CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Brazil

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Published Date: 13-Jul-2015
No. of pages: 247

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Brazil

Summary

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

Brazil’s population in 2013 was approximately 198 million, having grown at a Compound Annual Growth Rate (CAGR) of 0.9% from 2008. The country’s increasingly elderly population and the corresponding increase in the incidence of chronic diseases will help to boost the growth of the pharmaceutical market, which was estimated to be worth $14.1 billion in 2008, and is projected to reach approximately $47.9 billion by 2020 at a CAGR of 8.5%. Approximately 60-80% of the Brazilian population has healthcare coverage, which has helped to create one of the most efficient healthcare systems among the BRICS countries, along with the fact that the government has taken new initiatives to promote generic drugs. The medical device market was valued at $6.4 billion in 2008, and is projected to grow at a CAGR of 7.5% to an estimated $14.2 billion in 2020, primarily attributed to –
– Sedentary lifestyles leading to a high chronic disease burden
– Easy accessibility to diagnostic technologies
– Increased accessibility to healthcare professionals in remote areas

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Brazil, and includes –
– An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
– Profiles and SWOT analyses of the major players in the pharmaceutical market: Hypermarcus, Pfizer, Novartis, Roche and EMS Sigma Pharma; and profiles and SWOT analyses of the major players in the medical device market: Siemens Healthcare, GE Healthcare, Roche, Essilor, and Philips
– Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
– Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
– An overview of the opportunities for and challenges to growth in the healthcare market

Reasons to buy

This report 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 revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect Brazil’s healthcare market in the future
– Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
– Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investment, and strategic partnerships
– Identify, understand, and capitalize on the opportunities and challenges in Brazil’s healthcare market

