Citeline药品研发年度回顾2015

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1、1citeline Pharma r these records do not have a development phase.Source: Pharmaprojects, Jan 2015, Citeline5The most keenly-tracked data from this graph is always the numbers of drugs which are in the three stages of clinical development. Our information here is always extremely robust, by dint of o

2、ur collaboration with the leading worldwide source of clinical trials intelligence, Citelines Trialtrove. Here we can see increases across the board; of 4.9% at Phase I, 7.0% at Phase II, and 8.6% at Phase III. Overall, the total number of drugs currently at any clinical phase has gone up by 7.7% to

3、 4625. Its interesting to note that percentage figure, which is only just behind the overall pipeline expansion rate we saw at the top of this paper. This would suggest that there is significant growth in the pipeline not just across the board, but where it matters.To give this further context, we c

4、an take a peek further back along the clinical trials time tunnel, and see how these growth rates compare to those seen in recent history. This is what Figure 3 visualizes. Its clear from this that the last couple of years have seen things gearing up a little following disappointing data during the

5、2011-2013 period. We can even surmise that, with the Phase III numbers increasing at a faster rate than those in Phase II, that there is some slight improvement in attrition rates at the end of the latter development stage.It is worth commenting at this point, as we are often asked, on the reason fo

6、r the seemingly counterintuitive fact that the Phase II figure always exceeds that for Phase I, when clearly drugs drop out of development between the two phases. This is an effect produced by the snapshot nature of the data: because drugs spend far less time passing through Phase I, at any one time

7、, more are undergoing the much longer Phase II trials.Figure 3. Clinical Phase Trends 200720150 500 1000 1500 2000 2500 Phase I Phase II Phase III 200720082014 20132015 2011 2012 2009 2010 Source: Pharmaprojects, Jan 2015, Citeline6top companies steady state at the industrys centreMoving on to compa

8、ny pipelines, the Top 25 firms are very much the pharma industrys supermassive black holes, these days often growing by drawing smaller bodies into their orbit and swallowing them up. But not a whole lot of sizeable merger and acquisition activity happened during 2014. The exception to this is Actav

9、is, which absorbed Forest Laboratories mid-year and thus makes its debut in this years Table 1.GlaxoSmithKline, despite having somewhat mixed fortunes during the year, retains the top spot with a portfolio of almost unchanged size. Just below it, the two Swiss superstars, Novartis and Roche, trade p

10、laces, with the former taking this years second spot. Novartis actually has the most self-originated drugs of any company, although Lilly is the company whose pipeline has the highest proportion of homemade candidates.Of course, the big story of the year was AstraZenecas thus far successful attempts

11、 to repel alien invaders from the planet Pfizer. So a wry smile will probably dance across the faces of those helming the UK company when they see that AZs pipeline size has this year overtaken that of its US aggressor. Its R for the latter, enough to put them into the Top 10 for the first time. The

12、re is a notable (and ongoing) uptick in biosimilar research, while gene therapy yoyos back into the Top 25 again, having been out in 2014, in in 2013, and out in 2012.Switching to an ever more powerful lens, we now examine the pipeline as categorized by the 1,258 individual diseases, or indications,

13、 which we report in Pharmaprojects as having been the focus of at least some drug development. Here, among other things, we can see clearly the individual cancer types currently enjoying table 2. top 25 therapeutic categoriesPoSItIon 2015 (2014)theraPyno of r there is certainly no sign of a scientif

14、ic big bang suggesting drug development innovation is in an expansionary phase. But the galaxy of drug targets does continue to slowly expand.Figure 9. Number of New Drug Protein Targets Identified by Pharmaprojects by Year.72 107 92 102 97 67 179 89 68 77 0 20 40 60 80 100 120 140 160 180 200 2005

15、2006 2007 2008 2009 2010 2011 2012 2013 2014 Source: Pharmaprojects, Jan 2015, CitelineOnce again, its pretty much good news across the board in terms of the metrics covered in this report. And early signs indicate that 2014 was a stellar year for new drug approvals. 18an ever-expanding universe?The

16、 year 2014 saw the 50th anniversary of the discovery and confirmation of cosmic microwave background radiation, a finding which enshrined the Big Bang Theory as the prevailing doctrine describing the origin and evolution of the cosmos. Although opinions differ and theories still compete, most cosmologists believe that, rather than reaching a point when it begins to contract again, expansion of the universe will continue forever, but that the rate will slow and the unive

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