This Market Spotlight report covers the Gout market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, recent events and analyst opinion, a 10-year disease prevalence forecast, probability of success, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 35.4 million prevalent cases of gout in people aged 15 years and older worldwide, and forecasts that number to increase to 39.4 million prevalent cases by 2028.
• The approved drugs in the gout space focus on targets such as microtubules, URAT1, xanthine oxidase, interleukin-1, and uric acid. These drugs are commonly administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
• Half of the industry-sponsored drugs in active clinical development for gout are in Phase I. Drugs in development for gout focus on targets such as uric acid, URAT1, xanthine oxidase, and NLR protein-3/inflammasome. The largest proportion of pipeline drugs are administered via the oral route, with two drugs being tested as intravenous and topical formulations.
• High-impact upcoming events for drugs in the gout space comprise topline Phase II trial results for ALLN-346, and topline Phase III trial results for SEL-212.
• The overall likelihood of approval of a Phase I arthritis asset is 8.4%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.3 years in the overall autoimmune/immunology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for gout have been in the early and midphases of development, with 72% of trials in Phase I–II, and 28% in Phase III–IV.
• The US has a substantial lead in the number of gout clinical trials globally. Germany leads the major European 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, with 72 trials.
• AstraZeneca leads industry sponsors with the highest overall number of clinical trials for gout.