Life Sciences Horizons Brochure 2025 - Flipbook - Page 72
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2025 Horizons Life Sciences and Health Care
Japanese life sciences industry poised for change
The Life Sciences industry in Japan is poised for
significant developments in 2025, influenced by
global trends, geopolitics, and domestic factors.
We anticipate the following areas may be especially
active in the year ahead.
Regulatory changes and compliance
with the Japanese regulator’s long-held position of ensuring a
stable supply of pharmaceutical products to the Japanese market.
It remains prudent to carefully track the nuances of these
on-going developments – particularly in the context of complex
pharmaceutical patent litigation matters that span multiple
jurisdictions – to ensure a coordinated approach that maximizes
the likelihood of success in one of the world’s largest markets.
Transactions
As set out in more detail on page 72, Japan’s regulator (the
Ministry of Health, Labour and Welfare (MHLW)) has been
focused on addressing “drug loss” and “drug lag”, and restoring
and enhancing the Japanese market’s attractiveness; for example,
the MHLW is encouraging simultaneous global development
of drugs.
We expect strategic transactional activity (i.e. licensing and M&A)
to increase in Japan as companies seek growth, diversification,
and enhanced competitive positioning. Recent trends include
interest by private equity companies and activist efforts.
There are renewed efforts to improving the drug discovery
infrastructure in Japan. We recommend closely monitoring
regulatory developments to facilitate smoother product approvals
and market entry and to minimize the risk of non-compliance
with evolving regulations.
The key risks to cross-border transactions remain geopolitical
disruptions, fluctuating valuations, and regulatory uncertainties,
some of which may be managed through effective and targeted
due diligence, as well as a meaningful assessment of geopolitical
risks and complex regulatory landscapes.
Digital transformation and AI integration
Personalized medicine, genomics, telemedicine, and
remote health care services
Japan is embracing digital transformation, and we expect further
implementation of digital technologies, especially wearable
technology and personalized data-driven care. We also anticipate
growth in generative AI, with companies seeking to enhance
operational efficiencies, drive innovation, and improve patient
outcomes.
We expect that Japan will continue to encourage advances in
genomics and tailored therapies, which may improve treatment
efficacy and patient satisfaction. We also predict that Japan may
continue to expand telemedicine services following certain
relaxations that occurred during the COVID-19 pandemic.
Cybersecurity threats and data breaches remain on-going risks. In
addition to periodic relevant “health checks,” we recommend
continual assessment of compliance with applicable laws and
regulations, including rules related to the handling of data and
strengthening cybersecurity, such as Japan’s Act on the Protection
of Personal Information.
IP litigation
We recommend being especially mindful of evolving regulatory,
telemedicine, and compliance changes, especially in respect of
data privacy rules and those governing the handling of sensitive
genetic information.
Navigating these trends requires a proactive approach,
including staying informed about regulatory updates, investing
in compliance and cybersecurity measures, and planning ahead
to mitigate risks effectively.
We expect originator versus generics – as well as biologics versus
biosimilars – patent litigation cases to persist for some time in
Japan, as we analyze in more detail on page 69.
Interestingly, a number of generic companies appear to be
benefitting from Japan’s non-statutory “patent linkage” system
and the regulator’s apparent readiness to grant generic marketing
authorization in certain cases (for instance, where a patent has
been held invalid by the JPO but not all avenues of appeal have yet
been exhausted and the decision finalized), potentially conflicting
Dr. Frederick Ch'en
Office Managing Partner
Tokyo
