Regenerative Medicine Market in Japan: Key Research Findings 2022

Backed by Regulatory Arrangement and Political Support, Forming of Regenerative Medicine Market Underway

Yano Research Institute (the President, Takashi Mizukoshi) carried out a survey on the regenerative medicine market, and found out the trends of the market players and future perspectives.

Market Overview

Following the announcement and enforcement of the Regenerative Medicine Promotion Act in 2013, the Act on Securing Safety of Regenerative Medicine and the PMD (Pharmaceuticals and Medical Devices) Act became effective in November, 2014, which outlines the government’s new regulation framework for regenerative medicine. Also, to address economic supports through large-scale national projects such as “Research Center Network for Realization of Regenerative Medicine”, infrastructure arrangement has been underway, as budget operations of medical research having been integrated at Japan Agency for Medical Research and Development, by which to make the operations efficient and effective.

In such an environment, the launch of regenerative medical products counted 16.

Noteworthy Topics

Clinical Study Trends using iPS Cells

In 2006, Professor Shinya Yamanaka at Kyoto University generated iPS (Induced pluripotent stem) cells for the first time ever in the world by introducing a few factors into somatic cells (fibroblasts) in a mouse. More than a decade has been passed from 2007 when human iPS cells were successfully generated.

During the period, technologies using iPS cells have become widely used, which led research and development for clinical applications to be in progress. By 2014, clinical applications to humans have been attempted for the first time in the world, which has developed the clinical studies and tests using iPS cells to gradually and steadily increase in Japan.

For clinical use of iPS cells, iPS cells stocks for use in regenerative medicine have started being provided since 2015, to make them the raw material of transplantable differentiated cells with low immune response, by which a system organization being underway to encourage clinical utilization of iPS cells in consideration of safety. 

Future Outlook

The regenerative medical products market is projected to expand, because of increase in the number of products to be launched, and penetration to prescribers and patients, together with tremendous sales expected due to high sales prices even though the number of patients may be small. While a series of products with superior effects and efficacies are expected to be developed and launched, concerns about financing for medical care are also heard caused by the current price conditions.

Research Outline

1.Research Period: December 2021 to March 2022
2.Research Object: Companies regarding regenerative medical products, companies relating to cell culturing/processing facilities
3.Research Methogology: Face-to-face interviews by specialized researchers, questionnaire, and literature research

What is Regenerative Medical Product Market?

Regenerative medical products are defined in the so-called PMD (Pharmaceuticals and Medical Devices) Act, and refer to those that are specified in the Cabinet Order. The regenerative medicine market in this research refers to the market consists of the following:

1) The items intended for use in human or animal healthcare which are obtained after culturing or other processes using human or animal cells in order for reconstruction, repairing or formation of the structure or function of the bodies of humans or animals; and for treatment or prevention of disease in humans or animals.

2) The items used in human cells aiming for gene therapy. 

Published Report

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