Abstract
Objective: This paper describes transitions in drug development in Japan over the past 20 years since the beginning of the 21st century by surveying drugs approved in Japan, doing so with a focus on new drugs originating in Japan (domestic-origin drugs).
Methods: A survey was conducted using the List of Approved New Drugs of the Pharmaceuticals and Medical Devices Agency (PMDA) to identify drugs containing new active ingredients (new drugs). For periods when the PMDA did not publish information, the authors used the Prescription Drug Package Insert XML and New Drug Application Review Report Database ─ New Drugs in Japan created by the Japan Pharmaceutical Information Center (JAPIC). Next, the domestic and overseas origins of the new drugs were investigated by referencing approval review reports, interview forms, and other documents of each company, and the modalities were then classified.
Results and Discussion: The number of domestic-origin drugs in Japan had been decreasing since the 1990s, but this trend reversed in the 2010s. While small-molecule drugs still account for the majority of approvals, the number of macromolecule biopharmaceuticals of domestic-origin drugs, including antibody drugs, has
been gradually increasing since 2005. In recent years, expensive biotech drugs, especially cancer therapy drugs, have dominated the pharmaceutical sales rankings, and new blockbuster drugs that target a large number of patients are becoming a thing of the past. The number of domestically produced macromolecule biopharmaceuticals, where Japan lagged behind, has been gradually increasing. The 20 years since 2001 can be described as a period of shift from small-molecule chemical pharmaceuticals to macromolecule biopharmaceuticals and multimodalities.
