NEW YORK, Aug. 28, 2017 /PRNewswire/ --
Microbiome therapeutics represent a new frontier in the field of medicine. The human microbiome is characterized by more than 100 trillion commensal, symbiotic and pathogenic microorganisms that colonize the gut, mouth, skin and various other parts of the body. Majority of these microorganisms benefit humans by supplementing them with traits that they do not otherwise possess; these include the capability to metabolize complex carbohydrates and prevention of growth of pathogens. However, some of these microorganisms are pathogenic in nature or have the capability to transform into disease-causing agents. In fact, an imbalance in the human microbiome, or dysbiosis, has been shown to be associated with various diseases, such as Clostridium difficile infections (CDIs), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), diabetes and other chronic conditions.
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In addition to the existing treatment plans for the above mentioned health conditions, approaches related to modifying the natural microbiome of an individual, either by adding / removing individual microbes or entire microbial communities, have been shown to demonstrate significant health benefits. Such therapies offer unique advantages over traditional small molecules or biologics based treatment regimens. In fact, one of the driving forces for developing microbiome therapeutics is to avoid the harmful side-effects of antibiotic therapies; some of these side-effects include disruption of protective / beneficial microbiota and the generation of antibiotic-resistant pathogenic strains.
Currently, there are many probiotics, prebiotics, and medical foods and supplements that are commercially available as over the counter (OTC) products. Such products claim to be capable of preventing a number of diseases by restoring the human microbiome to its natural (normal) state; however, these products cannot be used as a replacement for medication or as a treatment option. At the same time, several drug / therapy candidates that claim to be capable of modifying / manipulating the microbiome in order to provide therapeutic benefits are being developed as prescription drugs. With a rich development pipeline, microbiome therapeutics has managed to capture the interest of several strategic investors and venture capital firms. We believe, if approved, these therapeutics are likely to change the treatment modalities for several indications across GI disorders, metabolic disorders, dermatological indications and inflammatory diseases.
SCOPE OF THE REPORT
The 'Microbiome Therapeutics and Diagnostics Market (2nd Edition), 2017-2030' report provides a comprehensive study on the current landscape and the future outlook of the growing pipeline of products (therapeutics and diagnostics) in this area. The rising popularity and potential within this domain can be correlated with the exponential increase in the number of citations of the term microbiome on PubMed, the popular scientific literature resource; the number increased from 959 citations in 2003 to 33,809 citations in the first half of 2017.
While the field has captured the interest of several companies and investors alike, no approved microbiome drugs are yet available in the market; FMT is currently the only commercially available microbiome based therapy. In addition, a few microbiome diagnostic tests are commercially available for the detection of gastrointestinal (GI) disorders and inflammatory diseases. Having said that, the development pipeline of microbiome therapeutics has several promising candidates that are likely to result in commercial success stories in the foreseen future.
The report is primarily focused on prescription drugs, probiotic drugs and prebiotic drugs, which are being developed in this domain. In addition, we have captured FMT products and screening / diagnostic tests that are already available / under development. During the course of our study, we identified over 170 microbiome therapeutics and close to 25 microbiome diagnostics across various stages of development; majority of the therapeutic products are currently in early phases of development. Amongst other elements, the report features:
- A review of the current status of the market with respect to the microbiome therapeutics pipeline, providing information on the developers, phase of development (clinical, preclinical or discovery stage) of various product candidates, product type, target indication(s) and therapeutic areas. In addition, the report highlights the growing pipeline of microbiome based diagnostics and FMTs.
- An assessment of the emerging role of big data in microbiome therapeutics, highlighting the development and implementation of various algorithms / tools to analyze data generated from research, in order to understand the relationship between the microbiome and the host.
- A discussion on potential target disease indications across popular therapeutic areas including metabolic disorders, GI disorders, oncological diseases, dermatological diseases, inflammatory disorders, and women disorders. It includes detailed disease descriptions, epidemiology, current treatment plans, side effects of current treatment options and upcoming microbiome therapies.
- Elaborate profiles of clinical stage companies (selected based on the number of pipeline products and year of establishment); each profile features an overview of the company, its financial performance, product portfolio, detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and clinical trial results) and a comprehensive future outlook.
- A detailed analysis of the database presented as three schematic representations; a world map depicting the most active geographies in terms of the presence of companies developing microbiome therapeutics, a heat map featuring the distribution of companies on the basis of their location, number of employees and phase of development of pipeline products, and a grid analysis of the microbiome therapeutics pipeline, wherein individual product candidates have been compared according to their respective target therapeutic areas and phases of development.
- A social media analysis on the emerging trends and popularity of microbiome therapeutics on the social media platform, Twitter.
- An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, manufacturing and services agreements, and other relevant agreements.
- An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, and capital raised from IPOs and subsequent offerings, received by companies that are focused in this area.
