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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela

Summary

GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela”. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Venezuela. 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 is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

The population of Venezuela grew from 27.7 million in 2008 to 29.8 million in 2013, mainly due to increasing life expectancy. Domestic production of medicines meets approximately 50% of the total demand of the Venezuelan population. The government has introduced the Mision Barrio Adentro program to provide universal healthcare access and Farmapatria to provide medicines on a discount up to 54%. The future growth in the pharmaceutical market will be dependent on the resolution of concerns related to inefficient patent protection laws, drug pricing policy, and dependency on imports. The country’s pharmaceutical market was approximately $10 billion in 2013 and is projected to reach $22.2 billion by 2020 at a CAGR of 12%. These positive growth trends can primarily be attributed to -
- Increasing elderly population
- Government initiatives in healthcare sector

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Venezuela, and includes -
- Overview of the pharmaceutical market of Venezuela including the market size, market segmentation, key drivers and barriers for the market
- Profiles and SWOT analyses of the major players in the pharmaceutical market: Pfizer, GlaxoSmithkline, Sanofi, Novartis and Groupo Farma
- Insightful review of the 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 political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An overview of the opportunities for and challenges to growth in the Venezuelan 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 Venezuela’s healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect Venezuela’s 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 best opportunities for consolidation, investment, and strategic partnership
- Identify, understand, and capitalize on the opportunities and challenges in Venezuela’s healthcare market

Table Of Contents

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela
1 Table of Contents

2 Introduction 16
2.1 GlobalData Report Guidance 16
3 Overview of Pharmaceutical and Medical Device Market 17
3.1 Pharmaceutical Market 17
3.1.1 Market Overview 17
3.1.2 Pharmaceutical Exports and Imports 20
3.1.3 Supply Channels 22
3.1.4 Market Segments 22
3.1.5 Overview of Major Disease Areas 24
3.1.6 Major Players 26
3.2 Medical Device Market 63
3.2.1 Market Overview 63
3.3 Market Drivers and Barriers 63
3.3.1 Drivers 63
3.3.2 Barriers 64
4 Market Access 67
4.1 Reimbursement and Payer Landscape 67
4.1.1 Overview of Healthcare system 67
4.1.2 Reimbursement Process 71
4.1.3 Overview of Insurance Providers 73
4.1.4 Patient Share in Healthcare Spending 74
4.1.5 Price Trends in the Healthcare Sector 75
4.1.6 Pricing Policies 77
4.2 Regulatory Landscape 77
4.2.1 Overview of Regulatory Agencies 77
4.2.2 Market Authorization Procedure for Pharmaceutical Products 78
4.2.3 New Medical Device Approval Process 80
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 80
4.2.5 Exports and Imports 81
4.2.6 Intellectual Property Rights 82
4.2.7 Clinical Trial Regulations 90
4.2.8 Pharmaceutical Advertising Regulations 92
4.2.9 Pharmacy Regulations 93
4.2.10 Labeling and Packaging Regulations 95
5 Country Analysis 98
5.1 Political Environment 98
5.1.1 Political Structure 98
5.1.2 Analysis of Current Political Environment 99
5.1.3 Healthcare Policy Initiatives 101
5.2 Economic Landscape 102
5.3 Economic Indicators 105
5.3.1 Gross Domestic Product 105
5.3.2 Gross National Income 110
5.3.3 Inflation 111
5.3.4 Currency Exchange Rate 116
5.3.5 Foreign Direct Investment 118
5.3.6 Foreign Exchange Reserves 119
5.3.7 Trade Balance 121
5.3.8 Government Structural Balance 123
5.3.9 Government Gross Debt 124
5.3.10 Major Industries 126
5.4 Demographics 127
5.4.1 Population 127
5.4.2 Education and Literacy 147
5.4.3 Employment 149
5.4.4 Disease Burden 150
5.5 Healthcare Infrastructure 152
5.5.1 Healthcare Facilities 152
5.5.2 Healthcare Parameters 159
5.5.3 Environmental Health 161
5.5.4 Healthcare Personnel 166
5.6 Healthcare Expenditure 167
5.6.1 Overview 167
5.6.2 Share of Public and Private Sectors 169
5.6.3 Major Components of Healthcare Spending 170
5.6.4 Spending in Pharmaceutical RandD 171
5.7 Trade Associations 171
5.7.1 Venezuelan Chamber of Medicine 171
5.7.2 Chamber of Pharmaceutical Industry 171
5.7.3 Chamber of Non-prescription Medicines 171
5.7.4 Venezuelan Association of Distributors of Medical Equipment, Dental Laboratories and Related Products 172
5.7.5 Venezuelan Chamber of Pharmacy 172
6 Opportunities and Challenges 173
6.1 Opportunities 173
6.2 Challenges 174
7 Appendix 176
7.1 Abbreviations 176
7.2 Bibliography 181
7.3 Research Methodology 198
7.3.1 Coverage 198
7.3.2 Secondary Research 199
7.3.3 Forecasts 199
7.3.4 Expert Panel 199
7.4 Disclaimer 200

