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    South America Montelukast API Market

    ID: MRFR/HC/51335-HCR
    200 Pages
    Garvit Vyas
    October 2025

    South America Montelukast API Market Research Report By Application (Asthma, Allergic Rhinitis, Bronchospasm, Urticaria, Others) and By Regional (Brazil, Mexico, Argentina, Rest of South America) - Forecast to 2035

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    South America Montelukast API Market Summary

    As per MRFR analysis, the South America montelukast api market Size was estimated at 80.8 USD Million in 2024. The South America montelukast api market is projected to grow from 83.09 USD Million in 2025 to 110.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 2.84% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The South America montelukast API market is experiencing a robust growth trajectory driven by increasing demand for respiratory treatments and a shift towards generics.

    • The demand for respiratory treatments is rising significantly across South America, particularly in Brazil, which remains the largest market.
    • There is a notable shift towards generic products, as healthcare providers and patients seek cost-effective alternatives.
    • Regulatory support and initiatives are fostering a favorable environment for the montelukast API market, especially in Mexico, the fastest-growing region.
    • Key market drivers include the increasing prevalence of allergic conditions and rising healthcare expenditure, which are propelling market growth.

    Market Size & Forecast

    2024 Market Size 80.8 (USD Million)
    2035 Market Size 110.0 (USD Million)

    Major Players

    Merck & Co (US), Mylan N.V. (US), Teva Pharmaceutical Industries Ltd. (IL), Aurobindo Pharma (IN), Cipla Ltd. (IN), Hikma Pharmaceuticals PLC (GB), Sandoz (CH), Zydus Cadila (IN)

    South America Montelukast API Market Trends

    The montelukast api market is currently experiencing notable developments, driven by increasing awareness of respiratory conditions and the growing prevalence of asthma and allergic rhinitis in South America. Regulatory bodies in the region are actively promoting the use of montelukast as a first-line treatment option, which appears to be enhancing its adoption among healthcare providers. Furthermore, the rise in healthcare expenditure and the expansion of pharmaceutical distribution networks are likely contributing to the accessibility of montelukast formulations. This trend suggests a positive outlook for the market, as more patients gain access to effective treatment options. In addition, the montelukast api market is witnessing a shift towards generic formulations, which may lead to increased competition among manufacturers. This shift could potentially lower prices and improve availability for patients. The emphasis on research and development in the pharmaceutical sector is also noteworthy, as companies strive to innovate and enhance the efficacy of montelukast products. Overall, the montelukast api market in South America seems poised for growth, driven by a combination of regulatory support, increased demand, and competitive dynamics.

    Rising Demand for Respiratory Treatments

    The montelukast api market is benefiting from a surge in demand for effective treatments for respiratory conditions. As awareness of asthma and allergies increases, healthcare providers are more frequently prescribing montelukast, leading to higher consumption rates.

    Shift Towards Generic Products

    There is a noticeable trend towards the production and distribution of generic montelukast formulations. This shift is likely to enhance market competition, resulting in lower prices and improved access for patients across South America.

    Regulatory Support and Initiatives

    Regulatory agencies in South America are actively promoting the use of montelukast as a standard treatment for respiratory issues. This support is expected to facilitate market growth by encouraging healthcare providers to adopt montelukast in their treatment protocols.

    South America Montelukast API Market Drivers

    Rising Healthcare Expenditure

    The montelukast api market is benefiting from the rising healthcare expenditure in South America. Governments and private sectors are increasingly investing in healthcare infrastructure, which includes the procurement of essential medications like montelukast. Reports indicate that healthcare spending in several South American countries has increased by over 5% annually, reflecting a commitment to improving health outcomes. This trend is likely to enhance the availability of montelukast in pharmacies and hospitals, thereby increasing its consumption. As healthcare systems evolve, the focus on preventive care and chronic disease management further supports the demand for effective treatments, positioning montelukast favorably in the market.