- A detailed discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, featuring information on various players that offer contract manufacturing services, or have in-house manufacturing capabilities, and those that offer other contract services, such as screening, sequencing and characterization of the microbiome, related to microbiome therapeutics.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030. The research, analysis and insights presented in this report include potential sales of FMT therapies, drugs in late stages of development and diagnostics that are already approved, and those that are likely to receive approval in the near future. The base year for the report is 2017. To account for the uncertainties associated with the development of novel therapeutic classes and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base and optimistic tracks of the market's evolution.
The opinions and insights presented in the report were influenced by discussions with senior stakeholders in the industry. These include James Burges (Executive Director, OpenBiome), Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic), Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics), Lee Jones (President and Chief Executive Officer, Rebiotix) and Colleen Cutcliffe (Co-founder and Chief Executive Officer, Whole Biome), JP Benya (Vice President, Business Development, Assembly Biosciences), Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra), Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)and Dr. Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics). 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.
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, medical practice 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 2 provides an executive summary of the insights captured in our research. It offers a high level view on the likely evolution of the microbiome therapeutics market in the short-mid and long term.
Chapter 3 provides a general introduction to the underlying concepts on human microbiota. In addition to reviewing the functions of the microbiota, we have also discussed key aspects of the Human Microbiome Project and the diseases caused by an imbalance in the microbiome. Further, we have discussed the various types of probiotic and prebiotic drugs that are under development. In addition, the chapter provides an overview of the regulatory landscape for live biotherapeutic products (LBPs), which are likely to be approved in the coming years.
Chapter 4 includes information on over 170 product candidates that are currently in different stages of development (both clinical and preclinical / discovery). It features a detailed and comprehensive analysis of the pipeline molecules, highlighting the key therapeutic areas, product type, phases of development, geographical locations of developers, and leading players in the field of microbiome therapeutics.
Chapter 5 provides detailed company and drug profiles of active players (selected based on the number of pipeline products and year of establishment) in the microbiome therapeutics market. Each company profile includes an overview of the company, its financial performance (wherever available) and details of its product portfolio. In addition, we have provided detailed profiles of advanced phase drugs (phase II and above); each drug profile contains information on its clinical development status, clinical trial endpoints and key clinical trial results.
Chapter 6 provides details on the microbiome diagnostics pipeline, featuring a comprehensive analysis of the various types of products that are being developed within this segment of the microbiome market. The chapter also contains brief profiles of various microbiome diagnostics developers covering information, such as technology platforms and products being developed by these companies.
Chapter 7 presents a brief history of FMTs, a review of the current market landscape (in terms of industry pipeline and non-industry clinical studies) of such products, and details on administration procedures and clinical relevance. In addition, the chapter provides an overview of the regulatory landscape related to these therapies. Further, it includes brief profiles on the various stool banks that have been established over the years.
Chapter 8 presents information on the role of big data and its applications in the healthcare industry. Further, the chapter elaborates on the use of big data analytics to understand microbiome consortium and to design microbiome based therapeutics. It also contains brief profiles of companies offering big data services related to microbiome.
Chapter 9 highlights the potential target indications (segregated by therapeutic areas) for microbiome therapeutics that are currently the prime focus of companies developing these drugs. These therapeutic areas include (in alphabetical order) dermatological diseases, GI disorders, inflammatory disorders, metabolic disorders, oncology, and women disorders. The chapter also provides details on disease epidemiology, currently available treatment options for each indication and their likely side effects.
Chapter 10 presents details on various investments and grants received by companies that are focused in this domain. It also includes an analysis of the funding instances that have taken place in the period between 2011 and 2017 (May), highlighting the growing interest of the venture capital community and other strategic investors in this market.
Chapter 11 features an elaborate discussion and analysis of the collaborations and partnerships that have been forged amongst players in this market. We have also discussed the various partnership models and the most common forms of deals / agreements that have been established in the period between 2013 and 2017 (May).
Chapter 12 provides details on various players that offer contract manufacturing services for microbiome based products, or possess the necessary capabilities and infrastructure to manufacture such products in-house. The chapter also provides information on companies that provide other affiliated contract services, such as screening, sequencing and characterization of the microbiome.
Chapter 13 highlights the likely growth of the market of microbiome therapeutics, diagnostics and FMTs from 2017-2030. We have segregated the financial opportunity in this domain by applications (therapeutics, diagnostics and FMTs) product types (probiotic drugs, prebiotic drugs and other drugs), key therapeutic areas, geographies and leading players. The projections related to the market's future are backed by robust data and credible inputs from primary research. Due to the uncertain nature of the market, we have presented three different tracks representing conservative, base and optimistic scenarios of the evolution of the market.
