Montelukast Sodium Market Report 2025

This Montelukast Sodium market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The montelukast sodium market size has grown strongly in recent years. It will grow from $3.86 billion in 2024 to $4.24 billion in 2025 at a compound annual growth rate (CAGR) of 9.9%. The growth in the historic period can be attributed to increasing respiratory disorders, an aging population, rising air pollution levels, growing awareness and education, and expansion in emerging markets.

The montelukast sodium market size is expected to see strong growth in the next few years. It will grow to $6.12 billion in 2029 at a compound annual growth rate (CAGR) of 9.6%. The growth in the forecast period can be attributed to approval and launch, clinical studies, patent expiry, regulatory changes, and physician prescribing patterns. Major trends in the forecast period include increased generic competition, a shift towards combination therapies, expansion in emerging markets, a focus on pediatric use, and digital health solutions.

The growing prevalence of asthma is expected to drive the expansion of the montelukast sodium market in the coming years. Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to recurring episodes of wheezing, shortness of breath, chest tightness, and coughing. The rising incidence of asthma is attributed to factors such as environmental pollution, exposure to allergens, genetic factors, urbanization, lifestyle changes, and respiratory infections. Montelukast sodium, a leukotriene receptor antagonist, is used in asthma treatment to prevent and control symptoms by blocking the action of leukotrienes, which are responsible for airway inflammation and constriction. For example, in July 2024, the American Lung Association, a US-based health organization, reported that in 2022, around 44.2 million Americans, or 13.5% of the population, were diagnosed with asthma. Therefore, the increasing prevalence of asthma is fueling the growth of the montelukast sodium market.

Leading companies in the montelukast sodium market are introducing new drugs, such as over-the-counter (OTC) generic medications, to offer more convenient treatment options for patients managing asthma and allergic rhinitis. OTC generic medications are drugs available without a prescription, typically sold in pharmacies or retail stores. For example, in July 2022, Dr. Reddy's Laboratories, a pharmaceutical company based in India, launched Fexofenadine HCL 180 mg and Pseudoephedrine HCl 240 mg in the US. This product provides temporary relief from nasal and sinus congestion caused by colds or allergies. It is equivalent to Allegra-D 24 HR, combining an antihistamine and nasal decongestant to alleviate symptoms such as sneezing, runny nose, itchy eyes, and sore throat. Available in pack sizes of 5, 10, and 15, it offers a high-quality, cost-effective solution for those seeking relief from upper respiratory discomfort.

In April 2023, SK Capital Partners LP, a US-based private investment firm, completed the acquisition of Apotex Pharmaceutical Holdings Inc. for an undisclosed sum. This acquisition bolsters SK Capital's presence in the pharmaceutical sector, granting it access to Apotex's extensive global operations, product portfolio, and skilled workforce. Apotex Pharmaceutical Holdings Inc., headquartered in Canada, is known for manufacturing montelukast sodium and engaging in commercial physical and biological research and development.

Major companies operating in the montelukast sodium market are Pfizer Inc., Merck & Co. Inc., Sanofi Aventis SA, Teva Pharmaceuticals USA Inc., Hetero Labs Ltd., Sun Pharma Industries Ltd., Aurobindo Pharma Limited, Cipla Inc., Intas Pharmaceuticals Ltd., Seqens Group, Sanyo Chemical Industries Ltd., Morepen Laboratories, Neuland Laboratories Ltd., Medopharm Private Ltd., BEC Chemicals Pvt. Ltd, Delmar Chemicals Inc., Kimia Biosciences Ltd., Ortin Laboratories Ltd., MSN Laboratories Pvt Ltd., Vamsi Labs Ltd., LGM Pharma LLC, HRV Global Life Sciences, Sigmak Lifesciences, Akums Lifesciences Ltd., Anwita Drugs & Chemicals Pvt Ltd.

North America was the largest region in the montelukast sodium market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the montelukast sodium market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the montelukast sodium market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Montelukast sodium functions as a leukotriene receptor antagonist, blocking the action of leukotrienes that induce asthma symptoms and allergic reactions. It is employed for managing and preventing asthma symptoms and alleviating seasonal and perennial allergic rhinitis. Typically, montelukast is administered orally in tablet form.

Montelukast sodium exists in several product types, including crystal-like, form-less, or amorphous variations. Crystal-like denotes a solid substance with a regular, repeating three-dimensional arrangement of its atoms or molecules. Different dosage forms such as tablets and oral solutions are utilized for various applications, including bronchospasm, allergic coryza, asthma, urticaria, among others.

The montelukast sodium market research report is one of a series of new reports that provides montelukast sodium market statistics, including montelukast sodium industry global market size, regional shares, competitors with a montelukast sodium market share, detailed montelukast sodium market segments, market trends, and opportunities, and any further data you may need to thrive in the montelukast sodium industry. This montelukast sodium market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The montelukast sodium market consists of sales of monteluksast oral granules, chewable tablets, pill organizers, dosing spoons and syringes, and tablet packaging material. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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