A retrospective observational study was performed to understand trends in new drugs (both chemical entities and biological drugs) launched in the UK between 1982 and 2011. The hypothesis that pharmaceutical innovation is declining was tested, and was found to be false. Even though the absolute numbers of new drugs has not declined, the cost of bringing a new drug to market has increased year over year since the 1950s. Development of a new compound has not become more efficient; the number of new drugs has not increased relative to the amount of R&D funding or time spent.
“Drug development times have been increasing; the time taken to bring a new drug to the market rose from approximately 3 years in 19602 to 12 years at the start of the new millennium.3 Notwithstanding the EMA’s (and FDA’s) attempts to accelerate approvals, these may reflect more rigorous processes and requirements, and higher rejection rates in establishing the safety and efficacy of new drugs.7 It has also been suggested that we are approaching the scientific and economic limits of innovation,37 so there may be a ceiling limiting drug discovery.”
Ward, D.J., Martino, O., Simpson, S., Stevens, A.J. 2013. Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK. BMJ; 3(2)