A Data-Based Assessment of Japan’s Flagship Innovation Policy
When Japan introduced the Sakigake designation system in 2015, the ambition was clear and bold: to position Japan as a global leader in the early development and approval of innovative medical products. Led by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), Sakigake was designed to address Japan’s long-standing challenges of drug lag and declining global relevance in pharmaceutical innovation.
A decade later, Sakigake is frequently cited as evidence of regulatory progress. But has it delivered on its stated goals — not anecdotally, but measurably?
This article examines Sakigake’s objectives, outputs, and real-world impact using publicly available data and comparisons with similar accelerated programs in the U.S. and Europe.
What Sakigake Was Designed to Achieve
Sakigake was launched in 2015 as a pilot under the government’s Strategy of Sakigake and made permanent in 2020. According to official MHLW and PMDA documentation, its objectives were not modest regulatory refinements, but structural change.
At its core, Sakigake aimed to:
1. Promote innovative R&D in Japan
The system was intended to encourage development of breakthrough therapies for serious diseases and unmet medical needs, with a strong preference for products developed first or concurrently in Japan. This Japan-first orientation was meant to strengthen domestic innovation capability and global competitiveness.
2. Enable early or first-in-world approvals
Eligibility requires that development and regulatory submission in Japan occur before or at the same time as the U.S. or EU, explicitly targeting first-in-world or simultaneous global launches.
3. Accelerate regulatory interaction and review
Sakigake provides priority PMDA consultations, assigned review teams (“concierge” support), and shortened review timelines — targeting roughly six months versus twelve months for standard reviews.
4. Provide post-approval incentives
Sakigake designation can make a product eligible for a limited Sakigake-specific pricing add-on at launch. In practice, these premiums are modest, time-limited, and do not materially alter long-term pricing dynamics or global development incentives.
Taken together, these measures were designed to reverse Japan’s historical drug lag and reposition the country as a hub for cutting-edge therapeutic development — not merely faster approvals of externally developed products.
What Has Sakigake Actually Delivered?
Designations and Approvals: The Hard Numbers
During the pilot phase (2015–2020):
- 37 products received Sakigake designation
- 10 products were approved in Japan
- 7 approvals were first-in-world
- Therapeutic focus areas included oncology, neurology, and rare diseases
After Sakigake became permanent, public reporting became less consolidated. Based on PMDA disclosures, academic reviews, and industry analyses:
- By 2021, approximately 10 Sakigake products had been approved
- By 2023, peer-reviewed analyses cited ~13 approvals
- By mid-2025, conservative estimates suggest ~15–20 total approvals, with ~50–60 total designations, including medical devices and regenerative medicine
- First-in-world approvals remain limited, estimated at 7–10 in total
While Sakigake has undeniably enabled some early approvals, the absolute volume remains small, and only one quarter to one third of designations result in approval.
How Sakigake Compares Globally (Pharmaceuticals Only)
To understand Sakigake’s impact, it must be viewed alongside similar accelerated pathways elsewhere.
Accelerated Regulatory Programs – Pharmaceuticals Only (approx. data as of 2022)
| Program | Start Year | Total Pharma Designations | Pharma Products Approved |
| FDA Breakthrough Therapy (BTD) | 2012 | ~500–600 | ~250–300 |
| EMA PRIME | 2016 | ~100–110 | ~20–25 |
| PMDA Sakigake (Pharma only) | 2015 | ~20–30 | ~10–15 |
Even allowing for differences in market size, Sakigake operates at an order of magnitude smaller scale than the FDA’s Breakthrough Therapy Designation. EMA’s PRIME has also designated far more pharmaceutical products.
This disparity reflects developer behavior, not review efficiency. Global pharmaceutical companies systematically integrate FDA BTD and EMA PRIME into development strategies, while Sakigake remains peripheral.
Measured Impact vs. Original Goals
Where Sakigake Has Worked
- Review timelines for designated products have been significantly shortened
- Several therapies achieved first-in-world approval in Japan
- Japan’s average regulatory drug lag narrowed by approximately 2.5 years between 2016 and 2019
- PMDA–sponsor interaction quality has improved for selected programs
Where Sakigake Falls Short
Scale
The number of designated and approved products is too small to meaningfully shift Japan’s position in global pharmaceutical innovation.
Global R&D prioritization
Industry surveys consistently show that U.S. and EU accelerated pathways dominate strategic planning. Sakigake rarely determines where early development occurs.
Drug loss remains unresolved
An estimated ~70% of drugs developed globally are never developed in Japan at all. This “drug loss” is driven primarily by pricing policy, market incentives, and development strategy — none of which Sakigake directly addresses.
Utilization gaps in high-innovation fields
In areas such as oncology, most global breakthrough programs use FDA BTD or EMA PRIME while bypassing Sakigake entirely.
What the Data Really Tells Us
Sakigake has succeeded as a regulatory acceleration tool, but it has not delivered the structural transformation envisioned in Japan’s innovation strategy.
It improves outcomes after a company has already decided to prioritize Japan, but it does little to influence that decision in the first place.
This distinction matters. Drug lag today is increasingly less about review speed and more about whether Japan is included in development at all. On that front, Sakigake has had limited impact.
Conclusion: A Useful Tool — But Failing Its Core Mission
Sakigake demonstrates that Japan’s regulators can move quickly and flexibly when conditions are right. As a regulatory mechanism, it works. As an innovation strategy, it falls short.
If Japan’s objective is to reclaim global leadership in pharmaceutical innovation and ensure timely patient access to breakthrough therapies, regulatory acceleration alone is insufficient. Sakigake must be paired with broader reforms — including pricing stability, incentives for early clinical development, integration into global trial strategies, and policies that materially change Japan’s attractiveness as a development anchor.
Until then, Sakigake remains exactly what the data shows it to be:
a successful tactical policy — but one that has failed to deliver on its strategic promise to Japanese patients.
References (Indicative, Non-Exhaustive)
- MHLW: Strategy of Sakigake policy documents
- PMDA: Sakigake designation lists and review statistics
- JPMA / EFPIA Japan: Drug lag and drug loss analyses
- FDA: Breakthrough Therapy Designation annual reports
- EMA: PRIME scheme public disclosures
- Academic reviews (2019–2024) on Japan regulatory reform and drug lag
Legal Disclaimer
This article is provided for informational and discussion purposes only. The views and interpretations expressed are those of the author alone and do not represent the official positions of any regulatory authority, government body, or organization. While the author has relied on publicly available sources believed to be reliable, no guarantee is made regarding the accuracy, completeness, or timeliness of the information presented. The author assumes no responsibility or liability for any decisions made based on this content.