Indian Pharma Updates

Indian pharmaceutical market accounts for 1-2% of the global pharmaceutical market in value terms and 8% in volume terms. In 2007 it has grown by 12.9% to reach USD8.16 billion. Market growth during 2007 was driven by a number of new product launches by both Indian and foreign companies. The pharmaceutical market has grown at a compounded annual growth rate (CAGR) of 13% during the last five years. The market size comprises of domestic consumption of bulk drugs and formulations and does not include exports of the same.

Major Therapeutic Segments
The growth of the domestic pharma industry is largely dependent on its therapeutic presence. In terms of end-use, the pharmaceutical industry is sub-divided into several therapeutic segments. These segments are broadly defined on the basis of therapeutic application. Some of these segments are low-volume, high-margin segments, while the others are high-volume with relatively low margins.

The new lifestyle category likes cardiovascular and anti-infectives are at double-digit growth rates. The key therapeutic segments include anti-infectives, cardiovascular and central nervous system drugs respiratory and pain/ analgesics. The upcoming segment is anti diabetic, which contributes 4.9%. Among the acute therapies, anti-infective is the major contributing segment accounting for 17.7% of the total pharma sales market in India. The anti-infectives segment, being the largest, consists of five sub-segments: antibiotics, anti-protozoals, anti-helmintics, anti-malarials, and anti-tuberculosis. The anti-infectives segment has been driven by new introductions in the year 2006-07.

Gastrointestinal drugs are the next major therapeutic segment contributing 11.1% of the total sales. The major sub-segments under this category include anti-hypertensives, statins and anticoagulants. Cardiovascular, respiratory and pain/analgesics were the next leading therapeutic sub-segments accounting for 11%, 9.0% and 8.9% in 2006-07.

USFDA Plants
India has the highest number of USFDA approved manufacturing facility outside the US. Therefore it is in a good position to manufacture bulk drugs and export to regulated markets in the coming years. There are over 80 USFDA-approved manufacturing facilities in India (2007) and the number is estimated to grow at the rate of 30% by the end of 2008. This would make India the only country having the largest number of such plants outside the US. As per 2006 figures, even China, supposedly the biggest threat to Indian business in CRAMS, had 27 FDA-approved manufacturing sites. India has almost three times the number of FDA-approved plants than China has. This is one of the most vital factors for outsourcing manufacturing services to India by the multinationals and global pharmaceutical companies.

Indian bulk drugs exports revenue were USD2.65 billion in 2006-07, with a robust growth of 25% over the previous year but the pace of growth was slower as compared to the pharmaceuticals, which grew at 28% during the same period. The reasons attributable to the higher growth in formulations exports as compared to bulk drugs are increased demand for generics coupled with better acceptability of Indian generics in the global market from perspectives of both quality and price.

Regulations

• DCGI to curb export of fake drugs: To address the problem of counterfeit drugs in pharma exports, the Drug Controller General of India (DCGI) will introduce a new scheme of sample testing over the next six months. Under this scheme, at least 50,000 samples of drugs, which go out of the country, will be tested in DCGI labs to establish their authenticity.
• Pharma body may fix price for 10 drugs: The National Pharma Price Authority is likely to fix the prices of an additional ten formulations, outside the list of essential medicines price-controlled by the government. The rates of these drugs, belonging to some of the leading pharmaceuticals in the country, have seen an increase of more than the 20% limit allowed during a 12-month period. The price monitoring body was returned its powers under Para 10 (B) of the Drug (Price Control) Order 1995 earlier this year by the government to fix prices of any non-scheduled drug in public interest.

The export growth is driven by the increasing number of patented drugs going off patent in the coming years. India has the highest number of USFDA-approved manufacturing facilities outside USA; placed in good condition for export to regulated markets. India currently has the highest number of USFDA approved plants at 75, followed by Italy with 55, and China at 27.

Outlook
India has had a strong domestic pharmaceutical industry and a rapidly expanding market with a population of over a billion and a rapidly expanding economy. Prevalence values of many diseases are likely to increase with expansion of population, urbanisation and with higher identification rates in the coming decade. As per the Cygnus estimates the Indian (in the figure) pharmaceutical industry is likely to double its value to USD14.70billion in 2011. The investment in R&D, filling of higher number of ANDAs and DMFs in highly regulated market, mergers & acquisitions, in-licensing, skilled labour force, high standard scientific base and revenues from CRAMS will give necessary edge to Indian companies in the coming years. India has over 80 FDA-approved manufacturing facilities in 2007, which is estimated to grow at the rate of 30% by the end of 2008.

*** article is an excerpt from Cygnus Business Consulting & Research (www.cygnusindia.com);

***as posted in http://www.kppub.com/indian_pharma_industry.htm

For more reading on Indian Pharmaceutical Industry, you may download the following files:

INDIA’S PHARMACEUTICAL INDUSTRY

GLOBAL PHARMA LOOKS TO INDIA