Global Montelukast API Market Size By Formulation Type, By Therapeutic Application, By End-User, By Geographic Scope And Forecast
Report ID: 388231|No. of Pages: 202
Montelukast API Market Size And Forecast
Montelukast API Market size was valued at USD 4.08 Billion in 2023 and is projected to reach USD 7.38 Billion by 2030, growing at a CAGR of 12.6% during the forecast period 2024-2030.
Global Montelukast API Market Drivers
The market drivers for the Montelukast API Market can be influenced by various factors. These may include:
- Growing Prevalence of Allergies and Asthma: Around the world, allergies and asthma continue to be major public health issues. The demand for montelukast’s API is fueled by the medication’s frequent prescription for the treatment of allergic rhinitis and asthma.
- Increasing Awareness and Diagnosis: A combination of better diagnostic methods and increased knowledge about respiratory diseases such as allergies and asthma contributes to a greater diagnosis rate. The market for its API is driven by this tendency, which increases demand for drugs like montelukast.
- Growing Healthcare Spending: More money spent on healthcare, especially in developing nations, enables people to have easier access to drugs like montelukast. The need for montelukast API is projected to rise as healthcare facilities get better and more individuals have access to healthcare.
- Patent Expirations: Generic versions of branded montelukast medications can enter the market once their patents expire. Generally, generic medications are marketed under multiple brand names but share the same active ingredient (API), which encourages competition and may result in lower prices.
- Preference for Oral Dosage Forms: Patients prefer oral dosage forms, such as chewable pills and tablets, because they are more convenient and easy to administer. Montelukast is frequently available in these forms. This inclination helps to maintain the API’s demand.
- R&D and Innovation: Continued attempts to improve drug formulations, increase efficacy, decrease adverse effects, and investigate novel therapeutic applications for montelukast may also propel the market for its active pharmaceutical ingredient.
Global Montelukast API Market Restraints
Several factors can act as restraints or challenges for the Montelukast API Market. These may include:
- Patent Expiration and Generic Competition: When the branded Montelukast medications’ patent protection ends, generic alternatives may enter the market. API manufacturers may see price erosion and decreased profitability as a result of this increased competition.
- Regulatory Obstacles: API producers may face difficulties adhering to the strict regulations governing pharmaceutical manufacturing, such as Good Manufacturing Practices (GMP) and other quality standards. It could be necessary to make large infrastructure and resource investments in order to meet these standards.
- Price Fluctuations: The cost of raw materials, currency exchange rates, and variations in market demand can all have an impact on the price of Montelukast API. Price volatility can affect makers of APIs’ profitability and breed doubt in the marketplace.
- Market Saturation: When many API manufacturers produce the medication, the Montelukast market may become saturated, resulting in fierce rivalry and pricing pressure. It may be challenging for new competitors to gain traction in the market as a result of this saturation.
- The emergence of Alternatives: The need for Montelukast API may decline if substitute therapies for respiratory ailments including asthma and allergic rhinitis are developed. Pharmaceutical companies might spend money on developing new medications that have lower side effects or greater efficacy, which could push Montelukast out of the market.
- Safety Issues and Side Consequences: Regulatory bodies or clinical studies that draw attention to safety issues or unfavorable consequences related to the use of montelukast may have a detrimental influence on the market for the API. Prescription practices and patient preferences may be influenced by how the general public views the drug’s safety profile.
Global Montelukast API Market Segmentation Analysis
The Global Montelukast API Market is Segmented on the basis of Formulation Type, Therapeutic Application, End-user, And Geography.
Montelukast API Market, By Formulation Type
- Tablets: The formulation of tablet forms is produced using Montelukast API.
- Granules: API in granule form is delivered to manufacturers of oral granules or sachets.
- Chewable Tablets: A specially prepared Montelukast API is used in the manufacturing of chewable tablets.
Montelukast API Market, By Therapeutic Application
- Asthma: The main application for montelukast API is asthma treatment.
- Allergic Rhinitis: API is used in formulations for the treatment of allergic rhinitis.
- Exercise-Induced Bronchoconstriction: Exercise-supported API formulations aimed for addressing bronchoconstriction caused by exercise.
