As a path has opened for human-derived fat, which had been entirely incinerated as medical waste, to be used in developing pharmaceuticals and medical devices, Korea's regenerative medicine industry is at a turning point.
The bio and medical communities say that as the foundation for securing key raw materials for regenerative medicine expands, competition to develop next-generation skin boosters (procedures or products that inject active ingredients into the skin to improve elasticity and hydration) and tissue regeneration products will intensify.
According to the National Assembly and the medical community on the 13th, the National Assembly last month passed an amendment to the Wastes Control Act allowing the medical reuse of human-derived fat.
Previously, only placentas could be reused for medical purposes, but now, under standards set by presidential decree, there is a legal basis to use human-derived fat for research and development of pharmaceuticals and medical devices. The amendment will take effect one year after promulgation.
Observers say the legal revision goes beyond merely changing how medical waste is handled. Human-derived fat contains various biological components used in tissue regeneration, such as ECM, collagen, growth factors, and adipose-derived stem cells (ADSC), making it a key raw material in regenerative medicine and tissue engineering.
This opens the way for fatty tissue, which had been classified as medical waste and mostly incinerated, to be used as a bio material going forward.
In particular, the industry is focusing on the potential shift in the raw material landscape of regenerative medicine due to the legal revision. Until now, domestic ECM-based products have mainly been developed using human-derived acellular dermal matrix (hADM). With a legal basis now in place to use adipose-derived ECM, some expect development of next-generation regenerative medicine materials to accelerate.
The industry expects the legal change to affect the fast-growing skin booster market.
According to Grand View Research, the global skin booster market is projected to grow from $1.7 billion (about 2.6 trillion won) this year at a compound annual rate of 13.1% to $4.1 billion (about 6.2 trillion won) in 2033.
The firm expects the Asia-Pacific region, led by Korea and China, to record the highest growth rate.
In fact, domestic companies are accelerating competition to develop next-generation ECM-based products.
L&C BIO(290650)'s Re2O has taken an early lead in the market, and Hans Biomed(042520) has launched the hADM-based skin booster "Cellrdm." After signing a domestic distribution and sales agreement with Hans Biomed this year, Hugel(145020) recently received approval to establish a tissue bank and began selling Cellrdm, moving to expand its distribution network.
JETEMA(216080) has also introduced the hADM-based skin booster "Adité," strengthening its portfolio centered on regenerative medicine.
L&C BIO is seen as having secured adipose-derived ECM technology ahead of others. The company said it has researched technologies to use adipose tissue for about eight years, developed the human-derived adipose ECM-based regenerative material "MegaAdipoECM," obtained related domestic patents, and filed for a U.S. patent.
In the United States, adipose-derived ECM-based regenerative platforms are being used for soft tissue reconstruction and volume deficit treatment. Renuva, an adipose tissue–derived ECM product, is a representative example.
In Korea, if a market centered on dermis-derived ECM expands to adipose-derived ECM, some expect the growth base of the broader regenerative medicine and aesthetic industries to widen.
However, the amendment merely provides the legal basis to allow the medical reuse of human-derived fat, while details such as eligible materials, uses, and methods are to be defined by presidential decree.
The Ministery of Food and Drug Safety told ChosunBiz in response to an inquiry that it "plans to review management measures after examining safety management cases for human tissue in major countries, including the United States." It also said that for products combining pharmaceuticals, medical devices, and human tissue, it will decide whether to apply the Pharmaceutical Affairs Act or the Medical Devices Act by considering the primary mechanism of action.
The medical community also says that a clearer approval framework is needed, as skin boosters are currently managed under multiple systems, including pharmaceuticals, medical devices, cosmetics, and human tissue.
Kim Beom-jun, a dermatologist at Chung-Ang University Hospital, said, "Global companies are simultaneously securing next-generation raw materials and overhauling systems, while domestic corporations lack a clear approval framework and dedicated guidelines, making it difficult to set investment and development directions."
Kim said, "National-level support for research and development and production infrastructure for next-generation bio raw materials such as recombinant collagen and ECM is needed," adding, "A review system and clinical trial guidelines tailored to skin boosters should also be established."