Roots Analysis

Roots Analysis has announced the addition of “Human Microbiome Market, 2019-2030” report to its list of offerings.

Key Market Insights

• Presently, 260 drug candidates are being evaluated in clinical / preclinical stages for the treatment of a wide variety of disease indications; the US has emerged as the major hub for microbiome-based research
• The pipeline features both prebiotic and probiotic drugs, being evaluated across different stages of development; majority of these products are designed for administration via non-invasive routes, such as oral and topical
• Microbiome therapeutics have demonstrated the potential to target a range of therapeutic areas; digestive and GI disorders, oncology, infectious diseases, and metabolic disorders are amongst the prime focus areas
• Over 10 microbiome-focused disease diagnosis tests are already available in the market; several companies claim to have initiatives in this domain based on different sample types and therapeutic areas
• Presently, FMTs are the only commercially available microbiome products for the treatment of recurrent CDIs; in fact, several trials evaluating FMTs, sponsored by non-industry players, have been registered in the past decade
• Over time, well funded start-ups have initiated product development programs, having invested significant time and effort to explore the applicability of microbiome therapeutics across various indications
• Several big pharmaceutical players have partnered with smaller and dedicated microbiome-based therapy / diagnostic developers in order to expand their respective capabilities in this upcoming field of pharmacology
• Contract service providers have become an integral part of microbiome supply chain owing to their technical expertise and ability to overcome existing challenges related to both R&D and production
• Prevalent trends indicate that microbiome drugs and diagnostics market is poised to grow significantly; the forecasted opportunity is anticipated to be distributed across different target indications and regions
• Microbiome therapeutic developers are expected to witness significant momentum, in terms of revenues generation, as multiple late stage molecules for the treatment of different clinical conditions get commercialized

Table of Contents

1. PREFACE
   • Scope of the Report
   • Research Methodology
   • Chapter Outlines
2. EXECUTIVE SUMMARY
4. INTRODUCTION
   • Chapter Overview
   • Concept of Microbiota and Microbiome
     • Discovery of the Human Microbiome
     • Functions of the Human Microbiome
   • Overview of Gut Flora
     • Role of Gut Flora in Healthy Individuals
     • Factors Affecting Gut Flora
       • Antibiotic Consumption
       • Age and Pregnancy
         • Mode of Childbirth
         • Type of Feeding
         • Antibiotic Consumption by Mother
       • Stress-related Factors
       • Dietary Factors
       • Impact of Lifestyle
     • The Microbiome and Disease
       • Cancer
       • Inflammatory Bowel Disease (IBD)
       • Obesity
       • Parkinson’s Disease
       • Type-II Diabetes
       • Other Disease Indications
     • Impact of Microbiota on Drug Pharmacokinetics
     • Impact of Microbiota on Therapeutic Outcomes
     • Microbiome Therapeutics
       • Probiotics
         • Beneficial Bacterial Strains
           • Lactobacilli
           • Bifidobacteria
           • Others
         • Key Therapeutic Areas
           • Antibiotic-Associated Diarrhea (AAD)
           • Bacterial Vaginosis
           • High Blood Pressure
           • Hypercholesterolemia
           • Infectious Childhood Diarrhea (ICD)
           • Inflammatory Bowel Disease (IBD)
           • Lactose Intolerance
           • Vitamin Production
           • Weight Management
         • Side Effects of Probiotics
       • Prebiotics
         • Sources of Prebiotics
         • Types of Prebiotics
           • Fructo-Oligosaccharides (FOS)
           • Galacto-Oligosaccharides (GOS)
           • Inulin
         • Key Therapeutic Areas
           • Antibiotic Associated Diarrhea (AAD)
           • Constipation
           • Gastrointestinal Disorders
           • Dysbiosis
         • Side Effects of Prebiotics
       • The Human Microbiome Project (HMP)
         • Project Approach
         • Project Initiatives
         • Project Achievements
       • Regulatory Guidelines for Live Biotherapeutic Products (LBPs)
       • Key Challenges in the Development of Microbiome Therapeutics
       • Future Perspectives

