In the Asia Pacific region, Korea has emerged as a leading player in the microbiome industry, with multiple genome-based companies entering the field in the last three years. The industry has experienced explosive growth, with the number of preclinical and clinical drug candidates increasing from 18 in 2020 to 105 in 2023.

Korea's microbiome therapeutics are receiving increasing attention, particularly as the first-ever Asian Microbiome Connect series is set to bring together microbiome experts from across the Asia-Pacific region in Seoul, Korea from May 17-18.

The microbiome therapeutic industry is particularly appealing due to the fact that microbiomes are naturally present in our bodies, providing a competitive advantage over chemical drugs that may exhibit antibiotic resistance.

These therapeutics can restore the gut microbiome through additive, subtractive, or modulatory methods, addressing diseases that arise from an imbalance in the microbial community. These diseases include but are not limited to diabetes, inflammatory bowel disease (IBD), obesity, autism spectrum disorders, and cancer.

Korean landscape for microbiome therapeutics

The global microbiome therapeutics market gained momentum in 2007 with the launch of the Human Microbiome Project, conducted by the National Institutes of Health (NIH) in the U.S. This groundbreaking project involved characterizing microbial communities at five major body sites.

Microbiome therapeutics were initially developed to address gastrointestinal tract diseases, such as ulcerative colitis and IBD. However, the scope of these therapeutics has since expanded to include a range of other conditions, such as metabolic disorders, diseases related to the gut-brain axis, immune-mediated disorders, and oncological diseases.

Particularly, in 2009, microbiomes as a therapeutic came to light when a published paper showed its effectiveness in treating Clostridium difficile infection (CDI).

A global report published in 2023 by Research and Markets identified the increasing prevalence of IBD as a factor driving the growth of the microbiome market. Some of the major microbiome players pinned by that report were MicroBiome Therapeutics LLC, Seres Therapeutics, Enterome Bioscience, Second Genome, Vedanta Biosciences Inc, and AbbVie.

KoBioLabs, a spin-off from the Microbiome Center at Seoul National University, is credited with starting Korea's microbiome industry around 2014. In 2019, they received approval for the first microbiome phase 1 trial, giving them a head start in the industry. As a result, they are now a leading player with two microbiome drugs in phase 2 clinical trials for psoriasis and IBD, and another one for asthma and atopic dermatitis awaiting phase 2 IND approval.

Genome&Company is another prominent player in Korea's microbiome industry, and they are now challenging KoBioLabs for a leading position. Recently, the company announced its plan to temporarily suspend clinical trials for solid cancers and prioritize GEN-001 for gastric and biliary cancers, which are currently in ongoing phase 2 trials with major players such as Merck, Pfizer, LG Chem, and MSD.

Additionally, other domestic microbiome companies include GI Biome, Macrogen, Liveome, and ImmunoBiome.

Recently, CJ Bioscience also picked up 4D pharma’s microbiome pipeline and aims to gain 10 new drug candidates by 2025.

Overall, Korea seems to be targeting blockbuster drugs in oncology and innovative drugs related to gut-brain access (GBA) in an effort to catch its overseas competitors which had an earlier start.

A recent microbiome investment and industry trends report published earlier this month by the Korea Biotechnology Industry Organization (KoreaBIO) stated that although investor sentiment remains low, there is still interest in the domestic and regional market which is driven by mergers and acquisitions.

In particular, Beiersdorf announced last December that it would acquire a majority stake in skin microbiome company S.Biomedics and Boston-based microbiome company, Holobiome, which acquired AsiaBiome to expand its bacterial strain collection for Asian countries.

In 2021, due to the Covid-19 pandemic, investments in the microbiome industry were focused on infectious diseases. However, in 2022, the oncology field took the lead in investments. 

The report went on say that microbiome-derived therapeutics in 2022 accounted for nearly half of related industry investments, almost tripling from 2021 while fecal microbiota transplants (FMT) funding was significantly reduced, citing regulatory risks due to unclear guidelines for this procedure as the reason.

How microbiome therapies are being used

Microbiomes can be employed either as FMT to transfer fecal bacteria and other microbes from a healthy individual into another individual or as an orally or fecally administered microbiome injected thereapeutic. Currently, both methods are being investigated as combination therapies with immune checkpoint inhibitors to increase its potency. However, they both can also be used as individual treatments as seen with Ferring Pharmaceutical’s recurrent C. difficile infection (rCDI) and several other FMT cases.

FMT therapy has also been applied to ulcerative colitis, Crohn’s disease, Parkinsons’, and sclerosis although none are officially approved. To prevent immune rejection of the recipient against the donor’s microbes, generally, a close relative of the recipient should be selected but unrelated donors are better choices for genetic disorders such as IBD. The success of this approach relies on the microbes being able to take up residence once transferred but immune-compromised patients often exhibit side effects from the stool transfer.

Conversely, as microbiome drugs, Christensenella sp. has shown effectiveness in reducing depression and anxiety, and Akkermansia muciniphila in relieving metabolic disorders as well as protecting against atherosclerosis by reducing gut permeability and preventing inflammation. Likewise, Lactobacillus johnsonii and Bifidobacterium longum can protect against cancer and reduce the severity of Crohn’s disease respectively.

Challenges faced by the microbiom industry

Microbiome therapies can be challenging to develop, as evidenced by the fact that only one therapy, Ferring Pharmaceuticals rCDI, has received FDA approval since the industry first began actively researching microbiome therapeutics in 2007.

One major barrier is the identification of microbes as different microbial strains are suitable for different therapeutic approaches. Thus, properly characterizing microbes based on their functional benefits is required before using them as a treatment.

From a CDMO perspective, Bacthera's Chief Commercial Officer, Felix Faupel, explained that the lack of clear guidelines from regulators creates uncertainties and serves as a significant barrier in the microbiome industry. The absence of established regulations can create obstacles in the development, manufacturing, and approval processes of microbiome therapies.

However, Bacthera’s recent acquisition of 4D Pharma Leon now equips them with multiple years of experience in producing live biotherapeutics (LBPs) to help companies scale up their capacity for microbiome therapeutics, he said.

Locally, HEM Pharma is also a GMP-certified CDMO by the Ministry of Food and Drug Safety (MFDS) operating in the microbiome business.