Benzocaine Market

The Benzocaine market is witnessing a CAGR of 5.8% during the forecast period of 2025-2035. Benzocaine is a topical anesthetic that has been used broadly for its analgesic features in medical as well as over-the-counter purposes. Chemically, it is produced by esterifying para-aminobenzoic acid with ethanol, and during this process, benzocaine is formed. It is primarily used in local formulations, such as gels, sprays, ointments, and lozenges, intended to provide pain relief for diseases like sore throat, canker sores, and small irritations of the mouth. Also, healthcare providers utilize benzocaine sprays to anesthetize mucous membranes when undertaking such medical interventions as endoscopy and intubation

Notwithstanding its extensive use, benzocaine has also been linked to serious safety concerns. The U.S. Food and Drug Administration (FDA) has issued several warnings about the risk of methemoglobinemia—a condition that is very severe and involves impaired delivery of oxygen to body tissues—associated with the use of benzocaine. In 2018, the FDA recommended that over-the-counter oral drug products with benzocaine be avoided in children and infants below the age of two years because of the risk of life-threatening adverse effects. The agency further recommended that these drugs be reserved only for use in adults and children above two years of age in case the labels have warnings.

There must be adherence by manufacturers of products containing benzocaine to Current Good Manufacturing Practices (CGMP) for their products to maintain quality and be safe. Companies that fail these standards have had enforcement actions imposed on them by the FDA. For example, in April 2022, the FDA issued a warning letter to Cetylite Industries, Inc., concerning serious CGMP deviations in making benzocaine products.

In addition, stability and physicochemical characteristics of benzocaine are important factors in drug formulations. Research indicates that the preparation methods of novel dosage forms may affect the generation of various polymorphs of benzocaine, impacting characteristics like solubility and chemical stability.