This report provides a comprehensive overview of the size of the microbiome therapeutic and diagnostic market, segmentation of the market (Gastrointestinal, Metabolic, Cancer, Neurological, Autoimmune, Skin), key players and the potential of therapies that are in clinical trials. Kelly Scientific analysis indicates that the global microbiome therapeutic and diagnostic market is worth $1.13 billion in 2018 and will grow at a CAGR of 19.03% over five years to $2.7 billion in 2023. The majority of the market will be dominated by microbiome based therapeutics, with an estimate of x%, compared to x% in microbiome diagnostics.
This report describes the evolution of such a prospective market in eight chapters supported by over 82 tables and figures in 165 pages.
• An overview of the human microbiome space that includes how the market is sub-divided into therapeutics (prebiotics, probiotics, fecal microbiota transplantation, small molecules) and diagnostics.
• Global microbiome market, global breakdown, application breakdown and leading market players
• Detailed account of the microbiome industry market by geography, indication and company profiles
• Profiles, pipeline products, financial analysis and business strategy of the major companies in this space
• Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for microbiome therapeutics and diagnostics
• Insight into the challenges faced by stakeholders
• Insight into the biobanking industry globally and its impact on the overall market
• Description and data for the prevalence of disease types that are addressed by harnessing the human microbiota
• Financial market forecast through 2023 with CAGR values of all market segments outlined in the objective
• SWOT analysis of the global market
• Geographical analysis and challenges within key topographies including North America, Europe, Asia/Pacific, Middle East/Africa, ROW
The global microbiome therapeutic and diagnostic market is worth $1.13 billion in 2018 and will grow at a CAGR of 19.03% over five years to $2.7 billion in 2023. The majority of the market will be dominated by microbiome based therapeutics, with an estimate of x%, compared to x% in microbiome diagnostics. Therefore, the global microbiome therapeutics market is worth $x billion in 2018, compared to $x billion in the diagnostic space. By 2023, therapeutics will grow to $x billion, and diagnostics will grow to $x billion globally. Growth will certainly depend on a number of factors including positive results from clinical trials, continued investment and regulatory strategies.
Our analysis indicates that North America holds the lions share of the microbiome therapeutic and diagnostic market in 2018 at $x million. This compares to $x million in Europe, $x million in Asia Pacific, and $x million in the Middle East. By 2023, North America will continue to dominate the market, with a revenue of $x billion, compared to $x million in Europe, $x million in Asia Pacific, and $x million in the Middle East.
Market Applications & Therapeutic Areas
Our Analysis has identified six key therapeutic areas that the microbiome therapeutic and diagnostic market is sub-divided into, namely:
• Skin Disorders
The gastrointestinal therapeutic market is the most dominant, demanding $x million in revenue in 2018, which will rise to $x million by 2023. This is mainly due to disease states such as Clostridium difficile infection, Crohn’s disease, ulcerative colitis and gastroenteritis. As mentioned throughout our report, this is the key area for active clinical trials and impending drug launches. This area currently demands x% of the overall market and will tend to dominate this space for the foreseeable future. The gastrointestinal diagnostic market is currently worth $x million and is set to reach $x million by 2023.
Second to this, metabolic therapeutics has a x% market share and in 2018 is worth $x million, and will hit $x million by 2023. The corresponding diagnostic market is currently worth about $x million, which will increase to $x million by 2023. The main indications within this field include diabetes, obesity and non alcoholic liver disease.
The microbiome cancer therapeutics market is currently worth $x million, or x% of the total market. Our analysis indicate that this will rise to $x million in 2023 and remain in third place behind metabolic and gastrointestinal disorders. The corresponding diagnostic submarket is currently worth $x million, which is set to grow to $x million in 2023.
The neurological market includes dominant indications such as Alzheimer’s, Parkinson’s, depression, anxiety disorders and autism. In 2018, the therapeutic submarket is worth $x million, with a x% share in the total market. This is set to increase to $x million by 2023. The neurological microbiome diagnostic market is currently worth $x million, which will increase to over $x million by 2023.
