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Montelukast API Market

ID: MRFR/HC/6414-CR
94 Pages
Rahul Gotadki
May 2019

Montelukast API Market Research Report Information By Application (Asthma, Allergic Rhinitis, Bronchospasm, Urticaria, and Others), and By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2035

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Montelukast API Market Summary

As per MRFR analysis, the Montelukast API Market Size was estimated at 1.01 USD Billion in 2024. The Montelukast API industry is projected to grow from 1.119 USD Billion in 2025 to 3.121 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 10.8 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Montelukast API Market is poised for growth driven by increasing demand for respiratory treatments and technological advancements.

  • The demand for respiratory treatments, particularly for asthma, continues to rise in North America, the largest market for Montelukast API Market.
  • Asia-Pacific emerges as the fastest-growing region, driven by increasing healthcare expenditure and awareness of respiratory health.
  • Advancements in manufacturing technologies are enhancing the production efficiency of Montelukast API Market, catering to diverse market needs.
  • Key market drivers include the rising prevalence of asthma and allergies, alongside regulatory approvals that facilitate market entry.

Market Size & Forecast

2024 Market Size 1.01 (USD Billion)
2035 Market Size 3.121 (USD Billion)
CAGR (2025 - 2035) 10.8%

Major Players

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

Montelukast API Market Trends

The Montelukast API Market is currently experiencing a dynamic phase characterized by evolving demand and regulatory landscapes. As healthcare systems worldwide increasingly prioritize respiratory health, the need for effective treatments for conditions such as asthma and allergic rhinitis has surged. This trend appears to be driven by a growing awareness of the importance of managing chronic respiratory diseases, which may lead to a sustained increase in the consumption of Montelukast API Market. Furthermore, the market seems to be influenced by advancements in pharmaceutical manufacturing processes, which could enhance the efficiency and quality of Montelukast production. In addition, the Montelukast API Market is likely to witness a shift towards more sustainable practices. Manufacturers may explore eco-friendly production methods and raw material sourcing to align with global sustainability goals. This inclination towards sustainability could not only improve the market's public perception but also potentially attract investment from environmentally conscious stakeholders. Overall, the Montelukast API Market appears poised for growth, driven by both demand for effective treatments and a commitment to sustainable practices.

Rising Demand for Respiratory Treatments

The Montelukast API Market is witnessing an increase in demand for effective treatments targeting respiratory conditions. This trend is likely fueled by heightened awareness of chronic respiratory diseases and their impact on quality of life.

Advancements in Manufacturing Technologies

Innovations in pharmaceutical manufacturing processes are shaping the Montelukast API Market. Enhanced production techniques may lead to improved efficiency and product quality, potentially benefiting both manufacturers and consumers.

Focus on Sustainability

There is a growing emphasis on sustainable practices within the Montelukast API Market. Manufacturers may adopt eco-friendly production methods and sourcing strategies, aligning with global sustainability initiatives and appealing to environmentally conscious consumers.

Montelukast API Market Drivers

Rising Healthcare Expenditure

An increase in healthcare expenditure across various regions is a significant driver for the Montelukast API Market. As countries allocate more resources to healthcare, there is a corresponding rise in the availability and accessibility of medications for chronic conditions such as asthma and allergies. This trend is particularly evident in emerging economies, where healthcare reforms are aimed at improving patient outcomes. The Montelukast API Market, being a cost-effective treatment option, is likely to benefit from this increased spending. Furthermore, the emphasis on preventive healthcare and chronic disease management aligns with the therapeutic profile of Montelukast, suggesting a favorable market environment for its continued growth.

Regulatory Approvals and Guidelines

The Montelukast API Market is significantly influenced by regulatory approvals and clinical guidelines that endorse the use of Montelukast for various respiratory conditions. Regulatory bodies, such as the FDA and EMA, have established guidelines that facilitate the approval process for new formulations and generics of Montelukast. This regulatory support not only enhances market accessibility but also encourages pharmaceutical companies to invest in research and development. As a result, the market is witnessing an influx of new entrants and innovative formulations, which could potentially expand the therapeutic applications of Montelukast. The alignment of clinical guidelines with emerging research further solidifies the role of Montelukast in asthma and allergy management, thereby driving market growth.

Increasing Prevalence of Asthma and Allergies

The rising incidence of asthma and allergic conditions is a primary driver for the Montelukast API Market. According to recent data, asthma affects approximately 300 million individuals worldwide, with a notable increase in prevalence among children. This growing patient population necessitates effective treatment options, thereby propelling the demand for Montelukast, a well-established leukotriene receptor antagonist. As healthcare providers seek to manage these chronic conditions more effectively, the Montelukast API Market is likely to experience substantial growth. Furthermore, the increasing awareness of asthma management strategies among patients and healthcare professionals contributes to the heightened demand for Montelukast, reinforcing its position in the therapeutic landscape.

