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INTERNATIONAL PHARMA BUSINESS DEVELOPMENT (IPBD) PROGRAM


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Modules Module 1: Global Pharma Market

Module 2: Indian Pharma Market Module 3: Pharma regulatory bodies Module 4: Techniques of analysis and application Module 5: Business Development Operations Module 6: Business Development Functions Module 7: IBD agreements, contracts etc. Module 8: International Patent Regulations (IPR) Module 9: Clinical Trials, and BA/BE Studies Module 10: ICH, CTD, ACTD guidelines Module 11: Techniques of report writing


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Module 1: Global Pharma Market Definition: Global Pharma Market is the total value of Pharmaceutical Formulations in the world sold at the retail level to the final consumers.

Why we should know? To know the pharmaceutical market potential country wise, therapeutic category wise, product wise etc., so that we can make appropriate choices and decisions to achieve company objectives.

Sources of data: Various data such as Health care, Disease pattern, regulatory data, etc., can be obtained from Respective Ministries of Health portals given below (Click on hyperlink): Country

Ministry of Health

Afghanistan

Ministry of Public Health http://moph.gov.af/

Algeria

Ministère de la Santé, de la Population et de la Réforme Hospitalière http://www.sante.gov.dz/

Andorra

Ministeri de Salut i Benestar http://www.salutibenestar.ad/

Angola

Ministério da Saúde http://www.minsa.gov.ao/

Anguilla

Ministry of Social Development http://gov.ai/ministry.php?id=2

Antigua and Barbuda

Minister of Health, Sports and Youth Affairs http://www.ab.gov.ag/gov_v2/governemnt/


4 Country

Ministry of Health

Argentina

Ministerio de Salud de la Nación http://www.msal.gov.ar/htm/site/default.asp

Armenia

Ministry of Health http://www.moh.am/

Australia

Australian Department of Health and Aged Care http://www.health.gov.au/

Austria

Bundesministerium für Gesundheit http://www.bmgfj.gv.at/

Azerbaijan

Ministry of Health http://www.mednet.az/

Bahamas

Ministry of Health http://www.bahamas.gov.bs/bahamasweb2/home.nsf/vContentW/MOHE-Welcome--MOHE+Homepage!Opendocument

Bahrain

Ministry of Health http://www.moh.gov.bh/

Bangladesh

Ministry of Health and Family Welfare http://www.mohfw.gov.bd/

Belarus

Minister of Health http://minzdrav.gov.by/

Belgium

Santé publique, Sécurité de la Chaîne alimentaire et Environnement

Belize

Ministry of Health http://minzdrav.gov.by/

Benin

Ministère de la Santé http://www.ministeresantebenin.com/

Bhutan

Ministry of Health http://www.health.gov.bt/

Bolivia

Ministerio de Salud y Deportes

Bosnia and Herzegovina

Federal Ministry of Health http://www.fbihvlada.gov.ba/english/ministarstva/zdravstvo.php

Botswana

Ministry of Health http://www.moh.gov.bw/

Brazil

Ministério da Saúde http://portal.saude.gov.br/saude/

Brunei

Ministry of Health


5 Country

Ministry of Health

Darussalam

http://www.moh.gov.bn/

Bulgaria

Ministry of Health http://www.mh.government.bg/

Burkina Faso

Ministère de la santé http://www.sante.gov.bf/SiteSante/index.jsp

Burundi

Ministère de la Santé Publique et de la Lutte contre le SIDA http://www.minisante.bi/

Cambodia

Ministry of Health

Cameroon

Ministère de la santé publique http://www.minsante.cm/

Canada

Health Canada http://www.hc-sc.gc.ca/

Cape Verde

Ministério da Saúde http://www.minsaude.gov.cv/

Cayman Islands

Ministry of Health, Environment, Youth, Sports and Culture http://www.gov.ky/portal/page?_pageid=1142,1594292&_dad=portal&_sch ema=PORTAL

Chile

Ministerio de Salud http://www.minsal.cl/portal/url/page/minsalcl/g_nuevo_home/nuevo_hom e.html

China

Ministry of Health http://www.moh.gov.cn/publicfiles//business/htmlfiles/wsb/index.htm

Colombia

Ministerio de la Protección Social http://www.minproteccionsocial.gov.co/Paginas/default.aspx

Cook Islands

Ministry of Health http://www.health.gov.ck/

Costa Rica

Ministerio de Salud

Croatia

Ministry of Health and Social Welfare http://www.mzss.hr/

Cuba

Infomed, Portal de Salud de Cuba http://www.sld.cu/

Cyprus

Ministry of Health http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en?OpenDocument

Czech Republic

Ministry of Health http://www.mzcr.cz/

Côte d’Ivoire

Ministère de la Santé et de l’Hygiène Publique


6 Country

Ministry of Health http://www.sante.gouv.ci/

Democratic Republic of Congo

Ministère de la Santé Publique http://www.minisanterdc.cd/fr/

Denmark

Ministry of Health and Prevention

Dominica

Ministry of Health and Environment http://www.dominica.gov.dm/cms/index.php?q=node/21

Dominican Republic

Secretaría de Estado de Salud Pública y Asistencia Social http://www.sespas.gov.do/

