Regenerative medicines in Japan can now get conditional marketing approval based on results from mid-stage, or Phase II, human trials that demonstrate safety and probable efficacy. Once lagging behind the U.S. and the E.U. on approval times, there is now an approximately three-year trajectory for approvals, according to Frost’s Kumar. That compares with seven to ten years before.
While the market potential is huge, technological challenges still need to be ironed out, said Atsushi Seki, a Tokyo-based health-care analyst with Barclays Plc. Therapies that use the patient’s own cells could be tougher to monetize and researchers will also need to find ways to handle transplants that are rejected by the body, he said.
The price of such therapies has been one hurdle. Around the world, companies have also faced setbacks while pushing such treatments. In the U.S., Geron Corp., which started the first nation-approved trial of human embryonic stem cells, ended the program in 2011, citing research costs and regulatory complexities.
With new treatments expected to come online in the next few years, Japan’s government, which has a national health-care program, now needs to come up with affordable payment models. Seki said he is watching to see how the country will set reimbursements for Temcell, a Mesoblast cell therapy distributed by JCR Pharmaceuticals Co. Expected towards the end of the year, if its price is disappointing, that could discourage the entire industry from developing such treatments, Seki said.
Despite the challenges, researchers like Sankai believe the new policies set the stage for various technologies to come together and new therapies to emerge.
“The speed of development is amazing: every day it’s going faster,” Sankai said in an interview at Cyberdyne’s headquarters, surrounded by a few of his robot prototypes. “But technology is only technology. What’s important is how they’re installed to the people.”