Global Phenylephrine API in Healthcare Market was valued at US $ 536.9 Mn in 2022 and is expected to reach US $ 1387.4 Mn by 2030 growing at a CAGR of 12.6% during the forecast period 2023 – 2030.
Phenylephrine API is functioning as the primary Active Pharmaceutical Ingredient (API) within various medications. An API represents the bioactive substance within a pharmaceutical drug responsible for generating the intended therapeutic effect. Phenylephrine, a synthetic compound, operates as a selective alpha-1 adrenergic receptor agonist. Its principal medical application lies in alleviating nasal congestion and related discomfort linked to conditions like the common cold, allergies, or sinusitis. When integrated into pharmaceutical formulations, Phenylephrine API assumes responsibility for its vasoconstrictive attributes, which involve the constriction of blood vessels, thereby diminishing swelling and congestion within the nasal passages.

Phenylephrine API can undergo formulation into diverse dosage forms, encompassing tablets, capsules, nasal sprays, eye drops, and more, contingent upon the designated route of administration and the medical product it is intended for. Pharmaceutical manufacturers produce Phenylephrine API, subsequently employing it to fabricate an array of over-the-counter (OTC) and prescription medications crafted to furnish relief from nasal congestion and associated symptoms. These final pharmaceutical products incorporate Phenylephrine API in conjunction with additional inactive components essential for the formulation's consistency and stability.

Also, Phenylephrine API (Active Pharmaceutical Ingredient) is used in the manufacturing of various pharmaceutical products, primarily as a decongestant to relieve nasal congestion. These products can take several different forms, depending on the intended route of administration and the specific medical need.

Some of the benefits of Phenylephrine API include:

• Accessible Without Prescription: Phenylephrine-based products are readily accessible without the need for a prescription in numerous countries, enhancing their availability to individuals seeking relief from nasal congestion.
• Nasal Decongestion: Phenylephrine is primarily used as a nasal decongestant, helping to relieve nasal congestion and stuffiness associated with various conditions such as the common cold, allergies, and sinusitis. It works by constricting blood vessels in the nasal passages, reducing swelling and allowing for easier breathing.
• Pediatric Usage: Phenylephrine is offered in formulations specifically designed for children, ensuring its appropriateness for pediatric use when administered under the supervision and guidance of a healthcare provider.

COVID -19 Impact

The COVID-19 pandemic, the Phenylephrine API market was experiencing steady demand primarily driven by the need for decongestants in cold and flu medications. Phenylephrine was a commonly used ingredient to relieve nasal congestion and had a well-established presence in over-the-counter and prescription products. Supply chains were relatively stable, and regulatory frameworks were in place to govern pharmaceutical production and distribution of Phenylephrine pharmaceuticals. The COVID-19 pandemic brought about significant disruptions and changes to the Phenylephrine API market. As the virus spread globally, there was a surge in demand for medications that could alleviate symptoms resembling COVID-19, including nasal congestion. This resulted in increased interest in Phenylephrine-based products, but it also exposed vulnerabilities in the pharmaceutical supply chain. Lockdowns, restrictions, and shifts in healthcare priorities impacted the production and distribution of Phenylephrine-containing medications. Regulatory agencies adapted to address the evolving situation, and telehealth services gained prominence, influencing how individuals accessed and used these products.

Furthermore, As the world navigated through the various phases of the pandemic and vaccination efforts progressed, the Phenylephrine API market continued to evolve. It adapted to the "new normal" of healthcare, where telehealth remained relevant, and consumer behavior around self-medication saw lasting changes. Supply chains were reinforced, and pharmaceutical companies adjusted to meet shifting demand patterns. While the heightened awareness of respiratory symptoms during the pandemic may have had a lasting impact on the demand for Phenylephrine, the market also saw a return to some pre-pandemic stability. However, ongoing monitoring and adaptation remained essential to address potential future disruptions and changing healthcare dynamics.

