What is life cycle management?

Life cycle management (LCM) is the process of planning for and managing the strategy around a drug’s place in the market from prior to regulatory approval through expiration of the patent or loss of exclusivity. LCM can include planning for follow-on studies after initial approval and potential label extensions.

Pricing can also be an important part of the LCM process as price hikes are typically lower in the earlier years of a drug’s life while focus is likely more on growth of the market and uptake, whereas when the drug nears generic or biosimilar competition, price hikes may be more common. In line with this, large capital investments such as new randomized clinical trials are more likely in the earlier years and investments in the product may go down as the long-term opportunity fades over time.

Market research, advisory boards, and forecasting are all very important parts of LCM as they help establish the potential opportunity for a given strategy.