Microbiome Therapeutics Market, 2015 - 2030
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. Using microbiome 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 difficile infections (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.
1. Overall, we have identified more than 100 microbiome products, in clinical and preclinical stages, which are being developed as therapeutic interventions for various disease areas. A healthy 27% of the pipeline accounts for molecules in clinical development; of these, majority are in phase II.
2. In addition, we have captured several start-ups and small-sized firms that have taken initiatives in developing innovative microbiome based therapeutics. Notable examples include (in alphabetical order) AOBiome, Avid Biotics, C3 Jian, Da Volterra, OpenBiome, Procarta Biosystems, Rebiotix, Ritter Pharmaceuticals, Quorum Innovations, Seres Therapeutics, Symbiotic Health, Vedanta Biosciences, Xycrobe Therapeutics.
3. Several firms are also developing microbiome related diagnostics and companion diagnostics. Examples include (in alphabetical order) Admera Health, Biocartis, Enterome Bioscience, Human Longevity, Metabiomics, Microbiome Diagnostics, Viomer, Whole Biome.
4. Encouraging clinical results and unexplored opportunities have yielded an intense framework of investment activity with a sizeable number of venture capitalists actively supporting the research. In fact, during 2014 and 2015, there have been investments (equity + debt) of close to USD 0.7 billion.
5. The microbiome therapeutics market is anticipated to grow aggressively with a healthy annual growth rate of 73% between 2015 and 2030. In the longer term, we expect the market to continue to rise steadily with high adoption rates of existing FMTs and emergence of novel microbiome related products.
6. Additional analysis suggests that metabolic disorders and gastrointestinal (GI) disorders are the key therapeutic areas likely to garner a significant proportion of the overall market.
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
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 8 features 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.
Chapter 14 is an appendix, which provides the list of companies and organisations mentioned in the report.
LIST OF COMPANIES AND ORGANISATIONS
The following companies and institutes have been mentioned in this report.
1. 4D Pharma
4. Admera Health
5. Advanced Technology Ventures
6. Advancing Bio
9. APC Microbiome Institute
10. Assembly Biosciences
11. Avid Biotics
13. Baylor College of Medicine
14. Beth Israel Deaconess Medical Center
15. Bill and Melinda Gates Foundation
16. BioAster Technology Research Institute
17. BioBalance Corporation
21. Biomecite Diagnostics
22. Boston Children's Hospital
23. Boston Medical Center
24. Brigham and Women's Hospital
25. Bright Medicine Clinic
26. Broad Institute
27. BTER Foundation
28. C3 Jian
29. Cedars-Sinai Medical Center (CSMC)
30. Center for Disease Control and Prevention
31. Cipac Therapeutics
33. Cleveland Clinic
34. Companion PBx
35. Concorde Medical Group
36. Crohn's and Colitis Foundation of America (CCFA)
37. Commonwealth Scientific and Industrial Research Organisation (CSIRO)
38. Dairy Innovation Australia Limited (DIAL)
39. Da Volterra
42. Defence Advanced Research Projects Agency (DARPA)
44. Duke University
45. Enso Ventures
47. Enterome BioScience
49. Epiva Therapeutics
50. Evelo Therapeutics
51. Evolve Biosystems
53. ExeGi Pharma
54. Center for Biologics Evaluation and Research (CBER)
55. Flagship Ventures
56. Food and Agricultural Organisation (FAO)
57. FUJIFILM Diosynth Biotechnologies
59. Genetic Analysis
61. GMU Microbiome Analysis Center (MBAC)
62. GT Biologics
63. Gustave Roussy
64. Hadassah Medical Center
65. Hospital Oberndorf
66. Human Longevity
67. Hy Laboratories
68. Institute of Cardio metabolism and Nutrition (ICAN)
69. Igen Biotech Group
70. Illumina Accelerator
71. Immune Biologics
73. Indiana University
75. Inocucor Technologies
76. INRA National Institute for Agronomic Research
78. Institut De Recherche Pour Le Developent (IRD)
79. Institut Merieux
80. Institute for Biomedical Research Dr JosepTrueta of Girona
81. International Agency for Research on Cancer (IARC)
82. J. Craig Venter Institute
84. Johnson & Johnson Innovation Center
85. Kindstar Global
86. KOLU POHAKU TECHNOLOGIES (KPT)
87. Lille Teaching Hospital (CHRU)
88. Lundbeckfond Ventures
89. MaaT Pharma
90. Macau University of Science and Technology
91. Manzo Pharmaceuticals
93. Mayo Clinic
95. Medical University Innsbruck
101. Metrodora Therapeutics
103. Microbiome Diagnostics
104. MicroBiome Therapeutics
105. Microbiota Company
107. Miyarisan Pharmaceutical
108. Monarch Labs
109. Monash University
110. MonterFiore Medical Research Center of Connecticut
113. National Center for Health Statistics (NCHS)
114. National Health Service (NHS)
115. National Institute of Allergic and Infectious Diseases (NIAID)
116. National Institute of Health (NIH)
117. NIZO Food Research
119. OmniBiome Therapeutics
120. One Way Liver
122. OptiBiotix Health
126. Pasteur Institute
128. Pivot Bio
129. Prev AbR
130. Procarta Biosystems
132. Quorum Innovations
134. Ritter Pharmaceuticals
135. Rush University Medical Center
136. Second Genome
137. Sen Nuo Wei Biotechnology
138. Seres Therapeutics
142. Shoreline Biome
143. Sigma-Tau Pharmaceuticals
148. Symbiotix Biotherapies
150. Synthetic Biologics
152. Therapeutic Solutions International
153. TriPhase Pharmaceuticals
154. Universal Stabilisation Technologies
155. Universite Pierre Et Marie Curie (UPMC)
156. University of California, San Diego (UCSD)
157. University of Chicago
158. University of Guelph
159. University of Maryland (UM) Ventures
160. University of Rome Tor Vergata
161. University of Virginia
162. UAS Labs
164. Vedanta Biosciences
165. Virginia Commonwealth University
166. ViroPharma Incorporated
167. Vithera Pharmaceuticals
168. VSL Pharmaceuticals
169. Washington University School of Medicine
170. Wavepoint Ventures
171. Weizmann Institute
172. Whole Biome
173. World Gastroenterology Organisation (WGO)
174. World Health Organisation (WHO)
175. Wyss Institute
176. Xycrobe Therapeutics
177. Yakult Honsha