As per MRFR analysis, the South America Montelukast API Market Size was estimated at 90 (USD Million) in 2023. The South America Montelukast API Market Industry is expected to grow from 110 (USD Million) in 2024 to 350 (USD Million) by 2035. The South America Montelukast API Market CAGR (growth rate) is expected to be around 11.096% during the forecast period (2025 - 2035).
The Montelukast API market in South America is experiencing substantial trends that are being driven by the increasing prevalence of respiratory diseases, such as allergic rhinitis and asthma. Montelukast, which is frequently prescribed for these conditions, is experiencing an increase in demand due to the availability of effective remedies and the growing awareness of asthma management among the general public.
Additionally, the market is being bolstered by the implementation of initiatives by healthcare authorities in countries such as Brazil and Argentina to enhance asthma care by encouraging the use of essential medications. The Montelukast API market is further stimulated by the region's economic advancements and increasing disposable incomes, which also facilitate improved access to medications.
Particularly through partnerships with pharmaceutical companies and local manufacturing, the Montelukast API market in South America remains brimming with opportunities. The potential for companies to invest in regional facilities and supply chains is expanding as a result of the emphasis on local production in several countries in South America as part of their healthcare policies.
The development of innovative treatments can be facilitated by the exploration of collaborations with research institutions to improve drug formulations and delivery systems. The availability of generic Montelukast products has increased in recent years as patents expire, thereby enabling a broader segment of the population to access these essential medications.
Furthermore, the proliferation of e-commerce platforms and online pharmacies in South America offers an alternative distribution channel, thereby facilitating patients' access to Montelukast products. The transition to digital solutions is transforming the way medications are supplied and ingested, resulting in a more well-informed patient population. In general, the South American Montelukast API market is poised for significant growth as a result of these dynamic market drivers and the changing behaviors of consumers.
Source: Primary Research, Secondary Research, MRFR Database, and Analyst Review
The increasing prevalence of respiratory disorders, particularly asthma and allergic rhinitis, is a significant driver of growth in the South America Montelukast API Market Industry. According to the Pan American Health Organization, it is estimated that around 15 million people in South America have asthma alone.
With a population of over 430 million in this region, this equates to approximately 3.5% of the population. Additionally, the World Health Organization has indicated a concerning growth trend, with cases of asthma increasing by 12% over the last decade due to urbanization and pollution.
Government initiatives focused on respiratory health in South America are bolstering the Montelukast API Market. For instance, Brazil's Ministry of Health has launched various programs aimed at improving respiratory health, allocating substantial budgets for asthma education and management. In Brazil alone, recent government initiatives have invested over 200 million USD in awareness campaigns and treatment accessibility for asthma, increasing the population's awareness of effective treatments like Montelukast.
Furthermore, these programs are likely to encourage pharmaceutical companies to invest more in Research and Development (R&D) related to Montelukast, thereby expanding the South America Montelukast API Market.
There is a marked increase in investment within the pharmaceutical manufacturing sector in South America, which directly benefits the Montelukast API Market. Recent reports from Brazil's National Association of Pharmaceutical Industries indicate that foreign direct investment in pharmaceutical manufacturing reached approximately 1.5 billion USD in the last year alone.
Such investments improve manufacturing capabilities and increase the availability of APIs like Montelukast in regional markets. Established companies, including Novartis and Pfizer, are enhancing their production facilities, adapting to both domestic needs and export opportunities, which positively affects the South America Montelukast API Market landscape.
The South America Montelukast API Market, particularly in the Application segment, is witnessing notable growth driven by an increasing demand for effective treatment options for various respiratory and allergic conditions. Asthma is a major contributor to this market, as it affects a substantial percentage of the population, leading to a high level of awareness and treatment-seeking among patients.
This respiratory ailment, characterized by inflamed airways, necessitates continued research and development of more effective medications to improve patients' quality of life. Allergic Rhinitis is also gaining significant attention within the South America Montelukast API Market, reflecting the rising prevalence of allergies due to environmental factors and lifestyle changes.
As allergies become more common across diverse demographics, they create a considerable opportunity for the market through the development of targeted therapies. Bronchospasm represents another critical area where timely medical intervention is essential to manage symptoms and improve lung function for affected individuals. Urticaria, characterized by itchy hives and flare-ups, further adds to the complexity of allergic conditions that Montelukast addresses.
Its management is vital, especially within urban populations exposed to various allergens. Lastly, the 'Others' segment highlights the diversity of conditions treated by Montelukast, representing additional avenues for growth in the market as awareness and prescription rates increase. Overall, the Application segment of the South America Montelukast API Market is not only significant due to its current value proposition but also critical in providing essential healthcare solutions to a growing number of patients in the region.
As the industry evolves, it continues to focus on addressing the unmet needs of patients suffering from these common yet impactful conditions, ensuring a comprehensive approach towards respiratory and allergy management in South America.
Source: Primary Research, Secondary Research, MRFR Database, and Analyst Review
The South America Montelukast API Market is seeing robust growth across its regional segments, with Brazil, Mexico, Argentina, and the Rest of South America playing pivotal roles in shaping the industry landscape. Brazil is one of the key players, commanding a significant portion of the market, driven by rising healthcare expenditures and an increasing prevalence of respiratory diseases.
