In 2023, the clavulanic acid series API market was valued at approximately USD 385 million and is expected to reach USD 777.66 million by 2034, growing at a compound annual growth rate (CAGR) of 6.6% from 2024 to 2034. This growth is driven by increasing cases of antibiotic-resistant bacterial infections and expanding research and development activities in the field.
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In March 2024, the Central Drug Standard Control Organization (CDSCO) approved an update to the prescribing information for GSK’s fixed-dose combination, Amoxicillin Trihydrate. The new formulation includes Amoxicillin free acid (652.78 mg) with Potassium Clavulanate (61.48 mg, equivalent to 50.41 mg of Clavulanic acid) per 5 ml of reconstituted suspension.
In September 2024, Kinvan, an Indian pharmaceutical company, began producing its first clavulanic acid formulation, Augmentin, targeting a range of bacterial infections. Kinvan has allocated INR 447.17 crores to establish a facility with a 300 metric ton annual production capacity for clavulanic acid, expected to be operational by the end of 2024.
The importance of clavulanic acid in healthcare continues to grow as researchers explore its potential in combination therapies. Clavulanic acid is being studied for effectiveness in treating surgical site infections in pediatric appendectomies, dental infections, and infections from colorectal surgeries, among others. As of October 2024, 39 clinical trials involving clavulanic acid as an intervention are registered on ClinicalTrials.gov, with 32 currently recruiting and seven active but not recruiting. These trials explore clavulanic acid’s potential in managing conditions like cocaine use disorder, obstetric perineal tears, appendectomies, and aspiration in ICU patients. The rising demand for clavulanic acid, coupled with ongoing research into expanded applications, is expected to support the market’s growth.
The production of clavulanic acid involves complex processes, primarily due to limited substrate availability. Clavulanic acid is derived from Streptomyces clavuligerus, which requires specific substrates that are often costly and scarce, causing production delays. For example, ATCC offers Streptomyces clavuligerus at around $420 per unit, making it an expensive starting material. Additionally, downstream processes like recovery and purification add to production challenges, impacting overall market growth.
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