    Regulatory Changes Favoring Generic Drugs

    Recent regulatory changes in South America are favoring the montelukast api market, particularly concerning the approval and distribution of generic drugs. Authorities are streamlining the approval process for generics, which allows for quicker market entry and increased competition. This is crucial as montelukast faces patent expirations, leading to a surge in generic alternatives. The affordability of these generics is likely to attract a broader patient base, thereby expanding the market. Furthermore, regulatory support for quality assurance in generic manufacturing ensures that these products meet safety standards, which is essential for maintaining consumer confidence in the montelukast api market.

    Growing Awareness of Preventive Healthcare

    There is a notable shift towards preventive healthcare in South America, which is influencing the montelukast api market. As public health campaigns promote awareness about asthma and allergies, more individuals are seeking preventive treatments. Montelukast is recognized for its role in preventing asthma attacks, making it a preferred choice among healthcare providers. The increasing emphasis on early intervention and management of chronic conditions is likely to drive the demand for montelukast. Additionally, educational initiatives aimed at both healthcare professionals and patients are expected to enhance understanding of the medication's benefits, further propelling its market presence.

    Advancements in Pharmaceutical Manufacturing

    Technological advancements in pharmaceutical manufacturing processes are positively impacting the montelukast api market in South America. Enhanced production techniques, such as continuous manufacturing and process optimization, have led to increased efficiency and reduced costs. This is particularly relevant as the market sees a shift towards more affordable generic versions of montelukast. The ability to produce high-quality APIs at lower costs allows manufacturers to offer competitive pricing, which is crucial in a price-sensitive market. Furthermore, the adoption of stringent quality control measures ensures that the products meet regulatory standards, thereby enhancing consumer trust and driving market growth.

    Increasing Prevalence of Allergic Conditions

    The montelukast api market in South America is experiencing growth due to the rising prevalence of allergic conditions such as asthma and allergic rhinitis. According to health reports, approximately 20% of the population in South America suffers from asthma, which is a significant driver for the demand for effective treatments. Montelukast, as a leukotriene receptor antagonist, is widely prescribed for managing these conditions. The increasing awareness among healthcare professionals and patients regarding the benefits of montelukast is likely to further boost its adoption. Additionally, the growing number of healthcare facilities and improved access to medications in urban areas contribute to the expansion of the montelukast api market.

    Market Segment Insights

    By Application: Asthma (Largest) vs. Allergic Rhinitis (Fastest-Growing)

    In the South America montelukast api market, the application segment reveals Asthma as the largest contributor, capturing a significant share, while Allergic Rhinitis shows potential as the fastest-growing area within this segment. Other applications like Bronchospasm and Urticaria also play pivotal roles, but their market presence is comparatively smaller, indicating a distinct distribution among these therapeutic areas. The growth trends for this segment are driven by increasing incidences of respiratory diseases, heightened awareness of allergies, and advancements in treatment options. Asthma remains a predominant health concern, funded by both public and private sectors, thus ensuring robust growth. Meanwhile, the rise in awareness and diagnosis of Allergic Rhinitis is propelling its rapid growth, making it an emerging focus area for healthcare providers.

    Asthma: Dominant vs. Allergic Rhinitis: Emerging

    Asthma holds a dominant position in the application segment due to its extensive prevalence across various demographics. This chronic condition requires continuous management, which fuels steady demand for montelukast api. In contrast, Allergic Rhinitis is emerging rapidly as awareness increases regarding its impact on quality of life. With changing climatic conditions contributing to higher allergen prevalence, the market sees an upward trajectory in treatments for Allergic Rhinitis. The contrast between these two values highlights a clear division where Asthma maintains a significant market share while Allergic Rhinitis is catching up quickly, thanks to evolving healthcare strategies and patient needs.

    Get more detailed insights about South America Montelukast API Market

    Regional Insights

    Brazil : Robust Growth and Demand Trends

    Key markets include São Paulo, Rio de Janeiro, and Minas Gerais, where demand for montelukast is particularly high. The competitive landscape features major players like Merck & Co and Mylan N.V., alongside local manufacturers. The business environment is characterized by a mix of multinational and domestic firms, fostering innovation and competitive pricing. The pharmaceutical sector is increasingly focusing on respiratory therapies, making montelukast a vital component of treatment regimens.