Montelukast API Market, By End-User
- Pharmaceutical firms: Pharmaceutical firms receive formulation and production supplies of montelukast API.
- Compounding Pharmacies: API is provided to pharmacies so they can prepare medications according to customer specifications.
- Contract Manufacturing Organizations (CMOs): API is provided to contract manufacturing organizations (CMOs) in exchange for their services.
Montelukast API Market, By Geography
- North America: Market conditions and demand in the United States, Canada, and Mexico.
- Europe: Analysis of the Montelukast API Market in European countries.
- Asia-Pacific: Focusing on countries like China, India, Japan, South Korea, and others.
- Middle East and Africa: Examining market dynamics in the Middle East and African regions.
- Latin America: Covering market trends and developments in countries across Latin America.
Key Players
The major players in the Montelukast API Market are:
- Aurobindo Pharma Ltd.
- Teva Pharmaceutical Industries Ltd.
- Dr. Reddy’s Laboratories Ltd.
- Mylan N.V.
- Lupin Limited
- Cipla Limited
- Hetero Drugs Limited
- Zhejiang Huahai Pharmaceutical Co., Ltd.
- Jubilant Life Sciences Ltd.
- Sun Pharmaceutical Industries Ltd.
Report Scope
REPORT ATTRIBUTES | DETAILS |
---|---|
STUDY PERIOD | 2020-2030 |
BASE YEAR | 2023 |
FORECAST PERIOD | 2024-2030 |
HISTORICAL PERIOD | 2020-2022 |
UNIT | Value (USD Billion) |
KEY COMPANIES PROFILED | Aurobindo Pharma Ltd., Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd., Mylan N.V., Lupin Limited, Cipla Limited, Hetero Drugs Limited, Zhejiang Huahai Pharmaceutical Co., Ltd. |
SEGMENTS COVERED | By Formulation Type, By Therapeutic Application, By End-user, And By Geography. |
CUSTOMIZATION SCOPE | Free report customization (equivalent to up to 4 analyst working days) with purchase. Addition or alteration to country, regional & segment scope |
Top Trending Reports:
Global Curing Agent For Epoxy Resin Market Size And Forecast
Global Phenol & Acetone Market Size And Forecast
Research Methodology of Verified Market Research:
To know more about the Research Methodology and other aspects of the research study, kindly get in touch with our Sales Team at Verified Market Research.
Reasons to Purchase this Report
• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
• Provision of market value (USD Billion) data for each segment and sub-segment
• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled
• Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players
• The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
• Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis
• Provides insight into the market through Value Chain
• Market dynamics scenario, along with growth opportunities of the market in the years to come
• 6-month post-sales analyst support
Customization of the Report
• In case of any Queries or Customization Requirements please connect with our sales team, who will ensure that your requirements are met.
Frequently Asked Questions
1. Introduction
• Market Definition
• Market Segmentation
• Research Methodology
2. Executive Summary
• Key Findings
• Market Overview
• Market Highlights
3. Market Overview
• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter’s Five Forces Analysis
4. Montelukast API Market, By Formulation Type
• Tablets
• Granules
• Chewable Tablets
5. Montelukast API Market, By Therapeutic Application
• Asthma
• Allergic Rhinitis
• Exercise-Induced Bronchoconstriction
6. Montelukast API Market, By End-user
• Pharmaceutical firms
• Compounding Pharmacies
• Contract Manufacturing Organizations (CMOs)
7. Regional Analysis
• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE
8. Market Dynamics
• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market
9. Competitive Landscape
• Key Players
• Market Share Analysis
10. Company Profiles
• Aurobindo Pharma Ltd.
• Teva Pharmaceutical Industries Ltd.
• Dr. Reddy’s Laboratories Ltd.
• Mylan N.V.
• Lupin Limited
• Cipla Limited
• Hetero Drugs Limited
• Zhejiang Huahai Pharmaceutical Co., Ltd.
• Jubilant Life Sciences Ltd.
• Sun Pharmaceutical Industries Ltd.
11. Market Outlook and Opportunities
• Emerging Technologies
• Future Market Trends
• Investment Opportunities
12. Appendix
• List of Abbreviations
• Sources and References
Report Research Methodology

Verified Market Research uses the latest researching tools to offer accurate data insights. Our experts deliver the best research reports that have revenue generating recommendations. Analysts carry out extensive research using both top-down and bottom up methods. This helps in exploring the market from different dimensions.
