Montelukast API Market Research Report - Global Forecast till 2032

Montelukast API Market Research Report: Information By Application (Asthma, Allergic Rhinitis, Bronchospasm, Urticaria, and Others), and By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2032

ID: MRFR/HC/6414-CR | 94 Pages | Author: Rahul Gotadki | May 2019         

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Global Montelukast API Market Overview


Montelukast API Market Size was valued at USD 0.8 Billion in 2022. The montelukast API market industry is projected to grow from USD 0.9 Billion in 2023 to USD 2.30 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 12.50% during the forecast period (2023 - 2032).The increase in the prevalence of disorders like asthma, exercise-induced bronchospasm, allergic rhinitis, primary dysmenorrhea, and urticaria are the key market drivers enhancing the market growth. The availability of well-established healthcare facilities and improvements in treatment alternatives are two more aspects that impact the market.


Montelukast API Market


Source: Secondary Research, Primary Research, MRFR Database and Analyst Review


Montelukast API Market Trends



  • Growing prevalence of asthma is driving the market growth


Market CAGR for montelukast API is driven by the increasing number of people who have asthma. Globally rising rates of chronic respiratory disorders like asthma are one of the major market factors driving this industry. Since asthma is estimated to be the most common chronic condition globally, there has been a significant demand for innovative treatments. If someone has severe asthma, it can be a crippling illness requiring asthma medicine. Hence, the market expansion is expected to be supported by the increased need for people with asthma to have higher-quality lifestyles. As per the American Academy of Asthma, Allergy & Immunology, 8.3% of kids in the US were predicted to have asthma in 2016. Creating economical and effective treatments will drive market expansion during the forecast period.


Worldwide pollution levels are increasing as a result of growing industrialization. The environment's carbon content is rising due to the overuse of coal in creating electricity and other production activities, raising temperatures. On the other hand, people's purchasing power is growing due to rising disposable income. They are purchasing automobiles as a result. All of these causes contribute to increased pollution, which worsens existing health issues, including asthma and allergic coryza. According to the WHO, asthma and other bronchial issues can develop in sensitive people when the air quality is above 101. Following this, nations like China and India have taken the lead in having high AQI, which will contribute to market expansion.


The world population is expanding steadily, particularly in Asian countries like China and India, which comprise around 36% of the population. Around 4.6 billion of the world's 7.9 billion inhabitants reside in Asia. Along with the general population increase, the elderly population is also rising. There are about 700 million individuals over the age of 65, and that figure is projected to grow to between 1 and 2 billion soon. Respiratory issues are more likely in older age, bringing physical suffering.


The strong and vigorous R&D efforts made by major industry players to produce montelukast API are one of the significant market trends currently dominating this market. Since asthma is a chronic condition affecting many people globally, including children, several renowned pharmaceutical companies are working to produce asthma medications. Several promising asthma treatment candidates undergo various clinical trial stages as part of this involvement. Thus, driving the montelukast API market revenue.


Montelukast API Market Segment Insights


Montelukast API Application Insights


The montelukast API market segmentation, based on application, includes asthma, allergic rhinitis, bronchospasm, urticaria, and others. The asthma segment dominated the market, accounting for 46.9% of market revenue (0.4 Billion). By preventing symptoms like wheezing, breathing issues, chest tightness, and coughing, montelukast sodium treats asthma in adults and children 12 months and older. Asthma, among the most prevalent ailments in the world, can be fatal and make breathing challenging for patients. Around 6.2 million children under the age of 18 have asthma. Asthma is responsible for 1.8 million trips to the emergency room, 188,968 hospital inpatient discharges, and 9.8 million visits to the doctor's office annually.


April 2020: Cipla Limited announced the successful completion of the Phase-3 clinical end-point trial for salmeterol inhalation powder and fluticasone propionate (50/100 mcg). Salmeterol inhalation and fluticasone propionate powder 500/50 mcg, 250/50 mcg, and 100/50 mcg are the generic equivalents of GSK's Advair Diskus. The medicine, a twice-daily prescription tablet, is intended for the prolonged treatment of chronic obstructive pulmonary disease in patients with asthma who are at least four years and have chronic bronchitis, emphysema, or both. This will result in better breathing and fewer asthma attacks.