East Timor

Ministério da Saúde

Ecuador

Ministerio de Salud Pública http://www.msp.gov.ec/

Egypt

Ministry of Health and Population http://www.mohp.gov.eg/

El Salvador

Ministerio de Salud Pública y Asistencia Social http://www.salud.gob.sv/

Estonia

Ministry of Social Affairs http://www.sm.ee/

Ethiopia

Ministry of Health http://www.moh.gov.et/

Fiji

Ministry of Health http://www.health.gov.fj/

Finland

Ministry of Social Affairs and Health http://www.stm.fi/sivukartta

France

Ministère de la Santé et des Sports http://www.sante.gouv.fr/

Gambia

Ministry of Health

Georgia

Ministry of Labour, Health and Social Affairs

Germany

Bundesministerium für Gesundheit http://www.bmg.bund.de/

Ghana

Ministry of Health http://www.moh-ghana.org/

Greece

Ministry of Health and Welfare http://www.mohaw.gr/

Grenada

Ministry of health, social security, the environment and ecclesiastic affairs


7 Country

Ministry of Health

Guatemala

Ministerio de Salud Pública y Asistencia Social http://portal.mspas.gob.gt/

Guyana

Ministry of Health http://www.health.gov.gy/

Honduras

Secretaría de Salud http://www.salud.gob.hn/

Hungary

Ministry of Health

Iceland

Ministry of Health http://eng.velferdarraduneyti.is/

India

Ministry of Health and Family Welfare http://mohfw.nic.in/welcome.html

Indonesia

Ministry of Health

Iran

Ministry of Health and Medical Education http://www.hbi.ir/

Iraq

Ministry of Health

Ireland

Department of Health and Children http://www.dohc.ie/

Israel

Ministry of Health http://www.health.gov.il/english/

Italy

Ministero della Salute http://www.salute.gov.it/

Jamaica

Ministry of Health http://www.moh.gov.jm/

Japan

Ministry of Health, Labour and Welfare http://www.mhlw.go.jp/english/

Jordan

Ministry of Health http://www.moh.gov.jo/MOH/arabic/home.php

Kazakhstan

Ministry of Public Health http://www.dari.kz/

Kenya

Ministry of Health http://www.statehousekenya.go.ke/government/health.htm

Kosovo

Ministry of Health

Kuwait

Ministry of Health http://www.moh.gov.kw/

Kyrgyzstan

Ministry of Healthcare


8 Country

Ministry of Health

Laos

Ministry of Health http://www.moh.gov.la/

Latvia

Ministry of Health http://www.vm.gov.lv/

Lebanon

Ministry of Public Health http://cms1.omsar.gov.lb/

Lesotho

Ministry of Health and Social Welfare

Liberia

Ministry of Health & Social Welfare http://liberiamohsw.org/

Libyan Arab Jamahiriya

Secretariat of Health and Environment http://health.gov.ly/web/

Lithuania

Ministry of Health http://www.sam.lt/

Luxembourg

Ministère de la Santé http://www.ms.public.lu/fr/

Macedonia

Ministry of Health http://www.moh.gov.mk/

Madagascar

Ministère de la Santé et du Planning Familial http://www.sante.gov.mg/

Malawi

Ministry of Health

Malaysia

Ministry of Health http://www.moh.gov.my/

Maldives

Ministry of Health http://www.health.gov.mv/

Mali

Ministère de la Santé http://www.sante.gov.ml/

Malta

Ministry for Social Policy http://www.sahha.gov.mt/pages.aspx

Marshall Islands

Ministry of Health http://www.rmiembassyus.org/Health.htm

Mauritania

Ministère de la Santé et des Affaires Sociales

Mauritius

Ministry of Health and Quality of Life http://www.gov.mu/portal/site/mohsite

Mexico

Secretaría de Salud http://portal.salud.gob.mx/


9 Country

Ministry of Health

Moldova

Ministry of Health http://www.ms.md/

Monaco

Département des Affaires Sociales et de la Santé

Mongolia

Ministry of Health http://www.moh.mn/

Montenegro

Ministry of Health

Morocco

Ministère de la Santé http://www.sante.gov.ma/

Mozambiqu e

Ministério da Saúde http://www.misau.gov.mz/

Myanmar

Ministry of Health http://www.moh.gov.mm/

Namibia

Ministry of Health and Social Services http://www.healthnet.org.na/

Nepal

Ministry of Health and Population

Netherlands

Ministry of Health, Welfare and Sport http://www.rijksoverheid.nl/

New Zealand

Ministry of Health http://www.moh.govt.nz/moh.nsf

Nicaragua

Ministerio de Salud http://www.minsa.gob.ni/

Nigeria

Federal Ministry of Health http://www.fmh.gov.ng/

Norway

Ministry of Health and Care Services http://www.regjeringen.no/en/dep/hod.html?id=421

Oman

Ministry of Health http://www.moh.gov.om/

Pakistan

Ministry of Health

Palau

Ministry of Health http://www.palau-health.net/

Palestine

Ministry of Health http://www.moh.gov.ps/newsite/ar/index.php?action=view&page=homepag e

Panama

Ministerio de Salud http://www.minsa.gob.pa/

http://www.gouv.mc/devwww/wwwnew.nsf/1909$/154b43cc4548b197c1256f8d004ffbf8fr?OpenDocument&4Fr


