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


ID: MRFR/HC/51333-HCR | 200 Pages | Author: Garvit Vyas| June 2025

GCC Montelukast API Market Overview:


As per MRFR analysis, the GCC Montelukast API Market Size was estimated at 27 (USD Million) in 2023. The GCC Montelukast API Market Industry is expected to grow from 30.3(USD Million) in 2024 to 99 (USD Million) by 2035. The GCC Montelukast API Market CAGR (growth rate) is expected to be around 11.364% during the forecast period (2025 - 2035).


Key GCC Montelukast API Market Trends Highlighted


The GCC Montelukast API market is experiencing an upward trend, which is primarily due to the rising prevalence of respiratory diseases, particularly asthma and allergic rhinitis, which are prevalent in the region. This increase in respiratory issues is associated with environmental factors, such as the urbanization and air pollution that are prevalent in numerous GCC countries.


Key market drivers are government initiatives that prioritize the importance of effective treatment options, with the objective of enhancing public health and alleviating the burden of these diseases. For example, the demand and awareness of medications such as Montelukast are being increased by initiatives that concentrate on asthma management in schools and communities. Exploring opportunities within the GCC Montelukast API market is being facilitated by the region's strategic location, which facilitates easy export and import activities.
By utilizing a variety of Free Trade Agreements (FTAs), manufacturers can gain access to potentially larger markets. Furthermore, there is an increasing trend toward the production of pharmaceuticals locally, which is facilitated by national policies that promote industrial development. This enables companies to more effectively access the domestic market. The GCC's expansion of healthcare facilities and services also presents an opportunity for increased consumption of Montelukast, which is indicative of a trend toward more accessible healthcare.
In recent years, there has been a growing trend of collaboration between the public and private sectors to improve the capabilities of pharmaceutical research and development. Regulatory bodies in the GCC are gradually simplifying the approval process for new medications, which will facilitate the entry of Montelukast APIs into the market. Additionally, regulatory reforms are fostering an increased emphasis on bioequivalence and quality assurance to guarantee the safety and efficacy of medications. These trends suggest that the Montelukast API market in the GCC will become more competitive and robust, which is indicative of the region's dedication to enhancing healthcare outcomes.


GCC Montelukast API Market Overview:


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


GCC Montelukast API Market Drivers


Rising Asthma Prevalence in GCC Countries


The increasing prevalence of asthma in the Gulf Cooperation Council (GCC) region is a significant driver for the GCC Montelukast API Market Industry. According to the World Health Organization (WHO), asthma affects approximately 300 million individuals globally, with elevated rates in the Middle East and North Africa region. Specifically, the Qatar National Health Strategy 2018-2022 reports that asthma prevalence in younger populations can reach as high as 15% in some GCC states.
This growing patient pool propels the demand for Montelukast, a medication widely prescribed to manage asthma symptoms effectively. Furthermore, the Gulf Research Centre indicates that public health campaigns in GCC countries are increasingly focused on respiratory diseases, fostering an environment conducive to the growth of the Montelukast API market. As awareness increases and more patients seek treatment, the market is expected to expand significantly.


Government Initiatives to Enhance Healthcare Accessibility


The GCC governments are intensifying efforts to improve healthcare accessibility, which is driving the GCC Montelukast API Market Industry. For instance, the Saudi Vision 2030 initiative aims to enhance health services, ensuring all citizens have adequate access to treatments for chronic conditions, including asthma. Public health reforms in countries like the United Arab Emirates (UAE) focus on integrating advanced medical treatments into the public health system.
According to the Ministry of Health and Prevention in the UAE, more than 30% of common respiratory disorders are treated with medications like Montelukast. Consequently, as healthcare infrastructure strengthens, availability and prescription rates of Montelukast are expected to rise, contributing to market growth.


