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免疫学におけるマイクロバイオーム (微生物叢) を標的とした治療

Microbiome-Targeted Therapeutics in Immunology

発行 GlobalData 商品コード 630767
出版日 ページ情報 英文 78 Pages
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免疫学におけるマイクロバイオーム (微生物叢) を標的とした治療 Microbiome-Targeted Therapeutics in Immunology
出版日: 2018年03月28日 ページ情報: 英文 78 Pages
概要

当レポートでは、免疫学におけるマイクロバイオーム (微生物叢) を標的とした治療について調査分析し、微生物叢の概要、疫学の概要、パイプライン評価、主要企業、治験マッピング・設計、機会と課題、規制戦略、市場の見通しなど、体系的な情報を提供しています。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 腸内/皮膚マイクロバイオームの概要

  • 皮膚のマイクロバイオーム
  • アトピー性皮膚炎におけるマイクロバイオーム
  • 座瘡におけるマイクロバイオーム
  • 乾癬におけるマイクロバイオーム
  • 腸内のマイクロバイオーム
  • 炎症性腸疾患 (IBD) におけるマイクロバイオーム
  • 過敏性腸症候群 (IBS) におけるマイクロバイオーム

第4章 疫学分析

  • 疫学分析:尋常性座瘡
  • 疫学分析:アトピー性皮膚炎
  • 疫学分析:乾癬
  • 疫学分析:クローン病
  • 疫学分析:潰瘍性結腸炎 (UC)
  • 疫学分析:過敏性腸症候群 (IBS)

第5章 パイプライン評価

  • パイプライン治療薬の開発の概要
  • パイプライン評価:腸内マイクロバイオーム
  • Qu Biologics:QBECO-SSI
  • Synthetic Biologics:SYN-010
  • パイプライン評価:皮膚マイクロバイオーム
  • AOBiome:B-244
  • Matrisys Bioscience:MSB-01

第6章 主要企業

  • 主要企業:マイクロバイオームを標的とした企業
  • 企業ポートフォリオギャップの分析:腸内マイクロバイオーム
  • 企業ポートフォリオギャップの分析:皮膚マイクロバイオーム

第7章 治験マッピング・設計

  • 治験マッピング・設計:腸内マイクロバイオーム
  • 治験マッピング・設計:皮膚マイクロバイオーム

第8章 腸内フローラ移植 (便微生物移植)

  • 実行可能な選択肢か
  • 治験マッピング・設計

第9章 価格、償還、規制戦略

  • 腸内症状に対する米国の戦略
  • QBECO-SSIに対する支払人の見通し
  • SYN-010に対する支払人の見通し
  • 皮膚症状に対する米国の戦略
  • B-244に対する支払人の見通し
  • MSB-01に対する支払人の見通し

第10章 市場の見通し

  • AOBiome:B-244
  • Synthetic Biologics:SYN-010
  • Qu Biologics:QBECO-SSI
  • パイプライン治療薬の開始日

第11章 付録

目次
Product Code: GDHCHT001

Flares in gastrointestinal and dermatology indications are characterized by a shift in the proportion of bacterial species in either the gut or skin microbiome. This report focuses on the development of therapies targeting the skin microbiome for the treatment of acne, atopic dermatitis and psoriasis and on the development of therapies targeting the gut microbiome for the treatment of Crohn's disease, ulcerative colitis, and irritable bowel syndrome.

There are 10 pipeline therapies in clinical development (Phase I through Phase IIb/III) targeting the gut microbiome for the treatment of Crohn's disease, UC, and IBS, while there are only three pipeline therapies in clinical development (Phase I through Phase III) targeting the skin microbiome for the treatment of acne, AD, and PsO.Currently, there are only three late-stage pipeline therapies targeting the microbiome in immunology - AOBiome's Phase III B-244 for the treatment of acne, Synthetic Biologics' Phase IIb/III SYN-010 (lovastatin MR) for the treatment of IBS-C, and Qu Biologics Phase IIB QBECO-SSI for Crohn's disease.

Qu Biologics and AOBiome are the only two companies with microbiome-targeted therapeutics in both early- and late-stage development, but they are both banking on the success of the same drug, marking a substantial risk for these companies. Qu Biologics' QBECO-SSI is in Phase IIb development for Crohn's disease and Phase IIa development for UC, while AOBiome's B-244 is in Phase III development for acne and Phase II development for AD.

The report "Microbiome-Targeted Therapeutics in Immunology", combines key opinion leader and payer insight with in-house analyst expertise to provide an insight-rich look at the microbiome space in immunology.

