PhI may still be a killing field of fail­ure but PhI­II suc­cess rates have surged, sig­nal­ing tec­ton­ic shifts in bio­phar­ma R&D

Those new drugs you see en­ter­ing the clin­ic with such promise and pride still suf­fer from a con­sis­tent­ly mea­ger suc­cess rate. And while Phase II suc­cess rates have edged up on­ly slight­ly, the odds have im­proved sub­stan­tial­ly for the drugs that are now go­ing in­to Phase III.

That’s the bot­tom line from a new analy­sis done by CMR In­ter­na­tion­al, which has been siz­ing up the suc­cess/fail­ure rates of 30 big and medi­um-sized bio­phar­mas, a group that in­cludes 16 of the top 20 play­ers.

In an analy­sis of the most re­cent set of da­ta stretch­ing from 2010 to 2018, pub­lished in Na­ture Re­views, their an­a­lysts found that the suc­cess rate of drugs start­ing out in Phase I has been con­sis­tent­ly bump­ing around in the mid-sin­gle dig­its for the past decade. Start­ing in 2010 through 2017 that rate has tracked steadi­ly at a poor 6% to 7%.

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