Healthcare, Regulatory and Reimbursement Landscape - South Africa

Healthcare, Regulatory and Reimbursement Landscape - SouthAfricaReport Details:Published:December 2012No. of Pages: 172Price: Single User License – US$1995Healthcare, Regulatory and Reimbursement Landscape - South AfricaSummaryGlobalData, the industry analysis specialist, has released its new report, “Healthcare, Regulatoryand Reimbursement Landscape - South Africa”. An essential source of information and analysison the South African healthcare, regulatory and reimbursement landscape, this report identifiesthe key trends in the healthcare market, as well as providing insights on the demographic,regulatory, and reimbursement landscape and healthcare infrastructure.Most importantly, the report provides valuable insights into the trends and segmentation of thepharmaceutical and medical device markets. It is built using data and information sourced fromproprietary databases, secondary research and in-house analysis by GlobalData’s team ofindustry experts.In 2011, South Africa’s population was 50.5 million, largely due to a positive balance between thebirth rate and mortality rate. The mortality rate is decreasing due to South Africa’s improvinghealthcare infrastructure and medical and diagnostic services. The pharmaceutical market wasestimated at $2.5 billion in 2011 and is expected to reach $4.2 billion by 2020 at a projectedCAGR of 5.8%. The medical device market was worth approximately $1.9 billion in 2011 and isexpected to reach $2.8 billion by 2020 at a projected CAGR of 4.3%.The positive trends in South Africa’s healthcare market can be attributed primarily to -- Increasing awareness of health and well-being in society- Growth in the healthcare infrastructure- The increasing availability of medicinesScope

The report provides information on South Africa’s healthcare, regulatory and reimbursementlandscape, including -- Overview of the pharmaceutical and medical device markets, including size, segmentation, andkey drivers and barriers.- Profiles and SWOT analyses of the major players in the pharmaceutical and medical devicemarkets. The key players covered for the pharmaceutical market are Aspen, Adcock Ingram,Sanofi, Novartis and Roche, and the key players covered for the medical devices market areSiemens Healthcare, Essilor International, Johnson & Johnson, F. Hoffmann-La Roche, and BBraun Melsungen.- Insightful review of the reimbursement and regulatory landscape, with details of thereimbursement process, regulatory agencies and market authorization processes for new drugand medical devices.- Detailed analysis of South Africa’s political and economic environment, including economicindicators, demographics, healthcare infrastructure and healthcare expenditure.- An overview of the opportunities for and challenges to growth in the healthcare market.Reasons to buyThe report will enhance your decision-making capability and allow you to -- Develop business strategies by understanding the trends shaping and driving the healthcaremarket.- Drive revenues by understanding the key trends, reimbursement and regulatory policies,pharmaceutical and medical devices market segments, and companies likely to impact thehealthcare market in the future.- Formulate effective sales and marketing strategies by understanding the competitive landscapeand analyzing the performance of various competitors.- Organize your sales and marketing efforts by identifying the market categories and segmentsthat present the most opportunities for consolidation, investment and strategic partnerships- Identify, understand and capitalize on the opportunities and challenges in the healthcare marketGet your copy of this report @http://www.reportsnreports.com/reports/213160-healthcare-regulatory-and-reimbursement-landscape-south-africa.htmlMajor points covered in Table of Contents of this report include1 Table of Contents1 Table of Contents 41.1 List of Tables 61.2 List of Figures 72 Introduction 92.1 Report Guidance 93 Overview of the Pharmaceutical and Medical Device Market 103.1 Pharmaceutical Market 10