Factors Driving the Market

Drivers

Increased Prevalence of Respiratory Conditions

The increased prevalence of respiratory conditions is a multifaceted and concerning global health trend marked by a growing number of individuals experiencing illnesses and disorders affecting the respiratory system. Factors such as environmental pollutants, such as air pollution from industrial emissions and vehicular traffic, expose individuals to harmful particulate matter and chemicals. Prolonged exposure can irritate the respiratory tract, leading to conditions like bronchitis, chronic obstructive pulmonary disease (COPD), and exacerbating asthma. Furthermore, the rise in allergenic particles and pollutants exacerbates respiratory symptoms in vulnerable populations. According to World Bank Organization, The global economy operates through highly interconnected supply chains, with over 100 billion tons of raw materials being introduced into this system annually. The extensive consumption of materials not only depletes precious natural resources but also triggers adverse environmental consequences throughout the entire product lifecycle, encompassing manufacturing, usage, and disposal phases. Projections indicate that global waste generation is on track to reach 3.4 billion tons by the year 2050.

Respiratory infections, both common (e.g., influenza, pneumonia) and emerging (e.g., COVID-19), significantly impact respiratory health. The frequent occurrence of respiratory infections has heightened public health concerns and emphasized the importance of preparedness and prevention measures. According to Statista, In 2019, Mexico recorded nearly 24 million estimated instances of acute respiratory infections, marking a reduction compared to 2017 when the country reported approximately 25.83 million new cases. Among the estimated 2019 cases, more than 4.2 million, or roughly 18 percent, were identified in adults aged 25 to 44. The second-largest group of estimated cases of acute respiratory infections consisted of children aged one to four years old. Additionally, in 2021, the mortality rates from respiratory system diseases in England were approximately 115 per 100,000 for men and 79 per 100,000 for women. Notably, the North West region of England exhibited the highest mortality rate among men, with nearly 136 per 100,000, while the North East region had the highest mortality rate among women, at 102 deaths per 100,000 in the population.

Hence, The increase in respiratory illnesses surge for an allocation of more resources to address the needs of diagnosis, treatment, and long-term care. This emphasizes the significance of public health programs that prioritize preventive measures, early interventions, and educational efforts to reduce the impact of respiratory conditions on both individuals and the broader society.

Challenges

Alternative decongestant ingredients and products

Various decongestants are available as alternatives to Phenylephrine in medications designed to alleviate nasal congestion. These include Pseudoephedrine, known for its effectiveness in cold and allergy remedies; Oxymetazoline, commonly found in nasal sprays; Xylometazoline, used in nasal sprays and drops; and Naphazoline, present in some eye drops and nasal sprays. While each of these decongestants operates by constricting blood vessels to relieve congestion, their formulations and applications can differ. Additionally, some older ingredients like Phenylpropanolamine have seen reduced usage due to safety concerns. Moreover, many cold and allergy medications combine various active ingredients to address multiple symptoms concurrently, making them a comprehensive option for individuals seeking relief from a range of symptoms. Selecting the appropriate decongestant depends on individual needs and considerations, and consultation with healthcare professionals is often advisable.

Rising side effect concerns

The use of Phenylephrine API, a common decongestant, can potentially lead to side effects in certain individuals. These side effects may encompass temporary increases in blood pressure, resulting in particular caution for those with hypertension or cardiovascular conditions. Phenylephrine may also induce sensations of nervousness, restlessness, or anxiety, especially at higher doses. Headaches, dizziness, and difficulty sleeping (insomnia) are among the possible side effects associated with this medication. It is crucial to adhere to recommended dosages and seek medical advice when necessary to manage potential side effects effectively and safely.

