Roots Analysis has announced the addition of “The Human Microbiome Market, (4^th 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. The human microbiome remained a largely unexplored area until 2007 when the Human Microbiome Project (HMP) was initiated. Given the role of microbiota in disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine. 

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.

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 RD 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 biotherapeutic 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.