Increased Focus on Chronic Respiratory Diseases Research


An increasing emphasis on Research and Development (R&D) for chronic respiratory diseases is propelling the GCC Montelukast API Market Industry. Institutions such as the Qatar Biomedical Research Institute are focused on lifting the level of research on respiratory illnesses, which has seen a significant boost in funding and collaboration. They report an expected 20% increase in R&D spending on respiratory diseases in the next five years.
This investment allows for innovations in treatment protocols and medications, which includes the potential development of advanced formulations of Montelukast.With more research backing the effectiveness of Montelukast, healthcare providers are more likely to recommend it as a first-line treatment, driving market growth forward.


GCC Montelukast API Market Segment Insights:


Montelukast API Market Application Insights


The GCC Montelukast API Market is showing significant potential within the Application segment, driven by a range of therapeutic needs across various respiratory and allergic conditions. The market reflects a substantial emphasis on managing asthma, a prevalent health issue in the Gulf Cooperation Council region, where rising pollution levels and lifestyle changes contribute to increasing cases of respiratory diseases. This aspect highlights the critical importance of effective treatments, making the asthma application a significant domain within this market.
Similarly, allergic rhinitis is a common ailment affecting a large portion of the population, reinforced by climatic conditions that trigger allergies. This drives demand for Montelukast as an effective option for alleviating symptoms. Bronchospasm presents another area where Montelukast is vital, often associated with chronic respiratory conditions, increasing the need for robust treatment options. Understanding the GCC's climatic challenges, it's essential to recognize how these conditions impact daily life and overall health, prompting a focus on effective management strategies.
Urticaria, though less prevalent, adds another layer to the market landscape, as it requires reliable treatment solutions to enhance patient quality of life. Other applications within this segment cater to a broad spectrum of needs, indicating diverse market interests. As the GCC market continues to grow, opportunities may arise from increasing awareness, healthcare investments, and the emergence of new therapeutic strategies related to Montelukast, highlighting the interconnectedness of healthcare and market growth in the region.
Collectively, these insights provide a clear perspective on how different applications of Montelukast serve vital roles in addressing health challenges within the GCC, positioning the market for continued evolution and expansion driven by diverse patient needs and the region's unique environmental factors.


Montelukast API Market Application Insights


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


GCC Montelukast API Market Key Players and Competitive Insights:


The GCC Montelukast API Market is characterized by a dynamic competitive landscape shaped by various factors including regulatory frameworks, market demand, and the increasing prevalence of respiratory conditions. Montelukast, a leukotriene receptor antagonist widely utilized for the treatment of asthma and allergic rhinitis, is gaining traction across the Gulf Cooperation Council countries due to rising awareness about respiratory disorders and the growing adoption of preventive healthcare measures.
The competitive environment in this market is influenced by the presence of both multinational corporations and emerging local players, which are focused on optimizing production capabilities and enhancing distribution networks. Furthermore, the pipeline for innovative formulations and collaborations within the region adds another layer of complexity to this market, as companies strive for competitive advantage through product diversity and improved efficacy.
Teva Pharmaceutical Industries has established a significant presence in the GCC Montelukast API Market, leveraging its global scale to penetrate local markets effectively. The company is recognized for its robust manufacturing capabilities and commitment to quality, which positions it favorably against competitors. Teva's strengths lie in its diverse portfolio of generic and specialty pharmaceuticals, allowing it to cater to varying patient needs across the region. With a strong emphasis on research and development, Teva continuously seeks to enhance its product offerings, ensuring compliance with local regulatory requirements.
Additionally, its strategic partnerships with local distributors facilitate improved access to its Montelukast products, enhancing visibility and market share in the GCC.Amgen, while primarily known for its biopharmaceutical innovations, is also making strides in the GCC Montelukast API Market by addressing respiratory health challenges within the region. The company's emphasis on research and development allows it to provide compelling therapies that enhance patient outcomes.
Amgen's strengths in the GCC stem from its strong branding and marketing strategies, which focus on building trusted relationships with healthcare professionals and stakeholders. Furthermore, the company's engagement in potential mergers and acquisitions within the strategic landscape of the GCC has allowed it to expand its footprint and diversify its product offerings. With a focus on delivering high-quality, patient-focused solutions, Amgen continues to solidify its position in the GCC Montelukast API Market, ensuring that it meets the evolving healthcare demands of the region.


