Global Montelukast Sodium Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Montelukast Sodium Market Size

• The global montelukast sodium market size was valued at USD 522.06 million in 2024 and is expected to reach USD 1,653.39 million by 2032, at a CAGR of 15.50% during the forecast period
• The market growth is largely fueled by the increasing prevalence of asthma, allergic rhinitis, and other respiratory disorders worldwide, leading to a heightened demand for effective leukotriene receptor antagonists such as montelukast sodium
• Furthermore, growing awareness of respiratory health, improved diagnosis rates, and the expansion of generic pharmaceutical production are contributing to wider accessibility and affordability of montelukast sodium formulations. These converging factors are accelerating the global consumption of montelukast sodium, thereby significantly boosting the industry's growth

Montelukast Sodium Market Analysis

• Montelukast sodium, a leukotriene receptor antagonist primarily used to treat asthma and allergic rhinitis, is becoming an increasingly essential component in global respiratory care protocols across both pediatric and adult patient populations due to its proven efficacy, oral administration convenience, and suitability for long-term management of chronic respiratory conditions
• The rising demand for montelukast sodium is primarily fueled by the global surge in respiratory disorders linked to urban pollution, changing lifestyles, and allergen exposure, as well as its inclusion in clinical guidelines and national formularies for asthma maintenance therapy
• North America dominated the montelukast sodium market with the largest revenue share of 39.6% in 2024, driven by a high prevalence of asthma and allergic conditions, robust healthcare infrastructure, and widespread use of generic medications in the U.S., supported by favorable reimbursement policies and strong pharmaceutical distribution networks
• Asia-Pacific is expected to be the fastest growing region in the montelukast sodium market during the forecast period due to rising awareness of respiratory diseases, expanding access to affordable generics, and government-led initiatives promoting respiratory health management
• Tablet segment dominated the montelukast sodium market with a market share of 61.9% in 2024, driven by its convenience of oral administration, longer shelf life, and widespread adoption in both prescription and over-the-counter formats

Report Scope and Montelukast Sodium Market Segmentation        

Montelukast Sodium Market Trends

Rising Preference for Generic and Pediatric Formulations

• A significant and accelerating trend in the global montelukast sodium market is the growing demand for generic versions and pediatric-specific formulations, driven by the need for cost-effective, accessible, and age-appropriate respiratory treatments. This trend is especially prominent in developing regions and public healthcare settings focused on affordability and widespread access
  • For instance, several pharmaceutical manufacturers, including Cipla and Teva Pharmaceuticals, have expanded their generic montelukast offerings in tablet and chewable tablet forms, catering to both adult and pediatric populations with varying dosage needs
• The increasing availability of flavored chewable tablets and granules designed for children has further broadened montelukast sodium’s applicability, enhancing adherence among pediatric patients. Innovations in oral dosage forms also contribute to ease of use and better treatment compliance in long-term asthma management
• Moreover, the rising prevalence of allergic rhinitis and asthma among children has prompted healthcare providers and policymakers to recommend preventive medications such as montelukast at earlier stages, promoting early intervention strategies
• This trend is reshaping product development priorities for pharmaceutical companies, encouraging them to focus on age-appropriate, easy-to-administer, and widely accessible formulations. Consequently, companies are increasingly investing in expanded manufacturing capacities and approvals for generic pediatric montelukast products across international markets
• The demand for such targeted and affordable formulations is growing across both high-income and emerging economies, as public and private healthcare systems strive to optimize treatment outcomes while controlling medication costs

Montelukast Sodium Market Dynamics

Driver

Surge in Respiratory Disorders and Preventive Therapy Demand

• The global rise in asthma, allergic rhinitis, and other chronic respiratory disorders is a major driver of the growing demand for montelukast sodium, which plays a critical role in preventive and maintenance therapy
  • For instance, according to the Global Asthma Report, over 260 million people are affected by asthma worldwide, and this figure is expected to rise due to increasing urbanization, pollution levels, and allergen exposure. The burden is particularly high among children and in urban areas, where air quality deterioration and indoor allergens contribute significantly to disease prevalence
• Montelukast sodium, as a non-steroidal, orally administered leukotriene receptor antagonist, provides a valuable option for long-term management, especially in cases unresponsive to inhaled corticosteroids or when compliance with inhalers is low
• In addition, the widespread inclusion of montelukast in essential drug lists and treatment guidelines across countries underscores its recognized therapeutic value and encourages its prescription in both public and private healthcare sectors
• The rising emphasis on preventive healthcare, early disease management, and the shift from acute to chronic care models are also fueling the continued use of montelukast sodium as part of standard treatment regimens
• Combined with its affordability as a generic drug, ease of use, and minimal systemic side effects, montelukast sodium continues to gain traction in global respiratory care strategies