    Mexico : Strategic Market Expansion Opportunities

    Key markets include Mexico City, Guadalajara, and Monterrey, where healthcare access is improving. The competitive landscape features players like Teva Pharmaceutical Industries and Aurobindo Pharma, which are expanding their presence. Local dynamics are influenced by a mix of public and private healthcare systems, creating opportunities for market entrants. The focus on respiratory health is driving innovation and product development in the sector.

    Argentina : Focus on Chronic Disease Management

    Key markets include Buenos Aires, Córdoba, and Mendoza, where healthcare facilities are expanding. The competitive landscape features significant players like Cipla Ltd. and Hikma Pharmaceuticals, which are well-positioned to capture market share. Local market dynamics are shaped by economic factors and healthcare policies, creating a favorable environment for growth. The focus on chronic disease management is driving demand for montelukast in various therapeutic applications.

    Rest of South America : Varied Growth Across Sub-regions

    Key markets include Chile, Colombia, and Peru, each with distinct competitive landscapes. Major players like Sandoz and Zydus Cadila are establishing a presence, but local firms also play a crucial role. The business environment is characterized by a mix of opportunities and challenges, with varying levels of healthcare access and affordability. The focus on respiratory health is becoming increasingly important, driving demand for montelukast across the region.

    Key Players and Competitive Insights

    The montelukast API market in South America is characterized by a competitive landscape that is both dynamic and multifaceted. Key growth drivers include the rising prevalence of asthma and allergic rhinitis, alongside an increasing demand for cost-effective therapeutic options. Major players such as Merck & Co (US), Mylan N.V. (US), and Teva Pharmaceutical Industries Ltd. (IL) are strategically positioned to leverage their extensive research capabilities and established distribution networks. Merck & Co (US) focuses on innovation through the development of new formulations, while Mylan N.V. (US) emphasizes regional expansion and partnerships to enhance market penetration. Teva Pharmaceutical Industries Ltd. (IL) appears to be concentrating on optimizing its supply chain to improve efficiency and reduce costs, collectively shaping a competitive environment that is increasingly reliant on strategic collaborations and technological advancements.

    In terms of business tactics, companies are localizing manufacturing to reduce costs and improve responsiveness to market demands. The market structure is moderately fragmented, with several players vying for market share, yet dominated by a few key companies that exert considerable influence. This fragmentation allows for niche players to emerge, but the collective strength of the major companies often dictates market trends and pricing strategies.

    In October 2025, Merck & Co (US) announced a partnership with a local South American pharmaceutical firm to enhance its distribution capabilities. This strategic move is likely to bolster Merck's presence in the region, allowing for more efficient delivery of its montelukast API products and potentially increasing market share. The partnership underscores the importance of local knowledge in navigating regulatory landscapes and consumer preferences.

    In September 2025, Mylan N.V. (US) launched a new generic version of montelukast in Brazil, aiming to capture a larger segment of the market. This initiative not only reflects Mylan's commitment to providing affordable healthcare solutions but also positions the company to compete more effectively against branded products. The introduction of generics is expected to drive down prices, benefiting consumers while intensifying competition among manufacturers.

    In August 2025, Teva Pharmaceutical Industries Ltd. (IL) expanded its production capacity in Argentina, a strategic decision aimed at meeting the growing demand for montelukast API in the region. This expansion is indicative of Teva's long-term commitment to the South American market and its recognition of the increasing need for respiratory medications. By enhancing production capabilities, Teva is likely to improve its supply chain reliability and responsiveness to market fluctuations.

    As of November 2025, current competitive trends in the montelukast API market are increasingly defined by digitalization, sustainability, and the integration of artificial intelligence in manufacturing processes. Strategic alliances are becoming more prevalent, as companies recognize the need to collaborate to enhance innovation and efficiency. Looking ahead, competitive differentiation is expected to evolve from traditional price-based competition to a focus on technological advancements, supply chain reliability, and innovative product offerings. This shift may redefine market dynamics, compelling companies to invest in R&D and sustainable practices to maintain a competitive edge.

    Key Companies in the South America Montelukast API Market market include

    Industry Developments

    The South America Montelukast Active Pharmaceutical Ingredient (API) Market has recently witnessed several important developments. In October 2023, Teva Pharmaceutical Industries announced the expansion of its production capacity for Montelukast API to cater to growing demands across South America. Significant enhancements in the manufacturing process were also reported by Hetero Labs, aimed at improving efficiency and compliance with local regulatory standards.

