PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIA (Set up by Ministry of Commerce & Industry, Govt.

of India) 101, Aditya Trade Center, Ameerpet, Hyderabad 500 038 Phone: 91 40 23735462/66; Fax: 91 40 23735464 E-Mail: info@pharmexcil.com; Website: www.pharmexcil.com

Indian Pharmaceutical Industry
Strengths & Future Cooperation

India- Indonesia : Towards Affordable Pharmaceuticals and Healthcare May 10th , 2012 Jakarta, Indonesia.

At

Presented by

Dr. P.V. Appaji, Director General
Pharmexcil

Pharma Emerging markets are expected to grow at a rate of 14.17% pace through 2014 (source: IMS). It is expected to reach 1100 bn US$ by 2015 (source: IMS) Generic Market in Yr 2010 is 234 bn US$ and is expected to touch 432 bn by the yr 2015 (source: IMS). Generics form 27% of Total Industry in yr 2010. l EU & USA likely to constitute only 44%. India and Russia are Key players in Emerging Pharma Markets.5%. May 2012 2 . growing at 4. World`s Pharmaceutical Market for yr 2010 is 856 bn US$ .)..International Pharma Trade Scenario EU & USA constitute 53% in yr 2010.

U.S. More than 55% exports of India are to highly regulated markets.The Indian Pharma Industry: A flag bearer for India's keen interest in contributing to World Trade.A happens to be the largest exporting partner followed by Russia Largest exporter of formulations (in terms of volume) In the year (2009 ) holding 12.9% market share (By Volumes) Source: UN COMTRADE May 2012 3 .4%. India’s Exports of Pharmaceuticals during the last Five years(USD million) 2006-07 2007-08 2008-09 2009-10 2010-11 CAGR% 5940 7644 8803 8955 10394 15 India`s contribution to World Generic Pharmaceutical Trade (inclusive of Domestic Industry) is 6.

07 Oceania 674 1929 698 810 2571 6.04 0.) (2010-11) Other European Other America Others Region 2010-11 1798 %share 17.30 AFRICA ASEAN ASIA (Excl middle east) CIS EUROPEAN UNION LAC Middle east North America 678 838 6.00 Middle East European Union Asia(excluding Middle East) CIS LAC May 2012 4 .80 24.50 1. Pharmaceuticals & fine chemicals (figs.53 8.18 1.72 7. in US$ mn.Region-wise Exports of India's Drugs.48 18.08 100.56 6.74 Africa North America ASEAN Oceania Othe european Other america Others Total 156 123 108 9 10394 1.

(Source: IMS) sector is Sixth largest principal commodity exported from India during 2010-11 pharmaceutical industry is responsible for 8% of world’s production(as per Espicom Reports).2%.53.372bn (Rs. May 2012 5 . there are around 130 Contract Research Organizations in India.500 crores) in the year 2011(Mar MAT) growing by healthy 16.Indian Pharma Industry Fact File  The Indian domestic pharmaceutical(Formulations at retail price) market size is estimated at US$11. Pharma  Indian Currently.

39% during 2009. Source: Un Comtrade 2009  It ranked 14th in value terms and 1St in volume terms in formulations exports and has 12.53% share by volumes  Source: Un Comtrade 2009 6 . Source: Un Comtrade 2009 The country is 2nd largest exporter of APIs/Formulations Drugs (together) and has 11.Indian Pharma Industry Fact File  Indian pharmaceutical industry is among the world’s largest and most developed.4% by volumes.   16th largest exporter of Bulk Drugs & Formulations(Together) in value terms with a share of 1.

Composition of India`s Exports of Bulk Drugs. & % ) Herbals 1% Bulk Drugs 37% Formulations 62% May 2012 7 . Pharmaceuticals & Fine Chemicals (Figs. in US$ mn.

AMB 2009 Indian generic ARVs approved by the US Food and Drug Administration (US FDA) also resulted in cost-savings of an over 90% of the ARVs for PEPFAR.  It is estimated that 70% of the patients belonging to 87 developing countries received medicine procured from India by  The United Nations Children’s Fund (UNICEF)     International Dispensary Association (IDA) the Global Fund and the Clinton Foundation.. Anti-tubercular & Anti-malarials ] are sourced from India. for its projects in over 30 countries.M. EPITHETS Global Pharmacy for Generic Medicines  Manufacturing Hub of the World Emerging Flagship Industry of India Finished generics supplied from India account for 20% of the global generics market. The changing dynamics of pharma outsourcing in Asia  More Than 90% of WHO Prequalified API [ARVs.India as Global Pharmacy for Affordable Quality Generic Medicine. 8  . from India. Source: Ellen F.M. ’t Hoen. LL. The Global Politics of Pharmaceutical Monopoly Power. Source: PricewaterhouseCoopers. Medicine Sans Frontiers also purchases 80% of its ARVs.

53 16.84 16.23 83.8 77.48 144.India`s Exports to ASEAN Regions in USD mn.65 608.59 18.68 9.00 11.82 May 2012 9 .18 9.15 21.45 8.01 2.52 1.05 60.08 21.20 14.52 -32.00 -2.8 61.78 57.34 49.39 121.7 106.83 Indonesia Laos Malaysia Myanmar 44. COUNTRIES Brunei Cambodia 2008-09 0.70 % SHARE 0.84 70.35 122.87 100.08 20.22 -19.87 19.86 501.98 3.34 Philippines Singapore Thailand Viet Nam Asean Total 56.93 49.58 12.19 -3.07 -4.37 2009-10 0 19.04 99.46 51.41 1.71 1.01 YOY 0.13 21.49 662.09 18.26 7.87 12.77 CAGR 6.33 60.22 62.87 9.95 41.36 116.29 2010-11 0.48 9.02 61.12 0.87 -12.49 -4.26 149.

Accreditations Country Name of Regulatory Agency DMFs filed with U. FDA (companies) No: of Sites(Bulk drugs + Formulations) registered with US FDA Nos. 225 500 2841 USA Total No Of DMF’s Filed from India (as on 31st March 2012) Formulation companies with USFDA approvals. Ethiopia (companies) (TFDA) Tanzania Food and Drugs Authority (companies) 10 .S.000 Number of Molecules for which CEPs have been filed with EDQM UK Ethiopia Tanzania India WHO GMP Certified Plants (as per Drug Controller General of India) Source: FDA websites of respective countries. Pharmexcil Research May 2012 MHRA (Medicines Healthcare Regulatory Agency). Market authorizations as March 2012 DACA (Drug Administration and Control Authority). EDQM EDQM (European Directorate of Quality Medicine) (Bulk drug facilities) Number of CEPs received (as of 30th April 2012) 29 153 851 195 937 50 1519 ~1.

Many multi national organizations are accessing this talence and have filed over 266 DMFs with USFDA. Cost of Manufacturing as per recent Deustche bank reports. Large talent pool of World class skills. and Ms.S cost. Crescent Pharmaceuticals has many market authorizations from UK MHRA filing from India India`s contribution in CRAMS sector is also appreciated and well utilized by many of Research oriented organizations around the world. May 2012 11 . is only half of Europe`s or U.India offers a congenial atmosphere foreign investments.

Thank You…) 12 .

Sign up to vote on this title
UsefulNot useful