CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Egypt

  • ID: 4450396
  • Report
  • Region: Egypt
  • 133 pages
  • GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Egypt

Summary

Egypt has the largest pharmaceutical manufacturing base in the Middle East and North Africa (MENA) region, representing around 30% of the regional market. Before the 1990s, the pharmaceutical industry was dominated by state-owned companies, but the overall scenario changed following economic liberalization, when the private sector took the highest share of production in the domestic market (GAFI, 2017a). Egypt Pharmaceutical market was worth $2.31 Billion in 2009 and an estimated $5.43 Billion in 2016, having grown at a Compound Annual Growth Rate (CAGR) of 14.1%.

Pharmaceutical companies in Egypt are classified as public sector companies (12 companies are affiliates of HoldiPharma), domestic private sector companies and multinational companies. The private sector dominates pharmaceutical production, with a market share of 75%. As of January 2016, there were around 130 local and foreign pharmaceutical factories in the Egyptian market and 70 additional plants under construction.

Ministry of Health and Population (MoHP) published the first Egyptian guidelines for the registration of biological products in 2015, in accordance with the World Health Organization (WHO) standards, but these have not led to the effective implementation of regulatory procedures to reduce development costs and shorten the time-to-market for biosimilar products.

Investment in the pharmaceutical industry totaled $5.02 Billion in the first three quarters of 2016, with domestic investment accounting for $3.16 Billion, foreign investment accounting for $1.63 Billion and Arab investment accounting for $0.23 Billion (GAFI, 2017a). GlaxoSmithKline (GSK), Novartis, Pfizer and Bristol-Myers Squibb are the largest multinational companies with production facilities in Egypt.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Egypt", provides information on the healthcare, regulatory, and reimbursement landscape in Egypt, and includes:
  • An overview of the Egyptian healthcare market and its key driving factors. It also gives a snapshot of the demographic, regulatory, and reimbursement landscape and healthcare infrastructure in Egypt.
  • Provides an overview of the Egyptian pharmaceutical and medical device markets, covering market size; the market shares of generic, Over-the-Counter (OTC) and biologic/biosimilar products; and the key drivers and barriers for the overall market. It also includes profiles of the major players, as well as SWOT assessments.
  • Covers the reimbursement and payer landscape and includes details of the reimbursement process, insurance providers, pricing policies and drug price trends in Egypt. It also looks at the regulatory landscape and gives an overview of the regulatory agencies and approval processes for new drugs and medical devices.
  • Provides detailed analysis of the political and economic environment in Egypt and analyzes economic indicators, demographics, and healthcare infrastructure and expenditure.
  • Provides an overview of the opportunities for and challenges to growth in the Egyptian healthcare market.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Egypt, 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 (GSK, Novartis, Sanofi, Egyptian International Pharmaceutical Industries Company (EIPICO) and South Egypt Drug Industries Company (SEDICO))
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the 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 Egyptian 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 the Egyptian healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the 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 most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in the Egyptian healthcare market
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1 Table of Contents

2 Executive Summary

3 Introduction
3.1 Report Guidance

4 Overview of the Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Imports and Exports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview of Major Therapeutic Areas
4.1.6 Major Players
4.2 Medical Device Market
4.2.1 Market Overview
4.2.2 Overview of Top Five Segments
4.2.3 Major Players
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
5.3 Drug Reimbursement Process
5.3.1 Overview of Insurance Providers
5.3.2 Patient Share in Healthcare Spending
5.3.3 Price Trend in Healthcare Services
5.3.4 Pricing Policies
5.4 Regulatory Landscape
5.4.1 Overview of Regulatory Agencies
5.4.2 Market Authorization Procedure for Pharmaceutical Products
5.4.3 Market Authorization Procedure for Medical Devices
5.4.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.4.5 Licensing Process for Pharmaceutical Imports and Exports
5.4.6 Intellectual Property Rights
5.4.7 Clinical Trial Regulations
5.4.8 Pharmaceutical Advertising Regulation
5.4.9 Pharmacy Regulations
5.4.10 Labeling and Packaging Regulations