Restraint/Challenge

Adverse Neuropsychiatric Effects and Regulatory Scrutiny

• Concerns regarding the potential neuropsychiatric side effects of montelukast sodium, particularly among children and adolescents, pose a significant challenge to its market expansion and continued prescription by healthcare providers
  • For instance, in March 2020, the U.S. FDA issued a boxed warning for montelukast due to risks of serious mental health side effects such as agitation, aggression, depression, and suicidal thoughts, advising prescribers to consider the risk–benefit ratio carefully before use, especially for mild conditions such as allergic rhinitis
• These warnings have led to increased caution among physicians and caregivers, resulting in reduced prescribing in some regions and a shift toward alternative therapies when available
• Addressing these safety concerns requires ongoing pharmacovigilance, transparent risk communication, and the development of clinical decision-making tools that help providers identify at-risk patients
• Furthermore, regulatory hurdles associated with post-marketing surveillance, updated labeling requirements, and the need for additional clinical evidence to support safety claims have added to the operational complexity for manufacturers
• Overcoming these challenges will require the pharmaceutical industry to invest in further clinical research, enhance physician and patient education, and explore newer formulations that minimize systemic exposure while maintaining therapeutic effectiveness

Montelukast Sodium Market Scope

The market is segmented on the basis of dosage form and application.

• By Dosage Form

On the basis of dosage form, the montelukast sodium market is segmented into tablets and oral solutions. The tablet segment dominated the market with the largest revenue share of 61.9% in 2024, primarily due to its widespread use in both adult and pediatric populations for long-term asthma and allergic rhinitis management. Tablets offer the advantage of convenience, stability, and ease of storage, making them a preferred option in both retail and institutional healthcare settings. Furthermore, the availability of generic tablets has significantly lowered costs, contributing to their high adoption across developed and developing regions.

The oral solutions segment is anticipated to witness the fastest growth rate from 2025 to 2032, driven by increasing demand in pediatric and geriatric care where swallowing tablets may be difficult. Oral solutions provide flexible dosing options and improved compliance for young children and elderly patients. The segment is further supported by rising respiratory disease prevalence among children and the need for early intervention using age-appropriate formulations.

• By Application

On the basis of application, the montelukast sodium market is segmented into asthma, allergic rhinitis, urticaria, and other applications. The asthma segment held the largest market revenue share in 2024 due to the drug’s established role in long-term asthma management and prophylactic use. Montelukast is often prescribed as a controller medication, particularly in cases of mild persistent asthma or as an add-on to inhaled corticosteroids. Its oral administration and minimal systemic side effects make it an accessible treatment across age groups.

The allergic rhinitis segment is expected to grow at the fastest CAGR from 2025 to 2032, owing to increasing global awareness of allergic conditions and their impact on quality of life. Montelukast’s ability to reduce symptoms such as nasal congestion, sneezing, and rhinorrhea has made it a popular choice, especially where antihistamines alone are insufficient. Over-the-counter availability in some markets further fuels demand.

Montelukast Sodium Market Regional Analysis

• North America dominated the montelukast sodium market with the largest revenue share of 39.6% in 2024, driven by a high prevalence of asthma and allergic conditions, robust healthcare infrastructure, and widespread use of generic medications in the U.S., supported by favorable reimbursement policies and strong pharmaceutical distribution networks
• Consumers in the region benefit from widespread availability of both branded and generic montelukast formulations, supported by extensive physician awareness and adherence to clinical guidelines recommending montelukast as a first-line or adjunct therapy
• This dominance is further reinforced by high healthcare spending, the presence of major pharmaceutical manufacturers, and growing demand for preventive respiratory care, positioning montelukast sodium as a key therapeutic option across both pediatric and adult populations

U.S. Montelukast Sodium Market Insight

The U.S. montelukast sodium market captured the largest revenue share of 78% in 2024 within North America, driven by the high prevalence of asthma and allergic rhinitis and widespread availability of generic formulations. Patients and providers increasingly rely on montelukast sodium as a convenient oral therapy for long-term respiratory management. The market is further fueled by established clinical guidelines, insurance coverage, and ongoing awareness campaigns about chronic respiratory health. Moreover, the country’s strong pharmaceutical supply chain and access to over-the-counter variants have significantly contributed to its market dominance.

Europe Montelukast Sodium Market Insight

The Europe montelukast sodium market is projected to expand at a substantial CAGR throughout the forecast period, primarily driven by rising cases of respiratory disorders and structured national healthcare systems. The region’s emphasis on cost-effective chronic care is supporting the widespread adoption of generic montelukast sodium, particularly in public health programs. With growing pediatric asthma diagnoses and environmental concerns, European countries are integrating montelukast more frequently into treatment plans. In addition, regulatory support and reimbursement policies across the EU are enhancing patient access to this essential medication.

U.K. Montelukast Sodium Market Insight

The U.K. montelukast sodium market is anticipated to grow at a noteworthy CAGR during the forecast period, fueled by increasing rates of allergic rhinitis and asthma, particularly among children and young adults. National prescribing standards promote the use of montelukast in both monotherapy and as an adjunct to inhaled corticosteroids. The NHS plays a key role in facilitating access through its generic drug inclusion, while a strong emphasis on early intervention in chronic respiratory care continues to drive steady demand.

