Japanese Pharmaceutical Industry: Recent Perspectives and Areas for Further Research

The Japanese pharmaceutical market is one of the largest in the world. The Japanese government has increasingly been trying to control rising health care costs, and as a result, pharmaceutical companies are expecting that fewer opportunities will be available to command a higher price based on higher levels of innovation; this will likely lead to decreased interest in research and development (R&D) activities. With this background, the purpose of this article is to review current perspectives for R&D by the Japanese pharmaceutical industry, and to discuss the limitations and challenges for further research from the regulatory science and management perspectives. Given the substantial amount of evidence of regulatory science and management perspectives from the pharmaceutical industry outside of Japan and the limited amount of evidence from inside of Japan, it is important to review perspectives focusing on the Japanese pharmaceutical industry in comparison with those from other countries to understand the complexities of the Japanese pharmaceutical market, as well as the limitations and challenges associated with increasing productivity. https://doi.org/10.21423/jrs-v08shoy

Emerging Growth of Orphan Drugs for Neurological Diseases in Japan: Potential Benefits for Both Patients and Pharmaceutical Companies

Despite the existence of numerous rare neurological diseases, no studies have been conducted on orphan drugs for neurological diseases available on the Japanese pharmaceutical market and their potential benefits. In this context, from a statistical perspective, we investigated 1) the market position of orphan drugs in Japan, and 2) the market penetration of generic medicines. To the best of our knowledge, this is the first empirical study to examine the current status and development strategy of orphan drugs approved for neurological diseases in the Japanese pharmaceutical market. The perspectives provided by this research are expected to promote the clinical development of orphan drugs in Japan for patients suffering from intractable neurological diseases that currently have no known effective therapies. The dataset used in this research was generated from publicly and commercially available data sources in Japan. Marketing approvals for orphan neurological products have increased dramatically in recent years. As much as 10% of all drugs approved for neurological diseases in Japan were orphan drugs that met urgent medical needs. Six of these orphan drugs were ranked in top 500 best-selling drugs in Japan, which indicated the presence of a potentially large market. Compared with more conventional drugs, the prices of orphan drugs are not expected to be reduced. In addition, due to an apparent lack of competition from generics, the quantity of available orphan drugs has remained steady, suggesting stable long-term sales. Most orphan drugs in Japan have adopted innovative marketing strategies that divide major neurological diseases into a more specific variety of rare disease categories. We found that orphan drugs approved for neurological diseases in Japan have been launched steadily. It is unlikely that these drugs will be affected by regular price revisions and the launch of their generic counterparts. Based on these findings, the further development of orphan drugs in Japan should be encouraged in order to meet urgent medical needs and deliver innovative drugs to patients suffering from rare neurological diseases.https://doi.org/10.21423/jrs-v04n03p007 (DOI assigned 5/31/2019

A Comprehensive Analysis of Factors That Contribute to Conditional Approval and All-Case Surveillance Designations That Subsequently Lead to Shortening of Review Times in Japan

We examined conditional approval and all-case surveillance designations for new molecular entities investigated between 2000 and 2014 in Japan. Using univariate or multivariate logistic-regression analysis, this study attempted to clarify profiles that affect the receipt of these designations, and to provide guidance for effectively using conditional approval and all-case surveillance designations. Analysis showed that the highest number of drugs to which these systems were applied was category L (“Antineoplastic and immunomodulating agents”) of the Anatomical Therapeutic Chemical Classification System. Orphan drug designation (ODD) and L drugs were significantly correlated with the receipt of both conditional approval and all-case surveillance. These designations shortened the review time. Positive factors that shortened the period of review included ODD, using global data, and joining a global study. Bridging strategy was the only negative factor. Utilization of this Japan-specific PMS system can shorten drug lag, thereby securing the safety of Japanese subjects.https://doi.org/10.21423/jrs-v04n01p001 (DOI assigned 7/23/2019

Can Rare Cancer Drugs Expect Sales in Japan?: A Prescription Pattern Analysis of Drugs for Chronic Myelogenous Leukemia and Neuroendocrine Tumor

Despite high unmet medical needs, investment in rare cancer drug development has stagnated, likely because the potential market for such drugs is small. In this context, we hypothesized that rare cancer drugs could achieve a higher sales margin. A dataset was created from publicly available information obtained from the IQVIA Solutions Japan K.K. Pharmaceutical Market database on the website of the Pharmaceuticals and Medical Devices Agency/Ministry of Health, Labour and Welfare of Japan. The total amount of sales and prescription volumes between 2010 and 2016 for drugs whose indications include chronic myelogenous leukemia (CML) and neuroendocrine tumor (NET) were investigated. Regarding drugs for CML, the sales and prescription volumes of imatinib have been decreasing every year, whereas those of dasatinib and nilotinib have been increasing. Regarding drugs for NET, the sales and prescription volumes of sunitinib, everolimus, and streptozocin have been increasing every year. The present study revealed two sales models for the development of rare cancer drugs. First, sales amounts can be assured if clinical positioning with other existing drugs is sufficiently clear. Second, obtaining a label for rare cancers can stimulate drug development for more common cancers. These findings suggest that rare cancer drugs can offer high market value and profit potential; thus, to meet high unmet medical needs, clinical development programs for the development of rare cancer drugs should be promoted. https://doi.org/10.21423/jrs-v07shibat

Supplemental Material, TIRS-17-0136_rev_Supplemental_Table_1_20171104 - Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan

<p>Supplemental Material, TIRS-17-0136_rev_Supplemental_Table_1_20171104 for Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan by Shoyo Shibata, Maiko Matsushita, Yoshimasa Saito and Takeshi Suzuki in Therapeutic Innovation & Regulatory Science</p