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