Urate-Lowering Biologics Market Size, Clinical Trials, Product Pipelines and Investment Trends, till 2032

Urate-Lowering Biologics Market Size is estimated to be $800 million in 2024 and is expected to grow at an average yearly rate of around 8 during the timeframe (2025-2032).

What is Urate-Lowering Biologics and what are the growth drivers of Urate-Lowering Biologics Market?

Urate-lowering biologics are advanced therapeutic agents designed to reduce elevated levels of uric acid in the body, a condition known as hyperuricemia. High uric acid levels can lead to gout, a painful inflammatory arthritis characterized by the buildup of urate crystals in the joints. While traditional urate-lowering therapies like allopurinol and febuxostat have been widely used, biologics offer a targeted and often more effective approach for patients who are unresponsive to standard treatments or have severe forms of the disease.

Mechanism of Action and Clinical Role

Biologic therapies for gout typically function by either breaking down uric acid directly or modulating the immune system to reduce inflammation caused by urate crystals. For instance, enzyme-based biologics convert uric acid into more soluble compounds that are easily eliminated from the body. Other biologics act by inhibiting inflammatory pathways, such as those involving interleukin proteins, which are responsible for triggering pain and swelling during gout flares. These therapies are generally reserved for patients with chronic refractory gout or those with significant comorbidities who cannot tolerate traditional drugs.

Growing Burden of Gout and Hyperuricemia

One of the key drivers of the urate-lowering biologics market is the increasing global prevalence of gout and hyperuricemia. Lifestyle changes, aging populations, rising obesity rates, and poor dietary habits have contributed to a steady rise in gout cases worldwide. As awareness and diagnosis improve, more patients are seeking effective long-term management, especially those who do not respond well to conventional treatment options. This growing patient pool fuels demand for innovative therapies, including biologics.

Unmet Medical Needs

Many patients suffer from persistent gout symptoms despite using standard oral medications. This group, classified as having treatment-resistant or refractory gout, faces limited therapeutic options. Biologics have shown promising results in reducing serum uric acid levels and resolving tophi, which are hardened deposits of urate crystals. For this reason, healthcare providers increasingly view biologics as a viable solution to a critical gap in gout management.

Advances in Biotechnology and Drug Development

The pharmaceutical industry continues to invest heavily in biotechnology research, leading to the development of more targeted and efficient biologic therapies. Modern biologics are being engineered for longer-lasting effects, reduced side effects, and improved patient adherence. These innovations make biologics more appealing to both physicians and patients, accelerating their market adoption.

Favorable Regulatory and Reimbursement Policies

Governments and health insurance providers in many countries are recognizing the value of biologic therapies, especially in complex or high-need cases. Reimbursement policies are evolving to include biologics as part of the treatment landscape for severe gout. This support helps reduce the financial burden on patients and encourages wider usage of these therapies.

Emerging Markets and Global Expansion

In developing regions, where healthcare infrastructure is rapidly improving, access to advanced therapies is becoming more feasible. As these markets grow, so does the demand for effective gout treatments. Biologics are gaining traction as clinicians seek to offer cutting-edge care to an expanding base of chronic disease patients.



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Clinical Trials in Urate-Lowering Biologics Market and New Product Pipelines

The clinical trial ecosystem for urate‐lowering biologics is expanding rapidly, encompassing advanced enzyme therapies, IL‐1 inhibitors, novel uricosurics, xanthine oxidase inhibitors, and combination regimens. Late‐stage trials dominate, underscoring a shift toward more targeted, durable therapies.

Pegloticase and Combination Strategies

Pegloticase (Krystexxa) remains the only FDA‐approved biologic for refractory gout. Recent trials are exploring co‐administration with methotrexate or rapamycin‐based immune tolerance agents to reduce immunogenicity, minimize infusion reactions, and extend therapeutic benefit. The DISSOLVE I/II phase 3 studies evaluating SEL‐212-a pegylated uricase formulated with immune tolerance technology-show sustained urate control in roughly half of patients during treatment. Co‐therapy approaches are central to ongoing studies aimed at repositioning pegloticase as a longer‐term and safer option.

SEL‐212 and ImmTOR Combination

SEL‐212 combines a pegylated recombinant uricase with a rapamycin‐based immune tolerance platform to suppress anti‐drug antibody formation. Two pivotal phase 3 trials have shown consistent maintenance of serum urate below 6 mg/dL in a majority of participants. Additional investigations are focusing on optimizing dosing schedules and assessing long‐term safety data in refractory gout populations.

