In addition to the increased investment in pharmaceutical research and development (R&D) in terms of the expenditure mentioned in the research and development expenditure section, further complexities in the development of new medicines are due to the nature of the scientific work itself. This work is a lengthy, costly and challenging process, where only one in 5,000 researched new compounds receive regulatory authority approval, taking an average of 10–12 years to get there.
The following graphs present information about the new medicines pipeline and the proportions of those new medicines in key therapeutic areas.
Figure 1 – Global pipeline analysis, all therapeutic areas (ATC1), as of February 2014
Globally, in February 2014, there was a total of 7450 compounds in the pipeline across all therapeutic areas, and all stages/phases of R&D. The graph below shows in percentage (%) the various therapeutic areas the pipeline targets.
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Source: IMS Health Lifecycle 2013
Note: Data excludes ATC code T (Technology)
Figure 2 – Medicines in development globally by stage, as of February 2014
From discovery through to launch, a potential new medicine goes through several stages of development. The graph below shows the breakdown of potential new medicines in the industry’s pipeline at the start of this year (February 2014). In addition to the three phases of clinical trials mentioned in the graph, there is a fourth clinical trials phase called pharmacovigilance or safety monitoring which takes place after a medicine has been launched on the market. This phase collects information on how patients have experienced the use of the medicine.