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市場調查報告書

微生物 (微生物叢) 治療、診斷:開發平台分析與市場預測

Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook

出版商 Arrowhead Publishers 商品編碼 370677
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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微生物 (微生物叢) 治療、診斷:開發平台分析與市場預測 Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook
出版日期: 2016年09月16日 內容資訊: 英文
簡介

人體微生物市場,預計至2025年規模擴大到22億美元。生物學治療的主要收益,是Rebiotix的RBX2660,Microbiome Therapeutics的NM504、NM505,Seres Therapeutics/Nestle Health Science的SER-109等,診斷的主要收益,是Metabiomics的結腸息肉、結腸癌症篩檢,Origin Sciences的大腸癌症篩檢,Enterome/AbbVie的IBD110等。

本報告提供全球微生物 (微生物叢) 治療、診斷市場相關調查分析,概要,研究開發產生影響的機會,主要開發平台候補,策略預測等系統性資訊。

第1章 摘要整理

第2章 人體微生物的介紹

  • 所謂人體微生物
  • 人體微生物的發現
  • 人體微生物研究開發的必要性
  • 人體微生物研究開發的目的
  • 到目前為止的成果

第3章 人體微生物研究開發的標的疾病

  • 粉刺
  • 氣喘
  • 自閉症
  • 動脈粥狀硬化性心血管疾病
  • 癌症
  • 難辨梭狀芽孢桿菌傳染病
  • 慢性阻塞性肺病 (COPD)
  • 憂鬱症、焦慮症
  • 糖尿病
  • 發炎性腸道疾病 (IBD)
  • 營養失調
  • 肥胖
  • 早產
  • 類風濕性關節炎 (RA)
  • 泌尿道感染 (UTI)

第4章 科學性、技術性策略促進人體微生物研究開發

  • 16S rRNA Annepretty conservative 定序
  • 元基因組/全基因 霰彈槍 定序
  • 單細胞定序
  • meta轉錄體學
  • meta蛋白質體學
  • 代謝體學
  • 微生物 生物標記

第5章 人體微生物研究開發的主要課題

  • 科學性、技術課題
  • 法規問題
  • 智慧財產權 (IP) 問題
  • 微生物的國際指南的缺乏
  • 倫理的、法律、社會問題

第6章 人體微生物主要企業的經營模式

  • Enterome Biosciences S.A.
  • Metabiomics Corporate
  • Metabogen AB
  • Microbiome Therapeutics LLC
  • Osel Inc.
  • Second Genome Inc.
  • Seres Therapeutics Inc.
  • Vithera Pharmaceuticals Inc.
  • Vedanta Biosciences
  • Janssen Research & Development LLC
  • Pfizer Inc.
  • Pennchop Microbiome Program
  • University of Michigan's Host Microbiome Initiative

第7章 人體微生物生物學的治療的案例研究

  • Intrexon/Merck:AG013
  • Microbiome Therapeutics:NM504
  • Microbiome Therapeutics:NM505
  • Osel:Lactin-V
  • Ritter Pharmaceuticals:RP-G28
  • Rebiotix:RBX2660
  • Seres Therapeutics/Nestle Health Science:SER-109
  • Synthetic Biologics:SYN-004

第8章 人體微生物診斷的案例研究

  • Metabiomic:結腸息肉、結腸癌症篩檢
  • Origin Sciences:大腸癌症篩檢
  • Enterome/Abbvie:IBD110

第9章 潛在的人體微生物生物學的治療、診斷市場財務狀況

  • 概要
  • 潛在的人體微生物生物學的治療、診斷市場SWOT分析
  • 潛在的人體微生物生物學的治療市場財務預測
  • 潛在的人體微生物診斷市場財務預測
  • 全球人體微生物市場潛在性
  • 結論

第10章 參考文獻

圖表

目錄

The human microbiome is an exciting revolutionary field captivating growing interest of biotech startup's, Big Pharma and academia. Since the Human Microbiome Project (HMP) and a surge in Next Generation Sequencing (NGS) and meta-omic tools; increasing efforts are underway to investigate the role of the human microbiome in health and disease and create innovative biotherapeutic and diagnostic products.

