Healthcare, Regulatory and Reimbursement Landscape - Brazil

NEW YORK, April 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Healthcare, Regulatory and Reimbursement Landscape - Brazil

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Healthcare, Regulatory and Reimbursement Landscape - Brazil

Summary

GlobalData, the industry analysis specialist, has released its new report, "Healthcare, Regulatory and Reimbursement Landscape - Brazil". The report is an essential source of information and analysis on Brazil's healthcare, regulatory and reimbursement landscape, and identifies the key trends in the healthcare market. The report also provides insights into the country's demographic, regulatory, and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData's team of industry experts.

Brazil is the most populated country in Latin America, and in 2010, with a population of 193 million, was the fifth most populated country in the world. It currently has a demographic advantage in terms of a large working age population. The available data for the age-wise distribution of the Brazilian population shows that the population in the working age group of 20-59 years increased from 2005 to 2010. The elderly population (60 years and above) is expected to increase in the future to account for more than 13% of the population by 2020. The disease burden associated with a large elderly population will require significant healthcare expenditure, thereby acting as a positive driver for the Brazilian healthcare market. The Brazilian Ministry of Health (MoH) enacted a complete National Drug Policy (NDP) in 1998 to support the national health policy and the public's right of access to healthcare. The NDP facilitates the guidelines and responsibilities for all government levels regarding the guarantee of access to medicines necessary to public health.

Scope

The report provides information on Brazil's healthcare, regulatory and reimbursement landscape. It includes -

- Overview of Brazil's pharmaceutical and medical device markets, including the market size, market segmentation, and key drivers of and barriers to the market.

- Profile and SWOT analysis of the major players in the pharmaceutical and medical device market. The major players covered for the pharmaceutical market are Pfizer, Novartis, Sanofi and Roche, while the major players covered for the medical device market are Siemens Healthcare, GE Healthcare, F. Hoffmann-la Roche, Essilor International and Philips Healthcare.

- Insightful review of the reimbursement and regulatory landscape. Analysis includes details of the healthcare reimbursement process, regulatory agencies and market authorization process for new drug and medical devices.

- A detailed analysis of Brazil's political and economic environment, including economic indicators, demographics, healthcare infrastructure and healthcare expenditure.

- An overview of the opportunities and challenges for growth that exist in Brazil's healthcare market of Brazil.

Reasons to buy

The report comprehensively covers the Brazilian pharmaceutical and medical device markets. It will enhance your decision making capability by allowing you to -

- Develop business strategies by understanding the trends shaping and driving Brazil's healthcare market.

- Drive revenue by understanding the key trends, reimbursement and regulatory policies, pharmaceutical and medical devices market segments and companies likely to impact the Brazilian healthcare market in the future.

- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

- Identify, understand and capitalize on the opportunities and challenges in Brazil's healthcare market.

