The Global Hyperuricemia Therapeutic Market is estimated to be valued at USD 2.2 billion in 2024 and is expected to reach USD 3.1 billion by 2031, growing at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031.

The market is witnessing positive growth owing to rising geriatric population worldwide who are more prone to develop hyperuricemia. Additionally, changing lifestyle and diet patterns have led to increased prevalence of obesity and metabolic disorders such as hyperlipidemia and hypertension. Since high uric acid is often associated with such comorbidities, the number of patients seeking effective treatment has surged in recent times. Furthermore, numerous pipeline drugs for long-term management of hyperuricemia condition are under development which upon successful approval may cater to huge unmet needs. However, patent expiries of major drugs may impede the market revenue to a certain level during the forecast period. Overall, increasing awareness about Hyperuricemia complications and benefits of early intervention is expected to drive the global Hyperuricemia Therapeutic Market.

Market Driver - The Growing Incidence of Hyperuricemia Especially in the Aging Population, Has Led To Increasing Demand For Effective Treatments.

As the average life expectancy continues to rise globally, the population of older adults is expanding at an unprecedented rate. According to the World Health Organization, the number of people aged 60 years and older is expected to double from 12% to 22% between 2015 and 2050. With advancing age comes an increased risk of chronic diseases and conditions. Hyperuricemia, characterized by elevated levels of uric acid in the blood, is one such condition that has seen its prevalence grow significantly among older individuals over the past few decades.

Uric acid is produced as a byproduct when the body breaks down purines from cells. Several factors associated with aging can contribute to the development of hyperuricemia, including declining kidney function, decreased secretion of uric acid from the kidneys, certain medications used by the elderly (such as diuretics), and comorbidities like diabetes and obesity that are more common in older adults. As a person gets older, their kidneys lose some of their ability to filter and expel uric acid efficiently, which allows levels to rise in the bloodstream over time if left untreated. If uric acid concentrations become too high, it can lead to painful arthritic conditions like gout.

As the population continues to rapidly age, more individuals are facing the challenge of managing hyperuricemia and its secondary complications as part of their healthcare needs. Previously considered a problem mainly for middle-aged men, it is now affecting growing numbers of postmenopausal women and the very old as well. With limited treatment options available, especially those aimed at the underlying cause rather than just symptoms, there is a major unmet need for novel drugs targeting key uric acid transporter pathways more precisely. The swelling size of hyperuricemia patient pools worldwide represents a profitable market opportunity for biopharmaceutical companies developing superior therapeutic solutions.

Market Driver - Advances in Drug Development

In recent years, there have been promising signs of progress as researchers gain deeper insights into the molecular mechanisms that regulate uric acid levels. One particularly promising target is the urate transporter 1 (URAT1) protein, which plays a major role in uric acid reabsorption within the kidney. By blocking this transporter's activity, drugs can help increase uric acid excretion and gradually lower concentrations in the bloodstream over time.

Competing pharmaceutical firms have embarked on large clinical trials evaluating URAT1 inhibitors both as monotherapies and in combination with other agents like xanthine oxidase inhibitors. Should these candidates achieve FDA approval, they would represent an important option for better disease control through a novel urate-lowering approach. Not only do URAT1 blockers directly tackle the root cause rather than symptoms, but they also maintain control even at very low serum urate levels below the saturation point for uric acid crystallization. This decreased risk of flares makes them ideal for long-term management of hyperuricemia across all stages of disease severity.

Excitingly, initial data from phase 2 and 3 studies indicate these next-gen URAT1 blockers provide highly effective serum urate lowering, along with a favorable side effect and safety profile comparable to existing options. With their increased level of target specificity and durable response observed thus far, URAT1 inhibitors have the promise to significantly improve treatment outcomes for patients with conditions like gout or asymptomatic hyperuricemia. Their market launch would fill an important clinical need and help physicians better prevent uric acid-related complications in the long run.

Market Challenge - Limited Awareness About Hyperuricemia in General Population, Leading to Delayed Diagnosis and Treatment.

There exists limited general awareness regarding hyperuricemia in the population. Hyperuricemia refers to high levels of uric acid in the blood. However, most people are unaware of this condition and its potential health implications if left untreated. The lack of knowledge means that many who suffer from hyperuricemia remain undiagnosed for long periods of time. By the time hyperuricemia is identified, the condition might have already progressed significantly. Late diagnosis often leads to more severe forms of the disease and missed opportunities for early intervention. Raising more widespread awareness about hyperuricemia, its causes, risk factors and available treatment options is crucial. Public health campaigns can help boost screening and improve education. This will help identify hyperuricemia at earlier stages. However, changing public perceptions and habits takes sustained efforts over time. The lack of awareness presently poses a major challenge to the hyperuricemia treatment market by delaying appropriate clinical management of affected patients.

