Montelukast Intermediate Market Size, Share & Trends Analysis Report By Type (GMP, Non-GMP), By Applications (Asthma , Bronchospasm, Allergic Rhinitis, Urticaria), By End-User (Pharmaceutical and Biotechnological Companies, Laboratories, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global montelukast intermediate market was valued at USD 7.23 million in 2023. It is estimated to reach USD 10.94 million by 2032, growing at a CAGR of 4.71% during the forecast period (2024–2032). The market for Montelukast intermediate is significantly driven by the rising prevalence of asthma around the globe. Asthma is becoming more common due to factors like air pollution, urbanization, and changing lifestyles, which raises the need for drugs like montelukast. Moreover, allergen exposure and air pollution are two environmental factors that are contributing to the rising incidence of asthma worldwide. The Montelukast intermediate market is anticipated to be driven further by the increased demand for asthma medications, such as Montelukast, as environmental conditions change.

Highlights

• Asthma dominates the application segment
• Biotechnology and pharmaceutical companies dominate the end-user segment
• Asia-Pacific is the highest shareholder in the global market

Montelukast, a drug used to treat allergic rhinitis and asthma, is synthesized from a chemical compound known as a Montelukast intermediate. Montelukast works as a leukotriene receptor antagonist by limiting the body's synthesis of leukotrienes, which are substances that induce bronchoconstriction, inflammation, and other symptoms associated with allergies and asthma. The synthesis of montelukast intermediates involves several steps and requires expertise in organic chemistry and pharmaceutical synthesis.

In the production of pharmaceuticals, Montelukast intermediates are created through several chemical reactions and procedures. The final active pharmaceutical ingredient (API), montelukast, is produced by additional chemical changes to these intermediates. These intermediates are critical to the synthesis of montelukast and are required by the pharmaceutical industry to produce the finished drug effectively and economically. The montelukast intermediates are used to stop asthma-related coughing, chest tightness, wheezing, and difficulty breathing.

Market Dynamics

Market drivers

Rising prevalence of asthma

The market for montelukast intermediate is seeing a significant surge in demand because asthma is becoming more commonplace globally. The prevalence of asthma, a long-term respiratory disease marked by inflammation and airway narrowing, has been rising steadily, which has increased the need for drugs like montelukast. This intermediate compound is essential to synthesizing Montelukast, a drug frequently prescribed to treat asthma. Adult females have a higher likelihood of having asthma compared to adult males.

Approximately 10.8% of adult females and 6.5% of adult males suffer from asthma. It is the most common chronic illness in kids. Approximately 4.5 million children under the age of 18 suffer from asthma at this time. Moreover, the market for Montelukast intermediates is driven by factors that contribute to the rise in asthma cases, including urbanization, pollution, and changing lifestyles. Such pharmaceutical intermediates are expected to remain in high demand as treatment goals shift to better symptom management and patient satisfaction.

Market restraint

Regulatory compliance

Regulatory compliance significantly limits the Montelukast intermediate market. Strict regulations for the production, testing, and distribution of pharmaceutical intermediates necessitate compliance with rigorous quality standards and documentation procedures. Failure to adhere to these guidelines may result in product approval delays, market entry obstacles, or legal consequences. Regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others establish strict rules for the production, examination, and delivery of pharmaceutical intermediates. The regulations cover Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and quality control standards.

Furthermore, companies producing Montelukast intermediates must comply with these regulations to guarantee the safety, effectiveness, and quality of their products. Compliance requires thorough documentation, quality assurance procedures, and strict adherence to manufacturing protocols. Noncompliance with regulations can result in product approval delays, market entry obstacles, or legal repercussions. Moreover, companies in the Montelukast intermediate market must focus on compliance strategies, maintain strong quality management systems, and keep up with changing regulatory environments to remain competitive and maintain a strong market presence.

Market opportunities

New products and innovation

The creation of sustained-release Montelukast formulations is one creative product idea for the intermediate Montelukast market. This may help with the existing drawbacks of conventional immediate-release formulations, like the requirement for several daily doses and variations in the body's drug levels. Manufacturers have developed novel approaches to address asthma-related issues in recent years; one such approach is the development of an inventive product portfolio. Nowadays, AstraZeneca manufactures more than 80 of the most popular asthma medications available.

Companies are also introducing new products to gain a competitive edge in the Montelukast intermediate market. For instance, Generic montelukast sodium tablets, approved by the FDA, are available from Aurobindo Pharma and Glenmark and are a viable substitute for Merck & Co.'s Singulair tablets. The rights to sell Morepen Laboratories' anti-asthmatic medication Montelukast in North American and European markets were granted in 2016.

Moreover, nanoparticle-based systems or microencapsulation are examples of advanced drug delivery technologies that could be used in the design of the sustained-release Montelukast intermediate. These technologies have the potential to release the active ingredient under controlled conditions for an extended period, leading to longer-lasting therapeutic effects and potentially improved patient adherence to treatment regimens.

