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市場調查報告書

疾病分析:阿茲海默症

Disease Analysis: Alzheimer's disease

出版商 Datamonitor Healthcare 商品編碼 920044
出版日期 內容資訊 英文 91 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:阿茲海默症 Disease Analysis: Alzheimer's disease
出版日期: 2020年09月17日內容資訊: 英文 91 Pages
簡介

2018年時,推測全球整體有7450萬名阿茲海默症患者,2027年其數將增加到1億0250萬人。

本報告提供全球阿茲海默症治療藥臨床實驗形勢與市場趨勢預測相關分析,疾病概要和流行病學的預測,目前主要治療藥 (已上市/開發中產品) 和臨床實驗的進展,目前未滿足需求和未來的市場機會,臨床實驗/市場前景相關專家的見解等資訊彙整,為您概述為以下內容。

概要

疾病的背景情況

  • 定義
  • 症狀
  • 風險要素
  • 患者的分類

治療方法

  • 膽鹼酯酶抑製劑:適合輕∼中度的阿茲海默症患者
  • Memantine:適合中∼重度的患者
  • 僅管欠缺功效,膽鹼酯酶抑制劑至今仍用於MCI(輕度認知障礙)的仿單標示外使用

流行病學

已上市醫藥品

開發平台醫藥品

近來的法規上的主要動向

成功的可能性

授權合約/資產收購交易

臨床實驗環境

  • 臨床試驗贊助者的分類:各狀況
  • 臨床試驗贊助者的分類:各相位
  • 目前的趨勢

醫藥品的評估模式

市場動態

未來趨勢

  • 非專利治療藥持續佔市場大半
  • aducanumab:混合的臨床實驗結果使未來模糊

共識的預測

近幾年的市場趨勢和分析師的見解

今後的市場主要動向

KOL (專家)的見解

  • 臨床端點的有意義的變更不可或缺
  • 非專利加入目前治療策略
  • 根據阿茲海默症的異質性,多樣的治療方法是必須的
  • 各個的治療範例

未滿足需求

  • 現在已認證的治療藥:最大也只有表現中度功效
  • 現狀的治療方法只有一時的效果,無法延長壽命
  • 不僅是認知方面、功能方面,阿茲海默症給行動方面也帶來不良影響

參考文獻

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0209750

Disease Overview

Alzheimer's disease is an irreversible, progressive, neurodegenerative disease that slowly affects memory, cognition, and function. It is a continuum of pathological changes in the brain that begin well before clinical symptoms emerge. The hallmark abnormalities of Alzheimer's disease are beta-amyloid deposits and tau tangles in the brain, while it is also characterized by the loss of neuronal connections. These pathological changes are thought to occur years in advance of the onset of dementia in patients with Alzheimer's disease. Studies indicate that people aged 65 years and over survive an average of four to eight years after a diagnosis of Alzheimer's disease, yet some live as long as 20 years or more, indicating the slow, insidious progression of the disease.

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 74.5 million prevalent cases of Alzheimer's disease in adults aged 65 years and older worldwide, and forecasts that number to increase to 102.5 million prevalent cases by 2027.

The US Alzheimer's disease market only includes four franchised products that are well established. The anticipation of growth has faded with the failure of immunotherapies to produce efficacious results on cognitive outcomes. The acetylcholinesterase class of drugs will continue to dominate the treatment of mild Alzheimer's disease, while NMDA receptor antagonist memantine is used primarily as an add-on or second-line therapy in more severe disease stages.

In 2020, a US FDA approval decision is expected for Adlarity, a once-weekly transdermal formulation of gold-standard Alzheimer's disease treatment donepezil. In late 2019, China granted a conditional approval for GV-971, an oligosaccharide derived from brown algae, representing the first novel drug approved for Alzheimer's disease in nearly two decades. The company has received FDA approval to start a Phase III trial to be conducted in North America, Europe, and Asia.