1. MICROBIOME THERAPEUTICS: MARKET LANDSCAPE
   • Chapter Overview
   • Microbiome Therapeutics: Clinical Pipeline
     • Analysis by Phase of Development
     • Analysis by Type of Molecule
     • Analysis by Type of Therapy
     • Analysis by Target Indication
     • Analysis by Therapeutic Area
     • Analysis by Dosing Frequency
     • Analysis by Route of Administration
     • Analysis by Drug Formulation
   • Microbiome Therapeutics: Early-Stage Pipeline
     • Analysis by Phase of Development
     • Analysis by Type of Molecule
     • Analysis by Type of Therapy
     • Analysis by Target Indication
     • Analysis by Therapeutic Area
   • Microbiome Therapeutics: List of Drug Developers
     • Analysis by Year of Establishment
     • Analysis by Location of Headquarters
     • Analysis by Company Size
     • Analysis by Company Size and Location of Headquarters
     • Leading Drug Developers: Analysis by Number of Microbiome Therapeutics
   • Grid Analysis: Microbiome and Key Therapeutic Areas
   • Microbiome Therapeutics: List of Discontinued Drugs
   • Emerging Role of Microbiome in Gut-Brain Axis
   • Microbiome Therapeutics: List of Technology Platforms
2. COMPANY AND DRUG PROFILES
   • Chapter Overview
   • 4D Pharma
     • Company Overview
     • Microbiome-based Product Portfolio
       • Blautix®
         • Drug Overview
         • Current Status of Development
         • Clinical Studies
         • Clinical Trial End-Point Analysis
       • Recent Developments and Future Outlook
     • Armata Pharmaceuticals
       • Company Overview
       • Microbiome-Based Product Portfolio
         • C16G2
           • Drug Overview
           • Current Status of Development
           • Clinical Studies
           • Clinical Trial End-Point Analysis
         • Recent Developments and Future Outlook
       • Evelo Biosciences
         • Company Overview
         • Microbiome-Based Product Portfolio
           • EDP1503
             • Drug Overview
             • Current Status of Development
             • Clinical Studies
             • Clinical Trial End-Point Analysis
           • Recent Developments and Future Outlook
         • Rebiotix (Acquired by Ferring Pharmaceuticals)
           • Company Overview
           • Financial Information
           • Microbiome-Based Product Portfolio
             • RBX2660
               • Drug Overview
               • Current Status of Development
               • Clinical Studies
               • Clinical Trial End-Point Analysis
             • Recent Developments and Future Outlook
           • Seres Therapeutics
             • Company Overview
             • Financial Information
             • Microbiome-Based Product Portfolio
               • SER-109
                 • Drug Overview
                 • Current Status of Development
                 • Clinical Studies
                 • Clinical Trial End-Point Analysis
               • SER-287
                 • Current Status of Development
                 • Clinical Studies
                 • Clinical Trial End-Point Analysis
               • Recent Developments and Future Outlook
             • Vedanta Biosciences
               • Company Overview
               • Microbiome-Based Product Portfolio
                 • VE303
                   • Drug Overview
                   • Current Status of Development
                   • Clinical Studies

5.7.3.1.4. Clinical Trial End-Point Analysis

• Recent Developments and Future Outlook

1. MICROBIOME DIAGNOSTICS: MARKET LANDSCAPE
   • Chapter Overview
   • Overview of Microbiome Diagnostic Tests
   • Microbiome Diagnostic Tests: Marketed and Under Development Products
     • Analysis by Stage of Development
     • Analysis by Type of Sample Required
     • Analysis by Target Indication
     • Analysis by Therapeutic Area
     • Analysis by Purpose
   • Microbiome Diagnostic Tests: List of Diagnostic Developers
     • Analysis by Year of Establishment
     • Analysis by Location of Headquarters
     • Analysis by Company Size
     • Analysis by Company Size and Location of Headquarters
     • Leading Diagnostic Developers: Analysis by Number of Microbiome Diagnostics
   • Profiles of Prominent Diagnostic Developers
     • Enterome Bioscience
       • Company Overview
       • Service Portfolio
     • Vaiomer
       • Company Overview
       • Service Portfolio
     • Overview of Microbiome Screening / Profiling Tests
       • List of Microbiome Screening / Profiling Tests
       • List of Microbiome Screening / Profiling Test Developers