Autoimmune disorders such as multiple sclerosis currently demand $x million in the microbiome therapeutics market, which will increase to $x million by 2023. The smaller diagnostic market is currently worth $x million, and will grow to $x million in 2023.
Skin disorders such as acne, dermatitis and psoriasis currently have about x% share in the overall microbiome market, and the therapeutics area is worth $x million in 2018. This is set to rise to $x million by 2023. The corresponding diagnostics area will hit $x million in 2023, from $x million in 2018.
The microbiome field is highly competitive, especially within the inflammatory bowel disease and Clostridium difficile infection therapeutic markets. A wide range of big pharma, biotech, early-stage companies, academic institutions, government agencies and other public and private research organizations are involved in this space.
The main therapeutic competitors within the microbiome industry are as follows:
• Johnson & Johnson
• Novartis International
• Merck & Co.,
• Bristol Myers Squibb
• Seres Therapeutics
• Vedanta Biosciences
• Finch Therapeutics
• Enterome Bioscience
• Second Genome
More specifically, companies involved in C. difficile infection include Actelion Pharmaceutical, Assembly Biosciences, AzurRx, Da Volterra, Pfizer, Merck, Merus, Rebiotix, Sanofi, Seres Therapeutics, Synthetic Biologics and Summit Therapeutics. Companies within the IBS-Constipation market include Ardelyx, Allergan, Ironwood Pharmaceuticals, Synergy Pharmaceuticals, Synthetic Biologics and Takeda. Within the pertussis market GlaxoSmithKline, Mitsubishi Tanabe Pharma Corporation and Sanofi are major players. BioMarin Pharmaceutical, Synthetic Biologics, Codexis and Synlogic are involved in the PKU market.
Within the diagnostic sub-market, the following are the main players:
• Metabiomics - Colon Polyp and Colon Cancer Test
• Origin Sciences - Colorectal Cancer (CRC) Test
• Enterome/AbbVie - IBD110
Key Questions Answered
• What are the Main Microbiome Therapeutics in the Pipeline?
• What are the Main Microbiome Diagnostics in the Pipeline?
• What Key Biologics are in the Pipeline?
• How Many Human Therapeutic and Diagnostic Microbiome Products are in the Pipeline?
• What is the Human Therapeutic Pipeline like by Drug, Company and Stage of Development?
• What Microbiome Therapeutics are in the Clostridium Difficile Infection Pipeline?
• Who are the Major Players in the Therapeutic and Diagnostic Spaces?
• What will the Microbiome Therapeutic Market be Worth in 2023?
• What will the Microbiome Therapeutic Sub-Markets (Gastrointestinal, Metabolic, Cancer, Neurological, Autoimmune, Skin) be Worth in 2023?
• What will the Microbiome Diagnostic Market be Worth in 2023?
• What will the Microbiome Diagnostic Sub-Markets (Gastrointestinal, Metabolic, Cancer, Neurological, Autoimmune, Skin) be Worth in 2023?
• What are the Main Drivers, Threats and Opportunities of these Markets?
• What were the Most Influential Market Deals to Date?
• How Much Venture Capital has Been Invested in the Microbiome Industry?
• What Major Microbiome Companies have Received Investment?
• What Microbiota are Associated with Cancer Development?
• How does Gut Dysbiosis influence the Host Inflammatory Response?
• Is there an Association Between the Development of Diabetes and Our Microbiota?
• How does Clostridium difficile Infection Impact the Microbiome?
• What Host-Microbe Interactions Occur During the Pathogenesis of Dental Caries?
• During Cirrhosis of the Liver, What Brain Dysfunction Occurs Due to Gut Dysbiosis?
• What are the Main Therapeutic Intervention Strategies for Microbiome Dysbiosis
• What Safety Requirements are Needed for Microbiome Therapeutics?
• What Clinical Trials are Investigating Probiotics and Obesity?
• What Clinical Trials are Investigating Probiotics and Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease?