Components of the report include -

  • Overview of the Gut and Skin Microbiome - microbial dysbiosis by indication
  • Epidemiology Overview - prevalent or diagnosed prevalent cases by indication for the 16MM
  • Pipeline Assessment-promising late-stage products and early-stage pipeline by indication
  • Key Players - leading industry companies by indication
  • Clinical Trials Mapping and Design - trial breakdown by phase/indication and trial design by indication
  • Fecal Microbiota Transplants-opportunities and challenges for gastrointestinal indications
  • Pricing, Reimbursement and Regulatory Strategy - US payer perspective on late-stage therapies
  • Market Outlook - market potential estimation of late-stage therapies and key launch dates

Companies mentioned in this report: Qu Biologics, Synthetic Biologics, 4D Pharma, Enterome Bioscience, Second Genome, Seres Therapeutics, Rebiotix, Intrexon, Vedanta Biosciences, AOBiome, Matrisys Bioscience and SFA Therapeutics

Scope

This report combines key opinion leader and payer insight with in-house analyst expertise to provide an insight-rich look at the microbiome space in immunology. Components of the report include -

  • Overview of the Gut and Skin Microbiome: microbial dysbiosis by indication
  • Epidemiology Overview: prevalent or diagnosed prevalent cases by indication for the 16MM
  • Pipeline Assessment: promising late-stage products and early-stage pipeline by indication
  • Key Players: leading industry companies by indication
  • Clinical Trials Mapping and Design: trial breakdown by phase/indication and trial design by inidcation
  • Fecal Microbiota Transplants: opportunities and challenges for gastrointestinal indications
  • Pricing, Reimbursement and Regulatory Stategy: US payer perspective on late-stage therapies
  • Market Outlook: market potential estimation of late-stage therapies and key launch dates

Reasons to buy

  • Develop business strategies by understanding the trends shaping and driving the global microbiome market in immunology.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Gain insights to help plan and design your clinical trials.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
  • Identify key pricing and reimbursement strategies.

Table of Contents

1. Introduction

  • 1.1 Related Reports 6
  • 1.2 Upcoming Related Reports 7

2. Executive Summary 8

  • 2.1 Key Findings 9
  • 2.2 KOL and Payer Insight on Microbiome Competitive Landscape 10

3. Overview of the Gut and Skin Microbiome 11

  • 3.1 Microbiome of the Skin 13
  • 3.2 Microbiome in Atopic Dermatitis 14
  • 3.3 Microbiome in Acne 15
  • 3.4 Microbiome in Psoriasis 16
  • 3.5 Microbiome of the Gut 17
  • 3.6 Microbiome in Inflammatory Bowel Disease 18
  • 3.7 Microbiome in Irritable Bowel Syndrome 19

4. Epidemiology Analysis 20

  • 4.1 Epidemiology Analysis - Acne Vulgaris 22
  • 4.2 Epidemiology Analysis - Atopic Dermatitis 23
  • 4.3 Epidemiology Analysis - Psoriasis 24
  • 4.4 Epidemiology Analysis - Crohn's Disease 25
  • 4.5 Epidemiology Analysis - Ulcerative Colitis 26
  • 4.6 Epidemiology Analysis - Irritable Bowel Syndrome 27

5. Pipeline Assessment 28

  • 5.1 Overview of the Development of Pipeline Therapies 30
  • 5.2 Pipeline Assessment - The Gut Microbiome 31
  • 5.3 Qu Biologics' QBECO-SSI 33
  • 5.4 Synthetic Biologics' SYN-010 35
  • 5.5 Pipeline Assessment - The Skin Microbiome 36
  • 5.6 AOBiome's B-244 38
  • 5.7 Matrisys Bioscience's MSB-01 40

6. Key Players 41

  • 6.1 Key Players - Companies Targeting the Microbiome 43
  • 6.2 Analysis of Company Portfolio Gap - Gut Microbiome 44
  • 6.3 Analysis of Company Portfolio Gap - Skin Microbiome 45

7. Clinical Trial Mapping and Design 46

  • 7.1 Clinical Trial Mapping and Design - Gut Microbiome 48
  • 7.2 Clinical Trial Mapping and Design - Skin Microbiome 50

8. Fecal Microbiota Transplants 52

  • 8.1 Is Fecal Microbiota Transplant a Viable Option? 54
  • 8.2 Clinical Trial Mapping and Design 55

9. Pricing, Reimbursement, and Regulatory Strategy 56

  • 9.1 US Strategies for Gastrointestinal Indications 58
  • 9.2 Payer Perspective on QBECO-SSI 59
  • 9.3 Payer Perspective on SYN-010 60
  • 9.4 US Strategies for Dermatology Indications 61
  • 9.5 Payer Perspective on B-244 62
  • 9.6 Payer Perspective on MSB-01 63

10. Market Outlook 64

  • 10.1 Market Outlook for AOBiome's B-244 66
  • 10.2 Market Outlook for Synthetic Biologics' SYN-010 67
  • 10.3 Market Outlook for Qu Biologics' QBECO-SSI 68
  • 10.4 Key Launch Dates for Pipeline Therapies 69

11. Appendix 70

  • 11.1 Sources 71
  • 11.2 Methodology 72
  • 11.3 Primary Research 73
  • 11.4 About the Authors 74
  • 11.5 About GlobalData 76
  • 11.6 Contact Us 77
  • 11.7 Disclaimer 78