Mexico follows closely, benefiting from enhanced regulatory frameworks and improving access to healthcare services, thereby fostering the adoption of Montelukast. Argentina remains an important segment as well, characterized by a growing emphasis on chronic disease management and prevention strategies. Meanwhile, the Rest of South America is gaining traction with expanding pharmaceutical industries, which contribute to increased production and availability of Montelukast APIs.
Collectively, these regions highlight various growth drivers, such as a rising awareness about asthma and allergies, and a greater push for innovation in the pharmaceutical sector. However, challenges, including market regulation and access disparities, may influence overall market dynamics. The diverse opportunities in South America ensure a promising outlook for the Montelukast API Market growth in the future, with potential for increased collaboration within the region's healthcare systems.
Source: Primary Research, Secondary Research, MRFR Database, and Analyst Review
The South America Montelukast API Market is witnessing a dynamic landscape characterized by a variety of competitive forces, with multiple players working to capitalize on the rising demand for this crucial asthma and allergy medication. As awareness of respiratory diseases increases and healthcare infrastructure improves, companies in this region are focusing on innovation, production capabilities, and strategic collaborations.
The market is shaped by factors including regulatory changes, supply chain advancements, and pricing strategies, which further define the competitive landscape. The ongoing efforts to expand market share and enhance product portfolios are evident as companies evaluate their positions and adapt to regional challenges while aiming for sustainability and patient-centric solutions.
Teva Pharmaceutical Industries holds a strong presence in the South America Montelukast API Market, well-regarded for its extensive experience and product offerings. The company has established a solid reputation by delivering high-quality APIs with a focus on Montelukast. Their strength lies in their robust research and development capabilities, allowing them to innovate effectively while maintaining cost efficiencies.
Teva's proactive approach to compliance with local regulations and its commitment to quality standards have further solidified its standing in the market. The company's distribution network and local partnerships enable it to reach a broad customer base, thereby reinforcing its competitive advantage in South America's increasingly demanding healthcare environment.
Amgen has also carved out a significant niche within the South America Montelukast API Market, leveraging its pharmaceutical expertise and advanced biotechnological capabilities. With a key focus on specialized products and innovative therapies, Amgen has positioned itself as a formidable player. The company’s strengths include substantial investments in research and development and a focus on optimizing production operations to increase efficiency.
Their commitment to creating impactful solutions for asthma and allergy patients significantly enhances their market presence. Amgen's strategic mergers and acquisitions in the region demonstrate its intent to expand its portfolio and strengthen its foothold in South America. This allows the company to remain competitive while catering to the evolving needs of healthcare providers and patients alike.
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.
| Report Attribute/Metric Source: | Details |
| MARKET SIZE 2018 | 90.0(USD Million) |
| MARKET SIZE 2024 | 110.0(USD Million) |
| MARKET SIZE 2035 | 350.0(USD Million) |
| COMPOUND ANNUAL GROWTH RATE (CAGR) | 11.096% (2025 - 2035) |
| REPORT COVERAGE | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| BASE YEAR | 2024 |
| MARKET FORECAST PERIOD | 2025 - 2035 |
| HISTORICAL DATA | 2019 - 2024 |
| MARKET FORECAST UNITS | USD Million |
| KEY COMPANIES PROFILED | Teva Pharmaceutical Industries, Amgen, Novartis, Roche, Dr. Reddy's Laboratories, Hetero Labs, Sun Pharmaceutical Industries, Zydus Cadila, Boehringer Ingelheim, Eisai, Merck & Co, Aurobindo Pharma, Cipla, Mylan, Sandoz |
| SEGMENTS COVERED | Application, Regional |
| KEY MARKET OPPORTUNITIES | Growing asthma prevalence, Increasing chronic respiratory disorders, Rising healthcare expenditure, Expanding generic drug market, Strategic partnerships with local manufacturers |
| KEY MARKET DYNAMICS | Increased asthma prevalence, Growing demand for generics, Regulatory compliance challenges, Price sensitivity among patients, Rising healthcare investments |
| COUNTRIES COVERED | Brazil, Mexico, Argentina, Rest of South America |
Frequently Asked Questions (FAQ) :
In 2024, the South America Montelukast API Market is valued at 110.0 million USD.
By 2035, the market is expected to reach a value of 350.0 million USD.
The market is anticipated to grow at a CAGR of 11.096% from 2025 to 2035.
Brazil holds the largest market share with an estimated value of 45.0 million USD 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.
The major players include Teva Pharmaceutical Industries, Amgen, Novartis, Roche, and Dr. Reddy's Laboratories.
Argentina's market is estimated to grow from 20.0 million USD in 2024 to 60.0 million USD by 2035.
The Rest of South America region is projected to reach a market value of 65.0 million USD by 2035.
The market is poised for growth due to increasing cases of asthma and allergic conditions across the region.
Regional growth is evident, with Brazil, Mexico, and Argentina driving significant contributions to the market expansion.
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