10 Country

Ministry of Health

Papua New Guinea

Department of Health http://www.health.gov.pg/

Paraguay

Ministerio de Salud Pública y Bienestar Social http://www.mspbs.gov.py/v2/index.php

Peru

Ministerio de Salud http://www.minsa.gob.pe/portada/

Philippines

Department of Health http://www.doh.gov.ph/

Poland

Ministry of Health http://www.mz.gov.pl/

Portugal

Direcção-Geral da Saúde http://www.dgs.pt/

Puerto Rico

Departamento de Salud http://www.salud.gov.pr/Pages/default.aspx

Qatar Romania Russian Federation Rwanda Saint Kitts and Nevis

Ministry of Health http://portal.www.gov.qa/wps/portal/frontpage/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3gzA0sjR18Lk9AgHyc LA09vD1NTP3cjYwMDM_1wkA6zeAMcwNFA388jPzdVvyA7rxwAav-zag!!/dl3/d3/L2dBISEvZ0FBIS9nQSEh/

Ministerul Sanatatii http://www.ms.ro/ Ministry of Health and Social Development http://www.minzdravsoc.ru/ Ministry of Health http://www.moh.gov.rw/ Ministry of Health http://mohdemo.gov.kn/

Saint Lucia

Ministry of Health, Human Services, Family Affairs and Gender Relations http://www.stlucia.gov.lc/agencies/ministry_of_health.htm

Samoa

Ministry of Health http://www.health.gov.ws/

San Marino

Segreteria di Stato per la Sanità, la Sicurezza Sociale, la Previdenza, la Famiglia, gli Affari Sociali e le Pari Opportunità http://www.sanita.sm/on-line/Home.html

Sao Tome and Principe

Ministério da Saúde http://www.gov.st/data/filestorage/docs/minsaude.htm


11 Country

Ministry of Health

Saudi Arabia

Ministry of Health http://www.moh.gov.sa/Pages/Default.aspx

Senegal

Ministère de la Santé et de la Prévention http://www.sante.gouv.sn/

Serbia

Ministry of Health http://www.zdravlje.gov.rs/

Seychelles

Ministry of Health http://www.moh.gov.sc/

Sierra Leone

Ministry of Health and Sanitation

Singapore

Ministry of Health http://www.moh.gov.sg/mohcorp/default.aspx

Slovakia

Ministry of Health http://www.health.gov.sk/

Slovenia

Ministry of Health http://www.mz.gov.si/

South Africa

Department of Health http://www.doh.gov.za/

South Korea

Ministry of Health, Welfare and Family Affairs http://www.mohw.go.kr/front/index.jsp

Spain

Ministerio de Sanidad y Política Social http://www.msc.es/

Sri Lanka

Ministry of Healthcare and Nutrition http://www.health.gov.lk/

Sudan

Federal Ministry of Health http://www.fmoh.gov.sd/

Suriname

Ministrie van Volksgezondheid http://www.volksgezondheid.gov.sr/

Swaziland

Ministry of Health and Social Welfare

Sweden

Ministry of Health and Social Affairs http://www.sweden.gov.se/sb/d/2061

Switzerland

Federal Office of Public Health http://www.bag.admin.ch/aktuell/

Syria

Ministry of Health

Taiwan

Department of Health http://www.doh.gov.tw/cht2006/index_populace.aspx

Tajikistan

Health Ministry


12 Country

Ministry of Health http://www.health.tj/

Tanzania

Ministry of Health and Social Welfare http://www.moh.go.tz/

Thailand

Ministry of Public Health http://www.moph.go.th/moph2/index4.php

Tonga

Ministry of Health http://www.health.gov.to/

Trinidad and Tobago

Ministry of Health http://www.health.gov.tt/

Tunisia

La santé en Tunisie

Turkey

Ministry of Health http://www.saglik.gov.tr/TR/ana-sayfa/1-0/20110427.html

Uganda

Ministry of Health http://www.health.go.ug/

Ukraine

Ministry of Health http://www.moz.gov.ua/ua/portal/

United Arab Emirates United Kingdom United States of America

Ministry of Health http://www.moh.gov.ae/ar/Pages/default.aspx Department of Health http://www.dh.gov.uk/en/index.htm Department of Health & Human Services http://www.dhhs.gov/

Uruguay

Ministerio de Salud Pública http://www.msp.gub.uy/index_1.html

Uzbekistan

Ministry of Health http://www.med.uz/

Venezuela

Ministerio del Poder Popular para la Salud

Vietnam

Ministry of Health http://www.moh.gov.vn/web/guest/home

Yemen

Ministry of Public Health and Population http://www.mophp-ye.org/english/index.html

Zambia

Ministry of Health


13 Country

Ministry of Health

Zimbabwe

Ministry of Health and Child Welfare http://www.mohcw.gov.zw/

On-line reports: On line reports on each country’s health and pharmaceuticals can also be obtained from the following websites: http://www.who.int/whr/en/index.html http://www.who.int/publications/en/ https://apps.who.int/infobase/report.aspx http://apps.who.int/globalatlas/ http://www.imshealth.com/portal/site/imshealth http://www.imsglobal.org/ http://www.fda.gov/ http://www.hhs.gov/ http://www.nih.gov/ http://www.pharmaceutical-business-review.com/ http://www.pharmiweb.com/