3.1.1 Supply Channels 133.1.2 Market Segments 143.1.3 Major Disease Areas 163.1.4 Major Players 183.2 Medical Device Market 433.2.1 Market Overview 433.2.2 Overview of the Top Five Segments 463.2.3 Major Players 573.3 Market Drivers and Barriers 773.3.1 Drivers 773.3.2 Barriers 784 Market Access 794.1 Reimbursement and Payers Landscape 794.1.1 Healthcare System Overview 794.1.2 Reimbursement Process 814.1.3 Overview of Insurance Providers 834.1.4 Patient Share in Healthcare Spending 854.1.5 Pricing Policies 864.2 Regulatory Landscape 874.2.1 Overview of Regulatory Agencies 874.2.2 New Drug Approval Process 894.2.3 New Medical Device Approval Process 924.2.4 Licensing Process for Pharmaceutical Manufacturing 934.2.5 Licensing Process for Pharmaceutical Exports and Imports 934.2.6 Intellectual Property Rights 954.2.7 Clinical Trial Regulations 984.2.8 Pharmaceutical Advertising Regulations 994.2.9 Pharmacy Regulations 1004.2.10 Labeling and Packaging Regulations 1015 Country Analysis 1045.1 Political Environment 1045.1.1 Political Structure 1045.1.2 Analysis of Current Political Environment 1055.1.3 Healthcare Policy Initiatives 1055.2 Economic Landscape 1065.3 Economic Indicators 1075.3.1 Gross Domestic Product 1075.3.2 Gross National Income 1115.3.3 Inflation 1125.3.4 Currency Exchange Rate 1155.3.5 Foreign Direct Investment 1165.3.6 Foreign Exchange Reserves 117

5.3.7 Trade Balance 1185.3.8 Government Structural Balance 1205.3.9 Government Net Debt 1215.3.10 Major Industries 1235.4 Demography 1245.4.1 Population 1245.4.2 Education and Literacy 1405.4.3 Employment 1425.4.4 Disease Burden 1435.5 Healthcare Infrastructure 1455.5.1 Healthcare Facilities 1455.5.2 Healthcare Parameters 1475.5.3 Healthcare Personnel 1495.5.4 Environmental Health 1515.6 Healthcare Expenditure 1535.6.1 Major Components of Healthcare Spending 1545.6.2 Share of Public and Private Sector in Healthcare 1555.6.3 Spending in Pharmaceutical R&D 1565.7 Trade Associations 1585.7.1 Pharmaceutical Industry Association of South Africa 1585.7.2 Pharmaceutical Society of South Africa 1585.7.3 National Association of Pharmaceutical Manufacturers 1585.7.4 Hospital Association of South Africa 1585.8 Trade Fairs 1596 Opportunities and Challenges 1606.1 Opportunities 1606.2 Challenges 1617 Appendix 1637.1 Abbreviations 1637.2 Bibliography 1657.3 Methodology 1707.3.1 Coverage 1707.3.2 Secondary Research 1707.3.3 Forecasting 1717.3.4 Primary Research 1717.3.5 Expert Panel Validation 1717.4 Contact Us 1727.5 Disclaimer 1721.1 List of TablesTable 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2006-2011 11Table 2: Pharmaceutical Market, South Africa, Revenue Forecast ($bn), 2012-2020 12

