The Human Microbiome Market (3rd Edition), 2019-2030: Focus on Therapeutics (including Gut-Brain Axis Targeting Drugs), Diagnostics and Fecal Microbiota Therapies
NEW YORK, Jan. 6, 2020 /PRNewswire/ --
INTRODUCTION
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.
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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. Despite the evident increase in interest (of therapy developers and investors alike) in this field of research, there are currently no approved microbiome-based drugs / therapy products available in the market. However, there is a FMT in the market that is designed to modulate the microbial population within the gut for the treatment of recurrent CDIs. This treatment has been shown to be particularly beneficial to those who are non-responsive to standard-of-care therapies. In addition, a number of microbiome diagnostic tests are available for the detection of digestive and gastrointestinal disorders, inflammatory diseases and certain oncological indications. Further, several technology developers have started using next-generation sequencing techniques and other versatile bioinformatics tools for the characterization of important species of gut microflora. It is also worth mentioning that, in the last 4-5 years, there has been a marked rise in the number of new entrants in this field. Interestingly, several big pharma players have also become actively involved in this domain. Given the fact that there are several candidate therapies in late phases of clinical development, the microbiome-based medical products market can be expected to witness substantial growth over the coming decade.
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.
-- 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.
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), [C] target indication (acne vulgaris, atopic dermatitis, CDI, Crohn's disease, diabetes, irritable bowel syndrome, lactose intolerance, nonalcoholic steatohepatitis (NASH), ulcerative colitis, and 5+ categories), [D] therapeutic area (autoimmune disorders, dental disorders, digestive and gastrointestinal disorders, dermatological disorders, infectious diseases, metabolic disorders, oncology, and others), [E] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world), [G] leading drug developers, and [H] leading therapeutic products. In addition, it also features the likely distribution of the current and forecasted opportunity within microbiome diagnostics market across [A] target indication (Crohn's disease, colorectal cancer, diabetes, irritable bowel syndrome, lung cancer, NASH, obesity, and ulcerative colitis), [B] therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and oncology), [C] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), and [D] 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, Whole Biome)
-- Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics)
-- James Burges (Executive Director, OpenBiome)
-- JP Benya (Vice President, Business Development, Assembly Biosciences)
-- Debbie Pinkston (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, MicroBiome Therapeutics)
-- Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)
-- Assaf Oron (Chief Business Officer, BiomX)
-- Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra)
-- Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)
-- Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)
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.
RESEARCH METHODOLOGY
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 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
-- Annual reports
-- Investor presentations
-- SEC filings
-- Industry databases
-- News releases from company websites
-- Government policy documents
-- Industry analysts' views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
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.
Chapter 4 includes information on 260 microbiome therapeutics that are currently being evaluated in different stages of development (both clinical and preclinical / discovery). It features a comprehensive analysis of pipeline molecules based on their phases of development (clinical, preclinical, and discovery stage), 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 designation (if any). Further, the chapter provides information on drug developer(s), highlighting their year of establishment, location of headquarters and company size. It also highlights the various microbiome therapeutics that have been discontinued over the last few years. In addition, the chapter highlights the various technology platforms that are being actively used for the development of microbiome therapeutics.
Chapter 5 features detailed profiles of key players (established after 2005) that are engaged in the development of three or more microbiome therapeutics in both preclinical and clinical stages of development, with at least one candidate in the late stages of development (phase II and above). 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.
Chapter 6 features a discussion on the various types of diagnostic tests, specifically highlighting the importance of next-generation sequencing within this field of research. Further, it includes information on over 30 microbiome diagnostic tests that are currently available / under development, along with 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. It also includes brief profiles of the popular diagnostic developers that are engaged in the development of four or more diagnostic tests. Additionally, it includes 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.
Chapter 7 presents an elaborate discussion on the historical evolution and other relevant aspects of FMT therapies, including details on the process of donor selection, procedure, route of administration, clinical guidelines, regulatory guidelines and insurance coverage. Further, it highlights the present scenario of FMT therapies, along with [A] a detailed assessment of the current market landscape of FMT therapies, providing information on industry 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 the 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.
Chapter 8 features an insightful analysis of top indications, across various therapeutic areas under investigation, based on the 9-box AC matrix framework. It further includes a discussion on the relative market attractiveness and existing competition across the most popular disease indication(s). The purpose of the analysis is to enable companies to analyze their product portfolio, develop informed growth strategies (with regard to indications), and also make decisions related to developing products for the top indications.