With no approved biotherapeutic or diagnostic product available to date, human microbiome R&D presents numerous challenges and opportunities. Stakeholders must collaborate to overcome unique scientific and technology hurdles, regulatory challenges, intellectual property barriers and important ethical and social issues to maximize success in this potentially lucrative market.

Several key leading pipeline biotherapeutic and diagnostic products will prove pivotal in shaping the future human microbiome market. In 2018, Metabiomic's Colon Polyp and Colon Cancer Test could become the first commercialized diagnostic. In 2019, Rebiotix's RBX2660 for recurrent C. difficile infection could become the first commercialized biotherapeutic.

This in-depth, quality report delivers:

  • Analysis of the market need for human microbiome products, scientific and technological strategies driving human microbiome R&D and successful business models
  • Identification of the major challenges within human microbiome R&D; examining scientific and technology barriers, regulatory and intellectual property hurdles, legal, ethical and social issues
  • Clinical and commercial analysis of key pivotal clinical-stage pipeline biotherapeutic and diagnostic candidates

Report Highlights:

The mainstay of human microbiome research involves cross-sectional observational/associative studies. However, it is extremely difficult to establish causality over correlation in dysbiosis using such studies. Prospective longitudinal studies are urgently needed to accelerate R&D, discover microbiome-based biomarkers and create novel biotherapeutic and diagnostic products.

The vast majority of human microbiome biotherapeutics in development fall under the FDA's definition of live biological products (LBPs). The CBER's Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information has paved the way for the creation of biotherapeutics.

By 2025, the human microbiome market could be worth $2.2 billion. Top revenue earning biotherapeutics may include Rebiotix's RBX2660, Microbiome Therapeutic's NM504 and NM505, Seres Therapeutics/ Nestlé Health Science's SER-109. Top earning diagnostics may include Metabiomics' Colon Polyp and Colon Cancer Test, Origin Sciences' Colorectal Cancer (CRC) Test and Enterome/AbbVie's IBD110.

Purchase of Arrowhead's Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook will enable you to:

  • Assess opportunities and challenges influencing human microbiome R&D
  • Identify key pivotal pipeline biotherapeutic and diagnostic candidates in clinical-stage development to maximize your products commercial potential
  • Gain an impartial perspective of strategies that can be used to enhance your products performance in the human microbiome market

Key questions answered by Arrowhead's Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook include:

  • What is the aim of human microbiome R&D?
  • Why is there a need for human microbiome R&D?
  • Which target diseases/therapeutic areas are involved in current human microbiome R&D, and what is their financial value?
  • What scientific and technology strategies are driving human microbiome R&D?
  • What are the major challenges involved in human microbiome R&D; and how can they be overcome?
  • How can players optimize strategic human microbiome R&D to maximize commercial success?
  • What recommendations does Arrowhead provide for successful human microbiome R&D?
  • Who are the key players involved in the human microbiome market and what business models are they using to raise company performance?
  • What are the key pivotal biotherapeutic candidates in the human microbiome pipeline?
  • What are the key leading diagnostic candidates in the human microbiome pipeline?
  • How much revenue will the key leading biotherapeutic pipeline candidates reach by 2025?
  • How much revenue will the key leading diagnostic pipeline candidates reach by 2025?
  • What lessons can investors learn from key pivotal pipeline biotherapeutic and diagnostic candidates?

