A new study has found that the number of new drugs entering the UK has actually increased over the past 40 years, despite concerns from the industry that was in fact in decline.
This is according to researchers from the University of Birmingham, writing in the BMJ Open Journal, who found that while there are “dips and peaks” during specific time periods, the longer term trend contradicts the widely held view that pharmaceutical innovation is declining, suggesting that the annual numbers of newly launched drugs may have increased since the early 1970s.
The researchers analysed data in the British National Formulary guide on drugs and looked at how many new medicines were added between 1971 and 2011.
The average number of drugs introduced per year was just under 23, varying from nine in the lowest year to 34 in the highest. The researchers said there were steep peaks and troughs over this period, including a dip between 1998 and 2006, but since this period, numbers have risen again.
It has meant in recent years there have been 0.16 more drugs being produced every year than there were in the 1970s, according to the University team.
Report author Dr Derek Ward, said: “We started this research because there was a great deal of pessimism within the industry and among pharmaceutical companies about the number of new drugs that were getting to the market.
“We found that looking at the data over the longer term there was a slight increase. This is obviously a good thing for patients, if more new medicines are becoming available.”
The team also found that after the USA, the UK is the next largest source of new chemical entities development, accounting for just over 10% of pharmaceutical innovation worldwide.
Dr Phil L’Huillier, from Cancer Research Technology, part of Cancer Research UK, said: “The landscape is shifting with pharmaceutical companies increasingly collaborating with academia for discovery and development of drugs. This more collaborative model is being applied to the high-risk innovative early stages of drug discovery, with companies taking on the highly expensive later stage development.”
‘Considerable’ increase in cost
The researchers also found that the cost per new drug produced is estimated to have grown at an annual compound rate of 13.4% since the 1950s; adjusting for inflation (3.7% per year) and other cost increases such as regulation (8.3%/year) increases the estimated cost per new drug considerably.
This may be a cause for concern, the authors note, and certainly for disappointment in the pharma industry.
Advances at the drug discovery stage in theory means that more new compounds can be investigated more quickly and the introduction of target-based drug discovery in the mid-1990s was a further promising breakthrough.
But the researchers say that drug development times have actually been increasing; the time taken to bring a new drug to the market rose from around three years in 1960, to 12 years at the start of the new millennium, increasing costs.
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. The authors add that we may be reaching the limits of innovation, and therefore a ‘drug discovery ceiling’, which could also help explain why R&D times have been increasing.