Over the years, extensive R&D efforts haveestablished the basis for a wide range of microbiome-based therapeutic and diagnosticproducts, which may cause a paradigm shift in the way healthcare is delivered inthe foreseen future
Theconcept of microbiome-based therapeutics has generated significant enthusiasmwithin the medical science community, defining a new frontier in the field ofmedicine. Despite having captured the interest of several venture capital firmsand big pharma players, no microbiome-based therapeutic has been officiallyapproved by an authorized medical product regulator. However, the current developmentpipeline of microbiome therapeutics has several promising candidates that arelikely to result in commercial success stories soon.
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260therapy candidates are currently in different phases of development
Nearly25% of pipeline drugs are in the clinical phase of development, while the restare in the preclinical / discovery stage. Interestingly, most of these drugstarget digestive and gastrointestinal disorders (20%); this is followed by productcandidates intended for treatment of oncological disorders (17%) and infectiousdiseases (13%).
Over30 microbiome diagnostic tests are currently available / under development
Around30% of the abovementioned tests have been commercialized, while the rest areunder development. Of the total tests, notable examples of companies that launcheda microbiome-based diagnostic solution include (in alphabetical order)ARTPred, Genetic Analysis, Goodgut, Invivo Healthcare, IS-diagnostics, LuxiaScientific and Varinos.
FMTsare the only commercially available microbiome therapy
Thistherapeutic product is presently indicated for the treatment of recurrent Clostridiumdifficile infections (rCDIs). Further, non-industry players (such asUniversity of Alberta, The Second Hospital of Nanjing Medical University,University of California and Chinese University of Hong Kong) are makingnotable contributions in this arena, having been involved in ~200 clinicaltrials till August 2019.
51%growth in capital investments has been observed since 2015; around 70%investment has come from Venture Capital investors
Itis worth noting that more than 80 investors have supported the R&D programsinitiated by start-ups focused on microbiome-related products. Well-funded start-ups have initiated productdevelopment programs, having invested significant time and effort to explorethe applicability of microbiome therapeutics across various indications.
Severalbig pharma players have microbiome-related initiatives
Leadingpharmaceutical companies have actively partnered with smaller business entitiesto develop capabilities related to microbiome-based therapies / diagnostics. Examplesof small ventures that have received support from big pharma players includeAssembly Biosciences, Enterome Bioscience, Finch Therapeutics and NuBiyota.
Contractservice providers have become an integral part of the microbiome supply chain
Presently,certain firms claim to offer a wide array of contract research / manufacturingservices for microbiome therapeutics. Examples of such players include AdarePharmaceuticals, Biose, Cobra Biologics, CoreBiome, List BiologicalLaboratories, NIZO, ProDigest, Quay Pharma and Wacker Chemie.
NorthAmerica and Europe are anticipated to capture over 85% of the market share by2030
As latestage products are commercialized, the microbiome therapeutics market is likelyto grow at an annualized growth rate of over 30%, during the next decade. Inaddition to North America and Europe, the market in China / broader AsiaPacific region is also anticipated to grow at a relatively faster rate.
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Key Questions Answered
§ Whoare the leading developers of microbiome therapeutics and diagnostic tests?
§ Whatare the key technology platforms (available / under development) for microbiome-relatedtherapies and diagnostics?
§ What are the disease indicationsagainst which microbiome-based therapeutics are being evaluated?
§ Which companies aretargeting gut-brain axis for the development of microbiome therapies?
§ Whoare the leading (industry and non-industry) players involved in the developmentof FMT products?
§ Who are the keycontract research / manufacturing service providers in this domain?
§ Whatis the trend in capital investments in microbiome-related R&D?
§ Whatare the contributions of big pharma players in this domain?
§ Whichare the popular players offering big data-related services / tools to supportmicrobiome research?
§ How is the currentand future market opportunity for microbiome-based therapeutics and diagnosticsis likely to be distributed across key market segments?
The USD 4 billion (by 2030) financial opportunitywithin the microbiome therapeutics (Tx) market and diagnostics (Dx) markets, hasbeen analyzed across the following segments:
§ Type of Therapy (Tx)
§ Prescription Drug
§ Type of Molecule (Tx)
§ Small Molecules
§ Target Indication(Tx+Dx)
§ Acne Vulgaris
§ Atopic Dermatitis
§ Clostridium difficileInfection
§ Colorectal Cancer
§ Crohn’s Disease
§ Irritable BowelSyndrome
§ Lactose Intolerance
§ Lung Cancer
§ Nonalcoholic steatohepatitis(NASH)
§ Ulcerative colitis
§ Therapeutic Area (Tx+Dx)
§ Autoimmune Disorders
§ Dental Disorders
§ Digestive andGastrointestinal Disorders
§ Infectious Disease
§ Metabolic Disorders
§ Key Geographical Regions(Tx+Dx)
§ North America
§ Asia-Pacific and Restof the World
Thereport features inputs from eminent industry stakeholders, according to whom innovationin microbiome-related research is mostly being driven by start-ups /small-sized companies. The report includes detailed transcripts of discussionsheld with the following experts:
§ Veronika Oudova(Co-founder and Chief Executive Officer, S-Biomedic)
§ Colleen Cutcliffe(Co-founder and Chief Executive Officer, Whole Biome)
§ Lee Jones (Presidentand Chief Executive Officer, Rebiotix)
§ Mark Heiman (ChiefScientific Officer and Vice President, Research, MicroBiome Therapeutics)
§ Assaf Oron (ChiefBusiness Officer, BiomX)
§ Pierre-AlainBandinelli (Chief Business Officer, Da Volterra)
§ Nikole E Kimes(Co-founder and Vice President, Siolta Therapeutics)
§ James Burges(Executive Director, OpenBiome)
§ JP Benya (VicePresident, Business Development, Assembly Biosciences)
§ Debbie Pinkston (VicePresident, Sales and Business Development, List Biological Laboratories)
§ Gregory J Kuehn (VicePresident, Business Development and Marketing, Metabiomics)
§ Alexander Segal (VicePresident, Business Development, Universal Stabilization Technologies)
§ Alexander Lin (AssociateGeneral Manager, Chung Mei Pharmaceutical)
§ Aaron Wright (SeniorScientist, Pacific Northwest National Laboratories)
Theresearch covers detailed profiles, featuring a brief company overview, itsfinancial information (if available),product portfolio details (such as status of development of pipeline candidates,clinical trial information and analysis of key trial end-points), recentdevelopments and an informed future outlook.
§ 4D Pharma
§ Evelo Biosciences
§ Rebiotix (Acquired byFerring Pharmaceuticals)
§ Seres Therapeutics
§ Vedanta Biosciences
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