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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela

  • ID: 2964312
  • Report
  • Region: Venezuela
  • 145 pages
  • GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela

Summary

Venezuela ranked 187 out of 190 countries in ease of doing business. In July 2017, rating firm Standard & Poor’s downgraded Venezuela’s economy to CCC with a negative outlook. Moody’s also downgraded its rating to Caa3 with a negative outlook, while Fitch rated it at CCC with a negative outlook.

Venezuela is one of the emerging pharmaceutical markets in South America, with a major dependence on imports. However, economic and political turmoil along with inefficient patent laws and drug pricing policies are major barriers. The value of the market was US$12.6 Billion in 2015, having increased from US$5.7 Billion in 2009, at a Compound Annual Growth Rate (CAGR) of 14.1%. Drug prices in Venezuela are considerably higher than the regional average of US$7.86; in 2016, the average drug price in Venezuela was US$21.95, which was the highest in the entire Latin America region.

Medical device market is also mainly dependent on imported products. The US is the major supplier for medical devices, although in recent times Cuba, Mexico and Brazil have replaced some of the US exports. Disposable healthcare items such as syringes, surgical cloths and hospital furniture are manufactured domestically.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Venezuela" is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Venezula. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure.

In particular, this report provides the following:
  • Provides an overview of the pharmaceutical and medical device market of Venezuela, including the market size; market segmentation by generic, Over-The-Counter (OTC), biologic and biosimilar products; and the key drivers and barriers for the market.
  • Covers the country’s reimbursement and payer landscape, as well as the regulatory landscape. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process for Venezuela.
  • Provides a detailed analysis of the political and economic environment of Venezuela. It analyzes its economic indicators, demographics, healthcare infrastructure and healthcare expenditure.
  • Provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Venezuela.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Venezuela, 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: Bayer, Abbott, Sanofi, Novartis and Merck & Co.
  • An 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 country’s 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 impact Venezuela’s 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
Note: Product cover images may vary from those shown
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1 Table of Contents

2 Executive Summary

3 Introduction
3.1 Report Guidance

4 Overview of Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Exports and Imports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview of Top Five Disease Areas
4.1.6 Major Players
4.2 Medical Device Market
4.2.1 Market Overview
4.3 Market Drivers and Barriers
4.3.1 Drivers
4.3.2 Barriers

5 Market Access
5.1 Overview of Healthcare system
5.2 Reimbursement and Payer Landscape
5.2.1 Overview of Insurance Providers
5.2.2 Patient Share in Healthcare Expenditure
5.2.3 Price Trends in the Healthcare Sector
5.2.4 Pricing Policies
5.3 Regulatory Landscape
5.3.1 Overview of Regulatory Agencies
5.3.2 Market Authorization Procedure for Pharmaceutical Products
5.3.3 New Medical Device Approval Process
5.3.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.3.5 Intellectual Property Rights
5.3.6 Clinical Trial Regulations
5.3.7 Pharmacy Regulations
5.3.8 Labeling and Packaging Regulations

6 Country Analysis
6.1 Political Environment
6.1.1 Political Structure
6.1.2 Current Political Environment
6.1.3 Healthcare Policy Initiatives
6.1.4 Economic Landscape
6.2 Economic Indicators
6.2.1 Gross Domestic Product
6.2.2 Gross National Income
6.2.3 Inflation
6.2.4 Currency Exchange Rate
6.2.5 Foreign Direct Investment
6.2.6 Foreign Exchange Reserves
6.2.7 Trade Balance
6.2.8 Government Structural Balance
6.2.9 Government Gross Debt
6.2.10 Major Industries
6.3 Demographics
6.3.1 Population
6.4 Healthcare Infrastructure
6.4.1 Healthcare Facilities
6.4.2 Healthcare Parameters
6.4.3 Environmental Health
6.5 Healthcare Expenditure
6.5.1 Overview
6.5.2 Share of Public and Private Sectors
6.5.3 Major Components of Healthcare Expenditure
6.5.4 Spending in Pharmaceutical R&D
6.6 Trade Associations
6.6.1 Venezuelan Chamber of Medicine
6.6.2 Chamber of Pharmaceutical Industry
6.6.3 Chamber of Non-prescription Medicines
6.6.4 Venezuelan Association of Distributors of Medical Equipment, Dental Laboratories and Related Products
6.6.5 Venezuelan Chamber of Pharmacy

