CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil

Published : Jun-2017

No. of Pages : 199

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Table of Contents

1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6

2 Executive Summary 8

3 Introduction 12
3.1 GlobalData Report Guidance 12

4 Overview of Pharmaceutical and Medical Device Markets 13
4.1 Pharmaceutical Market 13
4.1.1 Market Overview 13
4.1.2 Pharmaceutical Exports and Imports 15
4.1.3 Supply Channels 16
4.1.4 Market Segments 18
4.1.5 Overview of Top Five Disease Areas 21
4.1.6 Major Players 23
4.2 Medical Device Market 53
4.2.1 Market Overview 53
4.2.2 Overview of Top Five Segments 55
4.2.3 Diagnostic Market 66
4.2.4 Major Players 67
4.3 Market Drivers and Barriers 96
4.3.1 Drivers 96
4.3.2 Barriers 97

5 Market Access 99
5.1 Overview of Healthcare system 99
5.2 Reimbursement and Payer Landscape 100
5.3 Reimbursement Process 101
5.3.1 Overview of Insurance Providers 102
5.3.2 Patient Share in Healthcare Expenditure 105
5.3.3 Price Trends in the Healthcare Sector 106
5.3.4 Pricing Policies 106
5.4 Regulatory Landscape 109
5.4.1 Overview of Regulatory Agencies 109
5.4.2 Market Authorization Procedure for Pharmaceutical Products 114
5.4.3 New Medical Device Approval Process 116
5.4.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 119
5.4.5 Intellectual Property Rights 120
5.4.6 Clinical Trial Regulations 124
5.4.7 Pharmaceutical Advertising Regulations 124
5.4.8 Pharmacy Regulations 125
5.4.9 Labeling and Packaging Regulations 126

6 Country Analysis 127
6.1 Political Environment 127
6.1.1 Political Structure 127
6.1.2 Current Political Environment 128
6.1.3 Healthcare Policy Initiatives 129
6.2 Economic Landscape 130
6.3 Economic Indicators 132
6.3.1 Gross Domestic Product 132
6.3.2 Gross National Income 136
6.3.3 Inflation 137
6.3.4 Currency Exchange Rate 140
6.3.5 Foreign Direct Investment 141
6.3.6 Foreign Exchange Reserves 142
6.3.7 Trade Balance 143
6.3.8 Government Structural Balance 145
6.3.9 Government Net Debt 146
6.3.10 Major Industries 148
6.4 Demographics 149
6.4.1 Population 149
6.5 Healthcare Infrastructure 168
6.5.1 Healthcare Facilities 168
6.5.2 Healthcare Parameters 171
6.5.3 Environmental Health 173
6.6 Healthcare Expenditure 175
6.6.1 Overview 175
6.6.2 Share of Public and Private Sectors 176
6.6.3 Major Components of Healthcare Expenditure 177
6.6.4 Spending in Pharmaceutical R&D 178
6.7 Trade Associations 179
6.7.1 ABIMO 179
6.7.2 ABIMED 179
6.7.3 Interfarma 179
6.7.4 Abiquifi 180
6.8 Trade Fairs 180

7 Opportunities and Challenges 181
7.1 Opportunities 181
7.2 Challenges 181

8 Appendix 183
8.1 Abbreviations 183
8.2 Bibliography 188
8.3 Research Methodology 197
8.3.1 Coverage 197
8.3.2 Secondary Research 197
8.3.3 Forecasts 198
8.3.4 Expert Panel 198
8.4 Contact Us 198
8.5 Disclaimer 199

