Montelukast Sodium Market Size, Share, Growth, and Industry Analysis, By Type (montelukast sodium amorphous and montelukast sodium crystalline), by application, (tablets, chewable tablet & oral solution), and Regional Insights and Forecast From 2026 to 2035

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MONTELUKAST SODIUM MARKET OVERVIEW

The global Montelukast Sodium Market is estimated to be valued at approximately USD 0.54 Billion in 2026. The market is projected to reach USD 1.56 Billion by 2035, expanding at a CAGR of 8.3% from 2026 to 2035.Asia-Pacific dominates with ~40% share, followed by Europe at ~30% and North America at ~25%. Growth is driven by asthma and allergy prevalence.

Montelukast sodium market is an important segment of the global pharmaceutical industry, which focuses on treatment for asthma, allergic rhinitis and other respiratory conditions. Montelukast sodium, is widely determined to manage chronic asthma and seasonal allergies, improves breathing. Increasing prevalence of respiratory disorders, environmental pollution, and lifestyle changes and increasing urbanization, promoting global demand. The availability of branded and generic yoga’s in the market is beneficial, which improves the reach and strength of the patient Strong healthcare infrastructure in developed areas supports market expansion, combined with increasing awareness in emerging economies. Constant R&D activities and supporting regulatory structure increased further growth, making Montelukast sodium a significant treatment within the widespread respiratory medicine market.

KEY FINDINGS

• Market Size and Growth: Global Montelukast Sodium Market size is valued at USD 0.54 billion in 2026, expected to reach USD 1.56 billion by 2035, with a CAGR of 8.3% from 2026 to 2035.
• Key Market Driver: Rising asthma and allergic rhinitis prevalence contributes 68%, while long-term maintenance therapy preference accounts for 42% demand growth.
• Major Market Restraint: Safety warnings influence 39%, while physician shift toward alternative therapies impacts nearly 31% prescription patterns.
• Emerging Trends: Generic penetration expansion represents 57%, while pediatric formulation development accounts for approximately 28% innovation focus.
• Regional Leadership: North America holds about 41%, followed by Asia-Pacific contributing nearly 34% of global consumption volume.
• Competitive Landscape: Generic manufacturers dominate with 63%, while branded drug players retain roughly 27% market influence.
• Market Segmentation: Montelukast Sodium Amorphous accounts for 54%, while Montelukast Sodium Crystalline represents around 46% usage share.
• Recent Development: Bioequivalence approvals increased 36%, while manufacturing capacity optimization initiatives rose by nearly 29%.

COVID-19 IMPACT

Pandemic hindered the market growth due to restrictions on manufacturing and lack of hospital visits

The Covid-19 pandemic impact the montelukast sodium market growth. Initially, there was a slow recipe rates in some areas due to disruption in supply chains, restrictions on manufacturing, and lack of hospital visits. However, increasing anxiety over respiratory health during epidemic increased awareness and demanded the use of asthma and allergic remedies indirectly supported the use of Montelukast sodium. Some studies also detected the possible benefits of Montelukast in managing related respiratory complications, promoting research interest. Telemedicine adoption and online pharmacy development improved the patient's access to drugs during lockdown. Post-pandemic, strengthening the healthcare system, managing chronic respiratory diseases and focusing on ensuring availability of drugs is expected to increase stable recovery and long-term growth in the Montelukast sodium market globally, which strengthens its role in respiratory care.

LATEST TRENDS

Increasing prevalence of asthma and allergic rhinitis to be prominent trends

Montelukast sodium market is looking at many major trends that shape its development. Increasing general yoga’s is making the drug more inexpensive and accessible, especially in emerging economies. The increasing prevalence of asthma and allergic rhinitis operated by urbanization and environmental pollution continues the demand for fuel. The combination is attracting attention to the technological progress in drug distribution, including remedies, to increase the results of treatment. In addition, beyond traditional uses, increasing interest in possible applications of Montelukast, such as neurological disorders and inflammation related to covid -19, expands research opportunities. Telemedicine and e-pharmacy platforms are also promoting prescription access and patient facility. Additionally, strong government initiative for respiratory disease management and increasing health care is supporting market expansion. These trends collectively keep Montelukast sodium as an important therapy in the respiratory care scenario developed.

• According to the U.S. Centers for Disease Control and Prevention (CDC), about 8.7% of adults aged 18 and over and 6.2% of children under 18 years had asthma in 2022, illustrating a substantial population eligible for montelukast sodium prescriptions as part of long-term asthma management. 

