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 drug 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?
 
 
  Table of Contents : 
Table of Contents
Latin American Pharmaceutical Market Outlook to 2014
Executive Summary 12
Macroeconomics and health status 12
Pharmaceutical regulatory environment 13
Therapeutic market analysis 14
Competitive landscape 15
Scope and methodology 18
Scope 18
Key therapy areas covered in this report 18
Methodology 19
Chapter 1 Macroeconomics, demographics and health status 22
Summary 22
Introduction 23
Socioeconomic trends 23
Demographic trends 24
Health status 25
Disease burden in the Americas 26
Health expenditure 29
Chapter 2 Pharmaceutical regulatory environment 32
Summary 32
Introduction 33
Regulatory environment in Latin America 34
Intellectual property 35
Rising trial registrations 36
Regulatory harmonization and tie-ups 38
Compulsory licensing trends in Latin America 39
Generic drug policy 39
Prescription policies 41
Biosimilar regulatory pathway in Latin America 41
Regulatory systems in Latin America 42
Brazil 42
Intellectual property rights 42
Adverse event notification system 43
Drug advertising 43
Pricing 43
Mexico 43
Intellectual property rights 43
Adverse event notification 44
Drug advertising 44
Pricing 44
Venezuela 45
Intellectual property rights 46
Adverse event notification 46
Drug advertising 46
Pricing 46
Argentina 47
Intellectual property rights 47
Adverse event notification 47
Drug advertising 48
Pricing 48
Colombia 48
Intellectual property rights 48
Adverse event notification 48
Drug advertising 49
Pricing 49
Chile 49
Intellectual property rights 49
Adverse event notification 49
Drug advertising 50
Pricing 50
Peru 50
Intellectual property rights 50
Adverse event notification 50
Pricing 51
Chapter 3 Therapeutic market analysis 54
Summary 54
Introduction 55
Country wise sales distribution 55
Forecast country wise sales distribution 56
Key statistics 57
Leading drug classes 57
Leading brands in Latin America 58
Regional market analysis 58
Brazil 58
Key market statistics 58
Leading therapy segments 59
Leading brands 61
NME launches in 2008 62
DPP-IV inhibitors and incretin mimetics draw focus to diabetes management 63
Mexico 64
Key market statistics 64
Leading therapy segments 65
Leading brands 67
NME launches in 2008 67
Venezuela 68
Key market statistics 68
Leading therapy segments 69
Leading brands 70
NME launches in 2008 71
NMDA-receptor antagonists make entry 72
Argentina 72
Key market statistics 72
Leading therapy segments 73
Leading brands 74
NME launches in 2008 75
Diabetes management witnesses entry of DPP-IV inhibitors and
incretin mimetics 75
Colombia 76
Key market statistics 76
Leading therapy segments 77
Leading brands 78
NME launches in 2008 79
Bayer introduces PGI2 analogues for PAH therapy 79
Chile 80
Key market statistics 80
Leading therapy segments 81
Leading brands 82
NME launches in 2008 83
Januvia and Rasilez bring new treatment options in respective therapeutic areas 83
Peru 84
Key market statistics 84
Leading therapy segments 85
Leading brands 86
NME launches in 2008 86
Chapter 4 Competitive landscape 90
Summary 90
Introduction 91
Top 10 players in the Latin American pharmaceutical market in 2008 91
Forecast performance of the top 10 Latin American players 95
Market concentration/fragmentation analysis 96
Leading players in Latin America 97
Sanofi-Aventis 97
Regional sales 97
Therapeutic sales distribution 98
Leading brands 99
Pipeline 100
Competitive analysis 101
Novartis 102
Regional sales 103
Therapeutic sales distribution 104
Leading brands 105
Pipeline 106
Competitive analysis 106
Bayer 107
Regional sales 108
Therapeutic sales distribution 109
Leading brands 110
Pipeline 111
Competitive analysis 111
Pfizer 114
Regional sales 115
Therapeutic sales distribution 116
Leading brands 117
Pipeline 118
Competitive analysis 118
Schering-Plough 119
Regional sales 120
Therapeutic sales distribution 121
Leading brands 122
Pipeline 123
Competitive analysis 123
Competitive landscape across countries 125
Brazil 125
Mexico 128
Venezuela 130
Argentina 131
Colombia 132
Chile 133
Peru 136
Chapter 5 Appendix 140
Abbreviations 140
Index 142

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