AMED and Its Role in Japan’s Pharma Investment

The Japan Agency for Medical Research and Development (AMED) is a government agency established in 2015 to centralize and streamline Japan’s national R&D efforts in the medical and life sciences fields. Modeled partly after the U.S. NIH, AMED operates under the Cabinet Office and three ministries: the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and the Ministry of Economy, Trade and Industry (METI).

Purpose and Mission

AMED’s primary mission is to promote integrated, strategic R&D in medical and pharmaceutical fields, translating basic research into practical healthcare solutions. It aims to improve public health, strengthen innovation, and enhance Japan’s global competitiveness in life sciences.

Influence on Government Investment in Pharma

  1. Centralized R&D Funding
    AMED consolidates research budgets from various ministries, allocating government funds to priority projects across academia, industry, and hospitals. This reduces fragmentation and duplication, ensuring a more efficient use of public funds.
  2. Strategic Research Programs
    It runs targeted funding programs in key areas such as regenerative medicine, rare diseases, infectious diseases (e.g., COVID-19), oncology, and AI-driven drug discovery. These focus areas reflect national priorities and help shape the pharma R&D agenda.
  3. Public-Private Partnerships
    AMED facilitates collaboration between government, academia, and industry by funding consortia and joint development projects, accelerating the commercialization of innovative therapies and technologies.
  4. Global Collaboration and Standards
    AMED promotes international cooperation by participating in global health initiatives and harmonizing Japanese research standards with global practices, making it easier for Japan-based pharma innovations to reach international markets.
  5. Support for Translational Research
    A key focus of AMED is bridging the “valley of death” between basic research and clinical application. It provides funding and infrastructure for early-stage trials, regulatory support, and manufacturing scale-up—crucial areas where government investment derisks pharma development.

Impact on Pharma Sector

Through its funding and strategic guidance, AMED directly influences where Japan’s pharmaceutical innovation efforts are directed. Its programs not only fund cutting-edge science but also de-risk and accelerate the development of products with high social and economic value. For pharma companies, AMED is both a critical funding source and a policy signaler of government-backed priorities.


In summary, AMED plays a central role in aligning government investment with national health priorities, strengthening Japan’s pharmaceutical innovation ecosystem, and fostering industry-academic collaboration to translate science into healthcare impact.

Sakigake Designation: Accelerating Innovation in Japan

In the competitive world of pharmaceutical development, speed to market is crucial, especially when it comes to addressing serious diseases with unmet medical needs. Japan’s Sakigake Designation provides a powerful opportunity for developers of groundbreaking therapies, offering fast-tracked approval and enhanced support throughout the regulatory process.

Introduced in 2015 and solidified under the Pharmaceuticals and Medical Devices Act in 2020, the Sakigake Designation is designed to accelerate the development and approval of first-in-class medical products in Japan, ensuring that transformative treatments reach patients as quickly as possible.

What Is the Sakigake Designation?

The term Sakigake, meaning “pioneer” in Japanese, reflects the designation’s focus on promoting innovative treatments that lead the way in addressing serious and life-threatening conditions. Through this program, the Pharmaceuticals and Medical Devices Agency (PMDA) streamlines the approval process, cutting down timelines and supporting sponsors in bringing their therapies to market faster.

Benefits of Sakigake Designation

  1. Priority Consultation and Review
    Developers benefit from prioritized, accelerated consultation with the PMDA, allowing for clear, timely guidance on regulatory requirements and development plans. This early interaction enhances the efficiency of the entire approval process.
  2. Faster Approval Timeline
    With Sakigake Designation, a product’s review period is shortened to around 6 months, compared to the usual 12 months, giving developers a competitive edge in the fast-paced pharmaceutical market.
  3. Dedicated PMDA Support
    A dedicated PMDA concierge (case manager) is assigned to guide the sponsor through every step of the process, offering expert advice and ensuring smooth coordination between all parties involved.
  4. Extended Market Exclusivity
    Approved products are granted an additional 2 years of market exclusivity after their initial approval, giving developers extra protection to capitalize on their investment without immediate competition.

Eligibility Criteria for Sakigake Designation

Not every product qualifies for Sakigake. To be eligible, a product must:

  • Be a first-in-class therapy or demonstrate exceptional efficacy compared to existing treatments.
  • Address serious, life-threatening, or rare diseases.
  • Show significant improvement in treatment outcomes.
  • Be intended for early development and application in Japan, with Japan as a primary market.

Developer Obligations

While Sakigake offers significant benefits, there are key responsibilities for developers:

  1. Early and Continuous Engagement
    Sponsors must engage with the PMDA early and maintain an ongoing dialogue, submitting detailed development plans and regular progress updates to ensure alignment throughout the process.
  2. Robust Data Requirements
    Developers must provide comprehensive non-clinical and clinical data to support their application, even if only preliminary. This helps demonstrate the potential of the product to address unmet medical needs.
  3. Japan-First Strategy
    Products developed under Sakigake should prioritize Japan as an early market. Simultaneous or earlier regulatory submissions in other regions could affect eligibility for the designation.
  4. Post-Marketing Surveillance
    Sponsors are required to implement enhanced post-marketing surveillance and risk management strategies to monitor the long-term safety and effectiveness of their products once they are in use by patients.

Conclusion

The Sakigake Designation offers developers a unique opportunity to fast-track innovative treatments in Japan, providing faster approvalsextended market protection, and dedicated PMDA support. However, it requires a commitment to early and continuous engagement with regulatory authorities, as well as ensuring Japan remains a focal point in the product’s development strategy.

