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US Montelukast API Market

ID: MRFR/HC/51550-HCR
128 Pages
Garvit Vyas
October 2025

US Montelukast API Market Research Report By Application (Asthma, Allergic Rhinitis, Bronchospasm, Urticaria, Others) - Forecast to 2035

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US Montelukast API Market Summary

As per MRFR analysis, the US montelukast api market Size was estimated at 212.1 USD Million in 2024. The US montelukast api market is projected to grow from 235.9 USD Million in 2025 to 683.43 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 11.22% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US montelukast API market is experiencing robust growth driven by increasing demand for respiratory treatments and advancements in healthcare.

  • The largest segment in the US montelukast API market is the the asthma treatment segment continues to expand due to rising awareness of asthma management.
  • The fastest-growing segment is the allergic rhinitis treatment segment, reflecting a shift towards preventive healthcare measures.
  • Technological advancements in manufacturing are enhancing production efficiency and reducing costs, thereby supporting market growth.
  • Key market drivers include the increasing prevalence of allergic conditions and the cost-effectiveness of montelukast, which appeal to both healthcare providers and patients.

Market Size & Forecast

2024 Market Size 212.1 (USD Million)
2035 Market Size 683.43 (USD Million)

Major Players

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

US Montelukast API Market Trends

The montelukast market is experiencing notable developments driven by increasing awareness of respiratory conditions and the growing demand for effective treatments. Montelukast, a leukotriene receptor antagonist, is widely utilized in managing asthma and allergic rhinitis. The market appears to be influenced by various factors, including regulatory changes, advancements in manufacturing processes, and the rising prevalence of respiratory diseases. As healthcare providers and patients seek more efficient therapeutic options, the montelukast api market is likely to expand, reflecting a shift towards more personalized medicine. In addition, the competitive landscape of the montelukast api market is evolving, with several manufacturers striving to enhance product quality and reduce production costs. This trend may lead to increased accessibility of montelukast formulations, potentially benefiting a larger patient population. Furthermore, ongoing research into the drug's efficacy and safety profile may contribute to its sustained relevance in treatment protocols. Overall, the montelukast api market is poised for growth, driven by innovation and a commitment to improving patient outcomes.

Rising Demand for Respiratory Treatments

The montelukast market is witnessing a surge in demand for treatments addressing respiratory conditions. This trend is largely attributed to the increasing incidence of asthma and allergies, prompting healthcare providers to seek effective therapeutic options. As awareness of these conditions grows, the market is likely to expand, reflecting a heightened focus on respiratory health.

Regulatory Developments

Recent regulatory changes are shaping the montelukast api market landscape. Authorities are implementing new guidelines aimed at ensuring the safety and efficacy of medications. These developments may influence manufacturing practices and product approvals, potentially impacting market dynamics and fostering innovation within the sector.

Technological Advancements in Manufacturing

Innovations in manufacturing processes are playing a crucial role in the montelukast api market. Enhanced production techniques may lead to improved product quality and cost efficiency. As manufacturers adopt advanced technologies, the market could experience a shift towards more sustainable practices, ultimately benefiting both producers and consumers.

US Montelukast API Market Drivers

Cost-Effectiveness of Montelukast

The montelukast api market benefits from the cost-effectiveness of montelukast as a treatment option for asthma and allergic rhinitis. With healthcare costs continuously rising, patients and providers are increasingly looking for affordable yet effective medications. Montelukast, being available in generic forms, offers a more economical choice compared to other treatments. The average retail price for montelukast is significantly lower than many branded alternatives, making it accessible to a broader patient population. This affordability is particularly crucial in the US, where healthcare expenses can be a barrier to treatment. As a result, the montelukast api market is likely to see sustained demand as patients prioritize cost-effective solutions for managing their respiratory conditions.

Rising Awareness of Asthma Management

The montelukast market is benefiting from rising awareness regarding asthma management among patients and healthcare providers. Educational campaigns and resources provided by organizations such as the American Lung Association have increased understanding of asthma and its treatment options. This heightened awareness encourages patients to seek appropriate medical care and adhere to prescribed treatments, including montelukast. As more individuals recognize the importance of effective asthma management, the demand for montelukast is likely to rise. Additionally, healthcare providers are increasingly recommending montelukast as a first-line treatment, further solidifying its position in the montelukast api market. This trend suggests a positive outlook for the market as awareness continues to grow.

Growing Focus on Preventive Healthcare

The montelukast market is influenced by the growing focus on preventive healthcare in the US. As healthcare systems shift towards preventive measures, there is an increasing emphasis on managing chronic conditions like asthma before they escalate. Montelukast is often prescribed as a preventive treatment, helping to reduce the frequency and severity of asthma attacks. This proactive approach aligns with public health initiatives aimed at reducing healthcare costs and improving patient outcomes. The US government has been promoting preventive healthcare strategies, which may further bolster the demand for montelukast. Consequently, the montelukast api market is poised for growth as more patients seek preventive solutions to manage their respiratory health.

