As the world market for active pharmaceutical ingredients (APIs) continues to decline, India’s API sector has been growing rapidly, bolstered by growing exports to the U.S. However, Indian suppliers are actively seeking new business niches and global markets. 

New contract manufacturing organizations (CMOs) have recently entered the Indian API market, while Aurobindo, an established API supplier, is now moving into generic drug manufacturing in Europe through its acquisition of Actavis’ generics businesses in Western Europe.

Between 2008 and 2012, global demand for API’s grew by five to six percent, 2 percent lower than it had been between 2004 and 2008, according to a report released last year by Italy’s Chemical Pharmaceutical Generic Association (CPA). India’s API production, meanwhile, more than doubled, from $2.27 billion in 2008 to $4.70 billion in 2012, the report showed.

During this period, India’s API exports to the US market grew by an average of 44% per year, increasing from $255 million in 2008 to $1.12 billion in 2012.

Increased M&A Activity in 2013 and 2014
Last year, there were major mergers and acquisitions in this field, including Mylan Labs’ acquisition of Strides, and Hospira’s of Orchid.

This year, Aurobindo Pharma bought Actavis Plc’s (Dublin) generics commercial operations in seven Western European markets. Aurobindo claims about 150 DMFs with FDA and over 2,000 filings in other markets.

With more than 200 APIs, Aurobindo aims to offer a varied set of products including sterile and non-sterile penicillin, cephalosporins and penems, and company managers say they are working to improve operational efficiencies and reduce costs. 
Aurobindo is based in Hyderabad, in southern India, a city which is a hub for API manufacturers. The company’s senior managers hope that the Actavis acquisition will allow it to enter the Top 10 list of European producers in several key markets.  They also see the buy as a way to ensure a long-term supply of APIs from India.

Will Actavis Acquisition Put Aurobindo in Europe’s Top 10?
The acquired business units had been running losses, but their new owner plans to integrate them with its existing manufacturing capabilities. Apart from nine API factories, Aurobindo has over half a dozen formulation facilities and is one of the top ANDA filers from India.

But others are entering India’s API business.  GVK Bio, known mainly as a contract research organization (CRO) plans to move into manufacturing with a $16.5-million API facility in the southeastern city of Vizag. Due to come online in two years, the new API center, with nearly 200,000-L of capacity, is meant to increase the company’s manufacturing revenues, now less than 40% of the total. 

The company recently started up a manufacturing facility for formulations, as well, in Bangalore. GVK, which gets nearly half of its earnings from drug discovery services, bought California’s Aragen Bioscience, a preclinical CRO specializing in biologics services, in February.

In April, the CMO, Neuland Pharma, started up its new API facility in Hyderabad, with funding from Tokyo-based API Corporation (APIC), a healthcare unit of Mitsubishi Chemical Holdings Group. The plant will supply API’s and intermediates to the Japanese firm as part of an agreement reached a year ago.