This report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of microbiome-based medical products (including therapeutics, diagnostics and FMTs), over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain.
One of the key objectives of the report was to estimate the existing market size and identify the future opportunity for microbiome therapeutics, diagnostics and FMTs, over the next decade. The research, analyses and insights presented in this report are based on revenue generation trends based on the sales of approved / late stage (estimated) microbiome therapeutics, diagnostic products and FMTs.
The report also features the likely distribution of the current and forecasted opportunity within microbiome therapeutics market across:
[A] type of therapy (prescription drugs, prebiotics, and probiotics)
[B] type of molecule (small molecules and biologics)
[B] therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and oncology)
[C] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies)
[D] key geographical regions (North America, Europe, Asia-Pacific and rest of the world)
In addition to other elements, the study includes:
A detailed assessment of the current market landscape of microbiome therapeutics, providing information on drug / therapy developer(s) (such as year of establishment, location of headquarters and company size), clinical study sponsor(s) or collaborators, phase of development (clinical, preclinical, and discovery stage) of product candidates, type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, and prescription drug), target indication(s), key therapeutic area(s), molecular / biological target (if available), mechanism of action (if available), route of administration, type of drug formulation (tablet, capsule, gel, lotion, cream, ointment, nasal spray and 4+ categories), dosing frequency (reported for clinical candidates only), and information on special drug designations (if any). In addition, the chapter highlights the various technology platforms that are being actively used for the development of microbiome therapeutics.
Elaborate profiles of key players (established after 2005) that are engaged in the development of microbiome therapeutics (which are presently in both preclinical and clinical stages of development); each profile features a brief overview of the company, its financial information (if available), microbiome-based product portfolio, information on advanced stage (phase II and above) pipeline candidates (featuring a drug overview, current status of development, clinical trial information, and clinical trial end-point analysis) and an informed future outlook.
A discussion on the various types of diagnostic tests, specifically highlighting the importance of next-generation sequencing within this field of research, along with [A] a detailed review of the current market landscape of microbiome diagnostic tests, including the information on the developer(s) (such as year of establishment, location of headquarters and company size), stage of development (commercialized and under development), type of sample used (blood, feces, saliva and vaginal swab), target indication(s), key therapeutic area(s), result turnaround time, and purpose of diagnosis, [B] brief profiles of popular diagnostic developers, and [C] an indicative list of screening and profiling test kits, including information on the developer(s) (such as year of establishment, location of headquarters and company size), type of sample used (blood, feces, saliva and vaginal swab), key therapeutic area(s), and result turnaround time.
A review of the historical evolution and other relevant aspects of FMT therapies, including details on the process of donor selection, therapy procedure, route of administration, important clinical guidelines, regulatory guidelines and insurance coverage, along with [A] a detailed assessment of the current market landscape of FMT therapies, providing information on FMT developer(s) (such as year of establishment, location of headquarters and company size), status of development (commercialized, clinical, and preclinical stage), target indication(s), key therapeutic area(s), and route of administration, [B] a geographical clinical trial analysis of ongoing / planned / completed studies of FMTs sponsored by non-industry players, featuring details related to specific FMT therapies and analysis based on relevant parameters, such as the number of registered trials, year of registration, current status, phase of development, study design, type of sponsor(s), target indication(s), key therapeutic area(s), key focus areas, number of patients enrolled and leading non-industry player(s), and [C] information on various stool banks (including year of establishment and location of headquarters), along with brief profiles of the most prominent stool banks located across the globe.
A detailed business portfolio analysis based on an attractiveness and competitiveness (AC) framework, highlighting the current market attractiveness and existing competition across the most popular disease indication(s) for which microbiome therapeutics are under investigation.
An analysis of the varied microbiome-focused initiatives of big pharma players (out of top 20 established pharmaceutical players), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome product developers), along with information on funding, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation of the individual competitiveness of the initiatives of big pharma players based on multiple relevant parameters.
An analysis of the start-ups / small-sized players (established in the last seven years, with less than 50 employees) engaged in the development of microbiome therapeutics and diagnostics, featuring heat map representation based on parameters, such as number of microbiome therapeutics under development, diversity of product portfolio, funding information (including funding amount, number of investors and evolution of investment activity), partnership activity, disease indication(s) being treated and focus therapeutic area(s), and strength of intellectual property portfolio.
An assessment of the most commonly targeted therapeutic indications and details of microbiome-based drugs that are being developed against them, highlighting key epidemiological facts about specific diseases, available methods of diagnosis, and currently available treatment options and their side effects.
An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small-sized companies (established in last seven years, with less than 50 employees) that are focused on developing microbiome therapeutics and diagnostics.
An elaborate discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, along with [A] an indicative list of contract manufacturers, along with details on year of establishment, location of headquarters, company size, scale of operation, facility location and microbiome production capacity, [B] an indicative list of companies with in-house manufacturing facilities for microbiome therapeutics, along with details on year of establishment, location of headquarters, and company size, [C] an indicative list of CROs that currently claim to have the necessary capabilities to offer various research services (such as screening, sequencing, characterization, analytical), along with details on year of establishment, location of headquarters, company size, and service portfolio details, and [D] an insightful Harvey ball analysis of key considerations that need to be taken into account by industry stakeholders while selecting a suitable CMO / CRO partner.
