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Contents
1. Executive Summary
1.1 Overview of Findings 1.2 Chapters in the Report 1.3 Research and Analysis Methods
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Contents
3.4 A Nation of Contrasts: Healthcare Variations in the Brazilian Regions 3.4.1 Southeast: Over 40% of the National Population, But Over Half of Pharmaceutical Market Revenues 3.4.2 Northeast: Shortest Life-Expectancies and Second-Highest Market Share 3.4.3 South: Smallest Region with Highest Per Capita GDP 3.4.4 MidWest: Landlocked Region with Lowest Population 3.4.5 North: Largest and Poorest Area Represents <5% of Market
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5. Therapeutic Areas in the Brazil Market, 2014-2024
5.1 Oncology to Overtake CNS Diseases by 2024 5.2 The Rise of Non-Communicable Diseases 5.3 CNS Conditions: Disease Burden Comparable to US 5.3.1 Domestic Companies Target OTC and Generic Pain Relief 5.3.2 Foreign Competition in the Analgesics Area 5.3.3 Prevalence of 10%+ Represents Major Opportunity in Antidepressant Space 5.3.4 CNS Conditions: A Therapeutic Area with Unique Relevance to Brazil 5.3.5 Market Forecast for CNS Therapeutic Area 2014-2024 5.4 Cardiovascular Diseases: Brazils Biggest Killer 5.4.1 Anti-hypertensives: One of the Nations Key Drugs 5.4.2 Decline of the Statins 5.4.3 Ache and Sanofi Among the Key Players in This Field 5.4.4 The Heart Disease Opportunity over the Next 10 Years 5.4.5 Market Forecast for Cardiovascular Therapeutic Area 2014-2024 5.5 Alimentary/Metabolic Diseases: Affecting More Than a Third of Brazilians 5.5.1 Lack of Diabetes Awareness Still an Issue 5.5.2 Biosimilar Insulins to Play an Important Role 5.5.3 EMS Generic Esomeprazole an Important Addition 5.5.4 Capturing the Alimentary/Metabolic Disease Opportunity 5.5.5 Market Forecast for Alimentary/Metabolic Therapeutic Area 2014-2024 5.6 Oncology: To Become the Biggest Therapeutic Area? 5.6.1 Breast Cancer Has the Highest Prevalence in Brazil 5.6.2 Biosimilars to Help Widen Medicine Access 5.6.3 Eurofarma, Cristalia and Libbs the Domestic Leaders 5.6.4 Will the Oncology Therapeutic Area Realise its Potential? 5.6.5 Market Forecast for Cancer Treatment 2014-2024 5.7 Infectious Diseases: Brazil Faces Unique Challenges 5.7.1 PPDs to Meet Vaccines Need 4.4.5 Market Forecast for the OTC Segment, 2014-2024
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5.7.2 Brazil Managing HIV Despite IP Concerns 5.7.3 Chagas Disease and Other Infectious Disease Concerns 5.7.4 Infectious Disease: The Past or the Future for Brazilian Pharma? 5.7.5 Market Forecast for Infectious Disease Treatment, 2014-2024 5.8 Other Therapeutic Areas
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6.9 Biolab-Sanus Farma: 100+ Products, Four Exclusive 6.9.1 Collaborations with Emcure and Merz 6.10 Laboratrio Cristlia: R&D Leader 6.10.1 Leader in API Manufacturing 6.10.2 Involved in Nearly Half of All PDP Arrangements 6.11 Libbs Farmacutica: Key Player in Cancer Treatment 6.11.1 Working on a Biosimilar Opening New Possibilities 6.12 Uniao Quimica Farmaceutica Nacional: Expanding in Minas Gerais 6.13 Other Domestic Players 6.14 The Major Biosimilar Collaborations 6.14.1 BioNovis: Aiming at Commercialisation by 2015 6.14.2 Orygem Biotecnologia 6.15 Other Potential Sources of Innovation 6.15.1 Fundao Oswaldo Cruz: At the Heart of PDP 6.15.2 ANVISA Reform of Brazilian Patent System
