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

Date: November 23, 2009
Pages: 143
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: L7EC36B3B73EN
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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?
  • 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
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