DUBLIN, October 25, 2016 /PRNewswire/ --

Research and Markets has announced the addition of the "Microbiome Therapeutics and Diagnostics: Pipeline Analysis and Market Outlook" report to their offering.

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.

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.

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.

Key Topics Covered:

1 Executive Summary

2 Introduction To The Human Microbiome

3 Target Diseases Of Human Microbiome R&D

4 Scientific And Technology Strategies Driving Human Microbiome R&D

5 Major Challenges Of Human Microbiome R&D

6 Business Models Of Key Human Microbiome Players

7 Case Studies Of Human Microbiome Biotherapeutics

8 Case Studies Of Human Microbiome Diagnostics

9 The Potential Financial Human Microbiome Biotherapeutic And Diagnostic Market

10 Bibliography

Companies Mentioned

• Abbvie Inc.
• Enterome Biosciences S.A.
• Intrexon
• Janssen Research & Development LLC
• Merck
• Metabiomics Corporate
• Metabogen AB
• Microbiome Therapeutics LLC
• Nestlé Health Science
• Origin Sciences
• Osel Inc.
• Pennchop Microbiome Program
• Pfizer Inc.
• Rebiotix
• Ritter Pharmaceuticals
• Second Genome Inc.
• Seres Therapeutics Inc.
• Synthetic Biologics
• University of Michigan's Host Microbiome Initiative
• Vedanta Biosciences
• Vithera Pharmaceuticals Inc.

For more information about this report visit http://www.researchandmarkets.com/research/9hf5tw/microbiome

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SOURCE Research and Markets