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7.5.2 Herceptin, Pricing and Reimbursement 7.6 Merck & Co. Long-Standing Presence in the Brazilian Market 7.6.1 Gardasil Added to SUS in 2013 7.6.2 ExcelRX JV to Increase Mercks Standing in Brazil 7.7 Pfizer: Targeting Emerging Market Growth via M&A 7.7.1 Portfolio Ranges from Orphan Biologics to Multivitamins 7.7.2 How Will a Pfizer Break-Up Affect Emerging Market Plans? 7.8 Bayer: Brazil Fifth-Largest Market for Diversified Conglomerate 7.8.1 Consumer Health a Major Focus in Brazil 7.9 AstraZeneca: Struggling with Patent Expiries in Brazil 7.9.1 Possible Future Growth Drivers Include Diabetes 7.10 Boehringer Ingelheim: Pain, Cardiovascular and Respiratory Drugs Bolster Strong National Portfolio 7.10.1 Technology Transfer Deal for Sifrol 7.11 Takeda: Entering the Top 10 with Multigrip OTC Acquisition 7.11.1 Nycomed Generics and Original Products Also Key to Strategy 7.12 Merck Serono: Over 6% Consumer Health Growth Forecast 7.13 Other Big-Pharma Competitors 7.13.1 Johnson & Johnson: Focusing on Consumer Health and Commodities 7.13.2 GlaxoSmithKline: Vaccines Technology Transfer Opportunities 7.13.3 Abbvie: Humira to Face Biosimilar Challenge in Brazil? 7.13.3.1 Abbott: Generics and Diagnostics-Led Growth Strategy 7.13.4 Eli Lilly: Patent Expiries Hit Emerging Market Revenues. 7.13.5 Bristol-Myers Squibb: Divesting its Brazilian OTC Portfolio Rights 7.13.6 Baxter: Entering Brazilian Haemophilia Market via Tech Transfer 7.13.7 Amgen Signals Brazilian Intent with Bergamo Acquisition 7.13.8 Other Top Biotechs Enter Brazil 7.13.9 Other Top Japanese Companies Trail Behind Takeda in Brazil 7.14 Will Multinational Generics Leaders Compete in Brazil? 7.14.1 Teva Pharmaceutical Industries: Generics Giant Targets Brazil
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7.14.2 Mylan: Agile Acquisition Boosts Latin American Strategy 7.14.3 Actavis: Newly-Merged Player to Challenge in Brazil 7.14.4 Ranbaxy Hands Over to Daiichi, but Other Indian Companies Still in the Hunt in Brazil 7.14.5 Glenmark, Strides and Biocon Looking to Enter Brazil 7.14.6 Valeant: Aggressive M&A Drive Into the Market 7.15 Brazil as Research Destination 7.16 Other Multinational Business in Brazil
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Contents
List of Tables
Table 1.1 Currency Exchange Rates Table 2.1 Brazilian Pharmaceutical Market: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 2.2 Brazilian Pharmaceutical Market: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 2.3 Product Mix Breakdown: Revenues ($m), Market Share (%), 2012 Table 2.4 Therapeutic Area Breakdown: Revenues ($m), Market Share (%), 2012 Table 2.5 Leading Companies in the Brazilian Pharma Market: Revenues ($m), Market Shares (%), 2012 Table 2.6 Leading National Markets Worldwide: Revenues ($m), Market Shares (%), 2012 Table 2.7 Leading National Markets in Latin America: Revenues ($m), Market Shares (%), 2012 Table 2.8 Leading National Pharmerging Markets: Revenues ($m), Market Shares (%), 2012 Table 3.1 Members of FenaSade, 2013 Table 4.1 Brazilian Pharma Market Breakdown by Product Type: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 4.2 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2017 Table 4.3 Brazilian Market Breakdown by Product Type: Revenues ($m), AGR (%), CAGR (%), Market Shares (%) 2018-2024 Table 4.4 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2024 Table 4.5 Selected Technology Transfer Agreements in Brazil 1985-2013 Table 4.6 Patented Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 4.7 Patented Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.8 Generic Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 4.9 Generic Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024
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Table 4.10 OTC Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20122017 Table 4.11 OTC Pharmaceuticals: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20182024 Table 5.1 Brazilian Market Breakdown by Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Shares (%) 2012-2017 Table 5.2 Therapeutic Area Breakdown: Revenues ($m), Market Share (%), 2017 Table 5.3 Brazilian Market Breakdown by Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Shares (%) 2018-2024 Table 5.4 Therapeutic Area Breakdown: Revenues ($m), Market Shares (%), 2024 Table 5.5 CNS Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 20122017 Table 5.6 CNS Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20182024 Table 5.7 Cardiovascular Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 5.8 Cardiovascular Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 5.9 Alimentary/Metabolic Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 5.10 Alimentary/Metabolic Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 5.11 Oncology Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 5.12 Oncology Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 5.13Infectious Disease Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 5.14 Infectious Disease Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024