IL‐1β and NLRP3 Inhibitors

Bio‐inflammatory biologics targeting IL‐1β-like canakinumab, anakinra, rilonacept-and small‐molecule NLRP3 inflammasome inhibitors such as dapansutrile are advancing. Dapansutrile is now in phase 2/3 studies for acute gout flares, showing good safety, effective pain relief, and a more favorable profile compared to traditional NSAIDs. Trials involving prophylactic IL‐1β blockers seek to reduce flare incidence during urate‐lowering initiation by minimizing crystal‐induced inflammation.

Novel Oral Uricosurics and Xanthine Oxidase Inhibitors

A wave of next‐generation oral agents is progressing. Dotinurad (approved in Japan) is moving through trials for regulatory approval in North America and Europe. Verinurad, AR‐882, epaminurad, darbinurad (D‐0120), and SAP‐001 are in advanced phase IIb or III, demonstrating strong urate‐lowering effects with acceptable tolerability. Arhalofenate, a dual‐action agent with both uricosuric and anti‐inflammatory properties, continues evaluation in phase III, promising a novel one‐two punch therapy that addresses both serum urate and flare prevention.

Early‐Stage and Dual‐Mechanism Pipelines

Several dual‐mechanism therapies aiming at both urate reduction and inflammation control are in early trials. These include molecules targeting URAT1, OAT4, and OAT10 transporters, or combining enzyme activity with immune modulation. Xanthine oxidase inhibitors like tigulixostat are entering phase III, showing comparable efficacy and tolerability to allopurinol at lower doses.

Emerging Biotech and Genetic Insights

Advancements in genetic understanding of gout and inflammasome activation have guided new pipelines targeting pathways such as NF‐κB, PI3K/AKT, TNF‐α, and IL‐6. Experimental biologics continue to explore these axes, though IL‐1β remains the most clinically advanced inflammatory target.

Regulatory and Development Outlook

The convergence of enzyme‐based biologics, immune tolerance technologies, oral uricosurics, and inflammasome inhibitors reflects a dynamic pipeline poised to reshape gout management. Approved drugs like dotinurad and pegloticase combos could enter key markets soon. Meanwhile, regulatory focus is tightening around long‐term safety and immunogenicity, especially in chronic refractory patient groups.


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Important target segments driving the demand for Urate-Lowering Biologics Market

One of the most important segments driving demand in the urate-lowering biologics market is patients suffering from chronic refractory gout. These individuals often fail to achieve target uric acid levels using conventional therapies such as allopurinol or febuxostat. They may also experience intolerable side effects or have contraindications to traditional medications. For this group, biologics offer a critical alternative by providing more effective and targeted urate-lowering solutions. These patients represent a high-need, high-value segment that is actively being pursued by pharmaceutical developers and healthcare providers.

Elderly Population

The aging global population is another major driver of the market. Older adults are more likely to suffer from comorbidities such as kidney disease, hypertension, and cardiovascular issues, all of which complicate the treatment of gout. Many of these individuals are unable to tolerate oral urate-lowering medications due to their side effects or interactions with other drugs. Biologics, especially those with anti-inflammatory or kidney-sparing profiles, present a safer and more effective option for elderly patients, making this a priority target segment for healthcare systems and drug manufacturers.

Patients with Tophaceous Gout

Tophaceous gout is an advanced form of the disease marked by the presence of tophi, which are deposits of urate crystals in soft tissues and joints. This condition leads to chronic pain, deformities, and decreased mobility. Traditional treatments often fail to reverse tophi development, but biologic therapies have shown significant potential in dissolving existing deposits and preventing new ones. This clinical benefit has made patients with tophaceous gout a prime focus for biologic treatments, especially in tertiary care and specialty clinics.

Individuals with Cardiovascular or Renal Comorbidities

People with gout often present with overlapping cardiovascular and renal diseases. These comorbidities complicate the use of some standard therapies that may increase the risk of adverse events. Biologic treatments that bypass the kidneys or minimize systemic toxicity are gaining popularity among this segment. Moreover, some biologics are being studied not just for gout control but also for their potential to reduce systemic inflammation and improve outcomes in heart and kidney health. This dual benefit increases the attractiveness of biologics to clinicians managing complex, multi-disease cases.

