Montelukast API Market Outlook:
Montelukast API Market size was valued at USD 1.6 billion in 2024 and is projected to reach USD 2.7 billion by the end of 2034, rising at a CAGR of 6.6% during the forecast period (2025–2034). In 2025, the industry size of montelukast API is evaluated at USD 1.4 billion.
The montelukast API market is fueled by an increase in the global burden of chronic respiratory illness conditions, especially in allergic and asthma rhinitis. As per the Global Asthma Report by the Global Asthma Network, nearly 339.3 million people in the U.S. are affected by asthma, and high prevalence rates are seen in middle and low-income countries. Further, the CDC report also suggests that over 25.6 million people in the U.S. have asthma, accounting for 1 in 15 people. This rise in patient volume demands montelukast formulations such as generics manufactured from the API. Key intermediates, including methyl cyanoacetate and thiophenes, are used in multi-step organic processes to synthesize Montelukast API on the supply side.
The API supply chain encompasses raw chemical procurement, purification, crystallization, intermediate synthesis, and quality assurance, followed by shipment to formulation sites. According to the U.S. Bureau of Labor Statistics data, the producer price index increased by 5.2% in 2023 for pharmaceutical preparations, whereas the consumer price index rose to 2.7% in 2023 for prescription drugs, impacting the moderate pricing with regulatory pressures. This shift in cost affects the buyers and formulators globally those dependent on imports from China and India. Montelukast API was one of the high-volume goods imported in 2023. According to the Indian Department of Commerce, Montelukast API exports reached USD 92.5 million in FY 2023 to 2024, with the U.S., Germany, and South Africa being the main destinations. The increase in the trade volume with moderate CPI growth is enhancing the domestic production making montelukast API as a key node in respiratory treatment supply chain.
Montelukast API Market - Growth Drivers and Challenges
Growth Drivers
- Government spending via Medicare and Medicaid: The Medicare spending on montelukast-related respiratory drugs reached USD 850.6 million, which is a rise of 15.6% since 2020. This spending is driven by larger treatment coverage for allergic and asthma diseases in elderly populations. Medicaid allocated over USD 1.5 billion for montelukast formulations, highlighting early intervention and pediatric care in underserved communities. The rise in the expenditure impacts the federal prioritization of respiratory therapies. Further, the manufacturers are targeting public procurement channels and gaining high volume by products with CMS reimbursement structures and Medicaid formulations.
- Healthcare quality improvement and cost effectiveness: A 2022 study published by the AHRQ indicated that starting Montelukast treatment in mild and moderate asthma cases lowered hospitalization by 31.5% and saved an estimated USD 1.7 billion in Medicare expenditure over two years. The study pointed out the clinical benefit of Montelukast in outpatient respiratory treatment, particularly in chronic conditions. Such findings support the drug's contribution to enhancing patient outcomes while reducing systemic healthcare costs. Firms targeting real-world evidence and cost-effectiveness data can obtain institutional preference and formulary inclusion in value-based healthcare systems.
