INTRODUCTION The human microbiome remained a largely unexplored area until 2007 when the Human Microbiome Project (HMP) was initiated. The project was undertaken to understand the concept of core human microbiome and its compatibility with the host physiology.
New York, May 02, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Human Microbiome Market : Focus on Therapeutics, Diagnostics and Fecal Microbiota Therapy : Industry Trends and Global Forecasts, 2022-2035" - https://www.reportlinker.com/p06272713/?utm_source=GNW
Further, with the significant advancements in the sequencing methods and analytical techniques, and 40% increase in the non-HMP investments, several microbiome-related studies have been conducted. Research insights generated from the HMP and other studies throw light on the role of gut microbiota in governing the overall health / well-being of an individual, and the pathogenesis of several diseases due to the alteration in the composition of resident gut microbiota. Specifically, the studies suggest that dysbiosis (imbalance of gut bacteria) leads to the development of several chronic conditions, including Clostridium difficile infections (CDIs), Crohn’s disease, irritable bowel disease, ulcerative colitis and diabetes. Given the role of microbiota in disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine. Manipulation of bacteria in the gut emerges to be a potential tool in the treatment of various medical conditions and associated diseases. The ongoing research efforts, focused on targeting and modulating microbiome, have led to the development of treatment options for more than 25 indications. In addition, probiotic therapies with live biotherapeutic products (microbes) are considered to be the most advanced microbiome-based therapies for restoring bacterial symbiosis.
At present, fecal microbiota transplantation (FMT) involving the transfer of complete microbial community from a healthy donor’s feces to recipient via oral (in form of a capsule) or rectal (enema and colonoscopy) is the only FDA-approved microbiome therapy, for the treatment of recurrent CDI. However, several players are engaged in developing prescription drugs modulating human microbiome for the treatment of various gastrointestinal and non-gastrointestinal disorders as well. Further, a number of microbiome diagnostic and screening / profiling tests are commercially available for the detection of different microbiome-related diseases. It is worth mentioning that, owing to the rising interest, a number of start-ups / small firms have established in the past few years and the contributions of big pharma players have fueled the overall growth in this domain. Driven by increasing prevalence of disease indications, promising therapeutic potential of microbiome-based therapies, encouraging clinical trial results and financial support from the investors, the human microbiome therapeutics and diagnostics market is likely to witness substantial growth in the mid to long-term.
SCOPE OF THE REPORT
The ‘The Human Microbiome Market (4th Edition), 2022-2035: Focus on Therapeutics, Diagnostics and Fecal Microbiota Therapies: Distribution by Type of Molecule (Small Molecule and Biologic), Type of Product (Probiotic Drugs and Other Drugs), Target Indication (Bacterial Vaginosis, Diabetes, Gingivitis, Irritable Bowel Syndrome, Leaky Gut Syndrome, Graft Versus Host Disease, Necrotizing Enterocolitis, Primary Hyperoxaluria, recurrent CDI, Trichomoniasis and Vaginal Candidiasis), Therapeutic Areas (Dental Disorders, Digestive and Gastrointestinal Disorders, Infectious Diseases, Metabolic Disorders, Rare Disorders and Others)Route of Administration (Oral and Rectal), Supply Channels (Hospital Pharmacies, Retail Pharmacies and Online Pharmacies) and Key Geographical Regions (North America, Europe and Asia-Pacific): Industry Trends and Global Forecasts’ 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 preclinical and clinical drugs along with information on clinical study sponsor(s) or collaborators, phase of development (clinical, preclinical, and discovery) of product candidates, type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, prescription drug and vaccine), target indication(s), therapeutic area(s), route of administration, type of drug formulation, type of therapy (monotherapy and combination therapy), combination drug (in case of combination therapies), dosing frequency (reported for clinical candidates only), and special drug designations (if any). In addition, the chapter provides details on the companies engaged in the development of microbiome therapeutics, along with information on their year of establishment, company size and location of headquarters.
Elaborate profiles of key players engaged in the development of microbiome therapeutics (which are presently in phase III clinical trials); each profile features a brief overview of the company, its financial information (if available), microbiome-based drug portfolio, information on clinical trial (featuring, current status of development and phase III clinical trial information) and an informed future outlook. In addition, the chapter also features profiles of the players engaged in more than six therapeutic programs, along with a company overview, financial information (if available), drug portfolio and an informed future outlook.
A detailed analysis of completed and ongoing clinical trials of various microbiome therapeutics, based on different parameters, such as trial status, trial registration year, trial status, year-wise trend of completed and recruiting trials, study design, number of patients enrolled. In addition, the chapter highlights, the age group of the patients enrolled, type of sponsor / collaborator, active industry and non-industry players and location of the trials.
An analysis on the various types of diagnostic and screening / profiling tests, specifically highlighting the importance of next-generation sequencing within this field of research, along with detailed review of the current market landscape of microbiome diagnostic and screening / profiling tests, including the information on stage of development (commercialized and under development), type of sample analyzed (blood, feces, saliva and vaginal swab), type of screening technique (gene sequencing, PCR, microarray, ELISA, DNA analysis, drug metabolites and others) target indication(s), key therapeutic area(s) and purpose of diagnosis. The chapter also features information on the diagnostics and screening / profiling test providers(s) along with information on their year of establishment, company size and location of headquarters.
