Brazil – Healthcare, Regulatory and Reimbursement Landscape

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Published: September 30, 2021 Report Code: GDHC0081CHR-ST

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GlobalData, the industry analysis specialist, has released its latest report, “Brazil – Healthcare, Regulatory and Reimbursement Landscape”. 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, which has guaranteed healthcare access through the Unified Health System (Sistema Único de Saúde, SUS), and a high elderly population, is among the top 10 pharmaceutical markets. Brazil faces increasing demand for all kinds of medicines, especially those used to treat chronic diseases like cancer, heart disease, and respiratory issues. The upsurge in non-communicable diseases makes Brazil one of the world’s biggest consumers of medications. In terms of Brazilian Reals, the country’s pharmaceutical market increased from R$57.9B in 2013 to R$126.2B in 2020. It is estimated to increase at a Compound Annual Growth Rate (CAGR) of 13% to R$229.8B in 2025. In the terms of US Dollars, the Brazilian pharmaceutical market decreased from $26.9B in 2013 to $24.6B in 2020, which is estimated to decrease at a negative CAGR of 4% to $20.2B in 2025. The difference is due to currency fluctuations. The medical devices market in Brazil was valued at $16.02B in 2015, which increased to $19.81B in 2020 at a CAGR of 4.3%. The market is expected to grow at a CAGR of 1.9% from $19.73B in 2021 to $21.27B in 2025.

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: GSK, Pfizer, Novartis, Sanofi, and EMS

Profiles and SWOT analyses of the major players in the medical device market: Roche, Abbott, Hologic, Zimmer Biomet, and Medtronic

An insightful review of the COVID-19 epidemiology, COVID-19 impact, and developments in healthcare market, HealthTech landscape, 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 healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure

An overview of the opportunities for and challenges to growth in 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 Brazil healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact Brazil 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 Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about Brazil Healthcare Market

2.3 Key Highlights: Healthcare Startups in Brazil

2.4 Key Events: Brazil Pharmaceutical News, 2015-2021

2.5 Key Events: Brazil Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019-2020

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Brazil, 2020

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – National Health Plan (Plano Nacional de Saúde, PNS), Ministry of Health, Brazil, 2020-2023

