Informa Pharma R&D Annual Review 2017
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Pharmaprojects Pharma intelligence | Pharma R&D Annual Review 2017 Ian Lloyd, Senior Director Pharmaprojects & Data Integration Introduction Welcome to Pharmaprojects’ 2017 review of trends event, a royal wedding, or a soap opera death, but in pharmaceutical R&D. For around a quarter of a a beautiful nature documentary featuring snow century now, I’ve been taking an annual look at leopards. British audiences swooned over the BBC’s the evolution of pharma R&D, and in this article, I’ll latest wildlife documentary series, Planet Earth look at how the land lies at the start of 2017. We’ll II, helmed as ever by the comforting presence of assess industry trends by examining the pipeline 90-year old Sir David Attenborough, venerated by company, therapeutic area, disease, target and throughout the realm as broadcasting royalty. This drug type, using data from Pharma Intelligence’s six-part televisual treat was stuffed with truly jaw- Phamaprojects, which has been tracking global dropping footage: goats clambering up sheer vertical drug development since 1980. This report will be cliffs, wild Mustang stallions fighting to gain control followed up by our annual supplement reviewing of a Nevada waterhole and its associated females, the New Active Substance launches for the year just rhesus macaques free-running their way across the past. But here, we will be focusing on research and buildings and roofs of Jaipur to conduct dawn raids development as it is now, how it is changing and on food from the local street market, and tiny glass mutating, and where it has been headed during frogs defending their eggs from attacking wasps by 2016. delivering a sharp boot to the face. Each film was full of astounding footage of amazing animals doing 2016, with the benefit of very near hindsight, looks extraordinary things, and couldn’t help but leave its to have been a momentous year for the world at audience in a state of perpetual wonder. large – and not necessarily all in good ways. Leaving aside the wailing and gnashing of teeth at the Whilst reminding us, as a climate change sceptic seemingly endless parade of celebrity deaths which takes office as leader of the free world, what an swept across social media almost daily, and the amazing and precious world we are lucky to share ongoing unspeakable humanitarian disaster of the in, I couldn’t help but be struck by some parallels Syrian civil war, two democratic rabbits out of hats from the show in how the natural world functions will undoubtedly change the fortunes of many for and the machinations of our own little biosphere, a generation. Few foresaw the UK’s Brexit vote, and the pharmaceutical industry. Our habitat has many still cannot quite believe that Donald Trump limited resources, but a growing population of is the US President. Whatever your views on these differing creatures all vying for their share. Some events, they unarguably have changed the direction animals are naturally top of the food chain, but of travel for most of the world, and will have wide- need to constantly compete to stay pack leaders. reaching consequences for us all. While it’s too early Meanwhile, there is huge biodiversity at the to detect their influence on pharma R&D, few would other end of the scale, but many of our smaller argue that that they won’t have any effect. community members continually face the risk of extinction, or of being gobbled up by their larger So in a world where it sometimes felt that the neighbours. And everyone is looking for that unique humans were making rather a hash of things, some property which will give it an evolutionary advantage sought solace last year in the somewhat purer or its own niche. So let us venture, bullwhip and motivations of the animal kingdom. In the UK, fedora in-hand, Indiana Jones-style, into the the highest rating TV programme in 2016 (leaving pharma jungle, and marvel at the creatures lurking aside, as I feel we should, a rather eccentric local there and the strategies which they are employing show about, ahem, baking cakes), was not a sports to not only survive, but to proliferate. 