CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil

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GlobalData, 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 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 grew from 191 million in 2009 to 202 million in 2016, mainly due to the increase in the life expectancy. The value of the pharmaceuticals market increased from $15.4 billion in 2009 to $25.3 billion in 2016 at a Compound Annual Growth Rate (CAGR) of 3.4%, and this value is expected to increase further from $26.1 billion in 2017 to $29.9 billion in 2021 at a CAGR of 3.4%. The medical device market was worth $7.1 billion in 2009 and reached $9.7 billion in 2016. It is forecast to grow at a CAGR of 6.4% from $10.9 billion in 2017 to $14 billion in 2021. These positive growth trends can be primarily attributed to:

  • An increasingly elderly population
  • 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: 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

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData Report Guidance

4 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData 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 Us

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 ...

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 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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