Impact of Brazil on the Pharmaceutical Industry – Thematic Intelligence

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Brazil Pharmaceutical Market Report Overview

Brazil is the largest pharmaceutical market in Central/Southern America and is the 12th largest in the world. Brazil is an untapped market for big pharma manufacturing, with domestic companies dominating the marketed products landscape. The domestic pharmaceutical companies will continue to grow due to favorable policies provided by the Brazilian government to promote domestic production of medicines. Furthermore, over the years, Brazil has elevated its infrastructure, scientific, and technological facilities and has created a sustainable strategy to promote drug discovery and other research activities.

The Brazil pharmaceutical industry thematic intelligence report provides an assessment of the major industry, and regulatory trends shaping the Brazil pharma industry.

Brazil Pharmaceutical Market Trends

The key trends impacting the Brazil pharmaceutical market are industry trends and regulatory trends.

Industry Trends: Brazil’s pharma industry has grown significantly over the last decade, driven by increasing household incomes, and it is well placed to provide medicines to other emerging markets in South America. The country also has a unified healthcare system known as Sistema Único de Saúde (SUS), the largest government-run public healthcare system in the world by number of beneficiaries. Moreover, Brazil is one of the major digital health markets of Latin America. Digitalization, eHealth, and telemedicine sectors are showing their ability to transition and adapt in Brazil, creating market potential opportunities, regardless of the fragmented market.

Regulatory Trends: Brazil has a decentralized, universal health system that is funded through taxes and contributions from federal, state, and municipal governments. The states or municipalities handle the administration and delivery of care. Additionally, the Chamber of Drug Market Regulations (CMED) creates the criteria to adjust and limit drug prices, adopts rules that encourage competition in the sector, monitors sales, and applies penalties for noncompliance with the rules.

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Brazil Pharmaceutical Market Value Chain

Most pharmaceutical companies holding medicine licenses in both the public and private sectors commercialize their products in the Brazilian market through distributors. The federal, state, or municipal public administration entities have the authority to directly sell pharmaceutical products to the government.

Brazil has several national programs for the distribution of medicines that appear on RENAME, including oncology drugs, human immunodeficiency virus (HIV) infection, and chronic diseases such as schizophrenia, rheumatism, and arthritis.

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Brazil Pharmaceutical Market Analysis

The Brazil pharmaceutical market was valued at $17.2 billion in 2021. Growth over the last decade has been driven by a growing population and increasing household incomes.

The most common deal types in the Brazilian pharmaceutical market are strategic alliances, mergers & acquisitions, contract service agreements, and capital raisings. The most common deal was strategic alliances, followed by M&As.

Brazil, with its progressive economic growth, stable political structure, expanding patient populations, and increasing governmental, private, and foreign investments, has favorable conditions to become an advanced pharmaceutical research center.

Brazil Pharmaceutical Revenue Forecast, 2015–30 ($ billions)

Brazil Pharmaceutical Revenue Forecast, 2015–30 ($ billions)

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Brazil Pharmaceutical Clinical Trial Analysis

The top therapy areas in the Brazil pharmaceutical market are oncology, central nervous system, infectious disease, respiratory, cardiovascular, metabolic disorders, and immunology among others. In 2020, the infectious disease therapy area saw a significant increase in clinical trials, due to the COVID-19 pandemic.

Of the top sponsors of clinical trials in Brazil, large international industry players are represented significantly more than domestic companies. Roche, Novartis, and AstraZeneca were the leading clinical trial sponsors in Brazil between 2019 and 2022YTD.

Clinical Trials by Top 10 Therapy Areas, 2019-2022

Clinical Trials by Top 10 Therapy Areas, 2019-2022

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Brazil Pharmaceutical Marketed Products

The leading therapy area for marketed drugs in Brazil is central nervous system (CNS). Marketed drugs in Brazil mainly follow global trends. Brazil matches the global market in having CNS, infectious disease, and respiratory as its top three therapeutic areas.

