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 -
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 -
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
1.1 List of Tables
1.2 List of Figures
2 INTRODUCTION
2.1 Report Guidance
3 OVERVIEW OF THE PHARMACEUTICAL AND MEDICAL DEVICES MARKET
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Supply Channels
3.1.3 Market Segments
3.1.4 Major Disease Areas
3.1.5 Major Players
3.2 Medical Device Market
3.2.1 Market Overview
3.2.2 Overview of Top Five Segments
3.2.3 Major Players
3.3 Market Drivers and Barriers
3.3.1 Drivers
3.3.2 Barriers
4 MARKET ACCESS
4.1 Reimbursement and Payer Landscape
4.1.1 Healthcare System in Brazil
4.1.2 Reimbursement Process
4.1.3 Overview of Insurance Provider
4.1.4 Patient Share in Healthcare Spending
4.1.5 Drug Price Trend
4.1.6 Pricing Policies
4.2 Regulatory Landscape
4.2.1 Overview of Regulatory Agencies
4.2.2 New Drug Approval Process
4.2.3 New Medical Device Approval Process
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
4.2.5 Licensing Process for Pharmaceutical Exports and Imports
4.2.6 Intellectual Property Rights
4.2.7 Clinical Trial Regulations
4.2.8 Pharmaceutical Advertising Regulations
4.2.9 Pharmacy Regulations
4.2.10 Labeling and Packaging Regulations
5 COUNTRY ANALYSIS
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserves
5.3.7 Trade Balance
5.3.8 Government Structural Balance
5.3.9 Government Net Debt
5.3.10 Major Industries
5.4 Demographics
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview
5.6.2 Major Components of Healthcare Spending
5.6.3 Share of Public and Private Sector
5.6.4 Spending in Pharmaceutical R&D
5.7 Trade Associations
5.7.1 ABIMO
5.7.2 ABIMED
5.7.3 Interfarma
5.7.4 Abiquifi
5.8 Trade Fairs
6 OPPORTUNITIES AND CHALLENGES
6.1 Opportunities
6.2 Challenges
7 APPENDIX
7.1 Abbreviations
7.2 Methodology
7.2.1 Coverage
7.2.2 Secondary Research
7.2.3 Forecasting
7.2.4 Primary Research
7.2.5 Expert Panel Validation
7.3 Contact Us
7.4 Bibliography
7.5 Disclaimer
LIST OF TABLES
Table 1: Pharmaceutical Market ($bn), Brazil, 2005-2010
Table 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020
Table 3: Price Margins of Distribution Channels (%), Brazil
Table 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010
Table 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020
Table 6: Major Domestic Companies with Focus on Biologics, Brazil, 2008
Table 7: Major Products, Pfizer, Global, Revenue ($m), 2010
Table 8: Late Stage Pipeline, Pfizer, 2011
Table 9: Major Products, Novartis, Global, Revenue ($m), 2010
Table 10: Planned Filings, Novartis, 2011 to ≥ 2015
Table 11: Major Products, Sanofi, Global, Revenue ($m), 2010
Table 12: Late Stage Pipeline, Sanofi, 2011
Table 13: Major Products, Roche, Global, Revenue ($m), 2010
Table 14: Late Stage Pipeline, Roche, 2011
Table 15: Medical Device Market ($bn), Brazil, 2005-2010
Table 16: Medical Device Market ($bn), Brazil, Forecast, 2011-2020
Table 17: Medical Device Market, Segments Revenue ($m), Brazil, 2010
Table 18: Ophthalmic Devices Market ($m), Brazil, 2005-2010
Table 19: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2010
Table 20: In Vitro Diagnostics Market ($m), Brazil, 2005-2010
Table 21: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2010
Table 22: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010
Table 23: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2010
Table 24: Orthopedic Devices Market ($m), Brazil, 2005-2010
Table 25: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2010
Table 26: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010
Table 27: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010
Table 28: Major Medical Device Companies, Brazil, Revenue, 2010
Table 29: Major Products, Siemens, Global, Revenue ($m), 2010
Table 30: Late Stage Pipeline, GE Healthcare, 2011
Table 31: Major Products, Roche, Global, Revenue ($m), 2010
Table 32: Late Stage Pipeline, F. Hoffmann-La Roche Ltd., 2010
Table 33: Major Products, Essilor, Revenue ($m), 2010
Table 34: Major Products, Philips Healthcare, Global, Revenue ($m), 2010
