Microbiome refers to the entire genetic information of microorganisms or the microorganisms themselves that exist in a particular environment. Related treatments are under development as they are known to be related to psoriasis, reflux esophagitis, obesity, colitis, and cardiovascular diseases.

Currently, there are 204 microbiome treatments being developed worldwide, and the market size is expected to increase by 167 times from $56.3 million in 2018 to $9.387 billion in 2024.

<Market Outlook for MicrobiomeTherapeutics >

Unit: Million Dollars (billion won)

Source : Human Microbiome Based Drugs and Diagnostics Market(BBC Research, 2017)

In December 2020, the Ministry of Food and Drug Safety has formed a "Microbiome Therapy Productization Support Team" to support the domestic development of microbiome treatments as the development of "microbiome treatments" using high-tech technologies is actively underway worldwide.

The support team will consist of three departments, including preliminary consultation with the Korea Food and Drug Safety Institute, related review departments, and research departments, and will prepare guidelines and licensing criteria such as quality, non-clinical and clinical data requirements considering microbiome characteristics through discussions.

Currently, five items are undergoing phase 3 clinical trials in the U.S. and the U.K. for treatment using microbiome, and one item has been approved for phase 1 clinical trials in Korea.

"We expect the productization support team to advance the development of domestic microbiome drugs to the global market faster," said Kim Kang-lip, head of the Ministry of Food and Drug Safety. "We will establish a scientific and efficient screening system and make various efforts to support domestic drug development in the future."