Global Phenylephrine Hydrochloride Market - 2023-2030

Overview

Phenylephrine hydrochloride is the salt form of phenylephrine, a direct-acting sympathomimetic amine chemically related to adrenaline and ephedrine with potent vasoconstrictor and decongestant properties. Phenylephrine is a post-synaptic alpha-adrenergic receptor agonist that causes vasoconstriction, increases systolic/diastolic pressures, reflex bradycardia, and stroke output. It is especially used for the treatment of colds, allergic rhinitis and sinusitis.

Moreover, phenylephrine hydrochloride is available in the form of tablets, capsules, injections, nasal sprays and eye drops. Phenylephrine hydrochloride is often used in nasal decongestant products to relieve congestion caused by conditions like the common cold or allergies. It is also used to relieve sinus congestion and pressure. It will relieve symptoms but will not treat the cause of the symptoms or speed recovery. It reduces the size of the blood vessels in the nose and sinuses helping to breathe more easily. It is also used to treat some eye disorders.

Market Dynamics: Drivers

Increasing adoption to alleviate nasal discomfort and eye disorders

The increasing adoption to alleviate nasal discomfort is expected to drive the market over the forecast period. The growing incidence of conditions that are leading to nasal discomforts, such as the common cold, allergies, or respiratory infections is expected to drive the demand for phenylephrine hydrochloride and this also leads to increasing adoption. Eye disorders are most common, and to get relief from eye disorders such as mydriasis, phenylephrine HCL sprays are commonly adopted.

For instance, on August 03, 2023, Eyenovia, Inc., an ophthalmic technology company commercializing Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, cleared the first commercial sale of Mydcombi. Mydcombi was approved by the US Food and Drug Administration.

Moreover, phenylephrine hydrochloride products are available over-the-counter (OTC), and consumers may be more inclined to self-treat nasal discomfort without the need for a prescription, contributing to increased adoption. The introduction of innovative formulations, such as convenient nasal sprays, eye drops and ophthalmic spray applications or combination products addressing multiple symptoms, may attract more consumers.

For instance, on November 15, 2022, KinderFarms, the Kinder Farmaceutical Company launched KinderMed, a line of clean children's medicines, made with clinically proven active ingredients, but clean, Kinder inactive ingredients. This launch includes Kids' Nighttime Cold and Cough (Diphenhydramine HCl, Phenylephrine HCl). KinderMed launched at over 19,000 stores nationwide.

In Addition, the increasing adoption leads to an increasing focus on developing more advanced phenylephrine hydrochloride products. For instance, on June 12, 2020, Caplin Point Laboratories Limited cleared the granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine Hydrochloride injection USP, 10 mg/mL Single-Dose Vial, 50 mg/5 mL (10mg/mL) Pharmacy Bulk Package, and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, a generic therapeutic equivalent version of (RLD), VAZCULEP Injection.

Further, the increasing prevalence of allergic, ophthalmic, nasal disorders and hypotension, rising FDA approvals, increasing clinical trials, increasing awareness about the advantages of phenylephrine hydrochloride and advancements in the development of products are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications and side effects associated with the phenylephrine hydrochloride such as mild upset stomach, trouble sleeping, dizziness, lightheadedness, headache, nervousness, shaking, or fast heartbeat and this product may also reduce blood flow to hands or feet are expected to hamper the market.

Segment Analysis

The global phenylephrine hydrochloride market is segmented based on type, application, route of administration, distribution channel and region.

The ®-(-)-phenylephrine hydrochloride segment accounted for approximately 48.5% of the phenylephrine hydrochloride market share

The ®-(-)-phenylephrine hydrochloride segment is expected to hold the largest market share over the forecast period. ®-(-)-Phenylephrine hydrochloride is a phenylephrine and an α1-adrenoceptor agonist that promotes hypertrophic growth in the ventricular myocytes and activates several MAPK signaling pathways. ®-(-)-Phenylephrine hydrochloride is an activator of α1A-AR, α1D-AR and α1B-AR.

Moreover, ®-(-)-Phenylephrine HCL is known to be more selective for alpha-adrenergic receptors. This selectivity can enhance its effectiveness in targeting specific receptors responsible for vasoconstriction and nasal decongestion. The ®-(-)-enantiomer is very well known for its fewer side effects. This can contribute to a better safety profile for individuals using medications containing phenylephrine hydrochloride.

Additionally, ®-(-)-Phenylephrine hydrochloride may have become an industry standard for pharmaceutical formulations designed to alleviate nasal congestion. With this increasing adoption due to their advantages, the demand for ®-(-)-Phenylephrine hydrochloride is continuously increasing.

Geographical Analysis

North America accounted for approximately 39.6% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare facilities. North America especially the United States is home to the presence of major players such as pharmaceutical companies which are focussing on developing the major phenylephrine hydrochloride products.

For instance, on May 21, 2021, Ritedose, launched two new unit dose syringe products, Phenylephrine Hydrochloride Injection 0.8 mg/10 mL (80 mcg/mL) and Phenylephrine Hydrochloride Injection 1 mg/10 mL (100 mcg/mL). These are part of a six-month, 12-product rollout from Ritedose for hospital pharmacies across the country.

Furthermore, the well-established healthcare infrastructure in the region, including pharmacies, clinics, and hospitals, facilitates the distribution and accessibility of these products. Phenylephrine hydrochloride is commonly available as an over-the-counter (OTC) medication. The accessibility of OTC products can contribute to a higher market share as consumers may purchase them without a prescription.

Competitive Landscape

The major global players in the phenylephrine hydrochloride market include: Thermo Fisher Scientific Inc., Hikma Pharmaceuticals PLC, Fresenius Kabi USA, Pfizer Inc., FUJIFILM Wako Pure Chemical Corporation, Merck KGaA, Sagent Pharmaceuticals, Inc., Dr. Reddy's Laboratories Inc., Ralington Pharma LLP and GRIFFITH OVERSEAS PVT. LTD. Among others.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global phenylephrine hydrochloride market. During the pandemic, healthcare systems globally focused on managing and treating COVID-19 cases. This shift in priorities impacted the demand for certain non-essential pharmaceuticals, including phenylephrine hydrochloride products like decongestants. The pandemic impacted the market by temporarily disrupting many clinical trials and research activities due to the redirected focus on the COVID-19 pandemic. The pandemic also disrupted the supply chain of these products globally.

Market Segmentation

By Type

• ®-(-)-Phenylephrine Hydrochloride
• L(-)-Phenylephrine Hydrochloride
• Others

By Application

• Respiratory Disorders
• Ophthalmic Disorders
• Allergic Disorders
• Others

By Route of Administration

• Oral
• Nasal
• Intravenous
• Ophthalmic
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?

• To visualize the global phenylephrine hydrochloride market segmentation based on type, application, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of phenylephrine hydrochloride market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global phenylephrine hydrochloride market report would provide approximately 69 tables, 70 figures, and 189 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies