Reportlinker Adds Brazil Pharmaceutical Market Overview - Expanding healthcare access drives double-digit sales growth

NEW YORK, Sept. 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Brazil Pharmaceutical Market Overview – Expanding healthcare access drives double-digit sales growth

http://www.reportlinker.com/p0289303/Brazil-Pharmaceutical-Market-Overview-–-Expanding-healthcare-access-drives-double-digit-sales-growth.html

Introduction

Brazil's retail pharmaceutical market was valued at $12.6 billion in 2009, having grown by 14.3% between 2008 and 2009. Key growth drivers include the expanding population, improved access to healthcare, and the burgeoning middle class which is increasingly opting for branded drugs. Consequently, Big Pharma is targeting Brazil to off-set slowing sales growth in more developed markets.

Scope

*Overview of socioeconomic and demographic trends, healthcare system, regulation, pricing, reimbursement and intellectual property position in Brazil

*Assesses the size of Brazil's pharmaceutical market by prescribing setting, therapy area, leading brands and by leading companies

*Examines Brazil's generics and biosimilars landscape in terms of regulatory issues, level of penetration, key players and degree of brand erosion

*Quantifies Brazil's R&D and manufacturing infrastructure for the leading pharmaceutical companies, including key metrics and domestic M&A analysis

Highlights

Brazil spent 10.8% of its GDP on both retail and hospital prescribed pharmaceuticals in 2009, reflecting the government's changing priorities, prioritizing healthcare including initiatives to expand access to medicines.

Intellectual property protection remains problematic for branded pharma, with issues associated with patent linkage, drawn out patent reviews, conflict between the two agencies involved in assessing patent applications, and the fact that there is no set period of data exclusivity.

Strong market growth in conjunction with improving regulatory standards has led to Brazil becoming a hotbed for investment from both multinational and domestic companies. Big Pharma players are gaining a stronger presence through M&A, expanding operations, and new product launches.

Reasons to Purchase

*Evaluate the evolving regulatory landscape and the impact of pricing and reimbursement controls on market access in Brazil.

*Quantify the size and growth of the prescription pharmaceutical market in Brazil, analyzing key therapy areas, brands and companies.

*Assess drivers and resistors of generic and biosimilars uptake in Brazil.

ABOUT DATAMONITOR HEALTHCARE 2

About the Healthcare Strategic Analysis Team 2

Geographic specific reports: 2

Global issue reports: 2

1. Brazil - Executive Summary 3

Strategic scoping and focus 3

Key findings - healthcare drivers and resistors in Brazil 4

Key findings - healthcare drivers and resistors in Brazil 4

Brazil - Socio-demographic and economic analysis 7

Socio-demographic trends 7

Socioeconomic trends 8

Brazil - Healthcare system and drug regulatory analysis 11

Brazil healthcare expenditure 11

Brazil healthcare system overview 12

Brazil regulatory issues 13

Brazil pricing and reimbursement issues 13

Brazil - Prescription pharmaceutical sales analysis 15

Pharmaceutical market size 15

Leading therapy areas 15

Leading pharmaceutical brands 15

Leading pharmaceutical companies 15

Brazil - Drug expiry analysis 17

Brazil retail generics market 17

Brazil brand erosion post patent expiry 17

Brazil biosimilars market 17

Brazil - Pharmaceutical Industry Infrastructure analysis 19

Pharmaceutical industry infrastructure overview 19

Related reports 21

Upcoming related reports 21

TABLE OF CONTENTS 22

2. Brazil - Socio-demographic and economic analysis 23

Key findings 23

Socio-demographic trends 23

Socioeconomic trends 23

Demographic trends in Brazil 25

Brazil's population expected to expand rapidly, peaking in 2040 26

Declining number of births with improving infant mortality rates 28

The Brazilian population is slowly aging 29

The Brazilian population is living longer 30

Disease burden in Brazil 31

Heart disease a leading cause of death in Brazil as in more developed markets 32

Violence and social deprivation still significant despite progress 33

An unexpectedly high rate of prostate cancer deaths representative of gaps in healthcare provision 34