Biogen's unexpected decision to pursue FDA approval for its previously discontinued amyloid-targeting biologic aducanumab in Alzheimer's disease was met with skepticism given the surprising nature of the turnaround. It is by no means clear the drug will skate through the FDA approval process. Even if the drug is approved, it is uncertain how patients, physicians, and payers might weigh the potential cost of the drug against what could be viewed as incremental efficacy.

Trial data from the Phase III clinical trials for remaining beta amyloid-targeting antibodies BAN2401 and gantenerumab are expected in 2022. Other Phase III products targeting additional pathways have not produced sufficient clinical evidence to suggest a high likelihood of approval.

Generic erosion has led to the contraction of the overall Alzheimer's disease market. This may be slightly offset by increased prevalence owing to an aging population and advances in screening for the earliest phases of Alzheimer's disease that may lead to improved diagnosis rates, with potential growth also possible from the anticipated anti-amyloid antibodies.

The likelihood of approval of a Phase III Alzheimer's disease asset is 17%, compared to 50% in the overall neurology space.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Symptoms
  • Risk factors
  • Patient segmentation

TREATMENT

  • Cholinesterase inhibitors are recommended for mild-to-moderate Alzheimer's disease
  • Memantine is reserved for moderate-to-severe disease
  • Despite lacking efficacy, cholinesterase inhibitors are still used off-label for MCI

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Adu-CAN-umab? Reading The Tea Leaves For Biogen's US Filing For Alzheimer's Drug
  • Biogen/Eisai Hit 'Send' On High Stakes BLA For Aducanumab In Alzheimer's Disease
  • China's First Alzheimer's Drug Enters US Trials To Much Fanfare
  • Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
  • China Alzheimer's Approval Raises Hope But Also Questions

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Roche Partners With UCB On Anti-Tau Alzheimer's Drug
  • Shionogi Set To Acquire R&D Partner Tetra After Raising Stake
  • Biogen Doubles Down On Alzheimer's and Neuroscience With Sangamo Gene Regulation Deal
  • Pfizer Licenses Asset With Potential In Alzheimer's, Parkinson's To Biogen
  • Biogen Licenses Potential Neurodegenerative Therapy From Ionis
  • Alkermes Invests In Novel CNS Targets With Rodin Acquisition

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Genericized symptomatic treatments
  • Disease-modifying candidates
  • Other pipeline drugs

MARKET DYNAMICS

FUTURE TRENDS

  • Generic therapies will continue to dominate the Alzheimer's disease market
  • Mixed results from aducanumab cloud the outlook

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Aducanumab for Alzheimer's Disease (August 7, 2020)
  • BPN14770 for Alzheimer's Disease (May 26, 2020)
  • AXS-05 for Alzheimer's Disease (April 27, 2020)
  • Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Multiple Drugs for Alzheimer's Disease (February 10, 2020)
  • Aducanumab for Alzheimer's Disease (December 5, 2019)
  • SUVN-502 for Alzheimer's Disease (November 30, 2019)
  • Neflamapimod for Alzheimer's Disease (November 7, 2019)
  • GV-971 for Alzheimer's Disease (November 2, 2019)
  • Aducanumab for Alzheimer's Disease (October 22, 2019)
  • Xanamem for Alzheimer's Disease (October 1, 2019)
  • AVP-786 for Alzheimer's Disease (September 27, 2019)
  • Elenbecestat for Alzheimer's Disease (September 13, 2019)
  • AADvac1 for Alzheimer's Disease (September 9, 2019)
  • Bryostatin for Alzheimer's Disease (September 9, 2019)
  • Sumifilam for Alzheimer's Disease (September 9, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Meaningful changes on clinical endpoints are essential
  • Generics are entrenched in current treatment strategies
  • Alzheimer's heterogeneity requires a diverse treatment approach
  • Individual treatment paradigms

UNMET NEEDS

  • Currently approved therapies display modest efficacy at best
  • Current treatments are only palliative and do not prolong survival
  • Beyond cognition and function, Alzheimer's disease also involves behavioral deficits