1. FECAL MICROBIOTA THERAPY (FMT)
   • Chapter Overview
   • Introduction to FMT
   • Historical Overview
   • FMT: Procedure and Clinical Relevance
     • Donor Selection
     • Administration Procedure
     • Routes of Administration
     • Consequences and Adverse Events
     • Clinical Guidelines Associated with FMT
   • Regulatory Guidelines Related to FMT
   • Insurance Coverage for FMT
   • FMT: Competitive Landscape
     • Marketed / Development Pipeline (Industry Players)
       • Analysis by Phase of Development
       • Analysis by Therapeutic Area
       • Analysis by Route of Administration
     • List of Developers (Industry Players)
       • Analysis by Year of Establishment
       • Analysis by Location of Headquarters
       • Analysis by Company Size
     • Clinical Trial Analysis (Non-Industry Sponsored)
       • Scope and Methodology
       • List of Clinical Trials
         • Analysis by Trial Registration Year
         • Analysis by Trial Status
         • Analysis by Phase of Development
         • Analysis by Patients Enrolled
         • Analysis of Number of Patients Enrolled by Trial Registration Year
         • Analysis by Therapeutic Area
         • Analysis by Popular Target Indications
         • Analysis by Trial Registration Year and Recruitment Status
         • Analysis by Study Design
         • Leading Non-Industry Players: Analysis by Number of Trials
         • Geographical Analysis by Number of Clinical Trials
         • Geographical Analysis by Enrolled Patient Population
         • Analysis by Type of Sponsor / Collaborator
         • Analysis by Trial Focus
         • Key Clinical Trials
       • Stool Banks
         • Introduction to Stool Banks
         • List of Stool Banks
         • Profiles of Prominent Stool Banks
           • AdvancingBio
             • Overview
             • Fecal Microbiota Preparation
           • Asia Microbiota bank
             • Overview
             • Fecal Microbiota Preparation
           • Enterobiotix
             • Overview
             • Fecal Microbiota Preparation
           • Flora Medicine
             • Overview
             • Fecal Microbiota Preparation
           • OpenBiome
             • Overview
             • Fecal Microbiota Preparation

1. ATTRACTIVENESS COMPETITIVENESS (AC) MATRIX
   • Chapter Overview
   • AC Matrix: An Overview
     • Strong Opportunity Areas
     • Average Opportunity Areas
     • Weak Opportunity Areas
   • AC Matrix: Analytical Methodology
   • AC Matrix: Plotting the Information
   • AC Matrix: Analyzing the Data
     • Strong Opportunity Areas
     • Average Opportunity Areas
     • Weak Opportunity Areas

1. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS
   • Chapter Overview
   • Scope and Methodology
   • Initiatives of Big Pharmaceutical Players
     • Analysis by Portfolio Diversity
     • Analysis by Phase of Development
     • Analysis by Type of Molecule
     • Analysis by Type of Therapy
     • Analysis by Diversity of Therapeutic Areas
   • Benchmark Analysis of Big Pharmaceutical Players
     • Spider Web Analysis: Company A
     • Spider Web Analysis: Company B
     • Spider Web Analysis: Company C
     • Spider Web Analysis: Company D
     • Spider Web Analysis: Company E
     • Spider Web Analysis: Company F
     • Spider Web Analysis: Company G
     • Spider Web Analysis: Company H
     • Spider Web Analysis: Company I
     • Spider Web Analysis: Company J
     • Spider Web Analysis: Company K
   • START-UP HEALTH INDEXING
     • Chapter Overview
     • Scope and Methodology
     • Benchmark Analysis of Start-ups
       • Benchmark Analysis by Portfolio Diversity
       • Benchmark Analysis by Phase of Development
       • Benchmark Analysis by Diversity in Therapeutic Areas
       • Benchmark Analysis by Funding Amount
       • Benchmark Analysis by Number of Investors
       • Benchmark Analysis by Progression in Funding
       • Benchmark Analysis by Partnership Activity
       • Benchmark Analysis by Patent Portfolio
       • Start-up Health Indexing: Roots Analysis Perspective
         • Short Profiles of Top Five Players
           • Evelo Biosciences
           • AOBiome Therapuetics
           • SFA Therapeutics
           • Azitra
           • Axial Biotherapeutics
         • KEY THERAPEUTIC AREAS
           • Chapter Overview
           • Metabolic Disorders
             • Diabetes
               • Disease Description
               • Associated Health Risks / Complications
               • Epidemiology
               • Disease Diagnosis
               • Current Treatment Options
                 • Insulin Therapies
                 • Non-Insulin Therapies
               • Side Effects of Current Treatment Options
               • Microbiome Therapeutics for Diabetes
             • Lactose Intolerance
               • Disease Description

