2006 - 2015年日本新分子实体趋势分析

Shoyo Shibata, Daigo Fukumoto, Koken Ozaki, Takeshi Suzuki
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引用次数: 0

摘要

日本是世界上最大的医药市场之一,因此,制药公司正在日本密集地进行新药的研究和开发。然而,关于日本制药市场概况的信息有限。在此背景下,我们阐明了2006年至2015年在日本批准的新分子实体的市场特征和趋势。在抗肿瘤和免疫调节剂中,数量最多的是在美国获得批准,而在神经系统药物中,数量最多的是在欧洲获得批准。消化道代谢和肌肉骨骼系统是日本首次获批药物最多的治疗领域。大多数肌肉骨骼系统药物是由日本公司开发的,大多数抗肿瘤和免疫调节剂是在日本以外开发的。利用市场预测、临床获益显著性等各项绩效指标,确定新分子实体数量和市场规模增加,临床获益显著的药物数量减少。这些结果表明,日本企业的新分子实体创新一直在减少,政府的比较定价方法在日本并不适用。
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Analysis of new molecular entity trends from 2006 to 2015 in Japan
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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