|
KMID : 1142220220170020129
|
|
Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 2 p.129 ~ p.136
|
|
|
The Trend of Changes in Substance Types and Corporate Characteristics in the Era of the New United States FDA-approved Drug
|
|
Hyun Jae-Won
Lee Sang-Won
|
|
|
Abstract
|
|
|
|
This study attempted to study the trend of changes in corporate characteristics such as corporate age, corporate size, and corporate nationality by dividing new drugs developed through FDA's CDER into chemical and bionew substances by era for 30 years from 1990 to 2019. In the aspect of the corporate age, the corporation exceeding 20 years has shown strength for 30 years for the chemical new drug field, but there was no constant direction of change observed. In contrast, the new biologics field showed definite growth for corporations exceeding 20 years. In the aspect of the corporate size, the proportion of the corporation groups other than the top 20 was increasing in the field of chemical drugs, while the proportion of the top 20 corporation groups continued to increase in new biologic drugs, showing conflicting results. The result of the analysis about corporate nationality indicates that the proportion of European corporations in the chemical new drug section was noticeably reduced, worthwhile the biologics drug decrease of the proportion of the US corporations and increase of European corporations was confirmed. In addition, pharmaceutical companies in Japan and other countries had no history of development for biologics drugs in the 1990s and 2000s. Besides, it was confirmed that they were successful in developing bio new drugs since 2010. Through this study, it was confirmed that the characteristics of new drug development corporations changed by the era according to the type of chemical and bio substance. This would be a good reference for the study of new drug development, in the aspect of the direction of change in substance type and corporate characteristics.
|
|
|
KEYWORD
|
|
|
FDA, New Drug Development, New Drug substance Types, by era, Corporate Characteristics
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|