Pharma research portals: Detailed research into various aspects of Pharma markets can also be obtained from the following research portals. Most of these need subscription or charge for each of the reports. http://www.datamonitor.com/ http://www.globalbusinessinsights.com/hc/hc_portfolio.htm http://www.businessmonitor.com/ http://www.frost.com/ http://www.marketlineinfo.com/ http://www.marketresearch.com/

Journal /Magazine publications etc.: Some of the secondary data can also be obtained from the following journals and magazines. European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) European Federation of Pharmaceutical Industries and Associations (EFPIA) European Pharmaceutical Market Research Association (EphMRA) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Japan Pharmaceutical Manufacturers Association (JPMA)


14 New York Health Products Council (NYHPC) Pharmaceutical Research and Manufacturers of America (PhRMA) Irish Pharmaceutical Healthcare Association (IPHA)

Types of data: Data such as basic statistics, overview, disease outbreaks & crises, mortality and burden of disease, health services, risk factors, health systems etc., could be obtained from each country profiles (Please click on each country’s link)

Country profiles Afghanistan Albania Algeria Andorra Angola Antigua and Barbuda Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bhutan Bolivia (Plurinational State of) Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso

Democratic People’s Republic of Korea Democratic Cuba Cyprus Czech Republic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Fiji Finland France Gabon Gambia Georgia Germany Ghana Greece

Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Lithuania Luxembourg Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Mauritania Mauritius Mexico Micronesia (Federated States of) Monaco Mongolia Montenegro

Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar Republic of Korea Republic of Moldova Romania Russian Federation Rwanda Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia

Somalia South Africa Spain Sri Lanka Sudan Suriname Swaziland Sweden Switzerland Syrian Arab Republic Tajikistan Thailand The former Yugoslav Republic of Macedonia Timor-Leste Togo Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Tuvalu Uganda Ukraine United Arab Emirates United


15 Burundi Cambodia Cameroon Canada Cape Verde Central African Republic Chad Chile China Colombia Comoros Congo Cook Islands Costa Rica Côte d’Ivoire Croatia

Grenada Guatemala Guinea Guinea-Bissau Guyana Haiti Honduras Hungary Iceland India Indonesia Iran (Islamic Republic of) Iraq Ireland Israel Italy Jamaica Japan Jordan

Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Zealand Nicaragua Niger Nigeria Niue Norway

Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands

Kingdom United Republic of Tanzania United States of America Uruguay Uzbekistan Vanuatu Venezuela (Bolivarian Republic of) Viet Nam Yemen Zambia Zimbabwe

Country wise healthcare data can also be obtained from the following:

http://www.who.int/whosis/en/ http://www.nationmaster.com/ Http://www.pwc.com/us/en/healthcare/.../secondary-health-data.jhtml http://www.imf.org/external/pubs/ft/survey/so/.../BOK051C.htm http://www.thehealthcareblog.com/...health_care.../medical-data-in-the-internetcloud-part-3-data-privacy.html Country wise Economic indicators could be obtained from the following links: https://www.cia.gov/library/publications/the-world-factbook/ http://www.economywatch.com/economic-statistics/country/ http://www.imf.org/external/data.htm http://www.oecd.org/.../0,3343,en_2649_34265_2367750_1_1_1_1,00.html http://www.forextradinghq.com/forex-information/economic-indicators http://unfccc.int/ghg_data/ghg_data_non_unfccc/items/3170.php http://www.library.mcgill.ca/edrs/links/country/country.html http://www.imf.org/external/pubs/ft/weo/2009/01/weodata/index.aspx Country wise Pharmaceutical sales data could also be obtained from: http://apps.who.int/medicinedocs/en/d/Js6160e/6.html


16 http://en.wikipedia.org/wiki/Pharmaceutical_industry http://www.piribo.com/publications/general_industry/pharmaceutical_market_trends_ 2008_2012.html http://www.marketresearch.com/map/prod/2539915.html http://www.researchandmarkets.com/reports/481962

What to analyze and why? Economic indicators: The following economic indicators are important to evaluate and formulate entry strategies for each country. GDP (purchasing power parity): A nation’s GDP at purchasing power parity (PPP) exchange rates is the sum value of all goods and services produced in the country valued at prices prevailing in the United States. This is the measure most economists prefer when looking at per-capita welfare and when comparing living conditions or use of resources across countries. GDP (official exchange rate): A nation’s GDP at official exchange rates (OER) is the home- currency-denominated annual GDP figure divided by the bilate ral average US exchange rate with that country in that year. The measure is simple to compute and gives a precise measure of the value of output. GDP - real growth rate: This entry gives GDP growth on an annual basis adjusted for inflation and expressed as a percent. GDP - per capita (PPP): This entry shows GDP on a purchasing power parity basis divided by population as of 1 July for the same year. Population: The total population presents one overall measure of the potential impact of the country on the world and within its region. Budget: This entry includes revenues, expenditures, and capital expenditures.

