Over the years, extensive R&D efforts have established the basis for a wide range of microbiome-based therapeutic and diagnostic products, which may cause a paradigm shift in the way healthcare is delivered in the foreseen future
The concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, defining a new frontier in the field of medicine. Despite having captured the interest of several venture capital firms and big pharma players, no microbiome-based therapeutic has been officially approved by an authorized medical product regulator. However, the current development pipeline of microbiome therapeutics has several promising candidates that are likely to result in commercial success stories soon.
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Key Market Insights
260 therapy candidates are currently in different phases of development
Nearly 25% of pipeline drugs are in the clinical phase of development, while the rest are in the preclinical / discovery stage. Interestingly, most of these drugs target digestive and gastrointestinal disorders (20%); this is followed by product candidates intended for treatment of oncological disorders (17%) and infectious diseases (13%).
Over 30 microbiome diagnostic tests are currently available / under development
Around 30% of the abovementioned tests have been commercialized, while the rest are under development. Of the total tests, notable examples of companies that launched a microbiome-based diagnostic solution include (in alphabetical order) ARTPred, Genetic Analysis, Goodgut, Invivo Healthcare, IS-diagnostics, Luxia Scientific and Varinos.
FMTs are the only commercially available microbiome therapy
This therapeutic product is presently indicated for the treatment of recurrent Clostridium difficile infections (rCDIs). Further, non-industry players (such as University of Alberta, The Second Hospital of Nanjing Medical University, University of California and Chinese University of Hong Kong) are making notable contributions in this arena, having been involved in ~200 clinical trials till August 2019.
51% growth in capital investments has been observed since 2015; around 70% investment has come from Venture Capital investors
It is worth noting that more than 80 investors have supported the R&D programs initiated by start-ups focused on microbiome-related products. Well-funded start-ups have initiated product development programs, having invested significant time and effort to explore the applicability of microbiome therapeutics across various indications.
Several big pharma players have microbiome-related initiatives
Leading pharmaceutical companies have actively partnered with smaller business entities to develop capabilities related to microbiome-based therapies / diagnostics. Examples of small ventures that have received support from big pharma players include Assembly Biosciences, Enterome Bioscience, Finch Therapeutics and NuBiyota.
Contract service providers have become an integral part of the microbiome supply chain
Presently, certain firms claim to offer a wide array of contract research / manufacturing services for microbiome therapeutics. Examples of such players include Adare Pharmaceuticals, Biose, Cobra Biologics, CoreBiome, List Biological Laboratories, NIZO, ProDigest, Quay Pharma and Wacker Chemie.
North America and Europe are anticipated to capture over 85% of the market share by 2030
As late stage products are commercialized, the microbiome therapeutics market is likely to grow at an annualized growth rate of over 30%, during the next decade. In addition to North America and Europe, the market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate.
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Key Questions Answered
§ Who are the leading developers of microbiome therapeutics and diagnostic tests?
§ What are the key technology platforms (available / under development) for microbiome-related therapies and diagnostics?
§ What are the disease indications against which microbiome-based therapeutics are being evaluated?
§ Which companies are targeting gut-brain axis for the development of microbiome therapies?
§ Who are the leading (industry and non-industry) players involved in the development of FMT products?
§ Who are the key contract research / manufacturing service providers in this domain?
§ What is the trend in capital investments in microbiome-related R&D?
§ What are the contributions of big pharma players in this domain?
§ Which are the popular players offering big data-related services / tools to support microbiome research?
§ How is the current and future market opportunity for microbiome-based therapeutics and diagnostics is likely to be distributed across key market segments?
The USD 4 billion (by 2030) financial opportunity within the microbiome therapeutics (Tx) market and diagnostics (Dx) markets, has been 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 difficile Infection
§ Colorectal Cancer
§ Crohn’s Disease
§ Irritable Bowel Syndrome
§ Lactose Intolerance
§ Lung Cancer
§ Nonalcoholic steatohepatitis (NASH)
§ Ulcerative colitis
§ Therapeutic Area (Tx+Dx)
§ Autoimmune Disorders
§ Dental Disorders
§ Digestive and Gastrointestinal Disorders
§ Dermatological Disorders
§ Infectious Disease
§ Metabolic Disorders
§ Key Geographical Regions (Tx+Dx)
§ North America
§ Asia-Pacific and Rest of the World
The report features inputs from eminent industry stakeholders, according to whom innovation in microbiome-related research is mostly being driven by start-ups / small-sized companies. The report includes detailed transcripts of discussions held 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 (President and Chief Executive Officer, Rebiotix)
§ Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)
§ Assaf Oron (Chief Business Officer, BiomX)
§ Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra)
§ 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)
§ Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)
§ Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)
§ Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)
The research covers detailed profiles, featuring a brief company overview, its financial information (if available), product portfolio details (such as status of development of pipeline candidates, clinical trial information and analysis of key trial end-points), recent developments and an informed future outlook.
§ 4D Pharma
§ Armata Pharmaceuticals
§ Evelo Biosciences
§ Rebiotix (Acquired by Ferring Pharmaceuticals)
§ Seres Therapeutics
§ Vedanta Biosciences
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