Additionally, in 2022, allergic rhinitis witnessed the fastest growth rate due to variables including pollen, a powder produced by many trees, grasses, and flowers that causes allergic rhinitis. Growing carbon dioxide emissions eventually contaminate the ecosystem and lengthen pollen seasons. The prolonged pollen season accelerates the occurrence of illnesses like headaches, dark undereye bags, runny nose, coughing, and throat pain.


Figure 1: Montelukast API Market, by Application, 2022 & 2032 (USD Billion)


Montelukast API Market, by Application, 2022 & 2032 (USD Billion)


Source: Secondary Research, Primary Research, MRFR Database and Analyst Review


Montelukast API Regional Insights


By region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. The Asia-Pacific Montelukast API Market area will dominate this market. This increase results from an aging population, particularly in developing nations like India and China, and an increase in pollution because these two nations are the largest emitters of carbon dioxide, making asthmatic conditions worse. On the other hand, because of their growing GDPs, these countries can afford to invest more money in R&D. Moreover, China’s montelukast API market held the major market share, and the Indian montelukast API market was the rapidly growing market in the Asia-Pacific region.


Further, the major countries studied in the market report are US, Canada, France, German, Italy, UK, Spain, Japan, China, Australia, India, South Korea, and Brazil.


Figure 2: MONTELUKAST API MARKET SHARE BY REGION 2022 (USD Billion)


MONTELUKAST API MARKET SHARE BY REGION 2022 (USD Billion)


Source: Secondary Research, Primary Research, MRFR Database and Analyst Review


The North American Montelukast API market accounts for the second-largest market share. Its significant market share is attributable to several factors, including the existence of prominent players, the high prevalence of asthma and other respiratory disorders, and the well-established healthcare infrastructure. In addition, encouraging government initiatives and a rise in research collaboration numbers are anticipated to boost market expansion. Moreover, the U.S. montelukast API market held the major market share, and the Canadian montelukast API market was the rapidly growing market in the Asia-Pacific region.


Europe’s Montelukast API Market is expected to grow at the fastest CAGR from 2023 to 2032 because eminent academics worldwide and top pharmaceutical firms like GSK and AstraZeneca are there. The area has a strong potential for cutting-edge cures and conducts top-notch research in bioinformatics and digital technology. Further, the German montelukast API market held the largest market share, and the UK montelukast API market was the rapidly growing market in the European region.


Montelukast API Key Market Players & Competitive Insights


Leading market players are largely investing in research and development to expand their product lines, which will help the montelukast API market, grow even more. The launch of new products, larger-scale mergers and acquisitions, contractual agreements, and collaboration with other organizations are significant market developments in which market participants engage to increase their presence. The Montelukast API industry must provide affordable products to expand and thrive in a more competitive and challenging market environment.


One of the major business strategies manufacturers use in the montelukast API industry to increase market sector and benefit customers is local manufacturing to lower operational costs. In recent years, the montelukast API industry has stipulated some of the most important medicinal benefits. Major players in the montelukast API industry, including Teva Pharmaceutical Industries Ltd (Israel), Sandoz International GmbH (Germany), Vintage Pharmaceuticals Inc (US), Morepen Laboratories Ltd (India), and others, are funding operations for research and development to boost market demand.


Morepen Laboratories is a renowned Pharmaceutical Company in Active Pharmaceutical Ingredients and Formulations. Morepen Laboratories Limited, founded in 1984 by Mr. KB Suri, began as a pure API manufacturer. The company manufactures and sells active formulations, pharmaceutical ingredients (APIs), and home health products. With approvals from all the major regulatory agencies, including the USFDA, WHO GMP, and EU GMP, Morepen has an important international footprint and distributes to over 75 countries. In December 2021, Morepen Laboratories announced that it had got approval from the US Food and Medicine Administration to market its anti-allergy medicine Fexofenadine Hydrochloride in the United States. In India, the medicine is marketed under the brand Allegra.


Valeo Pharma Inc is a Canadian specialty pharmaceutical business focused on acquisitions, in-licensing, and similar partnerships. It now markets Synacthen Depot, a synthetic ACTH medication used in cases where natural cortisol and other hormone synthesis is needed. In March 2021, Valeo Pharma Inc. announced a Commercialization and Supply Contract with Novartis Pharmaceuticals Canada Inc. for the Canadian marketing of two asthma therapies, Enerzair Breezhaler (indacaterol (as acetate), glycopyrronium (as bromide), and mometasone furoate) and Atectura Breezhaler (indacaterol (as acetate) and mometasone furoate).