Inflation rate (consumer prices): This entry furnishes the annual percent change in consumer prices compared with the previous year’s consumer prices. Exports: This entry provides the total US dollar amount of merchandise exports on an f.o.b. (free on board) basis. These figures are calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms. Imports: This entry provides the total US dollar amount of merchandise imports on a c.i.f. (cost, insurance, and freight) or f.o.b. (free on board) basis. These figures are


17 calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms. Reserves of foreign exchange and gold: This entry gives the dollar value for the stock of all financial assets that are available to the central monetary authority for use in meeting a country’s balance of payments needs as of the end -date of the period specified. This category includes not only foreign currency and gold, but also a country’s holdings of Special Drawing Rights in the International Monetary Fund, and its reserve position in the Fund. Debt - external: This entry gives the total public and private debt owed to nonresidents repayable in foreign currency, goods, or servi ces. These figures are calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms. Exchange rates: This entry provides the official value of a country’s monetary unit at a given date or over a given period of time, as expressed in units of local currency per US dollar and as determined by international market forces or official fiat. The International Organization for Standardization (ISO) 4217 alphabetic currency code for the national medium of exchange is presented in parenthesis. (Source: https://www.cia.gov/library/publications/the-world factbook/docs/notesanddefs.html)

Global Pharma Market 1. Total Unaudited and Audited Global Pharmaceutical Market, 2002 – 2009 2002 2003 2004 2005 2006 433 499 559 605 649 Total World market (*US$ in billions) 515 562 605 650 694 Total World market (**Constant US$ in billions) 9.10% 9.10% 7.70% 7.30% 6.80% Growth Over Previous year in % (**Constant US$ Growth) Source: IMS Health Market Prognosis, March 2010 Includes IMS Audited and Unaudited markets All information current as of March, 2010 * US$ uses actual quarterly exchange rates ** Constant $ uses Q409 average exchange rates

2007 717

2008 781

2009 808

742

782

837

6.80%

5.50%

7.00%


18 2. Total Unaudited and Audited Global Pharmaceutical Market By Region 2008 2009 Mkt Size Mkt Size % Growth % Growth *US$bn **Const. **Const. **Const US$ US$ US$ Global 808.3 837.3 7.00% 5.50% 322.1 323.8 5.5% 1.9% North America 247.6 263.9 4.8% 7.0% Europe 102.6 106.6 15.9% 15.0% Asia/Africa/Australia 90.3 95.0 7.6% 2.1% Japan 45.8 47.9 10.6% 12.7% Latin America Source: IMS Health Market Prognosis, March 2010

2004-2009 2010 2009-2014 CAGR % Forecast % CAGR % **Const Growth **Const **Const US$ US$ US$ 6.70% 4 - 6% 5 - 8% 5.2% 3 - 5% 3 - 6% 6.6% 3 - 5% 3 - 6% 13.9% 13 - 15% 12 - 15% 3.9% 0 - 2% 2 - 5% 10.9% 10 - 12% 12 - 15%

Notes on Numbers: All forecasts are from IMS Market Prognosis International 2010-2014 which provides a view of the audited and unaudited market, using audited sales and adjusting for unaudited sales. The forecasts are based on the March 2010 Market Prognosis release; the next scheduled update is end of October 2010. Includes IMS Audited and Unaudited markets * US$ uses actual quarterly exchange rates ** Constant $ uses Q409 average exchange rates

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3. Global Products, 2009, Total Audited Markets 2009 rank 2009 Sales % Growth 2008 Sales % Growth 2007 Sales % Growth 2006 Sales (US$) (US$ MN) 2009 (LC$) (US$ MN) 2008 (LC$) (US$ MN) 2007 (LC$) (US$ MN) Global Market 0 752,022 6.7 727,067 5.1 671164 6.3 609,614 LIPITOR 1 13,288 -0.3 13,646 -0.1 13454 -2.4 13,458 PLAVIX 2 9,100 7.9 8,657 16.8 7289 21.8 5,751 NEXIUM 3 8,236 7.1 7,828 8.3 7146 5.8 6,607 SERETIDE 4 8,099 8.9 7,697 7.3 7113 10.0 6,254 SEROQUEL 5 6,012 13.4 5,376 15.0 4619 17.1 3,875 ENBREL 6 5,863 9.3 5,521 8.6 4993 10.8 4,404 REMICADE 7 5,453 13.1 4,919 14.9 4198 15.4 3,564 CRESTOR 8 5,383 39.2 3,942 30.9 2988 41.0 2,081 ZYPREXIA 9 5,357 9.3 5,026 -2.2 5016 3.5 4,697 HUMIRA 10 5,032 31.8 3,941 43.6 2692 34.8 1,928 AVASTIN 11 5,015 27.2 4,009 40.2 2837 41.3 1,981 SINGULAR 12 4,986 8.9 4,639 3.9 4407 15.3 3,763 MABTHERA 13 4,681 9.5 4,404 15.4 3712 12.3 3,213 ABILIFY 14 4,673 31.7 3,574 30.6 2714 26.4 2,130 LOVENOX 15 4,572 8.1 4,375 9.0 3921 12.9 3,345 Source: IMS Health Midas, December 2009 US$: Sales and Rank are in US$ with quarterly exchange rates LC$: Growth is in constant $ to normalize for exchange rate fluctuations Growth rates in US$ are not recommended due to extreme fluctuations in the value of the dollar Sales cover direct and indirect pharmaceutical channel wholesalers and manufacturers. The figures above include prescription and certain over the counter data and represent manufacturer prices.