Table 3: Price Margins of Distribution Channel (%), South Africa 14Table 4: Major Disease Areas, South Africa, Treated Patients (‘000), 2011 16Table 5: Major Products, Aspen, Global, 2011 18Table 6: Late-stage Pipeline, Aspen, 2012 19Table 7: Major Products, Adcock, Global, 2011 23Table 8: Major Products, Sanofi, Global, Revenue ($m), 2011 27Table 9: Late-stage Pipeline, Sanofi, 2012 28Table 10: Major Products, Novartis, Global, Revenue ($m), 2011 32Table 11: Planned Filings, Novartis, 2012 to = 2016 32Table 12: Major Products, Roche, Global, Revenue ($m), 2011 38Table 13: Planned Filings, Roche, Global, 2012-2016 39Table 14: Medical Device Market, South Africa, Revenue ($bn), 2006-2011 44Table 15: Medical Device Market, South Africa, Revenue Forecast ($bn), 2012-2020 45Table 16: Medical Device Market, South Africa, Segments, Revenue ($m), 2011 46Table 17: Ophthalmic Devices Market, South Africa, Revenue ($m), 2006-2011 47Table 18: Sales Trends for Major Players*, Ophthalmic Devices, South Africa, 2010 48Table 19: Orthopedic Devices Market, South Africa, Revenue ($m), 2006-2011 49Table 20: Sales Trends for Major Players*, Orthopedic Devices, South Africa, 2011 50Table 21: Nephrology and Urology Devices Market, South Africa, Revenue ($m), 2006-2011 51Table 22: Sales Trends for Major Players*, Nephrology and Urology Devices, South Africa, 201152Table 23: Cardiovascular Devices Market, South Africa, Revenue ($m), 2006-2011 53Table 24: Sales Trends for Major Players*, Cardiovascular Devices, South Africa, 2011 54Table 25: In Vitro Diagnostic Market, South Africa, Revenue ($m), 2006-2011 55Table 26: Sales Trends for Major Players*, In Vitro Diagnostic, South Africa, 2010 56Table 27: Major Medical Device Companies, South Africa, Revenue ($m), 2010 57Table 28: Major Products, Siemens, Global, Revenue ($m), 2010 58Table 29: Major Product Segments, Essilor International, Global, Revenue ($m), 2010 61Table 30: Major Products, Johnson & Johnson Vision Care, 2011 64Table 31: Major Products, Roche, Global, Revenue ($m), 2010 70Table 32: Late-stage Pipeline, Roche, 2012 71Table 33: Major Product Divisions, B. Braun, Global, Revenue ($m), 2011 74Table 34: Government Employees Medical Scheme, South Africa, 2012 83Table 35: Healthcare Spending, South Africa, Patients Share (%), 2005-2010 85Table 36: South Africa, Tiered Pricing System, 2010 86Table 37: GDP Per Capita ($), South Africa, 2006-2011 107Table 38: GDP Per Capita ($), South Africa, Forecast, 2012-2020 108Table 39: GDP, Annual Growth (%), South Africa, 2006-2011 109Table 40: GDP, Annual Growth (%), South Africa, Forecast, 2012-2020 110Table 41: GNI Per Capita ($), South Africa, 2006-2011 111Table 42: Average Consumer Price Index, South Africa, 2006-2011 112Table 43: Average Consumer Price Index, South Africa, Forecast, 2012-2020 113

Table 44: Average Consumer Price, South Africa, Annual Change (%), 2006-2011 114Table 45: Currency Exchange Rate (ZAR/$), South Africa, 2006-2011 115Table 46: Foreign Direct Investment ($bn), South Africa, 2006-2011 116Table 47: Foreign Exchange Reserves ($bn), South Africa, 2006-2011 117Table 48: Imports of Goods and Services ($bn), South Africa, 2006-2011 118Table 49: Exports of Goods and Services ($bn), South Africa, 2006-2011 119Table 50: General Government Structural Balance ($bn), South Africa, 2006-2011 120Table 51: General Government Net Debt ($bn), South Africa, 2006-2011 121Table 52: General Government Net Debt ($bn), South Africa, Forecast, 2012-2020 122Table 53: Major Industry Sectors, Percentage of GDP (%), South Africa, 2010 123Table 54: Population (m), South Africa, 2006-2011 124Table 55: Population (m), South Africa, Forecast, 2012-2020 125Table 56: Urban and Rural Population, South Africa, Share (%), 2005-2010 126Table 57: Age Groups, South Africa, Population Distribution (%), 2006-2011 127Table 58: Age Groups, South Africa, Population Distribution (%), Forecast, 2012-2020 128Table 59: Births (Per 1,000 Population), South Africa, 2006-2011 129Table 60: Births (Per 1,000 Population), South Africa, Forecast, 2012-2020 130Table 61: Mortality (Per 1,000 Population), South Africa, 2006-2011 131Table 62: Mortality (Per 1,000 Population), South Africa, Forecast, 2012-2020 132Table 63: Major Causes of Mortality (‘000), South Africa, 2008 133Table 64: Children Table 65: Immunization Rate (%), South Africa, 2005-2010 135Table 66: Major Causes of Male Mortality (‘000), South Africa, 2008 136Table 67: Major Causes of Female Mortality (‘000), South Africa, 2008 137Table 68: Gender Ratio (M/F), South Africa, 2006-2011 138Table 69: Life Expectancy at Birth (Years), South Africa, 2006-2011 139Table 70: Levels of Education, South Africa, Student Enrolment Share (%), 2005-2010 140Table 71: Education Components, South Africa, Expenditure Share (%), 2010 141Table 72: Unemployment Rate (%), South Africa, 2006-2011 142Table 73: Most Frequently Diagnosed Diseases (‘000), South Africa, 2011 143Table 74: Major Diseases, South Africa, DALY (Per 100,000 Population), 2004 144Table 75: Hospitals, South Africa, 2006-2011 145Table 76: Hospital Beds by Ownership, South Africa, 2011 146Table 77: Hospital Beds (Per 1,000 Population), South Africa, 2006-2011 147Table 78: Medical Practitioners (Per 100,000 Population), South Africa, 2006-2011 148Table 79: Healthcare Personnel, South Africa, 2011 149Table 80: Nurses (Per 100,000 Population), South Africa, 2006-2011 150Table 81: PM10 (µg/m3), South Africa, 2005-2010 151Table 82: CO2 Emissions (‘000 Tons), South Africa, 2005-2010 152Table 83: Healthcare Expenditure (% of GDP), South Africa, 2005-2010 153Table 84: Healthcare Expenditure, South Africa, Share of Major Components (%), 2011 154Table 85: Healthcare Expenditure, South Africa, Public-Private Share (%), 2005-2010 155Table 86: Medical and Health Sciences R&D Expenditure ($bn), South Africa, 2006-2011 156