• According to a 19-year national prescription review, the prevalence of montelukast use in Denmark grew from 0.9 per 1,000 persons in 1998 to 3.3 per 1,000 persons in 2016, indicating rising adoption in clinical practice over time. 

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MONTELUKAST SODIUM MARKET SEGMENTATION

By Type

Based on type, the global market can be categorized into montelukast sodium amorphous and montelukast sodium crystalline.

• Montelukast sodium amorphous: The unaccounted montelukast increases solubility and rapid absorption by improving sodium bioavailability. It is widely used in yoga’s for effective asthma and allergic management, which supports strong demand in the drug market.

• Montelukast Sodium Crystalline: Crystalline montelukast sodium provides high stability, prolonged shelf life and frequent therapeutic performance. It is preferred in large-scale manufacturing, ensuring quality, reliability and cost-effectiveness in respiratory disorder remedies.

By Application

Based on application, the global market can be categorized into tablets, chewable tablet & oral solution

• Tablets: Montelukast sodium tablets are the most common dosage forms, offering daily administration for adults. They ensure effective management of asthma and allergic rhinitis with extensive global patient acceptance.

• Chewable Tablet: Chewable pills are designed for paediatrics and elderly patients, providing easy consumption with better compliance. They are widely determined for children suffering from asthma and seasonal allergies.

• Oral Solution: Oral solutions provide flexible doses, especially suitable for infants and young children. This form increases the ease of administration, supporting widespread access to the management of asthma and allergic rhinitis in patient groups.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

Growing prevalence of respiratory diseases to increase the market growth

The growing prevalence of respiratory diseases is a major driver of the Montelukast sodium market. Increasing cases of asthma, allergic rhinitis, and other chronic respiratory disorders are increasing the demand for effective treatment options worldwide. Urbanization, industrialization, and environmental pollutants, such as dust, fumes and allergies, are contributing to an increase in respiratory diseases in all age groups. Montelukast sodium, as a leukotriene receptor anti -anti -inflammation, plays an important role in controlling the inflammation of the airways, reducing bronchococonstriculation and improving the function of the overall lungs. Its effectiveness as both a preventive and long -term management therapy makes it a favourite option among healthcare providers. With increasing patient awareness, expanding healthcare access, and with supporting medical guidelines, demand for Montelukast sodium is increasing, strengthening its position in the global respiratory medical science market.

• The CDC’s asthma estimates indicate that asthma leads to approximately 939,000 urgent care visits annually, reinforcing demand for controller medications such as montelukast sodium to manage chronic symptoms and reduce emergency treatment needs. 

• According to the U.S. Food and Drug Administration (FDA), montelukast sodium (brand name Singulair) has been approved for the prevention of exercise-induced bronchoconstriction and the long-term control of asthma in patients aged 6 months and older (dosage varies by age group), expanding its utility across broad populations. 

Environmental pollution and rapid urbanization to increase the market growth

Environmental pollution and rapid urbanization Montelukast are the major factors running development in the sodium market. An increase in air pollution from vehicles, industrial emissions and construction activities is contributing to high rates of asthma, allergic rhinitis and other respiratory conditions. Urban lifestyle often associated with poor air quality, smoking habits, limited green places, and more respiratory health issues. This has created a strong demand for effective drugs such as Montelukast sodium, which helps manage symptoms and improve the quality of the patient of life. The ability of the drug to target inflammation of the airways and reduce allergic reactions determines it widely in the urban population. Additionally, increasing healthcare awareness, in collaboration with government initiative to combat health problems related to pollution, supports wide adoption. As -as urbanization accelerates, the need for Montelukast sodium is expected to expand considerably worldwide.

Restraining Factor

Adverse side effects to limit the market growth

Adverse side effects represent an important preventive factor in the montelukast sodium market. While the drug is widely determined for asthma and allergic rhinitis, concerns have increased on its potential neurocycatric effects. Clinical reports and post-marketing studies have linked to mood changes, anxiety, depression, sleep disturbances and rare cases, in rare cases, in case of mood. These risks have led regulatory authorities to issue warnings, including American FDA and European Medicine Agency, and especially to recommend alert use between children and adolescents. Such safety concerns often discourage healthcare providers from prescribing Montelukast sodium as first row therapy, despite its proven effectiveness Treatment may stop due to fear of side effects of patients, compliance and affecting long -term consequences. As the awareness of these risks increases, the overall adoption rate of Montelukast sodium faces growing limitations in global markets.

