Glenmark banks on specialty, innovative drugs for next leg of growth


Glenmark to spend 11% of its revenue on research and development annually over the next few years

Glenmark Pharmaceuticals Ltd is relying on its specialty and innovative drugs pipeline, focused mainly on three therapeutic areas—oncology, dermatology and respiratory -- to play out in the coming years and expects to launch specialty products in the US by 2020 and innovative drugs by 2025.

To counter the challenging pricing environment in the US, the biggest market for Indian pharmaceutical companies, top generic drug makers in the country have started making significant investments in developing a pipeline of complex generics and specialty products, which are generally high-value and limited-competition drugs.

Unveiling a roadmap for growth over the next 10 years, Glenn Saldanha, chairman and managing director of Glenmark said the company will focus on enhancing presence in existing markets, increasing portfolio of complex generics, launching specialty and innovative products, pushing the pipeline of novel drugs development to advanced stages and expanding manufacturing capabilities.

Saldanha said the company will spend 11% of its revenue on research and development annually over the next few years.

Glenmark, which is among the few early movers in India to invest in research and development of novel drugs, currently has 13 new drugs under development at various stages. By 2025, the company expects its specialty and innovative drugs portfolio to contribute 30% to the total sales.

As the company will start reaping benefits of high-value drugs portfolio, its profit margin is likely to reach 23% by 2020 and 25% by 2025 from 20% in 2016, Saldanha said.

The company will continue to explore out-licensing opportunities for its novel drugs portfolio, for the 3-4 molecules which do not form a part of its core focus areas of oncology, dermatology and respiratory.

Among the new molecules, respiratory drugs are likely to be the first ones to be filed for regulatory approvals in the US. The company expects to file two respiratory products in 2019 and one in 2020. One product each in the dermatology and oncology space is expected to be filed in 2022 and four drugs—three in the oncology segment and one in the respiratory space—are likely to be filed in 2013 or beyond.

The US and India are the major markets for the company, accounting for 60% of sales currently. Over the next four-five years, the company plans to file 20-25 abbreviated new drug applications (ANDAs) with the US Food and Drug Administration annually and launch around 20 products. The company also plans to launch specialty respiratory products in the US in the next three-four years.

Glenmark has 110 products approved in the US, over 60 ANDAs awaiting regulatory approval and more than 75 products under development. During the next five years, 35% of the total filings will be topical products, 22% oral solids, 16% drug-device combinations, 12% oncology injectables, 8% hormones and 7% control substances.

For the Indian market, the company plans to strengthen presence in dermatology, cardiovascular, anti-diabetic, respiratory and oncology drugs as well as grow the over-the-counter products’ business.

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