This additionally supports the market researchers in segmenting different segments of the market for analysing them individually.
We appoint data triangulation strategies to explore different areas of the market. This way, we ensure that all our clients get reliable insights associated with the market. Different elements of research methodology appointed by our experts include:
Exploratory data mining
Market is filled with data. All the data is collected in raw format that undergoes a strict filtering system to ensure that only the required data is left behind. The leftover data is properly validated and its authenticity (of source) is checked before using it further. We also collect and mix the data from our previous market research reports.
All the previous reports are stored in our large in-house data repository. Also, the experts gather reliable information from the paid databases.

For understanding the entire market landscape, we need to get details about the past and ongoing trends also. To achieve this, we collect data from different members of the market (distributors and suppliers) along with government websites.
Last piece of the ‘market research’ puzzle is done by going through the data collected from questionnaires, journals and surveys. VMR analysts also give emphasis to different industry dynamics such as market drivers, restraints and monetary trends. As a result, the final set of collected data is a combination of different forms of raw statistics. All of this data is carved into usable information by putting it through authentication procedures and by using best in-class cross-validation techniques.
Data Collection Matrix
Perspective | Primary Research | Secondary Research |
---|---|---|
Supplier side |
|
|
Demand side |
|
|
Econometrics and data visualization model

Our analysts offer market evaluations and forecasts using the industry-first simulation models. They utilize the BI-enabled dashboard to deliver real-time market statistics. With the help of embedded analytics, the clients can get details associated with brand analysis. They can also use the online reporting software to understand the different key performance indicators.
All the research models are customized to the prerequisites shared by the global clients.
The collected data includes market dynamics, technology landscape, application development and pricing trends. All of this is fed to the research model which then churns out the relevant data for market study.
Our market research experts offer both short-term (econometric models) and long-term analysis (technology market model) of the market in the same report. This way, the clients can achieve all their goals along with jumping on the emerging opportunities. Technological advancements, new product launches and money flow of the market is compared in different cases to showcase their impacts over the forecasted period.
Analysts use correlation, regression and time series analysis to deliver reliable business insights. Our experienced team of professionals diffuse the technology landscape, regulatory frameworks, economic outlook and business principles to share the details of external factors on the market under investigation.
Different demographics are analyzed individually to give appropriate details about the market. After this, all the region-wise data is joined together to serve the clients with glo-cal perspective. We ensure that all the data is accurate and all the actionable recommendations can be achieved in record time. We work with our clients in every step of the work, from exploring the market to implementing business plans. We largely focus on the following parameters for forecasting about the market under lens:
- Market drivers and restraints, along with their current and expected impact
- Raw material scenario and supply v/s price trends
- Regulatory scenario and expected developments
- Current capacity and expected capacity additions up to 2027
We assign different weights to the above parameters. This way, we are empowered to quantify their impact on the market’s momentum. Further, it helps us in delivering the evidence related to market growth rates.
Primary validation
The last step of the report making revolves around forecasting of the market. Exhaustive interviews of the industry experts and decision makers of the esteemed organizations are taken to validate the findings of our experts.
The assumptions that are made to obtain the statistics and data elements are cross-checked by interviewing managers over F2F discussions as well as over phone calls.

Different members of the market’s value chain such as suppliers, distributors, vendors and end consumers are also approached to deliver an unbiased market picture. All the interviews are conducted across the globe. There is no language barrier due to our experienced and multi-lingual team of professionals. Interviews have the capability to offer critical insights about the market. Current business scenarios and future market expectations escalate the quality of our five-star rated market research reports. Our highly trained team use the primary research with Key Industry Participants (KIPs) for validating the market forecasts:
- Established market players
- Raw data suppliers
- Network participants such as distributors
- End consumers
The aims of doing primary research are:
- Verifying the collected data in terms of accuracy and reliability.
- To understand the ongoing market trends and to foresee the future market growth patterns.
Industry Analysis Matrix
Qualitative analysis | Quantitative analysis |
---|---|
|
|