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Published in: Journal of Translational Medicine 1/2020

Open Access 01-12-2020 | Research

The endless frontier? The recent increase of R&D productivity in pharmaceuticals

Authors: Fabio Pammolli, Lorenzo Righetto, Sergio Abrignani, Luca Pani, Pier Giuseppe Pelicci, Emanuele Rabosio

Published in: Journal of Translational Medicine | Issue 1/2020

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Abstract

Background

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). 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.

Methods

We 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.

Results

First, 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.

Conclusions

Our 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.
Appendix
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Footnotes
3
A disease is defined as rare if it has a prevalence of \(\le\) 200,000 affected individuals in the US. A disease is multifactorial when its causes are represented by the competition of several factors of a different nature, apparently not in direct connection between each other.
 
4
PCT patents are filed under the Patent Cooperation Treaty. The Patent Cooperation Treaty is an international treaty with more than 150 contracting states, which makes it possible to seek patent protection for an invention simultaneously in a large number of countries. A PCT patent application has the effect of a national patent application in all PCT contracting states.
 
5
According to the amyloid hypothesis, the main cause of Alzheimer’s disease is the accumulation and deposition of oligomeric or fibrillar amyloid \(\beta\) peptide [30].
 
6
ClinicalTrials.gov [31] is a database of privately and publicly funded clinical studies conducted around the world.
 
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Metadata
Title
The endless frontier? The recent increase of R&D productivity in pharmaceuticals
Authors
Fabio Pammolli
Lorenzo Righetto
Sergio Abrignani
Luca Pani
Pier Giuseppe Pelicci
Emanuele Rabosio
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Journal of Translational Medicine / Issue 1/2020
Electronic ISSN: 1479-5876
DOI
https://doi.org/10.1186/s12967-020-02313-z

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