Chronic Refractory Gout (CRG) Market is Projected to Witness Significant Growth by 2036 Owing to the Launch of Novel Urate-Lowering Therapies and Rising Burden of Uncontrolled Gout | DelveInsight

The Chronic Refractory Gout (CRG) Market is growing due to the rising prevalence of chronic gout, uncontrolled hyperuricemia, and increasing demand for effective urate-lowering therapies. Growing awareness of treatment-resistant gout and the development of pipeline candidates such as NASP (SEL-212), ABP-671, and AR882 are expected to further drive market growth during the forecast period.
DelveInsight, a leading market research firm, announces the release of its latest report, "DelveInsight's Chronic Refractory Gout (CRG) Market Insights, Epidemiology, and Market Forecast - 2036." This comprehensive report provides an in-depth understanding of Chronic Refractory Gout Epidemiology, CRG Market Size, Chronic Refractory Gout Market Forecast, current treatment landscape, CRG Clinical Trials, Chronic Refractory Gout Pipeline, emerging Chronic Refractory Gout Therapies, and market dynamics across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan (7MM).

Key Takeaways from the Chronic Refractory Gout Market

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The Chronic Refractory Gout Market Size across the 7MM is expected to witness robust growth by 2036, driven by increasing diagnosed prevalence, greater adoption of biologic therapies, expanding use of urate-lowering treatments, and the anticipated launch of several novel Chronic Refractory Gout Drugs. According to DelveInsight estimates, the 7MM market is projected to grow from approximately USD 2.94 billion in 2022 to nearly USD 10.07 billion by 2036, reflecting strong commercial potential for innovative therapies.

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According to DelveInsight's analysis, the total diagnosed prevalent cases of Chronic Refractory Gout in the 7MM exceeded 400,000 patients in 2025 and are expected to increase at a significant CAGR throughout the forecast period owing to improved diagnosis, longer disease duration, and increasing numbers of patients with treatment-resistant disease.

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The United States accounted for the largest Chronic Refractory Gout Treatment Market in 2025 and is expected to maintain its leadership throughout the forecast period due to higher disease awareness, increasing use of advanced biologic therapies, favorable reimbursement, and growing healthcare expenditure. The report estimates that more than 200,000 diagnosed prevalent cases of CRG were reported in the United States during 2025.

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The report further estimates that more than 10 million individuals in the United States were living with gout in 2025, while over 1.5 million were diagnosed with chronic gout, demonstrating the substantial patient pool that may progress to refractory disease despite standard urate-lowering therapy.

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Across the EU4 and the United Kingdom, Germany accounted for the highest diagnosed prevalent chronic gout population in 2025, while Italy reported the lowest diagnosed prevalence among the major European markets. Japan represented approximately 10% of the total diagnosed prevalent Chronic Refractory Gout cases across the 7MM during the same period.

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KRYSTEXXA (pegloticase) remains the only US FDA-approved therapy specifically indicated for patients with Chronic Refractory Gout who remain uncontrolled despite conventional treatment, representing the current standard of care for severe refractory disease.

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Leading Chronic Refractory Gout Companies, including Sobi, Amgen, Atom Therapeutics, Arthrosi Therapeutics, and others, are actively advancing innovative CRG therapies designed to improve serum uric acid control, reduce gout flares, resolve tophi, and improve long-term clinical outcomes for patients with uncontrolled gout.

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The promising Chronic Refractory Gout Pipeline includes NASP (SEL-212), ABP-671, AR882, and several additional investigational therapies expected to transform the future Chronic Refractory Gout Market through novel urate-lowering mechanisms and improved treatment convenience.

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Key Factors Driving the Chronic Refractory Gout Market

Rising Prevalence of Chronic Gout and Treatment-Resistant Disease: The increasing global prevalence of gout, driven by aging populations, obesity, metabolic syndrome, chronic kidney disease, hypertension, diabetes, and unhealthy dietary habits, has substantially increased the number of patients progressing to Chronic Refractory Gout (CRG). Despite the availability of conventional urate-lowering therapies, a significant proportion of patients fail to achieve target serum uric acid levels or continue to experience recurrent gout flares, creating a strong demand for innovative Chronic Refractory Gout therapies.

