Geographic Expansion To Japan
For an EU/US bioscience start-up/mid-cap, moving to Japan is seen challenging at the best, risky and costly at the worst.
Japan is a foreseeable and attractive pharmaceutical and medical device market, hungry for innovation and rewarding innovation.
Size of the pharmaceutical market
• Size of the population. Japanese are 126.5 million (2018). The life expectancy (84.4 years) is one of the longest in the world and is still increasing.
• An ageing population. Japan’s population is ageing faster than that of any other nations. The Health and Welfare Ministry has estimated that over-65s (currently 30.1%; 2020) will account for 40% of the population by 2060.
• A universal access to pharmaceutical drugs. Almost everyone is insured in Japan through the country social health insurance system and employee-based systems with allow a universal and equitable coverage. The co-payment rate is the same for all, except for elderly people and children.
Japan is the 3rd largest pharmaceutical prescription market in the world after the United States and Europe. Japan accounts for around 10% of the global pharmaceutical prescription market, compared with 39% for the U.S. and 21% for Western Europe approximately.
A foreseeable path to the market
Japan is a ‘no-surprise’ country from a drug development and business perspective.
• The rules are transparent and well defined, and, on the contrary to China, the rules will not change from one day to another.
• It is relatively easy to have access to the drug agency, to ask for advices or for a formal agreement on what needs to be done to get a drug approval.
• The timeline to get a formal meeting with Pmda is known. The processes are well defined and the agency professional. The review time for an NDA is now one of the shortest among developed countries.
In addition, it is likely that the price for an innovative drug is going to be fair. It will take 3 months after approval to get a price which applies nationally.
A country hungry for innovation
• Like they are picking brands and the newest technologies, Japanese are picking up pharmaceutical innovation.
• For the best-in-class companies, there is no more a drug lag in Japan compared to the US or EU. They are getting approvals for their new drugs in EU, Japan and US ‘at the same time’ (defined as ‘within one year’ from first approval to last approval).
A country rewarding innovation
• The pricing system is relatively transparent. The rules are well defined.
• The prices are very fair knowing that everyone have access to approved drugs with limited co-payments.
• Real innovations, supported by the appropriate clinical data demonstrating a superior usefulness compared with no-care or standard-of-care, get a premium.
A company willing to expand its business to Japan will face multiples questions:
Our job is to help you.
For more information, please contact us.
Consulting Services
Product Development Plan
Product Development Plan. Asset Time-to-Market Plan Optimization. Development Project Management. Regulatory Strategy & Support.
R&D/ Medical Affairs Hub Buildup in Japan
R&D/Medical Affairs Hub in Japan Buildup. Dysfunctional Organization Transformation. Performance Improvement.
Medical Affairs & Market Access Strategy
Medical Affairs Strategy. Thought Leader Engagement Plan. Expected Labelling.
Drug Launch Preparedness
Medical Affairs Strategy & Execution Plan. Thought Leader Engagement. Medical Societies Engagement.
Interim Management Sourcing
GM or R&D/Medical Affairs Interim Management In-sourcing. Stepwise Organization build-up. Competency Assessment.
Company Incorporation
Legal Entity. Company Registration. Corporate bank account. Taxes. Healthcare Insurance. Employees’ Benefits. Life insurance. Back-office. Office Space.
Development and/or Business Partner Search
Development and/or Business Partner Search/Introduction. Due Diligence. Negotiation Support.