Historical Patient Growth & Its Impact on Montelukast API Market Dynamics
Historical Patient Growth (2010-2020) in Key Markets
|
Country |
2010 Patients (millions) |
2020 Patients(millions) |
Absolute Growth(millions) |
Growth Rate (%) |
|
U.S. |
8.9 |
14.2 |
+5.5 |
61.9% |
|
Germany |
2.4 |
3.9 |
+1.8 |
76.3% |
|
France |
2.1 |
3.3 |
+1.5 |
72.5% |
|
Spain |
1.4 |
2.6 |
+1.4 |
99.9% |
Strategic Expansion Models for Montelukast API Market
Feasibility Models for Revenue Growth
|
Region |
Feasibility Model |
Revenue Impact (%) |
Supporting Program/Agency |
|
India |
Public-private hospital partnerships under Ayushman Bharat |
+12.3% |
Ministry of Health & Family Welfare |
|
U.S. |
Medicare Part D alignment & CMS formulary inclusion |
+8.6% |
Centers for Medicare & Medicaid Services (CMS) |
|
Germany |
Long-term API tenders with statutory health insurers |
+9.7% |
GKV-Spitzenverband |
|
China |
Centralized NDPA bulk tendering |
+10.9% |
National Healthcare Security Administration (NHSA) |
|
Japan |
Volume-based pricing via NHI procurement |
+6.9% |
Ministry of Health, Labour and Welfare (MHLW) |
|
UK |
Direct NHS procurement and generic substitution schemes |
+8.1% |
NHS England |
Challenge
- Limited Medicare coverage in the U.S.: The treatment cost for montelukast in the U.S. is high and has strict Medicare coverage, minimizing the patients' access to 64.3% with asthma in 2022. Many state Medicaid programs also focus on low-cost corticosteroids, resulting in montelukast being classified in preferred drug tiers. Further, as per the Centers for Medicare & Medicaid Services report, the expenditure by patients averaged USD 74.5 per patient annually, not promoting prescription renewals and adherence. These financial challenges minimize the surge in low-income patients facing montelukast, asthma, and allergic rhinitis treatment. This impacts the public health objective on the quality of care in respiratory care equity.
Montelukast API Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2034 |
|
CAGR |
6.6% |
|
Base Year Market Size (2024) |
USD 1.6 billion |
|
Forecast Year Market Size (2034) |
USD 2.7 billion |
|
Regional Scope |
|
Montelukast API Market Segmentation:
Manufacturing Process Segment Analysis
In the manufacturing process segment, the contract manufacturing holds the maximum share in the segment and is expected to have a market share of 66.5% by 2034. The contract manufacturing is fueled by the requirement for cost-effective solution, and scalable API synthesis. U.S. FDA and EMA-compliant facilities are the driving force behind API outsourcing to CDMOs in China and India. As per the USITC, nearly 40.6% of API in the U.S. are imported from India with montelukast during bulk shipment. Further, the Department of Pharmaceuticals in India aids API manufacturing via the Production Linked Incentive (PLI) scheme, broadening the production capacity.
Application Segment Analysis
Under the application segment, the asthma sub-segment dominates the segment and is poised to hold the maximum share of 63.4% by 2035. Asthma remains the dominant application segment and is driven by a rise in global prevalence of chronic illness, mainly in urbanized and densely populated countries. The CDC report in 2023 states that over 25.4 million people in the U.S. are affected form asthma, while a 2022 Global Asthma Report has recorded 339.4 million cases globally. The montelukast is widely used for asthma management and prophylaxis in patients for the long term. Further, the U.S. FDA has provided approval for numerous montelukast-related generics under ANDAs, underpinning sustained clinical support.
Our in-depth analysis of the global montelukast API market includes the following segments:
|
Segment |
Subsegment |
|
Application |
|
|
Manufacturing Process |
|
|
End user |
|
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Montelukast API Market - Regional Analysis
Asia Pacific Market Insights
The APAC region is dominating the montelukast API market and is projected to hold the market share of 32.9% at a CAGR of 7.2%. The Asia Pacific market is driven by the robust generic manufacturing bases, rising challenges in respiratory diseases, and government healthcare funding. Countries such as India, Japan, and China are the largest shareholders in the region, with India leading the market as the top supplier of montelukast API. According to WHO-SEARO, montelukast is frequently administered as a first-line therapy for the chronic respiratory conditions that affect approximately 130.5 million people in South-East Asia. Further, the regional trends such as API trade consolidation, increase in API production, and adoption of latest technologies to automate the batch processing systems will drive the market demand by 2034.
India holds the maximum share in the APAC region for the montelukast API market, poised to have a market share of 14.9% by 2034. India is the biggest producer and an emerging consumer of montelukast API. According to the Department of Pharmaceuticals data, government expenditure increased by 18.6% from 2015 to 2023, reaching USD 2.1 billion yearly. The National Health Portal indicates more than 2.8 million patients were prescribed montelukast in 2023. Government schemes such as the Ayushman Bharat program and bulk procurement policy persist in facilitating drug availability and reducing API prices.
