– The market for Montelukast Active Pharmaceutical Ingredient (API), a crucial component in medications for asthma and allergic conditions, is experiencing robust growth, particularly in India. Driven by the increasing prevalence of respiratory ailments and strategic manufacturing advancements, the Montelukast API sector is set for significant expansion, though it continues to navigate regulatory landscapes and competitive pressures.

Indian Manufacturers Poised for Growth

India is emerging as a pivotal hub in the global Montelukast API market. A recent analysis projects the Indian Montelukast API market to grow from USD 63.12 million in 2024 to an estimated USD 210 million by 2035. This substantial growth is fueled by the rising incidence of asthma and allergic rhinitis across the country, coupled with a push for more localized production and favorable regulatory frameworks.

Indian pharmaceutical companies are actively investing in enhancing their manufacturing capabilities and adopting Good Manufacturing Practices (GMP) to meet escalating domestic and international demand. Companies like Intas Pharmaceuticals, Jubilant Life Sciences, Dr. Reddy's Laboratories, Cipla, Torrent Pharmaceuticals, and Glenmark Pharmaceuticals are key players, with some having recently expanded facilities or forged strategic partnerships to boost production capacity. Morepen Laboratories, an Indian company, is noted as a global sales leader in Montelukast, holding a significant market share.

Global Market Dynamics and Drivers

Globally, the Montelukast sodium market, which encompasses the API, is also seeing strong growth, projected to reach USD 6.12 billion by 2029. Key drivers include:

• Increasing Prevalence of Respiratory Disorders: Asthma and allergic rhinitis continue to affect millions worldwide, creating a steady demand for effective symptom management.
• Patent Expirations and Generic Competition: The availability of generic versions of Montelukast has made the medication more accessible and affordable, expanding its market reach.
• Focus on Preventative Care: A growing emphasis on proactive management of respiratory conditions, including early interventions with medications like Montelukast, is further stimulating demand.
• Advancements in Manufacturing and RD: Continuous efforts to improve synthesis efficiency, cost-effectiveness, and purity of Montelukast API are enhancing market competitiveness.

Regulatory Scrutiny and Safety Updates

While the market expands, regulatory bodies globally continue to monitor Montelukast closely. Health