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API manufacturing: India set to overtake Italy

Pharma success
API from India are expected to touch $10 billion by 2010, if one takes into consideration the number of drug master file submissions.
The CPA study said sales by Italian API manufacturers are expected to increase to $3.3 billion by 2010 from $3.2 billion in 2005.

New Delhi , May 24
The Indian pharmaceutical industry is all set to overtake Italy as the world's second largest manufacturer of active pharmaceutical ingredients (API).

The Indian API manufacturing industry is currently the third largest in the world and is expected to generate sales of $4.8 billion by 2010 from $2 billion in 2005, at an average yearly growth rate of 19.3 per cent, according to a study conducted by Italy's Chemical Pharmaceutical Generic Association.

Indian industry officials, however, are of the opinion that India would achieve this landmark in 2007 itself, going by the number of DMF (drug master file) submissions.

According to Mr D.G. Shah, Secretary-General, Indian Pharmaceutical Alliance, exports of API from India are expected to touch $10 billion by 2010, if one takes into consideration the number of DMF submissioactive pharmaceutical ingredients apins.

"The API sales are expected to grow at a CAGR of 30 plus per cent in the current decade, particularly because of the breakthroughs Indian manufacturers have been able to make in highly regulated markets such as the US and Europe," Mr Shah said.

Indian API makers made some 579 DMF submissions in 2004.

Meanwhile, according to the CPA study, sales by Italian API manufacturers are expected to increase to $3.3 billion by 2010 from $3.2 billion in 2005.

China No. 1

The largest API manufacturer, China, is set to maintain its double-digit growth run and is expected to see API sales increase to $9.9 billion from $4.4 billion in 2005, an increase of 17.6 per cent.

The report also said that India, with low labour costs and focus on innovation, can hit the margins of not only Europe-based manufacturers but even Chinese firms. For example, India's API exports growth rates are the highest in the world, including exports to highly regulated markets like the US. Further, India's API sales in overseas markets are expected to increase at a rate higher than domestic sales.

India also has the largest number of US Food and Drug Administration approved plants on a worldwide scale.

Market share


Meanwhile, with India and China increasing their market share in the API market, the report has cautioned European API manufacturers to try and improve their market shares through cost cutting, as they are seen to be losing share in a rapidly growing market.

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