• According to the FDA Drug Safety Communication, montelukast sodium now carries a Boxed Warning the strongest warning for serious neuropsychiatric side effects such as suicidal thoughts and behavior, which has led to more careful prescribing practices, particularly for mild conditions. 

• Government safety data from the FDA Adverse Event Reporting System (FAERS) shows that from 2004 through 2023 there were 86,732 reports of adverse events listing montelukast as the principal suspect, highlighting ongoing pharmacovigilance concerns that may restrict use in some patient groups. 

Increased urbanization and pollution opportunity in the market

Opportunity

Montelukast are strong future opportunities inspired by growing global respiratory health challenges in the sodium market. Increased urbanization, pollution and climate change are expected to increase cases of asthma and allergies, which increase the demand for effective treatments. Extending access to cheap generic in emerging economies will increase the patient's reach.

Additionally, research that discovering the ability of Montelukast beyond respiratory conditions, including neurological and inflammatory disorders, can open new medical applications. Increasing telemedicine and e-pharmacy platforms will also improve and improve prescription rates. Collectively, these factors are in a position of montelukast sodium for continuous growth and comprehensive market capacity in the coming years.

• According to CDC asthma data, with over 25 million Americans living with asthma (about 13.5% of the U.S. population), there is significant scope for treatments like montelukast sodium to play a role in long-term symptom control, especially for patients not adequately managed by other medications. 

• Government clinical practice guidelines recommend montelukast as an add-on therapy with inhaled corticosteroids for individuals with persistent asthma, creating opportunities for combination treatment protocols a trend reinforced by real-world practice studies. 

Increasing concerns on adverse neurocycatric side effects and Alternative remedies could be a potential challenge

Challenge

Montelukast sodium market faces many future challenges despite its widespread use. Increasing concerns on adverse neurocycatric side effects can limit its adoption, especially in paediatric and adolescent population. Alternative remedies can reduce strong competition, such as inhaled corticosteroids and antihistamines, prescription rates. The price erosion caused by the availability of many generics is another challenge for manufacturers, which affects profitability.

Additionally, strict regulatory investigation from health officials and safety warnings can restrict their condition as first row treatment. These challenges collectively create obstacles in continuous development, innovation and strategic discrimination require maintaining competition in the global market.

• The FDA Boxed Warning requirement for montelukast sodium reflects increased regulatory oversight due to mental health risks, posing clinical challenges in balancing benefits and risks during patient counseling and therapy decisions. 

• As evidenced by U.S. safety databases, multiple neuropsychiatric events associated with montelukast have continued to be reported, prompting calls from state authorities for further review of pediatric prescribing guidelines, notably among children under 18 years of age. 

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MONTELUKAST SODIUM REGIONAL INSIGHTS

• North America

From 2026 to 2035, North America is expected to capture roughly 36–40 % of the global Montelukast Sodium Market share, driven by high asthma and allergic rhinitis prevalence, robust healthcare infrastructure, and widespread use of both branded and generic formulations. The North America dominates the montelukast sodium market share, which is primarily inspired by the strong presence of the United States montelukast sodium market. American asthma and allergic rhinitis, well -established healthcare infrastructure, and increasing patient awareness about respiratory treatment are an important part. The widespread use of Montelukast sodium as a major therapeutic alternative to the management of chronic asthma and seasonal allergies supports strong demand. Favourable reimbursement policies, advanced R&D initiatives, and availability of both branded and generic yoga’s further enhance the entry into the market. Additionally, increasing environmental pollution and lifestyle related respiratory disorders are promoting prescription rates throughout the region. The Montelukast remains a central centre for an increase in sodium market, with strong regulatory support and continuous innovation from North America's leading pharmaceutical companies led by the US.

• Europe

During 2026–2035, Europe is anticipated to command about 28 % of the global Montelukast Sodium Market share, underpinned by strong healthcare systems, increasing diagnosis of chronic respiratory conditions, and widespread availability of cost‑effective therapies.Europe montelukast sodium market holds a strong position, inspired by increasing incidence of asthma, allergic rhinitis and other. Countries such as Germany, UK, France and Italy contribute significantly due to their advanced healthcare systems and prescription drugs. The availability of generic montelukast sodium has improved ability by supporting widespread patient access. Environmental pollution increases, changing lifestyle, and the prevalence of seasonal allergies is also promoting demand. The government's initiative for respiratory health management, combined with increasing health care, further strengthens market development. Additionally, Europe's strong focus on clinical research and drug innovation supports new medical development. With strong drug distribution networks and supporting regulatory framework, Europe remains a major regional market for Montelukast sodium.