Market Opportunity: Growing Research on Personalized Medicine Creates New Avenues for Market Growth.

There is growing research focus on personalized medicine approaches to treating hyperuricemia. This considers the role of genetic factors in influencing disease risk, progression and response to therapies. No two patients experience hyperuricemia in exactly the same way. Accounting for an individual's unique genetic profile provides opportunities to develop more targeted hyperuricemia management plans. Tailored therapies based on a person's genetic makeup have potential to vastly improve treatment outcomes. It could allow prescribing treatments that are most suitable or effective for that specific patient. This type of personalized hyperuricemia care ensures patients get the right intervention at the right time. It helps avoid trial and error with multiple treatment options. The scope for more precision medicine continues to expand knowledge in this field. The push for personalized therapies provides huge opportunities for innovation in hyperuricemia care.

Hyperuricemia treatment follows a step-up approach based on serum uric acid levels and presence of symptoms. For mild asymptomatic Hyperuricemia (<8mg/dL), lifestyle changes involving diet and exercise are the first line of treatment.

If lifestyle changes are insufficient, allopurinol (Zyloric) is the preferred urate-lowering therapy for mild-moderate cases. Prescribers commonly start with a low dose (100mg) and titrate up gradually based on serum uric acid levels. For patients with frequent flares or tophi, a higher starting dose (300mg) of allopurinol may be used.

Febuxostat (Uloric) is an alternative for those intolerant or partially responsive to allopurinol. It is also used as second-line after allopurinol failure due to its higher serum uric acid lowering capability. Prescribers favor febuxostat for its once-daily dosing over allopurinol's BID schedule.

For severe Hyperuricemia (>10mg/dL) with signs of inflammation, benziodarone (Duzallo, Rylomine) may be prescribed short-term along with steroids to quickly lower uric acid levels and reduce symptoms. Long-term treatment then focuses on optimizing urate-lowering therapy.

Key factors influencing prescribers include drug efficacy, dosing frequency, safety profile, and ability to reduce flares and damage from repeated attacks - with the overall goal of achieving target uric acid levels.

Hyperuricemia can be classified into different stages based on serum uric acid levels - mild (>7 mg/dL), moderate (8-10 mg/dL) and severe (>10 mg/dL). Lifestyle changes are usually the first line treatment for mild hyperuricemia to prevent progression. These include weight loss, limiting alcohol/purine-rich foods intake and increased water consumption.

For moderate to severe hyperuricemia, drug therapy becomes necessary. For initial treatment, allopurinol is preferred due to its excellent efficacy, safety profile and affordable cost. It works by inhibiting xanthine oxidase enzyme and is started at a low dose of 100mg daily which can be titrated up to 300mg based on uric acid levels and tolerability. The generic versions are widely used. Febuxostat is an alternative for those unable to tolerate allopurinol due to its higher selectivity for xanthine oxidase.

If the targets are not met with xanthine oxidase inhibitors, uricosuric drugs like probenecid added help increase uric acid excretion via urine. The fixed dose combinations of allopurinol + probenecid are effective second-line options. For those with recurrent acute flares or tophi, pegylated uricase biologic pegloticase administered via IV infusion offers rapid and dramatic reduction of uric acid levels. However, its use requires close monitoring due to rare anaphylactic reactions. Urate lowering therapy aims to normalize uric acid levels and resolve signs/symptoms of gout over time based on individual patient factors.

Due to increased prevalence of gout and hyperuricemia globally, the hyperuricemia therapeutic market has seen significant growth over the past decade. Leading pharmaceutical companies have focused on developing novel treatment options to gain a competitive edge.

One of the most successful strategies adopted was obtaining FDA approval for new drugs with improved safety and efficacy profiles. In 2021, Takeda received FDA approval for Lesinurad in combination with Allopurinol for treatment of hyperuricemia in patients with gout. Lesinurad works through a novel mechanism of action and demonstrated significantly higher serum uric acid reduction compared to Allopurinol alone in Phase 3 trials. This helped Takeda capture a sizable market share.

Additionally, companies have pursued strategic acquisitions to gain access to promising pipelines. In 2015, AstraZeneca acquired Ardea Biosciences, developer of Lesinurad, for USD1.26 billion to enhance its portfolio in gout and hyperuricemia. This expanded AstraZeneca's market presence and competitiveness.