Table of Contents For This Report

1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 13

2 Introduction 17

2.1 GlobalData Report Guidance 17

3 Overview of Pharmaceutical and Medical Device Markets 18

3.1 Pharmaceutical Market 18

3.1.1 Market Overview 18

3.1.2 Pharmaceutical Exports and Imports 20

3.1.3 Supply Channels 22

3.1.4 Market Segments 23

3.1.5 Overview of Top Five Disease Areas 28

3.1.6 Major Players 31

3.2 Medical Device Market 62

3.2.1 Market Overview 62

3.2.2 Overview of Top Five Segments 64

3.2.3 Diagnostic Market 82

3.2.4 Major Players 84

3.3 Market Drivers and Barriers 110

3.3.1 Drivers 110

3.3.2 Barriers 111

4 Market Access 113

4.1 Overview of the Healthcare System 113

4.2 Reimbursement and Payer Landscape 114

4.2.1 Reimbursement Process 116

4.2.2 Overview of Insurance Providers 118

4.2.3 Patient Share in Healthcare Spending 124

4.2.4 Prescription Drug Price Trend 125

4.2.5 Pricing Policies 125

4.3 Regulatory Landscape 129

4.3.1 Overview of Regulatory Agencies 129

4.3.2 Market Authorization Procedure for Pharmaceutical Products 134

4.3.3 Market Authorization Procedure for Medical Devices 137

4.3.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 140

4.3.5 Licensing Process for Pharmaceutical Exports and Imports 141

4.3.6 Intellectual Property Rights 143

4.3.7 Clinical Trial Regulations 147

4.3.8 Pharmaceutical Advertising Regulations 149

4.3.9 Pharmacy Regulations 149

4.3.10 Labeling and Packaging Regulations 151

5 Country Analysis 152

5.1 Political Environment 152

5.1.1 Political Structure 152

5.1.2 Analysis of the Current Political Environment 153

5.1.3 Healthcare Policy Initiatives 154

5.2 Economic Landscape 160

5.3 Economic Indicators 161

5.3.1 Gross Domestic Product 161

5.3.2 Gross National Income 165

5.3.3 Inflation 166

5.3.4 Currency Exchange Rate 168

5.3.5 Foreign Direct Investment 169

5.3.6 Foreign Exchange Reserves 170

5.3.7 Trade Balance 171

5.3.8 General Government Structural Balance 174

5.3.9 General Government Net Debt 175

5.3.10 Major Industries 176

5.4 Demographics 178

5.4.1 Population 178

5.4.2 Education and Literacy Rate 194

5.4.3 Employment 195

5.4.4 Disease Burden 196

5.5 Healthcare Infrastructure 198

5.5.2 Healthcare Facilities 198

5.5.3 Healthcare Parameters 202

5.5.4 Environmental Health 204

5.5.5 Healthcare Personnel 207

5.6 Healthcare Expenditure 208

5.6.1 Overview 208

5.6.2 Major Components of Healthcare Spending 209

5.6.3 Public and Private Sector Share 210

5.6.4 Spending in Pharmaceutical Research and Development 211

5.7 Trade Associations 212

5.7.1 ABIMO 212

5.7.2 ABIMED 212

5.7.3 Interfarma 212

5.7.4 Abiquifi 213

5.8 Trade Fairs 214

6 Opportunities and Challenges 215

6.1 Opportunities 215

6.2 Challenges 216

7 Appendix 217

7.1 Abbreviations 217

7.2 Bibliography 229

7.3 Research Methodology 244

7.3.1 Coverage 244

7.3.2 Secondary Research 245

7.3.3 Forecasts 245

7.3.4 Expert Panel 246

7.4 Disclaimer 246

1.1 List of Tables

Table 1: Pharmaceutical Market, Brazil, Revenue ($bn), 2008-2013 19

Table 2: Pharmaceutical Market, Brazil, Revenue Forecast ($bn), 2014-2020 20

Table 3: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2008-2013 21

Table 4: Pharmaceutical Market, Brazil, Generic Drug Sales ($bn), 2008-2013 24

Table 5: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2013 28

Table 6: Pharmaceutical Market, Pfizer, Global, Major Products, 2014 36

Table 7: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2015 37

Table 8: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2014 43

Table 9: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014-2019 44

Table 10: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2014 52

Table 11: Pharmaceutical Market, Roche, Global, Late-Stage Pipeline, 2015 54

Table 12: Medical Device Market, Brazil, Revenue ($bn), 2008-2013 63

Table 13: Medical Device Market, Brazil, Revenue Forecast ($bn), 2014-2020 64

Table 14: Medical Device Market, Brazil, Revenue by Segment, 2013 65

Table 15: Medical Device Market, Brazil, Ophthalmic Devices Market, Revenue ($bn), 2008-2013 67

Table 16: Medical Device Market, Brazil, Ophthalmic Devices Market, Sales Trends for Major Players, 2012 68

Table 17: Medical Device Market, Brazil, In Vitro Diagnostics Market, Revenue ($bn), 2008-2013 70

Table 18: Medical Device Market, Brazil, In Vitro Diagnostics Market, Sales Trends for Major Players, 2012 71

Table 19: Medical Device Market, Brazil, Orthopedic Devices Market, Revenue ($bn), 2008-2013 73

Table 20: Medical Device Market, Brazil, Orthopedic Devices Market, Sales Trends for Major Players, 2012 74

Table 21: Medical Device Market, Brazil, Diagnostic Imaging Market, Revenue ($bn), 2008-2013 76

Table 22: Medical Device Market, Brazil, Diagnostic Imaging Market, Sales Trends for Major Players, 2012 78

Table 23: Medical Device Market, Brazil, Cardiovascular Device Market, Revenue ($bn), 2008-2013 80

Table 24: Medical Device Market, Brazil, Cardiovascular Device Market, Sales Trends for Major Players, 2012 81

Table 25: Medical Device Market, Brazil, Diagnostic Market, Revenue ($bn), 2008-2013 82

Table 26: Medical Device Market, Brazil, Diagnostic Market, Revenue Forecast ($bn), 2014-2020 83

Table 27: Medical Device Market, Brazil, Major Medical Device Companies, Revenue, 2012 84

Table 28: Healthcare System, Brazil, 2014 113

Table 29: Market Access, Brazil, Number of Items Listed in RENAME, 2013-2014 116

Table 30: Healthcare Spending, Brazil, Private Health Plans (million), 2008-2013 123

Table 31: Healthcare Spending, Brazil, Out-of-Pocket Expenditure (%), 2008-2013 124

Table 32: Market Access, Brazil, Price Change (%), 2008-2013 125

Table 33: Pricing Policies, Brazil, 2014 126

Table 34: Market Access, Brazil, Compensation Services for Patents ($), 2014 145

Table 35: Market Access, Brazil, Compensation Services for Trademarks ($), 2014 146

