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 2021, there were 49.2 million prevalent cases of gout in people aged 20 years and older worldwide, and forecasts that number to increase to 52.9 million prevalent cases by 2030.
• 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.
• The majority of industry-sponsored drugs in active clinical development for gout are in Phase II, with just one drug in Phase III. 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 the remainder being tested as intravenous, topical, and transdermal formulations.
• High-impact upcoming events for drugs in the gout space comprise topline Phase III trial results for SEL-212, and an expected PDUFA date for Krystexxa.
• The overall likelihood of approval of a Phase I arthritis asset is 8.3%, and the average probability a drug advances from Phase III is 79.5%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.5 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 70% of trials in Phase I–II, and 30% 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 China 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 61 trials.
• AstraZeneca leads industry sponsors with the highest overall number of clinical trials for gout.