As the number of drug approvals declined between 2012 and 2013 by more than 30%, the value of new therapeutic agent approvals seems to indicate a stronger year than initially thought.
For instance, on a value basis, 2013 seems to be a better year than 2012 as 36 NTDs (new therapeutic drugs -- which includes bioengineered vaccines, combination products, enantiomers, prodrugs and therapeutic blood and plasma products) approved at an aggregate peak sale value of $39bn, compared to 40 NTDs and an aggregate peak sale value of $33bn in 2012, according to research from Boston Consulting Group researchers in Nature Drug Discovery .
The researchers calculated a long-term average of 32 NTDs and $32bn since the early 1990s, which was bested in 2013. It was also a year that saw its value more than three times higher than in 2008, which had an accumulated value of $12bn.
But a closer look at the 2013 approvals reveals a high concentration of blockbusters at the top. The top five products — Gilead’s Sovaldi: $8.4bn, Biogen Idec’s Tecfidera: $5.1bn, Genentech’s Kadcyla: $3.8bn, Janssen’s Imbruvica: $2.7bn, and Viiv’s Tivicay: $2.1bn — generated $22bn in peak sales, or almost 60% of the year's total.
The share of specialty drugs from 2013 also continued to grow, comprising more than 80% of the total peak sales value in 2013, which was the highest level ever recorded, and which represents “almost a complete inverse of the situation in the early 1990s, when it constituted less than 20%,” the researchers found.
And despite a significant focus on oncology, cancer drugs only constituted 26% of the year’s value, which was down from 36% in 2012. The largest area by value in 2013 was anti-infectives, with 29% of the year’s value.
Growth in R&D spending seems to have tapered off between 2008 and now, with grew a total investment in 2013 of $137bn, which matched 2012’s investment and was even slightly less than the $140bn invested in 2011.
The researchers also figured out that a company spending $1bn annually on R&D needs to generate, on average, new drug approvals with $250–350m in peak sales every year. “So, although not approaching the productivity ratios of the late 1990s and early 2000s, the industry moved back towards an acceptable productivity ratio overall in 2013,” the researchers wrote.
Companies with productivity ratios that suggest they are exceeding the cost of capital on their R&D spending included some large R&D spenders, such as Roche, Johnson & Johnson and GlaxoSmithKline, as well as relatively modest spenders such as Biogen Idec, Astellas and Bayer.
As far as the future is concerned, the researchers seem optimistic that the recent advancements will continue as long as the top companies continue to remain vigilant.
“Although it is unclear whether the recent trend will be sustained, we are cautiously optimistic that the significant efforts of much of the industry since 2008 to refocus its R&D strategies, to pursue promising biology and platform technologies, to continue in-licensing, and to redesign how it operates is starting to pay dividends,” the researchers wrote.