Table of Contents

LICENSING POLICY

1 EXECUTIVE SUMMARY

  • 1.1 Scope of Translating the Microbiome from Bench to Bedside: Challenges and Opportunities in Developing Biotherapeutics and Diagnostics
  • 1.2 Methodology of Translating the Microbiome from Bench to Bedside: Challenges and Opportunities in Developing Biotherapeutics and Diagnostics
  • 1.3 The Aim of Human Microbiome R&D
  • 1.4 The Need for Human Microbiome R&D
  • 1.5 Target Diseases of Human Microbiome R&D
  • 1.6 Major Challenges of Human Microbiome R&D
  • 1.7 The Potential Financial Human Microbiome Biotherapeutic and Diagnostic Market

2 INTRODUCTION TO THE HUMAN MICROBIOME

  • 2.1 What is the Human Microbiome?
    • 2.1.1 Definition of the Human Microbiome
    • 2.1.2 The Role of the Human Microbiome
    • 2.1.3 Where Does the Human Microbiome Come From?
  • 2.2 Discovery of the Human Microbiome
    • 2.2.1 The Human Microbiome Project (HMP)
    • 2.2.2 Metagenomics of the Human Intestinal Tract (MetaHIT) Project
    • 2.2.3 International Human Microbiome Consortium (IHMC)
  • 2.3 The Need for Human Microbiome R&D
  • 2.4 The Aim of Human Microbiome R&D
    • 2.4.1 Applications of the Human Microbiome
  • 2.5 What Have We Achieved So Far?
    • 2.5.1 Fecal Microbiota Transplant (FMT)
    • 2.5.2 OpenBiome

3 TARGET DISEASES OF HUMAN MICROBIOME R&D

  • 3.1 Acne
  • 3.2 Asthma
  • 3.3 Autism
  • 3.4 Atherosclerosis
  • 3.5 Cancer
  • 3.6 Clostridium Difficile Infection
  • 3.7 Chronic Obstructive Pulmonary Disease (COPD)
  • 3.8 Depression and Anxiety
  • 3.9 Diabetes
  • 3.10 Irritable Bowel Disease (IBD)
  • 3.11 Malnutrition
  • 3.12 Obesity
  • 3.13 Preterm Birth
  • 3.14 Rheumatoid Arthritis
  • 3.15 Urinary Tract Infection (UTI)

4 SCIENTIFIC AND TECHNOLOGY STRATEGIES DRIVING HUMAN MICROBIOME R&D

  • 4.1 16S Ribosomal RNA (RRNA) Amplicon Sequencing
  • 4.2 Metagenomic/Whole-Genome Shotgun (WGS) Sequencing
  • 4.3 Single-Cell Sequencing
  • 4.4 Metatranscriptomics
  • 4.5 Metaproteomics
  • 4.6 Metabolomics
  • 4.7 Microbiome-Based Biomarkers

5 MAJOR CHALLENGES OF HUMAN MICROBIOME R&D

  • 5.1 Scientific and Technology Challenges
    • 5.1.1 Standardization
    • 5.1.2 Microbial Sampling
    • 5.1.3 Dysbiosis: Establishing Causality versus Correlation
    • 5.1.4 In Vivo Models
    • 5.1.5 Data Deluge
  • 5.2 Regulatory Issues
    • 5.2.1 Live Biological Products
    • 5.2.2 Biologics License Application (BLA)
  • 5.3 Intellectual Property Issues
  • 5.4 Lack of a Global Microbiome Initiative
  • 5.5 Ethical, Legal, and Social Issues
    • 5.5.1 Informed Consent and Respect for Autonomy
    • 5.5.2 Informing Subjects of Research-Related Results
    • 5.5.3 Data Sharing and Protection of Privacy
    • 5.5.4 Invasiveness of Sampling and Minimizing Risk

6 BUSINESS MODELS OF KEY HUMAN MICROBIOME PLAYERS

  • 6.1 Enterome Biosciences S.A.
  • 6.2 Metabiomics Corporate
  • 6.3 Metabogen AB
  • 6.4 Microbiome Therapeutics LLC
  • 6.5 Osel Inc. 6.6 Second Genome Inc.
  • 6.7 Seres Therapeutics Inc.
  • 6.8 Vithera Pharmaceuticals Inc.
  • 6.9 Vedanta Biosciences
  • 6.10 Janssen Research & Development LLC
  • 6.11 Pfizer Inc.
  • 6.12 Pennchop Microbiome Program
  • 6.13 University of Michigan's Host Microbiome Initiative

