Global Montelukast Sodium Market Growth 2026-2032
Description
The global Montelukast Sodium market size is predicted to grow from US$ 66.52 million in 2025 to US$ 150 million in 2032; it is expected to grow at a CAGR of 13.5% from 2026 to 2032.
Montelukast sodium is a hygroscopic, optically active, and white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. It is administered orally for prophylaxis and chronic treatment of asthma, exercise-induced bronchoconstriction, and allergic rhinitis.In 2024, global Montelukast Sodium production reached approximately 122 MT, with an average global market price of around US$ 562 per kg.
Montelukast sodium demand is mainly driven by the large and persistent patient base for asthma control, exercise-induced bronchoconstriction prevention, and allergic rhinitis, plus the product’s “system” advantages: it’s oral, convenient for long-term use (including pediatric chewables/granules), and often positioned as add-on therapy when inhaled regimens don’t fully control symptoms or when adherence to inhalers is an issue. Because it is widely generic, volume is also shaped by payer formularies and tendering, seasonal allergy cycles, and growth in emerging markets; at the same time, utilization can be pressured by safety-risk communication around neuropsychiatric events (especially for mild allergic rhinitis), and by competition from inhaled corticosteroid/combination inhalers, inexpensive OTC allergy options, and (for severe asthma) biologics that can reduce reliance on oral add-ons.
Upstream, the montelukast sodium “market” is anchored in the API supply chain and its chemical building blocks: production relies on multi-step synthesis using specialty aromatic/heteroaromatic intermediates (quinoline-type cores and substituted phenyl side chains), sulfur-containing reagents for thioether construction, bases/acids for couplings and workups, and then salt formation to the sodium form (typically using sodium bases and tightly controlled crystallization/isolation). Costs and availability are therefore influenced by upstream petrochemical aromatics (benzene/toluene/xylene derivatives feeding advanced intermediates), chlorinating/activating reagents, catalysts, and large volumes of solvents and utilities, as well as by GMP-grade raw-material qualification, impurity controls (including “special attention” impurity classes such as nitrosamines where applicable), solvent recovery capacity, and hazardous-waste treatment economics. Downstream from API, finished-dose manufacturers pull on upstream markets for excipients (binders, disintegrants, coatings, sweeteners/flavors for pediatric forms) and packaging (blister films/foils, bottles), and the overall chain is highly sensitive to regulatory compliance, site approvals, and supply reliability because switching sources can require re-qualification.
As a mature, highly competitive generic small-molecule, the industry typically runs at mid-teens to mid-20% gross margins at the API level
LP Information, Inc. (LPI) ' newest research report, the “Montelukast Sodium Industry Forecast” looks at past sales and reviews total world Montelukast Sodium sales in 2025, providing a comprehensive analysis by region and market sector of projected Montelukast Sodium sales for 2026 through 2032. With Montelukast Sodium sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Montelukast Sodium industry.
This Insight Report provides a comprehensive analysis of the global Montelukast Sodium landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyzes the strategies of leading global companies with a focus on Montelukast Sodium portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Montelukast Sodium market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Montelukast Sodium and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Montelukast Sodium.
This report presents a comprehensive overview, market shares, and growth opportunities of Montelukast Sodium market by product type, application, key manufacturers and key regions and countries.
Segmentation by Type:
Montelukast Sodium Amorphous
Montelukast Sodium Crystalline
Segmentation by Feature:
Dodecyl Alcohol High-pressure Process
Dodecyl Chloride Process
Segmentation by Channel:
Direct Selling
Distribution
Segmentation by Application:
Asthma
Allergic Rhinitis
Other
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analysing the company's coverage, product portfolio, its market penetration.
Morepen Laboratories
Mylan
TAPI
Ultratech India
Aurobindo Pharma
Hetero Labs
Unimark Remedies
Ortin Laboratories
Vamsi Labs
Adley Group
Arromax Pharmaceutical Technology
Lunan
Dongyue
Anxin
Key Questions Addressed in this Report
What is the 10-year outlook for the global Montelukast Sodium market?
What factors are driving Montelukast Sodium market growth, globally and by region?
Which technologies are poised for the fastest growth by market and region?
How do Montelukast Sodium market opportunities vary by end market size?
How does Montelukast Sodium break out by Type, by Application?
Please note: The report will take approximately 2 business days to prepare and deliver.
Montelukast sodium is a hygroscopic, optically active, and white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. It is administered orally for prophylaxis and chronic treatment of asthma, exercise-induced bronchoconstriction, and allergic rhinitis.In 2024, global Montelukast Sodium production reached approximately 122 MT, with an average global market price of around US$ 562 per kg.