Chapter 14 is a compilation of key insights gathered from the study. It features a schematic representation on a world map, highlighting the key regional hubs driving the research on microbiome therapeutics. Further, we have provided a heat map analysis of the distribution of companies involved in this field, based on their location (continent-wise distribution), number of employees and phase of development of pipeline molecules (clinical and / or preclinical). The chapter also features a comprehensive grid analysis of the various therapeutic product candidates, highlighting their respective target therapeutic areas and phases of development. In addition, the chapter includes a discussion on the emerging trends and the growing popularity of microbiome therapeutics, as observed on the social media platform, Twitter, over the period between January 2013 and June 2017.
Chapter 15 is a summary of the overall report, featuring a list of key takeaways from the research and our independent opinion on the nature and potential of the microbiome therapeutics market.
Chapter 16 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. These include James Burges (Executive Director, OpenBiome), Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic), Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics), Lee Jones (President and Chief Executive Officer, Rebiotix) and Colleen Cutcliffe (Co-founder and Chief Executive Officer, Whole Biome), JP Benya (Vice President, Business Development, Assembly Biosciences), Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra), Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics) and Dr. Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics).
Chapter 17 is an appendix, which provides a list of microbiome based probiotic supplements, medical foods and consumer products.
Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. Close to 67% of the microbiome therapeutic products are in preclinical stage of development while seven products are in advanced stages (phase II/III and above). These include (in alphabetical order) B244 (AOBiome), HOST-G904 (HOST Therabiomics), Oxabact® (OxThera), RBX2660 (Rebiotix), RP-G28 (Ritter Pharmaceuticals), SER-109 (Seres Therapeutics) and SYN-010 (Synthetic Biologics).
2. The innovation in this market is largely driven by smaller players, most of which are start-ups. Some of the start-ups involved in the development of microbiome therapeutics include (in alphabetical order) Axial Biotherapeutics, Azitra, ClostraBio, Evelo Biosciences, HOST Therabiomics, MicroViable Therapeutics and Siolta Therapeutics. In addition, this domain has witnessed the establishment of several university spin-offs; examples include (in alphabetical order), A-mansia (University catholique de Louvain and Wageningen University), Nubiyota (University of Guelph) and Symberix (University of North Carolina).
3. In addition to the start-ups, some large and mid-sized companies are driving the development of microbiome based therapies. Examples of the large and mid-sized companies that are active in this field are (in alphabetical order) Assembly Biosciences, Biose, Igen Biotech, Leadiant Biosciences, Merck, Novartis, OxThera and Seres Therapeutics. Some of the other large pharmaceutical players, such as Johnson & Johnson, Pfizer and Roche, have been actively funding the initiatives of companies engaged in development of microbiome therapeutics.
4. Several industry and non-industry players are contributing to the development of the FMT pipeline. Currently, FMTs are approved for the treatment of recurrent CDI (not responding to standard care). Prominent players that are developing FMTs include OpenBiome, Bright Medicine Clinic and Advancing Bio.
5. Close to 20 microbiome based diagnostics are already available / under development in the market; these are capable of diagnosing IBS and dysbiosis of the gut. Examples of companies that have a diagnostic product available in the market include (in alphabetical order) Genetic Analysis, Genova Diagnostics, IS-diagnostics and Wellmicro. Other prominent players involved in this segment include (in alphabetical order) Enterome bioscience, C3J Therapautics and Vaiomer.
6. Over 115 funding instances to support the development of microbiome therapeutics, diagnostic tests and FMTs have been reported between 2011 and May 2017. 49% of the total investment is in the form of venture capital financing; Seventure Partners has emerged as one of the prominent investors in this domain. In addition, 26% of the funding instances were related to seed, debt financing and grants. In the given period, three companies in this domain went public; these include Seres Therapeutics (2015, USD 139.3 million), Ritter Pharmaceuticals (2015, USD 20 million) and 4D Pharma (2014, USD 27.6 million).
7. Close to 100 partnerships were inked during the period 2013 to May 2017. Of these, approximately 60% were signed for early R&D activities. Other popular types of collaborations in this domain include licensing agreements (product / technology) (14%), followed by mergers and acquisitions (9%). Recent examples of mergers and acquisitions include Mirna Therapeutics (Synlogic, May 2017), Epiva Biosciences (Evelo Sciences, July 2016) and Tucana Health (4D Pharma, April 2016).
8. Overall, the microbiome therapeutics and diagnostics market is anticipated to grow at a healthy pace. Of the total market, the therapeutics segment is expected to occupy a share of close to 79% (in 2030), growing at an annualized growth rate of 84% between 2019 and 2030. As more microbiome therapeutics move to higher phases of development, the combined contribution of probiotic drugs and prebiotic drugs is likely to be close to 48% of the total market. This will be driven by the likely approval of a number of clinical stage products currently in the development pipeline.
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