CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil

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 and analysis on the healthcare, regulatory and reimbursement landscape in Brazil. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Brazil. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the 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 (Sanofi, GSK, Pfizer, Novartis and Hypera) and profiles and SWOT analyses of the major players in the medical device market (Medtronic, GE Healthcare, Roche, B Braun and Hologic)
  • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Brazil
  • Porter’s five forces analysis for pharmaceutical and medical devices market of Brazil
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
  • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities and challenges to growth in the Brazilian 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 the Italian healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in the Brazilian healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key ...

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: Brazil Pharmaceutical History, 2010–2018

2.4 Key Events: Brazil Pharmaceutical Market

2.5 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2018–2019

2.6 Key Events: Mergers and Acquisitions

2.7 Country Profile, Brazil, 2018

3 Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.4 Pharmaceutical Market – Supply Channels

3.5 Pharmaceutical Market – Market Segments

3.6 Pharmaceutical Market – Top Five Disease Areas

3.7 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Diagnostic Market

4.4 Medical Device Market – Major Players

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal Analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, Brazil

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, Brazil

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, Brazil – Porter’s Five Forces Analysis

7.2 Medical Device Market, Brazil – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, Brazil

8.2 Reimbursement Process, Brazil

8.2.1 Overview of Insurance, Brazil

8.2.2 Healthcare Spending and Medical Price Index, Brazil

8.2.3 Pricing Policies, Brazil

8.3 Regulatory Landscape, Brazil

8.3.1 Marketing Authorization for Pharmaceutical Products, Brazil

8.3.2 Market Authorization for Biopharmaceutical Drugs, Brazil

8.3.3 Market Authorization for Medical Devices, Brazil

8.3.4 Intellectual Property Rights, Patent, Brazil

8.3.5 Intellectual Property Rights, Trademarks, Brazil

8.3.6 Clinical Trial Regulations, Brazil

8.3.7 Pharmaceutical Advertising Regulations, Brazil

8.3.8 Pharmacy Regulations, Brazil

8.3.9 Labeling and Packaging Regulations, Brazil

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Public and Private Sectors

10 Trade Associations, Brazil

11 Trade Fairs, Brazil

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Top Five Therapeutic Areas based on Mortality by Major Disease Areas (thousand), Brazil, 2016

Table 2: Medical Device Market, Brazil, Revenue by Segment ...

Table 1: Top Five Therapeutic Areas based on Mortality by Major Disease Areas (thousand), Brazil, 2016

Table 2: Medical Device Market, Brazil, Revenue by Segment ($B), 2018

Table 3: General Surgery Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2018

Table 4: Diagnostic Imaging Market, Brazil, Revenue ($B) and Market Share (%) of Major Companies, 2015

Table 5: IVD Market, Brazil, Revenue ($B) and Market Share (%) of Major Companies, 2017

Table 6:Ophthalmic Market, Brazil, Revenue ($B) and Market Share (%) of Major Companies, 2015

Table 7: Orthopedic Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2018

Table 8: Patent Fees, Brazil, 2017

Table 9: Trademarks Fees ($), Brazil, 2014

List of Figures

Figure 1: Pharmaceutical Market, Brazil, Revenue ($B), 2015–2020

Figure 2: Medical Device Market, Brazil, Revenue ($B), 2015–2020

Figure 3: Number of Deals (2018–2019)

Figure 4: ...

Figure 1: Pharmaceutical Market, Brazil, Revenue ($B), 2015–2020

Figure 2: Medical Device Market, Brazil, Revenue ($B), 2015–2020

Figure 3: Number of Deals (2018–2019)

Figure 4: 2018-19 Deal Overview By Region

Figure 5: Country Profile, Brazil, 2018

Figure 6: Pharmaceutical Market, Brazil, Revenue ($B), 2010–2018

Figure 7: Pharmaceutical Market, Brazil, Revenue Forecast ($B), 2019–2022

Figure 8: Pharmaceutical Market, Brazil, Pharmaceutical Exports

Figure 9: Pharmaceutical Market, Brazil, Top Export Partners

Figure 10: Pharmaceutical Market, Brazil, Pharmaceutical Imports

Figure 11: Pharmaceutical Market, Brazil, Top Import Partners

Figure 12: Pharmaceutical Supply Channels, Brazil

Figure 13: Generic Drugs Market, Brazil($B), 2010–2018

Figure 14: OTC Product Group Sales ($M), Brazil, 2013–2016

Figure 15: Top Five Therapeutic Areas based on Mortality by Major Disease Areas (thousand), Brazil, 2016

Figure 16: Pharmaceutical Market, Major Players, Brazil

Figure 17: Medical Device Market, Brazil, Revenue Forecast ($B), 2021–2025

Figure 18: Medical Device Market, Brazil, Revenue by Segment ($B), 2018

Figure 19: General Surgery Devices Market, Brazil, Revenue ($B), 2015–2022

Figure 20: General Surgery Devices Market, Brazil, Market Share of Major Players (%), 2018

