Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is due to the fact that this type of product provides a fundamentally new approach to the treatment of many diseases: malignant neoplasms, cardiovascular diseases, diseases of the nervous system and musculoskeletal system, as well as diabetes mellitus. BMCP is also actively used in the field of aesthetic medicine to cope with age-related skin changes.

Two commercial companies Fibrocell Inc. (USA) and their LaViv product and PJSC “Institute of Human Stem Cells” (Russia) with product SPRS-therapy deserve special attention in the analysis of the application of the BMCPs in the field of aesthetic medicine.

A drug LaViv approved by the US Food and Drug Administration (FDA) is an autologous cellular product, i.e. patient fibroblasts are isolated from his/her body and transplanted back. The drug is designed to smooth out the skin relief and showed visible results in clinical trials. According to US scientists, the mechanism of action of the drug remains unknown, although there are several assumptions about how fibroblasts help fight wrinkles [3]:

• Fibroblasts produce a large amount of collagen and elastin
• Induce proliferation of native fibroblasts
• Extensively proliferate themselves

Information on the product can be found on the FDA website: https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM260489.pdf

Russian technology SPRS-therapy has permission to use from Roszdravnadzor and belongs to the Institute of Human Stem Cells. Along with therapy with biomedical cellular products, the Institute also offers SPRS-diagnostics with the purpose of obtaining a skin passport, where the morpho-functional properties of a specific patient’s fibroblasts are reflected.

SPRS-therapy also involves transplanting patient’s own fibroblasts from the area behind the ear to the places which require correction. As a result of two years clinical studies, it was shown that fibroblasts were fully integrated into the dermis and maintained their biosynthetic activity for 12 months. As a result, the content of collagen was increased in the skin. Thus, the elasticity of the skin was improved, and the depth and number of wrinkles reduced. [2]

According to the annual reports of the above-mentioned companies, the market share of biomedical cell products in the field of aesthetic medicine is 800 thousand US dollars. [1]

In general, the growth of the market of biomedical cell products is forecasted. So, according to Scalar Market Research, in 2016, the market of BMCP was about 12 billion dollars (USD). Taking into account the annual growth of 31.1%, by 2020 the market of the BMCP can reach 61 billion dollars (USD).

References:

1. N. Korsakov, I.I. Nadelyaeva, I.I. Eremin, A.A. Pulin , K.V. Kotenko, V.L. Zorin Analysis of the market of products of regenerative medicine 72-89111 (1)
2. VL Zorin, AI Zorina, PB Kopnin, SZ Kantserov, AA Isaev Autologous dermal fibroblasts for the correction of age-related skin changes (SPRS-therapy®). Results of 2-year clinical trials and post-marketing clinical studies. CellR4 2016 regenera_global_2016 (1)
3. STACY R. SMITH, GIRISH MUNAVALLI, MD, ROBERT WEISS, MD, JOHN M.M.ASLOWSKI, MS. KEVIN P.HENNEGAN, MA,AND JEANNE M.N.OVAK, PHD A Multicenter, Double-Blind, Placebo-Controlled Trial of Autologous Fibroblast Therapy (Azficel-T) for the Treatment of Nasolabial Fold Wrinkles Clinical trials (1)