pivotal Phase III Clarity AD trial demonstrated that LEQEMBI, initially administered biweekly via intravenous infusion, reduced clinical decline by 27% on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale compared to placebo at 18 months. The trial also showed significant amyloid plaque clearance, with 76% of patients exhibiting no disease progression on cognitive assessments.

Initially approved for intravenous use in July 2023, LEQEMBI's subcutaneous approval strengthens Eisai and Biogen's leadership in AD therapeutics. It offers a convenient, patient-friendly option for those with mild cognitive impairment (MCI) or mild AD, enhancing adherence and quality of life in Alzheimer's disease treatment. This advancement strengthens LEQEMBI's position in the Alzheimer's pipeline and underscores its role as a leading therapy in the Alzheimer's treatment market.

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DelveInsight's Analytical Overview of LEQEMBI

The Alzheimer's disease market is undergoing a transformative shift with the FDA approval of LEQEMBI Registered IQLIK Trademark (lecanemab-irmb) subcutaneous injection for maintenance dosing in early Alzheimer's disease treatment. Developed by Eisai and Biogen, LEQEMBI strengthens its position as a leading therapy in the Alzheimer's treatment market, with ongoing trials reinforcing its role among Alzheimer's therapies and in the Alzheimer's pipeline.

Insights into Ongoing Trials

LEQEMBI's subcutaneous approval is supported by the Phase III Clarity AD open-label extension (OLE) sub-studies, which evaluated various subcutaneous doses in over 600 patients with early Alzheimer's disease (AD). Data from 49 patients receiving a weekly 360 mg subcutaneous maintenance dose after 18 months of 10 mg/kg intravenous (IV) biweekly dosing demonstrated sustained clinical and biomarker benefits, comparable to continued IV dosing. Notably, none of these patients experienced local or systemic injection-related adverse events (AEs), with systemic reactions occurring in less than 1% of subcutaneous cases compared to ~26% with IV infusions.

Approximately 11% reported mild-to-moderate local reactions (e.g., redness, swelling, itching), which did not disrupt treatment. Amyloid-related imaging abnormalities (ARIA) rates for the 360 mg subcutaneous dose aligned with IV maintenance and untreated background rates, with most ARIA occurring within the first 6 months of IV initiation. Additional studies, including a human factors study and device tolerability assessment, confirmed LEQEMBI IQLIK's safe and effective use in home settings, enhancing its potential in Alzheimer's disease treatment.

The ongoing AHEAD 3-45 study is evaluating LEQEMBI's long-term efficacy in preclinical and early AD, with topline data expected by 2027, further solidifying its role in the Alzheimer's pipeline.

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Alzheimer's Disease Patient Pool

The Alzheimer's disease market is expanding rapidly, fueled by a growing patient population, rising aging demographics, and the urgent demand for innovative Alzheimer's therapies such as LEQEMBI IQLIK.

DelveInsight's analysis indicates that in 2024, there were around 15 million diagnosed prevalent cases of Alzheimer's disease and nearly 100 million prevalent cases of preclinical Alzheimer's disease across the 7MM (US, EU4, UK, Japan). These figures are expected to rise steadily through 2034, driven by improved diagnostics and increasing life expectancy.

The United States dominated the Alzheimer's disease market in 2024, accounting for nearly 44% of all diagnosed prevalent cases, while the UK held the lowest share, representing just about 4%. Within Europe, Germany reported the highest number of diagnosed prevalent cases (~1.5 million), followed by France with ~1 million cases.

Diagnosed AD cases are projected to grow across the 7MM by 2034, driven by aging populations and enhanced diagnostics. The US and Japan will see notable increases, boosting the Alzheimer's pipeline.

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Competitive Landscape: LEQEMBI vs. Emerging Therapies

The Alzheimer's disease market is highly competitive, with LEQEMBI Registered IQLIK Trademark (lecanemab-irmb) leading as a transformative Alzheimer's therapy. As a key player in the Alzheimer's treatment market, LEQEMBI faces competition from approved Alzheimer's drugs and a robust Alzheimer's pipeline, with emerging therapies poised to reshape Alzheimer's disease treatment.

LEQEMBI, an anti-amyloid beta protofibril antibody, reduced cognitive decline by 27% in the Clarity AD trial, outperforming Aduhelm (aducanumab), which faced limited adoption due to modest efficacy and safety concerns, leading to its discontinuation in 2024. KISUNLA, approved in July 2024, showed a 29% reduction in decline but requires ongoing infusions, unlike LEQEMBI's subcutaneous maintenance dosing, which enhances patient convenience in the Alzheimer's treatment market.

Emerging Alzheimer's therapies are advancing:

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Gantenerumab (Roche): This anti-amyloid antibody failed to meet primary endpoints in Phase III GRADUATE trials, reducing amyloid plaques but not significantly slowing cognitive decline. Roche's reformulated trontinemab, using Brainshuttle Trademark technology, is in Phase II, with Phase III trials planned for 2025.