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of Alzheimer's disease, 2018-27
  • Figure 2: Overview of pipeline drugs for Alzheimer's disease in the US
  • Figure 3: Pipeline drugs for Alzheimer's disease, by company
  • Figure 4: Pipeline drugs for Alzheimer's disease, by drug type
  • Figure 5: Pipeline drugs for Alzheimer's disease, by classification
  • Figure 6: Probability of success in the Alzheimer's disease pipeline
  • Figure 7: Clinical trials in Alzheimer's disease
  • Figure 8: Top 10 drugs for clinical trials in Alzheimer's disease
  • Figure 9: Top 10 companies for clinical trials in Alzheimer's disease
  • Figure 10: Trial locations in Alzheimer's disease
  • Figure 11: Alzheimer's disease trials status
  • Figure 12: Alzheimer's disease trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for Alzheimer's disease
  • Figure 14: Market dynamics in Alzheimer's disease
  • Figure 15: Future trends in Alzheimer's disease
  • Figure 16: BPN14770 for Alzheimer's Disease (May 26, 2020): Phase II - PICASSO AD
  • Figure 17: Sumifilam for Alzheimer's Disease (May 15, 2020): Phase IIb - Mild-to-Moderate AD
  • Figure 18: AXS-05 for Alzheimer's Disease (April 27, 2020): Phase II/III - ADVANCE-1 (w/Agitation)
  • Figure 19: Vafidemstat for Alzheimer's Disease (April 3, 2020): Phase IIa - REIMAGINE-AD (Spain)
  • Figure 20: Aducanumab for Alzheimer's Disease (December 5, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 21: Neflamapimod for Alzheimer's Disease (November 7, 2019): Phase IIb - REVERSE-SD
  • Figure 22: Aducanumab for Alzheimer's Disease (October 22, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 23: Xanamem for Alzheimer's Disease (October 1, 2019): Phase I - XanaHES (Elderly)
  • Figure 24: AADvac1 for Alzheimer's Disease (September 9, 2019): Phase II - ADAMANT
  • Figure 25: Bryostatin for Alzheimer's disease (September 9, 2019): Phase II - Confirmatory Study
  • Figure 26: Sumifilam for Alzheimer's Disease (September 9, 2019): Phase IIa - Mild to Moderate AD
  • Figure 27: Key upcoming events in Alzheimer's disease

LIST OF TABLES

  • Table 1: Alzheimer's disease severity, by rating scale
  • Table 2: FDA stages by disease attributes
  • Table 3: Prevalent cases of Alzheimer's disease, 2018-27
  • Table 4: Marketed drugs for Alzheimer's disease
  • Table 5: Pipeline drugs for Alzheimer's disease in the US
  • Table 6: Historical global sales, by drug ($m), 2015-19
  • Table 7: Forecasted global sales, by drug ($m), 2020-24
  • Table 8: Aducanumab for Alzheimer's Disease (August 7, 2020)
  • Table 9: BPN14770 for Alzheimer's Disease (May 26, 2020)
  • Table 10: Sumifilam for Alzheimer's Disease (May 15, 2020)
  • Table 11: AXS-05 for Alzheimer's Disease (April 27, 2020)
  • Table 12: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 13: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 14: Multiple Drugs for Alzheimer's Disease (February 10, 2020)
  • Table 15: Aducanumab for Alzheimer's Disease (December 5, 2019)
  • Table 16: SUVN-502 for Alzheimer's Disease (November 30, 2019)
  • Table 17: Neflamapimod for Alzheimer's Disease (November 7, 2019)
  • Table 18: GV-971 for Alzheimer's Disease (November 2, 2019)
  • Table 19: Aducanumab for Alzheimer's Disease (October 22, 2019)
  • Table 20: Xanamem for Alzheimer's Disease (October 1, 2019)
  • Table 21: AVP-786 for Alzheimer's Disease (September 27, 2019)
  • Table 22: Elenbecestat for Alzheimer's Disease (September 13, 2019)
  • Table 23: AADvac1 for Alzheimer's Disease (September 9, 2019)
  • Table 24: Bryostatin for Alzheimer's Disease (September 9, 2019)
  • Table 25: Sumifilam for Alzheimer's Disease (September 9, 2019)