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% Growth 2005 Sales 2006 (LC$) (US$ MN) 6.8 568,047 4.4 12,846 -2.6 5,904 17.3 5,607 10.4 5,617 18.9 3,255 17.2 3,768 21.4 2,942 57.5 1,306 0.4 4,680 50.3 1,276 104.8 976 18.2 3,178 19.5 2,681 33.2 1,605 12.3 2,959

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% Growth 2005 (LC$) 7.5 6.0 16.1 17.0 19.0 28.0 42.9 17.6 43.8 -5.8 72.3 284.5 16.2 23.7 60.0 13.0

4. Global Therapeutic Classes, 2009, Total Audited Markets 2009 rank 2009 Sales % Growth 2008 Sales % Growth 2007 Sales (US$) (US$ MN) 2009 (LC$) (US$ MN) 2008 (LC$) (US$ MN) Global Market 0 752,022 6.7 727,067 5.0 671,164 Oncologics 1 52,372 8.8 49,438 13.4 41,949 Lipid Regulators 2 35,281 4.9 34,445 -1.2 34,141 Respiratory Agents 3 33,596 11.0 31,186 5.9 28,775 Antidiabetics 4 30,406 13.4 27,548 10.1 24,401 Anti-ulcerants 5 29,610 0.6 30,032 0.0 29,174 Angiotensin II Antagonists 6 25,209 11.5 22,998 13.3 19,418 Antipsychotics 7 23,248 4.6 22,742 7.7 20,693 Antidepressants 8 19,416 -1.3 20,194 1.1 19,581 Autoimmune agents 9 17,961 18.0 15,612 19.3 12,815 Platelet Aggr. Inhibitors 10 14,604 9.0 13,647 10.4 11,952 HIV Antivirals 11 13,758 14.9 12,280 12.7 10,699 Anti-epilectics 12 12,995 -19.8 16,792 9.8 15,136 Narcotic analgesics 13 11,235 8.6 10,534 8.9 9,530 Non-narcotic analgesics 14 11,174 7.3 11,187 4.1 10,451 Erythropoietins 15 10,806 -4.1 11,467 -13.2 12,883 Source: IMS Health Midas, December 2009 US$: Sales and Rank are in US$ with quarterly exchange rates LC$: Growth is in constant $ to normalize for exchange rate fluctuations Growth rates in US$ are not recommended due to extreme fluctuations in the value of the dollar Sales cover direct and indirect pharmaceutical channel wholesalers and manufacturers. The figures above include prescription and certain over the counter data and represent manufacturer prices.

% Growth 2007 (LC$) 6.3 15.8 -5.8 11.9 10.8 2.6 14.0 11.4 -6.2 17.4 8.7 12.8 13.7 12.9 7.9 -8.3

2006 Sales % Growth 2006 (US$ MN) (LC$) 609,614 6.8 34,905 21.6 35,358 7.9 24,796 11.4 21,310 12.7 27,619 3.0 16,405 15.2 18,060 11.7 20,374 3.6 10,629 21.6 10,624 8.1 9,175 10.9 12,955 11.3 8,219 -1.1 9,110 3.1 13,803 12.0

2005 Sales % Growth 2005 (US$ MN) (LC$) 568,047 7.5 28,555 19.2 32,601 6.9 22,106 13.8 18,790 12.6 26,792 4.2 14,255 18.3 16,115 11.1 19,586 -3.6 8,755 32.0 9,810 10.1 8,236 11.4 11,569 1.3 8,301 3.1 8,726 6.7 12,254 7.2


19 5. Global Corporations, 2009, Total Audited Markets 2009 rank (US$)

2009 Sales (US$ MN) 752,022 57,024 38,963 38,460 35,524 34,973 34,434 32,763 26,783 20,310 19,840 15,947 15,711 15,275 15,038 14,352

2008 Sales (US$ MN) 727,067 58,677 39,488 36,684 36,437 36,736 32,498 30,285 29,638 19,042 19,401 15,143 15,887 14,109 15,281 13,835

2007 Sales (US$ MN) 671,164 59,909 39,365 34,479 34,390 37,620 29,999 27,232 29,010 17,177 17,359 13,295 14,103 12,556 15,900 12,754

2006 Sales (US$ MN) 609,614 59,415 35,965 31,653 31,843 36,212 27,311 23,168 27,615 15,176 15,971 11,664 12,329 11,320 15,932 11,786

2005 Sales (US 568,047 59,204 33,676 29,427 31,286 34,222 24,420 19,706 26,771 13,977 14,715 9,677 11,588 10,385 13,162 11,265

0 Global Market 1 PFIZER 2 MERCK & CO 3 NOVARTIS 4 SANOFI-AVENTIS 5 GLAXOSMITHKLINE 6 ASTRAZENECA 7 ROCHE 8 JOHNSON & JOHNSON 9 LILLY 10 ABBOTT 11 TEVA 12 BAYER 13 BOEHRINGER INGEL 14 AMGEN 15 TAKEDA Source: IMS Health Midas, December 2009 US$: Sales and Rank are in US$ with quarterly exchange rates Sales cover direct and indirect pharmaceutical channel wholesalers and manufacturers. The figures above include prescription and certain over the counter data and represent manufacturer prices.