Table 35: Healthcare System, Brazil, 2011
Table 36: Comparative Analysis of CITEC and CONITEC, Brazil, 2011
Table 37: Decision-Making Structure of SUS, Brazil
Table 38: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010
Table 39: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010
Table 40: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010
Table 41: Drug Price Trend, Price Change (%), Brazil, 2005-2010
Table 42: Pricing Criteria for Various Drugs, Brazil
Table 43: Documents Required for Dossier Submission of Clinical Trial, Brazil, 2011
Table 44: GDP Per Capita ($), Brazil, 2005-2010
Table 45: GDP Per Capita ($), Brazil, Forecast, 2011-2020
Table 46: GDP, Annual Growth (%), Brazil, 2005-2010
Table 47: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020
Table 48: GNI Per Capita ($), Brazil, 2005-2010
Table 49: Average Consumer Price Index, Brazil, 2005-2010
Table 50: Average Consumer Price, Annual Change (%), Brazil, 2005-2010
Table 51: Currency Exchange Rate ($/BRL), Brazil, 2005-2010
Table 52: Foreign Direct Investment ($bn), Brazil, 2005-2010
Table 53: Foreign Exchange Reserves ($bn), Brazil, 2005-2010
Table 54: Trade Balance ($bn), Brazil, 2005-2010
Table 55: Imports of Goods and Services ($bn), Brazil, 2005-2010
Table 56: Exports of Goods and Services ($bn), Brazil, 2005-2010
Table 57: General Government Structural Balance ($bn), Brazil, 2005-2010
Table 58: General Government Net Debt (% of GDP), Brazil, 2005-2010
Table 59: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020
Table 60: Major Service Industries by Revenue ($bn), 2008
Table 61: Major Manufacturing Industries by Revenue ($bn), 2008
Table 62: Population (m), Brazil, 2005-2010
Table 63: Population (m), Brazil, Forecast, 2011-2020
Table 64: Urban and Rural Population, Brazil, Share (%), 2005-2010
Table 65: Age Groups, Population Distribution (%), Brazil, 2005-2010
Table 66: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020
Table 67: Birth Rate (Per 1,000 Population), Brazil, 2005-2010
Table 68: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020
Table 69: Mortality (Per 1,000 Population), Brazil, 2005-2010
Table 70: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020
Table 71: Major Causes of Mortality (‘000), Brazil, 2008
Table 72: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010
Table 73: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020
Table 74: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010
Table 75: Causes of Male Mortality (‘000), Brazil, 2008
Table 76: Causes of Female Mortality (‘000), Brazil, 2008
Table 77: Gender Ratio (M/F), Brazil, 2005-2010
Table 78: Life Expectancy at Birth (Years), Brazil, 2005-2010
Table 79: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020
Table 80: Illiteracy (%), Brazil, 2005-2010
Table 81: Unemployment (%), Brazil, 2005-2010
Table 82: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004
Table 83: Major Diseases, Brazil, In Patients (‘000), 2010
Table 84: Hospital Funding, Brazil, Share of Sources (%), 2009
Table 85: Public and Private Hospitals, Brazil, 2005-2010
Table 86: Hospitals by Type of Services (%), Brazil, 2009
Table 87: Beds (Per 1,000 Population), Brazil, 2005-2010
Table 88: Public-Private Beds, Brazil, 2005-2010
Table 89: Diagnostic Equipment, Brazil, 2009
Table 90: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007
Table 91: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008
Table 92: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008
Table 93: Targets for Carbon Reduction, Brazil, 2009
Table 94: CO2 Emissions (‘000 Metric Tons), Brazil, 2005-2010
Table 95: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010
Table 96: Healthcare Personnel (‘000), Brazil, 2009
Table 97: Doctors (Per 1,000 Population), Brazil, 2005-2010
Table 98: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007
Table 99: Healthcare Expenditure (% of GDP), Brazil, 2005-2010
Table 100: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007
Table 101: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007
Table 102: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010
