Hyperuricemia Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Primary, Secondary), By Drug Type (Xanthine Oxidase Inhibitors, Nonsteroidal Anti-Inflammatory Drugs, Corticosteroids, Others), By Route of Administration (Oral, Injectable), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.78 Billion
CAGR (2026-2031)	6.89%
Fastest Growing Segment	Secondary
Largest Market	North America
Market Size (2031)	USD 7.13 Billion

Market Overview

The Global Hyperuricemia Market will grow from USD 4.78 Billion in 2025 to USD 7.13 Billion by 2031 at a 6.89% CAGR. The Global Hyperuricemia Market encompasses the development and commercialization of urate-lowering therapeutics and diagnostic tools aimed at managing elevated serum uric acid levels, a precursor to gout and chronic kidney disease. The primary drivers propelling market growth include the escalating global prevalence of gouty arthritis and the expanding geriatric demographics susceptible to metabolic disorders. Furthermore, widespread lifestyle shifts toward purine-rich diets and the concurrent rise in obesity rates are substantially increasing the patient pool requiring long-term pharmacological intervention, thereby stimulating demand for xanthine oxidase inhibitors and uricosuric agents.

However, market expansion is frequently hindered by poor patient adherence to chronic therapy and the potential toxicity associated with existing first-line medications. According to the American College of Rheumatology, in 2025, the national average disability-adjusted life year rate for gout in the United States increased by 93.7% over the preceding two decades, highlighting a growing burden that current management strategies have failed to fully mitigate. This gap in effective long-term care presents a formidable challenge to the industry, as safety concerns and compliance issues limit the consistent uptake of available treatments.

Key Market Drivers

The Rising Global Incidence of Gout and Asymptomatic Hyperuricemia stands as a primary catalyst for market expansion, driven by demographic shifts towards an aging society and evolving dietary patterns. As life expectancy increases, the geriatric population is expanding, leading to a higher frequency of crystal deposition diseases associated with reduced renal urate excretion. This demographic trend is compounded by the prevalence of high-purine diets and sedentary lifestyles, which accelerate metabolic dysfunction and widen the addressable patient pool requiring pharmacological intervention. According to a study published in PubMed Central, June 2025, the age-standardized prevalence rate of gout among older adults is projected to rise to 3,628.85 per 100,000 population by 2050, underscoring the long-term sustainability of demand for effective management solutions.

Simultaneously, the Escalating Burden of Chronic Kidney Disease (CKD) and Metabolic Disorders amplifies the necessity for hyperuricemia management, as elevated uric acid is both a complication and a potential progression factor for renal impairment. The market is increasingly driven by the clinical urgency to treat hyperuricemia in nephrology settings to prevent further kidney deterioration and manage cardiovascular risks. This intersection of comorbidities forces healthcare providers to prioritize aggressive urate monitoring and intervention. According to Scientific Reports, November 2025, a clinical investigation revealed that 65.6% of non-dialysis chronic kidney disease patients presented with hyperuricemia, highlighting the critical overlap between these conditions. Reflecting the commercial scale of this high-need segment, Amgen reported in February 2025 that its targeted gout therapy, KRYSTEXXA, generated $1.2 billion in sales during 2024, demonstrating the substantial market value generated by addressing severe and refractory cases.

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Key Market Challenges

The widespread issue of poor patient adherence to chronic therapy, compounded by safety concerns associated with first-line medications, stands as a critical barrier hindering the expansion of the Global Hyperuricemia Market. Although the potential patient base is expanding, the market's realized growth is significantly throttled because a large proportion of individuals discontinue treatment prematurely. This high discontinuation rate is frequently driven by the asymptomatic nature of hyperuricemia during inter-critical periods, which leads patients to underestimate the necessity of daily pharmacological intervention. Furthermore, fear of toxicity, such as severe cutaneous reactions or cardiovascular risks linked to standard xanthine oxidase inhibitors, causes hesitation among prescribers and patients alike, limiting the volume of long-term prescriptions.

This pervasive lack of compliance directly impacts market performance by reducing the frequency of prescription refills and diminishing the real-world efficacy of therapeutic agents. When treatment protocols are not sustained, patient outcomes stagnate, preventing the widespread adoption of higher-value therapies. According to the American College of Rheumatology, in 2025, survey data indicated that adherence to recommended dosing standards for urate-lowering therapy remains suboptimal, with less than 50% of treatment regimens fully aligning with the guidelines necessary to maintain target serum urate levels. This gap in effective utilization ensures that a substantial segment of the addressable market remains under-monetized, preventing the industry from capitalizing on the rising prevalence of the disease.

Key Market Trends

The Rapid Emergence of Novel Selective URAT1 Inhibitors is transforming the treatment landscape by addressing the efficacy limitations of existing xanthine oxidase inhibitors. Pharmaceutical developers are increasingly prioritizing high-potency uricosuric agents that directly target renal transporters to enhance uric acid excretion, offering a viable alternative for patients who fail to achieve target serum levels with standard oral therapies. This clinical shift is exemplified by the advancement of next-generation candidates designed to maximize efficacy while minimizing renal toxicity. According to FierceBiotech, September 2025, in the 'Atom claims phase 3 win shows gout drug can beat competition in efficacy, safety' article, Atom Therapeutics reported that its novel URAT1 inhibitor, ABP-671, achieved a 91% response rate in tophus diameter reduction by week 28 in a pivotal Phase 2b/3 clinical trial.

