Synex Korea Medical Device Market Report - Dermal Fillers 2023

Dermal fillers are classified by the MFDS as Class Ⅳ medical devices, with the product classification number B04230.01 (biomaterial graft/prosthesis) or B04230.02 (graft/prosthesis).
According to the , dermal fillers are non-reimbursement devices for cosmetic surgeries with aesthetic purposes. Therefore, unlike other medical devices, they can be supplied directly to medical institutions even if they are not on the National Health Insurance Therapeutic Materials Formulary. The suppliers can literally provide dermal fillers as long as they receive approval from the MFDS.
As of 2022, the dermal filler market in Korea is estimated to be about USD *** million, growing at an average annual rate of ***% over the past four years from about USD *** million in 2018. The manufactured product market is estimated to be about USD *** million (***% of the total market), growing at an average annual rate of ***% and the imported product market is estimated to be about USD ***million (***% of the total market), growing at an average annual rate of ***%.
In terms of the number of dermal fillers supplied, it is estimated that about *** million fillers were circulated in the market in 2022. This is the result of an average annual growth of ***% over the past four years from *** million fillers in 2018.
The number of manufactured products supplied in 2022 was approximately *** million (***% of the total supply), an increase of ***% compared to approximately ***million in 2018. The number of imported products supplied in 2022 was approximately *** (***% of the total supply), an increase of ***% compared to approximately *** in 2018. In the dermal filler market, the supply of manufactured products is overwhelming compare to that of imported products.
Based on end-user (medical institution) purchase price, the dermal filler market in 2022 is estimated to be about USD *** million. This is the result of an average annual growth of ***% over the past four years from 2018 to 2022, including salmon injections and water glow injections which are also called skin boosters by providers. With an average annual growth rate of ***% over the next five years, the market size in 2027 is expected to reach about USD *** million based on initial supply price and USD *** million based on end-user (medical institution) purchase price.
Dermal fillers are divided into fillers and skin boosters depending on their specific purpose of use. Fillers aim to visually improve wrinkles or increase the volume of the skin through physical restoration. Skin boosters are injected into the skin with a syringe for the purpose of regenerating damaged skin such as improving skin tone, moisturizing the skin, alleviating skin inflammation, and synthesizing collagen. Of the USD *** million filler market in 2022, fillers are estimated at approximately USD *** million (***%) and skin boosters at approximately USD *** million (***%).
In 2022, hyaluronic acid had the market share of ***Biodegradable synthetic polymers such as polyelactic acid and polycaprolactone are estimated to be about ***%, and polynucleotides about ***%.
The treatment areas of dermal fillers are nose and lip wrinkles (nasolabial folds) ***%, cheeks ***%, lips ***%, forehead ***%, and corners of the eyes (around the eyes) ***%. Out of the total number of clinical trial approvals by indication, nose and lip wrinkles was the highest with *** cases (***%).
Based on the product names approved (graft/prosthesis, biomaterial and graft/prosthesis) by the Ministry of Food and Drug Safety, there are *** non-reimbursement products out of the total model names which are presumed to be actually supplied in the market.
Of all these products, *** (***%) products were for export and *** (***%) products were for domestic distribution. In terms of the model names for distribution in Korea, there are *** models (***%) approved as graft/prosthesis, biomaterial products and there are *** models (***%) approved as graft/prosthesis. It is calculated that manufactured products are *** (***%) and imported products are *** (***%).
After the government's decision of "the whole drug price cut" in 2012, the number of domestic dermal filler manufacturers increased rapidly as domestic pharmaceutical companies entered the dermal filler market in order to diversify their businesses. Since 2014, domestically manufactured products have begun to exceed the market share of imported products and this appears to be due to their price competitiveness.
As of 2022, the market share of the dermal filler market is as follows: Neuramis of Medytox (***%), Belotero of Merz (***%), Restylane of Galderma (***%) and Elravie of Humedix (***%).
Galderma's Restylane and AbbVie's Juvederm, both imported from overseas, have maintained a stable market share despite their relatively high unit price compared to other dermal fillers. It is understood that the premium images and various indications of the brands play a part behind their market shares.
The dermal filler market is expected to grow steadily driven by increasing numbers of plastic surgery clinics and dermatology clinics, domestic suppliers, and demand for cosmetic procedures.
Domestic manufacturers and companies considering new entry need to keep an eye on the export market. Most manufacturers are breaking away from fierce competition in the domestic market and turning their attention to overseas markets such as China, Brazil and Thailand.
In order to enter the dermal filler market, it is necessary to develop products with new substances, expand existing indications, or develop new products with ensured safety. For example, it is advantageous to research and develop substances similar to skin tissue or to conduct additional clinical trials so that the same product can have various indications.
In particular, we recommend to set a product with relatively proven safety as a control group and to conduct a clinical trial designed to prove non-inferiority or equivalence for various indications.