7 Opportunities and Challenges
7.1 Opportunities
7.2 Challenges

8 Appendix
8.1 Abbreviations
8.2 Bibliography
8.3 Research Methodology
8.3.1 Coverage
8.3.2 Secondary Research
8.3.3 Forecasts
8.3.4 Expert Panel
8.4 Contact
8.5 Disclaimer

List of Tables
Table 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Venezuela, Revenue ($bn), 2017-2021
Table 3: Pharmaceutical Market, Venezuela, Exports and Imports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Venezuela, Total Deaths (%), 2014
Table 5: Bayer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 6: Pharmaceutical Market,Bayer, Global, Late-Stage Pipeline, 2017
Table 7: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 8: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2017
Table 9: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 10: Pharmaceutical Market, Novartis, Planned Filings, 2017-2020
Table 11: Pharmaceutical Market, Merck & Co., Global, Late-Stage Pipeline, 2017
Table 12: Healthcare Expenditure, Venezuela, Out-of-Pocket Expenditure (%), 2009-2015
Table 13: Market Access, Venezuela, Change in Average Prices of Healthcare Services (%), 2009-2015
Table 14: Market Access, Venezuela, Patent Fees ($), 2015
Table 15: Economic Indicators, Venezuela, GDP per Capita ($), 2009-2016
Table 16: Economic Indicators, Venezuela, GDP per Capita ($), 2017-2021
Table 17: Economic Indicators, Venezuela, GDP Annual Growth (%), 2009-2016
Table 18: Economic Indicators, Venezuela, GDP Annual Growth (%), 2017-2021
Table 19: Economic Indicators, Venezuela, GNI per Capita ($), 2009-2016
Table 20: Economic Indicators, Venezuela, Consumer Price Index, 2009-2016
Table 21: Economic Indicators, Venezuela, Average Consumer Price Index Annual Change (%), 2009-2016
Table 22: Economic Indicators, Venezuela, Currency Exchange Rate ($/VEF), 2009-2016
Table 23: Economic Indicators, Venezuela, Foreign Direct Investment ($bn), 2009-2015
Table 24: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2009-2016
Table 25: Economic Indicators, Venezuela, Imports of Goods and Services ($bn), 2009-2016
Table 26: Economic Indicators, Venezuela, Exports of Goods and Services ($bn), 2009-2016
Table 27: Economic Indicators, Venezuela, General Government Structural Balance ($bn), 2009-2016
Table 28: Economic Indicators, Venezuela, Government Gross Debt ($bn), 2009-2016
Table 29: Economic Indicators, Venezuela, Production Index of Major Industries (physical production), 2017
Table 30: Demographics, Venezuela, Population (million), 2009-2016
Table 31: Demographics, Venezuela, Population (million), 2017-2021
Table 32: Demographics, Venezuela, Urban-Rural Population Share (%), 2009-2016
Table 33: Demographics, Venezuela, Urban-Rural Population Share (%), 2017-2021
Table 34: Demographics, Venezuela, Population Distribution by Age Group (%), 2009-2016
Table 35: Demographics, Venezuela, Population Distribution by Age Group (%), 2017-2021
Table 36: Demographics, Venezuela, Births (per 1,000 population), 2009-2016
Table 37: Demographics, Venezuela, Mortality (per 1,000 Population), 2009-2016
Table 38: Demographics, Venezuela, Major Causes of Mortality (Number of deaths), 2015
Table 39: Demographics, Venezuela, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016
Table 40: Demographics, Venezuela, Immunization Rate (%), 2009-2016
Table 41: Demographics, Venezuela, Major Causes of Male Mortality (number of deaths), 2015
Table 42: Demographics, Venezuela, Major Causes of Female Mortality (per 100,000 population), 2014
Table 43: Demographics, Venezuela, Gender Ratio (M/F), 2009-2016
Table 44: Demographics, Venezuela, Life Expectancy at Birth (years), 2009-2016
Table 45: Demographics, Venezuela, Life Expectancy at Birth (years), 2017-2021
Table 46: Demographics, Venezuela, Gross Enrollment Ratio (%), 2009-2016
Table 47: Demographics, Venezuela, Unemployment Rate (%), 2009-2016
Table 48: Demographics, Venezuela, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Table 49: Healthcare Infrastructure, Venezuela, Hospitals, 2008-2013
Table 50: Healthcare Infrastructure, Venezuela, Doctors (per 1,000 population), 2009-2016
Table 51: Healthcare Infrastructure, Venezuela, PM2.5 (µg per m³), 2009-2016
Table 52: Healthcare Infrastructure, Venezuela, CO2 Emissions (metric tons per capita), 2009-2016
Table 53: Healthcare Infrastructure, Venezuela, Healthcare Expenditure as Percentage of GDP (%), 2009-2016
Table 54: Healthcare Infrastructure, Venezuela, Public-Private Share of Expenditure (%), 2009-2016
Table 55: Healthcare Infrastructure, Venezuela, Major Components of Healthcare Expenditure (%), 2014