Table 103: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008
Table 104: Major Healthcare Trade Fairs, Brazil, 2012
LIST OF FIGURES
Figure 1: Pharomaceutical Market ($bn), Brazil, 2005-2010
Figure 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020
Figure 3: Pharmaceutical Supply Chain, Brazil, 2007
Figure 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010
Figure 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020
Figure 6: Biotech Regions, Brazil, Companies Distribution (%), 2006
Figure 7: Medical Device Market ($bn), Brazil, 2005-2010
Figure 8: Medical Device Market ($bn), Brazil, Forecast, 2011-2020
Figure 9: Medical Device Market, Segments Revenue ($m), Brazil, 2010
Figure 10: Ophthalmic Devices Market ($m), Brazil, 2005-2010
Figure 11: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2005-2010
Figure 12: In Vitro Diagnostics Market ($m), Brazil, 2005-2010
Figure 13: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2005-2010
Figure 14: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010
Figure 15: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2005-2010
Figure 16: Orthopedic Devices Market ($m), Brazil, 2005-2010
Figure 17: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2005-2010
Figure 18: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010
Figure 19: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010
Figure 20: Major Medical Device Companies, Brazil, Revenue ($m), 2010
Figure 21: Drivers and Barriers, Healthcare Market, Brazil, 2011
Figure 22: Reimbursement System, Brazil, 2011
Figure 23: Reimbursement Process, Brazil, 2011
Figure 24: Health Insurance Providers, Brazil, 2011
Figure 25: Health Policy Packages, Brazil, 2007
Figure 26: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010
Figure 27: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010
Figure 28: Organization Structure of ANS, Brazil, 2011
Figure 29: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010
Figure 30: Drug Price Trend, Price Change (%), Brazil, 2005-2010
Figure 31: ANVISA Structure, Brazil, 2011
Figure 32: Roles and Responsibilities of Regulatory Bodies, Brazil, 2011
Figure 33: New Drug Approval Stages, Brazil, 2011
Figure 34: New Drug Approval Process, Brazil, 2011
Figure 35: New Medical Device Approval Process, Brazil, 2011
Figure 36: GDP Per Capita ($), Brazil, 2005-2010
Figure 37: GDP Per Capita ($), Brazil, Forecast, 2011-2020
Figure 38: GDP, Annual Growth (%), Brazil, 2005-2010
Figure 39: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020
Figure 40: GNI Per Capita ($), Brazil, 2005-2010
Figure 41: Average Consumer Price Index, Brazil, 2005-2010
Figure 42: Average Consumer Price, Annual Change (%), Brazil, 2005-2010
Figure 43: Currency Exchange Rate ($/BRL), Brazil, 2005-2010
Figure 44: Foreign Direct Investment ($bn), Brazil, 2005-2010
Figure 45: Foreign Exchange Reserves ($bn), Brazil, 2005-2010
Figure 46: Trade Balance ($bn), Brazil, 2005-2010
Figure 47: Imports of Goods and Services ($bn), Brazil, 2005-2010
Figure 48: Exports of Goods and Services ($bn), Brazil, 2005-2010
Figure 49: General Government Structural Balance ($bn), Brazil, 2005-2010
Figure 50: General Government Net Debt (% of GDP), Brazil, 2005-2010
Figure 51: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020
Figure 52: Major Service Industries by Revenue ($bn), 2008
Figure 53: Major Manufacturing Industries by Revenue ($bn), 2008
Figure 54: Population (m), Brazil, 2005-2010
Figure 55: Population (m), Brazil, Forecast, 2011-2020
Figure 56: Urban and Rural Population, Brazil, Share (%), 2005-2010
Figure 57: Age Groups, Population Distribution (%), Brazil, 2005-2010
Figure 58: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020
Figure 59: Birth Rate (Per 1,000 Population), Brazil, 2005-2010
Figure 60: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020
Figure 61: Mortality (Per 1,000 Population), Brazil, 2005-2010
Figure 62: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020
Figure 63: Major Causes of Mortality (‘000), Brazil, 2008
Figure 64: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010