Global Pharma Market maintains growth expectations of 4-6% in 2010. Forecast: 5-8% annually through 2014. To reach $1.1 trillion by 2014 growing nearly $300 billion in the next 5 years. The growth in 2008 was 4.8 percent but where as in 2009, the market growth was 7% reaching $837 billion. Leading products loose patent protection in developed markets and strong growth in emerging markets tilt growth towards generics Pressure from the payers to curb drug spending on the publicly funded healthcare plans in developed markets will only intensify growth, which will be more than offset by the ongoing, rapid expansion of demand in the Pharmerging markets. The net result over the next five years will be a strong growth — in spite of industry facing the peak years of patent expiries and entry of lower-cost generic alternatives. Pharmerging countries continue to tilt the geographic balance of Global pharmaceutical market. While developed markets will grow only 3-6%, Pharmerging markets will record a growth of 14 – 17% through 2014 which will be around $120-$140 billion from $69 billion over the past 5 years, similar to the growth of developed markets. The U.S. shall continue to remain the single largest market, reaching $360 - $390 billion in 2014, up from $300 billion in 2009, with 3 - 6 percent growth expected annually in the next five years. Therapy area growth dynamics driven by innovation cycle and areas of unmet need. Higher growth will occur in the therapy areas where there is significant unmet clinical need, high cost burden of disease and new treatment options through innovative science. As the new drugs are brought to market, patient access is expanded and funding is redirected from other areas where lower-cost generics will be available, annual growth is expected to exceed 10 percent through 2014 in the areas of oncology, diabetes, multiple sclerosis and HIV.


20 Drug budgets growth reduced due to cuts in spending applied by public payers. Due to global economic down turn, publicly funded health systems are under increased pressure to reduce growth in drug budgets. Countries such as Turkey, Spain, Germany and France already have announced restrictions on access or reductions in reimbursements to reduce drug spending growth. Other countries under pressure to restore fiscal balance may take similar actions, or shift more costs to patients. Generic dominance shall increase as patents expire. In the next five years, as the patents of products with sales of more than $142 billion expire and face generic competition in major developed markets, the patients shift to lower-cost generics in major therapy areas such as cholesterol regulators, antipsychotics and anti-ulcerants reducing the total drug spending by about $80 - $100 billion worldwide through 2014. This will impact the U.S., where nearly twothirds of the total value of patent expiries will occur. Patents of 6 products out of 10 will face generic competition in the U.S. and will peak in 2011 and 2012. Payers spend less initially while new products await scrutiny. 30 -35 new molecular entities will be launched annually over the next five years. But before being accepted into clinical practice and reimbursed, these will be subject to more rigorous and complex assessments by payers. In many countries such as China, Spain, Italy and Canada, funding and implementation of healthcare at regional or local levels is becoming more significant which will extend the time it takes for new medicines to become available to patients, and therefore contribute to lower initial spending by payers.

The US market – growth improves to 6% The US pharmaceutical market, which constitutes around 45% of the global market, Grew by 6% — from US$206.4bn to US$218.8bn (Rs9, 310bn-Rs9, 870bn). The growth Rate for Nov’09 was 5%, indicating a steady improvement of the US Pharma market. Moreover, the US Pharma market is growing at 6% in line with the global markets indicating steady and sustainable growth. The Canadian pharmaceutical market, much smaller in size as compared to the US market, grew by 7% — from US$16.3bn to US$17.4bn (Rs735bn to Rs785bn).

European markets – signs of sluggishness The five major European pharmaceutical markets (Germany, France, Italy, UK and Spain) grew by 2% — from US$108.1bn to US$110.3bn (Rs4,880bn to Rs4,980bn). The growth rate of 3% in November’09 fell to 2% indicating that the European market is showing signs of sluggishness.


21

Details of key country drug purchases in these markets are shown in the table below: Particulars 12 months ending

12 months ending Jan’09 % Growth Economic downturn affects markets Growth has slowed in countries where with high out-of-pocket spending on drugs and steep decline in macroeconomic activity especially in Russia, Mexico and S. Korea. Growth has been less affected in countries where drugs are largely funded publicly, such as Germany, Japan and Spain. Chinese market – likely to grow over 20% China’s pharma market is expected to grow at over 20% per annum and contribute 21% of overall global growth through 2013. Global events According to IMS data (for 12 months ending January 2010): The top five global pharmaceutical companies were Pfizer, Merck, Astra Zeneca, Novartis and Glaxo Smith Kline (GSK). The five largest-selling drugs were Lipitor (Pfizer), Plavix (Bristol Meyer Squibb, Sanofi Aventis), Nexium (Astra Zeneca), Seretide/Advair (Glaxo Smith Kline) and Crestor (Astra Zeneca). The top five therapeutic classes were: cholesterol and triglyceride regulators, anti-ulcerants, anti-depressants, anti-psychotics and Angioten-II antagonists. Global news


