With the increasing concept of precision medicine, several scientists have demonstrated interest in the therapeutic manipulation of human microbiome (commonly gut bacteria) for the treatment of a wide range of disease indications
Roots Analysis has announced the addition of “The Human Microbiome Market, (4th Edition) 2022-2035” report to its list of offerings.
The microbiome-based therapies pipeline features six drugs in phase III clinical development, over 200 candidates in other clinical and preclinical stages of development along with more than 60 diagnostics and screening / profiling tests that are commercialized for the detection of various diseases. However, the current microbiome market is driven by the fecal microbiota therapies approved by the FDA, particularly for the recurrent CDI and the commercialized diagnostic tests available to the patients.
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Key Market Insights
Over 230 drug candidates are currently being developed by more than 70 drug developers
Nearly 30% of the pipeline drugs are in clinical phase of development, while more than 150 drugs are in preclinical and discovery stages. Clinical stage drugs are primarily being developed for infectious diseases and digestive disorders, while candidates in preclinical and discovery stages are focused on oncological disorders.
More than 75 diagnostics and screening / profiling test are available / under development
Of these, around 80% of the tests are available in the market, while rest are under development. More than 40 companies are engaged in providing these tests; these are primarily based in North America (45%) and Europe (39%). It is worth highlighting that majority (68%) of the players are small companies.
FMTs are the only commercially available microbiome therapies approved by the FDA
These therapies are primarily used for the treatment of recurrent Clostridium difficile infection (rCDIs). It is worth mentioning that more than 400 trials have been registered for evaluating these therapies for a wide range of indications.
Partnership activity in this domain has increased at a CAGR of 26%, between 2017 and 2021
Maximum number of partnerships were established in 2021, indicating a recent rise in the interest of players engaged in this domain. It is worth highlighting that majority of the deals were R&D agreements, representing over 35% of the total number of partnerships signed in the given time period.
More than USD 1 billion has been invested by both private and public investors, since 2017
Of the total amount invested, over USD 563 million was raised through venture capital financing, representing over 56% of the overall funding activity in this domain. Further, 36 instances of grants / awards were also reported, wherein players collectively raised more than USD 137 million.
Outsourcing has become an integral part of the microbiome and live biotherapeutics development process
Presently, over 25 service providers claim to offer a multitude of contract manufacturing services for microbiome and live bio therapeutic products. It is worth noting that close to 10 firms were established post 2010 and around 45% of the players are located in Europe.
Microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035
As late-stage therapeutics will get approved by the FDA in the foreseen future, the microbiome therapeutics market is likely to grow at an annualized rate of 37% till 2035. It is worth mentioning that microbiome diagnostics is likely to capture 20% of the total microbiome market share by 2035.
Request for Customization: Human Microbiome Market is projected to grow at CAGR of 24% by 2035
Key Questions Answered
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The financial opportunity within the human microbiome therapeutics market has been analyzed across the following segments:
Type of Product
Route of Administration
Type of Formulation
Key Geographical Regions
The financial opportunity within the human microbiome diagnostics and screening / profiling tests market has been analyzed across the following segments:
Key Geographical Regions
The report features inputs from eminent industry stakeholder(s), who were very optimistic concerning the growth of the human microbiome market. It includes detailed transcripts of the discussions held with the senior representatives of the stakeholder firms, including:
The report also includes detailed profiles of the companies (listed below) engaged in developing microbiome therapeutics, diagnostics and screening / profiling test; each profile features an overview of the company, its financial information (if available), details on its product portfolio, recent developments, and an informed future outlook.
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