2 / February 2017 © Informa UK Ltd 2017 (Unauthorized photocopying prohibited.) Total pipeline size – The pharma forest is teeming with life We are starting our zoological survey as always by development by pharmaceutical companies, from taking a complete census of the pharma biosphere. those at the preclinical stage, through the various Figure 1 shows the total number of drugs in the stages of clinical testing and regulatory approval, R&D pipeline as of January 2017, and how this has and up to and including launch. Launched drugs changed since the start of the century. By pipeline are still counted, but only if they are in still in here, we mean that we are counting all drugs in development for additional indications or markets. Figure 1: Total R&D Pipeline Size by Year 2001-2017 16000 14872 14000 13718 12300 12000 11307 10452 10479 10000 9605 9737 9713 9217 8000 7737 7360 7406 6994 6416 Drug Count 6198 6000 5995 4000 2000 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Source: Pharmaprojects®, January 2017 This year’s figure is a massive 14,872 pipeline Ultimately, any biological entity exists to produce projects, an increase of 8.4% on the corresponding offspring, and in the pharmaceutical industry, figure from 2016. And as the graph clearly shows, perhaps its ‘children’ are new drug launches. If it this continues the steep upward climb seen over doesn’t successfully and continually bring new and the past five years. However, it is worth noting that innovative entities to the market, the organization the rate of increase has slowed somewhat – it was must gradually become moribund, affecting its 11.5% through 2015-16, and 8.8% the previous ability to continue to fund innovative R&D. In other year. But I think it’s a little early to suggest that words, the pipeline cannot expand indefinitely if its the pipeline population is about to peak. Just as end products start to diminish. one swallow does not make a summer, a slight slowdown over one year doesn’t necessarily indicate It’s therefore interesting to note that the rate of that resource constraints are starting to have an pipeline expansion fell back a little following a year effect on restricting pipeline expansion. But it where the number of new active substance (NAS) certainly makes next year’s figure an intriguing launches was lower than the preceding year (46 in prospect. 2015 vs 63 the previous year). The NAS number for © Informa UK Ltd 2017 (Unauthorized photocopying prohibited.) February 2017 / 3 2016 is still being finalized at the time of writing, but launches to replenish their ecosystem, otherwise it will certainly be lower still than that in 2015. Are they will find they start to compete more heavily we beginning to see the fall in pharma’s birth rate for dwindling resources. Check back in the spring for starting to peg back its population growth? All the our NAS supplement to see which way the wind is animals in pharmaland are depending on new drug blowing. The 2017 pipeline by phase – Baby boom leads the way, but growth throughout the family Whatever the long-term fate of the size of the growth occurred at the preclinical stage, with an pharma pipeline, it’s encouraging to see that extra 632 hatchlings joining the brood of early drug the 8.4% growth is spread once again across candidates, a rise of 9.2%. But there are increases all development phases. Figure 2 compares the across the board throughout the clinical and later number of drugs at each stage of development regulatory phases, which suggests that the pipeline with the equivalent data for last year. The greatest colony as a whole is flourishing. Figure 2: Pipeline by Development Phase 2017 vs 2016 8000 7493 6861 7000 6000 5000 4000 Drug Count 3000 2357 2064 2261 2000 1856 1395 1025 1273 1000 954 220 197 116 79 102 70 0 Preclin Phase I Phase II Phase III Pre-reg Registered Launched Suspended 2016 2017 Source: Pharmaprojects®, January 2017 4 / February 2017 © Informa UK Ltd 2017 (Unauthorized photocopying prohibited.) Preclinical figures will always be more difficult to candidates at this first stage in humans increasing gauge accurately, but due to the need to register by an impressive 11.2%. This number is now at trial protocols with relevant authorities, data is very almost twice the number of that seen ten years ago. robust across the clinical phases. So perhaps one of The corresponding values for Phase II and Phase III the best measures of pipeline health is looking at are 4.2% and 7.4%, respectively. While increases the herd migrating through the challenging terrain in clinical candidate numbers are generally to be of clinical trials. Here, we can take a longer view welcomed, there are two caveats. One, all of these back across a decade, to examine population growth increase rates are lower than those seen a year ago, in this most important family of drugs. the Phase III figure considerably so (it rose by 18.1% last year). Two, clinical trials are a cost. Unless they As Figure 3 shows, while there were increases in the are leading to new drug progeny, they are simply numbers of drugs at every clinical phase, this year, using up the valuable and limited resources of the Phase I saw the greatest rise, with the number of pharma ecosystem.