Развитие регенеративной медицины в России и в мире: исследователи-лидеры и технологические драйверы

Abstract

An assessment was made of the current level of development of the thematic area of «regenerative medicine» in Russia and in the world based on an analysis of the list of methods of cell, gene therapy and tissue engineering officially approved by the regulatory authorities of the world as of November 2022, as well as an analysis of the global publication and patent portfolio.

It is shown that the practical result of the 20-year development of regenerative medicine was the creation and approval of 70 products and technologies, of which 12 are methods (products) of cellular immunotherapy, 11 are gene therapy products, 17 are cell therapy products, 8 are cord blood therapy methods, 22 – products of tissue engineering. The United States is the leader in terms of the number of regenerative medicine technologies and products approved by regulatory authorities for the use of technologies and products in healthcare practice – 32 methods and products, the second position is occupied by the EU (21), followed by the Republic of Korea (16), Japan (10), Canada (7). 3 technologies and products were approved in India, China and Australia, 2 in Singapore, 1 in New Zealand. During the observation period, only one gene therapy product was recalled (ZYNTEGLO in the EU in 2021). The country that makes the most significant contribution to research and development in the field of regenerative medicine is the United States, which has a national publication portfolio that is at least three times larger than the top 5 countries in this topic area (China, Japan, UK and Italy). The Russian Federation ranks 17th with the total number of publications in the national portfolio. The performed scientometric analysis made it possible to identify the most developed scientific areas in the Russian Federation related to the field of regenerative medicine.