An assessment of the emerging role of big data, highlighting efforts focused on the development and implementation of various algorithms / tools to analyze data generated from microbiome research along with [A] an insightful google trends analysis to demonstrate the rising interest of stakeholders in using big data tools to support microbiome research over the past decade, [B] a list of companies offering big data-related services / tools to support microbiome research, and [C] brief profiles of some of the popular companies that are engaged in this field of research.
An informative case study on the various other applications of microbiome products, such as agriculture, animal health, plant health, food products, featuring a list of nearly 80 products, including probiotic supplements, cosmetics, and over-the-counter (OTC) products that are being used as dietary supplements.
In order to account for the uncertainties associated with the growth of microbiome market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.
Key Topics Covered
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 3.3. Overview of Gut Flora 3.4. The Microbiome and Disease 3.5. Impact of Microbiota on Drug Pharmacokinetics 3.6. Impact of Microbiota on Therapeutic Outcomes 3.7. Microbiome Therapeutics 3.8. The Human Microbiome Project (HMP) 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 4.3. Microbiome Therapeutics: Early-Stage Pipeline 4.4. Microbiome Therapeutics: List of Drug Developers 4.5. Microbiome Therapeutics: List of Discontinued Drugs 4.6. Emerging Role of Microbiome in Gut-Brain Axis 4.7. Microbiome Therapeutics: List of Technology Platforms
5. COMPANY AND DRUG PROFILES 5.1. Chapter Overview 5.2. 4D Pharma 5.3. Armata Pharmaceuticals 5.4. Evelo Biosciences 5.5. Rebiotix (Acquired by Ferring Pharmaceuticals) 5.6. Seres Therapeutics 5.7. Vedanta Biosciences
6. MICROBIOME DIAGNOSTICS: MARKET LANDSCAPE 6.1. Chapter Overview 6.2. Overview of Microbiome Diagnostic Tests 6.3. Microbiome Diagnostic Tests: Marketed and Under Development Products 6.4. Microbiome Diagnostic Tests: List of Diagnostic Developers 6.5. Profiles of Prominent Diagnostic Developers 6.6. Overview of Microbiome Screening / Profiling Tests
7. FECAL MICROBIOTA THERAPY (FMT) 7.1. Chapter Overview 7.2. Introduction to FMT 7.3. Historical Overview 7.4. FMT: Procedure and Clinical Relevance 7.5. Regulatory Guidelines Related to FMT 7.6. Insurance Coverage for FMT 7.7. FMT: Competitive Landscape 7.8. Clinical Trial Analysis (Non-Industry Sponsored) 7.9. Stool Banks
8. ATTRACTIVENESS COMPETITIVENESS (AC) MATRIX 8.1. Chapter Overview 8.2. AC Matrix: An Overview 8.3. AC Matrix: Analytical Methodology 8.4. AC Matrix: Plotting the Information 8.5. AC Matrix: Analyzing the Data 8.6. Concluding Remarks
9. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS 9.1. Chapter Overview 9.2. Scope and Methodology 9.3. Initiatives of Big Pharmaceutical Players 9.4. Benchmark Analysis of Big Pharmaceutical Players
10. START-UP HEALTH INDEXING 10.1. Chapter Overview 10.2. Scope and Methodology 10.3. Benchmark Analysis of Start-ups
12. FUNDING AND INVESTMENT ANALYSIS 12.1. Chapter Overview 12.2. Types of Funding 12.3. Microbiome Therapeutics and Diagnostics: List of Funding and Investments 12.4. Concluding Remarks
13. CONTRACT SERVICES FOR MICROBIOME THERAPEUTICS 13.1. Chapter Overview 13.2. Manufacturing Microbiome Therapeutics 13.3. Microbiome Therapeutics-related R&D 13.4. Key Considerations for Selecting a Suitable CMO / CRO Partner
14. BIG DATA AND MICROBIOME THERAPEUTICS 14.1. Chapter Overview 14.2. Introduction to Big Data 14.3. Internet of Things 14.4. Growing Interest in Big Data: Google Trends Analysis 14.5. Key Application Areas 14.6. Big Data in Microbiome Research 14.7. Big Data Services for Microbiome Research: List of Companies 14.8. Big Data Services for Microbiome Research: Profiles of Key Players
15. MICROBIOME THERAPEUTICS: MARKET FORECAST AND OPPORTUNITY ANALYSIS 15.1. Chapter Overview 15.2. Scope and Limitations 15.3. Forecast Methodology 15.4. Overall Microbiome Therapeutics Market, 2019-2030 15.5. Microbiome Therapeutics Market: Distribution by Leading Therapeutic Products, 2019-2030
16. MICROBIOME DIAGNOSTICS: MARKET FORECAST AND OPPORTUNITY ANALYSIS 16.1. Chapter Overview 16.2. Scope and Limitations 16.3 Forecast Methodology 16.4. Overall Microbiome Diagnostics Market, 2019-2030 16.5. Microbiome Diagnostics Market: Distribution by Target Indications, 2019-2030 16.6. Microbiome Diagnostics Market: Distribution by Therapeutic Areas, 2019-2030 16.7. Microbiome Diagnostics Market: Distribution by Supply Channel, 2019-2030 16.8. Microbiome Diagnostics Market: Distribution by Key Geographical Regions, 2019-2030
18. CASE STUDY: MICROBIOME-BASED PRODUCTS IN OTHER INDUSTRIES 18.1. Chapter Overview 18.2. List of Microbiome Products in Other Industries 18.3. Applications of Microbiome Based Products in Agriculture Industry 18.4. Future Prospects