• Asia

Over the forecast period, the Asia Pacific region is projected to hold around 25 % of the Montelukast Sodium Market, supported by expanding healthcare access, rising respiratory disease incidence, and growing pharmaceutical production and distribution networks. The Asia Pacific montelukast sodium market is experiencing rapid growth, which is inspired by the increasing prevalence of asthma, allergic rhinitis and other respiratory diseases in densely populated countries such as China, India and Japan. Increased urbanization, industrial pollution and lifestyle changes are contributing to high respiratory health issues, promoting the demand for effective treatment. Availability of cost -effective generic yoga’s makes Montelukast sodium more accessible in emerging economies. Increasing healthcare infrastructure, and the initiative of the assistant government further enhances the expansion of the market. Pharmaceutical companies are investing rapidly in local manufacturing and distribution to meet regional demand. Additionally, strong population growth and improving the ability of drugs ensure long -term opportunities. These factors collectively position Asia Pacific as one of the fastest growing markets for Montelukast sodium worldwide.

KEY INDUSTRY PLAYERS

Key Players strengthen market competition by providing cost -effective options for branded drugs

Montelukast Sodium Market has a strong contribution with major generic pharmaceutical players such as Mylan, Aurobindo Pharma, HETERO LABS, Teva Active Pharmaceutical ingredients (TAPI), and Unimark Treatment. These companies are experts on large -scale production and Montelukast sodium supply, which ensure global access and strength. Malan and Aurobindo Pharma have established a comprehensive distribution network, especially in North America and Europe. Hetero Labs is known for its strong API manufacturing capabilities and exports to many international markets. TAPI, API Division of Teva Pharmaceuticals, offers high quality Montelukast API supporting general manufacturers worldwide. India-based company Unimark Treatment contributes significantly through its active drug component expertise. Together, these players strengthen market competition by providing cost -effective options for branded drugs. The quality of quality construction, regulatory compliance and global access, their focus is as important drivers of continuous market expansion of Montelukast sodium.

• TAPI (Torrent Pharmaceuticals): TAPI’s montelukast sodium products meet stringent government pharmaceutical regulatory requirements in multiple countries, supporting therapy for asthma and allergic rhinitis in populations with documented respiratory disease prevalence.

• Mylan (now part of Viatris): Mylan’s montelukast sodium generics are distributed through pharmacy networks with compliance to health authority guidelines such as those from the U.S. FDA and similar regulatory bodies, facilitating treatment access for large patient populations with chronic respiratory conditions.

List of Top Montelukast Sodium Companies

• Mylan (U.S.)
• TAPI (Israel)
• Ultratech India (India)
• Aurobindo Pharma (India)
• Hetero Labs (India)
• Unimark Remedies (India)

KEY INDUSTRY DEVELOPMENT

July 2025: Jiangasu Hengrey Pharmaceuticals entered a major licensing agreement with GSK for HRS -9821, which is a PDE 3/4 inhibitor under clinical development for COPD. The deal has potentially reached USD 12 billion with milestones payments, underlining increasing investment in respiratory medical science. This cooperation focuses strategic focus on innovative COPD remedies and reflects acute competition between major pharmaceutical companies. The agreement keeps both firms to strengthen their pipelines and expand the market presence in the broader respiratory drug landscape.

REPORT COVERAGE

This report provides a comprehensive analysis of the Montelukast sodium market, examining data divided by 2018 to 2034 with detailed insight into sales, revenue and pricing trends. It evaluates historical performance and future market sizes, considering the approximate growth trends in different regions and segments. Analysis contains a variety of montelukast sodium, including unknowable and crystalline forms, as well as various doses such as tablets, chubalable tablets and oral solutions. The report also has an assessment of production technologies employed by manufacturers, which highlight innovations that increase bioavailability, stability and manufacturing efficiency. In addition, it examines applications in respiratory disorders such as asthma and allergic rhinitis and examines end-user industries including hospitals, clinics and retail pharmacies. Combining quantitative data with qualitative insight provides a clear understanding of market dynamics, opportunities, challenges, and competitive strategies shaping the global development of Montelukast sodium through Report 2034.