Technological Advancements in Drug Delivery Systems

Technological advancements in drug delivery systems are poised to impact the Montelukast API Market positively. Innovations such as smart inhalers and sustained-release formulations enhance the efficacy and patient compliance of Montelukast. These advancements not only improve the therapeutic outcomes for patients but also create new market opportunities for pharmaceutical companies. As the industry embraces these technologies, the Montelukast API Market is likely to be integrated into more sophisticated delivery systems, thereby expanding its market reach. The potential for personalized medicine, where treatments are tailored to individual patient needs, further underscores the importance of these technological developments in shaping the future of the Montelukast API Market.

Growing Awareness and Education on Respiratory Health

The increasing awareness and education regarding respiratory health are crucial drivers for the Montelukast API Market. Public health campaigns and educational initiatives aimed at asthma and allergy management have led to a greater understanding of these conditions among patients and healthcare providers. This heightened awareness encourages individuals to seek treatment options, including Montelukast, thereby driving demand. Additionally, healthcare professionals are more equipped to recommend Montelukast as a viable treatment option, further enhancing its market presence. The focus on respiratory health education is likely to continue, suggesting a sustained growth trajectory for the Montelukast API Market as more patients become informed about their treatment choices.

Market Segment Insights

Montelukast API Market Application Insights

The montelukast API market segmentation, based on application, includes asthma, allergic rhinitis, bronchospasm, urticaria, and others. The asthma segment dominated the market, accounting for 46.9% of market revenue (0.4 Billion). By preventing symptoms like wheezing, breathing issues, chest tightness, and coughing, montelukast sodium treats asthma in adults and children 12 months and older. Asthma, among the most prevalent ailments in the world, can be fatal and make breathing challenging for patients. Around 6.2 million children under the age of 18 have asthma.

Asthma is responsible for 1.8 million trips to the emergency room, 188,968 hospital inpatient discharges, and 9.8 million visits to the doctor's office annually.

April 2020: Cipla Limited announced the successful completion of the Phase-3 clinical end-point trial for salmeterol inhalation powder and fluticasone propionate (50/100 mcg). Salmeterol inhalation and fluticasone propionate powder 500/50 mcg, 250/50 mcg, and 100/50 mcg are the generic equivalents of GSK's Advair Diskus. The medicine, a twice-daily prescription tablet, is intended for the prolonged treatment of chronic obstructive pulmonary disease in patients with asthma who are at least four years and have chronic bronchitis, emphysema, or both. This will result in better breathing and fewer asthma attacks.

Additionally, in 2022, allergic rhinitis witnessed the fastest growth rate due to variables including pollen, a powder produced by many trees, grasses, and flowers that causes allergic rhinitis. Growing carbon dioxide emissions eventually contaminate the ecosystem and lengthen pollen seasons. The prolonged pollen season accelerates the occurrence of illnesses like headaches, dark undereye bags, runny nose, coughing, and throat pain.

Figure 1: Montelukast API Market, by Application, 2022 & 2032 (USD Billion)

Get more detailed insights about Montelukast API Market

Regional Insights

North America : Market Leader in Innovation

North America is the largest market for Montelukast API Market, holding approximately 45% of the global market share. The region benefits from advanced healthcare infrastructure, high prevalence of asthma and allergies, and strong regulatory support from agencies like the FDA. The increasing demand for effective asthma management solutions is driving growth, alongside a rise in generic drug approvals, which enhances market accessibility. The United States is the primary contributor, with significant participation from Canada. Key players such as Merck & Co. and Teva Pharmaceutical Industries dominate the landscape, leveraging their extensive distribution networks and R&D capabilities. The competitive environment is characterized by a focus on innovation and strategic partnerships, ensuring a steady supply of Montelukast API Market to meet growing healthcare needs.

Europe : Emerging Market with Regulations

Europe is the second-largest market for Montelukast API Market, accounting for around 30% of the global share. The region's growth is propelled by increasing asthma prevalence, supportive regulatory frameworks, and a strong emphasis on generic medications. The European Medicines Agency (EMA) plays a crucial role in facilitating market entry for new generics, which enhances competition and affordability for patients. Leading countries include Germany, France, and the UK, where the presence of major pharmaceutical companies like Mylan N.V. and Sandoz International GmbH strengthens the market. The competitive landscape is marked by a mix of established players and emerging firms, all striving to capture market share through innovation and cost-effective solutions. The focus on patient-centric approaches further drives demand for Montelukast API Market in the region.

