With the rebound in annual new drug approval rates and groundbreaking advances including the immuno-oncology revolution and pioneering gene and cell therapies reaching patients, optimism about biopharma industry productivity has risen substantially in the past few years. However, in the light of the ongoing debate about how new therapeutics will be paid for, the long-term sustainability of the current output is likely to depend heavily on the ability of pipeline products to provide meaningful benefits over existing treatment options in order to justify reimbursement.

Oncology is clearly an area of major unmet need, with a strong substrate of research advances to translate into new therapeutics, which is driving companies to focus in the area. However, it must be questioned whether, for example, in non-Hodgkin lymphoma (NHL) how many of the ~30 NMEs that are modelled to eventually reach the market based on the 179 that are currently in clinical trials for NHL (Fig. 1b) have strong potential to offer meaningful benefit to patients, rather than incremental improvements in outcomes, particularly as the market becomes more crowded. If it is the latter, there is a substantial risk that many of the projects may be terminated at some point because of a lack of potential for meaningful clinical benefit and commercial viability. A similar question could be asked about many of the other top 15 indications in Fig. 1b, 11 of which are in oncology. More broadly, given the intense debate about drug prices and higher barriers to commercial success, this analysis supports the view that a wider focus — including more of the multitude of difficult-to-treat conditions beyond oncology as well as clearly demonstrating value to cost-constrained health-care systems — will be needed for productivity to be sustained in the longer term.

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