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市場調查報告書
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920044

疾病分析:阿茲海默症

Disease Analysis: Alzheimer's Disease

出版日期: | 出版商: Datamonitor Healthcare | 英文 87 Pages | 商品交期: 最快1-2個工作天內

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  • 全貌
  • 簡介
  • 目錄
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: Pammy Spicer

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 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.

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.

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. Despite a promotional attitude from the FDA neurology division's clinical team, it is by no means clear that the drug will skate through the FDA approval process since an advisory committee meeting came up negative. 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. Regardless, the approval of an anti-amyloid antibody has the potential to transform the Alzheimer's disease market.

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.

Results from Phase III clinical trials for beta amyloid-targeting antibodies lecanemab and gantenerumab are not expected until 2022.

The likelihood of approval of a Phase III Alzheimer's disease asset is less than 20%, compared to nearly 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

  • Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups
  • Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)
  • Aducanumab Approval Decision Delayed: Could This Be Good News?
  • Aducanumab Filed In Japan Despite Recent US Setback
  • Biogen's Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA
  • Biogen's Aducanumab Falls Hard At Panel Review, Leaving US FDA In A Tight Spot
  • What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List
  • Biogen's Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says
  • US FDA Gives Biogen Big Hand In Effort To Get Its Alzheimer's Treatment On The Market
  • 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

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

LICENSING AND ASSET ACQUISITION DEALS

  • Core One Takes In Akome Biotech In All-Stock Deal
  • Italfarmaco To Market Luye's Dementia Patch Product In Four EU Nations
  • Lilly Broadens Its CNS Reach With Rigel RIPK1 Deal
  • Grifols Buys Remaining Interest In Alkahest It Didn't Own Already
  • Roche Partners With UCB On Anti-Tau Alzheimer's Drug

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 may not deter approval

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • AR1001 for Alzheimer's Disease (March 29, 2021)
  • Atuzaginstat for Alzheimer's Disease (February 15, 2021)
  • Troriluzole for Alzheimer's Disease (January 18, 2021)
  • LY3002813 for Alzheimer's Disease (January 11, 2021)
  • Masitinib for Alzheimer's Disease (December 16, 2020)
  • Azeliragon for Alzheimer's Disease (December 15, 2020)
  • Aducanumab for Alzheimer's Disease (November 6, 2020)
  • Aducanumab for Alzheimer's Disease (November 4, 2020)
  • Semorinemab for Alzheimer's Disease (September 23, 2020)
  • Aducanumab for Alzheimer's Disease (August 7, 2020)
  • BPN14770 for Alzheimer's Disease (May 26, 2020)
  • Sumifilam for Alzheimer's Disease (May 15, 2020)

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

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: AR1001 for Alzheimer's Disease (March 29, 2021): Phase II - ADP2-US01
  • Figure 17: Troriluzole for Alzheimer's Disease (January 18, 2021): Phase II/III - T2 Protect AD (ADCS)
  • Figure 18: LY3002813 for Alzheimer's Disease (January 11, 2021): Phase II - TRAILBLAZER-ALZ (w/LY3202626)
  • Figure 19: Masitinib for Alzheimer's Disease (December 16, 2020): Phase III - Add-On Therapy (Spain)
  • Figure 20: Azeliragon for Alzheimer's Disease (December 15, 2020): Phase II/III - Elevage (Mild Alzheimer/T2D)
  • Figure 21: Semorinemab for Alzheimer's Disease (September 23, 2020): Phase II - TAURIEL (Prodromal to Mild)
  • Figure 22: BPN14770 for Alzheimer's Disease (May 26, 2020): Phase II - PICASSO AD
  • Figure 23: Sumifilam for Alzheimer's Disease (May 15, 2020): Phase IIb - Mild-to-Moderate AD
  • Figure 24: 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 ($m), 2016-20
  • Table 7: Forecasted global sales, by drug ($m), 2021-25
  • Table 8: AR1001 for Alzheimer's Disease (March 29, 2021)
  • Table 9: Atuzaginstat for Alzheimer's Disease (February 15, 2021)
  • Table 10: Troriluzole for Alzheimer's Disease (January 18, 2021)
  • Table 11: LY3002813 for Alzheimer's Disease (January 11, 2021)
  • Table 12: Masitinib for Alzheimer's Disease (December 16, 2020)
  • Table 13: Azeliragon for Alzheimer's Disease (December 15, 2020)
  • Table 14: Aducanumab for Alzheimer's Disease (November 6, 2020)
  • Table 15: Aducanumab for Alzheimer's Disease (November 4, 2020)
  • Table 16: Semorinemab for Alzheimer's Disease (September 23, 2020)
  • Table 17: Aducanumab for Alzheimer's Disease (August 7, 2020)
  • Table 18: BPN14770 for Alzheimer's Disease (May 26, 2020)
  • Table 19: Sumifilam for Alzheimer's Disease (May 15, 2020)