Key Companies in the GCC Montelukast API Market Include:



    • Teva Pharmaceutical Industries

    • Amgen

    • Medichem

    • Hikma Pharmaceuticals

    • Merck


    • Fresenius Kabi

    • Glenmark Pharmaceuticals

    • Hetero Labs

    • Sun Pharmaceutical Industries

    • Zydus Cadila

    • Aurobindo Pharma

    • Cipla

    • Mylan

    • Sandoz


GCC Montelukast API Market Industry Developments


Recent developments in the GCC Montelukast Active Pharmaceutical Ingredient (API) Market have shown significant growth, with key players like Teva Pharmaceutical Industries, Hikma Pharmaceuticals, and Merck expanding their operations. In September 2023, Hikma Pharmaceuticals secured approval for a new Montelukast formulation which is expected to increase market penetration in the GCC region. Meanwhile, Amgen and Lupin Pharmaceuticals are enhancing their presence through collaborations and partnerships aimed at improving accessibility to Montelukast in local markets. In July 2023, Fresenius Kabi announced its plan to increase manufacturing capacity for Montelukast API, responding to rising demand.Over the past two years, the GCC market has witnessed steady growth, bolstered by the increasing prevalence of asthma and allergic rhinitis, driving demand for Montelukast. Additionally, in early 2022, Zydus Cadila announced a strategic partnership with local distributors to enhance its market share in GCC countries. However, no significant mergers and acquisitions involving the specified companies have been reported recently. Overall, the market continues to evolve with strong contributions from various players, reflecting an optimistic outlook driven by healthcare reforms and regulatory support across the GCC.


GCC Montelukast API Market Segmentation Insights


Montelukast API Market Application Outlook



    • Asthma

    • Allergic Rhinitis

    • Bronchospasm

    • Urticaria

    • Others


 

Report Attribute/Metric Source: Details
MARKET SIZE 2018 27.0(USD Million)
MARKET SIZE 2024 30.3(USD Million)
MARKET SIZE 2035 99.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 11.364% (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, Medichem, Hikma Pharmaceuticals, Merck, Lupin Pharmaceuticals, Fresenius Kabi, Glenmark Pharmaceuticals, Hetero Labs, Sun Pharmaceutical Industries, Zydus Cadila, Aurobindo Pharma, Cipla, Mylan, Sandoz
SEGMENTS COVERED Application
KEY MARKET OPPORTUNITIES Growing asthma prevalence, Increasing respiratory disorder awareness, Expansion of pharmaceutical manufacturing, Rising demand for cost-effective APIs, Strategic partnerships with regional suppliers
KEY MARKET DYNAMICS rising asthma prevalence, regulatory compliance challenges, growing demand for generics, increasing healthcare expenditure, competition from alternative therapies
COUNTRIES COVERED GCC


Frequently Asked Questions (FAQ) :

The GCC Montelukast API Market is expected to be valued at 30.3 million USD in 2024.

By 2035, the market is projected to reach a value of 99.0 million USD.

The expected CAGR for the GCC Montelukast API Market is 11.364% during the period from 2025 to 2035.

In 2024, the Asthma application segment contributes the most with a value of 10.0 million USD.

The market value for the Allergic Rhinitis application segment is projected to be 25.0 million USD by 2035.

Key players include Teva Pharmaceutical Industries, Amgen, Medichem, Hikma Pharmaceuticals, and Merck.

The Bronchospasm application segment is valued at 5.5 million USD in 2024.

The Urticaria application segment is projected to reach a value of 10.0 million USD by 2035.

The market faces challenges such as competition among key players and regulatory changes impacting the API industry.

Growth opportunities exist in expanding applications and increasing demand for asthma and allergic rhinitis treatments.

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