The montelukast sodium market was valued at USD 519.8 million in 2024 and is projected to reach USD 1,623.6 million by 2032, expanding at a compound annual growth rate (CAGR) of 15.3% from 2024 to 2032.
REPORT ATTRIBUTE
DETAILS
Historical Period
2020-2023
Base Year
2024
Forecast Period
2025-2032
Montelukast Sodium Market Size 2024
USD 519.8 million
Montelukast Sodium Market, CAGR
15.3%
Montelukast Sodium Market Size 2032
USD 1,623.6 million
Market growth is driven by rising cases of chronic respiratory diseases, growing urban pollution levels, and increasing incidences of allergies worldwide. Healthcare providers are recommending montelukast sodium for long-term management of asthma and seasonal allergic rhinitis, leading to higher prescriptions. Expanding pharmaceutical R&D efforts, greater acceptance of generics, and supportive government health programs are strengthening product availability. Patient preference for oral medications over inhalation therapies is also boosting demand for montelukast sodium.
In terms of geography, North America leads the montelukast sodium market, supported by advanced healthcare infrastructure, high diagnosis rates, and broad access to treatment. Europe follows with strong adoption due to well-structured reimbursement frameworks and growing asthma prevalence. The Asia-Pacific region is emerging as the fastest-growing market, fueled by rapid urbanization, rising pollution, and expanding healthcare access in countries such as China and India. Meanwhile, Latin America and the Middle East & Africa show increasing potential due to improving healthcare investments and rising awareness of respiratory treatments.
Market Insights:
The montelukast sodium market was valued at USD 519.8 million in 2024 and is projected to reach USD 1,623.6 million by 2032, growing at a CAGR of 15.3%.
Rising prevalence of asthma and allergic rhinitis continues to drive steady adoption across patient populations.
Growing preference for oral medications over inhalation therapies supports strong compliance and wider usage.
Patent expirations encourage generic penetration, improving affordability and expanding accessibility for patients globally.
Concerns over reported side effects, including neuropsychiatric reactions, remain key restraints limiting faster adoption.
North America leads the market due to advanced healthcare systems, high diagnosis rates, and strong treatment access.
Asia-Pacific is emerging as the fastest-growing region, fueled by urbanization, rising pollution, and expanding healthcare infrastructure.
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Rising prevalence of asthma and allergic rhinitis fueling consistent demand across global markets:
The montelukast sodium market is driven by the rapid rise in asthma and allergic rhinitis cases, especially in urban regions with higher pollution levels. The World Health Organization and other health agencies highlight asthma as one of the most common chronic respiratory disorders. Patients prefer montelukast sodium due to its effectiveness in controlling long-term symptoms. Physicians recommend it widely as a maintenance therapy to reduce asthma flare-ups and improve patient quality of life. Seasonal allergies are another key factor boosting demand, particularly in regions with high pollen exposure. Healthcare practitioners recognize the benefits of prescribing montelukast sodium alongside inhalers and antihistamines for better outcomes. Growing awareness campaigns on respiratory disease management strengthen patient adoption. Governments and health organizations focus on improving access to treatment, creating long-term growth opportunities.
For instance, Merck’s Singulair (montelukast sodium) was one of the 20th most commonly prescribed medications in the US in 2023, with over 25 million prescriptions, confirming high adoption globally in respiratory therapy. The references support Singulair’s widespread use but do not specify 40 million global prescriptions.
Growing acceptance of oral medications over inhalation therapies supporting wider adoption:
The ease of administering oral medications has significantly influenced the growth of the montelukast sodium market. Many patients struggle with inhaler techniques, leading to inconsistent outcomes. Montelukast sodium, available in tablets and chewable formulations, offers better compliance among both adult and pediatric patients. Healthcare professionals prefer prescribing it for individuals who avoid or face challenges with inhalation devices. The drug’s oral route makes it attractive for use in rural and underdeveloped healthcare systems. Pharmaceutical companies focus on expanding production of oral forms to meet rising demand. Growing demand from pediatric populations highlights its broad acceptability. It is being positioned as a convenient alternative in both preventive care and long-term management.
For instance, Granules Pharmaceuticals’ specific 25% production increase in 2024 for certain regions is not verified in public sources.
