Clinical data and industry partnerships have fueled a shift in perception of the microbiome-based therapeutic market from nascent to developing, with GlobalData forecasting the market to be worth $1.554B in 2026. For developers, therapeutic areas of interest include infectious disease, gastrointestinal, dermatology, and oncology, with these segments holding 33.3%, 24.0%, 16.0%, and 13.0% of total pipeline products, respectively. Candidates with a higher number of total pipeline products include Vedanta Biosciences, Mikrobiomik, Kaleido Biosciences, 4D Pharma, Seres Therapeutics, and Galenus Therapeutics. The distribution of clinical trials across therapeutic areas mirrors the pipeline such that infectious disease (32.6%), gastrointestinal (23.8%), dermatology (14.4%), and oncology (12.7%) hold the most trials. While big pharma has generally adopted a cautious approach, several players such as Merck and Co, Takeda, Genentech, Gilead, and Johnson & Johnson are forming selective partnerships with companies in the microbiome space.

Reported successes reinforcing market value include the positive Phase III results attained by Seres Therapeutics’ leading candidate SER-109, which significantly reduced recurrence rates of C. difficile infection. Encouraging clinical data have also been reported by the Ferring-owned microbiome firm Rebiotix as well as major player Finch Therapeutics. However, outcomes from the collaboration between Merck and 4D Pharma have garnered attention as a key value-adding event. When combined with Keytruda, 4D’s candidate MRx0518 managed to exceed the predetermined threshold for disease control rate (DCR) of 10% to obtain 42% in patients refractory to prior immune checkpoint inhibitor (ICI) therapy, with monotherapy data demonstrating single-agent immunomodulation. Aims to further evaluate its lead single-strain live biotherapeutic product in new combinations and in earlier treatment settings are therefore unsurprising, with 4D Pharma reporting a clinical trial collaboration and supply agreement with Merck KGaA and Pfizer for Bavencio.

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Evidently, immune checkpoint inhibitors have revolutionized cancer therapeutics; however, most patients fail to respond to these agents. Merck therefore stands to benefit, as 4D Pharma may provide an avenue to overcome resistance to checkpoint inhibitors, thereby increasing the addressable market; advantageously, live biotherapeutics are anticipated to have a favorable safety profile. Smaller cap microbiome companies will also benefit from having a higher number of industry partnerships relative to competitors. By leveraging the understanding of immunotherapy and the microbiome in disease states, oncology may be an attractive therapeutic area for transforming early-stage research into commercial assets. The most significant requirement for growth is clear demonstration of clinical applications of these microbiome therapeutics, and 4D Pharma has been able to showcase enhancement of cancer therapeutics by utilizing the microbiome. Microbiome companies appear to have followed suit with numerous companies pairing their microbiome assets alongside immunotherapy; 40% of oncology trials for pipeline products utilize microbiome therapeutics and approved checkpoint inhibitors.

Sponsors evaluating these combinations include Enterome, Japanese pharma Osel, 4D Pharma in collaboration with Merck KGaA and Pfizer, US-based Vedanta Biosciences in collaboration with Bristol Myers Squibb, and immuno-oncology-focused Ella Therapeutics. South Korea’s biopharmaceutical venture Genome & Co is in collaborations with Merck, as is University of Texas MD Anderson Cancer Center. Nubiyota’s product MET-4 is also being investigated, sponsored by University Health Network; notably, the company also has collaborations with Takeda across gastrointestinal indications. Most oncology trials for pipeline products do not combine indications across other therapeutic areas (83.3%). There is an observable shift from classic fecal microbiota transplantation (FMT) to investigating varying approaches for leveraging the microbiome, with some players opting for genetically modified microbial strains as opposed to microbial consortia. GlobalData expects approvals of live biotherapeutic products to gain traction once a regulatory framework is laid out within the next two years, with more companies exploring the emerging role of the microbiome in cancer.