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疾患分析:アルツハイマー病

Disease Analysis: Alzheimer's disease

発行 Datamonitor Healthcare 商品コード 920044
出版日 ページ情報 英文 87 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=108.54円で換算しております。
疾患分析:アルツハイマー病 Disease Analysis: Alzheimer's disease
出版日: 2020年05月07日 ページ情報: 英文 87 Pages
概要

2018年現在、世界全体で7450万人のアルツハイマー病患者が存在し、2027年にはその数が1億0250万人にまで増加する、と推測されています。

当レポートでは、世界のアルツハイマー病向け治療薬の治験情勢と市場動向見通しについて分析し、疾患の概要や疫学的予測、現在の主な治療薬 (上市済み/パイプライン製品) や治験の進行状況、現在のアンメットニーズと将来的な市場機会、治験/市場の先行きに関する専門家の見解、といった情報を取りまとめてお届けいたします。

概要

疾患の背景事情

  • 定義
  • 症状
  • リスク要因
  • 患者の分類

治療法

  • コリンエストラーゼ阻害剤:軽~中度のアルツハイマー病患者向け
  • メマンチン:中~重度の患者向け
  • 効能に欠けるにも関わらず、コリンエストラーゼ阻害剤が未だにMCI (軽度認知障害) への適応外使用に使われている

疫学

上市済み医薬品

パイプライン医薬品

昨今の規制上の主な動き

成功の可能性

ライセンス契約/資産買収取引

治験環境

  • 治験依頼者の分類:状況別
  • 治験依頼者の分類:相 (フェーズ) 別
  • 昨今の動向

医薬品の評価モデル

市場のダイナミクス

将来の動向

  • ジェネリック治療薬が市場の大半を占め続ける
  • アデュカヌマブ:相反する治験結果が先行きを見えなくする

コンセンサスの予測

近年の市場動向とアナリストの見解

今後の市場の主な動き

KOL (専門家) の見解

  • 臨床エンドポイントの有意義な変更が不可欠
  • 現在の治療戦略に組み込まれているジェネリック
  • アルツハイマー病の異質性により、多様な治療アプローチが必要となる
  • 個々の治療パラダイム

アンメットニーズ

  • 現在認証済みの治療薬:最大でも中程度の効能を示す
  • 現状の治療法は一時的効果のみで、余命延長にはつながらない
  • 認知面・機能面だけでなく、アルツハイマー病は行動面にも悪影響を及ぼす

参考文献

  • 処方薬の情報

付録

目次
Product Code: DMKC0209750

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 marketed 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 the first half of 2020, an 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.

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 in Japan will contract the overall Alzheimer's disease market. This may be slightly offset by the 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.

The likelihood of approval of a Phase III Alzheimer's disease asset is 15%, compared to 51% in the overall neurology space.

TABLE OF 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

  • Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
  • China Alzheimer's Approval Raises Hope But Also Questions
  • AARP-Funded Researchers Say Forget About Supplements To Improve Memory

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • 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

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

  • 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)
  • PTI-125 for Alzheimer's Disease (September 9, 2019)
  • GRF6019 for Alzheimer's Disease (August 5, 2019)
  • CNP520 for Alzheimer's Disease (July 11, 2019)
  • Azeliragon for Alzheimer's Disease (June 28, 2019)
  • Masitinib for Alzheimer's Disease (June 26, 2019)
  • Multiple Drugs for Alzheimer's Disease (June 25, 2019)
  • Xanamem for Alzheimer's Disease (May 7, 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: Vafidemstat for Alzheimer's Disease (April 3, 2020): Phase IIa - REIMAGINE-AD (Spain)
  • Figure 17: Aducanumab for Alzheimer's Disease (December 5, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 18: Neflamapimod for Alzheimer's Disease (November 7, 2019): Phase IIb - REVERSE-SD
  • Figure 19: Aducanumab for Alzheimer's Disease (October 22, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 20: Xanamem for Alzheimer's Disease (October 1, 2019): Phase I - XanaHES (Elderly)
  • Figure 21: AADvac1 for Alzheimer's Disease (September 9, 2019): Phase II - ADAMANT
  • Figure 22: Bryostatin for Alzheimer's disease (September 9, 2019): Phase II - Confirmatory Study
  • Figure 23: PTI-125 for Alzheimer's Disease (September 9, 2019): Phase IIa - 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 ($m), 2014-18
  • Table 7: Forecasted global sales, by drug ($m), 2020-24
  • Table 8: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 9: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 10: Multiple Drugs for Alzheimer's Disease (February 10, 2020)
  • Table 11: Aducanumab for Alzheimer's Disease (December 5, 2019)
  • Table 12: SUVN-502 for Alzheimer's Disease (November 30, 2019)
  • Table 13: Neflamapimod for Alzheimer's Disease (November 7, 2019)
  • Table 14: GV-971 for Alzheimer's Disease (November 2, 2019)
  • Table 15: Aducanumab for Alzheimer's Disease (October 22, 2019)
  • Table 16: Xanamem for Alzheimer's Disease (October 1, 2019)
  • Table 17: AVP-786 for Alzheimer's Disease (September 27, 2019)
  • Table 18: Elenbecestat for Alzheimer's Disease (September 13, 2019)
  • Table 19: AADvac1 for Alzheimer's Disease (September 9, 2019)
  • Table 20: Bryostatin for Alzheimer's Disease (September 9, 2019)
  • Table 21: PTI-125 for Alzheimer's Disease (September 9, 2019)
  • Table 22: GRF6019 for Alzheimer's Disease (August 5, 2019)
  • Table 23: CNP520 for Alzheimer's Disease (July 11, 2019)
  • Table 24: Azeliragon for Alzheimer's Disease (June 28, 2019)
  • Table 25: Masitinib for Alzheimer's Disease (June 26, 2019)
  • Table 26: Multiple Drugs for Alzheimer's Disease (June 25, 2019)
  • Table 27: Xanamem for Alzheimer's Disease (May 7, 2019)