Plan de Internacionalización de la Industria Farmacéutica

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Nicolás Ponce Piñeiro
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Plan de Internacionalización de la Industria Farmacéutica Introducción al Grupo CTPSYSTEM 1 Programa de Internacionalización del Sector Farmacéutico Argentino Análisis de Oportunidades en Distintos

África Perfil Exportador Local Perfil Importador Local Plan de Internacionalización de la Industria Farmacéutica Sitio web: sectorfarmaceutico.mdebuenosaires.gob.

Apertura Aspectos comerciales del comercio exterior.

1 Plan de Internacionalización de la Industria Farmacéutica Introducción al Grupo CTPSYSTEM 1 Programa de Internacionalización del Sector Farmacéutico Argentino Análisis de Oportunidades en Distintos Mercados Internacionales Relatores: Myriam Tevez / Leandro Mbarak Evolución del Mercado Farmacéutico Internacional Análisis de Oportunidades Brasil Rusia y Asia Central India China Japón Norte de África Perfil Exportador Local Perfil Importador Local Plan de Internacionalización de la Industria Farmacéutica Sitio web: sectorfarmaceutico.mdebuenosaires.gob.ar 4 Conferencia Abierta ETIF (19 de Octubre) Participación CPhI Buenos Aires Conferencias ETIF Organización Ronda de Negocios ETIF Conferencia sobre Requerimientos Regulatorios Internacionales Apertura Aspectos comerciales del comercio exterior.(estoy preparado para exportar mis productos o servicios) Qué tipo de cliente busco y cómo detecto mis contrapartes; Herramientas de promoción comercial. Aspectos legales del comercio internacional.(contratos y aspectos relevantes en las negociaciones) Herramientas de apoyo a pymes. Dirección de Comercio Exterior de la Ciudad. Oportunidades de negocios para empresas Argentinas. 6 1

Congreso ETIF (0 de Octubre) CTD and Regional Variations of CTD MENA and Caspian Region

Requirements 7 8 Requerimientos para la Exportación: cuál es el GAP con las regulaciones

Estudio del Perfil Importador y Exportador Local Estudio del Perfil Importador y Exportador

Análisis de Regulaciones locales vs EMEA/FDA Compatibilidad de Requisitos Regulatorios y

2 Congreso ETIF (0 de Octubre) CTD and Regional Variations of CTD MENA and Caspian Region Pharmaceutical Markets and Regulatory Strategies International and ANVISA Traceability Requirements 7 8 Requerimientos para la Exportación: cuál es el GAP con las regulaciones EMEA/FDA y que fortalezas poseen los productores Argentinos Fecha: 16 y 18 de noviembre Estudio del Perfil Importador y Exportador Local Estudio del Perfil Importador y Exportador de Brasil Oportunidades en Mercados no Tradicionales Introducción al Grupo CTPSYSTEM GAP Análisis de Regulaciones locales vs EMEA/FDA Compatibilidad de Requisitos Regulatorios y Estrategias de Exportación Evolución del CTD en Distintos Mercados Workshop y discusión del GAP Análisis

3 R&D Regulatory Engineering Engineering & Validation Process & Quality IT to Compliance GMP System Integration Business Development Auditing & Quality in Outsourcing Training Basic Chemical & Microbiological Analysis Formulation Development Stability Studies (ICH/ASEAN) Analytical Methods & Library Development & Validation Analytical for Regulatory Issues (Dossier, re-testing. etc.) Raw Material Qualification Analytical Methods Transfer & Labs Qualification 1 Methods Transfer & Labs Qualification Equipment Qualification Validation of Sanitizing products AAA Abbott Acom ACRAF Acs Dobfar Alfa Wassermann Antibioticos Astra Zeneca Bausch & Lomb Baxter Bayer Boehringer-Ingelheim Bracco Bristol-Myers Squibb Cambrex Chemifarma Chiesi Farmaceutici CCT Di pharma Dompé Doppel DSM Edmond Pharma Eli Lilly E-pharma Eurand Fidia FIS Flamma Formenti Gambro GE GelfiPharma, Gnosis GSK Hardis Helsinn Hospira IBA IBN Savio Infra Italfarmaco ITEL Janssen-Cilag 14 Kedrion Menarini Merck-Serono NSA Novartis Opocrin Patheon Pfizer Pierrel Procos RBM Recordati Sanofi-Aventis Schering-Plough Sigma-Tau S.I.M.S. Takeda Temmler Wyeth Zambon RANKING BY ETHICAL DRUG SALES Vs Evolución del Mercado Farmacéutico Internacional Hoechst Bayer Merck & Co Ciba Geigy Pfizer AHP Roche Sandoz Eli Lilly Abbott Warner Lambert Upjohn Johnson & Johnson Pfizer Roche GSK Novartis Sanofi Aventis Astrazeneca Abbott Merck & Co BMS Bayer Eli Lilly 1 16 Rank Company Country 17 Total Revenues (USD millions) 1 Johnson & Johnson [] United States 61,897 Pfizer [] United States 0,009 Roche [4] Switzerland 4,04 4 GlaxoSmithKline [] United Kingdom 44,41 Novartis [6] Switzerland 44,67 6 Sanofi-Aventis [7] France 40,870 7 AstraZeneca [8] United Kingdom,804 8 Abbott Laboratories United States 0,800 9 Merck & Co. [9] United States 7,48 10 Bristol-Myers Squibb United States tbd 11 Bayer HealthCare[ 10] Germany,97 1 Eli Lilly [11] United States 1,86 Pharma Market: Growth Expectations for 010 Will hold steady at 009 levels * US: 1-%, EU: -4% Japan: 4-% BRIC: 14-16% Brand Pharma Innovation slump Blockbusters losing patent protection In 01 Brand products will represent from 60% to 0-0% of the total revenues Generics Increasing competition, especially from India Low cost API coming from India, China Margin pressures in U.S., UK, Germany Drop in small molecule opportunities post Reference: IMS Global Pharmaceutical and Therapy Forecast

