Abstract
BackgroundStudies on the early 2000s documented increasing attrition rates and duration of clinical trials, leading to a representation of a “productivity crisis” in pharmaceutical research and development (R&D). In this paper, we produce a new set of analyses for the last decade and report a recent increase of R&D productivity within the industry.MethodsWe use an extensive data set on the development history of more than 50,000 projects between 1990 and 2017, which we integrate with data on sales, patents, and anagraphical information on each institution involved. We devise an indicator to quantify the novelty of each project, based on its set of mechanisms of action.ResultsFirst, we investigate how R&D projects are allocated across therapeutic areas and find a polarization towards high uncertainty/high potential reward indications, with a strong focus on oncology. Second, we find that attrition rates have been decreasing at all stages of clinical research in recent years. In parallel, for each phase, we observe a significant reduction of time required to identify projects to be discontinued. Moreover, our analysis shows that more recent successful R&D projects are increasingly based on novel mechanisms of action and target novel indications, which are characterized by relatively small patient populations. Third, we find that the number of R&D projects on advanced therapies is also growing. Finally, we investigate the relative contribution to productivity variations of different types of institutions along the drug development process, with a specific focus on the distinction between the roles of Originators and Developers of R&D projects. We document that in the last decade Originator–Developer collaborations in which biotech companies act as Developers have been growing in importance. Moreover, we show that biotechnology companies have reached levels of productivity in project development that are equivalent to those of large pharmaceutical companies.ConclusionsOur study reports on the state of R&D productivity in the bio-pharmaceutical industry, finding several signals of an improving performance, with R&D projects becoming more targeted and novel in terms of indications and mechanisms of action.
Highlights
Studies on the early 2000s documented increasing attrition rates and duration of clinical trials, leading to a representation of a “productivity crisis” in pharmaceutical research and development (R&D)
Notwithstanding the persistent contribution of scientific research to pharmaceutical R&D [2,3,4], in the early 2000s many concerns were raised on the ongoing process of drug development, which culminated in a diffuse perception of a “productivity crisis” [5, 6]
Signals have started to emerge of a change of tendency: (i) the number of New Therapeutic Entities (NTE) approved by year has increased regularly [10, 11]; (ii) research in oncology has benefited from the introduction of biomarkers for the targeting of therapies [12, 13]; (iii) several innovations are shaping the process of pharmaceutical R&D, from artificial intelligence to 3D printing for drug design and production [14, 15]
Summary
Data Data on R&D projects has been collected from R&D Focus, a comprehensive proprietary database on pharmaceutical R&D pipelines. Each pair (compound, indication), which defines an R&D project, is connected with information that reconstructs its development history. Statistical techniques Statistical tests To assess the significance of a change in productivity measures in two different time spans, we use Wilcoxon test [25], which is a nonparametric test to detect differences in the medians of two distributions To perform such a test on attrition rates, we compare the distributions of phase transitions, treated as a binary variable indicating failure/success for each phase occurrence, in the two time spans. The regression model for the generic response variable X can be written as: Ny. where OD is the binary variable classifying each project by either a relevant project according to the O–D relationship under study, or a baseline project (pharmaceutical as originator and developer both)
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