JSBMarketResearch: CountryFocus: Healthcare, Regulatory and Reimbursement Landscape

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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Brazil Released On 19th September 2015

Summary 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 JSB Market Research Pvt. Ltd.

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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 JSB Market Research Pvt. Ltd.

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- 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 Browse complete Report on: http://www.jsbmarketresearch.com/healthcare-medical/r-countryfocushealthcare-regulatory-and-reimbursement-landscape-brazil-192163 Table of Contents 1.1 List of Tables 9 1.2 List of Figures 13 2 Introductions 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 JSB Market Research Pvt. Ltd.

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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 JSB Market Research Pvt. Ltd.

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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 List Of Tables Table 1: Pharmaceutical Market, Brazil, Revenue ($bn), 2008-2013 19 Table 2: Pharmaceutical Market, Brazil, Revenue Forecast ($bn), 2014-2020 20 JSB Market Research Pvt. Ltd.

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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 ($bn), 20082013 73 Table 20: Medical Device Market, Brazil, Orthopedic Devices Market, Sales Trends for Major Players, 2012 74 Table 21: Medical Device Market, Brazil, Diagnostic Imaging Market, Revenue ($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 JSB Market Research Pvt. Ltd.

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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 ($), 2008-2013 166 Table 42: Economic Indicators, Brazil, Average Consumer Price Index, 2008-2013 167 Table 43: Economic Indicators, Brazil, Average Consumer Price Annual Change (%), 20082013 168 Table 44: Economic Indicators, Brazil, Currency Exchange Rate (BRL/$), 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 JSB Market Research Pvt. Ltd.

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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), 20082013 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), 20082013 204 Table 77: Healthcare Infrastructure, Brazil, N2O Emissions (Million Metric Tons), 20082013 205 Table 78: Healthcare Infrastructure, Brazil, PM10 Emissions (¾g/m3), 2008-2013 206 JSB Market Research Pvt. Ltd.

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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 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 JSB Market Research Pvt. Ltd.

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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 JSB Market Research Pvt. Ltd.

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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 JSB Market Research Pvt. Ltd.

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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), 20082013 205 Figure 75: Healthcare Infrastructure, Brazil, PM10 Emissions (Âľg/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), 20082013 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 Product Price : License Type

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