Trends

Growing need for safe and effective medications for children

The Phenylephrine API market has witnessed a significant rise in the demand for safe and effective medications tailored specifically to children. This trend is fueled by a heightened awareness of pediatric healthcare needs and a growing emphasis on children's well-being. Respiratory conditions, including nasal congestion, commonly afflict children, prompting the development of pediatric formulations containing Phenylephrine to alleviate these symptoms. Parents and caregivers, deeply concerned about the safety of medications for their children, seek formulations designed for pediatric use, complete with accurate dosing instructions and minimal risk of adverse effects. The medical community, in turn, plays a pivotal role by offering guidance and prescribing Phenylephrine-based products when suitable, always considering the child's age, weight, and medical history. Regulatory agencies' focus on pediatric safety and efficacy assessments further reinforces the importance of developing medications that cater to the unique requirements of young patients, ensuring their well-being and overall health.

According to Statista, in 2022, the prescription rate for medications aimed at treating respiratory disorders in Italy stood at approximately 522.9 prescriptions per 1,000 individuals. This data provides a detailed breakdown based on the active ingredients within these medications. Within the category of respiratory drugs, beclomethasone emerged as the most frequently prescribed active ingredient, with a prescription rate of 101 per 1,000 inhabitants, closely followed by budesonide at 100.8 prescriptions. Furthermore, in the same year, under-aged individuals in Italy consumed approximately 1.91 pharmaceutical drug packages. This data highlights variations across gender and age groups, with a higher prevalence of medication usage observed among children aged one to five years compared to other age brackets. Additionally, the average number of packages consumed was slightly higher among males than females across all age groups. This statistic elucidates the per capita consumption of prescription drug packages by children in Italy in 2022, offering insights into gender and age-related differences in medication usage. Hence, the growing need for safe and effective medications for children within the Phenylephrine API market underscores the importance of addressing the unique healthcare requirements of pediatric patients and ensuring that medications meet stringent safety and efficacy standards for this vulnerable population.

Market Segmentation

By Purity Type

By Purity Type, the global Phenylephrine API market is divided into Purity 10%, Purity 20%, Purity 40%, and Purity 60%. For pharmaceutical applications, a purity level exceeding 99% is commonly sought after and is considered the industry standard.

A purity level of 10% in Phenylephrine API (Active Pharmaceutical Ingredient) signifies that Phenylephrine makes up only 10% of the total substance, with the remaining 90% composed of various components, including potential impurities, diluents, or excipients. This level of purity is notably below the standard for Phenylephrine API used in pharmaceutical applications, where significantly higher purity levels are mandated to ensure both the safety and efficacy of medicinal products. Purity levels as low as 10% or even 20% are unusual within the pharmaceutical manufacturing realm, as they typically fail to meet the stringent requirements and quality standards that pharmaceutical products necessitate. The selection of purity levels is contingent on specific applications and industry norms.

A purity level of 10% in Phenylephrine API (Active Pharmaceutical Ingredient) implies that the Phenylephrine compound within the API accounts for only 10% of the total substance, while the remaining 90% consists of other components, which may include impurities, diluents, or excipients. Such a low purity level is atypical for Phenylephrine API used in pharmaceutical applications, as medicinal products require a much higher level of purity to ensure safety and efficacy

By Application

By application, the Phenylephrine API market is divided by Pharmaceutical, Research Organizations, and Others. Other sub segment includes medical education.

Phenylephrine API (Active Pharmaceutical Ingredient) is primarily used in pharmaceutical end-user applications. Within the pharmaceutical industry, Phenylephrine is commonly incorporated into various medications, including over the counter (OTC) and prescription products, to alleviate nasal congestion and other symptoms associated with respiratory conditions, allergies, colds, and sinusitis.

