The patent expiration of several blockbuster drugs in recent years can hamper the global gout disease treatment market growth. When profitable drugs lose their patent protection, generic versions enter the market at much lower prices, capturing a major share of sales from the original brand. This drastically reduces revenue for companies that held the initial patents. For example, the patent expiration of allopurinol, one of the most commonly prescribed medications for chronic gout, in the late 2010s had a noticeable impact. Allopurinol, also known by its brand name Zyloprim, lost exclusivity in the U.S. in 2016 and in Europe in 2018. Several generic drugmakers were then able to mass produce allopurinol at a fraction of the original cost. As a result, sales of the branded Zyloprim declined sharply as patients and physicians opted for the cheaper generics instead. The patent loss of allopurinol removed a key profit driver for its innovator company and curtailed opportunities for growth in that drug segment. Patent expirations of major biologic drugs for gout such as Krystexxa (pegloticase) and IIumina (canakinumab), which occurred in 2021 and 2022 respectively also hampered the market growth. Biologics represented an area that previously showed high potential for the gout therapy market. However, with the ability of biosimilars to capture up to 80% of the market within a year or two after losing exclusivity, the biosimilar competition will seriously limit the gains that innovators anticipated from these biologic drugs.
Market Opportunities: Adoption of Combination Therapies
The treatment of gout has traditionally relied on monotherapies to manage inflammation and reduce uric acid levels. However, gout is a complex disease with multiple pathogenic factors, and patients often struggle to maintain target uric acid levels and experience flare ups long term with single drugs. Combination therapies employing two or more drugs with complementary mechanisms of action have shown promise in improving outcomes for patients. Combining a urate-lowering therapy with an anti-inflammatory provides a dual approach to both reduce uric acid build up and control flare ups more effectively. In 2021, according to the study published by Arthritis & Rheumatology Journal, combining allopurinol with febuxostat led to a higher percentage of patients achieving target uric acid levels compared to either drug alone, reducing flares and improving quality of life. Combining anti-inflammatories like colchicine or NSAIDs with a urate-lowering drug has also significantly decrease the risk of flares in patients starting urate-lowering treatment, according to a 2020 report from the Centers for Disease Control. As physicians and patients realize the advantages of combination strategies, there will be huge adoption. . This presents a major opportunity for pharmaceutical companies to develop innovative fixed-dose combination products that improve outcomes and adherence for gout patients.
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