1.2.2.2.    Epidemiology

• Current Treatment Options
• Microbiome Therapeutics for Lactose Intolerance

• Nonalcoholic Steatohepatitis (NASH)
  • Disease Description
  • Epidemiology
  • Current Treatment Options
  • Microbiome Therapeutics for NASH
• Primary Hyperoxaluria
  • Disease Description
  • Epidemiology
  • Current Treatment Options
  • Microbiome Therapeutics for Primary Hyperoxaluria
• Obesity
  • Disease Description
  • Epidemiology
  • Current Treatment Options
  • Side Effects of Current Treatment Options
  • Microbiome Therapeutics for Obesity
• Digestive and Gastrointestinal Disorders
  • Crohn’s Disease
    • Disease Description
    • Epidemiology
    • Current Treatment Options
    • Side Effects of Current Treatment Options
    • Microbiome Therapeutics for Crohn’s Disease
  • Irritable Bowel Syndrome (IBS)
    • Disease Description
    • Epidemiology
    • Current Treatment Options
    • Microbiome Therapeutics for IBS
  • Ulcerative Colitis
    • Disease Description
    • Epidemiology
    • Current Treatment Options
    • Side Effects of Current Treatment Options
    • Microbiome Therapeutics for Ulcerative Colitis
  • Oncological Indications
    • Colorectal Cancer
      • Disease Description
      • Epidemiology
      • Current Treatment Options
      • Side Effects of Current Treatments
      • Microbiome Therapeutics for Colorectal Cancer
    • Lung Cancer
      • Disease Description
      • Epidemiology
      • Current Treatment Options
      • Side Effects of Current Treatment Options
      • Microbiome Therapeutics for Lung Cancer
    • Dermatological Disorders
      • Acne Vulgaris
        • Disease Description
        • Epidemiology
        • Current Treatment Options
        • Side Effects of Current Treatment Options
        • Microbiome Therapeutics for Acne Vulgaris
      • Infectious Diseases
        • Clostridium Difficile Infections (CDIs)
          • Description
          • Epidemiology
          • Disease Diagnosis
          • Current Treatment Options
          • Side Effects of Current Treatment Options
          • Microbiome Therapeutics for CDI
        • Bacterial Vaginosis
          • Disease Description
          • Epidemiology
          • Current Treatment Options
          • Side Effects of Current Treatment Options
          • Microbiome Therapeutics for Bacterial Vaginosis
        • FUNDING AND INVESTMENT ANALYSIS
          • Chapter Overview
          • Types of Funding
          • Microbiome Therapeutics and Diagnostics: List of Funding and Investments
            • Analysis by Number of Instances
            • Analysis by Amount Invested
            • Analysis by Type of Funding
            • Analysis by Type of Company
            • Analysis by Purpose of Funding
            • Analysis by Type of Molecule
            • Analysis by Target Indication
            • Analysis by Therapeutic Area
            • Analysis by Geography
            • Most Active Players
            • Most Active Investors
            • Analysis by Type of Investors
            • Analysis by Location of Investors
          • Concluding Remarks
        • CONTRACT SERVICES FOR MICROBIOME THERAPEUTICS
          • Chapter Overview
          • Manufacturing Microbiome Therapeutics
            • Key Steps Involved
            • Associated Challenges
            • Growing Demand for Contract Manufacturing Services
            • Contract Manufacturing Organizations (CMOs)
              • Introduction to Contract Manufacturing
              • List of Organizations Offering Services for Microbiome Therapeutics
            • In-House Manufacturers
              • Introduction to In-House Manufacturing
              • List of In-House Manufacturers
            • Microbiome Therapeutics-related R&D
              • Growing Demand for Contract Research Services
              • Contract Research Organizations (CROs)
                • Introduction to Contract Research
                • List of Organizations Offering Services for Microbiome Therapeutics
              • Key Considerations for Selecting a Suitable CMO / CRO Partner
            • BIG DATA AND MICROBIOME THERAPEUTICS
              • Chapter Overview
              • Introduction to Big Data
              • Internet of Things