Figure 65: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020
Figure 66: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010
Figure 67: Causes of Male Mortality (‘000), Brazil, 2008
Figure 68: Causes of Female Mortality (‘000), Brazil, 2008
Figure 69: Gender Ratio (M/F), Brazil, 2005-2010
Figure 70: Life Expectancy at Birth (Years), Brazil, 2005-2010
Figure 71: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020
Figure 72: Illiteracy (%), Brazil, 2005-2010
Figure 73: Unemployment (%), Brazil, 2005-2010
Figure 74: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004
Figure 75: Major Diseases, Brazil, In Patients (‘000), 2010
Figure 76: Hospital Funding, Brazil, Share of Sources (%), 2009
Figure 77: Flow of Funds to Hospitals, Brazil, 2008
Figure 78: Public and Private Hospitals, Brazil, 2005-2010
Figure 79: Hospitals by Type of Services (%), Brazil, 2009
Figure 80: Beds (Per 1,000 Population), Brazil, 2005-2010
Figure 81: Public-Private Beds, Brazil, 2005-2010
Figure 82: Diagnostic Equipment, Brazil, 2009
Figure 83: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007
Figure 84: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008
Figure 85: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008
Figure 86: CO2 Emissions (‘000 Metric Tons), Brazil, 2005-2010
Figure 87: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010
Figure 88: Healthcare Personnel (‘000), Brazil, 2009
Figure 89: Doctors (Per 1,000 Population), Brazil, 2005-2010
Figure 90: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007
Figure 91: Healthcare Expenditure (% of GDP), Brazil, 2005-2010
Figure 92: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007
Figure 93: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007
Figure 94: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010
Figure 95: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008
Figure 96: Opportunities and Challenges, Healthcare Market, Brazil, 2011
1.1 List of Tables
1.2 List of Figures
2 INTRODUCTION
2.1 Report Guidance
3 OVERVIEW OF THE PHARMACEUTICAL AND MEDICAL DEVICES MARKET
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Supply Channels
3.1.3 Market Segments
3.1.4 Major Disease Areas
3.1.5 Major Players
3.2 Medical Device Market
3.2.1 Market Overview
3.2.2 Overview of Top Five Segments
3.2.3 Major Players
3.3 Market Drivers and Barriers
3.3.1 Drivers
3.3.2 Barriers
4 MARKET ACCESS
4.1 Reimbursement and Payer Landscape
4.1.1 Healthcare System in Brazil
4.1.2 Reimbursement Process
4.1.3 Overview of Insurance Provider
4.1.4 Patient Share in Healthcare Spending
4.1.5 Drug Price Trend
4.1.6 Pricing Policies
4.2 Regulatory Landscape
4.2.1 Overview of Regulatory Agencies
4.2.2 New Drug Approval Process
4.2.3 New Medical Device Approval Process
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
4.2.5 Licensing Process for Pharmaceutical Exports and Imports
4.2.6 Intellectual Property Rights
4.2.7 Clinical Trial Regulations
4.2.8 Pharmaceutical Advertising Regulations
4.2.9 Pharmacy Regulations
4.2.10 Labeling and Packaging Regulations
5 COUNTRY ANALYSIS
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserves
5.3.7 Trade Balance
5.3.8 Government Structural Balance
5.3.9 Government Net Debt
5.3.10 Major Industries
5.4 Demographics
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview
5.6.2 Major Components of Healthcare Spending
5.6.3 Share of Public and Private Sector
5.6.4 Spending in Pharmaceutical R&D
5.7 Trade Associations
5.7.1 ABIMO
5.7.2 ABIMED
5.7.3 Interfarma
5.7.4 Abiquifi
5.8 Trade Fairs
6 OPPORTUNITIES AND CHALLENGES
6.1 Opportunities
6.2 Challenges
7 APPENDIX
7.1 Abbreviations
7.2 Methodology
7.2.1 Coverage
7.2.2 Secondary Research
7.2.3 Forecasting
7.2.4 Primary Research
7.2.5 Expert Panel Validation
7.3 Contact Us
7.4 Bibliography
7.5 Disclaimer
LIST OF TABLES
Table 1: Pharmaceutical Market ($bn), Brazil, 2005-2010
Table 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020
Table 3: Price Margins of Distribution Channels (%), Brazil
Table 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010
Table 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020