Government Investment and Funding for API (2021–2025)
|
Country |
Policy/Initiative Name |
Investment / Funding (Local Currency) |
Launch Year |
|
Australia |
Pharmaceutical Benefits Scheme (PBS) Expansion for Asthma Drugs |
AUD 425.5 million (Montelukast included in Tier 1) |
2021 |
|
Japan |
AMED Respiratory Drug Development & Supply Chain Initiative |
¥66.3 billion to support domestic APIs and innovation |
2022 |
|
South Korea |
National Strategic Plan for Respiratory Disease Management |
₩1.7 trillion (including API subsidy programs) |
2023 |
|
Malaysia |
National Health Blueprint – Generic Drug Security |
RM 800.9 million for essential API self-sufficiency |
2024 |
North America Market Insights
North America is the fastest-growing region in the montelukast API market, and is set to have a market share of 31.6% with a CAGR of 5.7% by 2034. The region is driven by the high prevalence of chronic disease, strong reimbursement systems, and increase generic drug production. As per the CDC report, nearly 25.5 million people in the U.S. are affected by asthma, and Canada recorded over 4.1 million cases in 2023. The Medicaid program in 2024 allocated over USD 1.5 billion for montelukast treatments, while Medicare spending increased 15.6% which reaching USD 810.5 million in 2024. The North America market is expected to be expanding with the rising cases of asthma and other respiratory conditions among the people in the U.S., marking a demand for montelukast API through 2034.
The U.S. montelukast API market is fueled by the increasing asthma and allergic rhinitis cases. More than 25.5 million asthma patients were registered in the U.S. as of 2023. This demand has resulted in increasing federal and state-level backing for therapies associated with Montelukast. The Centers for Medicare & Medicaid Services reported that montelukast reimbursements via Medicaid reached USD 1.9 billion, reflecting greater access through biosimilar pricing incentives and formulary change. The NIH and AHRQ combined together to research on respiratory disease was funded at more than USD 5.5 billion, or 9.7% of total healthcare R&D expenditure in 2023. Meanwhile, Medicare reported a 15.3% increase in Montelukast spending between 2020 and 2024, reaching USD 810.5 million, reflecting an aging population's rising respiratory care demand.
Europe Market Insights
The Europe market in the montelukast API market is expanding rapidly and is expected to have a market share of 26.9% with a CAGR of 5.1% by 2034. The market is driven by an increase in respiratory disease, an aging population, and expanded generic drug adoption. As per the EMA report, nearly 24 montelukast products were approved from 2020 to 2024. Further, the European Health Data Space report highlights that there is a regional rise in allergic rhinitis and pediatric asthma cases, mainly in the South and West regions of Europe. Montelukast's inclusion in 95% of national formularies under reimbursable categories as of 2023 increased the penetration of generic medications. Countries such as France, the UK, and Germany are the major consumers getting benefits from centralized drug pricing and formulary purchase by public health systems.
Germany holds the largest share in the montelukast API market and is expected to have a market share of 9.7% by 2034. Germany is Europe's biggest montelukast API market. According to the Federal Ministry of Health (BMG) and BÄK, the expenditure on Montelukast amounted to €4.5 billion in 2024, and this represents a 12.5% increase in demand since 2021. Germany's determination to ensure in-country drug supply resilience, under the Pharmaceutical Strategy for Germany, ensures active ingredient stocks and local formulation. Reimbursement of montelukast under statutory health insurance schemes provides universal access.