Elaborate profiles of key players engaged in the development of microbiome diagnostics and screening / profiling tests. Each profile features a brief overview of the company, its financial information (if available), diagnostic or screening / profiling test portfolio, recent developments and an informed future outlook.
A review of the historical evolution and other relevant aspects of FMT, including details on the process of donor selection, therapy procedure, route of administration, important clinical guidelines, regulatory guidelines and insurance coverage, along with detailed assessment of the current market landscape of FMT, providing information on various parameters of FMT such as, the status of development (commercialized, clinical, and preclinical stage), target indication(s), key therapeutic area(s), and route of administration. In addition, the chapter includes information on FMT provider(s), along with information on their year of establishment, company size and location of headquarters.
A detailed analysis of completed and ongoing clinical trials of FMT, based on different parameters, such as trial status, trial registration year, trial phase, year-wise trend of completed and recruiting trials, study design, number of patients enrolled. In addition, the chapter highlights age category of the patients enrolled, type of sponsor / collaborator, active industry and non-industry players and location of the trials. Furthermore, the chapter also features 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 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 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).
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 partnerships that have been established since 2017, covering various parameters such as, research and development, clinical trials agreement, merger / acquisition, product development and commercialization agreement and product development and manufacturing agreement of the companies focused on developing microbiome-based therapeutics, diagnostics and FMTs.
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 (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 an indicative list of contract manufacturers, along with details on year of establishment, location of headquarters, company size, scale of operation, type of product manufactured and type of formulation. In addition, the chapter highlights key consideration for selecting a 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 insightful google trends analysis to demonstrate the rising interest of stakeholders in using big data tools to support microbiome research over the past decade. The chapter also features a list of companies offering big data-related services / tools to support microbiome research, and brief profiles of some of the popular companies that are engaged in this field of research.
A case study on 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.
One of the key objectives of the report was to estimate the existing market size and future growth 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 of 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 type of molecule (small molecule and biologics), type of product (probiotic and other drug), target indication (graft versus host disease, necrotizing enterocolitis, primary hyperoxaluria and recurrent CDI ), therapeutic area (digestive and gastrointestinal disorders, infectious diseases and rare disorders), route of administration (oral and rectal), key geographical regions (North America, Europe, Asia-Pacific and rest of the world), leading drug developers, and leading therapeutic products. In addition, it also features the likely distribution of the current and forecasted opportunity within microbiome diagnostics market across target indications (bacterial vaginosis, diabetes, gingivitis, irritable bowel syndrome, leaky gut syndrome, trichomoniasis and vaginal candidiasis), therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and others), supply channel (hospital, retail , and online pharmacies), and key geographical regions (North America, Europe, Asia-Pacific and rest of the world). 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.
The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company / organization names):
Lee Jones (President and Chief Executive Officer, Rebiotix)
Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)
Colleen Cutcliffe (Co-founder and Chief Executive Officer, Pendulum Therapeutics)
Nikole Kimes (Co-founder and Chief Executive Officer, Siolta Therapeutics)
James Burges (Co-founder and Vice President of Innovation, Finch Therapeutics)
JP Benya (Vice President, Operations, Flame Biosciences)
Debbie Pinkston (Former Vice President, Sales and Business Development, List Biological Laboratories)
Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)
Mark Heiman (Chief Scientific Officer and Vice President, Research, Scioto Biosciences)
Alexander Segal (Founder, Stealth Startup)
Assaf Oron (Chief Business Officer, BiomX)
Pierre-Alain Bandinelli (Chief Strategy Officer, Da Volterra)
Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)
Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)
Nicholas Monsul (Co-founder and Chairman, Quorum Innovations)
Charlie Badham (Senior Manager, Corporate Development, 4D Pharma)
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
News releases from company websites
Government policy documents
Industry analysts’ views
While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market trends gathered from various secondary and primary sources of information.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
KEY QUESTIONS ANSWERED
Who are the leading players engaged in the development of microbiome therapeutics?
Which are the key drugs being developed across various stages of development?
Which companies are actively involved in conducting clinical trials for microbiome therapeutics and FMTs?
Who are the leading players engaged in the development of microbiome diagnostics and screening / profiling tests?
What kind of partnership models are commonly adopted by industry stakeholders?
Who are the key investors active in the field of human microbiome therapeutics and diagnostics?
What are the different initiatives undertaken by big pharma players for the development of human microbiome therapeutics in the recent past?
What is the role of various start-ups engaged in the developing human microbiome therapeutics?
Which are the most commonly targeted therapeutic indications for microbiome therapeutics are being developed?
What are the various steps involved in the manufacturing of microbiome therapeutics and what are the key considerations for selecting a CMO / CRO?
What are the various algorithms / tools used to analyze data generated from microbiome research?
How is the current and future opportunity, related to microbiome therapeutics, diagnostics and FMT likely to be distributed across key market segments?
What are the various non-pharma applications of microbiome products?
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