Increasing Demand for Novel Urate-Lowering Therapies: Current treatment strategies rely primarily on xanthine oxidase inhibitors (XOIs), uricosuric agents, and biologic therapies to reduce serum uric acid levels and prevent disease progression. However, many patients remain inadequately controlled due to poor tolerability, treatment resistance, immunogenicity, or multiple comorbidities. This unmet need is accelerating the development of next-generation urate-lowering therapies, URAT1 inhibitors, and novel biologics for the Chronic Refractory Gout Treatment Market.

Growing Awareness and Earlier Diagnosis: Improved physician awareness, updated rheumatology treatment guidelines, wider adoption of serum uric acid monitoring, and enhanced understanding of uncontrolled gout are facilitating earlier diagnosis of Chronic Refractory Gout. Earlier identification enables timely treatment escalation and better disease management, supporting continued market growth across the 7MM.

Strong Pipeline of Emerging Therapies: Pharmaceutical companies continue to invest in innovative therapies designed to provide superior serum uric acid reduction, fewer infusion-related reactions, improved safety, convenient oral administration, and better long-term disease control. The emergence of multiple late-stage pipeline therapies is expected to significantly expand the Chronic Refractory Gout Market over the coming decade.

Chronic Refractory Gout Competitive Landscape

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The Chronic Refractory Gout Pipeline is evolving rapidly with several innovative therapies under clinical development. Leading companies including Sobi, Atom Therapeutics, Arthrosi Therapeutics, and Amgen are actively developing novel Chronic Refractory Gout Drugs aimed at improving disease control in patients who fail to respond adequately to conventional urate-lowering therapy.

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The current treatment landscape is led by KRYSTEXXA (pegloticase), developed by Horizon Therapeutics and now marketed by Amgen following its acquisition of Horizon. KRYSTEXXA is the first and only US FDA-approved therapy specifically indicated for adults with Chronic Refractory Gout who remain uncontrolled despite conventional treatment. Administered via intravenous infusion every two weeks, the recombinant uricase enzyme rapidly lowers serum uric acid levels and promotes dissolution of urate crystal deposits, although its use may be limited by infusion reactions and immunogenicity.

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Among the most promising pipeline therapies is NASP (formerly SEL-212), being developed by Sobi. NASP is an investigational combination therapy designed to provide sustained serum uric acid reduction while minimizing anti-drug antibody formation. In September 2025, the US FDA accepted the Biologics License Application (BLA) for NASP for the treatment of uncontrolled gout, with a PDUFA target action date of June 27, 2026, representing one of the most significant upcoming milestones in the CRG Market.

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ABP-671, developed by Atom Therapeutics, is an investigational oral URAT1 inhibitor designed to reduce renal uric acid reabsorption and increase urinary uric acid excretion. As a once-daily oral therapy, ABP-671 has demonstrated promising serum uric acid reduction with favorable safety and tolerability, positioning it as a potential first-line option for chronic gout management.

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Another promising candidate, AR882, developed by Arthrosi Therapeutics, is a highly potent and selective URAT1 inhibitor intended to provide sustained urate lowering in patients with chronic and refractory gout. The therapy has demonstrated encouraging efficacy in reducing serum uric acid levels and is expected to further strengthen the competitive landscape of the Chronic Refractory Gout Treatment Market.

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Recent Developments in the Chronic Refractory Gout Market

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In September 2025, Sobi announced that the US FDA accepted the Biologics License Application (BLA) for NASP (formerly SEL-212) for the treatment of uncontrolled gout, assigning a PDUFA target action date of June 27, 2026.

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In September 2025, Atom Therapeutics reported that its global Phase IIb/III clinical trial evaluating ABP-671 successfully met its primary endpoint, demonstrating significant serum uric acid reduction together with favorable safety and tolerability in patients with chronic gout.

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In August 2024, the US FDA granted Fast Track Designation (FTD) to AR882 for the potential treatment of clinically visible tophi in patients with gout, supporting accelerated development of this investigational therapy.

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In July 2024, Sobi initiated a rolling Biologics License Application (BLA) submission for SEL-212, following positive results from the pivotal DISSOLVE I and DISSOLVE II clinical studies in patients with Chronic Refractory Gout.