Advancements in Pharmaceutical Research

The montelukast market is positively impacted by advancements in pharmaceutical research and development. Ongoing studies are exploring the efficacy of montelukast in various patient populations, including children and those with comorbid conditions. Research indicates that montelukast may have additional benefits beyond asthma management, such as its potential role in treating exercise-induced bronchoconstriction. These findings could expand the therapeutic applications of montelukast, leading to increased prescriptions and market growth. Furthermore, as pharmaceutical companies invest in research to enhance drug formulations and delivery methods, the montelukast api market may see innovations that improve patient compliance and outcomes. This dynamic environment suggests a promising future for the montelukast api market.

Increasing Prevalence of Allergic Conditions

The montelukast market is experiencing growth due to the rising prevalence of allergic conditions such as asthma and allergic rhinitis in the US. According to the CDC, approximately 25 million Americans suffer from asthma, which translates to about 8% of the population. This increasing incidence drives demand for effective treatments, including montelukast, which is widely prescribed for managing these conditions. As healthcare providers seek to address the needs of patients with respiratory issues, the montelukast api market is likely to expand. Furthermore, the growing awareness of the importance of managing allergies effectively contributes to the market's upward trajectory, as patients and healthcare professionals alike recognize the benefits of montelukast in improving quality of life.

Market Segment Insights

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

The US montelukast api market demonstrates a distinctive segmentation wherein Asthma holds the largest share. The segment for Asthma significantly outperforms its counterparts, especially in patient prescriptions and treatment plans among various demographics. Following Asthma, Allergic Rhinitis emerges as an essential segment, capitalizing on the rising incidence of allergic conditions. Other segments like Bronchospasm and Urticaria, while contributing to the market, occupy a smaller share proportion. In recent years, the demand for montelukast api products focused on Asthma has seen considerable growth, driven by increasing awareness and prevalence of respiratory diseases. The Allergic Rhinitis segment is expanding rapidly, attributed to increased environmental allergens and enhanced diagnosis rates. Overall, innovation in drug formulations and a greater emphasis on preventive healthcare are key trends shaping these segments market trajectory.

Asthma (Dominant) vs. Allergic Rhinitis (Emerging)

Asthma has established itself as the dominant segment in the US montelukast api market due to its high prevalence among both adults and children, making it a focal point for pharmaceutical interventions. Numerous studies and clinical applications focus on optimal treatment methodologies, positioning companies to meet increasing patient needs efficiently. In contrast, Allergic Rhinitis is emerging rapidly, propelled by a growing number of patients seeking relief from seasonal and perennial allergies. This segment is gaining traction through targeted marketing campaigns and the introduction of innovative treatment protocols that enhance patient adherence. As research into allergic conditions advances, both segments are expected to remain crucial to the overall landscape of the US montelukast api market.

Get more detailed insights about US Montelukast API Market

Key Players and Competitive Insights

The montelukast API market is characterized by a competitive landscape that is increasingly shaped by innovation, strategic partnerships, and regional expansion. Key players such as Merck & Co (US), Teva Pharmaceutical Industries (IL), and Mylan N.V. (NL) are actively pursuing strategies that enhance their market positioning. Merck & Co (US) has focused on strengthening its research and development capabilities, aiming to innovate within the respiratory therapeutic area. Meanwhile, Teva Pharmaceutical Industries (IL) has been expanding its manufacturing footprint in the US, which appears to be a strategic move to optimize supply chain efficiencies and meet growing demand. Mylan N.V. (NL) is also enhancing its operational focus on digital transformation, which may provide a competitive edge in terms of customer engagement and operational agility.

The business tactics employed by these companies include localizing manufacturing and optimizing supply chains to respond swiftly to market demands. The montelukast API market is moderately fragmented, with several players vying for market share. However, the collective influence of these key players is significant, as they drive innovation and set industry standards that smaller competitors may struggle to match.

In October 2025, Merck & Co (US) announced a collaboration with a leading technology firm to integrate AI into its drug development processes. This strategic move is likely to enhance Merck's ability to streamline research timelines and improve the efficacy of its product offerings, thereby reinforcing its competitive position in the market.

In September 2025, Teva Pharmaceutical Industries (IL) launched a new initiative aimed at increasing the sustainability of its manufacturing processes. This initiative not only aligns with global sustainability trends but also positions Teva as a responsible player in the pharmaceutical industry, potentially attracting environmentally conscious consumers and stakeholders.

