LEQEMBI Sales Forecast, and Market Size Analysis - 2034

Key Factors Driving LEQEMBI Growth

1. Market Share Gains and New Patient Starts

• LEQEMBI, jointly developed by Eisai and Biogen, is gaining momentum in the Alzheimer's disease (AD) market as one of the first disease-modifying therapies targeting amyloid-B pathology.
• New patient starts are steadily increasing, driven by growing physician familiarity, expanding diagnostic infrastructure (amyloid PET and blood-based biomarkers), and broader reimbursement access.
• Eisai's focused commercial execution, coupled with neurologist education and memory-clinic engagement, is supporting early adoption in eligible early Alzheimer's patients.

2. Expansion Across Key Indications

• Early Alzheimer's Disease (MCI due to AD and Mild AD Dementia): LEQEMBI is approved for patients in the earliest symptomatic stages, supported by clinical evidence demonstrating slowing of cognitive and functional decline.
• Earlier Diagnosis Enablement: Increasing use of biomarkers and cognitive screening is expanding the addressable patient pool, indirectly supporting LEQEMBI uptake.
• Combination and Continuum Strategies: Ongoing research into combination approaches and treatment sequencing may further extend LEQEMBI's role across the Alzheimer's disease continuum.
• Pipeline Synergies: LEQEMBI serves as a foundational asset within Eisai's broader neurodegeneration pipeline, reinforcing long-term lifecycle potential.

3. Geographic Expansion

• United States: The U.S. remains the primary commercial market, supported by regulatory approval and Medicare coverage for eligible patients enrolled in registries.
• Japan: Early approval and reimbursement have positioned Japan as a key growth market, benefiting from strong government support for dementia care.
• Global Expansion Efforts: Eisai and Biogen continue to pursue access in additional regions, including Europe and other developed markets, despite regulatory complexity.
• Asia-Pacific Growth Potential: Rising aging populations, improving diagnostic capabilities, and increased policy focus on dementia are expected to drive long-term growth in Asia-Pacific markets.

4. New Indication Approvals

• Regulatory Milestones: LEQEMBI has received full approval in the U.S. for early Alzheimer's disease, reinforcing its position as a cornerstone disease-modifying therapy.
• Label Stability with Expansion Potential: While current approval is limited to early disease, ongoing studies and real-world evidence could support broader utilization or optimized treatment protocols.
• Portfolio Diversification: LEQEMBI significantly strengthens Eisai and Biogen's neuroscience portfolios and establishes a commercial foothold in disease-modifying Alzheimer's therapy.

5. Strong Early Alzheimer's Volume Momentum

• High Unmet Need: Alzheimer's disease has limited disease-modifying options, driving strong interest from patients, caregivers, and clinicians.
• Growing Treatment Infrastructure: Expansion of infusion centers, registry enrollment systems, and monitoring protocols is enabling higher treatment volumes.
• Real-World Uptake Trends: Prescription growth is supported by accumulating real-world experience, increasing confidence in patient selection and management of safety risks such as ARIA.

6. Competitive Differentiation and Market Trends

• Disease-Modifying Mechanism: LEQEMBI's amyloid-B protofibril targeting differentiates it from symptomatic therapies and supports its role in slowing disease progression.
• First-Mover Advantage: Early entry into the disease-modifying AD space provides brand recognition and formulary positioning advantages.
• Alignment with Precision Medicine Trends: Increased use of biomarkers and imaging aligns with broader trends toward personalized and biologically defined treatment pathways.
• Growing Role of Real-World Evidence (RWE): Post-approval RWE is critical in reinforcing payer confidence, refining patient selection, and supporting long-term reimbursement sustainability.

LEQEMBI Recent Developments

• In December 2025, Eisai and Biogen announced that anti-AB protofibril antibody "LEQEMBI" had been included in the "Commercial Insurance Innovative Drug List", introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of LEQEMBI in this list marks a meaningful step toward expanding access to early Alzheimer's Disease (AD) treatment in China.