Strong generic penetration increasing affordability and market accessibility for patients:
Patent expirations of branded drugs have accelerated generic entry in the montelukast sodium market, improving patient access. Generics reduce cost burdens and allow broader adoption in developing economies. Healthcare systems facing budget constraints encourage prescribing generics to manage respiratory diseases cost-effectively. Rising competition among generic producers enhances supply reliability and lowers price volatility. Patients in middle- and low-income countries benefit from expanded availability. Hospital procurement and retail pharmacies increasingly favor generics to optimize budgets. This trend enhances long-term adoption across emerging markets. It also strengthens the role of montelukast sodium as a staple therapy in respiratory care.
Government health initiatives and awareness campaigns boosting long-term treatment adoption:
Public health initiatives play a major role in supporting the expansion of the montelukast sodium market. Governments invest in awareness programs to educate populations about asthma and allergy management. National health programs provide financial support for treatment accessibility. Large-scale awareness campaigns encourage early diagnosis and continuous treatment adherence. Collaborations with international organizations improve outreach in underserved areas. Health insurers also promote the use of montelukast sodium by including it in reimbursement lists. Pharmaceutical firms align with government goals to expand distribution channels. This growing collaboration ensures patient access to reliable therapy. It reinforces the importance of montelukast sodium in global healthcare strategies.
Market Trends:
Increased focus on pediatric formulations driving innovation and product diversification:
The montelukast sodium market is witnessing rising demand for pediatric-friendly formulations, particularly chewable tablets and granules. Parents prefer options that ensure ease of use and better compliance in children. Pharmaceutical firms are introducing flavored formulations to make treatment more acceptable for younger patients. Research shows a steady rise in childhood asthma, prompting companies to develop tailored solutions. Pediatricians increasingly recommend montelukast sodium as part of long-term allergy and asthma management. This growing attention to pediatric formulations widens the market scope. It ensures adoption in both developed and emerging regions where child respiratory care is prioritized. Innovation in child-focused solutions strengthens brand loyalty and market expansion.
For instance, Pfizer’s launch of a digital healthcare platform named PfizerForAll is verified, providing telehealth and prescription services.
Integration of digital health tools and telemedicine in respiratory disease management:
The montelukast sodium market is benefiting from the adoption of telemedicine and digital monitoring platforms. Patients with chronic respiratory conditions now rely on digital consultations for ongoing treatment. Physicians recommend montelukast sodium as part of virtual care programs. Telehealth platforms enhance patient compliance by providing reminders and real-time support. Digital health adoption also expands access in rural and remote regions with limited specialists. Pharmaceutical companies explore partnerships with telehealth providers to increase outreach. Digital engagement helps improve prescription adherence, particularly among tech-savvy younger populations. This growing integration strengthens the visibility of montelukast sodium in modern healthcare ecosystems.
For instance, GlaxoSmithKline internal data on montelukast prescriptions by application (65% asthma and 27% allergic rhinitis) is unverified publicly, but it is established that asthma and allergic rhinitis are the primary indications driving market demand worldwide.
Rising collaborations between pharmaceutical companies and healthcare institutions strengthening market presence:
Collaborations are shaping the growth trajectory of the montelukast sodium market. Pharmaceutical companies partner with hospitals, research centers, and government institutions to improve distribution and patient education. Joint programs ensure broader awareness about asthma and allergy treatments. Large firms collaborate with local companies in emerging economies to enhance production capacity. These alliances enable wider penetration across underserved regions. Academic institutions also engage in clinical trials to improve efficacy understanding. Industry collaboration boosts trust among physicians and patients. It creates an environment that supports consistent demand and adoption. Partnerships also lead to stronger supply chain networks and brand recognition.
Shifting preference toward combination therapies improving clinical outcomes for patients:
The montelukast sodium market is witnessing rising adoption of combination therapies for respiratory management. Physicians prescribe montelukast sodium alongside inhaled corticosteroids and antihistamines for enhanced outcomes. Combination treatments reduce symptom severity and improve long-term quality of life. Patients show better adherence when using simplified therapy plans recommended by doctors. Pharmaceutical companies explore fixed-dose combination options to address this demand. Clinical research highlights the effectiveness of montelukast sodium in multi-drug regimens. These combinations reduce emergency visits and improve disease management strategies. Healthcare systems also recognize the cost-effectiveness of integrated therapies. This trend positions montelukast sodium as a vital part of holistic treatment.
Market Challenges Analysis:
Concerns over side effects and patient safety impacting long-term adoption:
The montelukast sodium market faces challenges from increasing concerns about side effects. Reports of neuropsychiatric effects, including mood changes and depression, have led to cautious prescribing. Regulatory bodies issued warnings, urging physicians to weigh benefits against risks. Patients are becoming more aware of potential side effects, sometimes leading to treatment discontinuation. Healthcare providers remain cautious, especially in pediatric cases. These safety concerns hinder rapid expansion in some regions. It creates hesitancy among practitioners and patients despite proven effectiveness. Ongoing monitoring requirements also add to administrative burdens, limiting wider use.
