Progress in Wound-Healing Products Based on Natural Compounds, Stem Cells, and MicroRNA-Based Biopolymers in the European, USA, and Asian Markets: Opportunities, Barriers, and Regulatory Issues

Abstract

Wounds are breaks in the continuity of the skin and underlying tissues, resulting from external causes such as cuts, blows, impacts, or surgical interventions. Countless individuals suffer minor to severe injuries, with unfortunate cases even leading to death. In today's scenario, several commercial products are available to facilitate the healing process of wounds, although chronic wounds still present more challenges than acute wounds. Nevertheless, the huge demand for wound-care products within the healthcare sector has given rise to a rapidly growing market, fostering continuous research and development endeavors for innovative wound-healing solutions. Today, there are many commercially available products including those based on natural biopolymers, stem cells, and microRNAs that promote healing from wounds. This article explores the recent breakthroughs in wound-healing products that harness the potential of natural biopolymers, stem cells, and microRNAs. A comprehensive exploration is undertaken, covering not only commercially available products but also those still in the research phase. Additionally, we provide a thorough examination of the opportunities, obstacles, and regulatory considerations influencing the potential commercialization of wound-healing products across the diverse markets of Europe, America, and Asia.

Keywords: ISO; caring; natural materials; regulatory issues; skin injuries; therapy.

Figure 1

Wound-healing process. (A) Wound repair begins with hemostasis, where an infiltration of erythrocytes and platelets occurs and form a fibrin clot. (B) After that, starts the inflammation phase, where multiple immune cells reach the place of damage to control bacterial invasion. (C) Next, during the proliferation stage keratinocytes migrate to close the wound gap, new blood vessels are formed, and fibroblasts replace the fibrin clot with granulation tissue. (D) Finally, the matrix is remodeled by fibroblasts, blood vessels return and myofibroblast produce wound contraction. Image made with Biorender.

Figure 2

Global, US, Europe and South East Asia advanced wound care market sizes between 2022 and 2030. For the global market, a mean annual increase of 3474 million USD is foreseen, while for the US market, a mean annual increase of 1130 million USD is estimated. For the European market, a mean annual increase of 2482 million USD is foreseen, while for the Southeast Asian market, a mean annual increase of 17 million USD is estimated.

Figure 3

(A) Advanced wound care share by end user (2021 data). The hospital sector commanded the market with the highest revenue share, followed by specialized clinics, home care, and finally, other segments. (B) The leading market for wound healing globally was North America, trailed by Europe, followed by the Asia-Pacific region, and lastly, South East Asia (2022 data). (C) Recent clinical trials on wound treatment classified into various categories, including wound management, anti-infective therapies, biologics, wound closure techniques, moisture balance strategies, negative pressure wound therapy, and pressure relief methods. The numbers represent the count of interventional clinical trials conducted between 2015 and 2022, including those that are recruiting, not yet recruiting, actively recruiting, completed, or enrolling by invitation.