List of Tables

Table 1: Pharmaceutical Market, Brazil, Revenue ($bn), 2009-2016 14
Table 2: Pharmaceutical Market, Brazil, Revenue ($bn), 2017-2021 15
Table 3: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2009-2016 16
Table 4: Pharmaceutical Market, Brazil, Generic Market ($bn), 2009-2016 18
Table 5: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2014 21
Table 6: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2017 24
Table 7: Pharmaceutical Market, Roche, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016 34
Table 8: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2017 35
Table 9: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016 41
Table 10: Pharmaceutical Market, Novartis, Planned Filings, 2017-2020 41
Table 11: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016 48
Table 12: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2017 49
Table 13: Medical Device Market, Brazil, Revenue ($bn), 2009-2016 53
Table 14: Medical Device Market, Brazil, Revenue ($bn), 2017-2021 54
Table 15: Medical Device Market, Brazil, Revenue ($m) and Market Share (%) by Segment, 2016 55
Table 16: In Vitro Diagnostics Market, Brazil, Revenue ($bn), 2009-2016 56
Table 17: In Vitro Diagnostics, Brazil, Revenue ($m) and Market Share (%) of Major Players, 2014 57
Table 18: Orthopedic Device Market, Brazil, Revenue ($bn), 2009-2016 58
Table 19: Orthopedic Devices, Brazil, Revenue ($m) and Market Share (%) of Major Players, 2015 59
Table 20: Diagnostic Imaging Market, Brazil, Revenue ($bn), 2009-2016 60
Table 21: Diagnostic Imaging, Brazil, Revenue ($m) and Market Share (%) of Major Players, 2015 61
Table 22: Ophthalmic Device Market, Brazil, Revenue ($m), 2009-2016 62
Table 23: Ophthalmic Device Market, Brazil, Revenue ($m) and Market Share (%) of Major Players, 2015 63
Table 24: Cardiovascular Device Market, Brazil, Revenue ($m), 2009-2016 64
Table 25: Cardiovascular Device Market, Brazil, Revenue ($m) and Market Share (%) of Major Players, 2016 65
Table 26: Cardiovascular Device Market, Brazil, Revenue ($m), 2009-2016 66
Table 27: Diagnostic Market, Brazil, Revenue ($m), 2017-2021 67
Table 28: Major Players, Brazil, Revenue ($m), 2012 68
Table 29: Medical Device Market, Medtronic, Major Products, 2016 80
Table 30: Baxter, Global, Major Products, 2016 86
Table 31: Healthcare System, Brazil, 2016 99
Table 32: Healthcare Expenditure, Brazil, Out-of-Pocket Expenditure (%), 2009-2016 105
Table 33: Market Access, Brazil, Price Change (%), 2009-2016 106
Table 34: Pricing Policies, Brazil, 2016 107
Table 35: Market Access, Brazil, Compensation Services for Patents ($), 2014 123
Table 36: Market Access, Brazil, Compensation Services for Trademarks ($), 2014 124
Table 37: Economic Indicators, Brazil, GDP per Capita ($), 2009-2016 132
Table 38: Economic Indicators, Brazil, GDP per Capita ($), 2017-2021 133
Table 39: Economic Indicators, Brazil, GDP Annual Growth (%), 2009-2016 134
Table 40: Economic Indicators, Brazil, GDP Annual Growth (%), 2017-2021 135
Table 41: Economic Indicators, Brazil, GNI per Capita ($), 2009-2016 136
Table 42: Economic Indicators, Brazil, Consumer Price Index, 2009-2016 137
Table 43: Economic Indicators, Brazil, Average Consumer Price Index Annual Change (%), 2009-2016 138
Table 44: Economic Indicators, Brazil, Average Consumer Price Index, Annual Change (%), 2017-2021 139
Table 45: Economic Indicators, Brazil, Currency Exchange Rate ($/BRL), 2009-2016 140
Table 46: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2009-2016 141
Table 47: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2009-2016 142
Table 48: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2009-2016 143
Table 49: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2009-2016 144
Table 50: Economic Indicators, Brazil, General Government Structural Balance ($bn), 2009-2016 145
Table 51: Economic Indicators, Brazil, Government Net Debt ($bn), 2009-2016 146
Table 52: Economic Indicators, Brazil, Government Net Debt ($bn), 2017-2021 147
Table 53: Economic Indicators, Brazil, Production Index of Major Industries (physical production), 2017 148
Table 54: Demographics, Brazil, Population (million), 2009-2016 149
Table 55: Demographics, Brazil, Population (million), 2017-2021 150
Table 56: Demographics, Brazil, Urban-Rural Population Share (%), 2009-2016 151
Table 57: Demographics, Brazil, Urban-Rural Population Share (%), 2017-2021 152
Table 58: Demographics, Brazil, Population Distribution by Age Group (%), 2009-2016 153
Table 59: Demographics, Brazil, Population Distribution by Age Group (%), 2017-2021 154
Table 60: Demographics, Brazil, Births (per 1,000 population), 2009-2016 155
Table 61: Demographics, Brazil, Mortality (per 1,000 Population), 2009-2016 156
Table 62: Demographics, Brazil, Major Causes of Mortality (per 100,000 population), 2014 157
Table 63: Demographics, Brazil, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 158
Table 64: Demographics, Brazil, Immunization Rate (%), 2009-2016 159
Table 65: Demographics, Brazil, Major Causes of Male Mortality (per 100,000 population), 2014 160
Table 66: Demographics, Brazil, Major Causes of Female Mortality (per 100,000 population), 2014 161
Table 67: Demographics, Brazil, Gender Ratio (M/F), 2009-2016 162
Table 68: Demographics, Brazil, Life Expectancy at Birth (years), 2009-2016 163
Table 69: Demographics, Brazil, Life Expectancy at Birth (years), 2017-2021 164
Table 70: Demographics, Brazil, Gross Enrollment Ratio (%), 2009-2016 165
Table 71: Demographics, Brazil, Unemployment Rate (%), 2009-2016 166
Table 72: Demographics, Brazil, Disability-Adjusted Life Years by Major Disease (000), 2012 167
Table 73: Healthcare Infrastructure, Brazil, Hospital Types (%), 2015 168
Table 74: Healthcare Infrastructure, Brazil, Hospital Beds, 2009-2016 169
Table 75: Healthcare Infrastructure, Brazil, Diagnostic Units (per 1,000,000 population), 2009-2016 170
Table 76: Healthcare Infrastructure, Brazil, Hospitals Beds (per 1,000 population), 2009-2016 171
Table 77: Healthcare Infrastructure, Brazil, Doctors (per 1,000 population), 2009-2016 172
Table 78: Healthcare Infrastructure, Brazil, PM2.5 (µg per m³), 2009-2016 173
Table 79: Healthcare Infrastructure, Brazil, CO2 Emissions (metric tons per capita), 2009-2016 174
Table 80: Healthcare Infrastructure, Brazil, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 175
Table 81: Healthcare Infrastructure, Brazil, Public-Private Share of Expenditure (%), 2009-2016 176
Table 82: Healthcare Infrastructure, Brazil, Major Components of Healthcare Expenditure (%), 2013 177
Table 83: Healthcare Infrastructure, Brazil, Share of R&D Expenditure (%), 2013 178
Table 84: Healthcare Expenditure, Brazil, Major Healthcare Trade Fairs, 2017 180

