SPI Infoamtion

Table of Contents

Executive Summary

Macroeconomics and health status
Pharmaceutical regulatory environment
Therapeutic market analysis
Competitive landscape

Scope and methodology

Scope

Key therapy areas covered in this report

Methodology

Chapter 1 Macroeconomics, demograph and health status

Summary
Introduction
Socioeconomic trends
Demographic trends
Health status

Disease burden in the Americas

Health expenditure

Chapter 2 Pharmaceutical regulatory environment

Summary
Introduction
Regulatory environment in Latin America

Intellectual property
Rising trial registrations
Regulatory harmonization and tie-ups
Compulsory licensing trends in Latin America
Generic drug policy
Prescription policies
Biosimilar regulatory pathway in Latin America

Regulatory systems in Latin America

Brazil

Intellectual property rights
Adverse event notification system
Drug advertising
Pricing

Mexico

Intellectual property rights
Adverse event notification
Drug advertising
Pricing

Venezuela

Intellectual property rights
Adverse event notification
Drug advertising
Pricing

Argentina

Intellectual property rights
Adverse event notification
Drug advertising
Pricing

Colombia

Intellectual property rights
Adverse event notification
Drug advertising
Pricing

Chile

Intellectual property rights
Adverse event notification
Drug advertising
Pricing

Peru

Intellectual property rights
Adverse event notification
Pricing

Chapter 3 Therapeutic market analysis

Summary
Introduction
Country wise sales distribution
Forecast country wise sales distribution
Key statistics

Leading drug classes
Leading brands in Latin America

Regional market analysis

Brazil

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008
DPP-IV inhibitors and incretin mimetics draw focus to diabetes
management

Mexico

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008

Venezuela

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008
NMDA-receptor antagonists make entry

Argentina

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008
Diabetes management witnesses entry of DPP-IV inhibitors and
incretin mimetics

Colombia

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008
Bayer introduces PGI2 analogues for PAH therapy

Chile

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008
Januvia and Rasilez bring new treatment options in respecti
therapeutic areas

Peru

Key market statistics
Leading therapy segments
Leading brands
NME launches in 2008

Chapter 4 Competitive landscape

Summary
Introduction
Top 10 players in the Latin American pharmaceutical market in 2008
Forecast performance of the top 10 Latin American players
Market concentration/fragmentation analysis
Leading players in Latin America

Sanofi-Aventis

Regional sales
Therapeutic sales distribution
Leading brands
Pipeline
Competitive analysis

Novartis

Regional sales
Therapeutic sales distribution
Leading brands
Pipeline
Competitive analysis

Bayer

Regional sales
Therapeutic sales distribution
Leading brands
Pipeline
Competitive analysis

Pfizer

Regional sales
Therapeutic sales distribution
Leading brands
Pipeline
Competitive analysis

Schering-Plough

Regional sales
Therapeutic sales distribution
Leading brands
Pipeline
Competitive analysis

Competitive landscape across countries

Brazil
Mexico
Venezuela
Argentina
Colombia
Chile
Peru

Chapter 5 Appendix

Abbreviations
Index

List of Figures
Figure 1.1: Comparison of DALYs (000s) of American LMICs and global high-income countries, 2008
Figure 1.2: GDP and health expenditure trends, 2008
Figure 2.3: SWOT - Latin American regulatory landscape
Figure 2.4: Clinical trial registrations in Latin America, 2008
Figure 3.5: Forecast sizes of Latin American markets
Figure 4.6: Sales distribution of leading MNCs and local players by country, 2008
Figure 4.7: Regional sales distribution of top 20 MNCs, 2004-2008
Figure 4.8: Market concentration analysis, 2004-08
Figure 4.9: Yasmin/Yaz sales growth trend, 2004-08
Figure 4.10: Performance of erectile dysfunction products in Latin America, 2004-08
Figure 4.11: Changing competitive positions of top five dermatological product marketers, 2004-08