1.1 List of Tables

Table 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2008-2013 19
Table 2: Pharmaceutical Market, Venezuela, Revenue Forecast ($bn), 2014-2020 20
Table 3: Pharmaceutical Market, Venezuela, Exports and Imports ($m), 2008-2013 21
Table 4: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 27
Table 5: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 28
Table 6: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 35
Table 7: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 36
Table 8: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 44
Table 9: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 45
Table 10: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 50
Table 11: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014?2018 51
Table 12: Pharmaceutical Market, Grupo Farma, Major Products, 2014 60
Table 13: Healthcare Spending, Venezuela, Out-of-Pocket Expenditure (%), 2008-2013 75
Table 14: Market Access, Price of Healthcare Products, Venezuela, Change in Average Price of Medicines (%), 2009-2013 76
Table 15: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), 2008-2013 106
Table 16: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), Forecast, 2014-2020 107
Table 17: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), 2008-2013 108
Table 18: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), Forecast, 2014-2020 109
Table 19: Economic Indicators, Venezuela, Gross National Income per Capita ($), 2008-2013 111
Table 20: Economic Indicators, Venezuela, Average Consumer Price Index, 2008-2013 112
Table 21: Economic Indicators, Venezuela, Average Consumer Price Index, Forecast, 2014-2020 113
Table 22: Economic Indicators, Venezuela, Average Consumer Price Index Annual Change (%), 2008-2013 115
Table 23: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), Forecast, 2014-2020 116
Table 24: Economic Indicators, Venezuela, Currency Exchange Rate (VEF/$), 2008-2013 117
Table 25: Economic Indicators, Venezuela, Foreign Direct Investment ($m), 2008-2013 119
Table 26: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2008-2013 120
Table 27: Economic Indicators, Venezuela, Imports of Goods and Services ($m), 2008-2013 122
Table 28: Economic Indicators, Venezuela, Exports of Goods and Services ($m), 2008-2013 123
Table 29: Economic Indicators, Venezuela, General Government Structural Balance ($bn), 2008-2013 124
Table 30: Economic Indicators, Venezuela, General Government Gross Debt ($bn), 2008-2013 125
Table 31: Economic Indicators, Venezuela, Major Industries, Industrial Sector, Gross Value Added ($bn), 2008-2009 127
Table 32: Demographics, Venezuela, Population (million), 2008-2013 128
Table 33: Demographics, Venezuela, Population Forecast (million), 2014-2020 129
Table 34: Demographics, Venezuela, Population, Urban and Rural Population Share (%), 2008-2013 130
Table 35: Demographics, Venezuela, Population, Urban and Rural Population Forecast Share (%), 2014-2020 131
Table 36: Demographics, Venezuela, Population Distribution by Age Group (%), 2008-2013 133
Table 37: Demographics, Venezuela, Population Distribution by Age Group Forecast (%), 2014-2020 134
Table 38: Demographics, Venezuela, Births (per 1,000 Population), 2008-2013 135
Table 39: Demographics, Venezuela, Mortality (per 1,000 Population), 2008-2013 136
Table 40: Demographics, Venezuela, Major Causes of Mortality (‘000), 2008 138
Table 41: Demographics, Venezuela, Children Table 42: Demographics, Venezuela, Immunization Rate (%), 2008-2013 141
Table 43: Demographics, Venezuela, Major Causes of Male Mortality (‘000), 2008 142
Table 44: Demographics, Venezuela, Major Causes of Female Mortality (‘000), 2008 143
Table 45: Demographics, Venezuela, Gender Ratio (M/F), 2008-2013 145
Table 46: Demographics, Venezuela, Life Expectancy at Birth (Years), 2008-2013 146
Table 47: Demographics, Venezuela, Student Enrollment by Level of Education (%), 2008-2013 148
Table 48: Demographics, Venezuela, Unemployment Rate (%), 2008-2013 150
Table 49: Demographics, Venezuela, Major Diseases, DALYs (per 100,000 Population), 2004 151
Table 50: Healthcare Infrastructure, Venezuela, Public Hospitals, 2008-2013 154
Table 51: Healthcare Infrastructure, Venezuela, Health System by Level of Care (%), 2010 156
Table 52: Healthcare Infrastructure, Venezuela, Urban and Rural Healthcare Facilities, 2008 and 2010 157
Table 53: Healthcare Infrastructure, Venezuela, Diagnostic Facilities, 2008-2013 159
Table 54: Healthcare Infrastructure, Venezuela, Hospitals Beds (per 1,000 Population), 2008-2013 160
Table 55: Healthcare Infrastructure, Venezuela, Physicians (per 10,000 Population), 2008-2013 161
Table 56: Healthcare Infrastructure, Venezuela, Environmental Attributable Deaths per 100,000 Population, 2004 162
Table 57: Healthcare Infrastructure, Venezuela, PM10 (µg/m³), 2008-2013 163
Table 58: Healthcare Infrastructure, Venezuela, CO2 Emissions (Million Metric Tons), 2008-2013 165
Table 59: Healthcare Infrastructure, Venezuela, Nurses (per 10,000 Population), 2008-2013 166
Table 60: Healthcare Infrastructure, Venezuela, Dentists (per 10,000 Population), 2008-2013 167
Table 61: Healthcare Infrastructure, Venezuela, Healthcare Expenditure (% of GDP), 2008-2013 168
Table 62: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008-2013 170
Table 63: Healthcare Infrastructure, Venezuela, Major Components of Healthcare Spending (%), 2012 170