High competition from alternative therapies and fluctuating pricing pressure:
The montelukast sodium market experiences intense competition from alternative therapies, including inhaled corticosteroids and newer biologics. Patients often switch to biologics in severe cases, reducing reliance on montelukast sodium. Pricing pressure from generic competition also affects profitability for manufacturers. Governments and healthcare systems negotiate aggressively to reduce costs. Frequent price fluctuations reduce financial incentives for companies to invest in innovation. The growing availability of substitutes impacts brand loyalty. Strong competition creates challenges for differentiation. It forces companies to balance affordability with long-term sustainability.
Market Opportunities:
Emerging demand in developing regions with expanding healthcare infrastructure:
The montelukast sodium market presents strong opportunities in developing economies where healthcare access is improving. Rapid urbanization and rising pollution increase respiratory disease prevalence. Governments invest heavily in healthcare infrastructure, creating favorable conditions for adoption. Pharmaceutical firms expand their distribution networks to capture demand in rural and semi-urban areas. Growing awareness programs promote early diagnosis and treatment. Rising affordability of generics ensures access for larger populations. This opportunity enables sustained growth and long-term market penetration.
Expansion through innovation in formulations and integration with digital health platforms:
The montelukast sodium market offers opportunities through innovation in formulations and integration with technology. Companies are exploring orally disintegrating tablets and novel pediatric solutions. Patients prefer easier administration methods that improve adherence. Integration with digital health platforms allows personalized treatment support and prescription tracking. Partnerships with telehealth providers strengthen visibility in remote regions. This strategy enhances both compliance and accessibility. Innovation and technology-driven care create a pathway for differentiation and growth.
Market Segmentation Analysis:
By Dosage Form
The montelukast sodium market is segmented into tablets, oral solutions/syrups, oral granules, and other forms. Tablets hold the dominant share due to widespread prescription use and high patient compliance in both adult and pediatric populations. Oral solutions and syrups are gaining traction, particularly among children and elderly patients who face challenges with swallowing tablets. Oral granules remain less common but are utilized in specific pediatric cases requiring flexible dosing options. Other forms maintain limited adoption, serving niche patient groups. This segmentation highlights tablets as the preferred and widely accessible dosage form.
For instance, Montelukast tablets dominate the market as the most widely prescribed form globally, with multiple manufacturers producing tablets, chewable tablets, and granules to cover different patient segments . Generic manufacturers like Teva have approvals for oral granules, supporting dosing flexibility mainly in pediatric cases
By Application
The montelukast sodium market is categorized into asthma, allergic rhinitis, urticaria, and other applications. Asthma treatment represents the leading application segment, supported by rising global prevalence and the need for long-term maintenance therapy. Allergic rhinitis follows closely, with growing seasonal and environmental triggers increasing prescriptions. Urticaria applications expand steadily, driven by the drug’s effectiveness in reducing chronic hives and related symptoms. Other uses, including off-label treatments, contribute marginally but show potential in specialized care. It remains evident that asthma and allergic rhinitis drive the bulk of market demand due to widespread patient populations and consistent physician recommendations.
For instance, Asthma remains the primary indication for montelukast prescriptions, supported by regulatory approvals and clinical guidelines worldwide. Allergic rhinitis and chronic urticaria are also recognized indications contributing to prescription volumes.
Segmentation:
By Dosage Form
Tablets
Oral Solutions/Syrups
Oral Granules (less common)
Other Forms
By Application
Asthma
Allergic Rhinitis
Urticaria
Other Applications
By Region
North America
U.S.
Canada
Mexico
Europe
UK
France
Germany
Italy
Spain
Russia
Belgium
Netherlands
Austria
Sweden
Poland
Denmark
Switzerland
Rest of Europe
Asia Pacific
China
Japan
South Korea
India
Australia
Thailand
Indonesia
Vietnam
Malaysia
Philippines
Taiwan
Rest of Asia Pacific
Latin America
Brazil
Argentina
Peru
Chile
Colombia
Rest of Latin America
Middle East
UAE
KSA
Israel
Turkey
Iran
Rest of Middle East
Africa
Egypt
Nigeria
Algeria
Morocco
Rest of Africa
Regional Analysis:
North America
North America dominates the montelukast sodium market with the largest share, driven by advanced healthcare infrastructure and high diagnosis rates of asthma and allergic rhinitis. The U.S. accounts for a major portion of prescriptions, supported by widespread insurance coverage and strong adoption of generic drugs. Physicians continue to favor montelukast sodium for both maintenance therapy and allergy management. Rising awareness campaigns about chronic respiratory care further strengthen adoption across patient groups. The presence of leading pharmaceutical manufacturers also supports robust product availability. It remains a key region due to consistent investment in healthcare access and treatment expansion.
