Gout Therapeutics Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

Global Gout Therapeutics Market Trends and Insights

Rising prevalence of gout driven by aging & obesity

Global cases climbed to more than 53 million in 2024, a 22.4% jump in age-standardized rates since 1990, and the trend is most pronounced among men older than 55 where prevalence exceeds 2,500 per 100,000 individuals. Aging populations in high-income nations combine with escalating obesity in urbanizing Asia-Pacific economies, broadening the base eligible for long-term urate-lowering therapy. Pacific Island communities illustrate genetically driven hyperuricemia compounded by rapid dietary westernization, a pattern expected to replicate across emerging markets. Persistent demand growth underpins steady expansion of the gout therapeutics market in both established and nascent healthcare systems.

Treat-to-target adoption of urate-lowering guidelines

Guidance from European and US rheumatology societies recommending serum urate below 6 mg/dL has recast gout management from episodic flare control to proactive disease modification. Health insurers increasingly reimburse serial serum-urate testing, combination therapy, and specialist visits because evidence shows that achieving target levels mitigates cardiovascular events. Although only 28.9% of US gout patients receive urate-lowering therapy today, compliance is expected to rise as digital adherence tools and pharmacist-led programs scale. Wider guideline adherence boosts average treatment duration per patient, directly enlarging the gout therapeutics market.

Biologics & next-gen URAT1 approvals (e.g., AR882, SEL-212)

AR882 won FDA Fast Track in August 2024 after Phase 3 data showed 50% complete tophus resolution at 12 months, while SEL-212 entered a rolling BLA on superior efficacy to pegloticase. These agents directly address roughly 200,000 US patients with chronic refractory gout, shifting the competitive field toward precision urate transport inhibition. As renal-safe URAT1 inhibitors move through late-stage trials, payers view them as cost-offsetting alternatives for patients with CKD who cannot escalate xanthine oxidase inhibitors. Portfolio-diversified companies with biologics and small-molecule URAT1 assets stand to capture outsized share of incremental gout therapeutics market growth.

Fast-track FDA programs for refractory gout therapies

Two gout assets received Fast Track status in 2024, reflecting regulator acknowledgment of significant unmet need among the 3-5% of US patients unresponsive to existing drugs. Accelerated review trims development timelines by up to 18 months and incentivizes early investment in companion diagnostics. Developers leveraging expedited pathways can achieve first-mover advantage and command premium pricing, further contributing to revenue momentum in the gout therapeutics market.

Boxed-warning safety issues for febuxostat & long-term NSAID use

The February 2023 FDA boxed warning that links febuxostat to greater cardiovascular mortality restricted its use to allopurinol-intolerant patients, cutting addressable volume by 70-80% fda.gov. Takeda’s decision to withdraw branded Uloric in January 2025 underscores the commercial fallout. Similar cardiovascular and renal risk profiles limit extended NSAID courses, prompting prescribers to favor costlier but safer mechanisms such as URAT1 inhibition or biologics, which elevates therapy costs and complicates formulary access.

Poor adherence owing to chronic dosing & flare paradox

Adherence rates dip below 40% globally because initiating urate-lowering therapy often triggers flares that erode patient trust. The requirement for lifelong daily medication contrasts with patient expectations for episodic relief, and provider knowledge gaps around prophylactic anti-inflammatory cover exacerbate early discontinuation. Wearable uric-acid sensors and tele-rheumatology platforms are being deployed to flag non-adherence early, yet the behavior barrier continues to cap realized growth in the gout therapeutics market.

Segment Analysis

By Drug Class: URAT1 Innovation Challenges XOI Dominance

Xanthine oxidase inhibitors captured 46.34% of gout therapeutics market share in 2024 on the strength of inexpensive generic allopurinol and brand-loyal febuxostat users. The segment still expands, but its 4% CAGR lags behind URAT1 inhibitors, whose 8.12% rate is redefining the gout therapeutics market size for uricosurics. Clinical data show that URAT1 inhibition retains efficacy even when ABCG2 polymorphisms blunt allopurinol response in over 50% of patients. These genetic insights dovetail with payer interest in precision medicine, pushing formulary committees to re-evaluate step-therapy rules that historically favored xanthine oxidase inhibition.

