Regulatory Process Overview – BASIC INFORMATION
Population Distribution in Japan (2023)
Japan has a long average lifespan, a high proportion of elderly citizens, and a balanced gender ratio.
Subject enrollment, tailored to the target disease of your product, is anticipated to be successful.
Source：https://www.populationpyramid.net/
Cancer incidence in Japan（2017-2020）
The annual number of cancer patients in Japan exceeds one million, with particularly high prevalence in digestive, respiratory, and breast cancers.
Oncology remains an area of significant unmet medical need, requiring innovative treatments.
| 2017 | 2018 | 2019 | 2020 | |
|---|---|---|---|---|
| All sites (including carcinoma in situ) | 1,093,280 | 1,099,164 | 1,123,038 | 1,055,728 |
| Large intestine (including carcinoma in situ) | 195,188 | 193,900 | 199,099 | 186,298 |
| Colon (including carcinoma in situ) | 132,303 | 131,487 | 134,735 | 126,202 |
| Lung (including carcinoma in situ) | 124,758 | 125,636 | 129,562 | 123,418 |
| Stomach | 129,476 | 126,009 | 124,319 | 109,679 |
| Breast (including carcinoma in situ) | 104,379 | 106,583 | 110,728 | 103,744 |
| Prostate | 91,215 | 92,021 | 94,749 | 87,756 |
| Rectum (including carcinoma in situ) | 62,885 | 62,413 | 64,364 | 60,096 |
| Uterus (including carcinoma in situ) | 51,291 | 52,346 | 53,247 | 50,873 |
| Bladder (including carcinoma in situ) | 42,627 | 43,242 | 44,096 | 43,270 |
| Pancreas | 40,981 | 42,361 | 43,865 | 44,448 |
Source: Cancer Statistics. Cancer Information Service, National Cancer Center, Japan (National Cancer Registry, Ministry of Health, Labour and Welfare)
Intractable diseases data (2022)
Numerous patient advocacy groups exist for intractable diseases, and they are publicly accessible.
You can expect to hear patients’ voices regarding their medical needs, and these advocacy groups often collaborate in clinical trials.
| Number of patients |
*Patient associations, etc. |
|
|---|---|---|
| Parkinson’s disease | 143,267 | X |
| Colitis ulcerative | 141,387 | X |
| Systemic lupus erythematosus | 65,145 | X |
| Crohn’s disease | 50,184 | X |
| Ossification of the posterior longitudinal ligament | 31,571 | X |
| Systemic Scleroderma | 27,013 | X |
| Spinocerebellar Degeneration (Excluding multiple system atrophy.) | 26,476 | X |
| Myasthenia Gravis | 26,387 | X |
| Dermatomyositis/Polymyositis | 26,046 | |
| Multiple sclerosis/Neuromyelitis optica | 23,105 | X |
| Eosinophilic sinusitis | 22,340 | |
| Retinitis pigmentosa | 21,263 | X |
- Numbers of designated intractable diseases: 341 (as of 1st April 2024)
- Ask CRO in Japan when you need detail information of Patient Associations
- Listed more than 20,000 patients designated intractable diseases. Other intractable diseases are also designated by Japan government, ask CRO in Japan when you need information of other designated intractable diseases.
*According to Japan CRO association’s research