3.3 Pharmaceutical Market – Exports

3.4 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels, Brazil

3.6 Pharmaceutical Market – Supply Channels, Counterfeiting of Medicines, Brazil

3.7 Pharmaceutical Market – Market Segments

3.8 Major Therapeutic Areas, Brazil

3.9 COVID-19 Epidemiology, Brazil

3.10 COVID-19 Impact and Developments, Brazil

3.11 COVID-19 Clinical Trials Landscape, Brazil

3.12 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, Brazil, 2019-2021

6.2 Deal Analysis: Medical Device Market, Brazil, 2019-2021

7. HealthTech Landscape

7.1 HealthTech Landscape, Brazil

7.2 HealthTech Deals Landscape, Brazil

7.3 Key HealthTech Deals, Brazil

7.4 Adoption of Technology in Healthcare, Brazil

7.5 Digital Health Regulations, Brazil

7.6 HealthTech Landscape: Benefits and Risks, Brazil

8. Market Access

8.1 Overview of Healthcare System, Brazil

8.2 Drug Reimbursement Process, Brazil

8.3 Overview of Insurance Providers, Brazil

8.4 Out-of-Pocket Spending and Pharmaceutical Price Index, Brazil

8.6 Pricing Policies, Brazil

8.7 Regulatory Landscape, Brazil

8.7.1 Overview of Regulatory Agencies, Brazil

8.7.2 Marketing Authorization for Pharmaceutical Products, Brazil

8.7.3 Marketing Authorization for Generic Medicines, Brazil

8.7.4 Marketing Authorization for Biosimilars, Brazil

8.7.5 Marketing Authorization for Medical Devices, Brazil

8.7.6 Export and Import Regulations, Brazil

8.7.7 Intellectual Property Rights, Patent, Brazil

8.7.8 Intellectual Property Rights, Trademark, Brazil

8.7.9 Clinical Trial Regulation Process, Brazil

8.7.10 Pharmaceutical Clinical Trials Landscape, Brazil

8.7.11 Medical Devices Clinical Trials Landscape, Brazil

8.7.12 Pharmacy License Regulations, Brazil

8.7.13 Pharmaceutical Advertisement Regulations, Brazil

8.7.14 Labeling and Packaging Regulations, Brazil

9. Country Healthcare Landscape

9.1 Healthcare Policy Highlights, Brazil

9.2 Healthcare Facilities, Brazil

9.3 Healthcare Resources, Brazil

9.4 Life Expectancy and Immunization Rate, Brazil

9.5 Environmental Health, Brazil

9.6 Healthcare Personnel, Brazil

9.7 Disease Burden, US Brazil

9.8 Healthcare Expenditure, Brazil

10. Trade Associations, Conferences, and Trade Fairs, Brazil

11. Opportunities and Challenges

12. Appendix

12.1 Research Methodology

12.1.1 Coverage

12.1.2 Secondary Research

12.1.3 Forecasts

12.2 Bibliography

12.3 About GlobalData

12.4 Contact Us

12.5 Disclaimer

Table

Table 1: Pharmaceutical Distribution Channels, Brazil, 2019

Table 2: Market Share of Medicines by Therapeutic Indicator Areas, Brazil, 2019

Table 3: COVID-19 Indicators (Number of cases), Brazil and Global, January’ 2020 – September’ 2021

Table 4: COVID-19-Related Travel Restrictions, Brazil, 2020-2021

Table 5: Available COVID-19 Vaccines, Brazil, 2020-2021

Table 6: Available COVID-19 IVD products, Brazil, 2020-2021

Table 7: Medical Devices Market, Brazil, Major Segments ($B), 2020

Table 8: Hospital Supplies Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 9: Diagnostic Imaging Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 10: General Surgery Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 11: In Vitro Diagnostics Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 12: Orthopedic Devices Market, Brazil, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 13: SUS Decentralization and Funding Channels, Brazil, 2019

Table 14: Categories and Criteria for Setting Entry Prices for New Products and New Presentations in the Brazilian market (Resolution No. 2, of March 5, 2004), 2019

Table 15: Fee for Marketing Authorization of Pharmaceutical Products, Brazil, 2019

Table 16: Regulatory Pathway for Registration of Biological Products, ANVISA, Brazil,2019

Table 17: Patent Application Fee, Brazil, 2019

Table 18: Trademark Application Fee, Brazil, 2019

Table 19: Trade Fairs, Brazil

Figures

Figure 1: Pharmaceutical Market, Brazil, Revenue ($B and R$B), 2013-2020

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

Figure 3: Healthcare Start-Ups in Brazil, 2020

Figure 4: Country Profile, Brazil, 2020

Figure 5: Pharmaceutical Market, Brazil, Revenue ($B), 2011-2020

Figure 6: Pharmaceutical Market, Brazil, Revenue Forecast ($B), 2021-2025

Figure 7: National Health Plan (Plano Nacional de Saúde, PNS), Ministry of Health, Brazil, 2020-2023

Figure 8: Pharmaceutical Exports ($B), Brazil, 2011-2020

Figure 9: Top Export Partners, Brazil, 2020

Figure 10: Pharmaceutical Imports ($B), Brazil, 2011-2020

Figure 11: Top Import Partners, Brazil, 2020

Figure 12: National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM) Brazil, 2019

Figure 13: Generics Market, Revenue ($B), Brazil, 2010-2020

Figure 14: Registered Generic Drugs per year (Number), Brazil, 2011-2020

Figure 15: OTC Market, Revenue ($B), Brazil, 2011-2020

Figure 16: OTC Medicines Market, Major Distribution Channels ($M), Brazil, 2020

Figure 17: OTC Market by Drug Category, Revenue ($M), Brazil, 2020

Figure 18: Major Therapeutic Categories based on Mortality by Major Disease Areas (thousand), Brazil, 2019

