Studie av livscykel hos nya läkemedel i Sverige som fick EMA godkännandet mellan 2006 och 2017

Sammanfattning: Abstract  Background  All products have a life cycle when they are on the market, including pharmaceutical products as they go through different phases from introduction, growth, maturation, to a declining phase.  Aim  To study the length of time for each phase for drugs approved in Sweden between 2006 and 2017, and to compare the times between the approval years studied and the various types of drugs such as oncology and orphan drugs.  Methods  The registry study was conducted in Sweden and is based on records of approved drugs with new substances in Sweden in 2004-2018. The time of the introduction phase was calculated from the EMA approval to the time of the TLV/NT decision. The growth phase was defined as time from the end of the introductory phase until sales reach 75% of maximum sales. The time of maturity phase was calculated from the end of the previous phase until the sales start to decrease or until introduction of generic drugs. The time for the onset of the decline phase was calculated from EMA approval to the end of the maturation phase.  Results  The median time of the introduction phase was approximately 9 months for all included drugs but was longer for products authorized in 2011 and 2012. The growth phase and maturation phase were estimated at about 5 years respectively 3 years. The decline phase started after about 10 years from the drug’s approval.  Conclusion  No obvious difference in time for the phases over time or between different types of drugs has been shown.