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Table 6.1 Leading Domestic Companies in the Brazilian Market: Revenues ($m), Market Shares (%), 2012 Table 6.2 EMS: Overview, 2013 Table 6.3 Medley: Overview, 2013 Table 6.4 Hypermarcas: Overview, 2013 Table 6.5 Ach: Overview, 2013 Table 6.6 Eurofarma: Overview, 2013 Table 6.7 Teuto: Overview, 2013 Table 6.8 Biolab Sanus: Overview, 2013 Table 6.9 Cristlia: Overview, 2013 Table 6.10 Libbs: Overview, 2013 Table 6.11 Uniao Quimica: Overview, 2013 Table 7.1 Leading Multinational Companies in the Brazilian Market: Revenues ($m), Market Shares (%), 2012 Table 7.2 Selected Multinational M&A Transactions in Brazilian Market, 2009-2012 Table 7.3 Sanofi: Overview, 2013 Table 7.4 Novartis: Overview, 2013 Table 7.5 Roche: Overview, 2013 Table 7.6 Merck: Overview, 2013 Table 7.7 Pfizer: Overview, 2013 Table 7.8 Bayer: Overview, 2013 Table 7.9 AstraZeneca: Overview, 2013 Table 7.10 Boehringer Ingelheim: Overview, 2013 Table 7.11 Takeda: Overview, 2013 Table 7.12 Merck Serono: Overview, 2013 Table 8.1 Brazilian Pharmaceutical Market: Strengths and Weaknesses, 2013 Table 8.2 Brazilian Pharmaceutical Market: Opportunities and Threats, 2013 Table 8.3 Brazilian Pharmaceutical Market: STEP Analysis, 2013-2024
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List of Figures
Figure 2.1 Brazilian Pharmaceutical Market: Revenues ($m), 2012-2024 Figure 2.2 Demographic Breakdown of Brazilian Population by Age, 2013 Figure 2.3 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2012 Figure 2.4 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2012 Figure 2.5 Leading Companies in the Brazilian Market: Revenues ($m), Market Shares (%), 2012 Figure 2.6 Leading National Markets Worldwide: Revenues ($m), Market Shares (%), 2012 Figure 2.7 Leading National Markets in Latin America: Revenues ($m), Market Shares (%), 2012 Figure 2.8 Leading National Pharmerging Markets: Revenues ($m), 2012 Figure 2.9 BRIC National Markets: Revenues ($m), 2012 Figure 3.1 Public/Private Balance in Healthcare Provision, 2008 Figure 3.2 CMED-Mandated Maximum Drug Price Rises, 2009-2013 Figure 3.3 Distribution (%) of Revenues Among Brazilian Regions, 2012 Figure 4.1 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2017 Figure 4.2 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), Market Shares (%), 2024 Figure 4.3 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), 2012-2024 Figure 4.4 Brazilian Pharmaceutical Market Product Mix Breakdown: Revenues ($m), 2012, 2017, 2024 Figure 4.5 Biologics in the Brazilian Market: Product Mix Breakdown: Revenues ($m) and Shares (%), 2012 Figure 4.6 Biologics in the Brazilian Market: Product Mix Breakdown: Revenues ($m), 2012, 2017 and 2024 Figure 4.7 Drivers and Restraints for Prescription Pharmaceuticals, 2013 Figure 4.8 Patented Pharmaceuticals: Revenues ($m), 2012-2024 Figure 4.9 Drivers and Restraints for Prescription Pharmaceuticals, 2013
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Figure 4.10 Generic Pharmaceuticals: Revenues ($m), 2012-2024 Figure 4.11 Drivers and Restraints for Generic Pharmaceuticals, 2013 Figure 4.12 OTC Pharmaceuticals: Revenues ($m), 2012-2024 Figure 5.1 Therapeutic Area Breakdown: Revenues ($m), Market Shares (%), 2017 Figure 5.2 Therapeutic Area Breakdown: Revenues ($m), Market Shares (%), 2024 Figure 5.3 Therapeutic Area Breakdown: Revenues ($m), 2012-2024 Figure 5.4 Therapeutic Area Breakdown: Revenues ($m), 2012, 2017, 2024 Figure 5.5 Drivers and Restraints for CNS Therapeutic Area, 2013 Figure 5.6 CNS Therapeutic Area: Revenues ($m), 2012-2024 Figure 5.7 Drivers and Restraints for Cardiovascular Therapeutic Area, 2013 Figure 5.8 Cardiovascular Therapeutic Area: Revenues ($m), 2012-2024 Figure 5.9 Drivers and Restraints for Alimentary/Metabolic Therapeutic Area, 2013 Figure 5.10 Alimentary/Metabolic Therapeutic Area: Revenues ($m), 2012-2024 Figure 5.11 Drivers and Restraints for Oncology Therapeutic Area, 2013 Figure 5.12 Oncology Therapeutic Area: Revenues ($m), 2012-2024 Figure 5.13 Drivers and Restraints for Infectious Disease Therapeutic Area, 2013 Figure 5.14 Infectious Disease Therapeutic Area: Revenues ($m), 2012-2024 Figure 6.1 Leading Domestic Companies in the Brazilian Market: Revenues ($m), Market Shares (%), 2012 Table 7.1 Leading Multinational Pharma Companies in the Brazilian Market: Revenues ($m), Market Shares (%), 2012 Figure 9.1 Brazilian Pharmaceutical Market: Revenues ($m), 2012-2017 Figure 9.2 Brazilian Pharmaceutical Market: Revenues ($m), 2018-2024 Figure 9.3 Product Mix: Revenues ($m), 2012-2017 Figure 9.4 Product Mix: Revenues ($m), 2018-2024 Figure 9.5 Top 10 Companies in the Brazilian Pharma Market, 2012 Figure 9.6 Therapeutic Areas: Revenues ($m) in Brazil, 2012-2017 Figure 9.7 Therapeutic Areas: Revenues ($m) in Brazil, 2018-2024
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Abbott Laboratories
Abbott Laboratories (including Abbvie) Ach Laboratrios Farmacuticos Actavis Agncia Nacional de Saude Suplementar Agncia Nacional de Vigilncia Sanitria (ANVISA) Agila Specialties AlfaRio Alliance Boots Allianz Health AMB (Brazilian Medical Association) American Diabetes Association American Varian Medical Systems Amgen Amil Participaes Antaris Consulting Arena Pharmaceuticals Arseus Associao Brasileira da Indstria de Medicamentos Isentos de Prescrio (ABIMIP) Associao Brasileira das Redes de Farmcias e Drogarias (ABRAFARMA) Associao Brasileira de Reabilitao de Coluna Associacao da Industria Farmaceutica de Pesquisa (InterFarma) Associao Nacional de Assistencia ao Diabetico (ANAD) Astellas AstraZeneca Athos Pharma Axis Biotec Baxter Bayer
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BD Biocon Biogen Idec Biolab Emcure Biolab-Sanus Farma Biomm Bionovis Biosidus Biovail Corporation Boehringer Ingelheim Boiron Bradesco Sade Brainfarma Industria e Farmaceutica Brasil Pharma Brazilian Development Bank (BNDES) Bristol-Myers Squibb BTG Pactual Bunker Industria Farmaceutica Caixa Seguros Cmara de Regulao do Mercado de Medicamentos (CMED) Cannes RJ Participacoes Castro Marques Group Celesio Chemo Claris Lifesciences CMED Comisso Nacional de Incorporao de Tecnologia (CONITEC) Comit Tcnico Assessor de Imunizaes (CTAI) Conselho Administrativo de Defesa Econmica Corporacion Infarmasa
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CPhI Worldwide CVS Pharmacy Daiichi Sankyo Datamatrix Delta Instituto Terapeutico Dimed Disaq Pharmaceuticals DM Industria Farmaceutica Dong-A DPSP Drogarias Tamoio Eisai Eli Lilly Emcure EMS Eurofarma Everis Excel RX FarmaBrasil group Farmcia Popular Farmadacta Informatica Farmais Far-Manguinhos Farmindustria FDA Federao Nacional de Sade Suplementar Federal Council of Medicine (CFM) Fiocruz Food and Drug Administration (US FDA) Forest Laboratories
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GE Genfar Genzyme Germed Pharma Gilead Sciences GlaxoSmithKline (GSK) Glenmark Golden Cross Assistance Grnenthal Grupo Bradesco Grupo Cimed Guararapes Health Canada Hebron Hemobrs Hospital das Clnicas Hospital Israelita Albert Einstein Hospital Santa Catarina Hypermarcas IMA Laboratories Indian Council of Medical Research Infectious Disease Research Institute (IDRI) Institut Pasteur Instituto Butantan Instituto de Estudos de Sade Suplementar (IESS) Interagile Propaganda e Promocoes Intermdica Itauseg Health Johnson &Johnson (J&J) Kenya Medical Research Institute
