A2 Healthcare has established an operation in Boston to help US biotechnology and biopharmaceutical firms access the Japanese market.
The Tokyo-headquartered trials contractor announced the new base last week, citing US drug developer’s pivotal role in global biopharmaceutical and biotech R&D as the primary motivation for the expansion.
CEO Hitoshi Kamiya predicted the Boston branch would help US companies access the Japanese market, explaining “Pharmaceutical companies shy away from the Japanese market due to Japan’s strict pharmaceutical regulations, complex clinical trial-related procedures, and drug pricing system that differs from Europe and the US.”
Winning approval for drugs in Europe and the US is typically faster than in Japan. The difference – known as “drug lag” – arises because of the country’s strict regulatory requirements, specifically that products are tested locally. For example, according to recent analysis approvals take an average of 1547 days longer in Japan than in the US.
Kamiya referenced the issue as a motivation for A2’s decision to set up the Boston office, commenting “More than half of the domestically unapproved drugs in Japan are developed by biotech companies overseas.
“With the launch of the US office in Boston, A2 Healthcare is optimally positioned to change this narrative. We are offering a new mechanism to eliminate drug loss by encouraging companies to develop drugs in Japan at ease.”
The CRO – which is a subsidiary of ITOCHU Corporation – described Boston as “an ideal networking environment as part of the world's largest biotech cluster with more than 1,000 biotech companies working on new drug development pipelines.”
It added that it offer its Pipeline Accelerator Program, a financing program, to US firms through the new office.
Hiroki Matsushima, head of A2 Healthcare’s Global Business Expansion in charge of the US Boston Office, predicted US firms’ would be interested in accessing Japan’s market.
“Japan is a country with a population of over 120 million people and an average lifespan of 84 years. In clinical trials, patient compliance is very high, while the drop-out rate is low.
“Sustained by a large patient pool for most target indications, Japan remains one of the most attractive and cost-effective places to implement global drug development plans. Additionally, Japan's low inflation over the past decades has helped keep costs down, unlike in most other countries” Matsushima said.
A2’s office opening comes a few months after fellow Japanese clinical trials contractor EPNextS Group teamed up with US-based Frontage Labs also citing the drug lag as a prompt for the partnership.
Unsplash/Roméo A.