List of Figures
Figure 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2009-2021
Figure 2: Country Profile, Venezuela, 2017
Figure 3: Pharmaceutical Market, Venezuela, Revenue ($bn), 2009-2016
Figure 4: Pharmaceutical Market, Venezuela, Revenue ($bn), 2017-2021
Figure 5: Pharmaceutical Market, Venezuela, Exports and Imports ($bn), 2009-2016
Figure 6: Pharmaceutical Market, Venezuela, Total Deaths (%), 2014
Figure 7: Healthcare Market, Venezuela, Drivers and Barriers, 2017
Figure 8: Market Access, Venezuela, Health System, 2017
Figure 9: Healthcare Expenditure, Venezuela, Out-of-Pocket Expenditure (%), 2009-2015
Figure 10: Market Access, Venezuela, Change in Average Prices of Healthcare Services (%), 2009-2015
Figure 11: Market Access, Venezuela, Drug Approval Process, 2016
Figure 12: Market Access, Venezuela, Patent Process, 2016
Figure 13: Market Access, Venezuela, Trademark Process, 2016
Figure 14: Market Access, Venezuela, Clinical Trial Approval Process, 2016
Figure 15: Economic Indicators, Venezuela, GDP per Capita ($), 2009-2016
Figure 16: Economic Indicators, Venezuela, GDP per Capita ($), 2017-2021
Figure 17: Economic Indicators, Venezuela, GDP Annual Growth (%), 2009-2016
Figure 18: Economic Indicators, Venezuela, GDP Annual Growth (%), 2017-2021
Figure 19: Economic Indicators, Venezuela, GNI per Capita ($), 2009-2016
Figure 20: Economic Indicators, Venezuela, Consumer Price Index, 2009-2016
Figure 21: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), 2009-2016
Figure 22: Economic Indicators, Venezuela, Currency Exchange Rate ($/VEF), 2009-2016
Figure 23: Economic Indicators, Venezuela, Foreign Direct Investment ($bn), 2009-2015
Figure 24: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2009-2016
Figure 25: Economic Indicators, Venezuela, Imports of Goods and Services ($bn), 2009-2016
Figure 26: Economic Indicators, Venezuela, Exports of Goods and Services ($bn), 2009-2016
Figure 27: Economic Indicators, Venezuela, Government Structural Balance ($bn), 2009-2016
Figure 28: Economic Indicators, Venezuela, Government Gross Debt ($bn), 2009-2016
Figure 29: Economic Indicators, Venezuela, Production Index of Major Industries (physical production), 2017
Figure 30: Demographics, Venezuela, Population (million), 2009-2016
Figure 31: Demographics, Venezuela, Population (million), 2017-2021
Figure 32: Demographics, Venezuela, Urban-Rural Population Share (%), 2009-2016
Figure 33: Demographics, Venezuela, Urban-Rural Population Share (%), 2017-2021
Figure 34: Demographics, Venezuela, Population Distribution by Age Group (%), 2009-2016
Figure 35: Demographics, Venezuela, Population Distribution by Age Group (%), 2017-2021
Figure 36: Demographics, Venezuela, Births (per 1,000 population), 2009-2016
Figure 37: Demographics, Venezuela, Mortality (per 1,000 Population), 2009-2016
Figure 38: Demographics, Venezuela, Major Causes of Mortality (number of deaths), 2015
Figure 39: Demographics, Venezuela, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016
Figure 40: Demographics, Venezuela, Immunization Rate (%), 2009-2016
Figure 41: Demographics, Venezuela, Major Causes of Male Mortality (number of deaths), 2015
Figure 42: Demographics, Venezuela, Major Causes of Female Mortality (per 100,000 population), 2014
Figure 43: Demographics, Venezuela, Gender Ratio (M/F), 2009-2016
Figure 44: Demographics, Venezuela, Life Expectancy at Birth (years), 2009-2016
Figure 45: Demographics, Venezuela, Life Expectancy at Birth (years), 2017-2021
Figure 46: Demographics, Venezuela, Gross Enrollment Ratio (%), 2009-2016
Figure 47: Demographics, Venezuela, Unemployment Rate (%), 2009-2016
Figure 48: Demographics, Venezuela, Major Diseases, Disability-Adjusted Life Years by Major Disease (‘000s), 2015
Figure 49: Healthcare Infrastructure, Venezuela, Hospitals, 2008-2013
Figure 50: Healthcare Infrastructure, Venezuela, Doctors (per 1,000 population), 2009-2016
Figure 51: Healthcare Infrastructure, Venezuela, PM2.5 (µg per m³), 2009-2016
Figure 52: Healthcare Infrastructure, Venezuela, CO2 Emissions (metric tons per capita), 2009-2016
Figure 53: Healthcare Infrastructure, Venezuela, Healthcare Expenditure as Percentage of GDP (%), 2009-2016
Figure 54: Healthcare Infrastructure, Venezuela, Public-Private Share of Expenditure (%), 2009-2016
Figure 55: Healthcare Infrastructure, Venezuela, Major Components of Healthcare Expenditure (%), 2014
Figure 56: Healthcare Market, Venezuela, Opportunities and Challenges, 2017
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Government initiatives and an increasingly elderly population have driven the growth of the healthcare market, but growth depends on the resolution of concerns over inefficient patent protection laws, drug pricing policy, and dependency on imports.

