Over time, the efforts of industry stakeholders and clinical researchers in this domain have led to the discovery of novel therapeutic strategies, including the establishment of a gut-brain axis, involving the human microbiome.
- 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.
The 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
Type of Molecule (Tx)
- Small Molecules
Target Indication (Tx+Dx)
- Acne Vulgaris
- Atopic Dermatitis
- Clostridium difficile Infection
- Colorectal Cancer
- Crohn’s Disease
- Irritable Bowel Syndrome
- Lactose Intolerance
- Lung Cancer
- Nonalcoholic steatohepatitis (NASH)
- Ulcerative colitis
Therapeutic Area (Tx+Dx)
- Autoimmune Disorders
- Dental Disorders
- Digestive and Gastrointestinal Disorders
- Dermatological Disorders
- Infectious Disease
- Metabolic Disorders
Key Geographical Regions (Tx+Dx)
- North America
- Asia-Pacific and Rest of the World
Key Questions Answered
- Who are the leading developers of microbiome therapeutics and diagnostic tests?
- What are the key technology platforms (available / under development) for microbiome-related therapies and diagnostics?
- What are the disease indications against which microbiome-based therapeutics are being evaluated?
- Which companies are targeting gut-brain axis for the development of microbiome therapies?
- Who are the leading (industry and non-industry) players involved in the development of FMT products?
- Who are the key contract research / manufacturing service providers in this domain?
- What is the trend in capital investments in microbiome-related R&D?
- What are the contributions of big pharma players in this domain?
- Which are the popular players offering big data-related services / tools to support microbiome research?
- How is the current and future market opportunity for microbiome-based therapeutics and diagnostics is likely to be distributed across key market segments?
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