• What Clinical Trials are Investigating Probiotics and Irritable Bowel Syndrome?
• What Clinical Trials are Investigating Probiotics and Obesity?
• How Has the Human Microbiome Project Investigated IBD, Prediabetes and Pregnancy?
• How does the Human Microbiome Differ Between Geographical Areas and Bodily Locations?
Chapter 1 Executive Summary
1.2 Objective of Report
1.3 Executive Summary
1.4 Key Questions Answered
1.5 Data Sources & Methodology
Chapter 2 Microbiome Overview
2.1 Microbiome Overview
2.2 Human Microbiome in Health and Disease
2.2.3 Microbiota Metabolism
2.2.3 Type 2 Diabetes Mellitus
2.2.4 Ulcerative Colitis and Crohn’s Disease
2.2.5 Clostridium Difficile Infection
2.2.6 Lactose Intolerance
2.2.7 CNS Disorders (gut brain axis)
2.2.8 Dental caries
2.2.9 Recurrent Bacterial Vaginosis and Urinary Tract Infection
2.2.10 Skin Diseases
2.2.12 Urea Cycle Disorder
2.2.13 Celiac Disease
2.2.14 Non-alcoholic Steatohepatitis (NASH)
2.2.15 Hepatic Encephalopathy
2.3 Types of Microbiome therapeutics
2.3.2 Live BioTherapeutic Agents (Probiotics)
2.3.3 Fecal Microbiota Transplantation (FMT)
2.3.4 Small Molecules
2.4 Advances in Microbiome Research
2.4.1 MetaHIT Consortium
2.4.2 Human Microbiome Project
2.4.3 Functional Metagenomics
2.4.4 Microbiome Metabolomics
2.4.5 Identifying Microbiome Targets – Enterome EB8018 Case Study
2.5 Geographical Variation of Microbiome Composition
Chapter 3 Human Therapeutic and Diagnostic Pipeline Analysis
3.1 Clostridium Difficile
3.1.1 SER-109 Seres Therapeutics
3.1.2 SER-262 Seres Therapeutics
3.1.3 RBX2660 Rebiotix
3.1.4 VE303 Vedanta Biosciences
3.1.5 IMM-529 Immuron
3.1.6 MET-2 NuBiyota
3.1.7 CP101 Finch Therapeutics
3.1.8 ABI-M101 Assembly Biosciences
3.1.9 CBM-588 Osel
3.1.10 SYN-004 Synthetic Biologics
3.1.11 SYN-006 Synthetic Biologics
3.2 Ulcerative Colitis
3.2.1 FIN-524 Finch Therapeutics
3.2.2 SER-287 Seres Therapeutics
3.2.3 ABI-M201 Assembly Biosciences
3.3 Crohn’s Disease
3.3.1 ABI-M301 Assembly Biosciences
3.3.2 Thetanix 4D Pharma
3.4 Inflammatory Bowel Disease
3.4.1 SER-301 Seres Therapeutics
3.4.2 SGM-1019 Second Genome
3.4.3 Blautix 4D Pharma
3.4.4 SG-2-0776 Second Genome
3.4.5 IBD110 – Enterome/AbbVie
3.5.1 SER-401 Seres Therapeutics
3.5.2 Colon Polyp & Colon Cancer Test - Metabiomics
3.5.3 Colorectal Cancer (CRC) Test – Origin Sciences
3.6 Graft Versus Host Disease
3.6.1 SER-155 Seres Therapeutics
3.7 Urinary Tract Infections
3.7.1 LACTIN-V Osel
3.8 Liver Disease
3.8.1 SGM-1019 Second Genome
3.9.1 SYNB1020 Synlogic
3.9.2 SYNB1618 Synlogic
Chapter 4 Market Analysis & Forecast to 2023
4.1 Market Applications
4.1.1 Clostridium Difficile Infection
4.1.2 Inflammatory Bowel Disease
4.1.3 Ulcerative Colitis
4.1.4 Crohn’s Disease
4.1.5 Liver Disease
4.2 Competitive Landscape
4.3 Market Forecast to 2023
4.3.2 Primary Research, Clinical Trial and Pipeline Trends and Analysis
4.3.3 Revenue Generation from Global Therapeutic and Diagnostic Microbiome Market 2018-2023
4.3.4 Geographical Breakdown Analysis and Forecast to 2023
4.3.5 Therapeutic and Diagnostic Submarket Breakdown By Indication
Chapter 5 Market Drivers, Trends & SWOT Analysis
5.1 Market Drivers & Trends
