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Table of Contents
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of Microbiota and Microbiome
3.2.1. Discovery of the Human Microbiome
3.2.2. Functions of the Human Microbiome
3.3. Overview of Gut Flora
3.3.1. Role of Gut Flora in Healthy Individuals
3.3.2. Factors Affecting Gut Flora
3.3.2.1. Antibiotic Consumption
3.3.2.2. Age and Pregnancy
3.3.2.2.1. Mode of Childbirth
3.3.2.2.2. Type of Feeding
3.3.2.2.3. Antibiotic Consumption by Mother
3.3.2.3. Stress-related Factors
3.3.2.4. Dietary Factors
3.3.2.5. Impact of Lifestyle
3.4. The Microbiome and Disease
3.4.1. Cancer
3.4.2. Inflammatory Bowel Disease (IBD)
3.4.3. Obesity
3.4.4. Parkinson’s Disease
3.4.5. Type-II Diabetes
3.4.6. Other Disease Indications
3.5. Impact of Microbiota on Drug Pharmacokinetics
3.6. Impact of Microbiota on Therapeutic Outcomes
3.7. Microbiome Therapeutics
3.7.1. Probiotics
3.7.1.1. Beneficial Bacterial Strains
3.7.1.1.1. Lactobacilli
3.7.1.1.2. Bifidobacteria
3.7.1.1.3. Others
3.7.1.2. Key Therapeutic Areas
3.7.1.2.1. Antibiotic-Associated Diarrhea (AAD)
3.7.1.2.2. Bacterial Vaginosis
3.7.1.2.3. High Blood Pressure
3.7.1.2.4. Hypercholesterolemia
3.7.1.2.5. Infectious Childhood Diarrhea (ICD)
3.7.1.2.6. Inflammatory Bowel Disease (IBD)
3.7.1.2.7. Lactose Intolerance
3.7.1.2.8. Vitamin Production
3.7.1.2.9. Weight Management
3.7.1.3. Side Effects of Probiotics
3.7.2. Prebiotics
3.7.2.1. Sources of Prebiotics
3.7.2.2. Types of Prebiotics
3.7.2.2.1. Fructo-Oligosaccharides (FOS)
3.7.2.2.2. Galacto-Oligosaccharides (GOS)
3.7.2.2.3. Inulin
3.7.2.3. Key Therapeutic Areas
3.7.2.3.1. Antibiotic Associated Diarrhea (AAD)
3.7.2.3.2. Constipation
3.7.2.3.3. Gastrointestinal Disorders
3.7.2.3.4. Dysbiosis
3.7.2.4. Side Effects of Prebiotics
3.8. The Human Microbiome Project (HMP)
3.8.1. Project Approach
3.8.2. Project Initiatives
3.8.3. Project Achievements
3.9. Regulatory Guidelines for Live Biotherapeutic Products (LBPs)
3.10. Key Challenges in the Development of Microbiome Therapeutics
3.11. Future Perspectives
4. MICROBIOME THERAPEUTICS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Microbiome Therapeutics: Clinical Pipeline
4.2.1. Analysis by Phase of Development
4.2.2. Analysis by Type of Molecule
4.2.3. Analysis by Type of Therapy
4.2.4. Analysis by Target Indication
4.2.5. Analysis by Therapeutic Area
4.2.6. Analysis by Dosing Frequency
4.2.7. Analysis by Route of Administration
4.2.8. Analysis by Drug Formulation
4.3. Microbiome Therapeutics: Early-Stage Pipeline
4.3.1. Analysis by Phase of Development
4.3.2. Analysis by Type of Molecule
4.3.3. Analysis by Type of Therapy
4.3.4. Analysis by Target Indication
4.3.5. Analysis by Therapeutic Area
4.4. Microbiome Therapeutics: List of Drug Developers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Location of Headquarters
4.4.3. Analysis by Company Size
4.4.4. Analysis by Company Size and Location of Headquarters
4.4.5. Leading Drug Developers: Analysis by Number of Microbiome Therapeutics
4.5. Grid Analysis: Microbiome and Key Therapeutic Areas
4.6. Microbiome Therapeutics: List of Discontinued Drugs
4.7. Emerging Role of Microbiome in Gut-Brain Axis
4.8. Microbiome Therapeutics: List of Technology Platforms
5. COMPANY AND DRUG PROFILES
5.1. Chapter Overview
5.2. 4D Pharma
5.2.1. Company Overview
5.2.2. Microbiome-based Product Portfolio
5.2.2.1. Blautix®
5.2.2.1.1. Drug Overview
5.2.2.1.2. Current Status of Development
5.2.2.1.3. Clinical Studies
5.2.2.1.4. Clinical Trial End-Point Analysis
5.2.3. Recent Developments and Future Outlook
5.3. Armata Pharmaceuticals
5.3.1. Company Overview
5.3.2. Microbiome-Based Product Portfolio
5.3.2.1. C16G2
5.3.2.1.1. Drug Overview
5.3.2.1.2. Current Status of Development
5.3.2.1.3. Clinical Studies
5.3.2.1.4. Clinical Trial End-Point Analysis
5.3.3. Recent Developments and Future Outlook
5.4. Evelo Biosciences
5.4.1. Company Overview
5.4.2. Microbiome-Based Product Portfolio
5.4.2.1. EDP1503
5.4.2.1.1. Drug Overview
5.4.2.1.2. Current Status of Development
5.4.2.1.3. Clinical Studies
5.4.2.1.4. Clinical Trial End-Point Analysis
5.4.3. Recent Developments and Future Outlook
5.5. Rebiotix (Acquired by Ferring Pharmaceuticals)
5.5.1. Company Overview
5.5.2. Financial Information
5.5.3. Microbiome-Based Product Portfolio
5.5.3.1. RBX2660
5.5.3.1.1. Drug Overview
5.5.3.1.2. Current Status of Development
5.5.3.1.3. Clinical Studies
5.5.3.1.4. Clinical Trial End-Point Analysis
5.5.4. Recent Developments and Future Outlook
5.6. Seres Therapeutics
5.6.1. Company Overview
5.6.2. Financial Information
5.6.3. Microbiome-Based Product Portfolio
5.6.3.1. SER-109
5.6.3.1.1. Drug Overview
5.6.3.1.2. Current Status of Development
5.6.3.1.3. Clinical Studies
5.6.3.1.4. Clinical Trial End-Point Analysis
5.6.3.2. SER-287
5.6.3.2.1. Current Status of Development
5.6.3.2.3. Clinical Studies
5.6.3.2.4. Clinical Trial End-Point Analysis
5.6.4. Recent Developments and Future Outlook
5.7. Vedant
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