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 9

2 Introduction 11

2.1 Report Guidance 11

3 Overview of the Pharmaceutical and Medical Devices Market 12

3.1 Pharmaceutical Market 12

3.1.1 Market Overview 12

3.1.2 Supply Channels 15

3.1.3 Market Segments 16

3.1.4 Major Disease Areas 22

3.1.5 Major Players 24

3.2 Medical Device Market 45

3.2.1 Market Overview 45

3.2.2 Overview of Top Five Segments 47

3.2.3 Major Players 63

3.3 Market Drivers and Barriers 81

3.3.1 Drivers 81

3.3.2 Barriers 81

4 Market Access 83

4.1 Reimbursement and Payer Landscape 83

4.1.1 Healthcare System in Brazil 83

4.1.2 Reimbursement Process 84

4.1.3 Overview of Insurance Provider 88

4.1.4 Patient Share in Healthcare Spending 95

4.1.5 Drug Price Trend 96

4.1.6 Pricing Policies 97

4.2 Regulatory Landscape 98

4.2.1 Overview of Regulatory Agencies 98

4.2.2 New Drug Approval Process 100

4.2.3 New Medical Device Approval Process 102

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 104

4.2.5 Licensing Process for Pharmaceutical Exports and Imports 105

4.2.6 Intellectual Property Rights 106

4.2.7 Clinical Trial Regulations 108

4.2.8 Pharmaceutical Advertising Regulations 110

4.2.9 Pharmacy Regulations 110

4.2.10 Labeling and Packaging Regulations 111

5 Country Analysis 112

5.1 Political Environment 112

5.1.1 Political Structure 112

5.1.2 Analysis of Current Political Environment 112

5.1.3 Healthcare Policy Initiatives 113

5.2 Economic Landscape 114

5.3 Economic Indicators 115

5.3.1 Gross Domestic Product 115

5.3.2 Gross National Income 120

5.3.3 Inflation 121

5.3.4 Currency Exchange Rate 123

5.3.5 Foreign Direct Investment 124

5.3.6 Foreign Exchange Reserves 125

5.3.7 Trade Balance 126

5.3.8 Government Structural Balance 129

5.3.9 Government Net Debt 130

5.3.10 Major Industries 132

5.4 Demographics 134

5.4.1 Population 134

5.4.2 Education and Literacy 152

5.4.3 Employment 153

5.4.4 Disease Burden 154

5.5 Healthcare Infrastructure 156

5.5.1 Healthcare Facilities 156

5.5.2 Healthcare Parameters 160

5.5.3 Environmental Health 164

5.5.4 Healthcare Personnel 168

5.6 Healthcare Expenditure 171

5.6.1 Overview 171

5.6.2 Major Components of Healthcare Spending 172

5.6.3 Share of Public and Private Sector 174

5.6.4 Spending in Pharmaceutical R&D 175

5.7 Trade Associations 176

5.7.1 ABIMO 176

5.7.2 ABIMED 176

5.7.3 Interfarma 176

5.7.4 Abiquifi 176

5.8 Trade Fairs 177

6 Opportunities and Challenges 178

6.1 Opportunities 178

6.2 Challenges 178

7 Appendix 180

7.1 Abbreviations 180

7.2 Methodology 185

7.2.1 Coverage 185

7.2.2 Secondary Research 186

7.2.3 Forecasting 186

7.2.4 Primary Research 186

7.2.5 Expert Panel Validation 186

7.3 Contact Us 187

7.4 Bibliography 187

7.5 Disclaimer 188

List of Tables

Table 1: Pharmaceutical Market ($bn), Brazil, 2005-2010 13

Table 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020 14

Table 3: Price Margins of Distribution Channels (%), Brazil 15

Table 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010 17

Table 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020 18

Table 6: Major Domestic Companies with Focus on Biologics, Brazil, 2008 20

Table 7: Major Products, Pfizer, Global, Revenue ($m), 2010 25

Table 8: Late Stage Pipeline, Pfizer, 2011 26

Table 9: Major Products, Novartis, Global, Revenue ($m), 2010 30

Table 10: Planned Filings, Novartis, 2011 to ? 2015 31

Table 11: Major Products, Sanofi, Global, Revenue ($m), 2010 36

Table 12: Late Stage Pipeline, Sanofi, 2011 36

Table 13: Major Products, Roche, Global, Revenue ($m), 2010 40

Table 14: Late Stage Pipeline, Roche, 2011 41

Table 15: Medical Device Market ($bn), Brazil, 2005-2010 45

Table 16: Medical Device Market ($bn), Brazil, Forecast, 2011-2020 46

Table 17: Medical Device Market, Segments Revenue ($m), Brazil, 2010 47

Table 18: Ophthalmic Devices Market ($m), Brazil, 2005-2010 49

Table 19: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2010 50

Table 20: In Vitro Diagnostics Market ($m), Brazil, 2005-2010 52

Table 21: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2010 53

Table 22: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010 55

Table 23: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2010 56

Table 24: Orthopedic Devices Market ($m), Brazil, 2005-2010 58

Table 25: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2010 59

Table 26: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010 61

Table 27: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010 62

Table 28: Major Medical Device Companies, Brazil, Revenue, 2010 63

Table 29: Major Products, Siemens, Global, Revenue ($m), 2010 64

Table 30: Late Stage Pipeline, GE Healthcare, 2011 68

Table 31: Major Products, Roche, Global, Revenue ($m), 2010 71

Table 32: Late Stage Pipeline, F. Hoffmann-La Roche Ltd., 2010 72

Table 33: Major Products, Essilor, Revenue ($m), 2010 74

Table 34: Major Products, Philips Healthcare, Global, Revenue ($m), 2010 78

Table 35: Healthcare System, Brazil, 2011 83

Table 36: Comparative Analysis of CITEC and CONITEC, Brazil, 2011 86

Table 37: Decision-Making Structure of SUS, Brazil 89

Table 38: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010 91

Table 39: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010 92

Table 40: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010 95

Table 41: Drug Price Trend, Price Change (%), Brazil, 2005-2010 96

Table 42: Pricing Criteria for Various Drugs, Brazil 97

Table 43: Documents Required for Dossier Submission of Clinical Trial, Brazil, 2011 109

