Global epidemiology of gout

November 21, 2017

Datamonitor Healthcare estimates that in 2016, there were 34.0 million prevalent cases of gout in people aged 15 years and older worldwide, and forecasts that number to increase to 37.9 million prevalent cases by 2025.

All of the industry-sponsored drugs in active clinical development for gout are in Phase II in the US. These therapies focus on targets such as uric acid, peroxisome proliferator-activated receptor (PPAR) gamma, the interleukin (IL)-1 receptor, and the immune system/reactive oxygen species/free radicals. The majority of pipeline drugs are administered via the oral route, with the remainder being intravenous and subcutaneous formulations.

The approved drugs in the gout space target microtubules, urate transporter 1, xanthine oxidase, and uric acid. These are commonly administered via the oral route, with one product being available in an intravenous formulation.

There were six licensing and asset acquisition activities involving gout drugs during 2012–17, three of which occurred in 2013.

The exclusive licensing agreement in 2016 between Ironwood and AstraZeneca worth $265m for the US rights to Zurampic(lesinurad) and the fixed-dose combination of lesinurad and allopurinol was the largest deal during the 2012–17 period.

Sales of Colcrys ranked highest among drugs in the gout space during 2012–16. However, during 2017–22, Ilaris is forecasted to have the largest amount of sales.

The distribution of clinical trials across Phase I–IV indicates that the majority of clinical trials for gout have occurred in Phase I–II, with 67% of trials in Phase I–II and 33% in Phase III–IV.

The US has a substantial lead in the number of gout clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.

Clinical trial activity in the gout space is dominated by completed trials. AstraZeneca has the highest number of completed clinical trials for gout.

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