Asia-Pacific : Rapid Growth and Demand

Asia-Pacific is witnessing rapid growth in the Montelukast API Market, holding approximately 20% of the global share. The region's expansion is driven by increasing healthcare expenditure, rising awareness of asthma management, and a growing population. Countries like India and China are at the forefront, with supportive government initiatives aimed at enhancing healthcare access and affordability, which are crucial for market growth. India is a significant player, with companies like Aurobindo Pharma and Cipla Limited leading the charge in production and distribution. The competitive landscape is evolving, with both local and international firms vying for market share. The focus on cost-effective solutions and the increasing demand for generics are shaping the market dynamics, making Asia-Pacific a key region for Montelukast API Market.

Middle East and Africa : Untapped Potential in Healthcare

The Middle East and Africa (MEA) region is gradually emerging in the Montelukast API Market, currently holding about 5% of the global share. The growth is driven by increasing healthcare investments, rising awareness of respiratory diseases, and a growing population. Regulatory bodies are beginning to implement frameworks that support the introduction of generic medications, which is expected to enhance market accessibility in the coming years. Countries like South Africa and the UAE are leading the way, with a growing number of local manufacturers entering the market. The competitive landscape is characterized by a mix of multinational corporations and regional players, all aiming to meet the rising demand for effective asthma treatments. The focus on improving healthcare infrastructure and patient access is crucial for the region's growth in the Montelukast API Market.

Montelukast API Market Regional Image

Key Players and Competitive Insights

Leading market players are largely investing in research and development to expand their product lines, which will help the montelukast API market, grow even more. The launch of new products, larger-scale mergers and acquisitions, contractual agreements, and collaboration with other organizations are significant market developments in which market participants engage to increase their presence. The Montelukast API industry must provide affordable products to expand and thrive in a more competitive and challenging market environment.

One of the major business strategies manufacturers use in the montelukast API industry to increase market sector and benefit customers is local manufacturing to lower operational costs. In recent years, the montelukast API industry has stipulated some of the most important medicinal benefits. Major players in the montelukast API industry, including Teva Pharmaceutical Industries Ltd (Israel), Sandoz International GmbH (Germany), Vintage Pharmaceuticals Inc (US), Morepen Laboratories Ltd (India), and others, are funding operations for research and development to boost market demand.

Morepen Laboratories is a renowned Pharmaceutical Company in Active Pharmaceutical Ingredients and Formulations. Morepen Laboratories Limited, founded in 1984 by Mr. KB Suri, began as a pure API manufacturer. The company manufactures and sells active formulations, pharmaceutical ingredients (APIs), and home health products. With approvals from all the major regulatory agencies, including the USFDA, WHO GMP, and EU GMP, Morepen has an important international footprint and distributes to over 75 countries. In December 2021, Morepen Laboratories announced that it had got approval from the US Food and Medicine Administration to market its anti-allergy medicine Fexofenadine Hydrochloride in the United States.

In India, the medicine is marketed under the brand Allegra.

Valeo Pharma Inc is a Canadian specialty pharmaceutical business focused on acquisitions, in-licensing, and similar partnerships. It now markets Synacthen Depot, a synthetic ACTH medication used in cases where natural cortisol and other hormone synthesis is needed. In March 2021, Valeo Pharma Inc. announced a Commercialization and Supply Contract with Novartis Pharmaceuticals Canada Inc. for the Canadian marketing of two asthma therapies, Enerzair Breezhaler (indacaterol (as acetate), glycopyrronium (as bromide), and mometasone furoate) and Atectura Breezhaler (indacaterol (as acetate) and mometasone furoate).

