Analysis of 10 years drug lifecycle management (LCM) activities in the Japanese market.

ABSTRACT

We investigated drug lifecycle management (LCM) activities in the Japanese market by examining new and updated approvals by the Pharmaceuticals and Medical Devices Agency (PMDA) between 2001 and 2010. PMDA gave a total of 726 approvals, of which 263 and 463 were new and updated approvals, respectively. Approvals for new indication comprised of more than 60% of updated approvals regardless of chemical or biological entities, therapeutic area and the company nationality. The case study on anti-rheumatoid arthritis biologics showed that the addition of new indications accelerated their sales exponentially. Thus, the development of new indications is an effective LCM approach for creation of new values of existing drugs.