아두카누맙(Aducanumab) 판매 예측과 시장 규모 분석(2034년)

Key Factors Driving Aducanumab Growth

1. Market Share Gains and New Patient Starts

• Aducanumab, developed by Biogen, was positioned as one of the first disease-modifying therapies targeting amyloid-B in Alzheimer's disease (AD).
• Initial new patient starts were limited and uneven, constrained by reimbursement restrictions, safety monitoring requirements, and mixed physician confidence following regulatory approval.
• Despite early commercial efforts and physician education initiatives, real-world uptake remained modest, preventing sustained market share gains in the Alzheimer's treatment landscape.

2. Expansion Across Key Indications

• Early Alzheimer's Disease (MCI due to AD and Mild AD Dementia): Aducanumab was approved for early-stage AD based on its ability to reduce amyloid plaques.
• Biomarker-Driven Use: Treatment eligibility depended on confirmed amyloid pathology, encouraging the use of PET imaging and CSF biomarkers.
• Limited Pipeline Expansion: Unlike later entrants, Aducanumab did not meaningfully expand into additional stages of Alzheimer's disease or combination strategies.
• Shift in Focus: Subsequent pipeline efforts increasingly prioritized next-generation anti-amyloid therapies with clearer clinical benefit.

3. Geographic Expansion

• United States-Centric Commercialization: Aducanumab's launch was largely confined to the U.S., with limited international uptake.
• Minimal Global Expansion: Regulatory uncertainty and lack of reimbursement prevented broader rollout across Europe and other developed markets.
• Asia-Pacific Constraints: Despite a growing Alzheimer's disease burden in Asia-Pacific, Aducanumab did not achieve meaningful penetration due to access and policy challenges.

4. New Indication Approvals

• Accelerated Approval in Alzheimer's Disease: Aducanumab received FDA accelerated approval based on amyloid plaque reduction, marking a regulatory milestone for the field.
• No Subsequent Label Expansion: The absence of confirmatory evidence demonstrating clear clinical benefit limited further indication expansion.
• Portfolio Impact: While scientifically significant, Aducanumab did not ultimately diversify or sustainably strengthen Biogen's commercial revenue base.

5. Early Alzheimer's Volume Momentum

• High Unmet Need but Limited Utilization: Although Alzheimer's disease represents a large unmet market, Aducanumab volumes remained low due to access barriers and clinical controversy.
• Reimbursement Limitations: Medicare coverage restrictions significantly constrained prescription growth and infusion center investment.
• Physician Caution: Safety concerns, including ARIA monitoring requirements, further tempered enthusiasm among neurologists.

6. Competitive Differentiation and Market Trends

• Amyloid-Targeting Mechanism: Aducanumab helped validate amyloid-B as a therapeutic target, paving the way for subsequent therapies.
• First-Mover Challenges: As an early entrant, Aducanumab faced heightened scrutiny around efficacy, regulatory standards, and payer expectations.
• Shift Toward Evidence-Driven Therapies: Market trends increasingly favored agents with demonstrated clinical slowing of cognitive decline.
• Growing Importance of Real-World Evidence (RWE): Limited supportive RWE reduced payer and prescriber confidence relative to newer anti-amyloid agents.

Aducanumab Recent Developments

The Federal US Food and Drug Administration (FDA) accepted the Biologics License Application for Aducanumab, an investigational treatment for Alzheimer's disease developed by Biogen and Eisai.

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

Aducanumab Drug Summary

Aducanumab (Aduhelm) is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody developed by Biogen and Eisai for early Alzheimer's disease, specifically targeting amyloid beta (AB) plaques. It selectively binds to aggregated AB forms, including soluble oligomers and insoluble fibrils at amino acids 3-7, promoting microglial phagocytosis, reducing plaque burden, and potentially slowing neurodegeneration per the amyloid hypothesis. Accelerated FDA-approved in June 2021 under confirmatory trial requirements for mild cognitive impairment or mild dementia with confirmed amyloid pathology, administered via monthly intravenous infusions (up to 10 mg/kg after titration) with MRI monitoring for amyloid-related imaging abnormalities (ARIA), it faced controversy over efficacy. The report provides Aducanumab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Aducanumab Market Report

The report provides insights into:

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

Methodology:

The Aducanumab 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.

Aducanumab Analytical Perspective by DelveInsight

• In-depth Aducanumab Market Assessment

This Aducanumab sales market forecast report provides a detailed market assessment of Aducanumab 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 Aducanumab sales data uptil 2034.

• Aducanumab Clinical Assessment

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

Aducanumab 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.

Aducanumab Market Potential & Revenue Forecast

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

Aducanumab Competitive Intelligence

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

Aducanumab Regulatory & Commercial Milestones

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

Aducanumab Clinical Differentiation

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

Aducanumab Market Report Highlights

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

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Aducanumab? How strong is Aducanumab's clinical and commercial performance?
• What is Aducanumab'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 Aducanumab Manufacturers?
• What are the key designations that have been granted to Aducanumab for approved indications? How are they going to impact Aducanumab's penetration in various geographies?
• What is the current and forecasted Aducanumab market scenario for approved indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Aducanumab 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 Aducanumab for approved indications?
• Which are the late-stage emerging therapies under development for the treatment of approved indications?
• How cost-effective is Aducanumab? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Aducanumab Overview in approved indications like Alzheimer's disease

• 2.1. Product Detail
• 2.2. Aducanumab Clinical Development
  • 2.2.1. Aducanumab Clinical studies
  • 2.2.2. Aducanumab Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Aducanumab Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Aducanumab Therapies)

5. Aducanumab Market Assessment

• 5.1. Aducanumab Market Outlook in approved indications
• 5.2. 7MM Analysis
  • 5.2.1. Aducanumab Market Size in the 7MM for approved indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. Aducanumab Market Size in the United States for approved indications
  • 5.3.2. Aducanumab Market Size in Germany for approved indications
  • 5.3.3. Aducanumab Market Size in France for approved indications
  • 5.3.4. Aducanumab Market Size in Italy for approved indications
  • 5.3.5. Aducanumab Market Size in Spain for approved indications
  • 5.3.6. Aducanumab Market Size in the United Kingdom for approved indications
  • 5.3.7. Aducanumab Market Size in Japan for approved indications

6. Aducanumab SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options