Drug Loss: A growing concern in Japan, but there is something new on the horizon.
The Japanese life science industry is currently facing a social problem known as "drug loss." Approximately 70% of NCEs commercialized in the U.S. and Europe have not yet been introduced in Japan during the last five years. This discrepancy rate has been increasing and many rare disease drugs never reach Japanese patients due to regulatory and commercially unique barriers. In response to this pressing concern, the Japanese authorities have initiated regulatory reforms to be more efficient in the drug development and marketing approval process, such as not requiring a Phase 1 study.
These MHLW regulation changes are welcoming for the private sector, and it motivates companies to re-evaluate the Japanese market, since the Japanese market is large due to the aging population and a good reimbursement package for every citizen.
However, it may not be enough for companies to re-evaluate Japanese market entry. The next question is how best do we enter the Japanese market with a profitable business structure? The solution is the J-ENTRY Consortium (JEC), especially for mid-sized or small-size assets. Let's see how JEC provides you with a Japanese business opportunity.
The J-ENTRY Consortium, the right platform for the right entry
As business professionals, we are expected to have our product assets projected to cover all essential expenses before entering a new market. Typically, a market like Japan needs to exceed the minimum size for licensing or setting up a subsidiary. But, what would you think if you had another option to minimize this barrier? This is where the JEC provides a different landscape to change this kind of pre-determined criteria.
Highlight 1: One-stop solution
Finding the right partner(s) in Japan that have multiple capabilities can be challenging. JEC provides a one-stop and end-to-end solution, including regulatory and operational capabilities with proven experience. One of the key companies in the Consortium is SKK. With over 70 years of history in Japan as a pharmaceutical company, they will manage all tasks from end to end; from the clinical trials, regulatory J-NDA filing, manufacturing and Japanese commercialization as a delegate of your company. Or you also might have faced cultural differences in the packaging since the Japanese market typically requires unique final packages. Another key company in our consortium is Bushu Pharma. With 26 years in the CDMO business, Bushu Pharma has regularly passed foreign audits, including the FDA and EMA. Furthermore, Suzuken, a leading Japanese pharmaceutical distributor with 80+ years of history, will seamlessly support delivery of your products to patients. No need to worry about the commercial communication difficulties, just connect with SKK.
Highlight 2: No initial investment and physical presence
You may need to prepare a clinical package even with a drug-loss asset. No worry about the Japanese clinical development burden. JEC covers initial clinical development costs and proceeds with all of the tasks all the way to achieve your J-NDA. Also, during the clinical development phase, EPS, the pioneer of Japanese CRO, supports and collaborates with SKK for local clinical trials. JEC offers to recover these clinical development burdens only after getting marketing authorization. Plus, you do not need to set up physical presence in Japan. This is the heart of the JEC opportunity for US and European companies.
Now is the time to re-evaluate the Japanese Market
If you have thought about Japanese market entry or have previously tried to enter the Japanese market but missed the opportunity, let's discuss with us as Japanese patients cannot wait for your asset. Please feel free to contact us to learn more.
About SANWA KAGAKU KENKYUSHO (SKK)
SKK is a subsidiary of Suzuken, and the company has full and end-to-end capabilities for pharmaceutical and diagnostic businesses driven by over 800 employees with 70+ years of history in Japan.
About Suzuken Group
Suzuken is one of Japan’s leading pharmaceutical wholesalers with 2,386 billion yen (about 15.7 billion USD) sales and 13,000+ employees as of March 2024. Notably, Suzuken has extensive knowledge and know-how for the distribution of rare disease drugs.
About Bushu Pharmaceuticals
Bushu Pharma is a Japan-based CDMO specializing in the production of pharmaceutical products and clinical trial materials. With 26 years of experience, Bushu supplies products to 56 countries and holds GMP certifications from major regulatory authorities, including Japan, the United States and Europe.
About EPS Group
EPS Group, since 1991, offers comprehensive solutions in drug development, marketing, and healthcare. Leveraging 7,000 employees' expertise, we serve pharmaceutical companies, medical device firms, hospitals, clinics and academia, providing innovative business solutions.