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ALZ-801 (Alzheon): An oral anti-amyloid oligomer inhibitor, ALZ-801's Phase III APOLLOE4 trial (NCT04770220) targets early AD patients with APOE4/4 genotypes. Topline data, expected in mid-2024, could position it as a novel Alzheimer's drug.

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NE3107 (BioVie): An oral anti-inflammatory insulin sensitizer, NE3107's Phase III trial (NCT04669028) for mild-to-moderate AD completed enrollment in 2023, with results expected in 2025, potentially impacting the Alzheimer's market.

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Masitinib (AB Science): A tyrosine kinase inhibitor, masitinib's Phase III trial (NCT05564169) for mild-to-moderate AD is set to conclude by December 2025, targeting cognitive and functional outcomes.

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Remternetug (Eli Lilly): A next-generation anti-amyloid antibody, remternetug's Phase III TRAILRUNNER-ALZ1 trial (NCT05463731) showed 75% amyloid clearance in 6 months, with completion expected in March 2025, positioning it as a strong contender in Alzheimer's disease treatment.

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Simufilam (Cassava Sciences): A filamin A inhibitor, simufilam's Phase III RETHINK-ALZ trial (NCT04994483) is due to report topline results by late 2024, with an open-label extension ongoing.

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Semaglutide (Novo Nordisk): A GLP-1 receptor agonist, semaglutide's Phase III trials for early AD are expected to conclude by October 2026. Recent studies suggest a 40-70% reduction in AD risk among diabetic patients.

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E2814 (Eisai): An anti-tau antibody, E2814's Phase II/III Tau NexGen study is underway, with results expected by 2027, complementing LEQEMBI in the Alzheimer's pipeline.

These advancements signal a dynamic Alzheimer's treatment market, with LEQEMBI maintaining a competitive edge through its subcutaneous delivery and proven efficacy.

Where is the Alzheimer's Market Headed?

The Alzheimer's disease market reached ~USD 5 billion across the 7MM in 2024, with the US contributing ~USD 2.5 billion, per DelveInsight. Projected to grow at a CAGR of 23.7% through 2034, the Alzheimer's treatment market is driven by novel Alzheimer's drugs, an aging population, and advanced diagnostics like blood-based biomarkers, expanding opportunities for Alzheimer's therapies.

Amyloid-targeting Alzheimer's treatments like LEQEMBI and donanemab lead the Alzheimer's market, slowing disease progression. Non-amyloid approaches, including BioVie's NE3107 (anti-inflammatory, Phase III results 2025), Novo Nordisk's semaglutide (GLP-1 agonist, Phase III due 2026, linked to 40-70% lower AD risk), and Eisai's E2814 (anti-tau, Phase II/III due 2027), are set to diversify Alzheimer's disease treatment.

High costs (~USD 26,500 annually for LEQEMBI), safety concerns like amyloid-related imaging abnormalities (ARIA), and competition from Alzheimer's pipeline candidates like Alzheon's ALZ-801 (Phase III, mid-2024) pose challenges. These dynamics will shape the evolving Alzheimer's market.

DelveInsight's latest report, titled Alzheimer's Disease Market Insight, Epidemiology, and Market Forecast - 2034, offers in-depth insights into market dynamics, competitive landscape, and epidemiological trends shaping the Alzheimer's treatment market. It provides country-specific analyses of treatment guidelines, patient populations, and market uptake, empowering stakeholders to identify growth opportunities and strengthen competitive positioning.

Stay ahead in the Alzheimer's market with insights on LEQEMBI and the Alzheimer's pipeline @ AD Market Insights [https://www.delveinsight.com/report-store/alzheimers-disease-ad-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Epidemiology Segmentation Included in the Report:

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Total Diagnosed Prevalent Cases of Alzheimer's Disease

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Age-specific Cases of Alzheimer's Disease

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Gender-specific Cases of Alzheimer's Disease

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Severity-specific Cases of Alzheimer's Disease

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Alzheimer's market. Highlights include:

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10-year Forecast

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7MM Analysis

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Epidemiology-based Market Forecasting

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Historical and Forecasted Market Analysis upto 2034

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Emerging Drug Market Uptake

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Peak Sales Analysis

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Key Cross Competition Analysis

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Industry Expert's Opinion

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Access and Reimbursement

By accessing the Alzheimer's disease market report, stakeholders can gain a clear understanding of patient journeys, expert KOL insights on evolving treatment paradigms, and the key drivers shaping market growth. The report also highlights potential challenges, unmet needs, and strategies to strengthen positioning in the Alzheimer's therapeutic landscape, making it an indispensable resource for decision-makers seeking to navigate and capitalize on this rapidly expanding market.

About DelveInsight

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