Key Companies in the Montelukast API market include




  • Sandoz International GmbH (Germany)




  • Teva Pharmaceutical Industries Ltd (Israel)




  • Dr. Reddys Laboratories Ltd (India)




  • Morepen Laboratories Ltd (India)




  • Mylan N.V. (US)




  • Teva Pharmaceutical Industries Ltd (Israel)




  • Vintage Pharmaceuticals Inc (US)




  • Hikma Pharmaceuticals PLC (UK)




  • Glenmark (India)




  • Merck Sharp and Dohme Corp (US)




  • Sandoz International GmbH (Germany)




  • Hetero (India)




  • Aurobindo Pharma (India)




Montelukast API Industry Developments


May 2021:The Health Choice Arizona Formulary / Preferred Drug List now includes Montelukast Sodium. A Preferred Drug List (PDL) is a list of pharmaceuticals selected by Health Choice Arizona and a team of doctors and chemists. As long as the drugs on our PDL are medically required and appropriate, Health Choice will cover them. All Health Choice Arizona network pharmacy prescriptions must be filled, and all other plan restrictions must be fulfilled.


March 2021:ALK-Abelló A/S, a pharmaceutical company, announced the submission of a registration application in China for its ACARIZAX, a house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet, to the National Medical Products Administration (NMPA), China's agency for regulating drugs and medical devices.


Montelukast API Market Segmentation


Montelukast API Application Outlook




  • Asthma




  • Allergic Rhinitis




  • Bronchospasm




  • Urticaria




  • Others




Montelukast API Regional Outlook




  • North America






  • US




  • Canada






  • Europe






  • Germany




  • France




  • UK




  • Italy




  • Spain




  • Rest of Europe






  • Asia-Pacific




    • China




    • Japan




    • India




    • Australia




    • South Korea




    • Australia




    • Rest of Asia-Pacific






  • Rest of the World




    • Middle East




    • Africa




    • Latin America





Report Scope:

Report Attribute/Metric Details
Market Size 2022 USD 0.8 Billion
Market Size 2023 USD 0.9 Billion
Market Size 2032 USD 2.30 Billion
Compound Annual Growth Rate (CAGR) 12.50% (2023-2032)
Base Year 2022
Market Forecast Period 2023-2032
Historical Data 2018- 2022
Market Forecast Units Value (USD Billion)
Report Coverage Market Competitive Landscape, Growth Factors, Revenue Forecast, and Trends
Segments Covered Application
Geographies Covered North America, Europe, Asia Pacific, and the Rest of the World
Countries Covered US, Canada, France, German, Italy, UK, Spain, Japan, China, Australia, India, South Korea, and Brazil.
Key Companies Profiled Teva Pharmaceutical Industries Ltd (Israel), Sandoz International GmbH (Germany), Vintage Pharmaceuticals Inc (US), and Morepen Laboratories Ltd (India).
Key Market Opportunities Opportunities associated with the technological advancements
Key Market Dynamics Increasing prevalence of diseases like asthma, allergic rhinitis, etc.




Frequently Asked Questions (FAQ) :

The market size of the montelukast API market was prized at USD 0.8 billion in 2022.

From 2023 to 2032, the anticipated CAGR for the market is 12.50%.

The major portion of the market was accounted for by Asia Pacific.

The prominent market players are Teva Pharmaceutical Industries Ltd (Israel), Sandoz International GmbH (Germany), Vintage Pharmaceuticals Inc (US), and Morepen Laboratories Ltd (India).

The asthma category dominated the market in 2022.

Key Questions Answered

  • Global Market Outlook
  • In-depth analysis of global and regional trends
  • Analyze and identify the major players in the market, their market share, key developments, etc.
  • To understand the capability of the major players based on products offered, financials, and strategies.
  • Identify disrupting products, companies, and trends.
  • To identify opportunities in the market.
  • Analyze the key challenges in the market.
  • Analyze the regional penetration of players, products, and services in the market.
  • Comparison of major players’ financial performance.
  • Evaluate strategies adopted by major players.
  • Recommendations
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