Regenerative medicine that uses stem cells, which can grow into all human cells, and organ-like organoids is drawing attention as a next-generation medical technology. Regenerative medicine is a medical field that regenerates and restores damaged human functions, and the market leader is Japan. After laying the institutional foundation in 2014, the Japanese government has conducted more than 100,000 cell therapies every year. About 70% of patients are foreigners, including about 20,000 Koreans.
Korea also belatedly established an institutional framework. Under the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act, enacted in 2020, patients with rare and intractable diseases have been able to participate in clinical trials of stem cell and gene therapies. With a legal revision in Feb. this year, the scope was expanded to all diseases, strengthening competitiveness.
Recently, Korean regenerative medicine corporations with technological capability and clinical experience have been steadily entering the Japanese market, raising their profile. They took part in BioJapan 2025, held in Yokohama, Japan, from the 8th to the 10th, to introduce their technologies and explore cooperation with local corporations. BioJapan is Asia's largest bioindustry exhibition, hosted by the Japan Bioindustry Association (JBA).
◇"More than 3,000 stem cell treatments a year in Japan"
Kwon Sin-uk, a director at Total Cell Clinic (TCC) in Japan, said at BioJapan 2025 on the 8th, "Total Cell Clinic is among Japan's top 15 medical institutions, performing more than 3,000 stem cell treatments annually, focusing on cancer, arthritis, and infertility/subfertility treatment," adding, "Following the Tokyo center, we are considering opening in other regions, including Fukuoka." Kwon said participation in the event was to discuss cooperation in stem cell therapy with three Japanese corporations.
Total Cell Clinic is a stem cell–specialized hospital established in Tokyo, Japan, in 2014 by CHA Hospital and CHA Bio Group. Based on the technological capability and infrastructure of CHA Hospital and CHA Bio Group, it obtained a Japanese patent related to immune cell culture and is equipped with a good manufacturing practice (GMP) facility for cell culture and production. More than 10,000 people have received regenerative medicine treatment there to date. It provides immune cell therapy for cancer patients and stem cell therapy for patients with diabetes and chronic pain, and recently has expanded into degenerative arthritis, infertility, atopy, and anti-aging.
Kwon said there has been more than 20 years of on-site experience in regenerative medicine in Japan. In 2000, entry into the medical field came by joining Kanagawa Clinic, Japan's largest dermatologic aesthetic medical institution, as a bilingual Japanese-English staff member. Subsequently, through a connection with Cha Kwang-ryeol, head of the Global Research Institute at CHA Hospital and CHA Bio Group, Kwon served as head of the Japan branch of CHA Hospital and CHA Bio Group and as head of CHA Hospital Japan, and has overseen the operation of Total Cell Clinic since 2021.
Since 2014, Japan has broadly allowed medical institutions to perform cell therapy procedures. That is because after Kyoto University Professor Yamanaka Shinya's induced pluripotent stem cell (iPS cell) research won the Nobel Prize in Physiology or Medicine in 2012, the government declared regenerative medicine "a core pillar of future medicine."
iPS cells are mature cells reverted to an embryonic stem cell state that can grow into all human cells. Embryonic stem cells are obtained from fertilized eggs, but iPS cells are not, avoiding ethical controversy. That makes them favorable for commercialization.
There are as many as 3,100 medical institutions in Japan that provide regenerative medicine. Last year, 150,000 people received stem cell treatment. While Korea limits stem cell treatment to serious and rare diseases, Japan allows procedures not only for serious illnesses such as cancer and diabetes but also for immune enhancement and anti-aging purposes. Treatment costs range widely from several million won per patient to amounts in the 100 million won range. The market size, including related industries, is estimated in the trillions of won.
Kwon said, "If safety and efficacy are proven in the exosome therapy clinical trial currently underway in Korea by CHA Hospital and CHA Bio Group, we plan to expand stem cell therapy to exosome therapy in Japan," adding, "We also see potential for application to treatments for degenerative diseases such as dementia and Parkinson's disease." Exosomes are bio-derived particles that mediate cell-to-cell signaling and are drawing attention as a next-generation therapeutic platform for delivering drugs to specific cells.
◇"Developing organoid therapeutics, considering a Japan subsidiary"
Organoid Science, an organoid regenerative therapeutics specialized corporation founded in 2018 by Cha University Professor Yu Jong-man, is also accelerating its entry into Japan's regenerative medicine market. Organoids are stem cells cultured into a three-dimensional structure similar to an organ. The term is formed by adding the suffix (oid), meaning similar to an organ, and they are also called mini-organs.
In May, the company became the world's first to list on KOSDAQ with organoid-based technology. Chief Technology Officer Lee Kyung-jin (CTO and executive director) said that day, "We have signed a business agreement with SPI, a Sumitomo-affiliated Japanese pharmaceutical distributor, and are discussing local application of organoid technology," adding, "We are also considering establishing a Japan subsidiary within the year."
The company is focusing on developing therapeutics for intractable diseases based on organoid models for each organ, including the intestine, salivary gland, liver, and endometrium. Its lead pipeline, "ATORM-C," is an intestinal organoid. It is a therapeutic candidate that cultures a patient's normal intestinal mucosal tissue collected via endoscopy and injects it into damaged areas. The goal is to treat proctitis and inflammatory bowel disease (IBD).
Organoids have also recently drawn significant attention as a technology to replace animal testing. That is because they are made from human cells and reflect the three-dimensional structure of organs. In April, the U.S. Food and Drug Administration (FDA) announced a plan to gradually phase out animal testing in the early stages of new drug development and introduce new approach methods (NAMs) that use artificial intelligence (AI), human-derived cells, organoids, and other alternatives.
Organoid Science has also developed a service that evaluates drug efficacy using organoids. It has established a joint venture, Podotherapeutics, with Yonsei University Severance Hospital to provide precision medicine services for immuno-oncology drugs. Launched at Severance Hospital in March, this service assesses anticancer drug sensitivity using a patient's organoids to help tailor individualized treatments.
Lee, the CTO, said, "Japan's regenerative medicine system is ahead of Korea's, but businesses using organoids are still in the early stage," adding, "We will expand cooperation with regenerative medicine research institutions and pharmaceutical companies in Japan to build marketability."