The global pharmaceutical markets were estimated at US$712bn in the year 2008 growing at 6.4 percent over 2006. This has grown at a compounded annual growth rate (CAGR) of 10.7 percent for the period 2002-07. The market size of USA is estimated at US$295-305bn with an estimated growth rate of 4-5 percent. It is followed by Top 5 European countries (EU-5) with an estimated market size of US$135-145bn growing at 4-5%, emerging markets VIZ., Brazil, China, India, Mexico, Russia, South Korea and Turkey with an estimated market size of US$85-90bn. (growing at 12-13%) and Japan with an estimated market size of US$64-68bn (growing at 1-2%). The pharmaceutical market size of the rest of the world (ROW) is estimated at US$125-135bn which is estimated to grow at 7-8 percent in the coming years.



The Indian Pharmaceuticals sector has come a long way, being almost non-existing during 1970, to a prominent provider of health care products, meeting almost 95% of country's pharmaceutical needs. The pharmaceutical sector is emerging as one of the major contributors to Indian exports with export earnings rising from a negligible amount in early 1990s to Rs.29,139.57 crores by 2007-08. The exports of Drugs, pharmaceuticals & fine chemicals of India were growing at a compounded annual growth rate (CAGR) of 17.8% during the five year period 2003-04 to 2007-08.

The Indian domestic pharmaceutical market size is estimated at US$10.76 bn in the year 2008 and is expected to grow at a high CAGR of 9.9% percent till 2010 and thereafter at a CAGR of 9.5% till 2015. Currently, the Indian pharmaceutical industry is one of the world's largest and most developed, ranking 4th in volume terms and 13th in value terms. The country accounted for 8 percent of global production and 2 percent of world markets in pharmaceuticals. Most of the domestic pharmaceutical drug requirements are met by the domestic industry. In the seg ment of Active Pharmaceutical Ingredients (APIs) India ranks third in the world producing about 500 different APIs.

Currently, India is recognised as a high-quality, low-cost skilled producer of pharmaceuticals. It is seen not only as a manufacturing base for APIs and formulations, but also as an emerging hub for biotechnology, bioinformatics, contract research, clinical data management and clinical trials.

India has achieved the distinction of providing healthcare at very low cost while maintaining profitability. India exports full basket of pharmaceutical products comprising intermediates, APIs, Finished Dosage Combinations (FDCs), biopharmaceuticals, vaccines, clinical services, etc., to various parts of the world.

At present, India is among the top 20 pharmaceutical exporters world-wide and with the largest number of US FDA inspected plants (119 plants), outside the USA. Various other agencies like MHRA UK, MCA South Africa, TGA Australia , HPB Canada have approved scores of plants in India.

India accounts for over one third of drug master files (DMFs) in USA. Thirty percent of all approved ANDAs in the US are from India, ranking the country number 2 next only to USA. Needless to mention scores of approvals by UK MHRA and various other agencies are also being filed from India. India ranks only next to USA with a share of 21 percent of patent challenges. This justifies that India is an emerging leader in pharmaceuticals.

The indigenous pharma market in value terms accounts for 1% of global pharmaceutical market and 8% in volume terms. Market growth be ment of Active Pharmaceutical Ingredients (APIs) India ranks third in the world producing about 500 different APIs.

Currently, India is recognised as a high-quality, low-cost skilled producer of pharmaceuticals. It is seen not only as a manufacturing base for APIs and formulations, but also as an emerging hub for biotechnology, bioinformatics, contract research, clinical data management and clinical trials.

India has achieved the distinction of providing healthcare at very low cost while maintaining profitability. India exports full basket of pharmaceutical products comprising intermediates, APIs, Finished Dosage Combinations (FDCs), biopharmaceuticals, vaccines, clinical services, etc., to various parts of the world.

At present, India is among the top 20 pharmaceutical exporters world-wide and with the largest number of US FDA inspected plants (119 plants), outside the USA. Various other agencies like MHRA UK, MCA South Africa, TGA Australia , HPB Canada have approved scores of plants in India.

India accounts for over one third of drug master files (DMFs) in USA. Thirty percent of all approved ANDAs in the US are from India, ranking the country number 2 next only to USA. Needless to mention scores of approvals by UK MHRA and various other agencies are also being filed from India. India ranks only next to USA with a share of 21 percent of patent challenges. This justifies that India is an emerging leader in pharmaceuticals.

The indigenous pharma market in value terms accounts for 1% of global pharmaceutical market and 8% in volume terms. Market growth be fore 2005 of domestic pharma industry was primarily driven by a number of new product launches by both Indian and foreign company. The Indian market started to attract a number of foreign players with the implementation of product patent in January 2005. The FDI in pharma industry is estimated at US$ 172 million during 2005-06, recording a CAGR of 62.6% during the period beginning 2002-06.

India has the advantage of offering three distinct waves of opportunities in offshoring over the next decade. The first wave basically focuses on developing drugs ?faster and cheaper? and extends from chemistry research to clinical trials to manufacturing. The sources of advantage are twofold: a cheaper skilled talent base ? chemists, MDs, nurses, quality control personnel ? along with the ability to expedite recruiting for trials due to a large na've patient base.

The second wave, which is likely to become mainstream over the next 3 to 5 years, will extend the breadth of capabilities to include more complex manufacturing to produce injectables; targeted and cutting edge clinical trials, including adaptive and proof of concept trials; and more sophisticated biology- based research platforms.

Around 2013-2015, the third opportunity wave is expected to occur when Indian drug manufacturers are likely to start manufacturing biologics (recombinant proteins) and offer cutting-edge disruptive R&D platforms such as pharmacogenetics and cheminformatics.