Political climate 35

The end of the Lula government but his legacy will live on 35

The effect of the global economic crisis has been felt less in Brazil 36

PAC gives Brazil much needed infrastructure development 36

Is the Brazilian economy in danger of overheating? 37

Debt reduction a fundamental feature of Lula's economic policy 38

Increased prosperity has brought income disparities 41

Business environment 41

Setting up business in Brazil can be complex and difficult 41

The Brazilian tax system is complicated and confusing 42

Workforce is extensive but poorly educated 42

3. Brazil - Healthcare system and drug regulatory analysis 44

Key findings 44

Brazil healthcare expenditure 44

Brazil healthcare system overview 44

Brazil regulatory issues 45

Brazil pricing and reimbursement issues 45

Healthcare system 47

Healthcare expenditure in Brazil is rising 47

Growing cost pressures may lead to a cut in the medication budget 49

Healthcare is delivered through two systems 50

The SUS provides universal healthcare coverage in Brazil 51

SUS management has become less centralized 52

Private health insurance system - most Brazilians use the SUS, but the private health segment is expanding 53

Brazil has sought to expand healthcare coverage to reduce inequalities 54

The Family Health Program reduces burden on hospitals and specialist care 54

The Popular Pharmacy program was set up to increase the supply of medicines to the poor 55

Regulatory issues in Brazil 56

Regulatory issues in Brazil 56

Drug approval and regulatory processes - pharma companies regard Brazil's regulatory environment as unpredictable 56

ANVISA is the national body in charge of regulating medicines in Brazil 56

Similares are being phased out - bioequivalence studies are required for generic drugs in Brazil since 2003 57

Plant inspections are causing lengthy approval times in Brazil 57

ANVISA introduces a new decree on pharmacovigilance 58

Intellectual property protection in Brazil 58

The speed of patent review is slow and backlogs exist 58

There is conflict between the two agencies involved in assessing patent applications 59

There is no set period of data exclusivity in Brazil 59

Compulsory licenses on HIV/AIDS drugs were used only as a threat until May 2007 60

Pipeline patents have awarded several HIV/AIDS drugs extra protections but could be overruled in the future 61

Drug counterfeiting is on the rise in Brazil 61

Drug importation - imported pharmaceuticals have to be registered with ANVISA 62

Pricing and reimbursement in Brazil 63

Pricing issues in Brazil 63

Pricing of new drugs is controlled by the CMED 63

Prices of marketed pharmaceuticals are controlled through price freezes and increases 64

Antiretroviral therapies are priced low in Brazil 65

Reimbursement issues in Brazil - Reimbursable pharmaceuticals are included on the National list of Essential Medicines 66

The Pharmaceutical Care in Primary Healthcare program provides access to essential drugs 67

Strategic program for pharmaceutical assistance includes medicines for neglected diseases 67

The Specialist Pharmaceutical Assistance Component provides specialist and high-cost medicines 68

Despite the SUS reimbursement programs, many patients still do not have access to medicines 68

4. Brazil - Prescription pharmaceutical sales analysis 70

Key findings 70

Pharmaceutical market size 70

Leading therapy areas 70

Leading pharmaceutical brands 70

Leading pharmaceutical companies 70

Pharmaceutical market size in Brazil 72

Leading therapy areas in Brazil 74

Central nervous system was the largest therapy area in terms of sales 76

Musculoskeletal drugs have shown the fastest growth rates 76

Urology and metabolic have shown the slowest growth rates 77

Leading pharmaceutical brands in Brazil 78

Top-selling drug Dorflex sees its franchise extended with follow-up product 81

Cialis to maintain momentum thanks to lifecycle management strategy 81

Lipitor is expected to continue reaching high sales even after patent expiration 81

Leading pharmaceutical companies in Brazil 82

Sanofi-Aventis is now the leading pharma company in Brazil following its acquisition of Medley 83

Novartis's Brazilian retail sales growth driven by its Diovan franchise 84

The leading domestic companies are exhibiting double-digit growth rates 86

EMS 87

Eurofarma 87

Neo Quimica 88

5. Brazil - Drug expiry analysis 89

Key findings 89

Brazil retail generics market 89

Brazil brand erosion post patent expiry 89

Brazil biosimilars market 89

Brazilian generics market dynamics 91

Similares versus true generics 92

Brazilian generics volume uptake 94

Brazilian generics value uptake 95

Brazilian generics market size 96

Drivers and resistors in the Brazilian generics market 97

Several legislative measures have driven generic uptake 98

Loose patent regulations lead to increased market potential for generic players 99