Figure 19: COVID-19 (Number of cases), Brazil, 2020-2021

Figure 20: COVID-19 (Number of deaths), Brazil, 2020-2021

Figure 21: COVID-19 Fiscal Stimulus Timeline, Brazil, 2020-2021

Figure 22: COVID-19 Vaccine Administration, Number of Vaccines administered, Brazil, 2021

Figure 23: Top COVID-19 Markets by Product Categories (Number of available marketed products), Brazil, 2020-2021

Figure 24: Top COVID-19 IVD Products by Device Class (Number of available marketed products), Brazil, 2020-2021

Figure 25: COVID-19 Clinical Trials Sponsors by Count, Brazil, 2020-2021

Figure 26: COVID-19 Clinical Trials Count by Phase, Brazil, 2020-2021

Figure 27: COVID-19 Clinical Trials Count by Trial Status, Brazil, 2020-2021

Figure 28: Medical Devices Market, Brazil, Revenue ($B), 2015-2020

Figure 29: Medical Devices Market, Brazil, Revenue Forecast ($B), 2021-2025

Figure 30: Medical Devices Market, Brazil, Major Segments (%), 2020

Figure 31: Hospital Supplies Market, Brazil, Revenue ($B), 2017-2025

Figure 32: Hospital Supplies Market, Brazil, Market Share of Major Players (%), 2020

Figure 33: Diagnostic Imaging Devices Market, Brazil, Revenue ($B), 2017-2025

Figure 34: Diagnostic Imaging Devices Market, Brazil, Market Share of Major Players (%), 2020

Figure 35: General Surgery Devices Market, Brazil, Revenue ($B), 2017-2025

Figure 36: General Surgery Devices Market, Brazil, Market Share of Major Players (%), 2020

Figure 37: In Vitro Diagnostics Market, Brazil, Revenue ($B), 2017-2025

Figure 38: In Vitro Diagnostics Market, Brazil, Market Share of Major Players (%), 2020

Figure 39: Orthopedic Devices Market, Brazil, Revenue ($B), 2017-2025

Figure 40: Orthopedic Devices Market, Brazil, Market Share of Major Players (%), 2020

Figure 41: Diagnostic Market, Brazil, Revenue ($B), 2015-2020

Figure 42: Diagnostic Market, Brazil, Revenue ($B), 2021-2025

Figure 43: Medical Devices Market, Brazil, Revenue ($M) of Major Companies, 2020

Figure 44: Deal Value and Deal Count, Pharmaceutical Market, Brazil, 2019-2021

Figure 45: Deal Value and Deal Count Subtypes, Pharmaceutical Market, Brazil, 2019-2021

Figure 46: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Brazil, 2019-2021

Figure 47: Top Therapy Areas by Deal Value ($M), Pharmaceutical Market, Brazil, 2019-2021

Figure 48: Top Therapy Areas by Deal Count, Pharmaceutical Market, Brazil, 2019-2021

Figure 49: M&A Deals by Quarter, Pharmaceutical Market, Brazil, 2019-2021 (by value and by number)

Figure 50: Deal Value and Deal Count, Medical Devices Market, Brazil, 2019-2021

Figure 51: Deal Value and Deal Count Subtypes, Medical Devices Market, Brazil, 2019-2021

Figure 52: Deal Value and Deal Count, Quarterly, Medical Devices Market, Brazil, 2019-2021

Figure 53: Top Equipment Sectors by Deal Value ($M), Medical Devices Market, Brazil, 2019-2021

Figure 54: Top Equipment Sectors by Deal Count, Medical Devices Market, Brazil, 2019-2021

Figure 55: M&A Deals by Quarter, Medical Devices Market, Brazil, 2019-2021 (by value and by number)