Key Companies in the Montelukast API Market market include

Industry Developments

  • Q2 2025: Corti Raises $60 Million to Expand AI Co-Pilot for Healthcare Providers Corti, a Copenhagen-based health tech startup, secured $60 million in funding to scale its AI-powered co-pilot platform, which assists healthcare providers with real-time triage, documentation automation, and clinical decision support, currently used in approximately 55 million medical consultations annually.
  • Q2 2024: Accenture Acquires Nautilus Consulting to Strengthen Digital Health Capabilities Accenture announced the acquisition of UK-based Nautilus Consulting, a healthcare technology consultancy specializing in electronic patient record (EPR) solutions, to bolster its digital health and transformation services for hospitals and health systems.
  • Q1 2024: PwC Appoints New Global Health Industries Leader PwC named Dr. Tim Wilson as its new Global Health Industries Leader, overseeing the firm's healthcare consulting strategy and client engagements across more than 50 countries.
  • Q2 2025: Deloitte Launches GenAI Consulting Practice for Healthcare Providers Deloitte introduced a dedicated Generative AI consulting practice focused on helping healthcare organizations implement advanced AI solutions for clinical workflow optimization, patient engagement, and operational efficiency.
  • Q1 2025: McKinsey & Company Wins Major NHS Digital Transformation Contract McKinsey & Company secured a multi-year contract with the UK National Health Service (NHS) to provide strategic consulting for the rollout of digital health platforms and interoperability solutions across regional trusts.
  • Q2 2024: KPMG Opens New Healthcare Innovation Hub in Singapore KPMG inaugurated a Healthcare Innovation Hub in Singapore to support Asia-Pacific clients with consulting services in digital health, regulatory compliance, and operational transformation.
  • Q1 2025: EY Acquires HealthTech Advisory Firm to Expand Consulting Portfolio EY announced the acquisition of a leading healthtech advisory firm, enhancing its healthcare consulting capabilities in digital transformation, data analytics, and regulatory strategy for hospitals and payers.
  • Q2 2025: Huron Consulting Group Appoints New Chief Executive Officer Huron Consulting Group named Mark Hussey as its new CEO, signaling a strategic focus on expanding healthcare consulting services in digital transformation and operational improvement.
  • Q1 2024: Guidehouse Completes Acquisition of Grant Thornton’s Public Sector Healthcare Practice Guidehouse finalized the acquisition of Grant Thornton’s public sector healthcare consulting division, strengthening its advisory services for government health agencies and public health initiatives.
  • Q2 2024: IQVIA Launches New Patient Engagement Consulting Service IQVIA introduced a consulting service focused on patient engagement strategies, leveraging digital tools and analytics to help healthcare providers improve patient outcomes and satisfaction.
  • Q1 2025: Bain & Company Partners with Epic Systems for EHR Optimization Consulting Bain & Company announced a strategic partnership with Epic Systems to offer joint consulting services for electronic health record (EHR) optimization and digital transformation projects for hospitals.
  • Q2 2025: ZS Associates Wins Contract to Advise on US Medicaid Modernization ZS Associates secured a consulting contract to advise several US states on Medicaid modernization, focusing on digital infrastructure upgrades and process optimization.

Future Outlook

Montelukast API Market Future Outlook

The Montelukast API Market is projected to grow at a 10.8% CAGR from 2024 to 2035, driven by increasing asthma prevalence, rising healthcare expenditure, and advancements in drug formulation.

New opportunities lie in:

  • Expansion into emerging markets with tailored formulations
  • Development of combination therapies to enhance efficacy
  • Investment in digital health platforms for patient engagement

By 2035, the Montelukast API Market is expected to achieve substantial growth and innovation.

Market Segmentation

Montelukast API Market Application Outlook

  • Asthma
  • Allergic Rhinitis
  • Bronchospasm
  • Urticaria
  • Others

Report Scope

MARKET SIZE 20241.01(USD Billion)
MARKET SIZE 20251.119(USD Billion)
MARKET SIZE 20353.121(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)10.8% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Billion
Key Companies ProfiledMarket analysis in progress
Segments CoveredMarket segmentation analysis in progress
Key Market OpportunitiesEmerging regulatory frameworks may enhance growth prospects in the Montelukast API Market.
Key Market DynamicsRising demand for Montelukast API driven by regulatory shifts and increasing prevalence of respiratory disorders.
Countries CoveredNorth America, Europe, APAC, South America, MEA

Market Highlights

Author
Rahul Gotadki
Assistant Manager

He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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FAQs

What is the current valuation of the Montelukast API Market as of 2024?

The Montelukast API Market was valued at 1.01 USD Billion in 2024.

What is the projected market valuation for the Montelukast API Market in 2035?

The market is projected to reach a valuation of 3.121 USD Billion by 2035.

What is the expected CAGR for the Montelukast API Market during the forecast period 2025 - 2035?

The expected CAGR for the Montelukast API Market during 2025 - 2035 is 10.8%.

Which companies are considered key players in the Montelukast API Market?

Key players in the market include Merck & Co., Teva Pharmaceutical Industries Ltd., Mylan N.V., Sandoz International GmbH, Aurobindo Pharma, Cipla Limited, Hikma Pharmaceuticals PLC, and Zydus Cadila.

What application segment had the highest valuation in the Montelukast API Market in 2024?

In 2024, the Asthma application segment had the highest valuation at 0.404 USD Billion.

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