Montelukast API Market Size & Share, by Customer Type (Generic Drug Manufacturers, Captive Use by Innovator Companies); Distribution Channel; Application; Purity Level; Formulation Type; End user - SWOT Analysis, Competitive Strategic Insights, Regional Trends 2026-2035

Montelukast API Market - Regional Analysis

APAC Market Insights

Asia Pacific market is projected to garner the highest share of 48.2% by the end of 2035. The market’s upliftment in the region is highly attributed to the strong generic manufacturing bases, a rise in challenges in respiratory diseases, and the presence of government healthcare funding. Besides, countries including China, Japan, and India are considered the largest shareholders in the overall region, with India deliberately leading the market as one of the topmost montelukast API suppliers. According to an article published by the World Health Organization in July 2025, noncommunicable diseases account for 55% of all deaths, with half prematurely occurring between 30 and 69 years of age, thus denoting a huge growth opportunity for the market.

The market in India is growing significantly, owing to the aspect of being the largest producer. Along with an emerging consumer of montelukast API. As per an article published by the PIB in December 2024, the pharmaceutical market in the country is valued at USD 50 billion, with the regional consumption accounting for USD 23.5 billion and export valuation of USD 26.5 billion. Besides, botanical products and pharmaceutical medications account for Rs. 4,56,246 crores as of 2023, while 9.2 lakhs people are readily engaged in these sectors, thereby positively impacting the overall market in the country.

China is also developing due to the presence of the National Medical Products Administration (NMPA) overseeing a huge domestic market, government healthcare reforms, expansion in insurance coverage, and an increase in accessibility to chronic disease treatments. As stated in the December 2023 NLM article, noncommunicable diseases account for 88.5% of the total country’s deaths and readily cater to 84.9% of the disease burden. However, to keep a check on this, the country’s present healthcare system has effectively emphasized specialist and hospital-based treatment, which is suitable for boosting the market’s development.

Noncommunicable Diseases and Treatment Prevalence in Asia (2023)

Source: The Lancet Regional Health - Southeast Asia

Europe Market Insights

Europe market is projected to emerge as the fastest-growing region during the forecast duration. The market’s growth in the region is highly driven by a surge in respiratory disease, an aging population, and expanded generic drug adoption. In addition, the Europe Health Data Space report highlighted that there is a regional rise in allergic rhinitis and pediatric asthma cases, particularly in the South and West parts of the region. Besides, countries such as Germany, the UK, and France are majorly contributing since these are the major consumers that deliberately receive advantages from formulary purchase and centralized drug pricing by public health systems, thus suitable for the market’s development.

The market in Germany is gaining increasing traction, owing to its determination to ensure in-country drug supply resilience under the domestic Pharmaceutical Strategy. In addition, the country also ensures active ingredient stocks and local formulation, along with reimbursement of montelukast under statutory health insurance schemes, which provides universal accessibility. According to an article published by NLM in May 2023, LLC cell migration has been evaluated by fixing migrated cell on lower surface by utilizing 4% paraformaldehyde solution and Leica, which is a light microscope launched by Wetzlar in the country. The evaluation was executed within 30 minutes and constituted a 0.5% crystal violet stain.

The montelukast API market in France is also developing due to the existence of the French National Authority for Health (HAS), which readily determines the reimbursement status for drugs. Additionally, the country has a huge prevalence of allergic rhinitis, while the Ministry of Solidarity and Health has focused on expenditure for long-lasting illnesses, including critical asthma, and deliberately ensured ongoing funding for suitable treatment options. As stated in the April 2024 World Allergy Organization Journal, 80% of patients suffer from rhinitis and 39% from asthma. Besides, over half of the patient population, which is 70.4% are affected with allergic rhinitis, thereby denoting a huge growth opportunity for the market in the country.

North America Market Insights

North America in the montelukast API market is expected to account for steady growth by the end of the projected timeline. The market’s upliftment in the region is highly fueled by the high prevalence of chronic disease, strong reimbursement systems, and increased generic drug production. According to an article published by the AAFA Organization in March 2025, 28 million people in the region, which is almost 1 in 12, effectively suffer from asthma. In addition, 47% of children in the U.S. with this disease are successfully enrolled in Medicaid, while adults enrolled in this reimbursement policy are twice as likely to suffer from the condition in comparison to adults with private insurance.

U.S. market is gaining increased exposure, owing to a surge in asthma and allergic rhinitis cases. This has readily led to an increase in federal and state-level backing for therapies associated with montelukast. As per the September 2023 CDC report, poorly administered asthma results in almost 2 million emergency department visits every year in the country. In addition, the condition accounts for USD 81.9 billion in annual economic expenses, with healthcare expenditure making up to USD 50.3 billion approximately, thus suitable for bolstering the overall market.

The montelukast API market in Canada is also growing, owing to its modification by the presence of a public healthcare system, which is readily focused on universal accessibility and cost containment. Besides, Health Canada’s administrative alignment with global mandates for high-quality API imports is also positively impacting the overall market in the country. For instance, in 2024, GSK Canada allocated a generous funding of USD 100,000 to effectively support Asthma Canada Awareness and Educational Initiatives on critical asthma, shingles, RSV, and CRSwNP. Additionally, the organization also provided USD 17,500 to initiate a collaboration on the Severe Asthma Patient Help Seeking Campaign, which accounted a 10% of the overall revenue.

Guideline-based Asthma Care Coverage in America

Source: CDC