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질환 분석 : 알츠하이머병

Disease Analysis: Alzheimer´s disease

리서치사 Datamonitor Healthcare
발행일 2021년 03월 상품 코드 920044
페이지 정보 영문 90 Pages
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질환 분석 : 알츠하이머병 Disease Analysis: Alzheimer´s disease
발행일 : 2021년 03월 페이지 정보 : 영문 90 Pages

본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

2018년 전 세계에 7450만 명의 알츠하이머병 환자가 존재하며, 2027년에는 그 수가 1억 250만 명으로 증가할 것으로 추산되고 있습니다.

세계 알츠하이머병 치료제의 임상시험 상황 및 시장 동향 전망에 대해 분석했으며, 질환의 개요와 역학 예측, 현재 주요 치료제(출시/파이프라인 제품)와 임상시험의 진행 상황, 현재의 미충족 요구와 향후 시장 기회, 임상시험/시장의 미래에 관한 전문가의 견해 등의 정보를 정리하여 전해드립니다.

요약

질환의 배경

  • 정의
  • 증상
  • 위험인자
  • 환자의 분류

치료

  • 콜린에스테라아제 억제제 : 경도-중도 알츠하이머병 환자용
  • 메만틴 : 중도-중증 환자용
  • 효능의 부족에도 불구하고 콜린에스테라아제 억제제가 여전히 MCI(경도 인지장애)의 오프라벨에 사용

역학

출시 의약품

파이프라인 의약품

최근 규제의 주요 동향

성공 가능성

라이선스 계약/자산 취득 거래

임상시험 환경

  • 임상시험 의뢰자의 분류 : 상황별
  • 임상시험 의뢰자의 분류 : 상(Phase)별
  • 최근 동향

의약품 평가 모델

시장 역학

향후 동향

  • 제네릭 치료제가 시장의 대부분을 계속 차지한다.
  • aducanumab : 상반되는 임상시험 결과가 전망을 어둡게 한다.

합의 예측

최근 시장 동향과 애널리스트의 견해

향후 시장의 주요 동향

KOL(전문가)의 견해

  • 임상 엔드포인트의 의미있는 변화가 필수적
  • 현재의 치료 전략에 포함된 제네릭
  • 알츠하이머병의 이질성에 의해 다양한 치료 접근이 필요하다.
  • 개별 치료 패러다임

미충족 요구

  • 현재 인증된 치료제 : 최대 중간 정도의 효능을 보인다.
  • 현재의 치료법은 일시적 효과만 보이며, 수명 연장으로는 연결되지 않는다.
  • 알츠하이머병은 인지면과 기능면뿐만 아니라 행동면에도 악영향을 미친다.

참고 문헌

  • 처방약 정보

부록

KSA 20.01.15

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; however, topline results from late-phase trials of ALZT-OP1 and atuzaginstat are anticipated in 2021.

The likelihood of approval of a Phase III Alzheimer's disease asset is 16.5%, compared to 48.6% 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

  • 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
  • USA 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
  • China's First Alzheimer's Drug Enters US Trials To Much Fanfare

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Grifols Buys Remaining Interest In Alkahest It Didn't Own Already
  • 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

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 may not deter approval

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • 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)
  • AXS-05 for Alzheimer's Disease (April 27, 2020)

LIST OF FIGURES

  • 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)

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: Troriluzole for Alzheimer's Disease (January 18, 2021): Phase II/III - T2 Protect AD (ADCS)
  • Figure 17: LY3002813 for Alzheimer's Disease (January 11, 2021): Phase II - TRAILBLAZER-ALZ (w/LY3202626)
  • Figure 18: Masitinib for Alzheimer's Disease (December 16, 2020): Phase III - Add-On Therapy (Spain)
  • Figure 19: Azeliragon for Alzheimer's Disease (December 15, 2020): Phase II/III - Elevage (Mild Alzheimer/T2D)
  • Figure 20: Semorinemab for Alzheimer's Disease (September 23, 2020): Phase II - TAURIEL (Prodromal to Mild)
  • Figure 21: BPN14770 for Alzheimer's Disease (May 26, 2020): Phase II - PICASSO AD
  • Figure 22: Sumifilam for Alzheimer's Disease (May 15, 2020): Phase IIb - Mild-to-Moderate AD
  • Figure 23: AXS-05 for Alzheimer's Disease (April 27, 2020): Phase II/III - ADVANCE-1 (w/Agitation)
  • Figure 24: Vafidemstat for Alzheimer's Disease (April 3, 2020): Phase IIa - REIMAGINE-AD (Spain)
  • Figure 25: 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), 2021-25
  • Table 8: Troriluzole for Alzheimer's Disease (January 18, 2021)
  • Table 9: LY3002813 for Alzheimer's Disease (January 11, 2021)
  • Table 10: Masitinib for Alzheimer's Disease (December 16, 2020)
  • Table 11: Azeliragon for Alzheimer's Disease (December 15, 2020)
  • Table 12: Aducanumab for Alzheimer's Disease (November 6, 2020)
  • Table 13: Aducanumab for Alzheimer's Disease (November 4, 2020)
  • Table 14: Semorinemab for Alzheimer's Disease (September 23, 2020)
  • Table 15: Aducanumab for Alzheimer's Disease (August 7, 2020)
  • Table 16: BPN14770 for Alzheimer's Disease (May 26, 2020)
  • Table 17: Sumifilam for Alzheimer's Disease (May 15, 2020)
  • Table 18: AXS-05 for Alzheimer's Disease (April 27, 2020)
  • Table 19: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 20: Vafidemstat for Alzheimer's Disease (April 3, 2020)
  • Table 21: Multiple Drugs for Alzheimer's Disease (February 10, 2020)
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