"LEQEMBI Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of LEQEMBI for approved indication like Alzheimer's disease; as well as potential indications like Brain injuries; Down syndrome in the 7MM. A detailed picture of LEQEMBI's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the LEQEMBI for approved and potential indications. The LEQEMBI market report provides insights about LEQEMBI's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current LEQEMBI performance, future market assessments inclusive of the LEQEMBI market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of LEQEMBI sales forecasts, along with factors driving its market.

LEQEMBI Drug Summary

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody developed by Eisai and Biogen for treating early Alzheimer's disease, specifically mild cognitive impairment or mild dementia stages confirmed by amyloid pathology. It selectively binds to aggregated forms of amyloid beta (AB), including soluble protofibrils, oligomers, and insoluble plaques, neutralizing their toxicity, preventing further deposition, and promoting clearance to reduce neuronal injury and slow cognitive decline. Administered via intravenous infusion every two weeks (now also approved for at-home subcutaneous use in some regions) under specialist supervision with MRI monitoring for amyloid-related imaging abnormalities (ARIA), LEQEMBI demonstrates modest slowing of disease progression by targeting the underlying amyloid pathology. The report provides LEQEMBI's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the LEQEMBI Market Report

The report provides insights into:

• A comprehensive product overview including the LEQEMBI MoA, description, dosage and administration, research and development activities in approved indications like Alzheimer's disease; as well as potential indications like Brain injuries; Down syndrome.
• Elaborated details on LEQEMBI regulatory milestones and other development activities have been provided in LEQEMBI market report.
• The report also highlights LEQEMBI's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The LEQEMBI market report also covers the patents information, generic entry and impact on cost cut.
• The LEQEMBI market report contains current and forecasted LEQEMBI sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The LEQEMBI market report also features the SWOT analysis with analyst views for LEQEMBI in approved and potential indications.

Methodology:

The LEQEMBI market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

LEQEMBI Analytical Perspective by DelveInsight

• In-depth LEQEMBI Market Assessment

This LEQEMBI sales market forecast report provides a detailed market assessment of LEQEMBI for approved indication like Alzheimer's disease; as well as potential indications like Brain injuries; Down syndrome in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted LEQEMBI sales data uptil 2034.

• LEQEMBI Clinical Assessment

The LEQEMBI market report provides the clinical trials information of LEQEMBI for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

LEQEMBI Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

LEQEMBI Market Potential & Revenue Forecast

• Projected market size for the LEQEMBI and its key indications
• Estimated LEQEMBI sales potential (LEQEMBI peak sales forecasts)
• LEQEMBI Pricing strategies and reimbursement landscape

LEQEMBI Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• LEQEMBI Market positioning compared to existing treatments
• LEQEMBI Strengths & weaknesses relative to competitors

LEQEMBI Regulatory & Commercial Milestones

• LEQEMBI Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

LEQEMBI Clinical Differentiation

• LEQEMBI Efficacy & safety advantages over existing drugs
• LEQEMBI Unique selling points

LEQEMBI Market Report Highlights

• In the coming years, the LEQEMBI market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The LEQEMBI companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence LEQEMBI's dominance.
• Other emerging products for Alzheimer's disease; as well as potential indications like Brain injuries; Down syndrome are expected to give tough market competition to LEQEMBI and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of LEQEMBI in approved and potential indications.
• Analyse LEQEMBI cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted LEQEMBI sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of LEQEMBI in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of LEQEMBI? How strong is LEQEMBI's clinical and commercial performance?
• What is LEQEMBI's clinical trial status in each individual indications such as Alzheimer's disease; as well as potential indications like Brain injuries; Down syndrome and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the LEQEMBI Manufacturers?
• What are the key designations that have been granted to LEQEMBI for approved and potential indications? How are they going to impact LEQEMBI's penetration in various geographies?
• What is the current and forecasted LEQEMBI market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of LEQEMBI in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to LEQEMBI for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is LEQEMBI? What is the duration of therapy and what are the geographical variations in cost per patient?