    In terms of current affairs, the region's pharmaceutical landscape has been impacted by the recent partnerships formed between Sun Pharmaceutical Industries and local distributors, which aim to streamline supply chains for Montelukast. Over the past two years, companies like Novartis and Roche have focused on bolstering their market presence through increased Research and Development initiatives specific to the South American population’s healthcare needs, seeking to decrease asthma prevalence among children.

    Additionally, in August 2023, Dr. Reddy's Laboratories completed a strategic acquisition of a local firm specializing in respiratory treatments, which should facilitate broader access to Montelukast in the South America market. Overall, these developments suggest a growing awareness and focus on the importance of effective asthma therapies across the region.

    Future Outlook

    South America Montelukast API Market Future Outlook

    The montelukast API market is projected to grow at a 2.84% CAGR from 2024 to 2035, driven by increasing respiratory disorders and rising healthcare investments.

    New opportunities lie in:

    • Expansion of online distribution channels for montelukast APIs
    • Development of combination therapies to enhance efficacy
    • Investment in local manufacturing to reduce costs and improve supply chain efficiency

    By 2035, the montelukast API market is expected to achieve robust growth and increased market penetration.

    Market Segmentation

    South America Montelukast API Market Application Outlook

    • Asthma
    • Allergic Rhinitis
    • Bronchospasm
    • Urticaria
    • Others

    Report Scope

    MARKET SIZE 202480.8(USD Million)
    MARKET SIZE 202583.09(USD Million)
    MARKET SIZE 2035110.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR)2.84% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Million
    Key Companies Profiled["Merck & Co (US)", "Mylan N.V. (US)", "Teva Pharmaceutical Industries Ltd. (IL)", "Aurobindo Pharma (IN)", "Cipla Ltd. (IN)", "Hikma Pharmaceuticals PLC (GB)", "Sandoz (CH)", "Zydus Cadila (IN)"]
    Segments CoveredApplication
    Key Market OpportunitiesGrowing demand for montelukast API driven by increasing respiratory disorders and regulatory support for generic formulations.
    Key Market DynamicsRising demand for montelukast API driven by regulatory support and increasing respiratory disease prevalence in South America.
    Countries CoveredBrazil, Mexico, Argentina, Rest of South America

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    FAQs

    What is the current market size of the South America Montelukast API Market?

    In 2024, the South America Montelukast API Market is valued at 110.0 million USD.

    What is the projected market size for the South America Montelukast API Market by 2035?

    By 2035, the market is expected to reach a value of 350.0 million USD.

    What is the expected compound annual growth rate (CAGR) for the Montelukast API Market from 2025 to 2035?

    The market is anticipated to grow at a CAGR of 11.096% from 2025 to 2035.

    Which country holds the largest market share in the South America Montelukast API Market?

    Brazil holds the largest market share with an estimated value of 45.0 million USD in 2024.

    What are the market size estimates for the major applications of Montelukast in 2024?

    The application values in 2024 are 60.0 million USD for asthma, 25.0 million USD for allergic rhinitis, 10.0 million USD for bronchospasm, 5.0 million USD for urticaria, and 10.0 million USD for others.

    Who are the key players in the South America Montelukast API Market?

    The major players include Teva Pharmaceutical Industries, Amgen, Novartis, Roche, and Dr. Reddy's Laboratories.

    What is the market growth rate anticipated for Argentina in the Montelukast API Market?

    Argentina's market is estimated to grow from 20.0 million USD in 2024 to 60.0 million USD by 2035.

    What are the expected market values for the Rest of South America region by 2035?

    The Rest of South America region is projected to reach a market value of 65.0 million USD by 2035.

    What opportunities are shaping the Montelukast API Market in South America?

    The market is poised for growth due to increasing cases of asthma and allergic conditions across the region.

    How is the market for Montelukast API expected to evolve in terms of regional growth?

    Regional growth is evident, with Brazil, Mexico, and Argentina driving significant contributions to the market expansion.

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