Table 6: Major Domestic Companies with Focus on Biologics, Brazil, 2008
Table 7: Major Products, Pfizer, Global, Revenue ($m), 2010
Table 8: Late Stage Pipeline, Pfizer, 2011
Table 9: Major Products, Novartis, Global, Revenue ($m), 2010
Table 10: Planned Filings, Novartis, 2011 to ≥ 2015
Table 11: Major Products, Sanofi, Global, Revenue ($m), 2010
Table 12: Late Stage Pipeline, Sanofi, 2011
Table 13: Major Products, Roche, Global, Revenue ($m), 2010
Table 14: Late Stage Pipeline, Roche, 2011
Table 15: Medical Device Market ($bn), Brazil, 2005-2010
Table 16: Medical Device Market ($bn), Brazil, Forecast, 2011-2020
Table 17: Medical Device Market, Segments Revenue ($m), Brazil, 2010
Table 18: Ophthalmic Devices Market ($m), Brazil, 2005-2010
Table 19: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2010
Table 20: In Vitro Diagnostics Market ($m), Brazil, 2005-2010
Table 21: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2010
Table 22: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010
Table 23: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2010
Table 24: Orthopedic Devices Market ($m), Brazil, 2005-2010
Table 25: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2010
Table 26: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010
Table 27: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010
Table 28: Major Medical Device Companies, Brazil, Revenue, 2010
Table 29: Major Products, Siemens, Global, Revenue ($m), 2010
Table 30: Late Stage Pipeline, GE Healthcare, 2011
Table 31: Major Products, Roche, Global, Revenue ($m), 2010
Table 32: Late Stage Pipeline, F. Hoffmann-La Roche Ltd., 2010
Table 33: Major Products, Essilor, Revenue ($m), 2010
Table 34: Major Products, Philips Healthcare, Global, Revenue ($m), 2010
Table 35: Healthcare System, Brazil, 2011
Table 36: Comparative Analysis of CITEC and CONITEC, Brazil, 2011
Table 37: Decision-Making Structure of SUS, Brazil
Table 38: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010
Table 39: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010
Table 40: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010
Table 41: Drug Price Trend, Price Change (%), Brazil, 2005-2010
Table 42: Pricing Criteria for Various Drugs, Brazil
Table 43: Documents Required for Dossier Submission of Clinical Trial, Brazil, 2011
Table 44: GDP Per Capita ($), Brazil, 2005-2010
Table 45: GDP Per Capita ($), Brazil, Forecast, 2011-2020
Table 46: GDP, Annual Growth (%), Brazil, 2005-2010
Table 47: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020
Table 48: GNI Per Capita ($), Brazil, 2005-2010
Table 49: Average Consumer Price Index, Brazil, 2005-2010
Table 50: Average Consumer Price, Annual Change (%), Brazil, 2005-2010
Table 51: Currency Exchange Rate ($/BRL), Brazil, 2005-2010
Table 52: Foreign Direct Investment ($bn), Brazil, 2005-2010
Table 53: Foreign Exchange Reserves ($bn), Brazil, 2005-2010
Table 54: Trade Balance ($bn), Brazil, 2005-2010
Table 55: Imports of Goods and Services ($bn), Brazil, 2005-2010
Table 56: Exports of Goods and Services ($bn), Brazil, 2005-2010
Table 57: General Government Structural Balance ($bn), Brazil, 2005-2010
Table 58: General Government Net Debt (% of GDP), Brazil, 2005-2010
Table 59: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020
Table 60: Major Service Industries by Revenue ($bn), 2008
Table 61: Major Manufacturing Industries by Revenue ($bn), 2008
Table 62: Population (m), Brazil, 2005-2010
Table 63: Population (m), Brazil, Forecast, 2011-2020
Table 64: Urban and Rural Population, Brazil, Share (%), 2005-2010
Table 65: Age Groups, Population Distribution (%), Brazil, 2005-2010
Table 66: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020
Table 67: Birth Rate (Per 1,000 Population), Brazil, 2005-2010
Table 68: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020
Table 69: Mortality (Per 1,000 Population), Brazil, 2005-2010
Table 70: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020
Table 71: Major Causes of Mortality (‘000), Brazil, 2008
Table 72: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010