List of Figures

Figure 1: Pharmaceutical Market, Brazil, Revenue ($bn), 2009-2021 8
Figure 2: Medical Device Market, Brazil, Revenue ($bn), 2009-2021 9
Figure 3: Country Profile, Brazil, 2017 11
Figure 4: Pharmaceutical Market, Brazil, Revenue ($bn), 2009-2016 14
Figure 5: Pharmaceutical Market, Brazil, Revenue ($bn), 2017-2021 15
Figure 6: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2009-2016 16
Figure 7: Pharmaceutical Market, Brazil, Distribution Channels, 2016 17
Figure 8: Pharmaceutical Market, Brazil, Generic Market ($bn), 2009-2016 18
Figure 9: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2014 21
Figure 10: Medical Device Market, Brazil, Revenue ($bn), 2009-2016 53
Figure 11: Medical Device Market, Brazil, Revenue ($bn), 2017-2021 54
Figure 12: Medical Device Market, Brazil, Revenue by Segment ($bn), 2016 55
Figure 13: In Vitro Diagnostics Market, Brazil, Revenue ($bn), 2009-2016 56
Figure 14: In Vitro Diagnostics, Brazil, Market Share of Major Players (%), 2014 57
Figure 15: Orthopedic Device Market, Brazil, Revenue ($bn), 2009-2016 58
Figure 16: Orthopedic Device Market, Brazil, Market Share of Major Players (%), 2016 59
Figure 17: Diagnostic Imaging Market, Brazil, Revenue ($bn), 2009-2016 60
Figure 18: Diagnostic Imaging, Brazil, Market Share of Major Players (%), 2015 61
Figure 19: Ophthalmic Device Market, Brazil, Revenue ($m), 2009-2016 62
Figure 20: Ophthalmic Device Market, Brazil, Market Share of Major Players (%), 2015 63
Figure 21: Cardiovascular Device Market, Brazil, Revenue ($m), 2009-2016 64
Figure 22: Cardiovascular Device Market, Brazil, Market Share of Major Players (%), 2016 65
Figure 23: Diagnostic Market, Brazil, Revenue ($m), 2009-2016 66
Figure 24: Diagnostic Market, Brazil, Revenue ($m), 2017-2021 67
Figure 25: Major Players, Brazil, Revenue ($m), 2012 68
Figure 26: Healthcare Market, Brazil, Drivers and Barriers, 2017 98
Figure 27: Market Access, Brazil, Reimbursement Process, 2014 102
Figure 28: Healthcare Expenditure, Brazil, Out-of-Pocket Expenditure (%), 2009-2016 105
Figure 29: Market Access, Brazil, Price Change (%), 2009-2016 106
Figure 30: Healthcare System, Brazil, Flowchart for Classification of Drugs into Categories, 2014 109
Figure 31: Market Access, Brazil, Ministry of Health Structure, 2016 111
Figure 32: Market Access, Brazil, Drug Approval Process, 2016 115
Figure 33: Economic Indicators, Brazil, GDP per Capita ($), 2009-2016 132
Figure 34: Economic Indicators, Brazil, GDP per Capita ($), 2017-2021 133
Figure 35: Economic Indicators, Brazil, GDP Annual Growth (%), 2009-2016 134
Figure 36: Economic Indicators, Brazil, GDP Annual Growth (%), 2017-2021 135
Figure 37: Economic Indicators, Brazil, GNI per Capita ($), 2009-2016 136
Figure 38: Economic Indicators, Brazil, Consumer Price Index, 2009-2016 137
Figure 39: Economic Indicators, Brazil, Average Consumer Price Index, Annual Change (%), 2009-2016 138
Figure 40: Economic Indicators, Brazil, Average Consumer Price Index, Annual Change (%), 2017-2021 139
Figure 41: Economic Indicators, Brazil, Currency Exchange Rate ($/BRL), 2009-2016 140
Figure 42: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2009-2016 141
Figure 43: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2009-2016 142
