Donanemab Sales Forecast, and Market Size Analysis - 2034

Key Factors Driving Donanemab Growth

1. Market Share Gains and New Patient Starts

• Donanemab is positioned as a high-impact disease-modifying therapy in early symptomatic Alzheimer's disease, addressing a large and rapidly expanding patient population.
• Rising new patient starts are anticipated as amyloid-targeting therapies gain clinical acceptance and diagnostic pathways for early AD improve.
• Increasing physician confidence is driven by robust amyloid clearance and clinically meaningful slowing of cognitive and functional decline in treated patients.
• Eli Lilly's focused commercial strategy, neurologist education, and diagnostic ecosystem support (amyloid PET and blood-based biomarkers) are expected to accelerate adoption.

2. Expansion Across Key Indications

• Early Symptomatic Alzheimer's Disease: Donanemab is primarily targeted at patients with mild cognitive impairment (MCI) and mild dementia due to AD, where disease modification has the greatest impact.
• Amyloid-Positive Populations: Use is guided by biomarker confirmation, aligning with precision medicine approaches in neurodegenerative diseases.
• Broader Alzheimer's Continuum: Ongoing and future studies may explore use in earlier or broader stages of AD, expanding the eligible patient pool.
• Pipeline and lifecycle strategies, including optimized treatment duration and monitoring paradigms, may further enhance market reach.

3. Geographic Expansion

• Donanemab is being developed with a global commercialization strategy, targeting major markets including the United States, Europe, and Japan.
• The Asia-Pacific region represents a significant long-term growth opportunity, driven by rapidly aging populations, increasing AD prevalence, and improving diagnostic infrastructure.
• Eli Lilly is investing in regional regulatory engagement, healthcare system readiness, and specialist training to support global uptake.

4. New Indication Approvals

• Regulatory approvals for Donanemab in early Alzheimer's disease would significantly broaden treatment options in a historically underserved market.
• Potential future label expansions across earlier disease stages or broader patient subsets could diversify revenue streams and strengthen competitive positioning.
• Given the high unmet need and disease burden, Donanemab has been evaluated under accelerated or priority regulatory frameworks, supporting timely market access.

5. Strong Alzheimer's Disease Volume Momentum

• Alzheimer's disease represents one of the largest and fastest-growing therapeutic markets, driven by global demographic aging.
• Growing awareness of early diagnosis and intervention is increasing patient identification and referral to specialist care.
• Recent company updates highlight strong momentum in amyloid-targeting therapy adoption, supported by positive clinical outcomes and increasing real-world experience.

6. Competitive Differentiation and Market Trends

• Donanemab's amyloid plaque-targeting mechanism with potential for treatment completion differentiates it from chronic, indefinite therapy models.
• Demonstrated rapid and deep amyloid clearance, along with clinically meaningful efficacy, supports strong prescriber interest.
• Broader market trends-such as biomarker-driven diagnosis, personalized neurology care, and value-based healthcare models-strongly favor Donanemab's positioning.
• Increasing reliance on real-world evidence (RWE) to assess long-term safety, ARIA management, and functional outcomes is expected to strengthen payer and physician confidence.

Donanemab Recent Developments

• In September 2025, Eli Lilly and Company announced that the European Commission (EC) granted marketing authorization for KISUNLA (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
• In July 2025, Eli Lilly and Company announced that the US Food and Drug Administration (FDA) approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology.

"Donanemab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Donanemab for approved indication like Alzheimer's disease in the 7MM. A detailed picture of Donanemab's existing usage in anticipated entry and performance in approved 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 Donanemab for approved indications. The Donanemab market report provides insights about Donanemab'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 Donanemab performance, future market assessments inclusive of the Donanemab market forecast analysis for approved 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 Donanemab sales forecasts, along with factors driving its market.

Donanemab Drug Summary

Donanemab, marketed as KISUNLA, is a humanized IgG1 monoclonal antibody that specifically targets the N3pG (N-terminal pyroglutamate at position 3) epitope on insoluble, modified amyloid-beta plaques in the brain. It binds to these plaques, promoting their clearance through microglial-mediated phagocytosis, which reduces amyloid beta plaque burden in a dose- and time-dependent manner, thereby slowing cognitive decline in early Alzheimer's disease. FDA-approved on July 2024, for adults with mild cognitive impairment or mild dementia due to Alzheimer's confirmed by amyloid imaging, it is administered intravenously starting at 700 mg every 4 weeks for three doses, then 1400 mg every 4 weeks, with treatment discontinuation recommended upon amyloid plaque clearance. The report provides Donanemab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Donanemab Market Report

The report provides insights into:

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

Methodology:

The Donanemab 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.

Donanemab Analytical Perspective by DelveInsight

• In-depth Donanemab Market Assessment

This Donanemab sales market forecast report provides a detailed market assessment of Donanemab for approved indication like Alzheimer's disease 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 Donanemab sales data uptil 2034.

• Donanemab Clinical Assessment

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

Donanemab 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.

Donanemab Market Potential & Revenue Forecast

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

Donanemab Competitive Intelligence

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

Donanemab Regulatory & Commercial Milestones

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

Donanemab Clinical Differentiation

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

Donanemab Market Report Highlights

• In the coming years, the Donanemab 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 Donanemab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Donanemab's dominance.
• Other emerging products for Alzheimer's disease are expected to give tough market competition to Donanemab 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 Donanemab in approved indications.
• Analyse Donanemab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Donanemab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Donanemab in approved indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Donanemab? How strong is Donanemab's clinical and commercial performance?
• What is Donanemab's clinical trial status in each individual indications such as Alzheimer's disease and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Donanemab Manufacturers?
• What are the key designations that have been granted to Donanemab for approved indications? How are they going to impact Donanemab's penetration in various geographies?
• What is the current and forecasted Donanemab market scenario for approved indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Donanemab 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 Donanemab for approved indications?
• Which are the late-stage emerging therapies under development for the treatment of approved indications?
• How cost-effective is Donanemab? What is the duration of therapy and what are the geographical variations in cost per patient?