Montelukast sodium demand is mainly driven by the large and persistent patient base for asthma control, exercise-induced bronchoconstriction prevention, and allergic rhinitis, plus the product’s “system” advantages: it’s oral, convenient for long-term use (including pediatric chewables/granules), and often positioned as add-on therapy when inhaled regimens don’t fully control symptoms or when adherence to inhalers is an issue. Because it is widely generic, volume is also shaped by payer formularies and tendering, seasonal allergy cycles, and growth in emerging markets; at the same time, utilization can be pressured by safety-risk communication around neuropsychiatric events (especially for mild allergic rhinitis), and by competition from inhaled corticosteroid/combination inhalers, inexpensive OTC allergy options, and (for severe asthma) biologics that can reduce reliance on oral add-ons.
Upstream, the montelukast sodium “market” is anchored in the API supply chain and its chemical building blocks: production relies on multi-step synthesis using specialty aromatic/heteroaromatic intermediates (quinoline-type cores and substituted phenyl side chains), sulfur-containing reagents for thioether construction, bases/acids for couplings and workups, and then salt formation to the sodium form (typically using sodium bases and tightly controlled crystallization/isolation). Costs and availability are therefore influenced by upstream petrochemical aromatics (benzene/toluene/xylene derivatives feeding advanced intermediates), chlorinating/activating reagents, catalysts, and large volumes of solvents and utilities, as well as by GMP-grade raw-material qualification, impurity controls (including “special attention” impurity classes such as nitrosamines where applicable), solvent recovery capacity, and hazardous-waste treatment economics. Downstream from API, finished-dose manufacturers pull on upstream markets for excipients (binders, disintegrants, coatings, sweeteners/flavors for pediatric forms) and packaging (blister films/foils, bottles), and the overall chain is highly sensitive to regulatory compliance, site approvals, and supply reliability because switching sources can require re-qualification.
As a mature, highly competitive generic small-molecule, the industry typically runs at mid-teens to mid-20% gross margins at the API level
LP Information, Inc. (LPI) ' newest research report, the “Montelukast Sodium Industry Forecast” looks at past sales and reviews total world Montelukast Sodium sales in 2025, providing a comprehensive analysis by region and market sector of projected Montelukast Sodium sales for 2026 through 2032. With Montelukast Sodium sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Montelukast Sodium industry.
This Insight Report provides a comprehensive analysis of the global Montelukast Sodium landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyzes the strategies of leading global companies with a focus on Montelukast Sodium portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Montelukast Sodium market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Montelukast Sodium and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Montelukast Sodium.
This report presents a comprehensive overview, market shares, and growth opportunities of Montelukast Sodium market by product type, application, key manufacturers and key regions and countries.
Segmentation by Type:
Montelukast Sodium Amorphous
Montelukast Sodium Crystalline
Segmentation by Feature:
Dodecyl Alcohol High-pressure Process
Dodecyl Chloride Process
Segmentation by Channel:
Direct Selling
Distribution
Segmentation by Application:
Asthma
Allergic Rhinitis
Other
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analysing the company's coverage, product portfolio, its market penetration.
Morepen Laboratories
Mylan
TAPI
Ultratech India
Aurobindo Pharma
Hetero Labs
Unimark Remedies
Ortin Laboratories
Vamsi Labs
Adley Group
Arromax Pharmaceutical Technology
Lunan
Dongyue
Anxin
Key Questions Addressed in this Report
What is the 10-year outlook for the global Montelukast Sodium market?
What factors are driving Montelukast Sodium market growth, globally and by region?
Which technologies are poised for the fastest growth by market and region?
How do Montelukast Sodium market opportunities vary by end market size?
How does Montelukast Sodium break out by Type, by Application?
Please note: The report will take approximately 2 business days to prepare and deliver.
Table of Contents
113 Pages
- *This is a tentative TOC and the final deliverable is subject to change.*
- 1 Scope of the Report
- 2 Executive Summary
- 3 Global by Company
- 4 World Historic Review for Montelukast Sodium by Geographic Region
- 5 Americas
- 6 APAC
- 7 Europe
- 8 Middle East & Africa
- 9 Market Drivers, Challenges and Trends
- 10 Manufacturing Cost Structure Analysis
- 11 Marketing, Distributors and Customer
- 12 World Forecast Review for Montelukast Sodium by Geographic Region
- 13 Key Players Analysis
- 14 Research Findings and Conclusion
Pricing
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