5.2 Market Threats & Challenges
5.3 Market Opportunities
Chapter 6 Investment and Market Deals
6.1 Public and Private Funding in the Microbiome Space
6.2 Current Market Deals
Chapter 7 Venture Capital and The Microbiome
7.1 How Much Investment Has been Poured into the Microbiome Space in Recent Years?
7.2 What Investment Firms are Interested in the Microbiome Space?
7.3 What Companies are Receiving Funding?
7.4 What Funding Cycles are Emerging in this Space?
Chapter 8 Major Players and Company Profiles
8.1 4D Pharma
8.4 Assembly Biosciences
8.5 Bristol Myers Squibb
8.6 C3J Therapeutics
8.7 Da Volterra
8.9 Finch Therapeutics
8.11 Matrisys Bioscience
8.15 Quorum Innovations
8.17 Second Genome
8.18 Seres Therapeutics
8.20 Synthetic Biologics
8.22 Vedanta Biosciences
List of Exhibits
Exhibit 2.1: Microbiota Associated with Cancer Development
Exhibit 2.2: Gut Microbiota Dysbiosis and the Development of Inflammatory Immune Responses
Exhibit 2.3: Microbiota Metabolites
Exhibit 2.4: Association of Diet and Microbiota with Development of Diabetes
Exhibit 2.5: Dysbiotic Microbiota and Development of the Inflammatory Response Following C. difficile Infection
Exhibit 2.6: Host-Microbe Interactions During the Pathogenesis of Dental Caries
Exhibit 2.7: Brain Dysfunction Due to Altered Microbiota in Cirrhosis
Exhibit 2.8: Therapeutic Intervention Strategies for Microbiome Dysbiosis
Exhibit 2.9: Characteristics of Prebiotics and Probiotics
Exhibit 2.10: Probiotic Safety, Functional and Technological Usability Requirements
Exhibit 2.11: Probiotics Action within the Human Gut
Exhibit 2.12: Clinical Trials Investigating Probiotics and Obesity
Exhibit 2.13: Clinical Trials on Probiotics, Type 2 Diabetes & Non-Alcoholic Fatty Liver Disease
Exhibit 2.14: Clinical Trials Investigating Probiotics and Irritable Bowel Syndrome
Exhibit 2.15: Timeline of Fecal Microbiota Transplantation
Exhibit 2.16: Small Molecules Derived from the Human Microbiota
Exhibit 2.17: Gut IBD Microbiome Analysis by the Human Microbiome Project
Exhibit 2.18: Prediabetes Microbiome Analysis by the Human Microbiome Project
Exhibit 2.19: Pregnancy and Neonate Microbiome Analysis by the Human Microbiome Project
Exhibit 2.20: Metagenomic Analysis of the Gut Microbiome
Exhibit 2.21: Microbiome Metabolomic Applications in Health and Disease
Exhibit 2.22: Metabolites Associated with Microbial and Host metabolism
Exhibit 2.23: Enterome Platform to Study Gut Microbiome in IBD
Exhibit 2.24: Enterome EB8018 Anti-FimH Molecule for the Treatment of IBD
Exhibit 2.25: Global Microbiome Diversity by Geography and Body Area
Exhibit 3.1: Human Therapeutics Microbiome Product Pipeline
Exhibit 3.2: Number of Human Therapeutic and Diagnostic Microbiome Pipeline Products, Globally
Exhibit 3.3: Human Microbiome Therapeutics Pipeline by Drug, Company, Development Stage and Indication
Exhibit 3.4: IMM-529 by Immuron Mechanism of Action
Exhibit 4.1: Microbiome Therapeutics in Clostridium Difficile Infection
Exhibit 4.2.: Microbiome Therapeutic and Diagnostic Major Player Market Share Forecast 2023
Exhibit 4.3: Percentage of PubMed Citations by Microbiome Disease Application
