The global microbiome therapeutics market size was estimated at around USD 84.3 million in 2021 and it is projected to hit around USD 973.86 million by 2030, growing at a CAGR of 31.24% from 2022 to 2030
The rise in prevalence of target diseases such as gastrointestinal diseases, diabetes, and immunological indications is anticipated to drive growth. The adoption of fecal microbial transplant and the availability of FMT in form of capsules has enhanced the acceptance of microbiome therapeutics amongst patients with C. difficile infection. Furthermore, increasing R&D investments and government support are anticipated to further drive the market.
FMT has demonstrated a considerable success rate in the treatment of patients with recurrent C. difficile infection. Thus, the growing prevalence of the condition is expected to escalate the demand for microbiome therapies. For instance, as per Therapeutic Advancements in Gastroenterology Journal, in 2022, after initial occurrence, 25-65% of the patients in the U.S. experience recurrent CDI which makes the treatment complex.
There has been increasing demand to understand the human microbiome to be able to transform the potential of the microbiome for use in therapeutics. This has led to an increase in R&D which has been driving the presence of a stronger pipeline in the market. Candidates such as CH-0601, and M-008 are under development for diabetes treatment. Moreover, companies are receiving heightened funding from investors owing to enhanced interest in the field. For instance, in July 2021, Vedanta Biosciences received funding of USD 68 million for phase III development of its product VE303 for high-risk CDI treatment.
Key players operating in the global market are engaged in extensive research to gain an advantage over other players. The companies are engaged in taking efforts to develop and manufacture products to be used for therapies. Numerous products are in the initial stages of trials and are expected to be developed and used in the market. For instance, in 2021, Ferring Pharmaceuticals and Rebiotix announced Phase III data of their candidate RBX2660 for the reduction in recurring C. difficile infection. The candidate further has a fast track, orphan, and breakthrough therapy designations from the FDA.
Scope of The Report
|Market Size in 2021||USD 84.3 million|
|Revenue Forecast by 2030||USD 973.86 million|
|Growth rate from 2022 to 2030||CAGR of 31.24%
|Forecast Period||2022 to 2030|
|Segmentation||Type, application, region
|Companies Covered||OpenBiome; Seres Therapeutics Inc.; 4D Pharma plc.; Locus Biosciences, Inc.; Enterome SA; Finch Therapeutics Group, Inc.; Intralytix, Inc.; Microbiotica; Second Genome; Rebiotix Inc.; Vedanta Bioscience, Inc.|
Fecal microbiota therapy (FMT) dominated the microbiome therapeutics market in 2021 with a share of 100%. The dominance of the segment is attributed to its wide usage in the treatment of C. difficile infection. Moreover, increasing R&D focusing on developments to discover other therapeutic applications of FMT and the introduction of capsules in the market is expected to drive the growth. For instance, in February 2021, new direct testing for SARS-COV-2 was announced by OpenBiome in fecal microbiota therapy preparation which is aimed at increasing the availability of FMT to any scheduled patient for emergency use without infection transmission risk.
Microbiome drugs are expected to expand at the fastest rate over the forecast period attributable to the presence of a robust pipeline and the development of advanced and novel drugs. The majority of drugs are still in the developmental stages. For instance, 4D Pharma plc’s drug, Blautix is under Phase II stage of clinical trials which is a single strain biotherapeutic product, under investigation for the treatment of both IBS-C and IBS-D.
Clostridium difficileinfection (CDI or C. difficile) application segment is projected to expand at the fastest growth rate with a CAGR of 33.82% from 2022 to 2030. The growth of this segment is attributed to the increasing use of Fecal microbiota transplants (FMT) in the treatment of C. difficile. According to a study published in 2020, by the University of Birmingham, FMT is highly accepted for the treatment of patients suffering from Clostridium difficile infections. Further, FMT is more efficient in the treatment of C difficile than an antibiotic, especially in recurrent cases.
Crohn’s disease application segment is expected to show lucrative growth during the forecast period owing to enhanced focus on gut microbial changes in patients with the condition. For instance, as per the Microbiome Journal in 2020, remission of Crohn’s disease can be maintained in patients with the use of fecal microbiota transplantation.
North America dominated the market with the largest market share of 74.22% in 2021. Highly established research facilities for the development of novel therapeutics and increasing target population are the major factors for the dominance of the region. Further, the prevalence of programs such as the Canadian Microbiome Initiative (CMI) in Canada facilitates collaboration with stakeholders and partners. This allows the focusing of research efforts on microbiome therapeutics development. For instance, in July 2021, Biocodex Microbiota Foundation announced a call for proposals for microbiome studies in Canada for over USD 26,000 in research grants. These grants are expected to fuel new developments in the market.
Europe is estimated to demonstrate significant growth during the forecast period. Germany is an emerging market in Europe for microbiome therapeutics. Despite the high cost of microbiome therapeutics, supportive reimbursement policies are expected to facilitate treatment adoption in upcoming years. Furthermore, startups are receiving funding to research and introduce microbiome-based products.
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