1.2 List of Figures
Figure 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2008-2013 19
Figure 2: Pharmaceutical Market, Venezuela, Revenue Forecast ($bn), 2014-2020 20
Figure 3: Pharmaceutical Market, Venezuela, Exports and Imports ($m), 2008-2013 21
Figure 4: Healthcare Market, Venezuela, Drivers and Barriers, 2014 66
Figure 5: Market Access, Venezuela, Healthcare System, 2014 70
Figure 6: Healthcare Spending, Venezuela, Out-of-Pocket Expenditure (%), 2008-2013 75
Figure 7: Market Access, Price of Healthcare Products, Venezuela, Change in Average Price of Medicines (%), 2009-2013 76
Figure 8: Market Access, Approval Process for New Drugs, Venezuela, 2014 79
Figure 9: Market Access, Venezuela, Patent Approval Process, 2014 85
Figure 10: Market Access, Venezuela, Trademark Approval Process, 2014 89
Figure 11: Market Access, Venezuela, Clinical Trial Approval Process, 2014 91
Figure 12: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), 2008-2013 106
Figure 13: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), Forecast, 2014-2020 107
Figure 14: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), 2008-2013 108
Figure 15: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), Forecast, 2014-2020 109
Figure 16: Economic Indicators, Venezuela, Gross National Income per Capita ($), 2008-2013 110
Figure 17: Economic Indicators, Venezuela, Average Consumer Price Index, 2008-2013 112
Figure 18: Economic Indicators, Venezuela, Average Consumer Price Index, Forecast, 2014-2020 113
Figure 19: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), 2008-2013 115
Figure 20: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), Forecast, 2014-2020 116
Figure 21: Economic Indicators, Venezuela, Currency Exchange Rate (VEF/$), 2008-2013 117
Figure 22: Economic Indicators, Venezuela, Foreign Direct Investment ($m), 2008-2013 119
Figure 23: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2008-2013 120
Figure 24: Economic Indicators, Venezuela, Imports of Goods and Services ($m), 2008-2013 121
Figure 25: Economic Indicators, Venezuela, Exports of Goods and Services ($m), 2008-2013 122
Figure 26: Economic Indicators, Venezuela, Government Structural Balance ($bn), 2008-2013 124
Figure 27: Economic Indicators, Venezuela, General Government Gross Debt ($bn), 2008-2013 125
Figure 28: Economic Indicators, Venezuela, Major Industries, Industrial Sector, Gross Value Added ($bn), 2008-2009 126
Figure 29: Demographics, Venezuela, Population (million), 2008-2013 128
Figure 30: Demographics, Venezuela, Population Forecast (million), 2014-2020 129
Figure 31: Demographics, Venezuela, Population, Urban and Rural Population Share (%), 2008-2013 130
