The Daily Item, Sunbury, PA


February 22, 2013

Legal rules proposed for cell therapies


Under the revised Pharmaceutical Affairs Law, products for regenerative medicine would be approved conditionally after their safety is established in clinical trials requiring fewer trial participants than needed under the current approval system.

The new system would also call for follow-up inspections of the safety and effectiveness of regenerative medicine products.

Medical institutions would be obliged to give patients explanations, obtain their approval and keep records on regenerative medicine. A formal approval to undertake treatment would be given after safety and effectiveness are confirmed.

A study panel of the industry ministry said Friday the domestic market for regenerative medicine will grow to 1.6 trillion yen by 2030.

According to the study group of the Economy, Trade and Industry Ministry, the demand for medical products in regenerative medicine, such as organ cells grown from iPS cells, will be about 1 trillion yen, including medical treatments using the products.

Related businesses such as devices and containers to culture iPScells will also grow to about 550 billion yen, the group said in its report.

The Study Group on Commercialization and Industrialization of Regenerative Medicine is headed by Prof. Mitsuo Okano of Tokyo Women’s Medical University.

In a breakdown of the market, the group said businesses involved in transplanting eye cells into eyes of age-related macular degeneration (AMD) patients are slated to grow to the 100 billion yen level and those involved in neural cells used in the treatment of Parkinson’s disease are expected to grow to 110 billion yen.

The study group also came up with a forecast of the extent to which treatments using regenerative techniques will be commercialized.

The market is expected to further grow to the 3.8 trillion yen level by 2050, the group added.

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