From microbes playing a role in our health, the discovery that microbes destroyed the Mayan civilization, to the potential of microbes aiding future interplanetary space exploration, the power of microbes is immense. Since the Human Microbiome Project began, driven by a surge in Next Generation Sequencing (NGS) tools; the human microbiome is drawing interest from Big Pharma, Startups and academia to revolutionize health and disease.
The race is now on to create innovative human microbiome products. However, human microbiome R&D presents numerous challenges. Collaboration is paramount for stakeholders to overcome unique scientific and technology hurdles, manufacturing and regulation challenges, intellectual property barriers and key ethical and social issues, to maximize successful opportunities in this potentially lucrative market.
Several key leading pipeline products will pave the way forward for the future human microbiome market. In 2019, the first biotherapeutics could hit the market with the arrival of Seres Therapeutics/ Nestlé Health Science's SER-109 and Rebiotix RBX2660, both for prevention of recurrent C. difficile infection. In 2020, the market could witness the arrival of the first human microbiome diagnostic product, Metabiomics' Colon Polyp and Colon Cancer Test.
This report delivers:
- Analysis of the market need for human microbiome products, scientific and technological strategies driving human microbiome R&D and successful human microbiome 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
Industry is facing an innovation crisis. In 2015, Pharmaceutical Research and Manufacturers of America (PhRMA) members invested a massive $58.8 billion into drug research. With the average cost of developing a new drug estimated at $2.6 billion, and in 2016 new drug approvals falling to a six year low, new R&D approaches are urgently needed.
In Europe, LBPs are not new products. Some strains were registered nationally as medicinal products in the 1950s and 1960s and the products are still on the market with valid national drug marketing authorizations. However, the extension of such marketing authorization at the EU level is compromised as the products are not registered to the Common Technical Document (CTD) and the marketing authorization dossiers have to be updated.
By 2027, Top revenue earning biotherapeutics may include Ritter Pharmaceuticals' RP-G28 and 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 & Diagnostics, 2nd Ed.: 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 & Diagnostics, 2nd Ed.: Pipeline Analysis and Market Outlook’ includes:
- 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 2027?
- How much revenue will the key leading diagnostic pipeline candidates reach by 2027?
- What lessons can investors learn from key pivotal pipeline biotherapeutic and diagnostic candidates?
TABLE OF CONTENTS
1. EXECUTIVE SUMMARY
- 1.1. Scope of Microbiome Therapeutics and Diagnotics
- 1.2. Methodology of Microbiome Therapeutics & 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
- 2.4.2. Human Microbiome Biotherapeutics
- 2.4.3. Human Microbiome Diagnostics
- 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. Atherosclerosis
- 3.4. Autism
- 3.5. Cancer
- 3.6. Chronic Obstructive Pulmonary Disease (COPD)
- 3.7. Clostridium Difficile Infection
- 3.8. Depression & Anxiety
- 3.9. Diabetes
- 3.10. Inflammatory Bowel Disease (IBD)
- 3.11. Malnutrion
- 3.12. Obesity
- 3.13. Preterm Birth
- 3.14. Rheumatoid Arthritis
- 3.15. Urinary Tract Infection (UTI)
4. SCIENTIFIC & 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 & 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)
- 5.2.3. Lack of European Regulation
- 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. AO Biome LLC
- 6.2. Assembly Biosciences
- 6.3. C3J Therapeutics Inc.
- 6.4. Enterome Biosciences S.A.
- 6.5. Finch Therapeutics
- 6.6. Metabiomics
- 6.7. Metabogen AB
- 6.8. Microbiome Therapeutics LLC
- 6.9. Osel Inc.
- 6.10. Rebiotix Inc.
- 6.11. Ritter Pharmaceuticals Inc.
- 6.12. Second Genome Inc.
- 6.13. Seres Therapeutics Inc.
- 6.14. Synlogic Inc.
- 6.15. Synthetic Biologics Inc.
- 6.16. Vithera Pharmaceuticals Inc.
- 6.17. Vedanta Biosciences
- 6.18. Janssen Research and Development LLC
- 6.19. Nestle Health Science S.A.
- 6.20. Pfizer Inc.
- 6.21. PennCHOP Microbiome Program
- 6.22. University of Michigan's Host Microbiome Initiative
7. THE HUMAN MICROBIOME BIOTHERAPEUTICS PIPELINE: KEY CLINICAL CANDIDATES
- 7.1. Intrexion/Merck's AG013
- 7.2. C3J Therapeutics' C16G2
- 7.3. Osel's Lactin-V
- 7.4. Ritter Pharmaceuticals' RP-G28
- 7.5. Rebiotix's RBX2660
- 7.6. Seres Therapeutics/Nestle Health Science's SER-109
- 7.7. Seres Therapeutics' SER-287
- 7.8. Synthetic Biologics' SYN-010
- 7.9. Synthetic Biologics' SYN-004(Ribaxamase)
8. THE HUMAN MICROBIOME DIAGNOSTICS PIPELINE: KEY PRODUCTS IN DEVELOPMENT
- 8.1. Metabiomics' Colon Polyp & Colon Cancer Test
- 8.2. Origin Sciences' Colorectal Cancer (CRC) Test
- 8.3. Enterome/Nestle Health Science/Abbvie's IBD110
9. THE FUTURE MARKET FOR HUMAN MICROBIOME BIOTHERAPEUTICS & DIAGNOSTICS
- 9.1. Overview
- 9.2. SWOT Analysis for the Human Microbiome Biotherapeutic and Diagnostic Market
- 9.3. Financial Forecast for the Global Human Microbiome Biotherapeutic Market
- 9.4. Financial Forecast for the Global Human Microbiome Diagnostic Market
- 9.5. Financial Forecast for the Global Human Microbiome Market
- 9.6. Conclusion
LIST OF TABLES
- Table 1: Global Prevalence and Drug Market Value of Disease Linked to Human Microbiome R&D
- Table 2: Global Human Microbiome Market Revenue Forecast, 2019 and 2027 ($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: Global Human Microbiome Biotherapeutics Market Revenue Forecast, 2018-2027 ($m)
- Table 8: Global Human Microbiome Diagnostics Market Revenue Forecast, 2018-2027 ($m)
- Table 9: Global Human Microbiome Market Revenue Forecast, 2018-2027 ($bn)
LIST OF FIGURES
- Figure 1: Productivity of the Pharmaceutical Industry 2000-2017
- Figure 2: Key Challenges in Human Microbiome R&D
- Figure 3: Total Global Human Microbiome Market Revenue Forecast, 2019 and 2027 ($bn)
- Figure 4: Pharmaceutical Industry R&D Spend, 2000-2017
- Figure 5: Number of FDA New Drugs Approved, 2000-2017
- Figure 6: Overview of 16s rRNA and WGS Sequencing Techniques
- Figure 7: Single-Cell Sequencing Methods
- Figure 8: Global Prevalence of Lactose Intolerance
- Figure 9: OriCol's Target Sampling Site within the Human Body
- Figure 10: SWOT Analysis for the Human Microbiome Biotherapeutic and Diagnostic Market
- Figure 11: Global Human Microbiome Biotherapeutics Market Revenue Forecast, 2018-2027 ($m)
- Figure 12: Global Human Microbiome Diagnostics Market Revenue Forecast, 2018-2027 ($m)
- Figure 13: Global Human Microbiome Market Revenue Forecast, 2018-2027 ($bn)