Simultaneously, a Shift Toward Biologic Combination Therapies for Refractory Gout is targeting the severe patient segment unresponsive to conventional oral medications. This trend focuses on integrating recombinant uricase enzymes with immunomodulatory technologies to mitigate anti-drug antibody formation and sustain therapeutic potency. These advanced regimens are critical for rapidly debulking crystal deposits in chronic cases, preventing irreversible joint damage. According to Pharmacy Times, January 2025, in the 'SEL-212 Shows Promise in Treating Chronic Refractory Gout with High Response Rates' article, the novel combination therapy SEL-212 demonstrated a response rate of 56% in maintaining serum urate levels below 6 mg/dL in high-dose cohorts, validating its potential to address significant unmet needs in the refractory setting.

Segmental Insights

The Secondary segment is identified as the fastest-growing category in the global hyperuricemia market due to the increasing occurrence of underlying health conditions. This growth is primarily fueled by the rising global rates of Type 2 diabetes, obesity, and kidney diseases which disrupt natural uric acid regulation. Furthermore, the frequent use of ongoing medications for these chronic illnesses often leads to higher uric acid levels as a side effect. Consequently, as the number of patients treated for these metabolic issues rises, the demand for managing secondary hyperuricemia expands at a rapid pace.

Regional Insights

North America holds the leading position in the global hyperuricemia market, driven by the high prevalence of gout and related metabolic conditions across the region. This dominance is supported by an established healthcare infrastructure that enables high diagnostic rates and consistent treatment adoption. Furthermore, the presence of major pharmaceutical manufacturers fosters continuous product development. The regulatory framework, guided by the US Food and Drug Administration, facilitates the approval and commercialization of new therapeutics, ensuring that patients have access to necessary medications for managing elevated uric acid levels effectively.

Recent Developments

• In September 2025, Sobi announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application for a new investigational therapy aimed at treating uncontrolled gout. The application for the drug, a combination of nanoencapsulated sirolimus and pegadricase, was supported by positive results from two pivotal Phase 3 clinical trials which demonstrated significant improvements in serum urate levels compared to placebo. The company noted that the regulatory agency set a target action date for mid-2026. This milestone followed an earlier Fast Track designation, underscoring the demand for new options for patients refractory to standard treatments.
• In December 2024, Atom Therapeutics entered into an exclusive commercialization agreement with China Medical System Holdings for its lead drug candidate, ABP-671, which targets chronic gout and hyperuricemia. Under the terms of the collaboration, the partner company secured exclusive rights to commercialize the novel oral URAT1 inhibitor across Greater China. Atom Therapeutics, which officially rebranded from Atom Bioscience earlier that year, intends to leverage the partner's extensive academic network to accelerate market access in the region. The drug is designed to reduce renal re-absorption of uric acid and was concurrently undergoing global late-stage clinical trials.
• In October 2024, Protalix BioTherapeutics announced that it would present positive data from a Phase I clinical trial of its investigational gout therapy, PRX-115, at a major rheumatology conference. The biopharmaceutical company reported that the study results demonstrated the candidate's ability to rapidly and sustainably lower plasma urate levels after a single intravenous administration. The drug, a recombinant PEGylated uricase produced through a proprietary plant cell-based expression system, is being developed to treat patients with uncontrolled gout who have not responded sufficiently to available oral therapies.
• In August 2024, Arthrosi Therapeutics received Fast Track designation from the U.S. FDA for its novel drug candidate, AR882, specifically for the treatment of clinically visible tophi in patients with gout. The company’s leadership highlighted that this regulatory status acknowledged the debilitating nature of the condition and the potential of the next-generation URAT1 inhibitor to address significant unmet medical needs. The designation allows for more frequent interactions with the regulator to expedite the development and review process for the drug, which had previously shown promising efficacy in reducing serum urate and dissolving tophi in Phase 2 studies.

Key Market Players

• Takeda Pharmaceutical Company Limited
• AstraZeneca plc
• Horizon Therapeutics plc
• Novartis AG
• Sanofi S.A.
• Teijin Pharma Limited
• Mylan N.V.
• Hikma Pharmaceuticals PLC
• Dr. Reddy’s Laboratories Ltd.
• Sun Pharmaceutical Industries Ltd

By Type	By Drug Type	By Route of Administration	By Distribution Channel	By Region
Primary Secondary	Xanthine Oxidase Inhibitors Nonsteroidal Anti-Inflammatory Drugs Corticosteroids Others	Oral Injectable	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Hyperuricemia Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Hyperuricemia Market, By Type:

• Primary
• Secondary

• Hyperuricemia Market, By Drug Type:

• Xanthine Oxidase Inhibitors
• Nonsteroidal Anti-Inflammatory Drugs
• Corticosteroids
• Others

• Hyperuricemia Market, By Route of Administration:

• Oral
• Injectable

• Hyperuricemia Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Hyperuricemia Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE