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Why Japan is a global destination for regenerative medicine

Through recent regulatory and policy reforms, Japan is becoming an increasingly attractive location for clinical research and development programmes, particularly in regenerative medicine. Although these reforms aim to modernise clinical trials, Japan has already established itself as a leader and prime destination in this fast-growing field.

Focused on the restoration, repair or formation of structures or functions in the human body, regenerative medicine is a broad discipline. It uses approaches, including tissue engineering, cell and gene therapies, medical devices and artificial organs, to replace or heal damaged tissues. 

Because this approach to medicine is inherently complex, its development needs and regulatory landscape can be equally difficult to navigate. With a large potential participant pool, well-established regulatory pathways supported by more than a decade of experience, national health insurance resources and alignment with global standards, Japan stands out in its ability to support regenerative medicine.

A relevant patient population

Japan’s population is ageing, with approximately 29% over the age of 65 as of October 2023.1 When people get older, they become susceptible to diseases and conditions with limited treatment options, including neurological, cardiovascular, musculoskeletal and metabolic degeneration. Consequently, this demographic is facing a rise in unmet medical needs.

Regenerative medicine has great potential to address age-related disease by restoring the structure and function of damaged tissue, providing an improved quality of life for older patients.2,3 Many therapies in this area are designed either to expand treatment options for age-related conditions or to alleviate disorders that frequently affect older adults. As a result, regenerative medicine is highly relevant to a significant portion of Japan’s population, giving research in this area a sizeable pool of potential patients for study enrolment.

Established regulatory pathways

Since 2014, Japan’s Pharmaceuticals and Medical Devices Agency has implemented a regulatory framework to support the advancement of regenerative medicine. The Act on the Safety of Regenerative Medicine, enacted in November 2014, instituted legal requirements for research and clinical use of cell therapies.4 

In parallel, the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act established the pathway governing the commercialisation of regenerative medical products.5 Together, these acts provide a clear structure for product development and regulatory review. They also demonstrate that, with more than a decade of experience, Japanese regulators already have a strong understanding of the field.

More recently, Japan released guidance in 2024 for the conditional and time-limited approval of regenerative medical products.6 It aims to increase the predictability of approval applications and support development in this area. Under this pathway, if a product’s safety is confirmed and its efficacy is reasonably predicted from early-stage trials, it may receive conditional approval, with full approval contingent on demonstrating efficacy within a defined post-marketing timeframe. In addition to allowing earlier market entry without waiting for the completion of lengthy efficacy studies, the approach enables patients to access therapies sooner, a meaningful advantage when conventional treatments are insufficient.   

National health insurance

A significant benefit to regenerative medicine developers in Japan is its universal health insurance coverage. On a basic level, widespread access to health insurance means coverage of routine care costs, meaning that many services over the course of the trial will be reimbursable and, as a result, costs to the sponsor will be lower.

Even more compelling, because coverage is universal, nearly all healthcare interactions in Japan are captured as insurance claims. This data feeds into the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which compiles claims and checkup data from all Japanese insurers. Estimated to hold approximately 98% of all medical data on healthcare services provided by medical institutions within the country, the NDB is a massive repository of real-world data.7

Because much regenerative medicine, in particular cell and gene therapies, requires lengthy follow-up, the NDB is an invaluable tool for monitoring safety and efficacy after a therapy reaches the market. Its unified data collection structure, which includes virtually all Japanese patients, helps solve common challenges in tracking patients over many years and in working with fragmented data. There have been multiple cases of NDB data being used to help support regulatory decisions regarding post-market drug safety.8

Aligning with global development

In addition to the characteristics outlined above, Japan has been aligning its broader clinical trial ecosystem with international standards. Reforms to multi-regional clinical trial requirements, for example, have made Japan-based development programmes more appealing to sponsors worldwide. Together, these changes position Japan as an early access market, one that can generate clinical and commercial validation for regenerative therapies ahead of large-scale global expansion.

 

References

  1. Statistics Bureau Home Page/Population Estimates/Current Population Estimates as of October 1, 2023. https://www.stat.go.jp/english/data/jinsui/2023np/index.html. Accessed 6 July 2026. 
  2. Yamada, Satsuki, et al. “Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial.” Stem Cells Translational Medicine, vol. 13, no. 2, Nov. 2023, pp. 116–24. PubMed Central, https://doi.org/10.1093/stcltm/szad078.
  3. Sinclair, Wynnet, et al. “Examining the Relationship between Stem Cell Treatment and Quality of Life in Recipients with Knee Conditions.” Journal of Bodywork and Movement Therapies, vol. 42, June 2025, pp. 452–62. DOI.org (Crossref), https://doi.org/10.1016/j.jbmt.2024.12.040.
  4. Regenerative Medical Products.” Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/review-services/reviews/0003.html. Accessed 6 July 2026.
  5. Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices - Japanese/English - Japanese Law Translation. https://www.japaneselawtranslation.go.jp/en/laws/view/3213. Accessed 6 July 2026.
  6. Guidance for Conditional and Time-Limited Approval for Regenerative Medical Products and the Development of Subsequent Efficacy Evaluation Plan. Accessed 6 July 2026. https://www.pmda.go.jp/files/000274350.pdf
  7. Yasunaga, Hideo. “Updated Information on NDB.” Annals of Clinical Epidemiology, vol. 6, no. 3, June 2024, pp. 73–76. PubMed Central, https://doi.org/10.37737/ace.24011.
  8. Shida, Haruka, et al. “Use of National Database of Health Insurance Claims and Specific Health Checkups for Examining Practical Utilization and Safety Signal of a Drug to Support Regulatory Assessment on Postmarketing Drug Safety in Japan.” Frontiers in Medicine, vol. 10, Feb. 2023, p. 1096992. PubMed Central, https://doi.org/10.3389/fmed.2023.1096992.
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