Montelukast Intermediate Market

• February 2023: A collaboration between a renowned neurologist at the Karolinska Institute in Sweden and IntelGenx led to the initiation of a clinical trial focusing on patients with Parkinson's disease. The trial utilized Montelukast VersaFilm, a proprietary oral thin-film formulation developed by IntelGenx. The multicenter trial, set to be spearheaded by Parkinson's specialist Per Svenningsson, MD, PhD, was scheduled to commence either in July or September.

• November 2023: Aurobindo Pharma's subsidiary received approval from the US health regulator to market a generic drug targeting pediatric asthma. The Hyderabad-based pharmaceutical company disclosed in a regulatory filing that Eugia Pharma Specialities, its wholly-owned subsidiary, obtained final approval from the US Food & Drug Administration (USFDA) for the manufacture and marketing of Budesonide Inhalation Suspension.

In this report, the Montelukast Intermediate Market has been segmented by Type,Formulation Type, Application,Distribution Channel and Geography.

Montelukast Intermediate Market, Segmentation by Type

The Montelukast Intermediate Market has been segmented by Type into GMP and Non-GMP.

GMP (Good Manufacturing Practice) grade Montelukast intermediates are widely preferred in pharmaceutical production due to their high quality, regulatory compliance, and safety standards. These intermediates are essential for manufacturing APIs that meet global health authority approvals. With over 70% of Montelukast intermediate demand coming from GMP-certified facilities, this segment dominates the market owing to its role in ensuring product consistency and patient safety.

Non-GMP Montelukast intermediates are primarily used in research, pilot-scale production, and non-pharmaceutical applications. Although they account for around 30% of the market, their use is often limited to internal R&D and pre-clinical studies. Cost-effectiveness and faster availability make non-GMP intermediates a viable choice for early-stage development, but they are not suitable for commercial drug manufacturing due to the lack of formal regulatory approval.

Montelukast Intermediate Market, Segmentation by Formulation Type

The Montelukast Intermediate Market has been segmented by Formulation Type into Tablets, Granules, and Oral Solution.

Montelukast tablets are the most common formulation, accounting for nearly 60% of the market due to their ease of administration, stability, and longer shelf life. They are widely prescribed for asthma, allergic rhinitis, and other respiratory conditions. The convenience of once-daily dosing and strong patient compliance makes tablets the preferred choice for both adults and children.

Montelukast granules represent around 25% of the market and are primarily targeted at pediatric patients or individuals with difficulty swallowing tablets. These granules can be easily mixed with food or liquids, improving treatment adherence. Their flexible dosing options make them a valuable alternative for specific patient groups, especially in the pediatric segment.

The oral solution formulation of Montelukast holds approximately 15% of the market share and is particularly suitable for young children and elderly patients. It offers precise dosing and easy administration, especially in cases where swallowing solid dosage forms is challenging. The segment is witnessing gradual growth due to its role in improving treatment accessibility for patients with special needs.

Pharmacies remain the dominant distribution channel for Montelukast intermediates-based drugs, contributing to nearly 50% of the overall sales. Their accessibility, immediate product availability, and trusted pharmacist guidance make them a preferred choice for patients. The segment benefits from high prescription refills and repeat purchases, especially for chronic conditions like asthma and allergic rhinitis.

Online pharmacies hold around 30% of the market share, driven by the growing preference for home delivery and convenience in ordering medications. The availability of competitive pricing, subscription-based services, and doorstep delivery has fueled the popularity of this channel. Digital health adoption and e-prescription integration are further accelerating growth in this segment.

Hospitals account for approximately 20% of the distribution, primarily through in-house pharmacies catering to admitted patients and outpatient prescriptions. This channel is crucial for acute cases and immediate treatment needs, ensuring direct access to medications after diagnosis. The segment is particularly strong in regions with advanced healthcare infrastructure and high patient admission rates.

Montelukast Intermediate Market, Segmentation by Geography

In this report, the Montelukast Intermediate Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Montelukast Intermediate Market Share (%), by Geographical Region

North America holds the largest share of the Montelukast intermediate market, accounting for nearly 40% of the global revenue. Strong pharmaceutical manufacturing capabilities, high asthma and allergy prevalence, and advanced healthcare infrastructure drive the region’s dominance. Regulatory support from agencies like the FDA ensures quality compliance, further boosting market growth.

Europe represents about 25% of the market, supported by well-established pharmaceutical industries and increasing investments in respiratory disease treatment. Countries such as Germany, France, and the UK contribute significantly due to high adoption of GMP-certified intermediates. The region also benefits from growing awareness of allergy management and advanced R&D facilities.

Asia Pacific accounts for roughly 20% of the global market, with rapid growth driven by rising asthma and allergic rhinitis cases, particularly in China and India. Expanding pharmaceutical manufacturing, cost-effective production, and government healthcare initiatives are fueling demand. The region is also becoming a preferred outsourcing hub for intermediate production.

Middle East and Africa collectively hold close to 8% of the market, with increasing investments in healthcare infrastructure and growing demand for respiratory disease treatments. The UAE, Saudi Arabia, and South Africa are leading contributors due to improved drug availability and rising awareness about preventive healthcare.

Latin America captures about 7% of the market, led by Brazil, Mexico, and Argentina. The region is witnessing steady growth in pharmaceutical manufacturing and an increasing prevalence of respiratory disorders. Strategic collaborations with global pharma companies are further enhancing access to Montelukast-based therapies.