Drugmakers rush for a lift from US hormones mart

Indian drugmakers are queuing up to get a piece of the lucrative hormones market in the US which is growing at a fast pace.

An area yet to be fully explored, hormones — specially the market for oral contraceptives — holds key significance for boosting pipelines and sales of pharma players.

Hitherto dominated by the likes of Israeli generic player Teva, and US majors like Watson, the oral contraceptives market in the US is growing at over 10% per annum and is valued at $4.5 billion, as per data by research firm IMS Health.

According to an official from Glenmark, there are about six abbreviated new drug applications (ANDAs) for hormones by the company pending approval with the US Food & Drug Administration (FDA), which monitors and regulates medicines in the country.

ANDA is an application for approval of a generic or off-patent medicine in the US.

“Glenmark Generics has generated revenues of approximately Rs 750 crore from the US in a span of five years. We have already received approval for an oral contraceptive product. This segment is crucial for growth,” said the official.

A spokesperson for Sun Pharmaceuticals, which gets about 30% of its revenues from the US, said hormones will be an imperative segment in the future, though at the moment, the company has marginal presence in this area. “We have some ANDAs pending for this segment,” the spokesperson said.

Nilesh Gupta, group president of drugmaker Lupin, said the company hopes to launch its oral contraceptive products next year. It plans to leverage its relationships in international market to make a mark in the area. “We will start with the US and then look at entering Europe and Brazil,” Gupta said.

Industry experts say the hormones business canfetch margins of 14-20%.

Sriram Rathi, analyst at Centrum Broking, said though hormones is not really a top priority segment currently, the margins and growth potential can make it noteworthy.

However, they entail a very complex manufacturing process as they have to match the structure and efficacy as the hormone in the human body. Its also requires a high level research & development expertise.

“Getting approvals is a tough game and thus, the opportunity all depends on how quickly and successfully approvals can be garnered by the players,” said Sarabjit Kour Nangra, VP-research, Angel Broking.