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Life Science Market Research Reports

Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook

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. 


Publication Date: August 1, 2016

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Company-Wide License: $4500

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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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