After drugmakers, it is the turn of stent manufacturers to explore markets overseas.
South East Asia, Middle East, Latin America, Eastern Europe — regions where regulatory clearances are relatively easy to get — are particularly attractive for these players.
Heart diseases are a major concern globally, with the World Health Organisation predicting that about 23.6 million people worldwide will die from heart-related ailments by 2030.
A major cause of death is the narrowing of arteries – which supply blood to the heart — due to fat deposits.
This is where stents come into play -- the devices are used to reopen blocked arteries and provide a scaffold to the reopened artery.
Similar to domestic pharma companies such as Dr Reddys, Sun Pharma, Lupin and Glenmark, which are seeing strong double-digit growth from overseas markets, heart stent-makers are also riding on some superb showing from international territories.
“The potential for Indian stents abroad is huge. We are looking for annual growth of over 40% from the international markets,” said Gautam Tripathy, national head, Meril Life Sciences.
Meril makes around 60,000 stents annually, of which over “25,000 are exported” to places like Germany, South Africa and Saarc countries, said Tripathy.
According to Gautam Agarwal, director, Innvolution Med System, though India still comprises around 80% of the market for their stents, the acceptance abroad for Indian stents is growing tremendously. “The perception is changing for the positive. Doctors are noticing that the outcomes are good.”
Experts say a major factor aiding export is lower costs -- similar to why Indian generics, which come at a 40-50% discount to MNC drugs, do well outside.
“Indian stents are priced at least 30% lower than those made by MNCs,” said Agarwal.
On an average, if an India-made stent costs Rs80,000 in the private market, then those made by MNCs sell for over Rs1.2-1.5 lakh.
Incidentally, compared with European countries, fewer stents are used in India. In 2012, rough estimates suggest around 2-3 lakh stents were used in India.
“Throughout Europe, the number was 20-25 lakh. In Germany itself, it was 3 lakh. So the opportunity there is much more,” said Tripathy.
It also helps the stent exporters that hospitals abroad make upfront payment compared with a 4-8 month lag in India.
“Sometimes (payments take) even a year. Though hospitals charge patients upfront, they keep delaying our payment,” said a manufacturer based in Gujarat.
However, the US – which uses a whopping 60 lakh or so stents a year -- continues to elude these manufacturers.
Agarwal said since the USFDA is one of the most stringent regulatory bodies, the time taken for getting approvals is also more. “At times, it may take even 3-4 years for getting approval for a stent. While the cost of obtaining the approval could be as high as $120-150 million.”