Figure 32: Demographics, Venezuela, Population, Urban and Rural Population Share Forecast (%), 2014-2020 131
Figure 33: Demographics, Venezuela, Population Distribution by Age Group (%), 2008-2013 133
Figure 34: Demographics, Venezuela, Population Distribution by Age Group Forecast (%), 2014-2020 134
Figure 35: Demographics, Venezuela, Births (per 1,000 Population), 2008-2013 135
Figure 36: Demographics, Venezuela, Mortality (per 1,000 Population), 2008-2013 136
Figure 37: Demographics, Venezuela, Major Causes of Mortality (‘000), 2008 137
Figure 38: Demographics, Venezuela, Children Figure 39: Demographics, Venezuela, Immunization Rate (%), 2008-2013 140
Figure 40: Demographics, Venezuela, Major Causes of Male Mortality (‘000), 2008 142
Figure 41: Demographics, Venezuela, Major Causes of Female Mortality (‘000), 2008 143
Figure 42: Demographics, Venezuela, Gender Ratio (M/F), 2008-2013 145
Figure 43: Demographics, Venezuela, Life Expectancy at Birth (Years), 2008-2013 146
Figure 44: Demographics, Venezuela, Student Enrollment by Level of Education (%), 2008-2013 148
Figure 45: Demographics, Venezuela, Unemployment Rate (%), 2008-2013 149
Figure 46: Demographics, Venezuela, Major Diseases, DALYs (per 100,000 Population), 2004 151
Figure 47: Healthcare Infrastructure, Venezuela, Public Hospitals, 2008-2013 154
Figure 48: Healthcare Infrastructure, Venezuela, Health System by Level of Care (%), 2010 156
Figure 49: Healthcare Infrastructure, Venezuela, Urban and Rural Healthcare Facilities, 2008 and 2010 157
Figure 50: Healthcare Infrastructure, Venezuela, Diagnostic Facilities, 2008-2013 158
Figure 51: Healthcare Infrastructure, Venezuela, Hospitals Beds (per 1,000 Population), 2008-2013 159
Figure 52: Healthcare Infrastructure, Venezuela, Physicians (per 10,000 Population), 2008-2013 160
Figure 53: Healthcare Infrastructure, Venezuela, Environmental Attributable Deaths (per 100,000 Population), 2004 162
Figure 54: Healthcare Infrastructure, Venezuela, PM10 (µg/m³), 2008-2013 163
Figure 55: Healthcare Infrastructure, Venezuela, CO2 Emissions (Million Metric Tons), 2008-2013 165
Figure 56: Healthcare Infrastructure, Venezuela, Nurses (per 10,000 Population), 2008-2013 166
Figure 57: Healthcare Infrastructure, Venezuela, Dentists (per 10,000 Population), 2008-2013 167
Figure 58: Healthcare Infrastructure, Venezuela, Healthcare Expenditure (% of GDP), 2008-2013 168
Figure 59: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008-2013 169
Figure 60: Healthcare Infrastructure, Venezuela, Share of Expenditure of Major Components of Healthcare Spending (%), 2012 170
Figure 61: Healthcare Market, Venezuela, Opportunities and Challenges, 2014 175

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