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

• Updated approvals are very common LCM activities.
• New indication is a major LCM approach.
• Companies have become engaged in LCM activities in earlier R&D stages.
• New indication creates new value and also addresses clinical value.
• Well planned LCM activities are very powerful tools to manage uncertainty.

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.