In 2003, the government launched the Inside the Neighborhood Mission (Misión Barrio Adentro), which it hoped would increase the efficiency of the healthcare system (see Section 6.1.3.). In 2009, it invested VEF28 billion ($13 billion) in an Autonomous Service of Pharmaceutical Elaborations (Servicio Autónomo de Elaboraciones Farmacéuticas, SEFAR) production plant, which provides medicines at a cheaper rate than private pharmaceutical manufacturers (MPPCI, 2009). These initiatives are expected to drive the Venezuelan pharmaceutical market. Furthermore, in May 2012, the government launched a chain of pharmacy stores named National pharmacy network (Farmapatria) which sell medicines covering 85% of the most common diseases at a discount of up to 54% (Venezuela Analysis, 2012; Arsenal Terapéutico, 2012).

The pharmaceutical market was valued at approximately $4.1 billion in 2008 and $10 billion in 2013, having grown at a Compound Annual Growth Rate (CAGR) of 19.7%. It is estimated to reach $22.2 billion in 2020 at a CAGR of 12.0% from 2014 (CIFAR, 2007; CIFAR, 2012). The estimated drop in the growth rate is due to the frequent devaluation of the Venezuelan bolívar (from VEF4.3 per US dollar to VEF6.3 per US dollar in February 2013) and shortages of drugs in pharmacies. Due to currency devaluation, the value of the pharmaceutical market will be less in US dollar terms than in local currency terms.

In 2008, Venezuela reinstated the “Industrial Property Law of 1955”, which prevents the patent of medicines and food. This step will prove to be a challenge for manufacturers of branded drugs operating in Venezuela.

In 2003, the government imposed a price regulation for essential medicines (classified according to the criteria of the World Health Organization (WHO)). In November 2011, the Fair Price Law (Ley de Costos y Precios Justos) was introduced to regulate the prices of products and profits (to a maximum of 30%) in the pharmaceutical industry. These price freezes are likely to negatively affect pharmaceutical companies.

The supply of pharmaceuticals is heavily dependent on imports. The pharmaceutical imports market grew at a CAGR of 17.8% from 2008 to 2013 (ITC, 2014). Furthermore, pharmacies face a shortage of essential medicines due to short supplies, despite the efforts of the government. The imports of pharmaceutical products are anticipated to increase due to the inefficient and non-favorable domestic healthcare market.

The elderly population accounted for 6.3% of the total Venezuelan population in 2013, which is expected to rise to 7.8% in 2020. The chronic conditions associated with changes in lifestyle and increasing population are the primary drivers for the pharmaceutical market.

The medical device market is mainly dependent on imported products. The US is the major supplier for medical devices. However, Cuba, Mexico and Brazil have replaced some of these US exporters. Disposable healthcare items such as syringes, surgical cloths and hospital furniture are manufactured domestically (US Commercial Service, 2011).
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