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注目市場の分析:ハンチントン病

Market Spotlight: Huntington's Disease

発行 Datamonitor Healthcare 商品コード 573554
出版日 ページ情報 英文 36 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.98円で換算しております。
注目市場の分析:ハンチントン病 Market Spotlight: Huntington's Disease
出版日: 2020年01月10日 ページ情報: 英文 36 Pages
概要

2017年の世界の30歳以上の人口におけるハンチントン病の有病者数は159,410人と推計されており、2026年には184,950人に増加すると予測されています。地域別では北米の有病者数がもっとも多く、アジア地域がもっとも少ないとされています。臨床開発中の薬剤の大半はフェーズIIの段階であり、2種の薬剤がフェーズIIIにあります。標的にはハンチンチン、小胞モノアミントランスポーター、p38 MAPキナーゼ、SIRT1、バソプレシン受容体、セマフォリン4D / CD100、アリール炭化水素受容体、NMDA型グルタミン酸受容体、PPARデルタ、PPARガンマなどがあり、パイプライン薬の大半は経口剤、その他には髄腔内製剤、静脈内製剤、脳内/脳室内製剤などがあります。臨床試験の地域別の取り組みでは、米国が世界を大幅にリードしており、EU内では英国がトップに位置付けています。

当レポートでは、世界のハンチントン病治療薬の市場を調査し、疾患の背景・概要、有病者数の10カ年予測、パイプライン薬および上市済み薬の概要、臨床試験の状況、ライセンシング・資産買収などの主要取引の動向、特許情報、主要薬剤の収益予測などをまとめています。

概要

要点

疾患の背景

治療

  • コレラ治療
  • パーキンソニズム治療
  • 行動機能・精神機能障害

疫学

上市済み薬剤

パイプライン薬

近年の展開・アナリストの見解

  • Nerventra

今後の展開

法規制上の展開

  • 希少疾病用医薬品認定

ライセンシング・資産取得契約

  • Alkermes:新たなCNS標的への投資・Rodinの買収
  • ■成功確率

親特許

収益機会

臨床試験環境

  • スポンサー:ステイタス別
  • スポンサー:フェーズ別

文献

付録

図表

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of HD, 2017-26
  • Figure 2: Overview of pipeline drugs for HD in the US
  • Figure 3: Pipeline drugs for HD, by company
  • Figure 4: Pipeline drugs for HD, by drug type
  • Figure 5: Pipeline drugs for HD, by classification
  • Figure 6: Nerventra for HD (July 31, 2018): Phase II - LEGATO-HD
  • Figure 7: Key upcoming events in HD
  • Figure 8: Probability of success in the HD pipeline
  • Figure 9: Licensing and asset acquisition deals in HD, 2015-20
  • Figure 10: Parent patents in HD
  • Figure 11: Clinical trials in HD
  • Figure 12: Top 10 drugs for clinical trials in HD
  • Figure 13: Top 10 companies for clinical trials in HD
  • Figure 14: Trial locations in HD
  • Figure 15: HD trials status
  • Figure 16: HD trials sponsors, by phase

LIST OF TABLES

  • Table 1: Prevalent cases of HD, 2017-26
  • Table 2: Prevalence proportions of HD, 2017-26
  • Table 3: Marketed drugs for HD
  • Table 4: Pipeline drugs for HD in the US
  • Table 5: Nerventra for HD (July 31, 2018)
  • Table 6: Historical global sales, by drug ($m), 2014-18
  • Table 7: Forecasted global sales, by drug ($m), 2020-24
目次
Product Code: DMKC0178508

Huntington's disease (HD) is a rare disorder of the central nervous system (CNS) which causes the degeneration of nerve cells. It is an autosomal dominant disease characterized by involuntary choreatic movements, psychiatric and behavioral disturbances, and dementia. The mean age of symptom onset is 30-50 years. HD is caused by the presence of >40 cytosine-adenine-guanine (CAG) repeats within the Huntingtin gene. The length of the CAG repeats is inversely associated with the age of disease onset - the longer the repeat, the earlier the onset. In the case of juvenile HD (JHD), the length of the repeat is >55 and the disease's symptoms are seen in patients aged <20 years. Learning disabilities and behavioral disturbances are the first symptoms in patients with JHD.

Key Takeaways:

Datamonitor Healthcare estimates that in 2017, there were 159,410 prevalent cases of Huntington's disease (HD) in adults aged 30 years and older worldwide, and forecasts that number to increase to 184,950 prevalent cases by 2026. Northern America is estimated to have the highest disease prevalence (0.0073%), while Asia has the lowest prevalence (0.0004%).

Teva's Austedo and Bausch Health's Xenazine, which target vesicular monamine transporters, are the only marketed drugs for HD. These drugs are administered via the oral route.

The majority of industry-sponsored drugs in active clinical development for HD are in Phase II, with two drugs in Phase III. Therapies in active clinical development for HD focus on targets such as huntingtin, vesicular monamine transporters, p38 MAP kinase, SIRT1, vasopressin receptors, semaphorin 4D/CD100, aryl hydrocarbon receptor, NMDA glutamate receptor, PPAR delta, and PPAR gamma. The majority of the pipeline drugs are administered via the oral route, with the remainder being intrathecal, intravenous, and intracerebral/cerebroventricular formulations.

High-impact upcoming events for drugs in the HD space comprise topline Phase Ib/IIa trial results for WVE-120101, topline Phase II trial results for pepinemab and HTT-ASO, and topline Phase III trial results for Ingrezza and HTT-ASO.

The overall likelihood of approval of a Phase I neurodegenerative asset is 7.5%, and the average probability a drug advances from Phase III is 47.8%. Drugs, on average, take 11.1 years from Phase I to approval, compared to 9.8 years in the overall neurology space.

There have been eight licensing and asset acquisition deals involving HD drugs during 2015-20. The $1,050m exclusive strategic collaboration and option agreement signed in 2018 between AbbVie and Voyager Therapeutics, for the development and commercialization of vectorized antibodies directed against tau for the treatment of Alzheimer's disease and other neurodegenerative diseases, was the largest deal.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for HD have been in the early and midphases of development, with 77% of trials in Phase I-II, and only 23% in Phase III-IV.

The US has a substantial lead in the number of HD clinical trials globally, while the UK leads the major EU markets. Clinical trial activity in the HD space is dominated by completed trials. Pfizer and Teva have the highest number of completed clinical trials for HD, with 14 trials each.

Pfizer and Teva lead industry sponsors with the highest overall number of clinical trials for HD.

TABLE OF CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Subtypes

TREATMENT

  • Treatment of chorea
  • Treatment of parkinsonism
  • Treatment of behavioral and psychiatric dysfunction

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • Nerventra for HD (July 31, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Orphan Designation Awarded In March

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Alkermes Invests In Novel CNS Targets With Rodin Acquisition

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHY

  • Prescription information

APPENDIX