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Regenerative medicine in Japan has shifted into high gear, with the domestic market projected to balloon into a ¥2.5 trillion industry ($20.7 billion) by 2050.

Japan is a research leader in the field, which focuses on treatments that use living cells to restore bodily functions, but it lags in commercialization. However, a recent legal revision could help Japan catch up.

A change to the Pharmaceutical Affairs Law that took effect last year reduces the time required for regulatory approval, slashing the time needed for commercialization from more than 10 years to three or four.

With the revision, many Japanese companies—including some considered medical industry outsiders—are poised to go toe-to-toe with their foreign competitors.

Cell Alliance
Japanese drug maker Takeda Pharmaceutical and Kyoto University’s Center for iPS Cell Research and Application (CiRA) have teamed up to conduct research on induced pluripotent stem (iPS) cells.

Nobel Prize-winning stem-cell researcher Shinya Yamanaka, a professor at the university and director of CiRA, together with Takeda President and CEO Christophe Weber announced the alliance on April 17.

Source: Ministry of Economy, Trade and Industry

Source: Ministry of Economy, Trade and Industry

“There has been no large-scale, comprehensive joint research like this before,” Yamanaka said. Weber called the union “historic” and spoke of the promise that regenerative medicine holds.

Takeda plans to spend ¥20 billion on the venture over the next 10 years. Kyoto University will send 50 of its researchers to the drug maker for the project.

Forum of 100+ companies
Another alliance targeting the field is the Forum for Innovative Regenerative Medicine. It comprises more than 100 companies interested in regenerative medicine, including such medical outsiders as Hitachi, Kawasaki Heavy Industries, and Dai Nippon Printing.

The forum’s commercialization task force opened a Tokyo office on April 1, with one employee. The unit was put together by forum members particularly keen to bring products to market, and many observers expect it to play a leading role in promoting regenerative medicine in Japan.

The task force has already decided to create development bases of member companies in a comprehensive special zone in Kawasaki, Kanagawa Prefecture. Regulations have been eased in the zone.

A forum representative will also serve as head of a panel at the International Organization for Standardization, through which the Japanese group will seek to establish global standards for Japanese regenerative medicine.

Some Japanese manufacturing technologies are already being used for processing cells. Hitachi, for example, has tied up with Tokyo Women’s Medical University to commercialize an automated culture device for cell sheets.

Fujifilm Holdings recently decided to buy US-based Cellular Dynamics International (CDI), the world’s largest iPS cell supplier. Patents held by CDI and Kyoto University account for the bulk of iPS cell-related intellectual property.

Attention is shifting to what specific results Japanese companies will be able to produce as they rush to commercialize regenerative medicine products.

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