Figure 44: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2009-2016 143
Figure 45: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2009-2016 144
Figure 46: Economic Indicators, Brazil, Government Structural Balance ($bn), 2009-2016 145
Figure 47: Economic Indicators, Brazil, Government Net Debt ($bn), 2009-2016 146
Figure 48: Economic Indicators, Brazil, Government Net Debt ($bn), 2017-2021 147
Figure 49: Economic Indicators, Brazil, Production Index of Major Industries (physical production), 2017 148
Figure 50: Demographics, Brazil, Population (million), 2009-2016 149
Figure 51: Demographics, Brazil, Population (million), 2017-2021 150
Figure 52: Demographics, Brazil, Urban-Rural Population Share (%), 2009-2016 151
Figure 53: Demographics, Brazil, Urban-Rural Population Share (%), 2017-2021 152
Figure 54: Demographics, Brazil, Population Distribution by Age Group (%), 2009-2016 153
Figure 55: Demographics, Brazil, Population Distribution by Age Group (%), 2017-2021 154
Figure 56: Demographics, Brazil, Births (per 1,000 population), 2009-2016 155
Figure 57: Demographics, Brazil, Mortality (per 1,000 Population), 2009-2016 156
Figure 58: Demographics, Brazil, Major Causes of Mortality (per 100,000 population), 2014 157
Figure 59: Demographics, Brazil, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 158
Figure 60: Demographics, Brazil, Immunization Rate (%), 2009-2016 159
Figure 61: Demographics, Brazil, Major Causes of Male Mortality (per 100,000 population), 2014 160
Figure 62: Demographics, Brazil, Major Causes of Female Mortality (per 100,000 population), 2014 161
Figure 63: Demographics, Brazil, Gender Ratio (M/F), 2009-2016 162
Figure 64: Demographics, Brazil, Life Expectancy at Birth (years), 2009-2016 163
Figure 65: Demographics, Brazil, Life Expectancy at Birth (years), 2017-2021 164
Figure 66: Demographics, Brazil, Gross Enrollment Ratio (%), 2009-2016 165
Figure 67: Demographics, Brazil, Unemployment Rate (%), 2009-2016 166
Figure 68: Demographics, Brazil, Major Diseases, Disability-Adjusted Life Years by Major Disease (000s), 2012 167
Figure 69: Healthcare Infrastructure, Brazil, Hospital Types (%), 2015 168
Figure 70: Healthcare Infrastructure, Brazil, Hospital Beds, 2009-2016 169
Figure 71: Healthcare Infrastructure, Brazil, Diagnostic Units (per 1,000,000 population), 2009-2016 170
Figure 72: Healthcare Infrastructure, Brazil, Hospitals Beds (per 1,000 population), 2009-2016 171
Figure 73: Healthcare Infrastructure, Brazil, Doctors (per 1,000 population), 2009-2016 172
Figure 74: Healthcare Infrastructure, Brazil, PM2.5 (µg per m³), 2009-2016 173
Figure 75: Healthcare Infrastructure, Brazil, CO2 Emissions (metric tons per capita), 2009-2016 174
Figure 76: Healthcare Infrastructure, Brazil, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 175
Figure 77: Healthcare Infrastructure, Brazil, Public-Private Share of Expenditure (%), 2009-2016 176
Figure 78: Healthcare Infrastructure, Brazil, Major Components of Healthcare Expenditure (%), 2013 177
Figure 79: Healthcare Infrastructure, Brazil, Share of R&D Expenditure (%), 2013 178
Figure 80: Healthcare Market, Brazil, Opportunities and Challenges, 2017 182

Filed in: Pharmaceutical, Pharmaceuticals and Healthcare

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