6 Country Healthcare Landscape
6.1 Healthcare Policy Initiatives
6.2 Healthcare Infrastructure
6.2.1 Healthcare Facilities
6.2.2 Healthcare Parameters
6.2.3 Healthcare Personnel
6.2.4 Environmental Health
6.3 Healthcare Expenditure
6.3.1 Overview
6.3.2 Public-Private Sector Share
6.4 Trade Associations
6.4.1 Arab Union of Manufacturers of Pharmaceuticals and Medical Appliances
6.4.2 Federation of Egyptian Industries
6.4.3 Egyptian Pharmaceutical Students Federation
6.5 Trade Fairs

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, Egypt, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Egypt, Revenue Forecast ($bn), 2017-2021
Table 3: Pharmaceutical Market, Egypt, Pharmaceutical Exports and Imports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Egypt, Price Mark-ups, 2016
Table 5: Pharmaceutical Market, Egypt, Annual Cost of Treatment ($m), 2016
Table 6: Pharmaceutical Market, Novartis, Major Products, 2017
Table 7: Pharmaceutical Market, Novartis, Planned Filings, 2017-2020
Table 8: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 9: Pharmaceutical Market, Sanofi, Global, Late-Stage Pipeline, 2017
Table 10: Medical Device Market, Egypt, Revenue ($bn), 2009-2016
Table 11: Medical Device Market, Egypt, Revenue Forecast ($bn), 2017-2021
Table 12: Medical Device Market, Egypt, Revenue ($m) and Market Share (%) by Segment, 2016
Table 13: Cardiovascular Devices Market, Egypt, Revenue ($m), 2009-2016
Table 14: Wound Care Management Market, Egypt, Revenue ($m), 2009-2016
Table 15: Orthopedic Devices Market, Egypt, Revenue ($m), 2009-2016
Table 16: Ophthalmic Devices Market, Egypt, Revenue of Major Players ($m), 2009-2016
Table 17: Diagnostic Imaging Market, Egypt, Revenue ($m), 2009-2016
Table 18: Medical Device Market, Egypt, Major Products by Segment, 2016
Table 19: Roche, Global, Major Products, 2015
Table 20: Medical Device Market, Roche, Global, Late-Stage Pipeline, 2016
Table 21: Market Access, Egypt, HIO Beneficiaries, Premium Rates (%), 2016
Table 22: Market Access, Egypt, Out-of-Pocket Expenditure as Percentage of Total Expenditure on Health (%), 2009-2015
Table 23: Market Access, Egypt, Healthcare Inflation (%), 2009-2016
Table 24: Healthcare Infrastructure, Egypt, Number of Hospitals, 2009-2015
Table 25: Healthcare Infrastructure, Egypt, Number of Government and Private Hospitals, 2009-2015
Table 26: Healthcare Infrastructure, Egypt, Health Centers, 2009-2015
Table 27: Healthcare Infrastructure, Egypt, Hospital Beds (‘000), 2009-2015
Table 28: Demographics, Egypt, Life Expectancy at Birth (years), 2009-2016
Table 29: Demographics, Egypt, Immunization Rate (%), 2009-2016
Table 30: Demographics, Egypt, Major Causes of Mortality (‘000), 2015
Table 31: Demographics, Egypt, Major Causes of Male Mortality (‘000), 2015
Table 32: Demographics, Egypt, Major Causes of Female Mortality (‘000), 2015
Table 33: Demographics, Egypt, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Table 34: Healthcare Infrastructure, Egypt, Physicians (‘000), 2009-2015
Table 35: Healthcare Infrastructure, Egypt, Dentists (‘000), 2009-2015
Table 36: Healthcare Infrastructure, Egypt, Pharmacists (‘000), 2009-2015
Table 37: Healthcare Infrastructure, Egypt, Nurses (‘000), 2009-2015
Table 38: Healthcare Infrastructure, Egypt, PM2.5 (µg per m3), 2009-2015
Table 39: Healthcare Infrastructure, Egypt, CO2 Emissions (million tons), 2009-2015
Table 40: Healthcare Expenditure, Egypt, Healthcare Expenditure as Percentage of GDP (%), 2009-2016
Table 41: Healthcare Expenditure, Egypt, Public-Private Share (%), 2009-2015
Table 42: Healthcare Expenditure, Egypt, Major Healthcare Trade Fairs, 2017

