Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and Germany

Shibata, Shoyo; Uemura, Ryotaro; Suzuki, Takeshi

doi:10.1177/2168479015604182

Cited by 16 publications

(20 citation statements)

References 17 publications

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“…Our results demonstrated that the mainstream of the current drug development focusing on anticancer drugs and especially on molecular targeted drugs, 25,26 and the highest ratio of molecular targeted agents in prescription pattern of drugs was observed in treatment of hematologic malignancies in Japan. 27,28 The findings of the present study suggested that medical costs for cancer as well as other diseases have continuously increased, although the pace of the increase may decline if precision medicine or related regulations are properly introduced.…”

Section: Discussionmentioning

confidence: 70%

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy

Shibata

Matsushita

Saito

et al. 2018

Ther Innov Regul Sci

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Section: Discussionmentioning

confidence: 70%

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy

Shibata

Matsushita

Saito

et al. 2018

Ther Innov Regul Sci

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“…6 Focusing in on the anticancer pharmaceutical market in Japan, there are indeed a lot of unmet medical needs, especially in oncology; with the indirect encouragement of the research and development of anticancer therapy by the Japan government, this area may be one of the most promising therapeutic areas in the near future. [7][8][9][10] In this context, drug development in Japan can be initiated with an eye on the global market, aiming for near-simultaneous regulatory approval for OVT products worldwide. 1 Of course, sufficient preclinical/clinical data must be collected to initiate drug development.…”

Section: Introductionmentioning

confidence: 99%

A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials

Matsuda

Karube

Aruga

2018

Ther Innov Regul Sci

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Oncolytic virus therapy (OVT) represents a new class of therapeutic agents in cancer treatment. The molecular and cellular mechanisms of action of OVTs have been evaluated in nonclinical/clinical phase trials. Various genetically modified viruses have been developed as oncolytic agents, and the first approval of an OVT for clinical use was issued by the US Food and Drug Administration in 2015. In this context, more and more clinical development of OVTs is anticipated in the future. This article provides a risk assessment of OVT based on the safety data obtained from all clinical trials to date using a publicly available database. The most common adverse events (AEs) observed in clinical trials have been infection-related symptoms such as fatigue, chills, fever, and nausea; few serious AEs have been observed, regardless of the kind of virus or transfected genes. In vivo systemic infusion of OVTs demonstrated a high percentage of AEs, but most AEs were manageable using common drugs. This paper describes OVTs' specific safety/toxicity profiles and encourages the performance of further clinical trials of OVTs to address the most serious challenges anticipated in the development of OVTs as a new class of drugs for the treatment of cancer.

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“…In 2014, Japan reportedly accounted for approximately 10% of global sales, which was the second largest share in the world. 1,2 Various differences have been reported between the current Japanese pharmaceutical market and markets of Western countries. The share of cardiovascular system drugs is relatively high among the top 100 drugs in the Japanese market, while that of antineoplastic and immunomodulating agents is relatively low.…”

Section: Introductionmentioning

confidence: 99%

Analysis of new molecular entity trends from 2006 to 2015 in Japan

Shibata

Fukumoto

Ozaki

et al. 2020

Journal of Generic Medicines

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Japan is one of the largest pharmaceutical markets in the world, and as such, pharmaceutical companies are intensively conducting research and development of new drugs in Japan. However, information on Japanese pharmaceutical market profiles is limited. In this context, we elucidated the market characteristics and trends of new molecular entities approved between 2006 and 2015 in Japan. Among antineoplastic and immunomodulating agents, the highest number was first approved in the United States, and for nervous system drugs, the highest number was first approved in Europe. The alimentary tract and metabolism and the musculoskeletal system were the therapeutic areas for which the most drugs were approved for the first time in Japan. Most of the musculoskeletal system drugs were developed by Japanese companies, and most of the antineoplastic and immunomodulating agents were developed outside of Japan. Using various performance indexes, such as market forecasts and significance of clinical benefits, we determined that the number of new molecular entities and market size increased and the number of drugs with significant clinical benefits decreased. These results suggest that new molecular entity innovation by Japanese companies has been decreasing and the government’s comparative method for pricing does not work well in Japan.

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Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and Germany

Abstract: These results suggest that the Japanese market will rival overseas markets in the near future. Pharmaceutical companies should seriously consider operating within Japan, whose market is currently transitioning to a global market.

Cited by 16 publications

References 17 publications

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy

A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials

Analysis of new molecular entity trends from 2006 to 2015 in Japan

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