Exhibit 4.4: Percentage of Clinical Trials by Microbiome Disease Application
Exhibit 4.5: Global Therapeutic and Diagnostic Microbiome Market Revenue Forecast 2018-2023
Exhibit 4.6: Current Global Therapeutic and Diagnostic Market Share of Microbiome Market
Exhibit 4.7: Global Therapeutic Microbiome Market Revenue Forecast 2018-2023
Exhibit 4.8: Global Diagnostic Microbiome Market Revenue Forecast 2018-2023
Exhibit 4.9: Geographical Microbiome Market Analysis 2018
Exhibit 4.10: Geographical Microbiome Market Forecast 2023
Exhibit 4.11: Gastrointestinal Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.12: Metabolic Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.13: Cancer Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.14: Neurological Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.15: Autoimmune Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.16: Skin Microbiome Therapeutic Market Forecast to 2023
Exhibit 4.17: Gastrointestinal Microbiome Diagnostic Market Forecast to 2023
Exhibit 4.18: Metabolic Microbiome Diagnostic Market Forecast to 2023
Exhibit 4.19: Cancer Microbiome Diagnostic Market Forecast to 2023
Exhibit 4.20: Neurological Microbiome Diagnostic Market Forecast to 2023
Exhibit 4.21: Autoimmune Microbiome Diagnostic Market Forecast to 2023
Exhibit 4.22: Skin Disorders Microbiome Diagnostic Market Forecast to 2023
Exhibit 5.1: Drivers of the Microbiome Market
Exhibit 5.2: Threats and Challenges of the Microbiome Market
Exhibit 6.1: Current Market Deals in the Microbiome Space
Exhibit 7.1: Total Venture Capital Invested in the Microbiome Space, 2013-2017
Exhibit 7.2: Venture Capital Invested in the Microbiome Space by Therapeutics, Diagnostics, Agriculture and Consumer Products, 2013-2017
Exhibit 7.3: Major Investment Firms and Investment Numbers in the Microbiome Industry by Therapeutics, Diagnostics, Agriculture and Consumer Products, 2010-2017
Exhibit 7.4: Major Microbiome Companies and Investment Received to 2017
Exhibit 7.5: Microbiome Industry Investors and Companies
Exhibit 7.6: Major Microbiome Companies and Investment Received to 2017
Exhibit 7.7: Therapeutic and Diagnostic Microbiome Investments by Funding Cycle 2010-2017
Exhibit 8.1: 4D Pharma Development Pipeline Product Portfolio
Exhibit 8.2: Assembly Biosciences Pipeline Product Pipeline
Exhibit 8.3: Assembly BioSciences R&D Expenditure 2015-2017
Exhibit 8.4: C3J Therapeutics STAMP Platform
Exhibit 8.5: C3J Therapeutics Product Pipeline
Exhibit 8.6: Da Volterra Product Pipeline Portfolio
Exhibit 8.7: Enterome Drug Discovery Platform
Exhibit 8.8: Enterome Product Pipeline
Exhibit 8.9: Osel Pipeline Product Portfolio by Clinical Stage
Exhibit 8.10: Quorum Innovations Product Pipeline Portfolio
Exhibit 8.11: Microbiota Restoration Therapy Application Areas
Exhibit 8.12: Second Genome Product Pipeline Portfolio
Exhibit 8.13: Seres Therapeutics Product Pipeline
Exhibit 8.14: Seres Therapeutics R&D Expenditure 2015-2017
Exhibit 8.15: Synlogic Product Pipeline Portfolio
Exhibit 8.16: Synthetic Biologics Product Pipeline
Exhibit 8.17: Synthetic Biologics R&D Expenditure 2015-2017
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