Aducanumab Sales Forecast, and Market Size Analysis - 2034
상품코드:1909216
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
아두카누맙(Aducanumab)의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 수 증가
바이오젠이 개발한 아두카누맙은 알츠하이머병(AD)에서 아밀로이드 베타를 표적으로 하는 최초의 질병 변형 치료제 중 하나로 자리매김했습니다.
규제 승인 후 상환 제약, 안전성 모니터링 요건, 의사의 확신도 차이로 인해 초기 신규 환자 도입은 제한적이고 불균등하게 이루어졌습니다.
초기 상업적 활동과 의사 교육 활동에도 불구하고 실제 보급은 제한적이어서 알츠하이머병 치료 환경에서 지속적인 시장 점유율 확대에 어려움을 겪었습니다.
2. 중요한 적응증으로 확대
초기 알츠하이머병(AD로 인한 경도인지장애 및 경증 AD 치매) : 아두카누맙은 아밀로이드 플라크를 감소시키는 능력에 기반하여 초기 단계의 알츠하이머병에 대한 승인을 받았습니다.
바이오마커 기반 사용: 치료 적격성 여부는 아밀로이드 병리 확인에 의존했으므로 PET 영상 및 수액 바이오마커의 사용이 촉진되었습니다.
제한적인 파이프라인 확장: 아두카누맙은 후발주자들과 달리 알츠하이머병의 추가 단계나 병용 전략으로 의미 있는 확장을 보여주지 못했습니다.
초점 전환: 이후 개발 파이프라인에서는 보다 명확한 임상적 이점이 기대되는 차세대 항아밀로이드 치료제가 우선순위를 차지하게 되었습니다.
3. 지역적 확장
미국 중심의 상업화: 아두카누맙의 출시는 대부분 미국에 국한되어 있으며, 국제적인 보급은 제한적이었습니다.
최소한의 세계 진출: 규제상의 불확실성 및 상환 제도의 부재로 인해 유럽 및 기타 선진국 시장에서의 광범위한 진출이 제한적이었습니다.
아시아태평양의 제약: 아두카누맙은 아시아태평양의 알츠하이머병 환자 수가 증가하고 있음에도 불구하고 접근성 및 정책적 문제로 인해 충분한 보급을 달성하지 못했습니다.
4. 신규 적응증 승인
알츠하이머병 신속 승인: 아두카누맙은 아밀로이드 플라크 감소를 근거로 FDA의 신속 승인을 획득하여 이 분야에서 규제상의 획기적인 진전을 이루었습니다.
이후 적응증 확대 없음: 명확한 임상적 이점을 보여주는 확증적 증거를 얻지 못했으므로 추가 적응증 확대는 이루어지지 않았습니다.
포트폴리오에 미치는 영향: 아두카누맙은 과학적 의미는 크지만, 결국 바이오젠의 상업적 매출 기반을 다각화하거나 지속적으로 강화하는 데는 도움이 되지 못했습니다.
5. 초기 알츠하이머병의 수량 확대의 모멘텀
높은 미충족 수요와 제한된 사용: 알츠하이머병은 미충족 수요가 큰 시장임에도 불구하고 접근 장벽과 임상적 논란으로 인해 아두카누맙의 사용량은 낮은 수준에 머물러 있습니다.
상환 제한: 메디케어의 적용 제한으로 인해 처방 증가와 링거센터 투자가 크게 억제되었습니다.
의사의 신중한 태도: ARIA 모니터링 요건을 포함한 안전에 대한 우려로 인해 신경과 의사들의 적극적인 도입 태도가 더욱 억제되었습니다.
6. 경쟁 우위 및 시장 동향
아두카누맙은 아밀로이드 표적화 기전: 아두카누맙은 아밀로이드 베타를 치료 표적으로 확립하는 데 기여하여 후속 치료법의 길을 열었습니다.
선구자로서의 도전: 아두카누맙은 초기 진입 약물로서 유효성, 규제 기준, 보험사 기대치에 대한 엄격한 모니터링에 직면했습니다.
근거 기반 치료로의 전환: 인지기능 저하를 임상적으로 지연시키는 효과가 입증된 약물이 시장 동향에서 점점 더 강조되고 있습니다.
리얼월드 데이터(RWE)의 중요성 증대: 제한된 리얼월드 데이터(RWE)는 새로운 항아밀로이드제에 비해 보험사 및 처방의사의 신뢰도를 떨어뜨렸습니다.
아두카누맙의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본) 시장을 조사 분석했으며, 각국 시장 규모와 예측, 연구개발(R&D) 활동, 경쟁 구도 등의 정보를 전해드립니다.
목차
제1장 리포트 개요
제2장 알츠하이머병 등의 승인된 적응증에서 아두카누맙의 개요
제품 상세
아두카누맙 임상 개발
아두카누맙 임상시험
아두카누맙 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 개요
제3장 아두카누맙의 경쟁 상황(출시 약품)
제4장 경쟁 구도(후기 단계 새로운 아두카누맙 요법)
제5장 아두카누맙 시장 평가
승인된 적응증에서 아두카누맙 시장 전망
주요 7 시장 분석
주요 7 시장의 승인된 적응증용 아두카누맙 시장 규모
각국의 시장 분석
미국의 승인된 적응증용 아두카누맙 시장 규모
독일의 승인된 적응증용 아두카누맙 시장 규모
영국의 승인된 적응증용 아두카누맙 시장 규모
제6장 아두카누맙 SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 리포트 구입 옵션
KSA
영문 목차
영문목차
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
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
