Many analysts have recently pondered the industry’s apparent lack of innovation and high failure rate in drug discovery. Yet the US Food and Drug Administration (FDA) approved more than 40 new molecular entities (NMEs) in 2015, and the European Medicines Agency (EMA) recommended the approval of 39 new therapeutics last year. In fact, biopharmaceutical drug development has been experiencing one of its most productive periods. In the past decade, NMEs in the R&D pipeline have been rising by 6% each year and now exceed 10,000 active drug candidates targeting unmet and under-served medical needs1.
As the blockbuster has been in decline, the market for personalised treatments has grown in size and value. The Personalized Medicine Coalition (PMC) concluded that of the new FDA-approved drugs in 2014, more than 20% were personalised medicines2. Meanwhile, market researcher GlobalData reports the market value for one of the first personalised medicines – HER2-negative breast cancer therapeutics – is forecast to increase more than fourfold from its 2013 US$1.45bn value to an estimated $6.12bn by 2023.3 These figures suggest a different story from the media’s doom and gloom predictions for the pharma industry.
That said, it cannot be denied that the number of new drugs per billion dollars spent has dropped sharply in recent decades. But take into consideration that the industry is now tackling some of the least understood, more complex therapeutic areas such as oncology and CNS – and that regulators expect more effective, better targeted medicines with fewer side-effects.
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