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非アルコール性脂肪性肝炎 (NASH) 管理におけるブレークスルー

Breakthroughs in Non-Alcoholic Steatohepatitis Management

発行 Frost & Sullivan 商品コード 820554
出版日 ページ情報 英文 46 Pages
納期: 即日から翌営業日
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非アルコール性脂肪性肝炎 (NASH) 管理におけるブレークスルー Breakthroughs in Non-Alcoholic Steatohepatitis Management
出版日: 2019年03月30日 ページ情報: 英文 46 Pages
概要

当レポートでは、非アルコール性脂肪性肝炎 (NASH) 治療薬の開発状況について調査し、NASHの概要、新薬開発プロセス、治療薬の臨床開発情勢、有望な臨床候補薬の比較、特許情勢、および成長機会などについてまとめています。

第1章 エグゼクティブサマリー

第2章 非アルコール性脂肪性肝炎 (NASH) :イントロダクション

  • NASHは非アルコール性脂肪肝疾患の進行型
  • 現在、NASHに利用できる治療は無い
  • NASHには市場での承認薬が無い

第3章 NASH:新薬開発プロセス

  • 新たなバイオマーカーの発見は複数のIND (治験薬) の開発をもたらす
  • NASH候補薬の臨床試験の成功に影響を及ぼす要因
  • 多くの臨床候補薬が (FXR) をターゲットに

第4章 NASHの治療に向けたIND (治験薬) の臨床開発情勢

  • INDの安定した流れは過去5年間でフェーズ1治験段階へ入る
  • Pfizer はNASH治療向けINDの強力なポートフォリオを維持
  • 現在、最も数が多いINDはフェーズ2の研究
  • NASH向けINDの多くはフェーズ2の治験で失敗
  • MGL-3196はNASH向けの最も有望な候補薬のひとつ、ほか

第5章 主な臨床候補薬の比較調査

  • NASH向けの4つの有望な臨床候補薬の比較

第6章 特許情勢の変化

  • 特許研究範囲・コンセプト
  • NASHにおける特許所有企業の上位10社
  • NASHにおける教育機関を所有する上位10社
  • 特許ポートフォリオのオフィス別の分布
  • NASH特許公開ポートフォリオの年度別の分布
  • NASH特許公開ポートフォリオの臓器別の分布

第7章 研究イノベーションのプロファイル

  • 製薬企業にとって学術的コラボレーションが実を結ぶ
  • NASHパイプラインにおける画期的な医薬品
  • 医薬品のヒトへの転換を改善するより良い疾病モデル

第8章 成長機会

  • 成長機会1:NASH治療のための医薬品の承認
  • 成長機会2:NASHのためのより良い前臨床モデル
  • 成長機会3:臨床試験におけるバイオマーカーの使用

第9章 付録

目次
Product Code: D89E

Multiple Investigational New Drugs with high potential for better treatment outcomes progressing through critical stages of clinical development

Non-Alcoholic Steatohepatitis or NASH is a liver disorder that is characterized by the build-up of fat in liver in addition to inflammation and liver cell damage eventually progressing to cirrhosis. Currently lifestyle interventions are suggested for the treatment of NASH with no drugs having been approved for the condition.

Multiple drugs are at the last stages of clinical trials with promising interim results while many more drugs are in early and mid-phase of clinical studies. Until now with no drugs approved for the condition of non-alcoholic steatohepatitis, there existed a huge unmet medical need.

Poor performance of INDs tested for the condition of non-alcoholic steatohepatitis over the years has been attributed to poor preclinical models which has led to poor human translation of drug safety and efficacy in addition to use of conservative biomarkers during clinical trials.

If companies can truly overcome the challenge of human translation of drug potential in terms of efficacy and safety, then non-alcoholic steatohepatitis as a manageable condition would be conquered within the next decade.

The United States leads the way in the number of NASH-related patents published. The major challenge to demonstrate translation of clinical endpoint data in NASH trials has been to stop the disease progression to cirrhosis.

Table of Contents

1.0 EXECUTIVE SUMMARY

  • 1.1. Research Objectives
  • 1.2. Research Methodology
  • 1.3. Key Findings

2.0 NON-ALCOHOLIC STEATOHEPATITIS (NASH): AN INTRODUCTION

  • 2.1. NASH Is A Progressive Form Of Non-alcoholic Fatty Liver Disease
  • 2.2. Currently There Are No Treatments Available For NASH
  • 2.3. NASH Has No Successfully Approved Drug On The Market

3.0 NASH: NOVEL DRUG DEVELOPMENT PROCESS

  • 3.1. New Biomarker Discoveries Have Led To Development Of Multiple INDs
  • 3.2. Factors Affecting Clinical Trial Success Of NASH Candidates
  • 3.3. A High Number Of Clinical Candidates Target Farnesoid X Receptor

4.0 CLINICAL DEVELOPMENT LANDSCAPE OF INDS FOR TREATMENT OF NASH

  • 4.1. A Steady Stream of INDs have Entered Phase 1 Trial Over Last 5 Years
  • 4.2. Pfizer Maintains a Strong Portfolio of Inds for NASH Treatment
  • 4.3. Currently, the Highest Number of Inds are at Phase 2 Studies
  • 4.4. Highest Number of Inds for NASH have Failed at Phase 2 Clinical Trials
  • 4.5. MGL-3196 Is One of the most Promising Candidates for NASH
  • 4.6. Phase 2 Studies also see the most Number of Study Terminations
  • 4.7. Three Inds are Expected to Seek Fda-approval By 2020
  • 4.8. Almost all INDs in Phase 3 are on Fast-track or Breakthrough Designation

5.0 COMPARATIVE STUDY OF SELECTED CLINICAL CANDIDATES

  • 5.1. Comparison of 4 Promising Clinical Candidates for NASH

6.0 PATENT LANDSCAPE ASSESSMENT

  • 6.1. Patent Research Scope And Concepts
  • 6.2. Top 10 Patent Holding Companies in NASH
  • 6.3. Top 10 Patent Holding Educational Institutes in NASH
  • 6.4. Office-wise Distribution of Patent Portfolio, 2008-2018*
  • 6.5. Year-wise Distribution of NASH Patent Publication Portfolio, 2008-2018*
  • 6.6. Organism-wise Distribution of NASH Patent Publication Portfolio, 2008-2018*

7.0 RESEARCH INNOVATION PROFILES

  • 7.1. Academic Collaborations Bear Fruit for Pharma Companies
  • 7.2. Innovative Drugs in the NASH Pipeline
  • 7.3. Better Disease Models To Improve Human Translation Of Drugs

8.0 GROWTH OPPORTUNITIES

  • 8.1. Growth Opportunity 1: Drug Approval for Treatment of NASH
  • 8.2. Growth Opportunity 2: Better Preclinical Models for NASH
  • 8.3. Growth Opportunity 3: Use of Biomarkers in Clinical Trials

9.0 APPENDIX

  • 9.1. Key Contacts
  • 9.1. Key Contacts (continued)
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