Table 73: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020
Table 74: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010
Table 75: Causes of Male Mortality (‘000), Brazil, 2008
Table 76: Causes of Female Mortality (‘000), Brazil, 2008
Table 77: Gender Ratio (M/F), Brazil, 2005-2010
Table 78: Life Expectancy at Birth (Years), Brazil, 2005-2010
Table 79: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020
Table 80: Illiteracy (%), Brazil, 2005-2010
Table 81: Unemployment (%), Brazil, 2005-2010
Table 82: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004
Table 83: Major Diseases, Brazil, In Patients (‘000), 2010
Table 84: Hospital Funding, Brazil, Share of Sources (%), 2009
Table 85: Public and Private Hospitals, Brazil, 2005-2010
Table 86: Hospitals by Type of Services (%), Brazil, 2009
Table 87: Beds (Per 1,000 Population), Brazil, 2005-2010
Table 88: Public-Private Beds, Brazil, 2005-2010
Table 89: Diagnostic Equipment, Brazil, 2009
Table 90: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007
Table 91: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008
Table 92: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008
Table 93: Targets for Carbon Reduction, Brazil, 2009
Table 94: CO2 Emissions (‘000 Metric Tons), Brazil, 2005-2010
Table 95: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010
Table 96: Healthcare Personnel (‘000), Brazil, 2009
Table 97: Doctors (Per 1,000 Population), Brazil, 2005-2010
Table 98: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007
Table 99: Healthcare Expenditure (% of GDP), Brazil, 2005-2010
Table 100: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007
Table 101: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007
Table 102: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010
Table 103: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008
Table 104: Major Healthcare Trade Fairs, Brazil, 2012
LIST OF FIGURES
Figure 1: Pharomaceutical Market ($bn), Brazil, 2005-2010
Figure 2: Pharmaceutical Market ($bn), Brazil, Forecast, 2011-2020
Figure 3: Pharmaceutical Supply Chain, Brazil, 2007
Figure 4: Pharmaceutical Market ($bn), Generics, Brazil, 2005-2010
Figure 5: Pharmaceutical Market ($bn), Generics, Brazil, Forecast, 2011-2020
Figure 6: Biotech Regions, Brazil, Companies Distribution (%), 2006
Figure 7: Medical Device Market ($bn), Brazil, 2005-2010
Figure 8: Medical Device Market ($bn), Brazil, Forecast, 2011-2020
Figure 9: Medical Device Market, Segments Revenue ($m), Brazil, 2010
Figure 10: Ophthalmic Devices Market ($m), Brazil, 2005-2010
Figure 11: Sales Trends for Major Players*, Ophthalmic Devices, Brazil, 2005-2010
Figure 12: In Vitro Diagnostics Market ($m), Brazil, 2005-2010
Figure 13: Sales Trends for Major Players*, In Vitro Diagnostics, Brazil, 2005-2010
Figure 14: Diagnostic Imaging Devices Market ($m), Brazil, 2005-2010
Figure 15: Sales Trends for Major Players*, Diagnostic Imaging, Brazil, 2005-2010
Figure 16: Orthopedic Devices Market ($m), Brazil, 2005-2010
Figure 17: Sales Trends for Major Players*, Orthopedic Devices, Brazil, 2005-2010
Figure 18: Nephrology and Urology Devices Market ($m), Brazil, 2005-2010
Figure 19: Sales Trends for Major Players*, Nephrology and Urology, Brazil, 2005-2010
Figure 20: Major Medical Device Companies, Brazil, Revenue ($m), 2010
Figure 21: Drivers and Barriers, Healthcare Market, Brazil, 2011
Figure 22: Reimbursement System, Brazil, 2011
Figure 23: Reimbursement Process, Brazil, 2011
Figure 24: Health Insurance Providers, Brazil, 2011
Figure 25: Health Policy Packages, Brazil, 2007
Figure 26: Distribution of Health Insurance Beneficiaries (%), Brazil, 2010
Figure 27: Top Private Insurance Providers, Brazil, Revenue ($bn), 2010
Figure 28: Organization Structure of ANS, Brazil, 2011
Figure 29: Healthcare Spending, Brazil, Out of Pocket Expenditure (%), 2005-2010
Figure 30: Drug Price Trend, Price Change (%), Brazil, 2005-2010
Figure 31: ANVISA Structure, Brazil, 2011
Figure 32: Roles and Responsibilities of Regulatory Bodies, Brazil, 2011
Figure 33: New Drug Approval Stages, Brazil, 2011
