Penetrating Japan's vaccine market by investigation of regulatory/political barriers

Japan is currently the world's second largest market for vaccines, behind the United States. However, due to regulatory ambiguity and political barriers, foreign manufacturers have very limited presence in the Japanese vaccine market. The client, a global vaccine manufacturer, was interested to further penetrate the Japanese market. They needed however, to understand the appropriate approach to take, and the possibility to collaborate with local firms to obtain approval for its vaccines. Synovate was hence tasked to understand the appropriate route of entry and assess the likelihood for success and regulatory risks.

Synovate conducted in-depth interviews the key approving ministries and departments within the Japanese government and gathered key insights from key opinion leaders, council members and government officials. Direct undisguised opinions from approving and influencing officials allowed Synovate to provide key insights to the approval process, political agendas, and subtleties beyond what is spoken or written for the Japanese biopharmaceuticals regulatory framework.

Synovate also engaged with key vaccine opinion leaders, research institutes and vaccine manufacturers to assess the adequacy and capacity for Japan to be self-sustainable in its vaccine technology and manufacturing capacity, hence assisting the client in developing propositions to the Japanese government for approval of its vaccines for market entry.

With better clarity on the key barriers and issues behind the delay on approval for its vaccines, the client was able to develop a more effective strategy, approach and proposition to the Japanese government for mutual benefits of cooperation, hence being one of the pioneers of foreign vaccine players in Japan, gaining first mover advantage in a tightly regulated and controlled market.


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