Latin American Pharmaceutical Market Outlook To 2014

Summary

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

• Table of 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