Table 36: Healthcare System, Brazil, Documents Required for Dossier Submission of Clinical Trial, 2014 148

Table 37: Economic Indicators, Brazil, GDP per Capita ($), 2008-2013 162

Table 38: Economic Indicators, Brazil, GDP per Capita Forecast ($), 2014-2020 163

Table 39: Economic Indicators, Brazil, GDP Annual Growth (%), 2008-2013 164

Table 40: Economic Indicators, Brazil, GDP Annual Growth Forecast (%), 2014-2020 165

Table 41: Economic Indicators, Brazil, Gross National Income per Capita ($), 2008-2013 166

Table 42: Economic Indicators, Brazil, Average Consumer Price Index, 2008-2013 167

Table 43: Economic Indicators, Brazil, Average Consumer Price Annual Change (%), 2008-2013 168

Table 44: Economic Indicators, Brazil, Currency Exchange Rate (BRL/$), 2008-2013 169

Table 45: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2008-2013 170

Table 46: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2008-2013 171

Table 47: Economic Indicators, Brazil, Trade balance ($bn), 2008-2013 172

Table 48: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2008-2013 173

Table 49: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2008-2013 174

Table 50: Economic Indicators, Brazil, Government Structural Balance ($bn), 2008-2013 175

Table 51: Economic Indicators, Brazil, General Government Net Debt ($bn), 2008-2013 176

Table 52: Economic Indicators, Brazil, Major Industries (Production Index), 2014 178

Table 53: Demographics, Brazil, Population (million), 2008-2013 179

Table 54: Demographics, Brazil, Population Forecast (million), 2014-2020 180

Table 55: Demographics, Brazil, Population, Urban and Rural Population (%), 2008-2013 181

Table 56: Demographics, Brazil, Population Distribution by Age Group (%), 2008-2013 182

Table 57: Demographics, Brazil, Population Distribution by Age Group Forecast (%), 2014-2020 183

Table 58: Demographics, Brazil, Births (per 1,000 population), 2008-2013 184

Table 59: Demographics, Brazil, Mortality (per 1,000 population), 2008-2013 185

Table 60: Demographics, Brazil, Major Causes of Mortality (per 1,000 population), 2013 186

Table 61: Demographics, Brazil, Children ?5 Years, Mortality (per 1,000 Live Births), 2008-2013 187

Table 62: Demographics, Brazil, Immunization Rate (%), 2008-2013 188

Table 63: Demographics, Brazil, Major Causes of Male Mortality (per 1,000 population), 2013 190

Table 64: Demographics, Brazil, Major Causes of Female Mortality (per 1,000 population), 2013 191

Table 65: Demographics, Brazil, Gender Ratio (Male/Female), 2008-2013 192

Table 66: Demographics, Brazil, Life Expectancy at Birth (Years), 2008-2013 193

Table 67: Demographics, Brazil, Literacy Rate (%), 2008-2013 195

Table 68: Demographics, Brazil, Employment Rate (%), 2008-2013 196

Table 69: Demographics, Brazil, Major Diseases, DALYs (per 100,000 population), 2004 197

Table 70: Healthcare Infrastructure, Brazil, Type of Hospital (%), 2015 198

Table 71: Healthcare Infrastructure, Hospital Beds by Type of Service, Brazil, 2008-2013 199

Table 72: Healthcare Infrastructure, Hospital beds by Type of Care, Brazil, 2015 200

Table 73: Healthcare Infrastructure, Brazil, Diagnostic Equipment, 2015 201

Table 74: Healthcare Infrastructure, Brazil, Hospital Beds (per 1,000 population), 2008-2013 202

Table 75: Healthcare Infrastructure, Brazil, Doctors (per 1,000 population), 2008-2013 203

Table 76: Healthcare Infrastructure, Brazil, CO2 Emissions (Metric Tons per Capita), 2008-2013 204

Table 77: Healthcare Infrastructure, Brazil, N2O Emissions (Million Metric Tons), 2008-2013 205

Table 78: Healthcare Infrastructure, Brazil, PM10 Emissions (µg/m3), 2008-2013 206

Table 79: Healthcare Infrastructure, Brazil, Nurses (per 1,000 population), 2008-2013 207

Table 80: Healthcare Expenditure, Brazil, Healthcare Expenditure (% of GDP), 2008-2013 208

