Global Montelukast Sodium Market Size study, by Dosage Form (Tablets, Oral Solutions), Application (Asthma, Allergic Rhinitis, Urticaria, Other Applications) and Regional Forecasts 2022-2032

Global Montelukast Sodium Market is valued approximately at USD 0.45 billion in 2023 and is anticipated to grow with a healthy growth rate of more than 15.60% over the forecast period 2024-2032. As allergic and respiratory disorders continue to proliferate worldwide, montelukast sodium—an oral leukotriene receptor antagonist—has carved a prominent niche in the pharmaceutical arena. With its well-established efficacy in mitigating inflammation and bronchoconstriction, the drug has transitioned from niche prescription status to a widely adopted component in the long-term management of asthma and allergic rhinitis. As more countries report spikes in pollution-induced allergies, and pediatric asthma becomes a growing concern, the global pharmaceutical community is leaning further into montelukast sodium as a cost-effective therapeutic intervention.

Pharmaceutical companies are enhancing bioavailability through advanced formulations, particularly chewable and oral disintegrating tablets that support pediatric and geriatric compliance. Furthermore, clinical applications are now expanding beyond asthma to encompass urticaria and exercise-induced bronchoconstriction, underscoring montelukast's versatility across inflammatory pathways. Regulatory incentives and accelerated approval pathways in emerging markets are motivating both generics and branded manufacturers to scale up production. Meanwhile, R&D teams are actively exploring synergistic combinations involving antihistamines or corticosteroids to target co-morbid allergic manifestations more holistically.

Despite the accelerating adoption, the market remains susceptible to a few hurdles. Patent expirations have sparked price wars in the generics segment, compressing margins in mature markets. Additionally, lingering concerns about neuropsychiatric side effects in children—although rare—have led to cautious prescribing patterns among pediatricians. However, ongoing post-marketing surveillance, reinforced by real-world evidence platforms, is gradually restoring clinician confidence while guiding safer, patient-specific prescribing.

Pharmaceutical distributors are ramping up omnichannel outreach to extend their footprint, particularly in regions with low allergy diagnosis rates. Growth is also being spurred by governments investing in national allergy and respiratory health programs, making montelukast a core inclusion in formulary lists. Telemedicine is another enabler—patients diagnosed remotely with allergic symptoms are now receiving montelukast prescriptions via e-pharmacy networks, reducing the traditional dependency on in-clinic consultations and promoting greater medication adherence.

Regionally, North America holds the dominant market position, owing to its high asthma prevalence and favorable reimbursement policies. Europe follows closely with an expanding geriatric population and a significant focus on allergic respiratory conditions in countries like Germany and the UK. The Asia Pacific region is poised for the fastest growth, driven by heightened pollution levels, poor indoor air quality, and underdiagnosis of respiratory disorders. Nations such as India and China are witnessing a wave of awareness campaigns and OTC product registrations that are unlocking vast consumer bases. Latin America and the Middle East & Africa are also on a growth trajectory, benefiting from increased access to generic montelukast and expanding healthcare infrastructure.

Major market player included in this report are:
• Teva Pharmaceutical Industries Ltd.
• Cipla Ltd.
• Pfizer Inc.
• Merck & Co., Inc.
• Apotex Inc.
• Mylan N.V.
• Lupin Pharmaceuticals, Inc.
• Glenmark Pharmaceuticals Ltd.
• Dr. Reddy’s Laboratories Ltd.
• Sun Pharmaceutical Industries Ltd.
• Sandoz International GmbH (a Novartis division)
• Torrent Pharmaceuticals Ltd.
• Hikma Pharmaceuticals PLC
• Aurobindo Pharma Ltd.
• Taro Pharmaceutical Industries Ltd.

The detailed segments and sub-segment of the market are explained below:

By Dosage Form
• Tablets
• Oral Solutions

By Application
• Asthma
• Allergic Rhinitis
• Urticaria
• Other Applications

By Region:

North America
• U.S.
• Canada

Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe

Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific

Latin America
• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa

Years considered for the study are as follows:
• Historical year: 2022
• Base year: 2023
• Forecast period: 2024 to 2032

Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with country-level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

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