revenues as a result of patent expires Company 010 011 01 AstraZeneca BMS Share of Revenues (%) Arimidex $.bn Seroquel $4.7bn Symbicort $.7bn 8 US Plavix Avapro $4.8bn $1.bn Abilify $.

0bn 14 Pfizer Aricept $800m Sanofi-Aventis Taxotere $bn Lipitor $1.1bn Viagra $4.bn Xalatan US Plavix Avapro $1.6bn $.8bn $.1bn Detrol $860m Geodon $1.1bn 41 Lovenox $.

product introduction no longer affordable at country/region level Leaders positioned in all key countries with globally designed business systems All major pharmaceutical companies want to

4 R&D cost, Dev.times, NME output and Sales world growth from 1996 to Reference: CMR International Table 1: The leading pharmaceutical companies will lose between 14% and 41% of their existing revenues as a result of patent expires Company AstraZeneca BMS Share of Revenues (%) Arimidex $.bn Seroquel $4.7bn Symbicort $.7bn 8 US Plavix Avapro $4.8bn $1.bn Abilify $.1bn 0 GSK Advair $.8bn Avandia $.bn Eli Lilly Zyprexa $4.8bn Merck Cozaar/ Hyzaar $.bn Singulair $4.bn Novartis Femara $1.1bn Diovan $6.0bn 14 Pfizer Aricept $800m Sanofi-Aventis Taxotere $bn Lipitor $1.1bn Viagra $4.bn Xalatan US Plavix Avapro $1.6bn $.8bn $.1bn Detrol $860m Geodon $1.1bn 41 Lovenox $.1bn 4 Dry pharma pipelines Increasing competition for in-licensing Price pressure from healthcare systems Increasing shift from Rx to Gx Globalization Focus Consolidation Innovation and product introduction no longer affordable at country/region level Leaders positioned in all key countries with globally designed business systems All major pharmaceutical companies want to move to a few attractive (highvolume, high-growth, high barriers to entry) therapeutic areas Ongoing industry consolidation Emergence of large global pharma players with potential scale advantages in M&S, R&D, and Operations 1 The Emerging Market 01: THE GREAT GLACIATION International Pharma Market Sales Evolution Latin and Central America Middle East - West and North Africa New Europe (MEWA/NA-NE) Asia Pacific 4 4

World Population Growth Is Almost Entirely Concentrated in the World's Poorer Countries World Population (in Billions): 190-00 BRIC Communalities More than / of the world population lives in these

Lack of transparency and complex bureaucracy Healthcare sector far behind the economic development and access limited even though plans are being developed to extend eligibility.

Russia) Differences Population growth rate: India 1,78% Brazil1,8%,China 0,69%, Russia 0,474% Life expectancy China 7,18, Brazil 7,1, India 69,, Russia 6,94, (9 male 7,1 fem) Education expenditure

lower in Russia,9, China 18,4, Brazil. 4, India 8 Source: United Nations Population Division, World Population Prospects, The 008 Revision.

5 World Population Growth Is Almost Entirely Concentrated in the World's Poorer Countries World Population (in Billions): BRIC Communalities More than / of the world population lives in these countries being a huge source of resources and consumers Living standards have improved but still a high % of the population below the poverty line Political uncertainty. Lack of transparency and complex bureaucracy Healthcare sector far behind the economic development and access limited even though plans are being developed to extend eligibility. Environmental risks Prevalence of mortality from chronic disease have been increasing as well as HIV and sexual transmitted diseases Members of WTO (exc. Russia) Differences Population growth rate: India 1,78% Brazil1,8%,China 0,69%, Russia 0,474% Life expectancy China 7,18, Brazil 7,1, India 69,, Russia 6,94, (9 male 7,1 fem) Education expenditure %GDP China 1,9 far behind GDP % growth China 11,4, India 8,, Russia 8, Brazil,4 Foreign direct investment: the highest in China 7bill $, 4 bill$ in Russia,$ bill $in Br Public debt as% of GDP Much lower in Russia,9, China 18,4, Brazil. 4, India 8 Source: United Nations Population Division, World Population Prospects, The 008 Revision. 6 Africa s Population of 1 Billion Is Projected to Grow Rapidly Through 00 Almost all Population Growth and 60% of Ex-US GDP Growth projected to occur in Emerging Markets 100% = Population 6.1B Growth % = 1B Emerging markets Ex-U.S. First World U.S. GDP 100% = $t CAGR % = Growth $4t Emerging Markets 84 9 We currently reach only -% of all patients Source: Carl Haub and Mary Mederios Kent, 009 World Population Data Sheet. Ex-U.S. First World U.S

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