Latin American Pharmaceutical Market Outlook To 2014: Policy environment, market analysis, forecasts and growth opportunities

The $28.8bn Latin American market delivered 15.3% y-o-y growth in 2008 as per IMS Health data. The market is expected to grow to $51.3bn in 2014 at a CAGR of 10.1%. Inconsistency in regulatory protocol in the seven major Latin American countries – Brazil, Mexico, Venezuela, Argentina, Colombia, Chile and Peru - has been the greatest concern to research based pharmaceutical companies. Several companies faced severe sales erosion due to launch of unauthorized generic versions of their leading brands. However, situation has improved considerably ever since these countries became signatories to TRIPS and other international trade treaties. The improved regulatory environment is beckoning pharmaceutical companies of all types including research driven firms as well as generic players to Latin America. Companies that already have registered their presence in the region have raised investments in their local production facilities. They have also increased the number of clinical trials conducted in the region due to progress in regional healthcare standards and resources. Historically, multinational players have held a majority share of the Latin American market. However, the market share held by domestic companies have continued to grow, while that held by multinational companies is steadily declining. The volume based business model of domestic companies, focused on generics, has proven to be the growth formula for success in Latin America. Considering the domination of generics in the region, multinational drug firms have accelerated their entry into generic business by raising investments in their local production facilities as well as acquiring local players.

Key Features of this report

• Assessment of socioeconomic and demographic features of the seven major Latin American markets. Evaluation of healthcare delivery parameters and disease burden in the region.
• Insights into the government policy environment relating to pharmaceutical regulation, pricing and reimbursement, and its impact on the industry.
• Comprehensive analysis of sales distribution in the Latin American market based on geography, therapeutic classes, brands and companies.

Scope of this report

• Quantify disease burden of various communicable and non-communicable pathophysiologic disorders.
• Gain a comprehensive understanding of the regulatory, pricing and reimbursement policies and their impact on the industry
• Explore therapy areas with the greatest franchise growth potential and understand the growth drivers.
• Compare the franchises of top marketers across major indications, and evaluate how market share of leading companies such as Sanofi-Aventis, Novartis, Bayer, Pfizer and Schering-Plough will evolve over the next five years.

Key Market Issues

• Compulsory licensing: Compulsory licensing has become a serious issue in the region since the controversial issue surrounding Merck’s Sustiva. In 2006, the Brazilian government had issued compulsory licenses for the product, thereby bypassing the patent issued earlier. The main issue behind this compulsory licensing was the high market price of Sustiva, which prevented its procurement. The situation in Mexico was comparatively better, as several attempts to procure compulsory licenses in the last 15 years have failed to bear fruit.
• Lack of implementation of intellectual property: The seven major Latin American countries vary considerably in the implementation of IPR. All these countries are signatories to WTO and other individual trade organizations. However, despite ratification of the various requirements instated in these treaties, there is a serious lack of implementation. The Pharmaceutical Research and Manufacturers of America’s (PhRMA) Special 301 submission to the United States Trade Representative (USTR) placed these countries under the Priority Watch List.

Key findings from this report

• The Latin American pharmaceutical market generated $28.8bn sales in 2008, an increase of 15.3% y–o–y according to IMS Health. Therapeutic indications that fuelled growth include included antihypertensives, dermatologicals and sex hormone preparations.
• Brazil was the largest market with $11.4bn sales amounting to 39.6% share of the Latin American market. Peru was the smallest accounting for only 1.9% share. Venezuela at 32.2% increase was the fastest growing regional market in 2008. Recession hit Mexico reported flat y-o-y growth of 0.1%.
• Eli Lilly’s erectile dysfunction drug Cialis remained the top-selling drug in the region in 2008 delivering $208m in sales, while outperforming world’s best-selling cholesterol drug Lipitor from Pfizer at $160m sales.

Key questions answered

What will be the leading indications and the accompanying growth drivers in the Latin American market over 2008–14?

How does government polices on pharmaceutical regulation, pricing and reimbursement impact the industry?

What are the current market trends across major therapy segments in Latin America as well as individual countries?

Which companies are best positioned to succeed in Latin America over the period 2008–14?

What is the forecast market size and growth rate of the seven major Latin American countries over the period 2008–14?

Contents

Latin American Pharmaceutical Market Outlook to 2014
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, DEMOGRAPHICS 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 respective 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 Skip to top