Domestic pharmaceutical companies such as EMS, Germed Pharma, Legrand Pharma, Eurofarma, and Medley are the top five developers of marketed drugs in Brazil. Large international pharmaceutical  companies, who have subsidiaries headquartered in Brazil,  with a large presence in the Brazil market include Novartis, Sanofi, and Pfizer.

Marketed Drugs in Brazil by Therapy Area

Marketed Drugs in Brazil by Therapy Area

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Brazil Pharmaceutical Pipeline Products

Most pipeline therapeutics are in Phase III and Phase II stages. There are only three companies with more than one pipeline product in Brazil. The leading pipeline biologic developers are the Butantan Institute and JCR Pharmaceuticals. All the Butantan Institutes’ products are in infectious disease, and one of JCR Pharmaceuticals’ drugs is in pre-registration.

The key molecule types in the COVID-19 pipeline in Brazil are subunit vaccine, small molecule, inactivated vaccine, cell therapy, monoclonal antibody, peptide, vaccine, and mRNA vaccine. In 2022, the subunit vaccine was the leading molecule type followed by small molecule and inactivated vaccine.

COVID-19 Pipeline Therapeutics by Molecule Type

COVID-19 Pipeline Therapeutics by Molecule Type

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Brazil Pharmaceutical Market Report Overview

Market Size (2021) $17.2 billion
Forecast Period 2022-2030
Historical Period 2015-2020
Key Trends Industry Trends and Regulatory Trends
Top Therapy Areas Oncology, Central Nervous System, Infectious Disease, Respiratory, Cardiovascular, Metabolic Disorders, and Immunology
Key Molecule Types Subunit Vaccine, Small Molecule, Inactivated Vaccine, Cell Therapy, Monoclonal Antibody, Peptide, Vaccine, and mRNA Vaccine

Segments Covered in the Report

Brazil Pharmaceutical Therapy Areas Outlook

  • Oncology
  • Central Nervous System
  • Infectious Disease
  • Respiratory
  • Cardiovascular
  • Metabolic Disorders
  • Immunology

Brazil Pharmaceutical Molecule Types Outlook

  • Subunit Vaccine
  • Small Molecule
  • Inactivated Vaccine
  • Cell Therapy
  • Monoclonal Antibody
  • Peptide
  • Vaccine
  • mRNA Vaccine

Scope

  • It provides a detailed analysis of deals, clinical trials, marketed and pipeline products, and contract manufacturing.
  • It also provides an overview of key regulatory and market access information, market drivers and barriers, and key players in the Brazilian pharma sector.

Reasons to Buy

  • Identify the trends that are shaping the Brazilian pharma market and driving innovation, including key government policies and strategic initiatives.
  • Identify key current and emerging players in the Brazil pharma market
  • Develop in-licensing and out-licensing strategies, using a detailed overview of current deals
  • Understand the challenges and strategies impacting the development of therapy agents, and market access in Brazil
  • Get an analysis of Brazil’s manufacturing and outsourcing sector

Catalent Inc
Patheon NV
Merieux NutriSciences Corp
EMS
Hypera
Medley Industria Farmaceutica
Europharma Laboratorios
Aché Laboratorios Farmaceuticos
Synova Pesquisa Cientifica
Blau Farmaceutica
Diagnosticos da America
AstraZeneca
Eisai
F. Hoffmann-La Roche
Novartis
Germed Pharma
Legrand Pharma
Sanofi
Pfizer
Butantan Institute
JCR Pharmaceuticals
Uniao Quimica Farmaceutica Nacional
Cristalia Produtos Quimicos Farmaceuticos

