The United States continues to be a key market for Indian generic firms, which garnered over 30% of approvals awarded in 2011, with the number of approvals growing by 1% from 2010.
IHS Global Insight Perspective | |
Significance | Indian generic firms received over 190 Abbreviated New Drug Application (ANDA) approvals from the US FDA during 2011. With 21 such approvals, Sun Pharma (India) beat its domestic counterparts to receive the highest number of marketing authorisations in the US over the year. |
Implications | The number of generic approvals received by Indian firms during 2011 increased by 1% from 2010 figures, compared with 15% growth in 2010 versus 2009, showing increased scrutiny from the US FDA in regards to manufacturing compliance. Despite this slowing growth, firms continue to look to the US to file ANDAs in order to grow presence. |
Outlook | The US will continue to be one of the leading countries for Indian generic firms' investment, with several blockbuster molecules set to go off-patent and an intensified drive to increase generics use. |
Indian Generic Firms' Focus on US Continues
Over 2011, the United States remained a major contributor to several generic firms' toplines, with Indian companies gaining 193 US FDA approvals—49 tentative and 144 final Abbreviated New Drug Application (ANDA) approvals—according to Pharmabiz.com. Indian companies accounted for 33.4% and 42% of the total final and tentative approvals respectively. The FDA's total number of final and tentative approvals reached 431 and 117 ANDAs respectively in 2011, up from 418 and down from 121 ANDAS respectively in 2010, versus 419 and 124 in 2009.
Source: US FDA
Over the five-year 2007–11 period, the FDA approved 2,244 ANDAs, with Indian generic firms accounting for 30.9% of these. Sun Pharma and its subsidiaries received the most US approvals in 2011, with 21 ANDAs—a 40% y/y increase, capitalising on the resumption of full operations at newly acquired Taro Pharmaceuticals (Israel) subsidiary and product expansion. Other Indian firms that also received a significant number of ANDA approvals over the year in question included Aurobindo, Strides Arcolab, Glenmark, Lupin, and Dr. Reddy's. Other significant Indian companies in the US market include Alembic, Orchid, Torrent, Hetero Drugs, Natco Pharma, and Unichem, with one to six approvals per year for the past three years. Approvals were most commonly granted to generic antibiotics, anti-retrovirals, central nervous system, gastro-intestinal, oncology and cardiovascular products.
Indian Firms with Highest FDA Approvals, 2011 | ||
Company | FDA Approvals 2011 | FDA Approvals 2010 |
Sun Pharma and Taro | 21 | 15 |
Strides Arcolab | 18 | 16 |
Aurobindo Pharma | 16 | 17 |
Dr. Reddy's | 15 | 11 |
Lupin | 14 | 12 |
Glenmark | 12 | 20 |
Torrent | 9 | 5 |
Wockhardt | 7 | 4 |
Zydus Cadila | 7 | 8 |
Matrix Labs | 5 | 10 |
Ranbaxy | 3 | 3 |
Orchid Chemicals and Pharma | 2 | 2 |
Outlook and Implications
The approval rates mean that, as was the case in 2009 and 2010, Indian firms continue to constitute over 30% of the FDA's generic drug approvals, despite an increased number of litigation battles as innovative pharma look to protect their revenues and Indian firms become more aggressive. The 1% y/y increase in approvals this year compared to the 15% y/y increase in 2010 may reflect the increased scrutiny in the US FDA approval process, which has seen major Indian firms being flagged for compliance issues. As Indian firms continue to garner more than 30% of approvals, however, clearly the leading Indian firms' increased investment in generic drug research and development—up by over 30% to approximately 40 billion Indian rupees (USD752million)—and aggressive market expansions are paying off, helping to establish a strong presence in the international markets. Nevertheless, as indicated above, Glenmark, Strides Arcolab and Aurobindo have displaced firms such as Dr. Reddy's and Ranbaxy to occupy the lead positions in terms of ANDA approvals (for Indian firms only). Generic approvals for Ranbaxy stagnated, meaning the firm almost lost out on its 180-day market exclusivity on the generic version of blockbuster drug Lipitor (atorvastatin). An FDA manufacturing ban imposed in 2008 on two of Ranbaxy's facilities continues to affect the firm's exports to the US market, with the firm in the process of rectifying such issues.
Glenmark, Sun Pharma, Lupin, and Aurobindo look set to dominate the US market in the coming years as they continue to file an increased number of ANDAs—Glenmark plans to file an average of 15 to 20 ANDAs per year as it builds its US product portfolio. Strides Arcolab, on the other hand, is set to continue it approval momentum in the injectables product segment as it looks to honour its partnership agreements with Sagent Pharma and Pfizer (both US). The projected 3–5% growth rate for the US pharma market will continue to attract generic firms, with pharmaceutical sales reaching USD320–330 billion, and the generics market accounting for approximately 75% of US prescriptions. Other generic market drivers in the US include the large number of blockbuster drugs coming off patent between now and 2015, such as Bristol-Myers Squibb (US) and Sanofi-Aventis (France)'s Plavix (clopidogrel). On the evidence of 2010 and 2011, however, Indian firms will also continue to expand into other pro-generic markets such as the Philippines, Japan, sub-Saharan Africa, and the Latin American region in parallel with US expansion.