Germany Montelukast Sodium Market Insight

The Germany montelukast sodium market is expected to expand at a considerable CAGR during the forecast period, supported by robust healthcare spending, patient-centric treatment protocols, and a growing aging population with respiratory conditions. Montelukast sodium's availability through statutory health insurance and its acceptance as a non-invasive, long-term maintenance therapy have strengthened its market footprint. Germany’s stringent safety regulations and pharmacovigilance also ensure continued physician and patient trust in the product.

Asia-Pacific Montelukast Sodium Market Insight

The Asia-Pacific montelukast sodium market is poised to grow at the fastest CAGR of 25% during the forecast period of 2025 to 2032, driven by rising air pollution, increasing asthma cases, and expanding access to generic drugs in countries such as India, China, and Japan. Public health campaigns, improved healthcare infrastructure, and growing awareness of respiratory health are facilitating greater use of montelukast sodium. In addition, local manufacturing capabilities and government price controls are improving affordability and distribution across both urban and rural areas.

Japan Montelukast Sodium Market Insight

The Japan montelukast sodium market is gaining momentum due to the country’s aging population, high asthma prevalence, and emphasis on effective long-term disease control. Montelukast is widely accepted as part of standardized asthma management protocols, particularly in pediatric and geriatric care. Its use is further supported by Japan’s rigorous clinical research and integration into advanced care systems. Digital health tools are also aiding in tracking and optimizing chronic disease management, supporting market growth.

India Montelukast Sodium Market Insight

The India montelukast sodium market accounted for the largest market revenue share in Asia Pacific in 2024, attributed to high rates of respiratory disorders, expanding access to generics, and increasing healthcare investments. Government initiatives promoting respiratory health under national programs and the inclusion of montelukast in essential drug lists have significantly driven demand. In addition, the country’s strong network of domestic pharmaceutical manufacturers ensures competitive pricing and wide availability, making montelukast sodium a go-to therapy in both public and private sectors.

Montelukast Sodium Market Share

The montelukast sodium industry is primarily led by well-established companies, including:

• Merck & Co., Inc. (U.S.)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Cipla Limited (India)
• Dr. Reddy’s Laboratories Ltd. (India)
• Sun Pharmaceutical Industries Ltd. (India)
• Aurobindo Pharma Ltd. (India)
• Torrent Pharmaceuticals Ltd. (India)
• Zydus Lifesciences Ltd. (India)
• Hetero Labs Ltd. (India)
• Lupin Limited (India)
• Glenmark Pharmaceuticals Ltd. (India)
• Sandoz International GmbH (Germany)
• Apotex Inc. (Canada)
• Amneal Pharmaceuticals, Inc. (U.S.)
• AstraZeneca (U.K.)
• Krka, d. d., Novo mesto (Slovenia)
• Novartis AG (Switzerland)
• Micro Labs Limited (India)
• Intas Pharmaceuticals Ltd. (India)

What are the Recent Developments in Global Montelukast Sodium Market?

• In May 2024, Teva Pharmaceuticals expanded its respiratory portfolio by launching a new generic version of chewable montelukast sodium tablets in several European markets. This move enhances accessibility to pediatric asthma and allergic rhinitis treatments and reflects Teva’s ongoing commitment to broadening its affordable respiratory care offerings. The launch aligns with regulatory support for generics and increasing demand for age-appropriate formulations across Europe, reinforcing Teva’s leadership in the global generic drug market
• In April 2024, Cipla Limited announced a strategic partnership with a regional pharmaceutical distributor in Southeast Asia to expand the distribution of its montelukast sodium product line. This collaboration aims to improve access to affordable asthma and allergy treatments in underserved markets, particularly in rural areas. The initiative highlights Cipla’s focus on respiratory health and regional growth in emerging markets with rising demand for essential medications
• In March 2024, Glenmark Pharmaceuticals received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA) to market its montelukast sodium tablets. The approval allows Glenmark to enter the Latin American market more aggressively, responding to growing cases of asthma and allergic conditions in the region. The move reflects the company’s international expansion strategy and its focus on non-communicable disease segments
• In February 2024, Mylan (a Viatris company) launched a patient education campaign across North America to raise awareness about the risks and benefits of montelukast sodium, particularly addressing the FDA’s boxed warning on neuropsychiatric events. The initiative is part of an effort to promote informed decision-making among healthcare providers and patients, ensuring continued trust and appropriate usage of the medication
• In January 2024, Dr. Reddy’s Laboratories introduced a new orally disintegrating tablet (ODT) form of montelukast sodium in India, aimed at improving compliance among pediatric and geriatric populations. This formulation provides an easier alternative for patients who have difficulty swallowing pills. The launch highlights Dr. Reddy’s focus on innovation in drug delivery and enhancing patient experience in chronic respiratory care

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