‘The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Mi

1. The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Microbiota Therapies (3rd Edition), 2019-2030 Roots Analysis www.RootsAnalysis.com https://www.rootsanalysis.com/reports/view_document/human-microbiome-market/281.html Roots Analysis - Leaders in Pharmaceutical & Biotechnology Market Research Consulting - Roots Analysis

2. Overview The human body is known to harbor numerous communities of microbes, including both beneficial and harmful species, which are collectively referred to as the microbiota. Likewise, the ecological system of commensal, symbiotic, and perhaps pathogenic microorganisms that reside within a host system is called the microbiome. Research insights, generated primarily from the Human Microbiome Project (2009) and other independent studies, have demonstrated that an imbalance in the microbiome (also known as dysbiosis) may lead to the development of several chronic clinical conditions, including Clostridium difficile infections (CDIs), irritable bowel syndrome (IBS), diabetes, Crohn’s disease and ulcerative colitis. Given the role of the microbiota in both disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, defining a new frontier in the field of medicine. The growing popularity and interest in the therapeutic potential of the microbiome is evident across scientific literature; commonly cited terms in this context include microbiome, microflora, microbiota, fecal microbiota therapy (FMT), microbiome diagnostics, or human microbiome, as observed on the NCBI’s PubMed portal, over the last three years.

4. Scope of the Report ‘The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Microbiota Therapies (3rd Edition), 2019-2030’ 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. 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.

5. 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 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.

6. Contents Chapter Outlines Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state and likely evolution of microbiome therapeutics, diagnostics and FMT therapies market in the short-mid term and long term. Chapter 3 is an introductory chapter that highlights important concepts related to the human microbiome, including a discussion on the role of resident microorganisms in disease development (particularly for conditions caused by an imbalance in the microbiome) and in certain cases, prevention. It presents an elaborate discussion on various functions of the microbiota, emphasizing on the key aspects of the Human Microbiome Project (HMP). Further, the chapter describes the various types of microbiome therapeutics, such as probiotics and prebiotic drugs, which are available / under development. It also provides an overview of the regulatory requirements for live biotherapeutic products (LBPs), in addition to highlighting the challenges associated with the development of microbiome therapeutics.

8. Segmentation Over USD 4 billion (by 2030) financial opportunity within the microbiome therapeutics (Tx) market and diagnostics (Dx) markets, has been analyzed across the following segments: Type of Therapy (Tx) • Prescription Drug • Prebiotics • Probiotics Type of Molecule (Tx) • Small Molecules • Biologics Target Indication (Tx+Dx) • Acne Vulgaris • Atopic Dermatitis • Clostridium difficile Infection • Colorectal Cancer • Crohn’s Disease • Diabetes • Irritable Bowel Syndrome • Lactose Intolerance • Lung Cancer • Nonalcoholic steatohepatitis (NASH) • Obesity • Ulcerative colitis

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