Chapter 9 highlights the efforts of the top 11 big pharma players engaged in the field of microbiome therapeutics and diagnostics. It features 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.
Chapter 10 presents the detailed analysis of 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. It includes a heat map analysis 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.
Chapter 11 presents an elaborate discussion on the most commonly targeted therapeutic indications and brief descriptions of the microbiome-based drugs that are being developed against them. It highlights the key epidemiological facts about the specific diseases, available methods of diagnosis, and currently available treatment options and their side effects.
Chapter 12 presents details on various investments received by start-ups / small-sized companies (established in the last seven years, with less than 50 employees) that are focused on developing microbiome therapeutics and diagnostics. It also includes an analysis of the funding instances that have taken place in the market, up to 2019 (till October), highlighting the growing interest of the venture capital (VC) community and other strategic investors within this domain.
Chapter 13 feature an elaborate discussion on the various steps involved in the development and manufacturing of microbiome therapeutics. Further, the chapter includes [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 their year of establishment, location of headquarters, company size, and [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. Additionally, it includes an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a suitable CMO / CRO partner.
Chapter 14 presents an assessment of the emerging role of big data, highlighting the development and implementation of various algorithms / tools to analyze data generated from microbiome research, in order to understand the relationship between the microbiome and the host. Further, it features [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.
Chapter 15 features an elaborate market forecast analysis, highlighting the future potential of microbiome therapeutics till 2030. Based on an informed top-down approach, taking into account current and projected performance of the microbiome therapeutics market, it features the likely distribution of the current and forecasted opportunity across [A] type of therapy (prescription drugs, prebiotics, and probiotics), [B] type of molecule (small molecules and biologics), [C] target indication (acne vulgaris, atopic dermatitis, CDI, Crohn's disease, diabetes, irritable bowel syndrome, lactose intolerance, NASH, ulcerative colitis, and 5+ categories), [D] therapeutic area (autoimmune disorders, dental disorders, digestive and gastrointestinal disorders, dermatological disorders, infectious diseases, metabolic disorders, oncology, and others), [E] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world), [G] leading drug developers, and [H] leading therapeutic products. The potential sales forecast of the therapeutic products that are in late stages of development (phase III and above) is based on multiple relevant parameters, such as target consumer segments, region-specific disease prevalence, anticipated adoption of the late stage drugs and likely selling price.
Chapter 16 features a detailed market forecast analysis, highlighting the future potential of microbiome-based diagnostic tests till 2030. Based on multiple parameters, such as target consumer segments, disease prevalence, anticipated adoption of diagnostic tests and price, the analysis provides an informed opinion on the likely distribution of the current and forecasted opportunity across [A] target indication (Crohn's disease, colorectal cancer, diabetes, irritable bowel syndrome, lung cancer, NASH, obesity, and ulcerative colitis), [B] therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and oncology), [C] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), and [D] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). It is worth mentioning that a bottom-up approach was adopted for this analysis, wherein our estimates of the likely size of the microbiome-based diagnostics market were validated using relevant datapoints and inputs from primary research. The chapter features market projections both in terms of value (USD million) and volume (number of diagnostic tests).
Chapter 17 features an informed market forecast analysis, highlighting the future opportunity within the FMT therapies market till 2030, based on parameters, such as the average number of FMT procedures conducted in a year and average cost of approved FMT therapies. It is worth mentioning that the chapter features market projections both in terms of value (USD million) and volume (number of procedures).
Chapter 18 is a case study focused on the other applications of microbiome products, such as in the field of agriculture, animal health, plant health, and food products. It also features a list of nearly 80 microbiome products, including probiotic supplements, medical food products, cosmetics, and OTC products, which are being used as dietary supplements.
Chapter 19 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.
Chapter 20 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with 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, Whole Biome), Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics), James Burges (Executive Director, OpenBiome), JP Benya (Vice President, Business Development, Assembly Biosciences), Debbie Pinkston (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, MicroBiome Therapeutics), Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies), Assaf Oron (Chief Business Officer, BiomX), Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra), Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical), and Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)
Chapter 21 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 22 is an appendix, which contains the list of companies and organizations mentioned in the report.
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