LEQEMBI Market Sales Reflect Growing Confidence in Disease-Modifying Alzheimer’s Treatments| DelveInsight

LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatments. With an aging population and limited competition in the early-stage Alzheimer’s space, it is expected to generate multi-billion-dollar revenues.

/EIN News/ -- New York, USA, March 03, 2025 (GLOBE NEWSWIRE) -- LEQEMBI Market Sales Reflect Growing Confidence in Disease-Modifying Alzheimer’s Treatments| DelveInsight

LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatments. With an aging population and limited competition in the early-stage Alzheimer’s space, it is expected to generate multi-billion-dollar revenues.

DelveInsight’s “LEQEMBI Market Size, Forecast, and Market Insight Report” highlights the details around LEQEMBI, a humanized IgG1 mAb directed against aggregated soluble (protofibrils) and insoluble forms of Aβ. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LEQEMBI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Biogen/Eisai’s LEQEMBI (lecanemab) Overview

LEQEMBI, developed by Biogen and Eisai, is a humanized IgG1 monoclonal antibody targeting both soluble aggregated forms (protofibrils) and insoluble deposits of amyloid beta (Aβ). It is approved for the treatment of mild cognitive impairment (MCI) and the mild dementia stage of Alzheimer’s disease. The buildup of amyloid beta plaques in the brain is a key pathological characteristic of Alzheimer’s disease. LEQEMBI has been shown in clinical trials to reduce these plaques.  

The recommended LEQEMBI dosage is 10 mg/kg, which is diluted and administered via intravenous (IV) infusion over approximately one hour every two weeks. Before starting treatment, patients must be confirmed to have Aβ pathology. Close monitoring for amyloid-related imaging abnormalities (ARIA) is advised during the first 14 weeks of treatment.  

In September 2023, Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved LEQEMBI (lecanemab), developed by Biogen, Eisai, and BioArctic, as a therapy to slow disease progression in MCI and mild dementia due to Alzheimer’s.  

In July 2023, the U.S. FDA granted traditional approval to LEQEMBI (lecanemab) 100 mg/mL injection under a supplemental Biologics License Application (sBLA). This approval allows its use in adults with Alzheimer’s disease to slow disease progression and mitigate cognitive and functional decline.  

Previously, in January 2023, the FDA granted accelerated approval for LEQEMBI as a treatment for Alzheimer’s disease. As in clinical trials, treatment is recommended for patients in the MCI or mild dementia stage.

Recently, in January 2025, Eisai Co., Ltd. and Biogen Inc. have announced that the FDA has approved their Supplemental Biologics License Application (sBLA) for a once-every-four-weeks intravenous (IV) maintenance dose of lecanemab-irmb (marketed in the U.S. as LEQEMBI). LEQEMBI is authorized for treating Alzheimer's disease (AD) in individuals with mild cognitive impairment (MCI) or mild dementia, collectively classified as early AD. Following an 18-month initiation phase with biweekly dosing, patients may either transition to a maintenance regimen of 10 mg/kg every four weeks or continue with the 10 mg/kg biweekly regimen.

Additionally, in January 2025, Eisai Co., Ltd. and Biogen Inc. provided an update on the regulatory review of their Marketing Authorization Application for lecanemab as a treatment for early Alzheimer’s disease (including mild cognitive impairment and mild AD) in the European Union.  

In November 2024, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending lecanemab's approval. As part of its decision-making process, the European Commission (EC) has requested CHMP to review newly available safety data on lecanemab that emerged after the November 2024 opinion. The CHMP will assess whether this information necessitates an update to its opinion and if the wording of the risk minimization measures is sufficiently clear for proper implementation. These discussions are scheduled for the CHMP meeting in February 2025.

LEQEMBI's global in-market sales for the fourth quarter reached approximately $87 million, with U.S. sales accounting for around $50 million, reflecting strong and consistent sequential growth. Currently, LEQEMBI is being evaluated in phase III trials for Early Alzheimer’s disease subcutaneous dosing and Preclinical Alzheimer’s disease. 

Drug Name	LEQEMBI (lecanemab)
Molecule type	Monoclonal antibody
Developer	Biogen/Eisai
Primary Indication	Alzheimer’s disease
Mechanism of action	Amyloid beta-protein inhibitors
Route of administration	IV

Learn more about LEQEMBI projected market size for Alzheimer’s disease @ LEQEMBI Market Potential 

Alzheimer’s disease, the most prevalent form of dementia, is a progressive neurodegenerative condition with a complex underlying pathology. It leads to a gradual decline in cognitive and functional abilities, eventually rendering individuals incapable of performing daily activities independently. According to DelveInsight’s analysis, the total number of diagnosed prevalent cases of Alzheimer’s disease in the 7MM was 15.8 million in 2023. This number is expected to rise further throughout the forecast period (2024–2034).  

