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Increasing Share of Indian Generics

in the Global Pharmaceutical

Market

Increasing Share of Indian generics in Global Pharmaceutical Market

2 | P a g e © Gyan Research and Analytics Pvt. Ltd., 2013

Synopsis

Over the last two decades, India has gradually evolved into an influential player in the global

pharmaceutical market. The country’s pharmaceutical industry is estimated as the third-largest in

the world in terms of volume and at USD 17.4 billion it was ranked 13th in terms of value in 2012.

The Indian pharma sector contributes around 10 percent of the total global production, including 20

percent of the total volume of global generics. India also manufactures around 30 percent of the

total requirement of anti-HIV drugs.

That India has become a force to reckon with in the generics drug manufacturing market is amply

borne out by the fact that in 2011 alone, 162 out of 442 approvals of the USFDA were to Indian

companies. Further, of the total Drug Master Filings (DMF) in the US, India accounted for 45 percent

in 2009, which reached 49 percent in 2010 and 51 percent in 2011. DMFs are approvals to supply

raw materials to all generic manufacturers catering to the US market. Moreover, in 2012, 37 percent

of the total USFDA approvals were given to Indian companies - a rise from 33 percent in 2011.

This report encompasses an assessment of the Indian generics pharmaceutical industry in India,

within the context of the global industry, and the opportunities and challenges it presents. It also

analyses the investment opportunities and financials of the top ten major players.

Increasing Share of Indian generics in Global Pharmaceutical Market

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Table of Contents

1. Overview

1.1 The Indian Pharmaceutical Industry

2. The Generics Market in India

2.1 The Menace of Counterfeit Drugs

3. Strong Product Filing Pipeline

4. Regulatory Framework

4.1 Policies

4.2 Quality Benchmark

5. External Trade

5.1 Export

5.2 Import

6. Financials

7. Opportunities in Generics

8. Outlook

Increasing Share of Indian generics in Global Pharmaceutical Market

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