To market pharmaceutical products in Japan, several methods are available. OP/CMIC can provide the best solution for your company in these endeavors.

1.Licensing Out

This involves partnering with a Japanese company to license the rights to your pharmaceutical product for marketing and distribution in Japan.

Advantages:

• Receive upfront and/or milestone payments

• Entrust the sales to a company with extensive experience in Japan

Disadvantages:

• Finding a suitable partner is challenging

• Difficult to align with a global branding plan

• Limited flexibility in future business options due to granting long-term rights.

2.Establishing a Subsidiary in Japan

Setting up a Japanese entity allows your company to directly market and distribute your pharmaceutical products in the Japanese market.

Advantages:

• Develop products in-house

• Efficient when multiple pipelines are available

Disadvantages:

• Time and cost associated with corporate establishment and maintenance

• Difficulty in securing talent

  • To obtain a pharmaceutical business license in Japan, a “TRIAD” (“San-yaku” in the below chart; General Manufacturing Compliance Officer, Quality Officer, Safety Officer) is required in the Japanese entity. However, securing such talent is challenging.

3.Another Option to Enter the Japanese Market:
“Real Option” through Japan Market Entry

This approach, facilitated by OrphanPacific/CMIC, provides a comprehensive solution tailored to your company's needs for successfully entering and marketing your orphan drugs or drug candidates in Japan. OrphanPacific can discuss mid-term collaboration, providing your company a “real option” for future business strategy in Japan.

This business model is attractive and useful for companies that:

• Wish to establish their own Japan KK in the future, but believe that it is too early at the timing of launch of their first asset

• Have not formulated a specific future business strategy in Japan, but wish to retain the product rights to consider future strategies.

Advantages:

• Development and approval can proceed without a having determined future business plan in Japan.

Disadvantages:

• Immediate cash-in, as expected in licensing out, does not occur

OrphanPacific can provide unique business model
You can make decisions about entering Japan market in an agile manner

“Real Option” through Japan Market Entry

OP/CMIC Group can assist in the strategic consideration and execution of market entry. We are able to identify partner needs and propose optimal solutions. Please contact us for more information.