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
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)
Type of Molecule (Tx)
Target Indication (Tx+Dx)
Therapeutic Area (Tx+Dx)
Key Geographical Regions (Tx+Dx)
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:
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.
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