Current dementia treatments primarily aim to regulate neurotransmitter activity in the brain—either by increasing levels of acetylcholine, serotonin, and noradrenaline or by reducing the activity of glutamate and dopamine. Due to potential side effects, treatment plans must be personalized based on a patient’s overall health and concurrent medications, ensuring minimal adverse interactions. Drugs such as acetylcholinesterase inhibitors (AChEIs) and the NMDA receptor antagonist memantine have been available in the U.S. for over a decade to provide symptomatic relief.  

The approval of novel anti-amyloid biologics, which modify the disease process itself through targeted mechanisms, has significantly advanced Alzheimer’s treatment beyond traditional symptomatic approaches. With a deeper understanding of the disease’s pathology and the identification of new therapeutic targets, several monoclonal antibodies have received regulatory approval in recent years.  

The Alzheimer’s disease market is highly competitive, with numerous companies striving for breakthroughs. The drug pipeline includes promising candidates in mid-stage development that are expected to be launched soon. DelveInsight projects that the market size for Alzheimer’s disease, valued at USD 1.9 billion in 2023, will experience substantial growth by 2034, driven by the introduction of innovative therapies and the increasing prevalence of the disease. The launch of these new treatments is expected to attract additional market players, fostering heightened competition and innovation.

Dive deep into an in-depth assessment of the Alzheimer’s Disease Market

Emerging Competitors of LEQEMBI

The Alzheimer’s disease pipeline is burgeoning, with a range of global companies advancing therapies for this indication. Some of the therapies in the pipeline include BioVie's Bezisterim (NE3107), AB Science's Masitinib (AB1010), Annovis Bio’s Buntanetap, Cassava Sciences' Simufilam (PTI-125), TauRx Therapeutics' Hydromethylthionine mesylate (TRx0237), Novo Nordisk's semaglutide (NN6535), Eli Lilly's Remternetug (LY3372993), Alzheon's ALZ-801 (valiltramiprosate), Eisai's E2814, UCB Pharma's  Bepranemab, and others shall create a positive impact on the market. Other therapies in the early stages of the trial are also being developed.

In February 2025, Alzheon revealed two new scientific papers ahead of the APOLLOE4 Phase 3 Trial Topline Symposium at the ADPD Conference in Vienna on April 1st, bringing the total number of groundbreaking peer-reviewed publications from Alzheon to 15.

In October 2024, Annovis Bio reported the successful outcome of the End-of-Phase II meeting with the US FDA. During the meeting, the FDA granted clearance to proceed with pivotal Phase III studies, based on the Company's Phase II/III clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap toward the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy.

The anticipated launch of these therapies will not only boost the Alzheimer’s disease treatment space but also pose a threat to Biogen/Eisai’s LEQEMBI, which is currently leading the Alzheimer’s disease market.

To know more about the number of competing drugs in development, visit @ LEQEMBI Market Positioning Compared to Other Drugs

Key Milestones of LEQEMBI 

• In January 2025, Eisai Co., Ltd. and Biogen Inc. provided an update on the ongoing regulatory review of their Marketing Authorization Application for lecanemab as a treatment for early Alzheimer's disease (including mild cognitive impairment and mild AD) in the European Union.
• In January 2025, Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb) intravenous (IV) maintenance dosing, administered once every four weeks.
• In September 2023, Japan’s MHLW approved Biogen, Eisai, and BioArctic’s LEQEMBI (lecanemab) as a treatment for slowing the progression of MCI and mild dementia due to Alzheimer's disease. 
• In July 2023, the US FDA approved the supplemental Biologics License Application (sBLA), granting traditional approval to LEQEMBI (lecanemab) 100 mg/mL injection for the treatment of adults with Alzheimer’s disease to reduce the rate of disease progression and to slow cognitive and functional decline. Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of the disease.
• In March 2023, the US FDA accepted Eisai’s sBLA for LEQEMBI, 100 mg/mL injection, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval.
• In January 2023, the US FDA approved LEQEMBI (lecanemab) via the accelerated approval pathway for treating Alzheimer’s disease.
• In January 2023, the application for manufacturing and marketing approval of LEQEMBI (lecanemab) for the treatment of MCI due to AD and mild Alzheimer’s disease dementia was designated for priority review by the MHLW.
• In March 2022, Eisai and Biogen amended the supply agreement related to lecanemab, extending it to 10 years from 5 years for commercial manufacturing by Biogen. Biogen manufactures lecanemab in its Solothurn, Switzerland facility to ensure reliable commercial supply worldwide.
• In December 2021, lecanemab was granted FTD by the US FDA to treat early Alzheimer’s disease.
• In June 2021, the US FDA granted accelerated approval to ADUHELM to treat patients with Alzheimer’s disease. Later, the US FDA updated the prescribing information to emphasize that the treatment should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
• In June 2021, lecanemab was granted BTD by the US FDA for treating Alzheimer’s disease.
• In March 2014, Eisai and Biogen entered a joint development and commercialization agreement for lecanemab. Eisai leads lecanemab development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
• In December 2007, Eisai obtained the global rights to study, develop, manufacture, and market lecanemab for treating Alzheimer’s disease, according to an agreement concluded with BioArctic.

