Gout market across 7MM set to reach $10.8 bn in 2032 fueled by novel ULTs and rising prevalence: GlobalData

The sales growth of gout therapies across the seven major markets (7MM: the US, 5EU, and Japan) is set to increase at a compound annual growth rate (CAGR) of 8.8 per cent from $4.6 billion in 2022 to $10.8 billion in 2032, in line with the steadily increasing disease prevalence and the entrance of novel agents, according to GlobalData.

GlobalData’s latest report, “Gout Market Opportunity Assessment, Epidemiology, Clinical Trials, Unmet Needs and Forecast to 2032,” reveals that there are nine therapies in the late-stage pipeline, most of which are urate-lowering therapies (ULTs) entering the US and Japan markets from 2025 onwards.

Akash Patel, Pharma Analyst at GlobalData, comments, “Projected for a 2025 release in Japan, Dotinurad, a pediatric URAT1 inhibitor, is set to debut alongside pegdricase, a recombinant enzyme therapy, launching in the US the same year. Following these, the US market anticipates the 2026 introduction of additional URAT1 inhibitors – ABP-671 and SAP-001 – along with tigulixostat, a xanthine dehydrogenase inhibitor, and a topical sodium bicarbonate therapy.”

These ULTs are expected to total to $673 million in sales by 2032, equating to 6 per cent of the sales across the 7MM and the urate-lowering therapies class is expected to have the largest sales at $5.2 billion by 2032 with a CAGR of 13.1 per cent. These therapies are likely to adopted for patients with chronic gout or with hyperuricemia that is likely to lead to gout in the long-term.

Towards the forecast period’s end, two additional anti-inflammatory therapies are expected to debut. Canakinumb, set for a 2030 launch, is a biosimilar to the established Ilaris therapy. With Ilaris’ US patent expiring in 2024, this biosimilar is anticipated to enter the market and potentially diminish Ilaris’ share.

Dapansutrile is the second anti-inflammatory therapy that is forecasted to launch in 2026. It is a inflammasome inhibitor that may potentially offer an improved safety profile for long-term use compared to the current treatment regimen of NSAIDs.

In 2022, there were several drug classes on the gout market: anti-inflammatory therapies (AI) for acute attack treatment, anti-inflammatory therapies (AI) for prophylaxis, and ULTs. About 15 marketed therapies, many of which are now generics, generated a total sales of $4.6 billion during the year.

Patel concludes, “The pivotal factors for securing reimbursement and coverage for late-stage pipeline ULTs are the cost-to-benefit ratio and quality-added life years (QALYs). Currently under development by Dyve Biosciences, the topical sodium bicarbonate therapy is yet to enter a Phase III trial. Should the trial proceed as planned and demonstrate notable efficacy in treating gout and crystallisation in affected joints among adults, it holds the potential to capture a substantial market share, offering a cost-effective alternative to pricier ULT therapies.”