Pipeline dynamism favors innovators. AR882 and dotinurad headline a cohort of small-molecule URAT1 agents designed for once-daily oral dosing without oxypurinol accumulation, offering renal-safe profiles and fewer drug-drug interactions. Recombinant uricase biologics hold their niche in chronic refractory gout where tophi burden is high; pegloticase revenues rose 33% year-on-year before Amgen’s acquisition of Horizon Therapeutics consolidated the category reuters.com. Meanwhile, IL-1 inhibitors such as canakinumab earned an adult-flare indication in December 2023^{[1]Source: Food and Drug Administration, “Ilaris (canakinumab) injection supplemental biologics license application approval letter,” fda.gov} , signaling expansion of anti-inflammatory biologics that complement urate-lowering backbones. Collectively, these evolving classes continue to broaden the gout therapeutics market by offering differentiated options matched to genetic, renal, and cardiovascular profiles.

Note: Segment shares of all individual segments available upon report purchase

By Route of Administration: Injectable Growth Outpaces Oral Dominance

Oral products generated 81.23% of 2024 revenue and remain indispensable for chronic therapy initiation, yet injectables are accelerating fastest at 8.45% CAGR as biologics penetrate earlier lines of care. Infusion-center build-outs and specialty-pharmacy expansion cut wait times and streamline reimbursement, lowering historical barriers associated with intravenous pegloticase. In real-world registries, pegloticase plus methotrexate achieves sustained serum-urate targets in two-thirds of previously uncontrolled patients, validating the clinical proposition for high-acuity cohorts. Injectable ACTH (Cortrophin Gel) is also gaining share in acute flare management, and its Phase 4 study seeks optimal dosing to capture under-served hospital and ambulatory settings.

Despite convenience advantages, oral adherence remains sub-optimal, driving interest in depot formulations and transdermal patches that could blur the oral-injectable divide. Developers are testing subcutaneous uricase candidates and long-acting IL-1 inhibitors aimed at quarterly dosing, potentially altering the calculus of patient preference. Should these formats prove non-inferior, injectable revenue could surpass earlier forecasts, further reshaping the gout therapeutics market.

By Disease Type: Tophaceous Gout Drives Therapeutic Innovation

Chronic refractory gout represented 52.40% of the gout therapeutics market size in 2024, but tophaceous gout’s projected 8.89% CAGR signals the next frontier of revenue growth. Advanced imaging—including ultrasound and dual-energy CT—detects monosodium-urate deposits sooner, expanding treatment-eligible cohorts mdpi.com. AR882’s 50% complete tophus resolution underscores the power of targeted URAT1 inhibition, while pegloticase combinations are setting new efficacy benchmarks in patients with established nodules. Such visible clinical gains translate into higher patient acceptance of biologic infusions despite cost and logistical hurdles.

Health-economic studies demonstrate that averting joint destruction and disability justifies biologic outlays, and payers increasingly reimburse aggressive early intervention. The therapeutic race for tophus clearance also catalyzes development of imaging-based companion endpoints, unlocking streamlined regulatory paths. Consequently, tophaceous gout’s expansion materially widens the gout therapeutics market and incentivizes pipeline investment in interventions capable of rapid tissue urate dissolution.

Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America generated 41.72% of 2024 revenue owing to early biologic adoption, broad insurance coverage, and widespread specialist availability. Treat-to-target guidelines enjoy strong professional-society endorsement, and payers often reimburse serial serum-urate tests, sustaining higher per-patient spending. The region’s dominance is reinforced by active clinical-trial networks that accelerate access to investigational URAT1 inhibitors and IL-1 biologics. Nevertheless, boxed-warning fallout and febuxostat discontinuation are reshaping formularies and nudging prescribers toward emerging mechanisms.

Europe contributes steady growth as universal coverage and stringent price controls temper margins. Uptake of biosimilars is higher, and health-technology assessment bodies require robust real-world data, slowing diffusion of new entrants. Yet the continent’s aging demographics and rising obesity sustain underlying demand, and centers of excellence in rheumatology produce influential guideline updates that ripple globally.

Asia-Pacific posts the highest 9.34% CAGR as rapid urbanization escalates metabolic syndrome prevalence. China’s gout prevalence is climbing alongside insurance expansion, prompting local firms such as LG Chem and JW Pharmaceutical to launch URAT1 programs that combine competitive pricing with tailored genetic screening. Pacific Island nations display some of the world’s highest serum-urate levels due to genetic predisposition, spurring public-health campaigns that could translate into pharmaceutical uptake once budget allocations rise. Tele-rheumatology and e-pharmacy platforms facilitate outreach to rural populations, amplifying product reach and strengthening the gout therapeutics market across diverse income strata.

South America and the Middle East/Africa together account for a smaller share today but exhibit double-digit unit growth as generics become more accessible and governments invest in non-communicable disease management. Sub-Saharan initiatives to train primary-care physicians in gout diagnosis, plus donor-funded screening programs, foreshadow future volume gains. Multinationals that localize manufacturing or deploy tiered-pricing models can capture early-mover advantages as these healthcare ecosystems mature.