NEW YORK, June 26, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Healthcare, Regulatory and Reimbursement Landscape - Brazil
http://www.reportlinker.com/p0829601/Healthcare-Regulatory-and-Reimbursement-Landscape---Brazil.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Diagnostics
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
<5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010 144>Table 73: Children
<5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020 145>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: Pharmaceutical 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
<5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010 144>Figure 65: Children
<5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020 145>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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