List of Figures
Figure 1: Pharmaceutical Market, Egypt, Revenue ($bn), 2009-2021
Figure 2: Medical Device Market, Egypt, Revenue ($bn), 2009-2021
Figure 3: Country Profile, Egypt, 2017
Figure 4: Pharmaceutical Market, Egypt, Revenue ($bn), 2009-2016
Figure 5: Pharmaceutical Market, Egypt, Revenue Forecast ($bn), 2017-2021
Figure 6: Pharmaceutical Market, Egypt, Pharmaceutical Exports and Imports ($bn), 2009-2016
Figure 7: Pharmaceutical Market, Egypt, Supply Channels, 2016
Figure 8: Pharmaceutical Market, Egypt, Annual Cost of Treatment ($m), 2016
Figure 9: Medical Device Market, Egypt, Revenue ($bn), 2009-2016
Figure 10: Medical Device Market, Egypt, Revenue Forecast ($bn), 2017-2021
Figure 11: Medical Device Market, Egypt, Revenue by Segment ($m), 2016
Figure 12: Cardiovascular Devices Market, Egypt, Revenue ($m), 2009-2016
Figure 13: Wound Care Management Market, Egypt, Revenue ($m), 2009-2016
Figure 14: Orthopedic Devices Market, Egypt, Revenue ($m), 2009-2016
Figure 15: Ophthalmic Devices Market, Egypt, Revenue ($m), 2009-2016
Figure 16: Diagnostic Imaging Market, Egypt, Revenue ($m), 2009-2016
Figure 17: Pharmaceutical Market, Egypt, Drivers and Barriers, 2017
Figure 18: Market Access, Egypt, Key Influencers in Decision-Making Process in Healthcare System, 2012
Figure 19: Market Access, Egypt, Public Insurance Reform Milestones, 1964-2017
Figure 20: Market Access, Egypt, Out-of-Pocket Expenditure as Percentage of Total Expenditure on Health (%), 2009-2015
Figure 21: Market Access, Egypt, Healthcare Inflation (%), 2009-2016
Figure 22: Egyptian Drug Authority, Organization Chart, Egypt, 2017
Figure 23: New Drug Approval Process, Egypt, 2013
Figure 24: Biosimilar Registration for Imported Products, Egypt, 2017
Figure 25: Biosimilar Registration for Locally Manufactured Products for Case I and II, Egypt, 2017
Figure 26: Biosimilar Registration for Locally Manufactured Products for Case III, Egypt, 2017
Figure 27: Licensing Process for Manufacturing Site, Egypt, 2017
Figure 28: Licensing Process for New Production Line, Egypt, 2017
Figure 29: Healthcare Infrastructure, Egypt, Number of Hospitals, 2009-2015
Figure 30: Healthcare Infrastructure, Egypt, Number of Government and Private Hospitals, 2009-2015
Figure 31: Healthcare Infrastructure, Egypt, Health Centers, 2009-2015
Figure 32: Healthcare Infrastructure, Egypt, Hospital Beds (‘000), 2009-2015
Figure 33: Demographics, Egypt, Life Expectancy at Birth (years), 2009-2016
Figure 34: Demographics, Egypt, Immunization Rate (%), 2009-2016
Figure 35: Demographics, Egypt, Major Causes of Mortality (‘000), 2015
Figure 36: Demographics, Egypt, Major Causes of Male Mortality (‘000), 2015
Figure 37: Demographics, Egypt, Major Causes of Female Mortality (‘000), 2015
Figure 38: Demographics, Egypt, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Figure 39: Healthcare Infrastructure, Egypt, Physicians (‘000), 2009-2015
Figure 40: Healthcare Infrastructure, Egypt, Dentists (‘000), 2009-2015
Figure 41: Healthcare Infrastructure, Egypt, Pharmacists (‘000), 2009-2015
Figure 42: Healthcare Infrastructure, Egypt, Nurses (‘000), 2009-2015
Figure 43: Healthcare Infrastructure, Egypt, PM2.5 (µg per m3), 2009-2015
Figure 44: Healthcare Infrastructure, Egypt, CO2 Emissions (million tons), 2009-2015
Figure 45: Healthcare Expenditure, Egypt, Healthcare Expenditure as Percentage of GDP (%), 2009-2016
Figure 46: Healthcare Expenditure, Egypt, Public-Private Share (%), 2009-2015
Figure 47: Healthcare Market, Egypt, Opportunities and Challenges, 2017
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