LONDON, May 16, 2016 /PRNewswire/ -- INTRODUCTION
The term "microbiota" refers to specific clusters of commensal, symbiotic and pathogenic microorganisms that reside in various regions on and within the human body. The human microbiome is involved in various functions that are essential to lead a healthy life. Majority of the microorganisms benefit humans by supplementing them with traits that they would otherwise not possess. These include metabolism of complex carbohydrates, renewal of gut epithelial cells and prevention of growth of pathogens. However, several microorganisms are associated with pathogenic organisms or have the capability of translating into a disease-causing microbe.In fact, an imbalance in the human flora or dysbiosis is also seen to be associated with several long-term diseases. During dysbiosis, it is observed that with the reducing number of beneficial microbes, there is a concurrent increase in the number of harmful microbes. The increase in the number of pathogenic microbes further leads to the development of several harmful diseases such as inflammatory bowel disease (IBD), cancer, bacterial vaginosis (BV), obesity and chronic fatigue syndrome.
In addition to the existing treatment plans for such health conditions, approaches that modify natural formulations by adding or removing individual microbes or entire microbial communities have been shown to have a significant impact on the health of an individual. Usingmicrobiome as a therapy has unique advantages over traditional small molecules or biologics.It can be used to identify individual therapeutic microorganisms and help in designing the therapies customised to the patient's microbiome. Unlike the adverse effects posed by the prolonged use of drugs such as the antibiotics, microbiome therapeutics have a lower risk of toxicity associated with them. In addition, microbiome based therapies provide a rich source of new biomarkers helping in the classification of the patients into relatively homogeneous subpopulations.
Currently, there are many popular probiotics, prebiotics, medical food and supplements commercially available in the market as OTC products. These products are known to prevent a number of diseases by restoring the human microbiome to its natural state. However, these products cannot be used as a replacement for medication or as a treatment for the eradication of the disease. The overall microbiome therapeutics market is still in its infancy with no approved drugs; Faecal microbial transplant (FMT) is the only microbiome related therapy that has entered the market. With several firms and investors displaying a growing interest in this field, the overall market holds a strong potential in the coming years.
SCOPE OF THE REPORT
The 'Microbiome Therapeutics Market, 2015-2030' report provides a comprehensive study on the current landscape and the future outlook of the evolving pipeline of products in this area. Imbalance in the natural microbiota are a known cause for many chronic diseases such as antibiotic associated diarrhoea (AAD), Clostridium difficileinfections (CDI), irritable bowel syndrome (IBS), diabetes, Crohn's disease and ulcerative colitis. While the field has gathered the interest of several companies, there are no approved microbiome drugs available in the market yet; FMT is the only commercially available therapy. The development pipeline of microbiome therapeutics, though, has several promising candidates that are likely to result in commercial success stories in the foreseen future.
Among other elements, the report also elaborates on new microbiome based diagnostic solutions being developed and the upcoming opportunities in this market for different stakeholders. As pharmaceutical companies continue to initiate and expand their research programs in this area, one of the key objectives outlined for this report was to understand the future potential of the market. This was done by analysing:
- The microbiome therapeutic pipeline in terms of phase of development, type of products and indications.
- The epidemiology, patient population and available treatment plans for the potential therapeutic areas in this field.
- Partnerships that have taken place in the recent past covering research and development collaborations, product development and commercialisation agreements, license agreements, acquisitions and other relevant agreements.
- Various investments and grants received by companies focused in this area.
- The likely adoption of the microbiome therapeutics, the competition posed by the current treatment plans and the expected growth rate over the coming few years.
The study provides a detailed market forecast and opportunity analysis for the short-mid term (2015-2022) and long term (2022-2030). The research, analysis and insights presented in this report include potential sales of FMT therapies and drugs in late stages of development. Our opinions and insights, presented in this study, were influenced by several discussions we conducted with experts in this area. These included senior representatives at Assembly Biosciences, Da Volterra, Metabiomics, MicroBiome Therapeutics and Rebiotix. All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Most of 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 over the coming ten years, 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.
1.1. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the report. It offers a high level view on where the microbiome therapeutics market is headed in the mid to long term.
Chapter 3 provides a general introduction to the underlying concepts on the human microbiota. In addition to reviewing the function of microbiota, we have also discussed key aspects of the human microbiome project and the diseases caused by imbalance in the microbiota. Further, we have highlighted the need for microbiome therapeutics along with a brief description of the existing FMT therapies.
Chapter 4 includes information on over 100 molecules that are currently in different stages of development (both clinical and preclinical/discovery). In this section, we have presented a detailed analysis of the microbiome therapeutics development pipeline including information on the phase of development, indications and the type of products. In addition, the chapter contains details on different microbiome based diagnostics, medical foods and over-the-counter (OTC) supplements that are approved or under development.
Chapter 5 provides information on the various types of probiotic and prebiotic drugs that are being developed as microbiome therapeutics. It features a detailed discussion on their mode of action, range of formulations and the different disease areas likely to benefit from the use of these drugs.
Chapter 6 highlights the promising therapeutic areas for microbiome therapeutics. These indications are the prime focus of companies developing microbiome based drugs. The chapter also highlights the epidemiological facts and currently available treatment options for each indication.These therapeutic areas include gastrointestinal (GI) disorders, inflammatory disorders, metabolic disorders and women disorders.
Chapter 7 presents details on various investments and grants received by companies focused in the area of microbiome therapeutics. The analysis highlights the growing interest of the VC community and other strategic investors in this market.
Chapter 8features an elaborate discussion on the collaborations and partnerships that have been forged amongst players in this market. We have also discussed the various partnership models in existence and the most common forms of deals/agreements that have evolved over time.
Chapter 9 highlights the monetary opportunity presented by these therapies.The analysis highlights the likely evolution of important parameters such as the target patient population and the likely market penetration rates. We have also presented an indicative distribution of the overall market across the well-known therapeutic areas.
Chapter 10 provides detailed company and drug profiles of the leading players in the market. Each profile includes information such as the company's financial performance (wherever available), geographical presence, pipeline of microbiome therapeutics and recent collaborations.
Chapter 11 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 12 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. These include JP Benya (Vice President, Business Development of Assembly Biosciences),Pierre-Alain Bandinelli (Chief Business Officer of Da Volterra), Gregory J. Kuehn (Vice President, Business Development and Marketing of Metabiomics), Dr. Mark Heiman (Vice President of Research and Chief Scientific Officer of MicroBiome Therapeutics) and Lee Jones (President and CEO of Rebiotix).
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter14 is an appendix, which provides the list of companies and organisations mentioned in the report.
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