India's leading pharmaceutical players will continue to experience revenue growth of over 20% this year, primarily led by exports and especially to the US, says a new report from India Ratings.
The US market will remain Indian pharma's main focus area in the medium to short term, mainly because of the sheer size of generic opportunities there, it says. The US generic market, now worth about $100 billion, could grow at an annual average rate of around 8%-9% in the medium term, due to patent expiries - set to be worth around $125 billion during 2013-15 - coupled with pro-generic policies.
Indian firms with robust product portfolios filings and the necessary manufacturing infrastructure are well-placed to capitalise on the upcoming generic opportunity, while President Barack Obama's Affordable Care Act (ACA) will increase demand for such products in the US, according to India Ratings, which is a Fitch Group company."We expect Indian players' continued focus toward the US market will also be led by the low investments required for setting up a distribution infrastructure," it adds.
The report also sees continued good growth for Indian-made generics in other developed and "pharmerging" markets, due to patent expiries and cost-cutting measures by payers. On the back of this increasing demand, exports now account for 60% of the Indian pharma sector's total revenues and they grew by an annual average of 19% between 2008 and 2012. In January-October 2012, Indian drug exports were worth 620 billion rupees, an increase of around 28% year-on-year. "We expect this trend to continue," it says.
Turning to R&D, India Ratings notes that Indian drugmakers' spending here has also been increasing year-on-year, and that, on the back of large investments, they have built a strong pipeline of products to be sold in the US.
During 2011, Indian firms accounted for 51% of total Abbreviated New Drug Application (ANDA) filings in the US, compared to 49% in 2010 and 45% in 2009, and their share of ANDA approvals increased to 37% in 2012 from 33% in 2011. 178 Indian ANDAs were approved by the US Food and Drug Administration (FDA) last year, out of a total of 476, compared with 144 out of 431 in 2011.
Besides their strong product pipelines, Indian firms' growth are also set to benefit from faster commercialisation of product filings in the US due to the Generic Drug User Fee Act (GDUFA). Implemented from October 2012, GDUFA aims to bring down approval times from 31 months at present to 10 months, the report points out.
Turning to the Indian pharma market, the study says that it accounts for 40% of domestic drugmakers’ revenues, and it believes that the growth drivers here - improving health infrastructures, wider health insurance and increasing health awareness in both rural and urban regions - remain intact. However, the government's recent decision to increase the number of drugs under official price control from 74 to 348 will have a negative impact on India's domestically-focused drugmakers, especially the multinationals, although the impact will be lower on companies which garner significant revenues from exports, it says.