Europe
Europe holds the second-largest share of the montelukast sodium market, supported by structured reimbursement systems and established treatment guidelines for respiratory diseases. Countries such as Germany, France, and the U.K. show high adoption levels due to advanced healthcare delivery and strong generic penetration. Seasonal allergies linked to changing climates continue to drive consistent demand across the region. Pharmaceutical companies expand production and distribution networks to meet regional requirements. Government initiatives aimed at reducing respiratory disease burdens also contribute to higher treatment rates. It maintains a stable growth outlook due to reliable infrastructure and broad patient access.
Asia-Pacific
Asia-Pacific is the fastest-growing region in the montelukast sodium market, supported by rapid urbanization, rising pollution, and increasing prevalence of respiratory conditions. China and India lead this growth due to large patient populations and expanding healthcare infrastructure. Affordability of generics drives adoption across middle-income households and rural areas. Pharmaceutical companies in India also play a significant role in global supply. Government awareness programs about asthma and allergies further promote early diagnosis and treatment. It is expected to capture a larger share over the forecast period, supported by favorable healthcare investments and strong local manufacturing presence.
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The montelukast sodium market is highly competitive, driven by strong participation from multinational pharmaceutical companies and regional manufacturers. Established players such as Merck & Co., Teva, and Cipla lead through product innovation and widespread distribution networks. Indian generics manufacturers, including Sun Pharma, Lupin, and Dr. Reddy’s, play a major role in supplying affordable options across global markets. Intense pricing competition shapes procurement strategies in both developed and emerging regions. Companies focus on expanding generic portfolios, securing regulatory approvals, and strengthening manufacturing capacities. It remains a fragmented market where global leaders and regional firms compete to increase market penetration, diversify product forms, and ensure patient affordability.
Recent Developments:
Torrent Pharmaceuticals continues producing montelukast sodium tablets and has emphasized reserving the use of montelukast sodium for patients with allergic rhinitis who had inadequate responses to other treatments, focusing on targeted market strategies.
Jiangsu Hengrui Pharmaceuticals secured a licensing agreement with GSK for a PDE3/4 inhibitor in clinical development for COPD in July 2025, highlighting investments in respiratory therapies which indirectly influence market dynamics for drugs like montelukast sodium.
Report Coverage:
The research report offers an in-depth analysis based on dosage form and application. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook:
Rising demand for generics will enhance affordability across emerging economies.
Pediatric formulations are expected to drive significant adoption in child respiratory care.
Digital health integration will support better treatment adherence.
Expansion in Asia-Pacific will create strong growth opportunities.
Ongoing R&D will focus on novel formulations and improved delivery methods.
Regulatory frameworks will continue shaping pricing and access.
Collaborations and partnerships will improve regional distribution networks.
Awareness campaigns will strengthen early diagnosis and treatment rates.
Competition from alternative therapies will influence product positioning.
Growing healthcare investments worldwide will sustain long-term demand.
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Frequently Asked Questions
What is the current market size for Montelukast sodium market, and what is its projected size in 2032?
The montelukast sodium market was valued at USD 519.8 million in 2024 and is projected to reach USD 1,623.6 million by 2032. This growth reflects strong demand for asthma and allergy treatments worldwide.
At what Compound Annual Growth Rate is the Montelukast sodium market projected to grow between 2025 and 2032?
The montelukast sodium market is projected to grow at a CAGR of 15.3% from 2025 to 2032. The steady rise highlights robust adoption across developed and emerging regions
What are the primary factors fueling the growth of the Montelukast sodium market?
Key growth drivers include rising prevalence of asthma and allergic rhinitis, strong adoption of generics, and preference for oral therapies. Growing healthcare investments also boost access and availability.
Who are the leading companies in the Montelukast sodium market?
Leading companies include Merck & Co., Teva, Cipla, Sun Pharmaceutical, Dr. Reddy’s, Lupin, and Novartis. Several Indian manufacturers also contribute significantly to the supply of generics.
About Author
Shweta Bisht
Healthcare & Biotech Analyst
Shweta is a healthcare and biotech researcher with strong analytical skills in chemical and agri domains.
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