CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil

  • ID: 2671774
  • Report
  • Region: Brazil
  • 199 pages
  • GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil


Summary

Brazil has one of the fastest growing pharmaceutical markets in the world. It is driven by an increasing disease burden and high affordability. However, a decrease in foreign investment and increased government promotion of generic drugs are barriers to growth. The value of the market was US$25.3 Billion in 2016, having increased from US$15.4 Billion in 2009 at a Compound Annual Growth Rate (CAGR) of 3.4%. Changing demographics are an important driver for the market, as the increasingly elderly population will lead to an increase in the incidence of chronic and other lifestyle-associated diseases. The growing middle class, who have high purchasing power, is another major driver.

Brazil’s medical device market was valued at US$7.1 Billion in 2009 and US$9.7 Billion in 2016. It is projected to grow at a CAGR of 6.4% from US$10.9 Billion in 2017 to US$14 Billion in 2021. In 2016, In Vitro Diagnostics (IVD) accounted for 11.5% of the medical device market, followed by orthopedic devices (10.8%), diagnostic imaging (10.6%), ophthalmic devices (8.8%) and cardiovascular devices (8.7%).

Most hospitals in Brazil offer primary care services exclusively. In 2016, health expenditure accounted for 8.2% of GDP, having accounted for 8.6% in 2009. Brazilian hospitals have inadequate resources and are thereby unable to provide access to healthcare provisions for every citizen, especially to those in weaker economic sections.

Brazil entered a period of recession in 2015. The economy contracted by 3.6% in 2016. This was due to a fall in commodity prices and political instability that led to a decline in investor confidence. This was augmented by the Chinese economic slowdown, which led to reduced demand for commodities and the corruption scandals involving government officials and major companies. In August 2016, following mass nationwide protests, President Rousseff was impeached on charges of breaking budgetary laws and the incumbent vice president Michel Temer took over.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil" an overview of the pharmaceutical and medical device market of Brazil, including the market size; market segmentation by generic, Over-The-Counter (OTC), biologic and biosimilar products; and the key drivers and barriers for the market.

In depth, this report provides the following analysis:
  • Covers the country’s reimbursement and payer landscape, as well as the regulatory landscape. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process for Brazil.
  • Provides a detailed analysis of the political and economic environment of Brazil. It analyzes its economic indicators, demographics, healthcare infrastructure and healthcare expenditure.
  • Provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Brazil.
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: Pfizer, Hypermarcas, Roche, Novartis and Sanofi and Profiles and SWOT analyses of the major players in the medical device market: Johnson & Johnson, B.Braun, Medtronic, Baxter and GSK.
  • An 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 country’s 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 Brazil 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 impact Brazil’s healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership
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1 Table of Contents
2 Executive Summary
3 Introduction
3.1 Report Guidance
4 Overview of Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Exports and Imports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview of Top Five Disease Areas
4.1.6 Major Players
4.2 Medical Device Market
4.2.1 Market Overview
4.2.2 Overview of Top Five Segments
4.2.3 Diagnostic Market
4.2.4 Major Players
4.3 Market Drivers and Barriers
4.3.1 Drivers
4.3.2 Barriers
5 Market Access
5.1 Overview of Healthcare system
5.2 Reimbursement and Payer Landscape
5.3 Reimbursement Process
5.3.1 Overview of Insurance Providers
5.3.2 Patient Share in Healthcare Expenditure
5.3.3 Price Trends in the Healthcare Sector
5.3.4 Pricing Policies
5.4 Regulatory Landscape
5.4.1 Overview of Regulatory Agencies
5.4.2 Market Authorization Procedure for Pharmaceutical Products
5.4.3 New Medical Device Approval Process
5.4.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.4.5 Intellectual Property Rights
5.4.6 Clinical Trial Regulations
5.4.7 Pharmaceutical Advertising Regulations
5.4.8 Pharmacy Regulations
5.4.9 Labeling and Packaging Regulations
6 Country Analysis
6.1 Political Environment
6.1.1 Political Structure
6.1.2 Current Political Environment
6.1.3 Healthcare Policy Initiatives
6.2 Economic Landscape
6.3 Economic Indicators
6.3.1 Gross Domestic Product
6.3.2 Gross National Income
6.3.3 Inflation
6.3.4 Currency Exchange Rate
6.3.5 Foreign Direct Investment
6.3.6 Foreign Exchange Reserves
6.3.7 Trade Balance
6.3.8 Government Structural Balance
6.3.9 Government Net Debt
6.3.10 Major Industries
6.4 Demographics
6.4.1 Population
6.5 Healthcare Infrastructure
6.5.1 Healthcare Facilities
6.5.2 Healthcare Parameters
6.5.3 Environmental Health
6.6 Healthcare Expenditure
6.6.1 Overview
6.6.2 Share of Public and Private Sectors
6.6.3 Major Components of Healthcare Expenditure
6.6.4 Spending in Pharmaceutical R&D
6.7 Trade Associations
6.7.1 ABIMO
6.7.2 ABIMED
6.7.3 Interfarma
6.7.4 Abiquifi
6.8 Trade Fairs
7 Opportunities and Challenges
7.1 Opportunities
7.2 Challenges
8 Appendix
8.1 Abbreviations
8.2 Bibliography
8.3 Research Methodology
8.3.1 Coverage
8.3.2 Secondary Research
8.3.3 Forecasts
8.3.4 Expert Panel
8.4 Contact
8.5 Disclaimer

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

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