Discover how LEQEMBI is shaping the Alzheimer’s disease treatment landscape @ LEQEMBI Alzheimer’s Disease

LEQEMBI Market Dynamics

LEQEMBI, developed by Eisai and Biogen, is a monoclonal antibody designed to treat early-stage Alzheimer’s disease by targeting amyloid-beta plaques. Since its FDA approval, the drug has been positioned as a key player in the emerging anti-amyloid therapy market. However, its adoption is shaped by several market dynamics, including regulatory hurdles, reimbursement challenges, and competition from other Alzheimer’s treatments. While LEQEMBI has demonstrated efficacy in slowing cognitive decline, concerns over safety, including the risk of amyloid-related imaging abnormalities (ARIA), impact its uptake among physicians and patients.  

Pricing and reimbursement remain crucial factors influencing LEQEMBI’s market penetration. At an annual cost of approximately $26,500 per patient, the drug faces scrutiny regarding cost-effectiveness, particularly from insurance providers and government healthcare programs like Medicare. The Centers for Medicare & Medicaid Services (CMS) has implemented coverage restrictions, requiring patient enrollment in registries to monitor real-world effectiveness. These barriers, along with logistical challenges such as the need for regular infusions and MRI monitoring, may limit widespread adoption despite strong demand for Alzheimer’s treatments.  

Competition in the Alzheimer’s space is also intensifying, with Eli Lilly’s donanemab and Roche’s gantenerumab in the pipeline. Donanemab, in particular, has shown comparable efficacy to LEQEMBI and could pose a direct challenge if it gains regulatory approval. Meanwhile, alternative approaches, such as non-amyloid-targeting therapies and combination treatments, could shift treatment paradigms in the long run. Eisai and Biogen’s ability to differentiate LEQEMBI based on clinical benefits, patient outcomes, and ease of access will be critical to sustaining its market share.  

Looking ahead, the success of LEQEMBI will depend on a combination of clinical data, real-world evidence, and strategic partnerships to improve patient access. Eisai has been actively engaging with healthcare providers and advocacy groups to raise awareness and streamline treatment pathways. As the Alzheimer’s market evolves, overcoming logistical and economic barriers while demonstrating long-term benefits will determine LEQEMBI’s commercial trajectory in an increasingly competitive landscape.

Dive deeper to get more insight into LEQEMBI’s strengths & weaknesses relative to competitors @ LEQEMBI Market Drug Report

Table of Contents

1	Report Introduction
2	LEQEMBI: Biogen/Eisai
2.1	Product Overview
2.2	Other Development Activities
2.3	Clinical Development
2.4	Clinical Trials Information
2.5	Safety and Efficacy
2.6	Product Profile
2.7	Market Assessment
2.7.1	The 7MM Analysis
2.7.1.1	Cost Assumptions and Rebate
2.7.1.2	Pricing Trends
2.7.1.3	Analogue Assessment
2.7.1.4	Launch Year and Therapy Uptake
2.7.2	The United States Market Analysis
2.7.3	EU4 and the United Kingdom Market Analysis
2.7.3.1	Germany
2.7.3.2	France
2.7.3.3	Italy
2.7.3.4	Spain
2.7.3.5	UK
2.7.4	Japan Market Analysis
2.8	Market Drivers
2.9	Market Barriers
2.10	SWOT Analysis
3	Key Cross of Marketed Competitors of LEQEMBI
4	Key Cross of Emerging Competitors of LEQEMBI

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