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

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

By Dosage Form

By Application

By Region:

Years considered for the study are as follows:

Key Takeaways:

Table of Contents

Chapter 1. Global Montelukast Sodium Market Executive Summary

Chapter 2. Global Montelukast Sodium Market Definition and Research Assumptions

Chapter 3. Global Montelukast Sodium Market Dynamics

Chapter 4. Global Montelukast Sodium Market Industry Analysis

Chapter 5. Global Montelukast Sodium Market Size & Forecasts by Dosage Form, 2022-2032

Chapter 6. Global Montelukast Sodium Market Size & Forecasts by Application, 2022-2032

Chapter 7. Global Montelukast Sodium Market Size & Forecasts by Region, 2022-2032

Chapter 8. Competitive Intelligence

Chapter 9. Research Process

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