Market pressures drive down generics prices below the mandatory 35% discount 99

International pressures could hamper generics importers 100

Similares provide affordable healthcare, but bioequivalence legislation has fueled the uptake of true generics 100

Key generics players in the Brazilian market 101

Acquiring local generics players is key strategy for foreign players to penetrate the Brazilian market 102

Sanofi-Aventis extends its dominance in Brazil 103

Pfizer seeks to extend its presence in Brazil 104

Valeant acquires two Brazilian generic drug companies 105

Lupin committed to gaining ground in Brazil 105

Opportunities for the generics industry 106

Small molecule brand erosion in the Brazilian market 107

Number of generic entrants by therapy area 107

Brazil biosimilars market dynamics 108

Drivers and resistors of biosimilar growth in Brazil 108

Rising healthcare costs 108

Biosimilars approval process enacted in 2005 109

Indian-based companies dominate the market 109

New and future biosimilar launches 111

Opportunities for the biosimilar industry 112

Monoclonal antibody therapies could soon face biosimilar incursion in Brazil 113

Biosimilars in development internationally 115

6. Brazil - Pharmaceutical Industry Infrastructure analysis 116

Key findings 116

Pharmaceutical industry infrastructure overview 116

Key company infrastructure in Brazil 117

EMS 118

Novartis 121

Ache Labs 125

Medley 128

Sanofi-Aventis 128

Eurofarma 131

Pfizer 134

Bayer Schering 138

Castro Marques 141

Merck & Co. 143

7. Bibliography 147

Brazil - Executive summary 147

Publications and online articles 147

Brazil - Socio-demographic and economic analysis 148

Publications and online articles 148

Datamonitor reports and products 151

Brazil - Healthcare systems and regulations 151

Publications and online articles 151

Datamonitor reports and products 155

Brazil - Prescription pharmaceutical sales 155

Publications and online articles 155

Brazil - Drug expiry analysis 156

Publications and online articles 156

Datamonitor reports and products 159

Brazil - Pharmaceutical industry infrastructure analysis 160

Publications and online articles 160

Datamonitor reports and products 161

APPENDIX 162

Exchange rates used in this report 162

Datamonitor prescription pharmaceutical definition and therapy area classification 163

About Datamonitor 164

About Datamonitor Healthcare 164

Datamonitor consulting 164

Disclaimer 165

Disclaimer 166

List of Tables

Table 1: Brazil - changes in the key value drivers of the Brazilian pharmaceutical market, 2005-09 5

Table 2: Brazil - demographic indicators, 2005 and 2010 8

Table 3: Brazil - key economic indicators, 2005-2012 10

Table 4: Brazil - healthcare expenditure indicators, 2006-09 12

Table 5: Brazil - a range of pricing and reimbursement tools are used, 2010 14

Table 6: Brazil - retail sales and volume of the pharmaceutical market $ and IMS Standard Units), 2009 16

Table 7: Brazil -key metrics for the retail generics and biosimilars market, 2010 18

Table 8: Brazil - R&D and manufacturing infrastructure data, 2010 20

Table 9: Brazil - demographic indicators, 2005 and 2010 25

Table 10: Brazil - top 10 causes of mortality, 2004 31

Table 11: Brazil - disability-adjusted life years (DALY) rates compared to Australia, Japan, the other BRIC nations, North America, and the five major EU markets (5EU), 2009 32

Table 12: Brazil - key economic indicators, 2005-2012 36

Table 13: Brazil - healthcare expenditure indicators, 2006-09 49

Table 14: Brazil - key health system indicators, 2000-09 51

Table 15: Brazil - a range of pricing and reimbursement tools are used, 2010 63

Table 16: Brazil - retail sales and volume of the pharmaceutical market $ and IMS Standard Units), 2009 73

Table 17: Brazil - retail pharmaceutical sales by therapy area ($m and %), 2005-09 75

Table 18: Brazil - retail pharmaceutical volume by therapy area (SUm and %), 2005-09 76

Table 19: Brazil - retail sales growth for top 20 pharmaceutical brands ($m and %), 2009 79