7 CASE STUDIES OF HUMAN MICROBIOME BIOTHERAPEUTICS

  • 7.1 Intrexon/Merck's AG013
  • 7.2 Microbiome Therapeutics' NM504
  • 7.3 Microbiome Therapeutics' NM505
  • 7.4 Osel's Lactin-V
  • 7.5 Ritter Pharmaceuticals' RP-G28
  • 7.6 Rebiotix's RBX2660
  • 7.7 Seres Therapeutics/Nestlé Health Science's SER-109
  • 7.8 Synthetic Biologics' SYN-004

8 CASE STUDIES OF HUMAN MICROBIOME DIAGNOSTICS

  • 8.1 Metabiomic's Colon Polyp and Colon Cancer Test
  • 8.2 Origin Sciences' Colorectal Cancer (CRC) Test
  • 8.3 Enterome/Abbvie's IBD110

9 THE POTENTIAL FINANCIAL HUMAN MICROBIOME BIOTHERAPEUTIC AND DIAGNOSTIC MARKET

  • 9.1 Overview 9.2 SWOT Analysis of the Potential Human Microbiome Biotherapeutic and Diagnostic Market
  • 9.3 Financial Forecast of the Potential Global Human Microbiome Biotherapeutic Market
  • 9.4 Financial Forecast of the Potential Global Human Microbiome Diagnostic Market
  • 9.5 Global Potential Human Microbiome Market
  • 9.6 Conclusion

10 BIBLIOGRAPHY

LIST OF TABLES

  • Table 1: Global Prevalence and Drug Market Value of Disease Linked to Human Microbiome R&D
  • Table 2: Total Global Human Microbiome Market Revenue Forecast, 2018 and 2025 ($bn)
  • Table 3: Overview of Microbes
  • Table 4: Applications of WGS Sequencing
  • Table 5: Comparison of 16s rRNA Amplicon versus WGS Sequencing
  • Table 6: Univariate Analysis of Five Candidate Biomarkers for Colorectal Cancer
  • Table 7: Total Global Human Microbiome Biotherapeutics Market Revenue Forecast, 2016-2025 ($m)
  • Table 8: Total Global Human Microbiome Diagnostics Market Revenue Forecast, 2016-2025 ($m)
  • Table 9: Total Global Human Microbiome Market Revenue Forecast, 2016-2025 ($bn)

LIST OF FIGURES

  • Figure 1: Productivity of the Pharmaceutical Industry 1998-2014
  • Figure 2: Key Challenges in Human Microbiome R&D
  • Figure 3: Total Global Human Microbiome Market Revenue Forecast, 2018 and 2025 ($bn)
  • Figure 4: Infograph of the Human Microbiome
  • Figure 5: Illustration of the Human Microbiome Figure 6: Infograph of the MetaHIT Project
  • Figure 7: Pharmaceutical Industry R&D Spend, 1998-2014
  • Figure 8: Number of FDA New Drugs Approved, 1998-2014
  • Figure 9: Range of Microbiome-Derived Modulators under Human Microbiome R&D
  • Figure 10: Overview of 16s rRNA and WGS Sequencing Techniques
  • Figure 11: Single-Cell Sequencing Methods
  • Figure 12: Summary of the Current Scientific and Technology Strategies Driving Human Microbiome R&D
  • Figure 13: Seres Therapeutics' Ecobiotic Mode of Action
  • Figure 14: Seres Therapeutics' Early Stage Developmental Process of Creating Ecobiotics
  • Figure 15: Global Prevalence of Lactose Intolerance
  • Figure 16: OriCol's Target Sampling Site within the Human Body
  • Figure 17: SWOT Analysis of the Potential Human Microbiome Biotherapeutic and Diagnostic Market
  • Figure 18: Total Global Human Microbiome Biotherapeutics Market Revenue Forecast, 2016-2025 ($m)
  • Figure 19: Total Global Human Microbiome Diagnostics Market Revenue Forecast, 2016-2025 ($m)
  • Figure 20: Total Global Human Microbiome Market Revenue Forecast, 2016-2025 ($bn)
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