In the past couple of years in particular, Indian pharma companies are seeing the fruits of their labour, particularly in the US generics market. However, retaining their competitive edge may not be as simple
For Big Pharma, this is a period of unprecedented difficulty, a time to retrospect on past failures. However, Indian generic firms are bang in the middle of a potential dream run. As a recent Frost & Sullivan report points out, drugs worth around $150 billion are expected to go off patent protection globally. This naturally opens a huge window of opportunities for Indian drug manufacturers. Are they ready?
Profitability figures certainly suggest that some players are moving away from the shadow of a difficult past in the latter part of the previous decade. Sun Pharma, which has got the highest number of drugs in its ANDA (Abbreviated New Drug Application) pipeline, reported revenues of Rs.40.15 billion, a growth of 29.3% yoy. Its net profit stood at Rs.19.27 billion, growing by 39% yoy; and it gained 13 places in the Power 100 list to rank at 41. The US business of Sun Pharma alone grew by nearly 30% in the same period. Cipla’s profit rose by 16% yoy to reach Rs.11.23 billion in FY 2011-12 and it was ranked 65 in the Power 100 (a gain of 12 positions). Dr. Reddy’s Laboratories, which has just entered the BSE-30, also reported a healthy 28% rise in topline in the fiscal to reach Rs.67.39 billion. Its net profit, however, grew by just 2.1% yoy to Rs.9.12 billion, even as it gained two places to be ranked 80 in the B&E Power 100. The company was stung by the poor performance of its generic version of Zyprexa and falling margins in its core business. Contrarily, launches of generic versions of Caudet and Zyprexa have helped Lupin. It managed double digit growth in US. However, its PAT for FY 2011-12 shrank nominally and stood at Rs.8.04 billion owing to high depreciation and interest costs; taking its rank to 86 (a gain by two positions). The BSE Healthcare Index surged by around 5.6% yoy and has outperformed the Sensex by around 14 percentage points.
In 2010 and 2011, companies like Glenmark, Aurobindo and Sun Pharma were able to further consolidate their positions in the US generics market by bagging around 33% of ANDA approvals from the US Food and Drug Administration (FDA). The FDA approved a 2,244 ANDAs between 2007 and 2011, of which Indian companies grabbed final approval for 694.
Considering the intense competition from their BRICS counterparts, the figure holds high significance. During the same period, aggregate tentative approvals by FDA reached 518, out of which Indian companies secured 200 (FDA data).
Also, Indian companies are consistently growing their para IV filings and niche complex chemistry molecules. Most of these segments, especially injectables, inhalers, ophthalmic, oral contraceptives and controlled release products are set to lose patent guard beyond 2012. Moreover, being characterized by complex manufacturing techniques, entailing greater investments in R&D and manufacturing, these segments have higher entry barriers and thereby potential for higher profitability. Also, the percentage of US FDA approvals won by Indian firms has jumped from 27% to 33%. Raghavendra Saha, Senior Advisor, CII asserts, “In the past 15 years, not even a single new molecule has been found. Hence, it isn’t hard to claim that the era of blockbuster drugs has gone and the future belongs to generics.”
However, Indian companies need to manage their litigation processes well, since this led to massive cost escalations in the past, particularly with Ranbaxy Laboratories (incidentally, the Daiichi Sankyo-owned company declared a loss of Rs.30.52 billion for the nine months ending December 2011, as per its most recent report). Dr. Kamal Kumar Sharma, MD, Lupin Ltd. says, “At Lupin, we do not chase any and everything possible. We try to sort out and identify cases where we have a decent chance of winning.”
For Big Pharma, this is a period of unprecedented difficulty, a time to retrospect on past failures. However, Indian generic firms are bang in the middle of a potential dream run. As a recent Frost & Sullivan report points out, drugs worth around $150 billion are expected to go off patent protection globally. This naturally opens a huge window of opportunities for Indian drug manufacturers. Are they ready?
Profitability figures certainly suggest that some players are moving away from the shadow of a difficult past in the latter part of the previous decade. Sun Pharma, which has got the highest number of drugs in its ANDA (Abbreviated New Drug Application) pipeline, reported revenues of Rs.40.15 billion, a growth of 29.3% yoy. Its net profit stood at Rs.19.27 billion, growing by 39% yoy; and it gained 13 places in the Power 100 list to rank at 41. The US business of Sun Pharma alone grew by nearly 30% in the same period. Cipla’s profit rose by 16% yoy to reach Rs.11.23 billion in FY 2011-12 and it was ranked 65 in the Power 100 (a gain of 12 positions). Dr. Reddy’s Laboratories, which has just entered the BSE-30, also reported a healthy 28% rise in topline in the fiscal to reach Rs.67.39 billion. Its net profit, however, grew by just 2.1% yoy to Rs.9.12 billion, even as it gained two places to be ranked 80 in the B&E Power 100. The company was stung by the poor performance of its generic version of Zyprexa and falling margins in its core business. Contrarily, launches of generic versions of Caudet and Zyprexa have helped Lupin. It managed double digit growth in US. However, its PAT for FY 2011-12 shrank nominally and stood at Rs.8.04 billion owing to high depreciation and interest costs; taking its rank to 86 (a gain by two positions). The BSE Healthcare Index surged by around 5.6% yoy and has outperformed the Sensex by around 14 percentage points.
In 2010 and 2011, companies like Glenmark, Aurobindo and Sun Pharma were able to further consolidate their positions in the US generics market by bagging around 33% of ANDA approvals from the US Food and Drug Administration (FDA). The FDA approved a 2,244 ANDAs between 2007 and 2011, of which Indian companies grabbed final approval for 694.
Considering the intense competition from their BRICS counterparts, the figure holds high significance. During the same period, aggregate tentative approvals by FDA reached 518, out of which Indian companies secured 200 (FDA data).
Also, Indian companies are consistently growing their para IV filings and niche complex chemistry molecules. Most of these segments, especially injectables, inhalers, ophthalmic, oral contraceptives and controlled release products are set to lose patent guard beyond 2012. Moreover, being characterized by complex manufacturing techniques, entailing greater investments in R&D and manufacturing, these segments have higher entry barriers and thereby potential for higher profitability. Also, the percentage of US FDA approvals won by Indian firms has jumped from 27% to 33%. Raghavendra Saha, Senior Advisor, CII asserts, “In the past 15 years, not even a single new molecule has been found. Hence, it isn’t hard to claim that the era of blockbuster drugs has gone and the future belongs to generics.”
However, Indian companies need to manage their litigation processes well, since this led to massive cost escalations in the past, particularly with Ranbaxy Laboratories (incidentally, the Daiichi Sankyo-owned company declared a loss of Rs.30.52 billion for the nine months ending December 2011, as per its most recent report). Dr. Kamal Kumar Sharma, MD, Lupin Ltd. says, “At Lupin, we do not chase any and everything possible. We try to sort out and identify cases where we have a decent chance of winning.”
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