Table 20: Brazil - retail volume growth for top 20 pharmaceutical brands (SUm and %), 2009 80

Table 21: Brazil - retail sales growth for the leading international pharmaceutical companies ($m and %), 2009 84

Table 22: Brazil - retail volume growth for the leading international pharmaceutical companies (SUm and %), 2009 85

Table 23: Brazil - retail sales growth for the leading Brazil-based pharmaceutical companies ($m and %), 2009 86

Table 24: Brazil - retail volume growth for the leading Brazil-based pharmaceutical companies (SUm and %), 2009 87

Table 25: Brazil -key metrics for the retail generics and biosimilars market, 2010 90

Table 26: Brazil - comparison of generic penetration versus other major pharmaceutical markets ($ billion and %), 2007-08 (retail market only for Brazil) 91

Table 27: Brazil - retail sales of the leading generics companies, 2009 101

Table 28: Brazil - healthcare expenditure indicators, 2006-09 108

Table 29: Brazil - a comparison of biosimilar prices in four government tender bids in Brazil 110

Table 30: Brazil - retail sales of biologics (both brands and biosimilars), 2009 111

Table 31: Brazil - retail sales of branded monoclonal antibodies, 2009 113

Table 32: Brazil - retail sales growth for the leading international pharmaceutical companies ($m and %), 2009 117

Table 33: Brazil - EMS's R&D and manufacturing infrastructure, 2010 118

Table 34: Brazil - EMS's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 119

Table 35: Brazil - Novartis's R&D and manufacturing infrastructure, 2010 121

Table 36: Brazil - Novartis's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 122

Table 37: Brazil - Ache Labs's R&D and manufacturing infrastructure, 2010 125

Table 38: Brazil - Ache Labs's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 126

Table 39: Brazil - Sanofi-Aventis's (post acquisition of Medley) R&D and manufacturing infrastructure, 2010 128

Table 40: Brazil - Sanofi-Aventis's (post acquisition of Medley) R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 129

Table 41: Brazil - Sanofi-Aventis's Brazilian-based M&A activity, 2008-2010 130

Table 42: Brazil - Eurofarma's R&D and manufacturing infrastructure, 2010 131

Table 43: Brazil - Eurofarma's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 132

Table 44: Brazil - Pfizer's R&D and manufacturing infrastructure (post-acquisition of Wyeth), 2010 134

Table 45: Brazil - Pfizer's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 135

Table 46: Brazil - Bayer Schering's R&D and manufacturing infrastructure, 2010 138

Table 47: Brazil - Bayer Schering's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 138

Table 48: Brazil - Castro Marques's R&D and manufacturing infrastructure, 2010 141

Table 49: Brazil - Castro Marques's R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 141

Table 50: Brazil - Merck & Co.'s R&D and manufacturing infrastructure, 2010 143

Table 51: Brazil - Merck & Co.'s R&D and manufacturing infrastructure data compared with other top 10 companies in Brazil, 2010 144

Table 52: Currency exchange rates, 2010 162

Table 53: ATC (anatomical therapeutic chemical) classification codes assigned to a given therapy area within the prescription pharmaceutical market 163

List of Figures

Figure 1: Brazil - key value drivers of Brazil's pharmaceutical market, 2009 4

Figure 2: Brazil - drivers and resistors facing branded pharmaceutical companies 6

Figure 3: Brazil - population and population growth rate, 1950-2050 26

Figure 4: Brazil - population growth compared to Australia, Japan, the other BRIC nations, North America and five major EU markets (5EU), 1950-2050 27

Figure 5: Brazil - birth rates per 1,000 individuals compared to Australia, Japan, the other BRIC nations, North America and the five major EU markets (5EU), 1950-2050 28

Figure 6: Brazil - proportion of population over 65 years compared to Australia. Japan, the other BRIC nations, North America and the five major EU markets (5EU), 1950-2050 29

Figure 7: Brazil - life expectancy compared to Australia, Japan, the other BRIC nations, North America and the five major EU markets (5EU), 1950-2050 30

Figure 8: Brazil - gross domestic product (GDP) per capita growth rate compared with Australia, Japan, the other BRIC nations, North America and the five major EU markets (5EU), 2005-09 38

