Phenylephrine Hydrochloride Market Size & Share, by Application (Nasal Decongestion, Cold, Eye Disease, Hypotension, Allergic Reaction); Mode; Use - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

Growth Drivers

• Increasing use in ophthalmic applications: Phenylephrine HCL is a well-known application in nasal decongestant drugs, it is becoming relevant in several medical and non-medical fields. Phenylephrine HCL has found use in ocular applications in addition to respiratory health. It is used as a mydriatic agent in ophthalmic solutions to help dilate the pupil during eye exams and procedures. This feature makes the inside parts of the eye more visible, which helps surgeons and other medical experts with diagnosis and surgery. For pupil dilation, the U.S. Food and Drug Administration (FDA) has authorized the use of up to three drops of phenylephrine hydrochloride ophthalmic solution at 2.5% or 10%.
• Growing use in the treatment of priapism: Usually ischemic, sickle cell disease (SCD) is the primary cause of priapism in children and teenagers. According to reports, 18–27% of boys with SCD experience priapism. Twelve years is the usual age for presentation, and each patient experiences 15 episodes on average over their lives. A prolonged penile erection that lasts for hours after or without sexual stimulation is known as priapism. The American Urological Association (AUA) and Sexual Medicine Society of North America (SMSNA) recommend phenylephrine, a pure alpha-adrenergic agonist, as the preferred sympathomimetic drug for treating ischemic priapism because of its quick onset and brief duration of action. Because of its alpha-1 selectivity, phenylephrine's cardiovascular adverse effects are less likely to occur than those of other sympathomimetic drugs.
• Advances in drug delivery systems: Advanced drug delivery systems are logically designed to improve the performance and distribution of current medications compared to conventional systems. Unlike traditional drug delivery systems, novel drug delivery systems target, control, and adjust drug administration by combining innovative dosage forms and sophisticated methodologies. Researchers are examining the use of nanoparticles, targeted delivery systems, and controlled release formulations to deliver phenylephrine HCL. Moreover, transdermal delivery systems, such as patches and gels, have been developed to provide controlled drug release over an extended period. These innovations have improved the safety and efficiency of phenylephrine HCL for various conditions including nasal congestion, hypertension, and priapism.

Challenges

• Adverse effects of the medication: Skin rash, itching, hives, and swelling of the face, lips, tongue, or throat are examples of adverse reactions that the patient taking phenylephrine hydrochloride may have. In a patient who is awake, the most frequent adverse responses are headache, nausea, vomiting, and anxiety. Phenylephrine can induce baroreceptor-mediated reflex bradycardia due to its exclusive activation of alpha-receptors. When treating a patient with bradycardia and hypotension, clinicians should consider various kinds of vasopressor drugs. Additionally, it has an impact on patients' renal efficacy and heart palpitations in the elderly population. Therefore, the side effects of this formulation may impede the phenylephrine hydrochloride market.
• Regulatory obstacles: Strict regulations about the efficacy, safety, and quality of active pharmaceutical ingredients manufacture are regularly enforced by the FDA and other regulatory bodies. The FDA announced in September 2023 that nasal congestion cannot be treated with oral phenylephrine (Sudafed PE). Although they were left out of this announcement, phenylephrine nasal sprays, often known as Neo-Synephrine, are still a viable alternative. This led to an increased demand for alternative medications such as fluticasone propionate (Flonase), oxymetazoline (Afrin), and pseudoephedrine (Sudafed). Therefore, these regulations may hinder the adoption and use of phenylephrine hydrochloride in the forecast period.