Table 87: Medical and Health Sciences R&D Expenditure by Sector ($bn), South Africa, 2008 157Table 88: Major Healthcare Trade Fairs, South Africa, 2012 1591.2 List of FiguresFigure 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2006-2011 11Figure 2: Pharmaceutical Market, South Africa, Revenue Forecast ($bn), 2012-2020 12Figure 3: Pharmaceutical Supply Chain, South Africa, 2012 13Figure 4: Major Disease Areas, South Africa, Treated Patients (‘000), 2011 16Figure 5: Medical Device Market, South Africa, Revenue ($bn), 2006-2011 44Figure 6: Medical Device Market, South Africa, Revenue Forecast ($bn), 2012-2020 45Figure 7: Medical Device Market, South Africa, Segments, Revenue ($m), 2011 46Figure 8: Ophthalmic Devices Market, South Africa, Revenue ($m), 2006-2011 47Figure 9: Sales Trends for Major Players*, Ophthalmic Devices, South Africa, 2006-2010 48Figure 10: Orthopedic Devices Market, South Africa, Revenue ($m), 2006-2011 49Figure 11: Sales Trends for Major Players*, Orthopedic Devices, South Africa, 2006-2011 50Figure 12: Nephrology and Urology Devices Market, South Africa, Revenue ($m), 2006-2011 51Figure 13: Sales Trends for Major Players*, Nephrology and Urology Devices, South Africa, 2006-2011 52Figure 14: Cardiovascular Devices Market, South Africa, Revenue ($m), 2006-2011 53Figure 15: Sales Trends for Major Players*, Cardiovascular Devices, South Africa, 2006-2011 54Figure 16: In Vitro Diagnostic Market, South Africa, Revenue ($m), 2006-2011 55Figure 17: Sales Trends for Major Players*, In Vitro Diagnostic, South Africa, 2006-2010 56Figure 18: Major Medical Device Companies, South Africa, Revenue ($m), 2010 57Figure 19: Drivers and Barriers, Healthcare Market, South Africa, 2012 78Figure 20: Major Healthcare Financing Reforms, South Africa, 1994-2012 80Figure 21: Drug Reimbursement Process, South Africa, 2012 82Figure 22: Healthcare Spending, South Africa, Patients Share (%), 2005-2010 85Figure 23: Medicines Control Council Structure, 2012 88Figure 24: New Drug Approval Process, South Africa, 2012 91Figure 25: Patent Approval Process, South Africa, 2012 96Figure 26: Trademark Registration Process, South Africa, 2012 97Figure 27: GDP Per Capita ($), South Africa, 2006-2011 107Figure 28: GDP Per Capita ($), South Africa, Forecast, 2012-2020 108Figure 29: GDP, Annual Growth (%), South Africa, 2006-2011 109Figure 30: GDP, Annual Growth (%), South Africa, Forecast, 2012-2020 110Figure 31: GNI Per Capita ($), South Africa, 2006-2011 111Figure 32: Average Consumer Price Index, South Africa, 2006-2011 112Figure 33: Average Consumer Price Index, South Africa, Forecast, 2012-2020 113Figure 34: Average Consumer Price, South Africa, Annual Change (%), 2006-2011 114Figure 35: Currency Exchange Rate (ZAR/$), South Africa, 2006-2011 115Figure 36: Foreign Direct Investment ($bn), South Africa, 2006-2011 116Figure 37: Foreign Exchange Reserves ($bn), South Africa, 2006-2011 117

