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韩国原研药专利到期后市场份额与销售增长的五年分析

A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea.

作者信息

Bae Minyoung, Shim Sung Ryul, Yang Dong-Wook, Son Kyung-Bok, Lee Sang-Won

机构信息

School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do, Republic of Korea.

Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon-si, Republic of Korea.

出版信息

Ther Innov Regul Sci. 2025 Mar;59(2):349-358. doi: 10.1007/s43441-025-00741-x. Epub 2025 Jan 10.

Abstract

INTRODUCTION

The sales patterns of original drugs after patent expiration in Korea show a relatively high market share and continuous sales growth differently from those in the U.S. and European countries. This study aims to investigates a five-year sales pattern of original drugs after patent expiration in Korea using empirical data.

METHODS

Using data from the Ministry of Food and Drug Safety, original drugs whose patents expired in 2012-2018 were extracted. And we used IQVIA data to determine the market share and sales growth rate of 48 original drugs, whose generic drug launched for the first time in the same molecule market, and whose sales data over five years after first generic entry were available. We analyzed the differences by the attribute of variables.

RESULTS

The sales volume of original drugs in the fifth year (Q 20) had an average growth rate of 150.6% compared with that before the first generic drug launched, indicating a continuous growth. The average market share of original drugs in the fifth year (Q 20) decreased to 70.6%, but it was higher than previously reported research results in Korea and other countries. Differences were observed across the category of attribute.

CONCLUSION

This study demonstrated that while market share of original drugs is decreasing, the sales volume increased continuously until the fifth year, differently from those of other countries. Variations in sales patterns by attributes reflect unique dynamics in Korea.

摘要

引言

韩国原研药专利到期后的销售模式显示出与美国和欧洲国家不同的较高市场份额和持续销售增长。本研究旨在利用实证数据调查韩国原研药专利到期后的五年销售模式。

方法

使用食品药品安全部的数据,提取2012 - 2018年专利到期的原研药。我们使用艾昆纬数据来确定48种原研药的市场份额和销售增长率,这些原研药在同一分子市场首次推出仿制药,且有首次仿制药进入后五年的销售数据。我们按变量属性分析差异。

结果

与首次仿制药推出前相比,原研药在第五年(第20季度)的销量平均增长率为150.6%,呈现持续增长。原研药在第五年(第20季度)的平均市场份额降至70.6%,但高于韩国和其他国家此前报道的研究结果。在属性类别中观察到差异。

结论

本研究表明,与其他国家不同,虽然原研药的市场份额在下降,但销量在第五年之前持续增长。销售模式按属性的变化反映了韩国独特的动态。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73e9/11880101/ad342bc14e77/43441_2025_741_Fig1_HTML.jpg

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