The utilization of Phenylephrine API in the pharmaceutical industry is driven by a confluence of factors. Its efficacy in relieving nasal congestion, a symptom commonly associated with respiratory conditions, makes it a valuable component in numerous medications. Moreover, the availability of pediatric formulations ensures safe usage in children, addressing the need for specialized pediatric medications. Phenylephrine-based over-the-counter (OTC) products provide consumers with accessible relief from common cold and allergy symptoms, aligning with self-care preferences. The prevalence of respiratory health concerns further underscores its demand, and pharmaceutical innovation continues to explore its potential in enhanced formulations. Regulatory approvals and healthcare provider recommendations also contribute to its widespread use. According to Statista, The OTC Pharmaceuticals market is set to achieve a revenue milestone of US$197.80 billion in 2023, with a projected annual growth rate of 4.85% (CAGR 2023-2028). The market's standout segment is Cold & Cough Remedies, boasting a market volume of US$42.41 billion in 2023. On a global scale, the United States takes the lead, generating the highest revenue, amounting to US$39,310 million in 2023. In 2020, India's production value for Active Pharmaceutical Ingredients (APIs) surpassed 13 billion U.S. dollars, and this figure was anticipated to surge to 18 billion U.S. dollars by 2023 in the South Asian nation. Hence, Phenylephrine API is a versatile ingredient, meeting the diverse needs of patients seeking relief from nasal congestion and related ailments.

By Region

By region, the global Phenylephrine API market is divided into North America, Europe, APAC and Others. Others is further divided into Middle East, Africa and South America.

In 2022, Europe emerged as the predominant region in the Phenylephrine API market, claiming a significant market share of 26.79%. However, Europe faces a notable burden of respiratory diseases, stemming from a multifaceted interplay of factors. These encompass challenges such as urban areas grappling with poor air quality, persistent tobacco use, a progressively aging population, exposure to environmental allergens, and occupational hazards—all contributing to the prevalence of respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and lung cancer. The complex landscape is further complicated by indoor air quality issues, the repercussions of climate change, variations in healthcare accessibility, and the influence of genetic factors. In response, comprehensive initiatives spanning environmental regulations, smoking cessation programs, improved healthcare accessibility, and research endeavors are crucial to effectively address and mitigate the impact of respiratory diseases across Europe.

Conversely, the escalating incidence of respiratory and lung diseases within South Asia and the Asia-Pacific (APAC) region can be primarily ascribed to heightened levels of air pollution. These regions have undergone rapid industrialization and urbanization, coupled with the use of inefficient energy sources, culminating in elevated concentrations of hazardous pollutants in the atmosphere. The issue encompasses both outdoor air pollution from sources like vehicular emissions and industrial processes and indoor air pollution arising from the utilization of solid fuels for cooking. Additional factors amplifying the problem include biomass burning practices, the influence of climate-related variables, and disparities in healthcare accessibility. To counteract this mounting health challenge, governments and organizations in South Asia and APAC are actively implementing strategies aimed at pollution reduction, enhancement of indoor air quality, and the expansion of healthcare access. These initiatives are essential in the quest to alleviate the impact of respiratory and lung diseases in these regions.

Competitive Landscape

The global Phenylephrine API market is consolidated with the presence of few major players contributing to the market revenue. This dominance of these major players is driven by their technological expertise, extensive resources, and established brand recognition. These companies typically offered comprehensive and diversified API solutions, dealing with various aspects of healthcare, such as patient-specific modeling, predictive analytics, and operational optimization.

However, the attractiveness of the market has resulted into many new start-ups entering the market with specific solutions and thereby attracting the healthcare providers.

Recent Developments

• In 2015, Korn, Inc. a prominent specialty pharmaceutical firm, has officially introduced Phenylephrine HCl Ophthalmic Solution, USP, in both 2.5% and 10% concentrations. This product launch comes on the heels of receiving approval for a New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA) on January 15, 2015. The addition of this product to Akorn's extensive line of generic and branded ophthalmic offerings signifies a notable expansion and marks the return of a shelf-stable phenylephrine formulation to the market.