22 • Clinical trials carried out by MNC pharma companies in India has seen a 30% drop from 229 trials in 2008 to 158 trials in 2009. This is due to sharp reduction in R & D budgets in 2009 due to global recession and shrinking R & D pipeline of MNC pharma companies. • Astra Zeneca has signed an agreement with Torrent Pharma to market 18 of its products in 9 emerging markets. • Glenmark Pharma has been issued a warning letter by US FDA for marketing unapproved Nitroglycerin tablets in the US. • Novo Nordisk has launched its new diabetes drug Victoza in the US. • The US FDA has approved Astra Zeneca’s statin Crestor for additional indications. • Roche and Biogen’s Rituxan were cleared by US FDA for the treatment of chronic leukemia. • The US FDA approved Pfizer’s Prevenar 13 pneumococcal vaccine. • Daiichi Sankyo is forming a new subsidiary in April’10 for the sale of generics in Japan. • US FDA has warned Eli Lilly about manufacturing problems at its Puerto Rican plant that manufactures Humalog Insulin. US Healthcare Bill • Legislation to overhaul US Healthcare system would cost $940bn over next 10 years. • The Bill will extend coverage to 32m uninsured Americans. This will include aged people or those deprived of insurance based on pre-conditions. The drug requirement for them will be high. • With this 95% of the US population will be covered by healthcare. • It will cut the federal budget deficit by $138bn in the first decade. • Insurers such as Cigna Corporation would get millions of new policyholders and are required to accept all customers. • Big pharma companies including Pfizer and Amgen will be major beneficiaries. • The new regulations are likely to generate direct new business of $115bn over the next 10 years ($11bn per annum). • The branded biologics will have exclusive period of 12 years instead of 7 years earlier, leading to prolonged protection. This is positive for US biotech companies.

Global Pharmaceutical Market Estimated to Double to $1.3 Trillion by 2020 The global pharmaceutical market shall more than double in value and reach $1.3 trillion by 2020, driven by soaring worldwide demand for medicines as the population grows, ages and becomes more obese and as chronic conditions and infectious diseases tied to global warming increase. It is warned that the current pharmaceutical business model is unsustainable and the industry must fundamentally change the way it operates if it is to capitalize on future growth opportunities. The E7 countries - Brazil, China, India, Indonesia, Mexico, Russia and Turkey – could account for as much as one-fifth of global pharmaceutical sales by 2020, an increase of 60 percent since 2004. Further, as these countries become more prosperous, the chronic conditions in the


23 developing world will increasingly resemble those of the developed world, with a significant rise in hypertension and diabetes. Many scientists also predict that global warming and rise in greenhouse gases will have a major effect on the world’s health, with the spreading of diseases such as malaria, cholera and higher prevalence of respiratory illnesses such as asthma and bronchitis. The pharma industry will not be able to meet the challenge unless R&D productivity improves. The Pharma Industry lacks innovation. The industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced. It is simply an unsustainable business model. The current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments that will be demanded by global markets. Pharmaceutical companies are facing a dearth of new compounds in the pipeline, poor share value performance, rising sales and marketing expenditures, increased legal and regulatory constraints and tarnished reputations. In the next decade, the industry must invest in research and focus less on sales and marketing. Pharma’s traditional strategy of placing big bets on a few small molecules, marketing them heavily into primary care with the aspiration of achieving blockbuster sales, will no longer be viable. The Industry must focus on the development of medicines that prevent, treat or cure. These must demonstrate tangible benefits and tackle unmet medical needs. Governments and payers must play their part and ensure the industry is rewarded for these efforts.� Some of the major changes expected are: The blockbuster sales model shall be replaced by a smaller, smarter and more effective sales force, led by key account managers who will negotiate contracts based on therapeutic benefit and outcomes. The quality of value shall prevail over the quantity. Integrated packages of medicines and services, and some services, such as personalized patient monitoring and disease management, shall be more valuable than the medicines themselves. Emphasis on outcomes to increase. Successful companies will prove that their products really work and add value. Companies also will be financially rewarded for developing new therapies versus me-too medicines. Risk-sharing agreements will become more mainstream with drug manufacturers adjusting prices according to the results of outcomes analysis data that demonstrates drug efficacy.


24 Compliance monitoring becomes win-win for patients, payers and providers. Solutions to monitor and ensure that patients are fully compliant with their medications could generate more revenue a year in new sales, and would improve outcome and patient safety. Pharmaceutical companies will revise their proposition, employ new technologies and develop personalized compliance monitoring techniques as a value-added service to patients, payers and providers. Prevention shall come first than treatment. Pharma companies health management, with wellness programs, compliance monitoring and a significant increase in the production of vaccinations. Vaccines market is estimated to grow to $42 billion by 2015. New technologies will drive R&D. Technological transformations such as genetic-based diagnostics, human genome etc., shall reshape the business strategies. The current linear R&D process will give way to in-life testing and live licensing. Phase I, II III and IV clinical trials will be replaced by collaborative in-life testing and ‘live license’ issued contingent on the ongoing performance. Greater international regulatory cooperation. There may well be one global regulatory system by 2020. Such a system would help to reduce the spiraling costs of regulatory compliance and reduce time to market. The supply chain functions will become revenue generating. The future supply chain will be revenue generating rather than a cost center. 2020 will likely give rise to ‘made to order’ therapies. More sophisticated direct-to-consumer distribution channels shall diminish the role of wholesalers. Growing self medication sector, automated dispensing direct to consumers, automated prescriptions etc., will supplant reliance on wholesalers. The entire global health care system is being subjected to a seismic shift or upheaval that will force the pharmaceutical companies to change the way they operate. The challenges are steep, but the rewards could be significant. (Adapted from http://www.PharmaManufacturing.com)


International Pharma Business - Global Pharma Market