Table 81: Healthcare Expenditure, Brazil, Share of Major Components (%), 2009 209

Table 82: Healthcare Expenditure, Brazil, Healthcare Expenditure, Public-Private Share (%), 2008-2013 210

Table 83: Healthcare Expenditure, Brazil, Research and Development Expenditure, Share (%), 2008 211

Table 84: Trade Fairs, Brazil, Major Healthcare Trade Fairs, 2015 214

1.2 List of Figures

Figure 1: Pharmaceutical Market, Brazil, Revenue ($bn), 2008-2013 19

Figure 2: Pharmaceutical Market, Brazil, Revenue Forecast ($bn), 2014-2020 20

Figure 3: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2008-2013 21

Figure 4: Pharmaceutical Distribution Channels, Brazil, 2011 23

Figure 5: Pharmaceutical Market, Brazil, Generic Drug Sales ($bn), 2008-2013 24

Figure 6: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2013 28

Figure 7: Medical Device Market, Brazil, Revenue ($bn), 2008-2013 63

Figure 8: Medical Device Market, Brazil, Revenue Forecast ($bn), 2014-2020 64

Figure 9: Medical Device Market, Brazil, Revenue by Segment ($bn), 2013 65

Figure 10: Medical Device Market, Brazil, Ophthalmic Devices Market, Revenue ($bn), 2008-2013 67

Figure 11: Medical Device Market, Brazil, Ophthalmic Devices Market, Sales Trends for Major Players, 2008-2012 68

Figure 12: Medical Device Market, Brazil, In Vitro Diagnostics Market, Revenue ($bn), 2008-2013 70

Figure 13: Medical Device Market, Brazil, In Vitro Diagnostics Market, Sales Trends for Major Players, 2008-2012 71

Figure 14: Medical Device Market, Brazil, Orthopedic Devices Market, Revenue ($bn), 2008-2013 73

Figure 15: Medical Device Market, Brazil, Orthopedic Devices Market, Sales Trends for Major Players, 2008-2012 74

Figure 16: Medical Device Market, Brazil, Diagnostic Imaging Market, Revenue ($bn), 2008-2013 76

Figure 17: Medical Device Market, Brazil, Diagnostic Imaging Market, Sales Trends for Major Players, 2008-2012 77

Figure 18: Medical Device Market, Brazil, Cardiovascular Device Market, Revenue ($bn), 2008-2013 80

Figure 19: Medical Device Market, Brazil, Cardiovascular Device Market, Sales Trends for Major Players, 2008-2012 81

Figure 20: Medical Device Market, Brazil, Diagnostic Market, Revenue ($bn), 2008-2013 82

Figure 21: Medical Device Market, Brazil, Diagnostic Market, Revenue Forecast ($bn), 2014-2020 83

Figure 22: Medical Device Market, Brazil, Major Medical Device Companies, Revenue ($m), 2012 84

Figure 23: Healthcare Market, Brazil, Drivers and Barriers, 2014 112

Figure 24: Healthcare System, Brazil, Reimbursement System, 2014 116

Figure 25: Healthcare System, Brazil, Reimbursement Process, 2014 118

Figure 26: Healthcare Spending, Brazil, Health Insurance Providers, 2014 119

Figure 27: Healthcare System, Brazil, Organization Structure of ANS, 2014 121

Figure 28: Healthcare Spending, Brazil, Private Health Plans (million), 2008-2013 123

Figure 29: Healthcare Spending, Brazil, Out-of-Pocket Expenditure (%), 2008-2013 124

Figure 30: Market Access, Brazil, Price Change (%), 2008-2013 125

Figure 31: Healthcare System, Brazil, Flowchart for Classification of Drugs into Categories, 2014 128

Figure 32: Market Access, Brazil, Ministry of Health Structure, 2014 131

Figure 33: Market Access, Brazil, Drug Approval Process, 2014 136

Figure 34: Economic Indicators, Brazil, GDP per Capita ($), 2008-2013 162

Figure 35: Economic Indicators, Brazil, GDP per Capita Forecast ($), 2014-2020 163

Figure 36: Economic Indicators, Brazil, GDP Annual Growth (%), 2008-2013 164

Figure 37: Economic Indicators, Brazil, GDP Annual Growth Forecast (%), 2014-2020 165