              • Growing Interest in Big Data: Google Trends Analysis
              • Key Application Areas
              • Big Data in Microbiome Research
                • Microbiome Data and Personalized Medicine
                • Microbiome-related Data Management Challenges
                • National Microbiome Data Center
              • Big Data Services for Microbiome Research: List of Companies
              • Big Data Services for Microbiome Research: Profiles of Key Players
                • Human Longevity
                  • Company Overview
                  • Technology and Service Portfolio
                  • Recent Developments
                • Resilient Biotics
                  • Company Overview
                  • Technology and Service Portfolio
                  • Recent Developments
                • Resphera Biosciences
                  • Company Overview
                  • Technology and Service Portfolio
                • MICROBIOME THERAPEUTICS: MARKET FORECAST AND OPPORTUNITY ANALYSIS
                  • Chapter Overview
                  • Scope and Limitations
                  • Forecast Methodology
                  • Overall Microbiome Therapeutics Market, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Type of Therapy, 2025 and 2030
                      • Microbiome Therapeutics Market for Prescription Drugs, 2019-2030
                      • Microbiome Therapeutics Market for Prebiotic Drugs, 2019-2030
                      • Microbiome Therapeutics Market for Probiotic Drugs, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Type of Molecule, 2025 and 2030
                      • Microbiome Therapeutics Market for Small Molecules, 2019-2030
                      • Microbiome Therapeutics Market for Biologics, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Target Indication, 2025 and 2030
                      • Microbiome Therapeutics Market for Acne Vulgaris, 2019-2030
                      • Microbiome Therapeutics Market for Atopic Dermatitis, 2019-2030
                      • Microbiome Therapeutics Market for CDI, 2019-2030
                      • Microbiome Therapeutics Market for Crohn’s Disease, 2019-2030
                      • Microbiome Therapeutics Market for Dental Caries, 2019-2030
                      • Microbiome Therapeutics Market for Diabetes, 2019-2030
                      • Microbiome Therapeutics Market for IBS, 2019-2030
                      • Microbiome Therapeutics Market for Lactose Intolerance, 2019-2030
                      • Microbiome Therapeutics Market for Lung Cancer, 2019-2030
                      • Microbiome Therapeutics Market for NASH, 2019-2030
                      • Microbiome Therapeutics Market for Primary Hyperoxaluria, 2019-2030
                      • Microbiome Therapeutics Market for Psoriasis, 2019-2030
                      • Microbiome Therapeutics Market for Ulcerative Colitis, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Therapeutic Area, 2025 and 2030
                      • Microbiome Therapeutics Market for Autoimmune Disorders, 2019-2030
                      • Microbiome Therapeutics Market for Dental Disorders, 2019-2030
                      • Microbiome Therapeutics Market for Digestive and Gastrointestinal Disorders, 2019-2030
                      • Microbiome Therapeutics Market for Dermatological Disorders, 2019-2030
                      • Microbiome Therapeutics Market for Infectious Diseases, 2019-2030
                      • Microbiome Therapeutics Market for Metabolic Disorders, 2019-2030
                      • Microbiome Therapeutics Market for Oncology, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Key Geographical Regions, 2025 and 2030
                      • Microbiome Therapeutics Market in North America, 2019-2030
                      • Microbiome Therapeutics Market in Europe, 2019-2030
                      • Microbiome Therapeutics Market in Asia-Pacific and Rest of the World, 2019-2030
                    • Microbiome Therapeutics Market: Distribution by Leading Drug Developers, 2025 and 2030
                  • Microbiome Therapeutics Market: Distribution by Leading Therapeutic Products, 2019-2030

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