Services
De-risk Your Japan Strategy with Scientific Insight.
We help global biotech and medtech companies make critical Japan entry decisions—before committing significant time, capital, and resources. Our approach integrates scientific understanding, clinical insight, and market strategy to ensure your success in one of the world’s most complex healthcare markets.
Our services cover the full lifecycle of Japan entry:
Japan Feasibility Study
Should You Enter Japan—And How?
We provide a comprehensive, evidence-based assessment of your opportunity in Japan. Our feasibility studies go beyond market sizing to evaluate clinical relevance, regulatory complexity, and real-world adoption potential.
What we deliver:
- Market attractiveness and competitive landscape
- Clinical positioning and indication prioritization
- Initial regulatory pathway assessment (PMDA readiness)
- KOL perspectives and unmet medical needs
- Strategic recommendation for go/no-go decision
Before：
- Overestimated market size
- No KOL alignment
- Unexpected PMDA barriers
After：
- Clear go/no-go decision
- Validated clinical positioning
- Defined regulatory pathway
KOL Access & Clinical Strategy
Validate Your Science with Japan’s Leading Experts
We connect you with top Japanese Key Opinion Leaders (KOLs) and translate scientific discussions into actionable clinical strategy. This is critical in Japan, where expert alignment often determines success.
What we deliver:
- Identification and engagement of top-tier KOLs
- Advisory board design and execution
- Clinical development direction tailored to Japan
- Validation of mechanism of action and differentiation
- Early signals for adoption and physician acceptance
RWE Strategy & Evidence Generation
Build Evidence That Drives Real Adoption in Japan
Real-World Evidence (RWE) is becoming increasingly important in Japan—not only for post-marketing evidence generation, but also for clinical positioning, stakeholder alignment, and long-term market success.
However, successful RWE execution in Japan requires more than data collection. Differences in site capabilities, investigator engagement, operational structure, and healthcare practice patterns can significantly impact study quality and execution speed.
We support biotech and medtech companies in designing and implementing practical, Japan-focused RWE strategies that align scientific objectives with business goals.
What we deliver:
- RWE strategy development tailored to Japan
- Study feasibility assessment and site selection support
- Identification and engagement of investigators and KOLs
- Registry study and observational study planning
- Support for evidence generation aligned with PMDA and market access strategy
- Operational guidance for study execution in Japan
- Strategic interpretation of RWE for clinical and commercial positioning
Our approach integrates scientific insight, operational feasibility, and stakeholder expectations—helping companies generate evidence that supports real-world adoption and long-term value creation in Japan.
Japan Entry Execution Design
Design the Right Path—Before You Execute
We design a clear, executable roadmap for entering Japan—without locking you into premature commitments. Our role is to architect your strategy, not to replace your execution partners.
What we deliver:
- Go-to-market strategy (partnering vs. direct entry)
- Distributor and partner landscape mapping
- Organizational and operational setup design
- Regulatory and clinical roadmap integration
- Introduction to CROs, CDMOs, and commercial partners
Strategic Collaboration with Japanese innovators
Strategic Collaboration & Cross-Border Innovation
We support strategic partnerships between Japanese and global healthcare innovators to accelerate technology development, clinical validation, and international expansion.
Support areas include:
- Cross-border collaboration strategy
- Partner identification and scientific matchmaking
- Joint research opportunities
- Clinical and commercial validation support
- International business development
Case Studies
Discover how MSC has helped global companies successfully enter and expand in the Japan market
Our case studies highlight real-world outcomes, including:
- Efficient Japan market entry with lean operational design
- Strong KOL engagement
- Accelerated market adoption by RWE
See how strategy translates into measurable impact.