Figure 21: Diagnostic Imaging Market, Brazil, Revenue ($B), 2015–2022

Figure 22: Diagnostic Imaging Market, Brazil, Market Share of Major Players (%), 2015

Figure 23: IVD Market, Brazil, Revenue ($B), 2015–2022

Figure 24: IVD Market, Brazil, Market Share of Major Players (%), 2017

Figure 25: Ophthalmic Devices Market, Brazil, Revenue ($B), 2015–2022

Figure 26: Ophthalmic Market, Brazil, Revenue ($B) and Market Share (%) of Major Companies, 2015

Figure 27: Orthopedic Devices Market, Brazil, Revenue ($M), 2015–2022

Figure 28: Orthopedic Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2018

Figure 29: Diagnostic Market, Brazil, Revenue ($B), 2015–2018

Figure 30: Diagnostic Market, Brazil, Revenue Forecast ($B), 2019–2022

Figure 31: Medical Device Market – Major Players

Figure 32: Deal Value and Deal Count, Pharmaceutical Market, Brazil, 2018–2019

Figure 33: Deal Value and Deal Count, by Quarter, Pharmaceutical Market, Brazil, 2018–2019

Figure 34: Deal Value and Deal Count, by Subtype, Pharmaceutical Market, Brazil, 2018–2019

Figure 35: Top Three Therapy Areas by Deal Value, Pharmaceutical Market, Brazil, 2018–2019

Figure 36:Top Five Therapy Areas by Deal Number, Pharmaceutical Market, Brazil, 2018–2019

Figure 37: M&A Deals by Therapy Area by Value and Number, Pharmaceutical Market, Brazil, 2018–2019

Figure 38: Medical Device Market Deals by Deal Value ($M), Brazil, 2018

Figure 39: Medical Device Market Deals, Brazil, Top Therapy Area by Deal Value and Deal Count, 2018

Figure 40: Ministry of Health, Structure, Brazil, 2018

Figure 41: Departments of Ministry of Health Structure, Brazil, 2018

Figure 42: Reimbursement Process, Brazil, 2018

Figure 43: Roles and Responsibilities of ANS

Figure 44: Responsibilities of CONSU

Figure 45: OOP Expenditure (% of total expenditure on health)

Figure 46: Annual Rate of Change (%), Consumer Price Index

Figure 47: Categorization of Drugs, Brazil

Figure 48: Pricing Policies, Brazil

Figure 49: ANVISA: Organization Structure and Responsibilities

Figure 50: ANVISA Organogram

Figure 51: Drug Approval Process, 2016

Figure 52: Regulatory Pathways for Dossier Registration, Brazil

Figure 53: Biologics Approved in Brazil

Figure 54: Regulatory Pathway for Registration of Biological Products by ANVISA

Figure 55: Medical Device Approval Process, Brazil, 2019

Figure 56: Medical Device Approval Timeframe and Fees, Brazil, 2019

Figure 57: Medical Device Approval Process, Brazil, 2019

Figure 58: Requirements of Patent Application, Brazil

Figure 59: Details to Be Submitted for Request of Examination

Figure 60: Trademark Requirements to Be Submitted in INPI

Figure 61: Clinical Trial Regulation, Brazil, 2018

Figure 62: OTC Advertising Acts Related to Prohibition, Brazil, 2018

Figure 63: Documents to Be Submitted to ANVISA for Setting Up the Pharmacy, Brazil, 2018

Figure 64: Circumstances Requiring Change in Pharmacy Permit, Brazil, 2018

Figure 65: Packaging Requirements, Brazil, 2018

Figure 66: Number of Hospitals, Brazil, 2010–2018

Figure 67: Number of ASCs, Brazil, 2010–2018

Figure 68: Hospital Beds (per million population), Brazil, 2010–2018

Figure 69: Diagnostic Equipment (per million population), Brazil, 2008–2016

Figure 70: Life Expectancy, Brazil, 2010–2016

Figure 71: Immunization Rate (%), Brazil, 2010–2017

Figure 72: PM2.5 (µg/m3), Brazil, 2010–2016

Figure 73: CO2 Emissions (mt), Brazil, 2010–2016

Figure 74: Physicians (per 1,000 population), Brazil, 2009–2018

Figure 75: Nurses (per 1,000 population), Brazil, 2010–2018

Figure 76: Major Causes of Mortality (number of deaths), Brazil, 2016

Figure 77: Major Causes of Male Mortality, No. of Deaths (‘000), Brazil, 2016

Figure 78: Major Causes of Female Mortality, No. of Deaths (‘000), Brazil, 2016

Figure 79: Disability-Adjusted Life Years by Major Disease (‘000), Brazil, 2016

Figure 80: Healthcare Expenditure as Percentage of GDP (%), Brazil, 2009–2017

Figure 81: Public-Private Share (%), Brazil, 2009–2015

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