Figure 56: History of Brazilian Digital Health Policies, Brazil, 2015-2021

Figure 57: Deal Value ($M), HealthTech, Brazil, 2020-2021

Figure 58: Deal Count (Number of Deals), HealthTech, Brazil, 2020-2021

Figure 59: Organization of Healthcare System, Brazil, 2020

Figure 60: Key Organizations and People of Unified Health System (SUS), Brazil, 2020

Figure 61: Organizational Structure, Ministry of Health, Brazil, 2019

Figure 62: Reimbursement Process, Brazil, 2019

Figure 63: Roles and Responsibilities of ANS, Brazil, 2020

Figure 64: Roles and Responsibilities of CONSU, Brazil, 2020

Figure 65: Out-of-Pocket Spending ($ per Capita), Brazil, 2011-2020

Figure 66: Change in Pharmaceutical Price Index (% change accumulated in the year), Brazil, 2011-2020

Figure 67: Organization Structure, ANVISA, Brazil, 2019

Figure 68: Marketing Authorization of Pharmaceutical Products, Brazil, 2019

Figure 69: Marketing Authorization of Medical Devices, Brazil, 2019

Figure 70: Patent Approval Process, Brazil, 2019

Figure 71: Trademark Registration Process, Brazil, 2019

Figure 72: Number of Pharmaceutical Clinical Trials Based on Drug Classification , Brazil, 2020

Figure 73: Clinical Trial Approval Process, Brazil, 2019

Figure 74: Pharmaceutical Clinical Trials Count by Trial Status, Brazil, 2019-2021

Figure 75: Pharmaceutical Clinical Trials Count by Indication, Brazil, 2019-2021

Figure 76: Pharmaceutical Clinical Trials Count by Phase, Brazil, 2019-2021

Figure 77: Pharmaceutical Clinical Trials Count by Phase, Brazil, 2019-2021

Figure 78: Medical Devices Clinical Trials Count by Trial Status, Brazil, 2019-2021

Figure 79: Medical Devices Clinical Trials Count by Device Category, Brazil, 2019-2021

Figure 80: Medical Devices Clinical Trials Count by Indication, Brazil, 2019-2021

Figure 81: Top Five Medical Devices Clinical Trials Sponsors by Count, Brazil, 2019-2021

Figure 82: Number of Hospitals, Brazil, 2012-2020

Figure 83: Number of Public and Private Hospitals, Brazil, 2012-2020

Figure 84: Distribution of private hospitals by hospital location, Brazil, 2020

Figure 85: Number of Hospital Beds, Brazil, 2012-2020

Figure 86: Hospital Beds Density (per 1,000 Population), Brazil, 2012-2020

Figure 87: Number of Diagnostic Equipment (per million population), Brazil, 2015-2020

Figure 88: Immunization Rate (% of Children Ages 12-23 months), Brazil, 2013-2020

Figure 89: Life Expectancy at Birth (years), Brazil, 2013-2020

Figure 90: PM2.5 (µg per m3), Brazil, 2012-2020

Figure 91: CO2 Emissions (Mt of CO2 ), Brazil, 2012-2020

Figure 92: Physicians (per 1,000 Population), Brazil, 2013-2020

Figure 93: Nurses (per 1,000 Population), Brazil, 2013-2020

Figure 94: Dentists (Total number of Dentists), Brazil, 2013-2020

Figure 95: Major Causes of Mortality (per 100,000 population), Brazil, 2019

Figure 96: Major Causes of Male Mortality (per 100,000 population), Brazil, 2019

Figure 97: Major Causes of Female Mortality (per 100,000 population), Brazil, 2019

Figure 98: Disability-Adjusted Life Years by Major Disease (per 100,000 population), Brazil, 2019

Figure 99: Healthcare Expenditure as Percentage of GDP (%), Brazil, 2012-2020

Figure 100: Health Expenditure Share (% of Health Spending), Brazil, 2012-2019

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