Table of Contents

1 Table of Contents (PowerPoint Deck)

1.1 Preface

1.1.1 Table of Contents

1.1.2 Abbreviations

1.1.3 Related Reports

1.2 Executive Summary

1.2.1 Key findings

1.3 Introduction

1.3.1 Brazil’s pharma market: Growing capabilities but still untapped by large international companies

1.3.2 Key influencer Twitter chat related to Brazil

1.4 Trends

1.4.1 Industry trends – Brazil is an untapped market for big pharma manufacturing

1.4.2 Industry trends – 2022 election results should help boost the pharma industry

1.4.3 Industry trends – The Brazil pharma market is dominated by generics

1.4.4 Industry trends – CNS and infectious disease lead the pharma market

1.4.5 Industry trends – Growing levels of R&D innovation

1.4.6 Industry trends – Increasing investment in healthtech

1.4.7 Industry trends – Domestic pharma companies dominate in Brazil

1.4.8 Regulatory trends – Regulatory trends in Brazil

1.4.9 Regulatory trends – Overcoming counterfeiting of medicines

1.5 Value Chain

1.6 Market Analysis

1.6.1 Brazil’s pharma market will see moderate growth up to 2030

1.6.2 Strategic alliances are the leading deal type in Brazil

1.6.3 Licensing agreements lead strategic alliance activity in Brazil

1.6.4 Top 10 licensing agreements involving Brazil by value, 2018–22 YTD

1.6.5 Asset transactions lead with majority of M&A deals in Brazil

1.6.6 Minimal capital raising and CSA activity in Brazil

1.7 Clinical Trials

1.7.1 The number of clinical trials in Brazil

1.7.2 The majority of trials in Brazil are mid/late phase

1.7.3 Infectious disease indications dominate clinical trials in Brazil

1.7.4 Major sponsors of clinical trials in Brazil

1.7.5 Top 10 clinical trial sites in Brazil by historical volume

1.7.6 Top 10 clinical trial investigators in Brazil by historical volume

1.7.7 Top 10 trials in Brazil by completed enrollment since 2019

1.8 Marketed Products

1.8.1 The US is the largest importer of pharmaceuticals from Brazil

1.8.2 Generics have the largest share of marketed drugs in Brazil

1.8.3 CNS disorders lead marketed drugs in Brazil

1.8.4 Leading drug developers in Brazil

1.8.5 The majority of marketed biologics in Brazil target infectious disease

1.8.6 Examples of Brazil approved biologics

1.8.7 Brazil in top 10 countries of COVID-19 vaccinations administered

1.8.8 Currently approved COVID-19 vaccines in Brazil

1.9 Pipeline Products

1.9.1 Majority of pipeline drugs are in Phase III and most are innovator biologics

1.9.2 Butantan Institute leads in pipeline products in Brazil

1.9.3 Infectious disease leads pipeline drug development in Brazil

1.9.4 Most pipeline biologics are in the infectious disease space

1.9.5 Pipeline COVID-19 vaccines and treatments in Brazil

1.9.6 Examples of pipeline COVID-19 vaccines and other treatments in Brazil

1.10 Contract Manufacturing in Brazil

1.10.1 Contract manufacturing companies and facilities in Brazil

1.10.2 CDMO facilities distribution in Brazil

1.11 Regulatory and Market Access

1.11.1 Overview of healthcare system in Brazil

1.11.2 Organization of healthcare system in Brazil

1.11.3 Drug approval process in Brazil

1.11.4 Regulation of drugs in Brazil – Generics

1.11.5 Regulation of drugs in Brazil – Biologics and biosimilars

1.11.6 Market access for drugs in Brazil – Drug pricing

1.11.7 Market access for drugs in Brazil – Reimbursement

1.11.8 Market access for drugs in Brazil – Regulatory landscape

1.12 Market Drivers and Barriers

1.12.1 Market drivers in Brazil

1.12.2 Market barriers in Brazil

1.13 Companies

1.13.1 Eurofarma

1.13.2 EMS

1.13.3 Medley

1.13.4 Aché

1.13.5 Novartis

1.13.6 Pfizer

1.13.7 Hypera

1.13.8 Cristalia

1.14 Appendix

1.14.1 Bibliography

1.14.2 Key themes impacting the pharmaceutical industry

1.14.3 Our thematic research methodology

1.14.4 About the authors

1.14.5 About GlobalData

1.14.6 Trusted intelligence in uncertain times

1.14.7. Contact us

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