Phenylephrine API in Healthcare Market Scope

Table of Contents

1 INTRODUCTION OF THE GLOBAL PHENYLEPHRINE API MARKET

1.1 Overview of the Market

1.2 Scope of Report

1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY

3.1 Data Mining

3.2 Validation

3.3 Primary Interviews

3.4 List of Data Sources

4 GLOBAL PHENYLEPHRINE API MARKET OUTLOOK

4.1 Overview

4.2 Market Dynamics

4.2.1 Drivers

4.2.2 Restraints

4.2.3 Opportunities

4.3 Porters Five Force Model

4.3.1. Bargaining Power of Suppliers

4.3.2. Threat of New Entrants

4.3.3. Threat of Substitutes

4.3.4. Competitive Rivalry

4.3.5. Bargaining Power among Buyers

4.4 Value Chain Analysis

5 GLOBAL PHENYLEPHRINE API MARKET, BY PURITY TYPE

5.1 Overview

5.2 Purity 10%

5.3 Purity 20%

5.4 Purity 40%

5.5 Purity 60%

6 GLOBAL PHENYLEPHRINE API MARKET, BY APPLICATION

6.1 Overview

6.2 Pharmaceutical

6.3 Research Organisation

6.4 Others

7 GLOBAL PHENYLEPHRINE API MARKET, By REGION

7.1 North America

7.1.1 U.S.

7.1.2 Canada

7.2 Europe

7.2.1 Germany

7.2.3 U.K.

7.2.4 France

7.2.5 Rest of Europe

7.3 Asia Pacific

7.3.1 China

7.3.2 Japan

7.3.3 India

7.3.4 South Korea

7.3.5 Singapore

7.3.6 Malaysia

7.3.7 Australia

7.3.8 Thailand

7.3.9 Indonesia

7.3.10 Philippines

7.3.11 Rest of Asia Pacific

7.4 Others

7.4.1 Saudi Arabia

7.4.2 U.A.E.

7.4.3 South Africa

7.4.4 Egypt

7.4.5 Israel

7.4.6 Rest of Middle East and Africa (MEA)

7.4.7 Brazil

7.4.8 Argentina

7.4.9 Mexico

7.4.10 Rest of South America

8 COMPANY PROFILES

8.1 Titan Laboratories

8.1.1. Company Overview

8.1.2. Key Executives

8.1.3. Operating Business Segments

8.1.4. Product Portfolio

8.1.5. Financial Performance (As per availability)

8.1.6 Key News

8.2 Spansules Pharma

8.2.1. Company Overview

8.2.2. Key Executives

8.2.3. Operating Business Segments

8.2.4. Product Portfolio

8.2.5. Financial Performance (As per availability)

8.2.6. Key News

8.3 Unichem Laboratories

8.3.1. Company Overview

8.3.2. Key Executives

8.3.3. Operating Business Segments

8.3.4. Product Portfolio

8.3.5. Financial Performance (As per availability)

8.3.6. Key News

8.4 Synergene

8.4.1. Company Overview

8.4.2. Key Executives

8.4.3. Operating Business Segments

8.4.4. Product Portfolio

8.4.5. Financial Performance (As per availability)

8.4.6. Key News

8.5 JSN Chemicals

8.5.1. Company Overview

8.5.2. Key Executives

8.5.3. Operating Business Segments

8.5.4. Product Portfolio

8.5.5. Financial Performance (As per availability)

8.5.6. Key News

8.6 Hygro Chemicals

8.6.1. Company Overview

8.6.2. Key Executives

8.6.3. Operating Business Segments

8.6.4. Product Portfolio

8.6.5. Financial Performance (As per availability)

8.6.6. Key News

8.7 Bazayan & Co

8.7.1. Company Overview

8.7.2. Key Executives

8.7.3. Operating Business Segments

8.7.4. Product Portfolio

8.7.5. Financial Performance (As per availability)

8.7.6. Key News

8.8  Beloorbayir Biotech

8.8.1. Company Overview

8.8.2. Key Executives

8.8.3. Operating Business Segments

8.8.4. Product Portfolio

8.8.5. Financial Performance (As per availability)

8.8.6. Key News

8.9 Malladi Drugs & Pharmaceuticals

8.9.1. Company Overview

8.9.2. Key Executives

8.9.3. Operating Business Segments

8.9.4. Product Portfolio

8.9.5. Financial Performance (As per availability)