For companies looking to bring breakthrough therapies to market quickly, the Sakigake Designation is an invaluable tool for accelerating the path from innovation to patient access.


By understanding the benefits and obligations of this regulatory program, pharmaceutical companies can leverage the Sakigake Designation as a strategic advantage in bringing their life-changing therapies to Japanese patients faster.

3 Med-Tech Success Stories in Japan: Key Lessons for Market Entry

Japan’s medical technology market is one of the most advanced and competitive in the world. For foreign med-tech companies, breaking into this market can be challenging, but the rewards are immense. Here are three success stories of med-tech solutions developed outside Japan that have successfully penetrated the Japanese market, along with the key factors that drove their success.


1. Intuitive Surgical’s da Vinci Surgical System

The Product

The da Vinci Surgical System, developed by California-based Intuitive Surgical, is a robotic-assisted surgical platform designed for minimally invasive procedures. It has revolutionized surgeries in urology, gynecology, and general surgery.

Success in Japan

The da Vinci system was introduced to Japan in 2009 and has since become a cornerstone of robotic surgery in the country. As of 2023, over 400 da Vinci systems are installed in Japanese hospitals, making Japan one of the largest markets for the technology outside the United States.

Key Success Factors

  1. Focus on Minimally Invasive Surgery: Japan’s aging population and preference for minimally invasive procedures aligned perfectly with the da Vinci system’s value proposition. The system’s ability to reduce recovery times and improve surgical precision resonated strongly with Japanese surgeons and patients.
  2. Strategic Partnerships: Intuitive Surgical partnered with local distributors and key opinion leaders (KOLs) to build trust and credibility in the Japanese market. They also invested heavily in training programs to ensure surgeons were proficient in using the system.
  3. Reimbursement Strategy: Intuitive Surgical worked closely with Japanese regulators to secure favorable reimbursement for procedures performed using the da Vinci system. This made the technology more accessible to hospitals and patients.

2. Medtronic’s Insulin Pumps for Diabetes Management

The Product

Medtronic, a global leader in medical technology, developed advanced insulin pumps for diabetes management. These devices offer continuous glucose monitoring and automated insulin delivery, improving the quality of life for patients with diabetes.

Success in Japan

Medtronic’s insulin pumps have gained significant traction in Japan, particularly among patients with Type 1 diabetes. The company has established a strong presence in the market, supported by a robust distribution network and localized patient support programs.

Key Success Factors

  1. Addressing a Critical Need: Japan’s aging population and rising diabetes prevalence created a strong demand for innovative diabetes management solutions. Medtronic’s insulin pumps offered a clear clinical benefit, making them highly attractive to Japanese healthcare providers and patients.
  2. Localized Marketing and Support: Medtronic tailored its marketing and patient education programs to meet the specific needs of Japanese patients. They also provided extensive after-sales support, including training for healthcare providers and patients.
  3. Regulatory Collaboration: Medtronic worked closely with the PMDA to ensure timely approvals and compliance with local regulations. Their proactive approach to regulatory engagement helped accelerate market entry.

3. Philips’ Imaging and Diagnostic Solutions

The Product

Philips, a Dutch multinational, offers a wide range of imaging and diagnostic solutions, including MRI machines, CT scanners, and ultrasound systems. These devices are known for their advanced technology and reliability.

Success in Japan

Philips has become a leading player in Japan’s imaging and diagnostics market, with its products widely used in hospitals and clinics across the country. The company’s success is driven by its ability to deliver high-quality, innovative solutions that meet the needs of Japanese healthcare providers.

Key Success Factors

  1. Innovation and Quality: Philips’ commitment to innovation and product quality aligned with Japan’s demand for cutting-edge medical technology. Their devices are known for their precision, durability, and advanced features, making them a preferred choice for Japanese hospitals.
  2. Strong Local Presence: Philips established a strong local presence in Japan, including manufacturing facilities and R&D centers. This allowed them to tailor their products to the specific needs of the Japanese market and respond quickly to customer feedback.
  3. Customer-Centric Approach: Philips invested heavily in building relationships with Japanese healthcare providers. They offered comprehensive training programs, technical support, and after-sales services, ensuring high levels of customer satisfaction.

Key Lessons for Market Entry

  1. Understand Local Needs: Each of these companies succeeded by addressing specific needs in the Japanese market, whether it was the demand for minimally invasive surgery, advanced diabetes management, or high-quality diagnostic imaging.
  2. Build Strong Local Partnerships: Collaborating with local distributors, KOLs, and regulatory bodies was critical to gaining trust and credibility in the market.
  3. Invest in Localization: Tailoring products, marketing, and support programs to meet the unique needs of Japanese customers was a key factor in their success.
  4. Focus on Regulatory Compliance: Proactive engagement with the PMDA and other regulatory bodies helped these companies navigate Japan’s complex approval process and secure favorable reimbursement.
  5. Commit to Long-Term Relationships: Building strong, long-term relationships with healthcare providers and patients was essential for sustained success in Japan.

Final Thought

Japan’s med-tech market offers immense opportunities for companies with innovative solutions and a strategic approach. By learning from the success stories of Intuitive Surgical, Medtronic, and Philips, foreign med-tech companies can position themselves for success in this dynamic and rewarding market.

Ready to take the next step? Let’s discuss how to turn your vision into reality. Schedule a free consultation or send us a message to explore how we can help you navigate Japan’s med-tech landscape with confidence.