Figure 34: New Drug Approval Process, Brazil, 2011
Figure 35: New Medical Device Approval Process, Brazil, 2011
Figure 36: GDP Per Capita ($), Brazil, 2005-2010
Figure 37: GDP Per Capita ($), Brazil, Forecast, 2011-2020
Figure 38: GDP, Annual Growth (%), Brazil, 2005-2010
Figure 39: GDP, Annual Growth (%), Brazil, Forecast, 2011-2020
Figure 40: GNI Per Capita ($), Brazil, 2005-2010
Figure 41: Average Consumer Price Index, Brazil, 2005-2010
Figure 42: Average Consumer Price, Annual Change (%), Brazil, 2005-2010
Figure 43: Currency Exchange Rate ($/BRL), Brazil, 2005-2010
Figure 44: Foreign Direct Investment ($bn), Brazil, 2005-2010
Figure 45: Foreign Exchange Reserves ($bn), Brazil, 2005-2010
Figure 46: Trade Balance ($bn), Brazil, 2005-2010
Figure 47: Imports of Goods and Services ($bn), Brazil, 2005-2010
Figure 48: Exports of Goods and Services ($bn), Brazil, 2005-2010
Figure 49: General Government Structural Balance ($bn), Brazil, 2005-2010
Figure 50: General Government Net Debt (% of GDP), Brazil, 2005-2010
Figure 51: General Government Net Debt (% of GDP), Brazil, Forecast, 2011-2020
Figure 52: Major Service Industries by Revenue ($bn), 2008
Figure 53: Major Manufacturing Industries by Revenue ($bn), 2008
Figure 54: Population (m), Brazil, 2005-2010
Figure 55: Population (m), Brazil, Forecast, 2011-2020
Figure 56: Urban and Rural Population, Brazil, Share (%), 2005-2010
Figure 57: Age Groups, Population Distribution (%), Brazil, 2005-2010
Figure 58: Age Groups, Population Distribution (%), Brazil, Forecast, 2011-2020
Figure 59: Birth Rate (Per 1,000 Population), Brazil, 2005-2010
Figure 60: Birth Rate (Per 1,000 Population), Brazil, Forecast, 2011-2020
Figure 61: Mortality (Per 1,000 Population), Brazil, 2005-2010
Figure 62: Mortality (Per 1,000 Population), Brazil, Forecast, 2011-2020
Figure 63: Major Causes of Mortality (‘000), Brazil, 2008
Figure 64: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), 2005-2010
Figure 65: Children <5 Years Age, Brazil, Mortality Rate (Per 1,000 Live Births), Forecast, 2011-2020
Figure 66: Immunization Rate for Measles, DTP, HepB3, Hib3, (%), Brazil, 2005-2010
Figure 67: Causes of Male Mortality (‘000), Brazil, 2008
Figure 68: Causes of Female Mortality (‘000), Brazil, 2008
Figure 69: Gender Ratio (M/F), Brazil, 2005-2010
Figure 70: Life Expectancy at Birth (Years), Brazil, 2005-2010
Figure 71: Life Expectancy at Birth (Years), Brazil, Forecast, 2011-2020
Figure 72: Illiteracy (%), Brazil, 2005-2010
Figure 73: Unemployment (%), Brazil, 2005-2010
Figure 74: Major Diseases, Brazil, DALY (Per 100,000 Population), 2004
Figure 75: Major Diseases, Brazil, In Patients (‘000), 2010
Figure 76: Hospital Funding, Brazil, Share of Sources (%), 2009
Figure 77: Flow of Funds to Hospitals, Brazil, 2008
Figure 78: Public and Private Hospitals, Brazil, 2005-2010
Figure 79: Hospitals by Type of Services (%), Brazil, 2009
Figure 80: Beds (Per 1,000 Population), Brazil, 2005-2010
Figure 81: Public-Private Beds, Brazil, 2005-2010
Figure 82: Diagnostic Equipment, Brazil, 2009
Figure 83: SUS Diagnostic Procedures (Per Medical Consultation), Brazil, 1995, 1999, 2003, 2007
Figure 84: Population Using Improved Sanitation Facilities (%), Brazil, 2000, 2005, 2008
Figure 85: Population Using an Improved Drinking Water Source (%), Brazil, 2000, 2005, 2008
Figure 86: CO2 Emissions (‘000 Metric Tons), Brazil, 2005-2010
Figure 87: Consumption of Ozone-Depleting Substances (ODP Metric Tons), Brazil, 2005-2010
Figure 88: Healthcare Personnel (‘000), Brazil, 2009
Figure 89: Doctors (Per 1,000 Population), Brazil, 2005-2010
Figure 90: Nurses (Per 1,000 Population), Brazil, 1997, 2002, 2007
Figure 91: Healthcare Expenditure (% of GDP), Brazil, 2005-2010
Figure 92: Household Healthcare Expenditure, Brazil, Major Components, Share (%), 2007
Figure 93: General Government Healthcare Expenditure, Brazil, Major Components Share (%), 2007
Figure 94: Health Expenditure, Public-Private Share (%), Brazil, 2005-2010
Figure 95: Pharmaceutical R&D Expenditure, Brazil, Components Share (%), 2008
Figure 96: Opportunities and Challenges, Healthcare Market, Brazil, 2011