Table 44: GDP Per Capita ($), Brazil, 2005-2010 116

Table 45: GDP Per Capita ($), Brazil, Forecast, 2011-2020 117

Table 46: GDP, Annual Growth (%), Brazil, 2005-2010 118

Table 47: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020 119

Table 48: GNI Per Capita ($), Brazil, 2005-2010 120

Table 49: Average Consumer Price Index, Brazil, 2005-2010 121

Table 50: Average Consumer Price, Annual Change (%), Brazil, 2005-2010 122

Table 51: Currency Exchange Rate ($/BRL), Brazil, 2005-2010 123

Table 52: Foreign Direct Investment ($bn), Brazil, 2005-2010 124

Table 53: Foreign Exchange Reserves ($bn), Brazil, 2005-2010 125

Table 54: Trade Balance ($bn), Brazil, 2005-2010 126

Table 55: Imports of Goods and Services ($bn), Brazil, 2005-2010 127

Table 56: Exports of Goods and Services ($bn), Brazil, 2005-2010 128

Table 57: General Government Structural Balance ($bn), Brazil, 2005-2010 129

Table 58: General Government Net Debt (% of GDP), Brazil, 2005-2010 130

Table 59: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020 131

Table 60: Major Service Industries by Revenue ($bn), 2008 132

Table 61: Major Manufacturing Industries by Revenue ($bn), 2008 133

Table 62: Population (m), Brazil, 2005-2010 134

Table 63: Population (m), Brazil, Forecast, 2011-2020 135

Table 64: Urban and Rural Population, Brazil, Share (%), 2005-2010 136

Table 65: Age Groups, Population Distribution (%), Brazil, 2005-2010 137

Table 66: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020 138

Table 67: Birth Rate (Per 1,000 Population), Brazil, 2005-2010 139

Table 68: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020 140

Table 69: Mortality (Per 1,000 Population), Brazil, 2005-2010 141

Table 70: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020 142

Table 71: Major Causes of Mortality ('000), Brazil, 2008 143

Table 72: Children

Table 73: Children

Table 74: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010 146

Table 75: Causes of Male Mortality ('000), Brazil, 2008 147

Table 76: Causes of Female Mortality ('000), Brazil, 2008 148

Table 77: Gender Ratio (M/F), Brazil, 2005-2010 149

Table 78: Life Expectancy at Birth (Years), Brazil, 2005-2010 150

Table 79: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020 151

Table 80: Illiteracy (%), Brazil, 2005-2010 152

Table 81: Unemployment (%), Brazil, 2005-2010 153

Table 82: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004 154

Table 83: Major Diseases, Brazil, In Patients ('000), 2010 155

Table 84: Hospital Funding, Brazil, Share of Sources (%), 2009 156

Table 85: Public and Private Hospitals, Brazil, 2005-2010 158

Table 86: Hospitals by Type of Services (%), Brazil, 2009 159

Table 87: Beds (Per 1,000 Population), Brazil, 2005-2010 160

Table 88: Public-Private Beds, Brazil, 2005-2010 161

Table 89: Diagnostic Equipment, Brazil, 2009 162

Table 90: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007 163

Table 91: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008 164

Table 92: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008 165

Table 93: Targets for Carbon Reduction, Brazil, 2009 166

Table 94: CO2 Emissions ('000 Metric Tons), Brazil, 2005-2010 166

Table 95: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010 167

Table 96: Healthcare Personnel ('000), Brazil, 2009 168

Table 97: Doctors (Per 1,000 Population), Brazil, 2005-2010 169

Table 98: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007 170

Table 99: Healthcare Expenditure (% of GDP), Brazil, 2005-2010 171

Table 100: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007 172

Table 101: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007 173

Table 102: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010 174

Table 103: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008 175

Table 104: Major Healthcare Trade Fairs, Brazil, 2012 177

List of Figures

Figure 1: Pharomaceutical Market ($bn), Brazil, 2005-2010 13

Figure 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020 14

Figure 3: Pharmaceutical Supply Chain, Brazil, 2007 15

Figure 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010 17

Figure 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020 18

Figure 6: Biotech Regions, Brazil, Companies Distribution (%), 2006 21

Figure 7: Medical Device Market ($bn), Brazil, 2005-2010 45

Figure 8: Medical Device Market ($bn), Brazil, Forecast, 2011-2020 46

Figure 9: Medical Device Market, Segments Revenue ($m), Brazil, 2010 47

Figure 10: Ophthalmic Devices Market ($m), Brazil, 2005-2010 49

Figure 11: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2005-2010 50

Figure 12: In Vitro Diagnostics Market ($m), Brazil, 2005-2010 52

Figure 13: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2005-2010 53

Figure 14: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010 55

Figure 15: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2005-2010 56

Figure 16: Orthopedic Devices Market ($m), Brazil, 2005-2010 58

Figure 17: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2005-2010 59