Figure 38: Imports of Goods and Services ($bn), South Africa, 2006-2011 118Figure 39: Exports of Goods and Services ($bn), South Africa, 2006-2011 119Figure 40: General Government Structural Balance ($bn), South Africa, 2006-2011 120Figure 41: General Government Net Debt ($bn), South Africa, 2006-2011 121Figure 42: General Government Net Debt ($bn), South Africa, Forecast, 2012-2020 122Figure 43: Major Industry Sectors, Percentage of GDP (%), South Africa, 2010 123Figure 44 Population (m), South Africa, 2006-2011 124Figure 45: Population (m), South Africa, Forecast, 2012-2020 125Figure 46: Urban and Rural Population, South Africa, Share (%), 2005-2010 126Figure 47: Age Groups, South Africa, Population Distribution (%), 2006-2011 127Figure 48: Age Groups, South Africa, Population Distribution (%), Forecast, 2012-2020 128Figure 49: Births (Per 1,000 Population), South Africa, 2006-2011 129Figure 50: Births (Per 1,000 Population), South Africa, Forecast, 2012-2020 130Figure 51: Mortality (Per 1,000 Population), South Africa, 2006-2011 131Figure 52: Mortality (Per 1,000 Population), South Africa, Forecast, 2012-2020 132Figure 53: Major Causes of Mortality (‘000), South Africa, 2008 133Figure 54: Children Figure 55: Immunization Rate (%), South Africa, 2005-2010 135Figure 56: Major Causes of Male Mortality (‘000), South Africa, 2008 136Figure 57: Major Causes of Female Mortality (‘000), South Africa, 2008 137Figure 58: Gender Ratio (M/F), South Africa, 2006-2011 138Figure 59: Life Expectancy at Birth (Years), South Africa, 2006-2011 139Figure 60: Levels of Education, South Africa, Student Enrolment Share (%), 2005-2010 140Figure 61: Education Components, South Africa, Expenditure Share (%), 2010 141Figure 62: Unemployment Rate (%), South Africa, 2006-2011 142Figure 63: Most Frequently Diagnosed Diseases (‘000), South Africa, 2011 143Figure 64: Major Diseases, South Africa, DALYs (Per 100,000 Population), 2004 144Figure 65: Hospitals, South Africa, 2006-2011 145Figure 66: Hospital Beds by Ownership, South Africa, 2011 146Figure 67: Hospital Beds (Per 1,000 Population), South Africa, 2006-2011 147Figure 68: Medical Practitioners (Per 100,000 Population), South Africa, 2006-2011 148Figure 69: Healthcare Personnel, South Africa, 2011 149Figure 70: Nurses (Per 100,000 Population), South Africa, 2006-2011 150Figure 71: PM10 (µg/m3), South Africa, 2005-2010 151Figure 72: CO2 Emissions (‘000 Tons), South Africa, 2005-2010 152Figure 73: Healthcare Expenditure (% of GDP), South Africa, 2005-2010 153Figure 74: Healthcare Expenditure, South Africa, Share of Major Components (%), 2011 154Figure 75: Healthcare Expenditure, South Africa, Public-Private Share (%), 2005-2010 155Figure 76: Medical and Health Sciences R&D Expenditure ($bn), South Africa, 2006-2011 156Figure 77: Medical and Health Sciences R&D Expenditure by Sector ($bn), South Africa, 2008 157Figure 78: Opportunities and Challenges, Healthcare Market, South Africa, 2012 162Contact: sales@reportsandreports.com for more information.

Healthcare, Regulatory and Reimbursement Landscape - South Africa

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