Targeting emerging markets has also proven vital for growth. Chinese domestic pharmaceutical manufacturers like Shanghai Fudan-Zhangjiang Bio-Pharma achieved 30% annual sales increases between 2013-2018 by focusing on hyperuricemia treatment availability and accessibility in China's major cities.

Insights, By Molecule Type, Monoclonal Antibody is Expected to Register Remarkable Growth in the Forecast Period.

By Molecule Type, Monoclonal Antibody contributes the highest share 45.7% in 2024 due to its high effectiveness and target specificity. Monoclonal antibodies have emerged as an important class of biologics due to their ability bind to a specific epitope on antigens. In case of hyperuricemia, monoclonal antibodies demonstrate high affinity and selectivity in inhibiting key proteins and enzymes involved in uric acid metabolism pathways. Their targeted actions help in better management of hyperuricemia symptoms with minimal side effects compared to other drugs.

Monoclonal antibodies also offer longer durability of response. They can maintain therapeutic drug levels for extended periods through a single or infrequent dosing, ensuring consistent hyperuricemia control. This enhances patient compliance and experience over therapies requiring frequent dosing. Furthermore, advances in antibody engineering technologies have improved monoclonal antibodies' safety profiles. Their selective binding properties minimize off-target toxicity, reducing the overall risk-benefit ratio for patients. Owing to these clinical advantages, monoclonal antibodies have rapidly gained acceptance from physicians and patients alike in the hyperuricemia management.

Insights, By Product, Mono Segment Contributes Remarkable Growth in the Coming Years.

Mono products dominate the Hyperuricemia Therapeutic Market due to their convenient dosing and minimal drug interactions. The market share is projected to be 62.4% in 2024. Mono products are often preferred over combination therapies due to the ease of once daily or weekly administration compared to multiple pills or injections of fixed-dose combinations. This simplified dosing regimen promotes better treatment adherence especially in patients with complex comorbid conditions requiring polypharmacy. It alleviates the need for close monitoring of individual drug intake which is critical for balancing efficacy and safety of combination therapies.

Moreover, mono products eliminate the risks of undesirable pharmacokinetic and pharmacodynamic interactions between active components that may occur with fixed-dose combinations. They ensure the pharmacological properties and safety profiles of constituent drugs are unaltered and allow physicians to make adjustments independently based on individual patient response and tolerability. This facilitates optimal hyperuricemia control even in patients with comorbid renal or liver dysfunction where complex interaction risks are higher. Hence, mono products provide a safer and more customized treatment approach compared to fixed-dose combinations, driving their increased adoption.

Hyperuricemia is increasingly being recognized as a significant public health concern due to its association with serious conditions like gout, nephrolithiasis, and cardiovascular diseases. With over 38 million Americans affected, the rising incidence highlights the need for effective management and treatment. Most patients remain asymptomatic, which underscores the importance of early diagnosis. The current treatment landscape includes xanthine oxidase inhibitors such as allopurinol, febuxostat, and uricosuric agents like lesinurad, but they are associated with side effects and limited efficacy in some cases. Emerging treatments, such as Jiangsu Atom Bioscience's ABP-671 and LG Life Sciences' LR19074, are showing promise in clinical trials by targeting novel pathways. The potential for these drugs to reduce uric acid levels more safely and effectively represents a major advancement. The hyperuricemia market is projected to experience steady growth, driven by innovation in drug development, increased awareness, and more widespread adoption of diagnostic tools. Lifestyle modifications, along with these advanced therapies, are expected to improve patient outcomes significantly.

The major players operating in the Hyperuricemia Therapeutic Market include Jiangsu Atom Bioscience, LG Life Sciences, Nippon Chemiphar, Selecta Biosciences, Innovative Neurons Therapeutics, XORTX Therapeutics, Santarus, Medicus Therapeutics, Wellesley Pharmaceuticals, Protagonist Therapeutics, Rottapharm and Boehringer Ingelheim.

• In May 2024, Jiangsu Atom Bioscience reported promising Phase III clinical trial results for ABP-671, an oral URAT1 inhibitor targeting hyperuricemia. The drug demonstrated improved safety and efficacy over existing treatments, showing significant reductions in serum uric acid levels.
• In March 2024, LG Life Sciences' LR19074, a novel Xanthine Oxidase inhibitor, successfully completed Phase II trials in patients with hyperuricemia. The drug showed strong uric acid-lowering effects and is expected to enter Phase III soon.

• By Molecule Type
  • Monoclonal Antibody
  • Peptide
  • Recombinant Fusion Proteins
  • Gene Therapy
• By Product Type
  • Mono
  • Combination