Approach:
The process begins by screening products from multiple regulatory and scientific databases (KEGG, PMDA, EMA, FDA) using defined inclusion and exclusion criteria. Selection focuses on products approved in the US or EU between 2016 and 2024, recognized as new molecular or biologic entities not yet approved in Japan, yielding an initial list of 170 molecules for basic profiling. From this list, 70 products with open licensing status are shortlisted for deeper evaluation.
Detailed profiling examines licensing terms, pricing, sales figures, competitor presence, and approval timelines. Products are then grouped based on global sales volumes (above $100M, $50M–$100M, under $50M, or no sales data). Competitor analysis identifies rival drugs sharing similar mechanisms of action and indications. Finally, candidates are prioritized by considering factors such as current sales, projected peak sales, competitive landscape, and the date of market approval to guide strategic in-licensing decisions.
Key findings:
A total of 70 products were shortlisted as potential candidates for in-licensing in Japan, all open for licensing with no existing collaborations in the region. These products were grouped by sales performance: 15 had sales exceeding $100 million, 5 ranged between $50 million and $100 million, 24 reported sales below $50 million, and 7 lacked sales data. Competitor analysis was conducted for each product based on shared mechanisms of action and indications. Prioritization of these candidates factored in current and peak sales, number of competitors, and approval dates, with products showing low sales after more than three years on the market being deprioritized to focus on higher-potential opportunities.
Business Impact:
We identified 70 potential in-licensing drug candidates approved in the US and EU but not yet available in Japan, presenting significant opportunities to strategically expand the client’s portfolio within the Japanese market. Comprehensive profiling of these candidates—including current sales performance, projected peak sales, and regulatory approval timelines—provides the client with critical, actionable insights. This enables informed decision-making regarding licensing opportunities, optimizing the client’s market entry strategy while effectively targeting high-potential assets for growth and competitive advantage.