Patients with Frequent Gout Flares

Another key target group includes individuals who suffer from frequent and severe gout flares, which impair quality of life and daily functioning. These patients often cycle through multiple treatments with limited success. Biologics that reduce flare frequency or target inflammatory pathways directly appeal to this group, offering both immediate and long-term symptom relief. Their demand contributes significantly to the overall market growth, particularly in regions with rising obesity and lifestyle-related gout cases.

Unresponsive or Intolerant to Conventional Therapies

A significant segment of the population either does not respond to conventional urate-lowering drugs or cannot tolerate them due to adverse reactions. This subset includes individuals with drug allergies, gastrointestinal issues, or genetic mutations affecting drug metabolism. Biologic therapies offer these patients an alternative treatment pathway, expanding the market beyond what is served by small-molecule drugs alone.



Key Players in Urate-Lowering Biologics, Market Share

The urate-lowering biologics market is shaped by a mix of large pharmaceutical companies and emerging biotech firms, each striving to address unmet needs in the management of gout and hyperuricemia. This market is relatively niche compared to other biologics segments, but it is experiencing growing investment due to the rising prevalence of gout and limitations of traditional therapies. Companies are competing through product innovation, clinical trial success, and strategic partnerships to increase their share.

Horizon Therapeutics

Horizon Therapeutics is a leading player in the urate-lowering biologics market, largely due to its ownership of pegloticase, marketed under the brand name Krystexxa. This biologic is approved for chronic refractory gout and holds a dominant position in its category. Horizon has focused extensively on expanding the reach of Krystexxa through combination therapies and improving outcomes via co-treatment with immunomodulators. With limited competition in the biologics space for refractory gout, Horizon currently enjoys the largest market share in this segment.

Selecta Biosciences

Selecta Biosciences is gaining traction through the development of SEL-212, a next-generation biologic that combines a pegylated uricase with an immune tolerance platform. The company is positioning SEL-212 as a more durable and less immunogenic alternative to existing therapies. Currently in late-stage clinical trials, SEL-212 has shown promise in maintaining low serum urate levels over extended periods. While not yet commercially available, its approval could significantly impact the market dynamics and challenge Horizon's dominance.

Novartis

Novartis plays a critical role in the inflammatory component of gout treatment through canakinumab, an interleukin-1 beta inhibitor originally developed for other inflammatory diseases. Though not primarily a urate-lowering drug, canakinumab is sometimes used in difficult gout cases to manage severe inflammation. Novartis holds a significant position in the broader gout treatment market and may further strengthen its role if new biologic combinations targeting both inflammation and uric acid levels prove successful.

Regeneron and Kiniksa Pharmaceuticals

Regeneron, in partnership with Kiniksa Pharmaceuticals, has developed rilonacept, another IL-1 inhibitor approved for rare auto-inflammatory conditions. Its use in gout is currently limited to off-label or experimental settings. However, ongoing research into the dual role of inflammation and urate metabolism could give companies like Regeneron an entry point into this growing market, especially for patients who experience frequent flares despite urate control.

Other Emerging Players

Smaller biotech companies such as Arthrosi Therapeutics and JW Pharmaceutical are also investing in novel uricosuric agents and dual-mechanism therapies that may eventually complement or compete with biologics. These companies are still in early-to-mid clinical phases but represent potential disruptors, particularly in regions like Asia-Pacific where gout prevalence is rising rapidly.

Market Share and Future Trends

Currently, Horizon Therapeutics holds the largest share of the urate-lowering biologics market due to the commercial success of Krystexxa. However, the entry of new biologics such as SEL-212 and the potential expansion of inflammation-focused therapies like canakinumab and rilonacept may gradually diversify market shares. As more biologics complete clinical trials and gain regulatory approval, competition is expected to intensify, pushing innovation, lowering costs, and increasing accessibility for a broader patient base.



Key Questions Answered in the Urate-Lowering Biologics market report:

What is the total global Urate-Lowering Biologics Sales, and how has it changed over the past five years?

What is Urate-Lowering Biologics investment trend?

Which countries have the highest Urate-Lowering Biologics, and what factors contribute to their dominance in the market?

How does Urate-Lowering Biologics Sales vary across key manufacturers, and what expansions have been observed recently?

What is the current global revenue generated from Urate-Lowering Biologics Sales, and how does it compare to previous years?

Which industries drive the highest demand for Urate-Lowering Biologics, and how is this demand expected to evolve in the next five years?

What are the major challenges impacting Urate-Lowering Biologics industry and supply chain operations across key markets?

How do government policies, environmental regulations, and trade restrictions affect Urate-Lowering Biologics and market dynamics?

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