Figure 38: Economic Indicators, Brazil, Gross National Income per Capita ($), 2008-2013 166

Figure 39: Economic Indicators, Brazil, Average Consumer Price Index, 2008-2013 167

Figure 40: Economic Indicators, Brazil, Average Consumer Price Annual Change (%), 2008-2013 168

Figure 41: Economic Indicators, Brazil, Currency Exchange Rate (BRL/$), 2008-2013 169

Figure 42: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2008-2013 170

Figure 43: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2008-2013 171

Figure 44: Economic Indicators, Brazil, Trade Balance ($bn), 2008-2013 172

Figure 45: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2008-2013 173

Figure 46: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2008-2013 174

Figure 47: Economic Indicators, Brazil, Government Structural Balance ($bn), 2008-2013 175

Figure 48: Economic Indicators, Brazil, General Government Net Debt ($bn), 2008-2013 176

Figure 49: Economic Indicators, Brazil, Major Industries (Production Index), 2014 177

Figure 50: Demographics, Brazil, Population (million), 2008-2013 179

Figure 51: Demographics, Brazil, Population Forecast (million), 2014-2020 180

Figure 52: Demographics, Brazil, Population, Urban and Rural Population (%), 2008-2013 181

Figure 53: Demographics, Brazil, Population Distribution by Age Group (%), 2008-2013 182

Figure 54: Demographics, Brazil, Population Distribution by Age Group Forecast (%), 2014-2020 183

Figure 55: Demographics, Brazil, Births (per 1,000 population), 2008-2013 184

Figure 56: Demographics, Brazil, Mortality (per 1,000 population), 2008-2013 185

Figure 57: Demographics, Brazil, Major Causes of Mortality (per 1,000 population), 2013 186

Figure 58: Demographics, Brazil, Children ?5 Years, Mortality (per 1,000 Live Births), 2008-2013 187

Figure 59: Demographics, Brazil, Immunization Rate (%), 2008-2013 188

Figure 60: Demographics, Brazil, Major Causes of Male Mortality (per 1,000 population), 2013 189

Figure 61: Demographics, Brazil, Major Causes of Female Mortality (per 1,000 population), 2013 190

Figure 62: Demographics, Brazil, Gender Ratio (Male/Female), 2008-2013 192

Figure 63: Demographics, Brazil, Life Expectancy at Birth (Years), 2008-2013 193

Figure 64: Demographics, Brazil, Literacy Rate (%), 2008-2013 195

Figure 65: Demographics, Brazil, Employment Rate (%), 2008-2013 196

Figure 66: Demographics, Brazil, Major Diseases, DALYs (per 100,000 population), 2004 197

Figure 67: Healthcare Infrastructure, Brazil, Type of Hospital (%), 2015 198

Figure 68: Healthcare Infrastructure, Hospital Beds by Type of Service, Brazil, 2008-2013 199

Figure 69: Healthcare Infrastructure, Hospital Beds by Type of Care, Brazil, 2015 200

Figure 70: Healthcare Infrastructure, Brazil, Diagnostic Equipment, 2015 201

Figure 71: Healthcare Infrastructure, Brazil, Total Hospital Beds (per 1,000 population), 2008-2013 202

Figure 72: Healthcare Infrastructure, Brazil, Doctors (per 1,000 population), 2008-2013 203

Figure 73: Healthcare Infrastructure, Brazil, CO2 Emissions (Metric Tons per Capita), 2008-2013 204

Figure 74: Healthcare Infrastructure, Brazil, N2O Emissions (Million Metric Tons), 2008-2013 205

Figure 75: Healthcare Infrastructure, Brazil, PM10 Emissions (µg/m3), 2008-2013 206

Figure 76: Healthcare Infrastructure, Brazil, Nurses (per 1,000 population), 2008-2013 207

Figure 77: Healthcare Expenditure, Brazil, Healthcare Expenditure (% of GDP), 2008-2013 208

Figure 78: Healthcare Expenditure, Brazil, Share of Major Components (%), 2012 209

Figure 79: Healthcare Expenditure, Brazil, Public-Private Share (%), 2008-2013 210

Figure 80: Healthcare Expenditure, Brazil, Research and Development Expenditure, Share (%), 2008 211

Figure 81: Healthcare Market, Brazil, Opportunities and Challenges, 2014 216

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