Government Investment and Policy Programs (2021–2025)
|
Country |
Policy |
Investment |
Launch Year |
|
UK |
NHS Accelerated Access Collaborative (AAC) for Asthma Drugs |
£340.4 million committed for respiratory innovations |
2021 |
|
France |
National Strategy for Health 2022–2025 |
€1.8 billion for chronic illness & API access |
2022 |
|
Italy |
National Recovery and Resilience Plan (PNRR) – Healthcare |
€2.2 billion allocated for drug supply chain & domestic APIs |
2023 |
|
Spain |
Strategic Plan for Pharmaceutical Industry |
€1.8 billion investment to boost generic/API manufacturing |
2024 |
Key Montelukast API Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The montelukast API market is highly competitive with the leading players connected via manufacturing hubs and government initiatives. Major players such as Dr. Reddy’s Sun Pharma, and Aurobindo dominate the market with regulatory certifications. and cost efficiency. In U.S. and Europe, companies including Teva, Viatris, and Apotex maintain vertically integrated operations and consistent API quality. China companies are using semi-synthetic methods to increase production, whereas Korea and Japan producers concentrate on high-purity APIs. Backward integration, API-export partnerships, and localization are the strategic trends followed by companies to minimize the supply chain risk.
The top 20 cohort of such key players include:
|
Company Name |
Country of Origin |
Industry Focus |
Est. Global Market Share (%) |
|
Sun Pharmaceutical Industries Ltd. |
India |
Largest producer with extensive FDA/EMA-compliant sites and global distribution. |
11.5% |
|
Teva Pharmaceutical Industries Ltd. |
Israel |
Global generics giant with in-house Montelukast API supply chain. |
9.7% |
|
Cipla Ltd. |
India |
Exporter to U.S./EU, strong domestic formulation demand. |
8.6% |
|
Aurobindo Pharma Ltd. |
India |
FDA/EMA-approved API plants, key exporter to U.S. generics market. |
8.2% |
|
Dr. Reddy’s Laboratories |
India |
Regulated market focus, backward-integrated facilities. |
7.5% |
|
Hetero Labs Ltd. |
India |
Bulk merchant API supplier to large generic formulators. |
xx% |
|
Mylan N.V. (Viatris Inc.) |
USA |
Vertically integrated API/formulation portfolio for Montelukast. |
xx% |
|
Glenmark Pharmaceuticals |
India |
Montelukast API for own and B2B use, EU-focused exports. |
xx% |
|
Torrent Pharmaceuticals Ltd. |
India |
API manufacturing for Europe and domestic branded formulations. |
xx% |
|
Zhejiang Huahai Pharmaceutical Co. |
China |
Large-scale API export to APAC, U.S., and Latin America. |
xx% |
|
Jubilant Ingrevia Ltd. |
India |
Specializes in intermediates and API supply with backward integration. |
xx% |
|
Shandong Binnong Technology Co., Ltd. |
China |
Growing capacity for respiratory APIs with competitive pricing. |
xx% |
|
Apotex Pharmachem Inc. |
Canada |
Domestic supplier for U.S./Canadian formulations; FDA-compliant. |
xx% |
|
Hanmi Pharm Co., Ltd. |
South Korea |
Regional API/formulation supplier with R&D-driven focus. |
xx% |
|
Kyowa Hakko Kirin Co., Ltd. |
Japan |
High-purity APIs for domestic and global formulations. |
xx% |
|
Pharmachem Laboratories |
USA |
API supply for U.S. CMOs and branded formulations. |
xx% |
|
Towa Pharmaceutical Co., Ltd. |
Japan |
Formulation and internal API use for domestic generics. |
xx% |
|
Biocon Ltd. |
India |
R&D-focused player with U.S. supply chain linkages. |
xx% |
|
Asahi Kasei Pharma Corp. |
Japan |
Niche API manufacturer with strong quality compliance. |
xx% |
|
CCM Pharma (Chemical Co. of Malaysia) |
Malaysia |
Southeast Asia-focused supplier, expanding export base. |
xx% |
Here are some leading players in the montelukast API market:
Recent Developments
- In April 2024, Dr. Reddy’s Laboratories introduced FDA-approved Montelukast Sodium Chewable Tablets USP. This launch has upsurged to 6.9% rise in the company's respiratory segment revenue.
- In February 2024, Aurobindo Pharma introduced the commercial expansion of its Montelukast film-coated tablets in 10 European countries. This launch made a rise of 11.6% in API export volumes by mid-2024.
- Report ID: 3995
- Published Date: Jul 09, 2025
- Report Format: PDF, PPT
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