Figure 9: Debt trap rankings for the Brazil, the UK, France, Germany, Italy, Spain, US, Canada, Australia and Japan, 2010 39

Figure 10: Total debt against GDP, and total cost of servicing debt against total government expenditure (minus annual budget balance) in Brazil, Japan, UK and US ($ billion), 2009 40

Figure 11: Unemployment rates in Brazil, the five major EU markets, North America, Japan, Australia and the other BRIC nations, 1990-2008 42

Figure 12: Brazil - proportion of GDP expenditure on healthcare is significantly higher than for the other BRIC nations, 2006 47

Figure 13: Brazil - structure of the healthcare system, 2008 50

Figure 14: Brazil - three funding schemes for drugs reimbursed by the Unified Health System (Sistema Unico de Saudi; SUS) 66

Figure 15: Brazil - relative retail sales and volume of the Brazilian retail pharmaceutical market (indexed against volume or value in 2005), 2005-09 72

Figure 16: Brazil - retail pharmaceutical sales by therapy area (%), 2005-09 74

Figure 17: Brazil - retail sales growth for the leading retail pharmaceutical brands($m and %), 2009 78

Figure 18: Brazil - retail sales growth for leading pharmaceutical companies (%), 2005-09 82

Figure 19: Brazil - aggregation of retail sales between 2005 and 2009 to demonstrate the affect of Sanofi-Aventis's acquisition of Medley 83

Figure 20: Brazil - volume (%) and value (%) of true generic retail and hospital sales as a share of total Brazilian pharmaceutical sales, 2004-09 93

Figure 21: Brazil - comparison of generic value uptake versus other major pharmaceutical markets (%). 2007-08 94

Figure 22: Brazil - comparison of generic value uptake in Brazil versus other pharmaceutical markets, 2007-08 95

Figure 23: Brazil - comparison of generics market size versus other pharmaceutical markets ($ billion), 2007-08 (retail market only for Brazil) 96

Figure 24: Brazil - drivers and resistors to generic uptake, 2010 97

Figure 25: Brazil - example of typical generic packaging 98

Figure 26: Brazil - benefits and challenges of achieving greater market access through acquisition 102

Figure 27: Brazil - aggregation of retail sales between 2005 and 2009 to demonstrate the affect of Sanofi-Aventis's acquisition of Medley 103

Figure 28: Brazil - Medley provides significant diversification of Sanofi-Aventis's Brazilian portfolio, 2009 104

Figure 29: Brazil - branded retail sales at risk of generic erosion ($m), 2010-13 106

Figure 30: Brazil - yearly generic entry across Anatomical Therapeutic Chemical-1 (ATC-1) groupings within a 5 year period, 2000-07 107

Figure 31: Brazil - total number of cancer cases, 2009-2015 109

Figure 32: Brazil - retail sales ($m) of marketed biologics due to come off-patent, 2010-2015 112

Figure 33: Brazil - drivers and resistors to biosimilar monoclonal antibody entry, 2010 114

Figure 34: Brazil - key biosimilars in development internationally by product class, 2010 115

Figure 35: Brazil - EMS's pharmaceutical operations, 2010 120

Figure 36: Brazil - Novartis's presence compared with other top 10 companies in Brazil 123

Figure 37: Brazil - Novartis's pharmaceutical operations, 2010 124

Figure 38: Brazil - Ache's pharmaceutical operations, 2010 127

Figure 39: Brazil - Sanofi-Aventis's (post acquisition of Medley) pharmaceutical operations, 2010 130

Figure 40: Brazil - Eurofarma's pharmaceutical operations, 2010 133

Figure 41: Brazil - Pfizer's presence (post-merger with Wyeth) compared with other top 10 companies in Brazil 136

Figure 42: Brazil - Pfizer's pharmaceutical operations (post-merger with Wyeth), 2010 137

Figure 43: Brazil - Bayer Schering's presence compared with other top 10 companies in Brazil 139

Figure 44: Brazil - Bayer Schering's pharmaceutical operations, 2010 140

Figure 45: Brazil - Castro Marques's pharmaceutical operations, 2010 142

Figure 46: Brazil - Merck & Co.'s presence compared with other top 10 companies in Brazil 145

Figure 47: Brazil - Merck & Co.'s pharmaceutical operations, 2010 146

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