List of Tables
Table 1.1: Socioeconomic indicators of Latin American countries, 2008
Table 1.2: Demographic profile of Latin American countries, 2008
Table 1.3: Healthcare delivery parameters of major Latin American countries
Table 1.4: DALYs (000s) across LMICs in the Americas, 2008-2014
Table 1.5: Government-private healthcare expenditure pattern, 2006
Table 2.6: PhRMA Special 301 submission regarding Latin America, 2009
Table 2.7: Clinical trials in Latin America
Table 2.8: Prescription criteria and generic substitution laws in Latin America
Table 2.9: Developments in biosimilar regulatory pathway formulation in Latin America
Table 3.10: Country wise sales distribution in Latin America, 2008
Table 3.11: Country wise sales forecasts, 2008-14
Table 3.12: Leading drug classes in Latin America, 2008
Table 3.13: Leading brands in Latin America, 2008
Table 3.14: Leading therapy segments in Brazil, 2008
Table 3.15: Leading brands in Brazil, 2008
Table 3.16: NME launches in Brazil, 2008
Table 3.17: Newer drug classes in Brazil, 2007-08
Table 3.18: Leading therapy segments in Mexico, 2008
Table 3.19: Leading brands in Mexico, 2008
Table 3.20: NME launches in Mexico, 2008
Table 3.21: Leading therapy segments in Venezuela, 2008
Table 3.22: Leading brands in Venezuela, 2008
Table 3.23: NME launches in Venezuela, 2008
Table 3.24: Newer drug classes in Venezuela, 2007-08
Table 3.25: Leading therapy segments in Argentina, 2008
Table 3.26: Leading brands in Argentina, 2008
Table 3.27: NME launches in Argentina, 2008
Table 3.28: Newer drug classes in Argentina, 2007-08
Table 3.29: Leading therapy segments in Colombia, 2008
Table 3.30: Leading brands in Colombia, 2008
Table 3.31: NME launches in Colombia, 2008
Table 3.32: Newer drug classes in Colombia, 2007-08
Table 3.33: Leading therapy segments in Chile, 2008
Table 3.34: Leading brands in Chile, 2008
Table 3.35: NME launches in Chile, 2008
Table 3.36: Newer drug classes in Chile, 2007-08
Table 3.37: Leading therapy segments in Peru, 2008
Table 3.38: Leading brands in Peru, 2008
Table 3.39: NME launches in Peru, 2008
Table 4.40: Leading Latin American pharmaceutical companies, 2008
Table 4.41: Sales distribution between leading MNCs and domestic players, 2008
Table 4.42: Sales forecasts of top 10 Latin American players, 2009-14
Table 4.43: Regional sales distribution of Sanofi-Aventis, 2008
Table 4.44: Therapeutic sales distribution of Sanofi-Aventis, 2008
Table 4.45: Leading brands from Sanofi-Aventis, 2008
Table 4.46: Sanofi-Aventis' pipeline portfolio, September 2009
Table 4.47: Regional sales distribution of Novartis, 2008
Table 4.48: Therapeutic sales distribution of Novartis, 2008
Table 4.49: Leading brands from Novartis, 2008
Table 4.50: Novartis' pipeline portfolio, September 2009
Table 4.51: Regional sales distribution of Bayer, 2008
Table 4.52: Therapeutic sales distribution of Bayer, 2008
Table 4.53: Leading brands from Bayer, 2008
Table 4.54: Bayer's pipeline portfolio, September 2009
Table 4.55: Regional sales distribution of Pfizer, 2008
Table 4.56: Therapeutic sales distribution of Pfizer, 2008
Table 4.57: Leading brands from Pfizer, 2008
Table 4.58: Pfizer's pipeline portfolio, September 2009
Table 4.59: Regional sales distribution of Schering-Plough, 2008
Table 4.60: Therapeutic sales distribution of Schering-Plough, 2008
Table 4.61: Leading brands from Schering-Plough, 2008
Table 4.62: Schering-Plough's pipeline portfolio, September 2009
Table 4.63: Leading players in Brazil, 2008
Table 4.64: Leading players in Mexico, 2008
Table 4.65: Leading players in Venezuela, 2008
Table 4.66: Leading players in Argentina, 2008
Table 4.67: Leading players in Colombia, 2008
Table 4.68: Leading players in Chile, 2008
Table 4.69: Leading players in Peru, 2008