Figure 18: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010 61

Figure 19: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010 62

Figure 20: Major Medical Device Companies, Brazil, Revenue ($m), 2010 63

Figure 21: Drivers and Barriers, Healthcare Market, Brazil, 2011 82

Figure 22: Reimbursement System, Brazil, 2011 84

Figure 23: Reimbursement Process, Brazil, 2011 87

Figure 24: Health Insurance Providers, Brazil, 2011 88

Figure 25: Health Policy Packages, Brazil, 2007 90

Figure 26: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010 91

Figure 27: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010 92

Figure 28: Organization Structure of ANS, Brazil, 2011 93

Figure 29: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010 95

Figure 30: Drug Price Trend, Price Change (%), Brazil, 2005-2010 96

Figure 31: ANVISA Structure, Brazil, 2011 99

Figure 32: Roles and Responsibilities of Regulatory Bodies, Brazil, 2011 100

Figure 33: New Drug Approval Stages, Brazil, 2011 101

Figure 34: New Drug Approval Process, Brazil, 2011 102

Figure 35: New Medical Device Approval Process, Brazil, 2011 103

Figure 36: GDP Per Capita ($), Brazil, 2005-2010 116

Figure 37: GDP Per Capita ($), Brazil, Forecast, 2011-2020 117

Figure 38: GDP, Annual Growth (%), Brazil, 2005-2010 118

Figure 39: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020 119

Figure 40: GNI Per Capita ($), Brazil, 2005-2010 120

Figure 41: Average Consumer Price Index, Brazil, 2005-2010 121

Figure 42: Average Consumer Price, Annual Change (%), Brazil, 2005-2010 122

Figure 43: Currency Exchange Rate ($/BRL), Brazil, 2005-2010 123

Figure 44: Foreign Direct Investment ($bn), Brazil, 2005-2010 124

Figure 45: Foreign Exchange Reserves ($bn), Brazil, 2005-2010 125

Figure 46: Trade Balance ($bn), Brazil, 2005-2010 126

Figure 47: Imports of Goods and Services ($bn), Brazil, 2005-2010 127

Figure 48: Exports of Goods and Services ($bn), Brazil, 2005-2010 128

Figure 49: General Government Structural Balance ($bn), Brazil, 2005-2010 129

Figure 50: General Government Net Debt (% of GDP), Brazil, 2005-2010 130

Figure 51: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020 131

Figure 52: Major Service Industries by Revenue ($bn), 2008 132

Figure 53: Major Manufacturing Industries by Revenue ($bn), 2008 133

Figure 54: Population (m), Brazil, 2005-2010 134

Figure 55: Population (m), Brazil, Forecast, 2011-2020 135

Figure 56: Urban and Rural Population, Brazil, Share (%), 2005-2010 136

Figure 57: Age Groups, Population Distribution (%), Brazil, 2005-2010 137

Figure 58: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020 138

Figure 59: Birth Rate (Per 1,000 Population), Brazil, 2005-2010 139

Figure 60: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020 140

Figure 61: Mortality (Per 1,000 Population), Brazil, 2005-2010 141

Figure 62: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020 142

Figure 63: Major Causes of Mortality ('000), Brazil, 2008 143

Figure 64: Children

Figure 65: Children

Figure 66: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010 146

Figure 67: Causes of Male Mortality ('000), Brazil, 2008 147

Figure 68: Causes of Female Mortality ('000), Brazil, 2008 148

Figure 69: Gender Ratio (M/F), Brazil, 2005-2010 149

Figure 70: Life Expectancy at Birth (Years), Brazil, 2005-2010 150

Figure 71: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020 151

Figure 72: Illiteracy (%), Brazil, 2005-2010 152

Figure 73: Unemployment (%), Brazil, 2005-2010 153

Figure 74: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004 154

Figure 75: Major Diseases, Brazil, In Patients ('000), 2010 155

Figure 76: Hospital Funding, Brazil, Share of Sources (%), 2009 156

Figure 77: Flow of Funds to Hospitals, Brazil, 2008 157

Figure 78: Public and Private Hospitals, Brazil, 2005-2010 158

Figure 79: Hospitals by Type of Services (%), Brazil, 2009 159

Figure 80: Beds (Per 1,000 Population), Brazil, 2005-2010 160

Figure 81: Public-Private Beds, Brazil, 2005-2010 161

Figure 82: Diagnostic Equipment, Brazil, 2009 162

Figure 83: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007 163

Figure 84: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008 164

Figure 85: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008 165

Figure 86: CO2 Emissions ('000 Metric Tons), Brazil, 2005-2010 166

Figure 87: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010 167

Figure 88: Healthcare Personnel ('000), Brazil, 2009 168

Figure 89: Doctors (Per 1,000 Population), Brazil, 2005-2010 169

Figure 90: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007 170

Figure 91: Healthcare Expenditure (% of GDP), Brazil, 2005-2010 171

Figure 92: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007 172

Figure 93: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007 173

Figure 94: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010 174

Figure 95: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008 175

Figure 96: Opportunities and Challenges, Healthcare Market, Brazil, 2011 179

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