Montelukast API Market

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 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.

The Global Montelukast API Market Industry is poised for substantial growth, with projections indicating a rise from 1.01 USD Billion in 2024 to 3.13 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate of 10.83% from 2025 to 2035. Such figures highlight the increasing demand for Montelukast as a therapeutic option for asthma and allergies. The market's expansion is likely influenced by various factors, including rising prevalence rates, advancements in drug formulations, and increased generic production. These dynamics collectively contribute to a promising outlook for the industry.

Supportive regulatory frameworks and timely approvals for Montelukast formulations enhance the growth prospects of the Global Montelukast API Market Industry. Regulatory agencies are increasingly streamlining the approval processes for new drugs and generics, facilitating quicker market entry. This trend is particularly beneficial for manufacturers looking to introduce innovative formulations or generic alternatives. As a result, the market is expected to experience robust growth, with projections indicating a rise to 3.13 USD Billion by 2035. The favorable regulatory environment encourages investment and innovation, further solidifying the market's trajectory.

The rise in generic drug manufacturing plays a crucial role in shaping the Global Montelukast API Market Industry. As patents for branded versions of Montelukast expire, generic alternatives become more accessible and affordable. This shift is particularly relevant in developing regions where cost-effective treatment options are essential for managing asthma and allergies. The influx of generic Montelukast products is likely to enhance market penetration, contributing to a projected compound annual growth rate of 10.83% from 2025 to 2035. This trend not only benefits patients but also stimulates competition among manufacturers.

The increasing incidence of asthma and allergic conditions globally drives the demand for Montelukast API. According to health statistics, asthma affects approximately 300 million people worldwide, with a substantial portion requiring long-term management. The Global Montelukast API Market Industry benefits from this trend as healthcare providers seek effective treatments. The anticipated growth in the market, projected to reach 1.01 USD Billion in 2024, reflects the urgent need for reliable therapeutic options. As awareness of asthma and allergy management rises, the demand for Montelukast is likely to increase, further propelling the market forward.

Innovations in drug formulation and delivery systems contribute significantly to the expansion of the Global Montelukast API Market Industry. Enhanced formulations, such as chewable tablets and granules, improve patient compliance, particularly among children. These advancements not only facilitate better therapeutic outcomes but also broaden the market reach. As pharmaceutical companies invest in research and development, the market is expected to grow, with projections indicating a rise to 3.13 USD Billion by 2035. This growth underscores the importance of continuous innovation in meeting diverse patient needs and preferences.

Educational campaigns aimed at raising awareness about asthma and allergy management significantly impact the Global Montelukast API Market Industry. Healthcare organizations and governments are increasingly investing in initiatives to inform the public about the importance of early diagnosis and effective treatment options. Such efforts lead to higher diagnosis rates and increased prescriptions for Montelukast. As awareness grows, the market is poised for expansion, with the potential for reaching 1.01 USD Billion in 2024. This proactive approach to health education is likely to foster a more informed patient population, ultimately driving demand.

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)

Source: Secondary Research, Primary Research, Market Research Future 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 2024 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.

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).