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In July 2022, the US FDA approved KRYSTEXXA (pegloticase) co-administered with methotrexate, expanding its labeling to improve complete response rates among patients with uncontrolled gout based on supportive clinical evidence.

What is Chronic Refractory Gout (CRG)?

Chronic Refractory Gout (CRG), also referred to as treatment-resistant gout, uncontrolled gout, or refractory gout, is a severe form of chronic gout characterized by persistent hyperuricemia despite optimal conventional urate-lowering therapy. Patients frequently experience recurrent debilitating gout flares, chronic arthritis, persistent joint inflammation, severe pain, tophaceous deposits, progressive joint destruction, and substantial impairment in quality of life. The disease develops when serum uric acid levels remain above therapeutic targets, resulting in continued monosodium urate crystal deposition within joints and surrounding tissues. Diagnosis involves assessment of serum uric acid levels, clinical evaluation, imaging studies, and definitive identification of monosodium urate crystals in synovial fluid obtained through joint aspiration. Current treatment focuses on aggressive urate-lowering therapy, biologic agents such as KRYSTEXXA (pegloticase), lifestyle modifications, and emerging targeted therapies designed to achieve sustained serum uric acid control, prevent recurrent flares, resolve tophi, and improve long-term outcomes. The introduction of novel URAT1 inhibitors, combination biologics, and next-generation urate-lowering agents is expected to significantly transform the future Chronic Refractory Gout Market.

Chronic Refractory Gout Epidemiology Segmentation

The Chronic Refractory Gout epidemiology section provides insights into the historical and current Chronic Refractory Gout patient pool and forecasted trends for the leading markets. The Chronic Refractory Gout market report proffers epidemiological analysis for the study period 2022-2036 in the leading markets, segmented into:

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Total Diagnosed Prevalent Cases of Chronic Refractory Gout

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Age-specific Diagnosed Prevalent Cases of Chronic Refractory Gout

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Gender-specific Diagnosed Prevalent Cases of Chronic Refractory Gout

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Severity-specific Diagnosed Prevalent Cases of Chronic Refractory Gout

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Treated Cases of Chronic Refractory Gout

Scope of the Chronic Refractory Gout Market Report

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Therapeutic Assessment: Current marketed and emerging Chronic Refractory Gout Therapies

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Chronic Refractory Gout Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Refractory Gout Drugs and Market Outlook

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Key Companies: Sobi, Amgen, Atom Therapeutics, Arthrosi Therapeutics, and others

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Key Therapies: KRYSTEXXA (Pegloticase), NASP (SEL-212), ABP-671, AR882, and others

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Competitive Intelligence Analysis: SWOT Analysis and Market Entry Strategies

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Unmet Needs, KOL's Views, Analyst's Views, Chronic Refractory Gout Market Access and Reimbursement

To know more about Chronic Refractory Gout companies working in the treatment market, visit @ Chronic Refractory Gout Clinical Trials and Therapeutic Assessment [https://www.delveinsight.com/sample-request/chronic-refractory-gout-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=kspr]

Table of Contents

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Chronic Refractory Gout Market Report Introduction

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Executive Summary for Chronic Refractory Gout

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SWOT Analysis of Chronic Refractory Gout

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Chronic Refractory Gout Patient Share (%) Overview at a Glance

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Chronic Refractory Gout Market Overview at a Glance

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Chronic Refractory Gout Background and Overview

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Chronic Refractory Gout Epidemiology and Patient Population

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Country-Specific Patient Population of Chronic Refractory Gout

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Chronic Refractory Gout Current Treatment and Medical Practices

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Chronic Refractory Gout Unmet Needs

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Chronic Refractory Gout Emerging Therapies

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Chronic Refractory Gout Market Outlook

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Country-Wise Chronic Refractory Gout Market Analysis (2022-2036)

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Chronic Refractory Gout Market Access and Reimbursement of Therapies

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Chronic Refractory Gout Market Drivers

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Chronic Refractory Gout Market Barriers

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Chronic Refractory Gout Appendix

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Chronic Refractory Gout Report Methodology

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DelveInsight Capabilities

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Disclaimer

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About DelveInsight

About DelveInsight

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