8.9.6. Key News

8.10  Transo-Pharm

8.10.1. Company Overview

8.10.2. Key Executives

8.10.3. Operating Business Segments

8.10.4. Product Portfolio

8.10.5. Financial Performance (As per availability)

8.10.6. Key News

8.11 INDOCO REMEDIES

8.11.1. Company Overview

8.11.2. Key Executives

8.11.3. Operating Business Segments

8.11.4. Product Portfolio

8.11.5. Financial Performance (As per availability)

8.11.6. Key News

8.12 Kimia BioSciences

8.12.1. Company Overview

8.12.2. Key Executives

8.12.3. Operating Business Segments

8.12.4. Product Portfolio

8.12.5. Financial Performance (As per availability)

8.12.6. Key News

8.13 Iwaki Seiyaku

8.13.1. Company Overview

8.13.2. Key Executives

8.13.3. Operating Business Segments

8.13.4. Product Portfolio

8.13.5. Financial Performance (As per availability)

8.13.6. Key News

8.14  Nishchem International

8.14.1. Company Overview

8.14.2. Key Executives

8.14.3. Operating Business Segments

8.14.4. Product Portfolio

8.14.5. Financial Performance (As per availability)

8.14.6. Key News

8.15 Qualitek Pharma

8.15.1. Company Overview

8.15.2. Key Executives

8.15.3. Operating Business Segments

8.15.4. Product Portfolio

8.15.5. Financial Performance (As per availability)

8.15.6. Key News

8.16 INDOCO REMEDIES

8.16.1. Company Overview

8.16.2. Key Executives

8.16.3. Operating Business Segments

8.16.4. Product Portfolio

8.16.5. Financial Performance (As per availability)

8.16.6. Key News

8.17 Mylan N.V.

8.17.1. Company Overview

8.17.2. Key Executives

8.17.3. Operating Business Segments

8.17.4. Product Portfolio

8.17.5. Financial Performance (As per availability)

8.17.6. Key News

8.18 Novartis

8.18.1. Company Overview

8.18.2. Key Executives

8.18.3. Operating Business Segments

8.18.4. Product Portfolio

8.18.5. Financial Performance (As per availability)

8.18.6. Key News

8.19 Merck & Co.

8.19.1. Company Overview

8.19.2. Key Executives

8.19.3. Operating Business Segments

8.19.4. Product Portfolio

8.19.5. Financial Performance (As per availability)

8.19.6. Key News

8.20 Eli Lilly and Company

8.20.1. Company Overview

8.20.2. Key Executives

8.20.3. Operating Business Segments

8.20.4. Product Portfolio

8.20.5. Financial Performance (As per availability)

8.20.6. Key News

Global Phenylephrine API Market Segmentation

Phenylephrine API by Purity Type: Market Size & Forecast 2023-2030

• Purity 10%
• Purity 20%
• Purity 40%
• Purity 60%

Phenylephrine API by Application: Market Size & Forecast 2023-2030

• Pharmaceutical 
• Research organization
• Others

Phenylephrine API by Geography: Market Size & Forecast 2023-2030

• North America (USA, Canada, Mexico)
• Europe (Germany, UK, France, Russia, Italy, Rest of Europe)
• Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)
• South America (Brazil, Argentina, Columbia, Rest of South America)
• Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

Major Players:

• Transo-Pharm
• Titan Laboratories
• Malladi Drugs & Pharmaceuticals
• Beloorbayir Biotech, Bazayan & Co
• Hygro Chemicals
• Qualitek Pharma
• INDOCO REMEDIES
• Iwaki Seiyaku
• Kimia BioSciences
• Nishchem International
• Shenzhen Oriental Pharmaceutial
• Unichem Laboratories
• Synergene
• Spansules Pharma
• JSN Chemicals
• Eli Lilly and Company
• Merck & Co.
• Novartis
• Mylan N.V.