Mumbai: After making inroads into the big US market with generic tablets and capsules, Indian drug makers are starting to grab a piece of the lucrative injectable drugs market, estimated to be worth $115 billion (Rs4,94,500 crore) each year.
Four Indian drug companies—Wockhardt Ltd, Lupin Ltd, Sun Pharmaceutical Industries Ltd and Orchid Chemicals and Pharmaceutical Ltd—have successfully entered the market for injectable drugs in the US, primarily with new generation antibiotics, a class of anti-infective drugs.
“Injectables are a key element of our US strategy, ” says Wockhardt chairman Habil Khorakiwala. Wockhardt, which already has three injectable products in the US market, has received approval for its fourth product, a Furosemide injection.
Furosemide, prescribed for boosting excretion of urine, is one of the most widely used injections in US hospitals in several life-threatening conditions.
Other Indian companies are also entering the fray.
Recently, the Ahmedabad-based Claris Life Sciences Ltd got one of its injectable plants approved by the US Food and Drug Administration (FDA). Many more companies, including the Hyderabad-based Aurobindo Pharma Ltd and the Ahmedabad-based Zydus Cadila Ltd, have applied for regulatory approvals for their injectables-manufacturing facilities, say industry analysts.
The biggest challenge for companies eyeing this big market has been the complex regulatory requirements that the FDA lays down for manufacturers of injectable drugs. India already has the largest number of FDA-approved plants outside the US, primarily for tablets and capsules.
Out of the 79 FDA-approved drug-manufacturing plants in India, just five are dedicated to injections.
Then there is the question of investments.
An injectable drug manufacturing facility costs up to four or five times that of a comparable factory for making tablets or capsules. S. Anantharaman, an independent pharmaceutical plant consultant in Mumbai, says the operating cost of an injectables manufacturing plant is about 300% higher than that of a factory making an oral drug.
Despite the costs as well as the difficult regulatory clearances, “the injectables market in the US is attractive as the price erosion is not as significant as tablets and capsules”, says C.B. Rao, deputy managing director, Orchid Chemicals.
With a 10% annual growth rate, injectables are also one of the fast-growing segments in the US drug market. Sun Pharma vice-president Uday Baldota says that though the FDA approval for injectables is more stringent and needs heavy investments, a US entry with an injectable product was still worth going after, because competition is less intense than it is in tablets and capsules.
Arjun Handa, chief operating officer of Claris Life Sciences, expects the company’s products to be in the US market by the end of this year. “With a strong regulatory pipeline for the US, we are confident of leveraging this lead into building even stronger revenues and financial track record,” he says.