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Laboratorio Cristlia Laboratrio Daudt Oliveira Laboratrio Farmaceutico do Estado de Pernambuco (LAFEPE) Laboratorio Quimico Farmaceutico Bergamo Laboratorio Teuto Brasileiro Laboratorios Gautier Laboratrios Kendrick Laboratrios Klinger Do Brasil Laramara Legrand Libbs Farmacutica Locafarma Solucoes de Transportes e Logistica Luper Indstria Farmacutica Mais Econmica Mantecorp Industria Quimica e Farmaceutica Maritima Seguros Mayne Pharma Mdecins sans Frontires Medley Meizler Biopharma Melcon Merck & Co. Merck Serono Merz Pharma Metlife Dental Plans Minas Gerais State Department of Health Ministrio da Sade (Ministry of Health, Brazil) moksha8 Multilab Industria e Comercio de Produtos Farmaceuticos Mylan
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Nature's Plus Farmaceutica Neo Qumica Neuberger Machines Novartis Novo Nordisk Nycomed Odontoprev Omint Health Services Oncoprod Optimer Pharmaceuticals Orygen Biotecnologia Oswaldo Cruz Foundation Otsuka Pan American Health Organization Panarello Panpharma Pasteur Institute Pele Nova Penha Pfizer Pharmaceutical Product Development, LLC (PPD) PharmaPraxis Porto Seguro Probiomed Probiotica Procter & Gamble Profarma Pr-Genricos Promovendas Representacoes Protalix BioTherapeutics Quesada Farmaceutica
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Quintiles RaiaDrogasil Ranbaxy Reckitt Benckiser Regional Council of Medicine, State of So Paulo Roche Rosrio Sabin Vaccine Institute Sandoz Sanofi SantAna Santa Cruz Shasun Pharma Siemens Sincamesp Sinclair IS Pharma Sindusfarma Sistema nico de Saude (SUS) Strides Arcolab SulAmrica Sun Supera Farma Laboratorios Takeda Telefnica Digital Tempo Participaes Teva Pharmaceutical industries TKS Farmaceutica Torrent Toshiba UCB
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UERJ UFMG UFRJ Uniao Quimica UNICAMP UNIFESP Unimed Seguros UnitedHealth University of So Paulo Valeant Varian Medical Systems Volta Walgreens Watson Pharmaceuticals (now Actavis) Wheaton Brazil Wockhardt World Health Organization (WHO) Zydus Cadila
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Figure 5.7 Drivers and Restraints for the Cardiovascular Therapeutic Area, 2013
Restraints
Patent expiries for statin drugs take away a key revenue driver for the therapeutic area Very high prevalence of cardiovascular disease, with strokes and heart attacks likely to rise sharply over the forecast period Government access to hypertension treatments allows major take-up for this leading unmet medical need Significant interest from companies at home and abroad Drivers Awareness of hypertension remains low among the population Heavy OTC use may restrict opportunities for more expensive Rx drugs
Source: visiongain 2013 The main driver for the cardiovascular therapeutic area lies simply in the vast levels of medical need in the country. If, as some estimates suggest, almost 60 million Brazilians suffer from some form of cardiovascular condition (principally hypertension), then this is a major commercial opportunity. The difficulty comes in the fact that the majority of cardiovascular treatments are preventative and depend on good information for personal health management on the part of the population. Since many of the most important cardiovascular drugs have also lost patent protection, the growth of the generics segment will be a necessary factor in the continued expansion of this therapeutic area. For example, generic simvastatin is a market leader, and other generic statins and other molecules will become key drivers in the near-term. The widespread use of OTC cardiovascular treatments may be a restraint on the market inasmuch as it restricts use of the major prescription drugs.
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2013 4865 7
2014 5237 8
2015 5566 6
2016 5914 6
2017 6211 5 6
4544
17
16
16
16
16
15
Table 5.8 Cardiovascular Therapeutic Area: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024
2018 Revenues ($m ) AGR (%) CAGR (%, 2018-2024) CAGR (%, 2012-2024) Market share (%)
Source: visiongain 2013
2019 6931 5
2020 7280 5
2021 7561 4
2022 7975 5
2023 8366 5
2024 8790 5 5 6
6570 6
15
14
14
14
14
13
13
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