In August 2025, Mylan N.V. (NL) entered into a strategic partnership with a digital health company to develop a comprehensive patient management platform. This collaboration is expected to enhance patient adherence to montelukast therapy, thereby improving health outcomes and solidifying Mylan's market presence through innovative patient engagement strategies.

As of November 2025, the montelukast API market is witnessing trends that emphasize digitalization, sustainability, and the integration of advanced technologies such as AI. Strategic alliances are increasingly shaping the competitive landscape, allowing companies to leverage each other's strengths. The shift from price-based competition to a focus on innovation, technology, and supply chain reliability is becoming evident. Moving forward, competitive differentiation will likely hinge on the ability to innovate and adapt to evolving market demands, rather than solely competing on price.

Key Companies in the US Montelukast API Market market include

Industry Developments

The US Montelukast API Market has seen significant activity recently, with continued interest from major pharmaceutical players such as Teva Pharmaceutical, Amgen, and Merck amidst ongoing regulatory scrutiny. In August 2023, the FDA acknowledged the importance of monitoring safety profiles for Montelukast, pushing companies to engage in more rigorous post-marketing studies, which may impact their operational strategies.

In terms of mergers and acquisitions, Dr. Reddy's Laboratories completed the acquisition of a generic medication portfolio, including Montelukast, in July 2023, targeting expansion in the respiratory segment. Growth in market valuation is evident, especially as companies like Sun Pharmaceutical and Lupin Pharmaceuticals continue to innovate and expand manufacturing capabilities.

Additionally, the rising prevalence of asthma and allergic rhinitis in the US generates a steady demand for Montelukast, highlighting its critical role in public health. Over the last few years, Zydus Cadila has also strengthened its position in the Montelukast API sector, leveraging advancements in biotechnology to enhance product offerings. The market remains dynamic as these companies navigate regulatory changes and seek to meet the evolving needs of healthcare providers and patients in the US.

Future Outlook

US Montelukast API Market Future Outlook

The montelukast API market is projected to grow at 11.22% CAGR from 2024 to 2035, driven by increasing asthma prevalence and rising healthcare expenditure.

New opportunities lie in:

  • Development of specialized montelukast formulations for pediatric use.
  • Expansion into emerging markets with tailored pricing strategies.
  • Partnerships with telehealth platforms for remote patient management solutions.

By 2035, the montelukast API market is expected to achieve substantial growth and innovation.

Market Segmentation

US Montelukast API Market Application Outlook

  • Asthma
  • Allergic Rhinitis
  • Bronchospasm
  • Urticaria
  • Others

Report Scope

MARKET SIZE 2024 212.1(USD Million)
MARKET SIZE 2025 235.9(USD Million)
MARKET SIZE 2035 683.43(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 11.22% (2024 - 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 Merck & Co (US), Teva Pharmaceutical Industries (IL), Mylan N.V. (NL), Cipla Limited (IN), Aurobindo Pharma (IN), Hikma Pharmaceuticals (GB), Sandoz (CH), Zydus Cadila (IN)
Segments Covered Application
Key Market Opportunities Growing demand for montelukast API in respiratory therapies presents significant market opportunities.
Key Market Dynamics Regulatory changes and competitive pressures drive innovation in the montelukast active pharmaceutical ingredient market.
Countries Covered US

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FAQs

What is the expected market size of the US Montelukast API Market in 2024?

The US Montelukast API Market is expected to be valued at 211.5 million USD in 2024.

What is the projected market size of the US Montelukast API Market by 2035?

By 2035, the market is projected to reach a value of 684.5 million USD.

What is the expected CAGR for the US Montelukast API Market from 2025 to 2035?

The expected compound annual growth rate (CAGR) for the market from 2025 to 2035 is 11.268%.

Which application segment holds the largest market value in 2024?

The Asthma application segment holds the largest market value at 90.0 million USD in 2024.

What will be the market value of the Asthma segment in 2035?

The market value of the Asthma segment is expected to increase to 300.0 million USD in 2035.

Who are the key players in the US Montelukast API Market?

Major players in the US Montelukast API Market include Teva Pharmaceutical, Amgen, Sun Pharmaceutical, and Merck.

What is the projected market value for the Allergic Rhinitis application in 2035?

The Allergic Rhinitis application segment is projected to reach 175.0 million USD by 2035.

What is the expected market value of the Bronchospasm segment in 2024?

In 2024, the Bronchospasm segment is expected to be valued at 30.0 million USD.

What is the expected market value for Urticaria in 2035?

The Urticaria application segment is expected to have a market value of 70.0 million USD in 2035.

What growth opportunities exist for the US Montelukast API Market?

Growth opportunities in the market stem from the increasing prevalence of asthma and allergic conditions, leading to higher demand for Montelukast API.

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