[Edaily Reporter Kim Jinsoo ] Competition is intensifying as skin boosters based on human tissue-derived extracellular matrix (ECM) are reshaping the market. With the ECM skin booster market expected to continue growing, securing well-vetted donors is projected to become a key factor in future market competitiveness. Amid ongoing debates over the safety and efficacy of ECM skin boosters, the ability to secure data proving their effectiveness is also expected to be a crucial advantage for surviving the competition.

A Tissue Processing License Is Required to Produce ECM Skin Boosters

According to the pharmaceutical and biotech industry on the 16th, since L&C BIO(290650)launched “Rituo,” the world’s first human-derived (hAMD) ECM skin booster, in 2024, seven companies have released a total of nine ECM skin boosters to date.

Notably, following the launch of “Rituo,” L&C BIO released “Rituo Fine” late last year, featuring smaller particles. L&C BIO plans to launch “Rituo Volume,” a new product focused on improving skin volume, within this year. Following suit, companies such as Iretec Korea are preparing to launch ECM skin boosters, and a series of product launches is expected in the near future.

To produce ECM skin boosters made from human-derived ingredients, it is mandatory to obtain a tissue processing license from the Ministry of Food and Drug Safety. This license is intended to ensure the safe management and transplantation of human tissue, requiring compliance with strict standards for facilities, equipment, personnel, and quality management systems.

Among domestic tissue banks, the following 14 companies are classified as tissue processing operators or tissue importers: △L&C BIO △HANS BIOMED CORPORATION(042520) △Dope △CG Bio △Jin Bio △MS Bio △CELLUMED CO., LTD.(049180) △Puzzle B △Iretec Korea △Regen Bio △Med Park △Allso Tech △Osgen Tissue Bank △KLM Bio. Of these, Osgen Tissue Bank and KLM Bio do not handle skin tissue, so it is estimated that 12 companies are capable of manufacturing ECM skin boosters.

AATB Certification for Donor Sourcing and Quality Control Is a Key Competitive Advantage

As ECM skin boosters establish themselves as a new trend in the cosmetic market and the market experiences rapid growth, a manufacturer’s ability to secure donors is considered a key factor in gaining a competitive edge.

An official from a human tissue company stated, “The most critical factor in the human tissue business is whether a sufficient number of donors can be secured,” adding, “While production capacity is also an issue, securing a steady supply of donors is the greatest challenge; therefore, ‘how this is addressed’ is directly linked to competitiveness in the human tissue market.”

South Korea relies on imports for more than 90% of its demand for human tissue. According to the Ministry of Food and Drug Safety, imported human tissue accounts for 87% of the domestic market. By country, the United States accounts for the largest share of imports, with approximately 430,000 units. Consequently, certification by the American Association of Tissue Banks (AATB)—which operates the world’s largest human tissue donation infrastructure—is a critical factor for ECM skin booster businesses. In South Korea, four companies are known to have received AATB certification: △L&C BIO, △HANS BIOMED CORPORATION, △CG Bio, and △Dope.

The AATB is a nonprofit organization dedicated to ensuring an adequate supply of human tissue. In particular, since the AATB guarantees a certain level of safety and consistent quality for human tissue, a stable tissue supply and strict quality control form the foundation of product trust.

In the United States, consent for use for cosmetic and reconstructive purposes is obtained as early as the donation consent stage, thereby eliminating ethical issues. In Korea, most donated tissues are primarily intended for therapeutic and reconstructive purposes, and it is understood that tissues for which consent for cosmetic use has been obtained are very limited. Therefore, securing AATB-certified tissues is virtually essential in the ECM skin booster market.

Furthermore, human tissue sourced through AATB-certified tissue banks boasts a high level of reliability, having undergone a thorough process ranging from rigorous tracking of the donor’s medical history to strict infection control systems. The AATB adheres to stringent standards based on relevant U.S. Food and Drug Administration (FDA) regulations and its own standards. The AATB uses only tissue that has undergone donor medical history verification and viral testing, and it tracks and manages the entire process.

Enhancing Product Competitiveness Through Verified Safety and Efficacy

As ECM skin boosters gain popularity, some critics point out a lack of clinical research on their safety and efficacy. Consequently, ECM skin booster products with proven safety and efficacy are expected to gain a competitive edge in the future.

Among ECM skin booster manufacturers, L&C BIO and HANS BIOMED CORPORATION can be considered to have already proven the safety and efficacy of their products—MegaDerm and BellaCell HD, respectively—as they utilize a manufacturing process that involves grinding existing skin graft materials. However, both companies are either currently conducting or plan to conduct additional research to further validate the safety and efficacy of their ECM skin boosters.

First, L&C BIO’s “Lituo” has demonstrated its efficacy and safety as a material for actual skin restoration through a study conducted by the Department of Dermatology at Severance Hospital. Specifically, in a 20-week study comparing the left and right sides of the faces of 20 participants, the areas injected with Lituo showed significant improvements compared to the control group in key indicators such as △skin density, △elasticity, △volume, △wrinkles, △pore area, △hydration, △pigmentation, and △erythema.

According to a study presented at a recent academic conference, clinical experience with over 1,000 cases of Lituo demonstrated consistent improvement and high patient satisfaction. No significant cases of side effects were identified. HANS BIOMED CORPORATION is currently in the early stages of clinical trials to verify the safety and efficacy of CellDiem.

An official from the human tissue graft industry stated, “ECM Skin Booster is a product made by pulverizing existing skin grafts to the extent that the ECM structure (scaffold) is maintained,” adding, “The safety and efficacy already confirmed in existing skin grafts are bound to be equally evident in ECM Skin Booster.”