Regional Analysis

Asia-pacific dominates the global market

Based on region, the global montelukast intermediate market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

Asia-Pacific is the most significant global montelukast intermediate market shareholder and is expected to expand substantially during the forecast period. This is due to rising respiratory illnesses, mainly brought on by increased air pollution and the elderly population. According to the WHO, a third of all air pollution-related deaths worldwide are reported to occur in the Asia-Pacific region. Similarly, there are significant health risks associated with exposure to toxic environments, including asthma and other respiratory conditions. The prevalence of asthma in India was estimated to be 2.05% among those over the age of 15, with an estimated 18 million asthmatics nationwide, according to a recent Indian study on the epidemiology of asthma, respiratory symptoms, and chronic bronchitis (INSEARCH), which involved 85,106 men and 84,471 women from 12 urban and 11 rural sites.

Moreover, the pharmaceutical industries in Asia-Pacific, especially in China, India, and South Korea, are growing at a rapid pace. Because of their skilled workforce and lower production costs, these nations are significant hubs for manufacturing pharmaceutical products, including intermediates of Montelukast. Japan's pharmaceutical industry, which has been a global leader in pharmaceutical revenue for the past ten years along with North America and Europe, has long served as Asia-Pacific's principal representative on the international market. Such factors propel regional market growth.

The European market is developing primarily because of the presence of large pharmaceutical companies, an increase in the prevalence of asthma and allergic rhinitis, and an advanced healthcare system in the US and Canada. Six million children under the age of eighteen suffer from asthma, which is more common in children than in adults. Asthma affects one in thirteen individuals and is more common in adult women than adult males. Therefore, the growing number of people suffering from asthma is driving up demand for montelukast and bolstering the market at large. Moreover, leading pharmaceutical companies like GSK and AstraZeneca and internationally renowned academics have contributed to the regional market's growth over the years. Apart from excellent research in digital technologies and bioinformatics, the field holds great potential for novel treatments.

Segmental Analysis

The global montelukast intermediate market is bifurcated into type, application, and end-user.

Based on type, the global market is segmented into GMP and non-GMP.

Good manufacturing practices, or GMPs, are crucial in the Montelukast intermediate market to guarantee pharmaceutical products' effectiveness, safety, and quality. Manufacturing facilities are required by GMP standards to be planned, built, and maintained in a way that facilitates correct operations and guards against contamination. Following GMP guidelines not only satisfies legal requirements but also promotes patient safety and market competitiveness by building trust in the quality of intermediates. GMP guidelines mandate strict control over the quality and traceability of raw materials used in the production of Montelukast intermediates. Materials must undergo rigorous testing, and suppliers must be qualified to ensure compliance with specifications and purity standards.

Based on application, the global montelukast intermediate market is segmented into asthma, bronchospasm, allergic rhinitis, and urticaria.

The asthma segment owns the highest market share. One of the main factors propelling demand in the Montelukast intermediate market is asthma. In its role as a leukotriene receptor antagonist, montelukast finds extensive use in the treatment of asthma. The rising demand for Montelukast intermediates is driven by the worldwide prevalence of asthma and the growing awareness of the effectiveness of Montelukast in managing asthma symptoms. For instance, asthma is becoming more common in children at a frightening rate; in 2021, for example, more than 8% of American children were diagnosed with the condition (American Academy of Allergy, Asthma & Immunology).

Moreover, the demand for effective asthma medications such as Montelukast is strong because the prevalence of asthma is on the rise, particularly in cities with higher pollution levels. global  market growth and stability are both aided by this sustained demand. The significance of Montelukast intermediates in meeting changing patient preferences and needs is further highlighted by continuing efforts to enhance asthma treatment methods.

Based on end-users, the global montelukast intermediate market is bifurcated into pharmaceutical and biotechnological companies, laboratories, and others.

The biotechnology and pharmaceutical companies dominate the global market. The Global  market is highly dependent on biotechnology and pharmaceutical companies. These companies play an important role in R&D, production, and delivery throughout the supply chain. Companies in the pharmaceutical and biotechnology sectors invest a significant amount of funds in R&D to discover novel chemical compounds for medications, like intermediates of montelukast.

Research is carried out with the goal of developing safer, more effective, and economically viable products by optimizing synthesis routes, increasing process efficiency, and improving the properties of intermediates. Moreover, these companies guarantee quality and safety throughout production by adhering to strict regulatory requirements. Some of the most important final consumers include Aurobindo Pharma, Glenmark, and Merck.

Recent Developments

• February 2023 - A renowned neurologist at the Karolinska Institute in Sweden and IntelGenx partnered to conduct a clinical trial on patients with Parkinson's disease using Montelukast VersaFilm, the company's proprietary oral thin-film formulation. The multicenter trial was expected to be headed by Parkinson's specialist Per Svenningsson, MD, PhD, and was anticipated to begin in July or September.
• November 2023 - The US health regulator has given Aurobindo Pharma's subsidiary permission to market a generic drug for the treatment of pediatric asthma. The Hyderabad-based pharmaceutical company announced in a regulatory filing that Eugia Pharma Specialities, a wholly-owned subsidiary of the company, received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension.