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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Africa

Summary

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

The population of South Africa in 2015 was 54.96 million, having grown at a CAGR of 2% from 2008. In 2011, the government introduced the National Health Insurance (NHI) policy to promote the pharmaceutical market. To increase the growth rate of the pharmaceutical industry, the government also introduced the South African Health Products Regulatory Authority (SAHPRA). Through SAHPRA, the government aims to increase the pace of the drug approval process, while maintaining the highest possible quality standards.

In 2015, the government spent 0.59% of GDP in 2015 on R&D on medical and health science and exported $2.31 billion of pharmaceutical products. The pharmaceutical market in South Africa was worth $5.16 billion in 2015 and is projected to reach $7.28 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 7%. The medical device market was valued at $1.8 billion in 2015 and is projected to grow at a CAGR of 4.1% to $2.19 billion by 2020.

These positive growth trends can be primarily attributed to -
- An increasingly elderly population
- Universal health coverage
- Government initiatives

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in South Africa which 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: Aspen Pharmacare, Adcock Ingram, Pfizer, GSK and Roche; and profiles and SWOT analyses of the major players in the medical device market: Essilor International, Sirona Dental System, Paul Hartmann, Alcon and GSK
- 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 South African 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 South Africa’s healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact South Africa’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

Table Of Contents

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Africa
1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 13
2 Introduction 17
2.1 GlobalData Report Guidance 17
3 Overview of the Pharmaceutical and Medical Device Markets 18
3.1 Pharmaceutical Market 18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical Exports and Imports 21
3.1.3 Supply Channels 23
3.1.4 Market Segments 24
3.1.5 Overview of Top Five Therapeutic Areas 27
3.1.6 Major Players 30
3.2 Medical Device Market 71
3.2.1 Market Overview 71
3.2.2 Overview of Top Five Segments 74
3.2.3 Major Players 84
3.3 Market Drivers and Barriers 111
3.3.1 Drivers 111
3.3.2 Barriers 112
4 Market Access 114
4.1 Reimbursement and Payer Landscape 114
4.1.1 Overview of Healthcare System 114
4.1.2 Reimbursement Process 116
4.1.3 Overview of Insurance Providers 118
4.1.4 Patient Share in Healthcare Spending 120
4.1.5 Pricing Policies 121
4.2 Regulatory Landscape 122
4.2.1 Overview of Regulatory Agencies 122
4.2.2 Market Authorization Procedure for Medicines 124
4.2.3 Market Authorization Procedure for Medical Devices 127
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 129
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 131
4.2.6 Intellectual Property Rights 134
4.2.7 Clinical Trial Regulations 138
4.2.8 Pharmaceutical Advertising Regulations 140
4.2.9 Pharmacy Regulations 142
4.2.10 Labeling and Packaging Regulations 143
5 Country Analysis 148
5.1 Political Environment 148
5.1.1 Political Structure 148
5.1.2 Analysis of Current Political Environment 151
5.1.3 Healthcare Policy Initiatives 152
5.2 Economic Landscape 154
5.3 Economic Indicators 158
5.3.1 Gross Domestic Product 158
5.3.2 Gross National Income 161
5.3.3 Inflation 162
5.3.4 Currency Exchange Rate 165
5.3.5 Foreign Direct Investment 166
5.3.6 Foreign Exchange Reserves 167
5.3.7 Trade Balance 168
5.3.8 General Government Structural Balance 171
5.3.9 General Government Net Debt 172
5.3.10 Major Industries 174
5.4 Demographics 176
5.4.1 Population 176
5.4.2 Education and Literacy 193
5.4.3 Employment 195
5.4.4 Disease Burden 196
5.5 Healthcare Infrastructure 198
5.5.1 Healthcare Facilities 198
5.5.2 Healthcare Parameters 201
5.5.3 Environmental Health 206
5.5.4 Healthcare Personnel 208
5.6 Healthcare Expenditure 212
5.6.1 Overview 212
5.6.2 Major Components of Healthcare Spending 213
5.6.3 Public-Private Sector Share 214
5.6.4 Spending in Healthcare, Research and Development 215
5.7 Trade Associations 216
5.7.1 Innovative Pharmaceutical Association South Africa 216
5.7.2 Pharmaceutical Society of South Africa 216
5.7.3 National Association of Pharmaceutical Manufacturers 217
5.7.4 Hospitals Association of South Africa 217
5.8 Trade Fairs 218
6 Opportunities and Challenges 219
6.1 Opportunities 219
6.2 Challenges 220
7 Appendix 222
7.1 Abbreviations 222
7.2 Bibliography 224
7.3 Research Methodology 237
7.3.1 Coverage 237
7.3.2 Secondary Research 237
7.3.3 Forecasts 238
7.3.4 Expert Panel 238
7.4 Disclaimer 239

1.1 List of Tables
Table 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2008-2015 20
Table 2: Pharmaceutical Market, South Africa, Revenue ($bn), 2016-2020 21
Table 3: Pharmaceutical Market, South Africa, Pharmaceutical Exports and Imports ($bn), 2008-2015 23
Table 4: Pharmaceutical Market, South Africa, Top Therapeutic Areas by Prevalence Rate (per 1,000), 2015 28
Table 5: Pharmaceutical Market, Aspen, Global, Major Products, 2016 31
Table 6: Pharmaceutical Market, South Africa, Major Products, Adcock Ingram, 2015 37
Table 7: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016 46
Table 8: GlaxoSmithKline, Global, Major Products Revenue ($m) and Annual Growth (%), 2015 55
Table 9: Pharmaceutical Market, GlaxoSmithKline, Late-Stage Pipeline, 2016 56
Table 10: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($m) and Annual Growth (%), 2016 63
Table 11: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2016 64
Table 12: Medical Device Market, South Africa, Revenue ($bn), 2008-2015 72
Table 13: Medical Device Market, South Africa, Revenue ($bn), 2016-2020 73
Table 14: Medical Device Market, South Africa, Revenue ($m) and Market Share (%) by Segment, 2015 74
Table 15: Ophthalmic Devices, South Africa, Revenue ($m), 2008-2015 75
Table 16: Ophthalmic Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 76
Table 17: Orthopedic Devices, South Africa, Revenue ($m), 2008-2015 77
Table 18: Orthopedic Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2015 78
Table 19: Cardiovascular Devices, South Africa, Revenue ($m), 2008-2015 79
Table 20: Cardiovascular Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2015 80
Table 21: Nephrology and Urology Devices, South Africa, Revenue ($m), 2008-2015 81
Table 22: Nephrology and Urology Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 82
Table 23: ENT Device Market, South Africa, Revenue ($m), 2008-2015 83
Table 24: ENT Device Market, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 84
Table 25: Medical Device Market, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 85
Table 26: Major Products, Alcon, Major Products, 2015 102
Table 27: Healthcare System, South Africa Government Employees Medical Scheme, 2016 119
Table 28: Healthcare Spending, South Africa, Patient Share in Healthcare Spending (%), 2008-2015 121
Table 29: Pricing Policies, South Africa, Pharmacist Markup Overview, 2010 122
Table 30: Economic Indicators, South Africa, Gross Domestic Product per Capita ($), 2008-2015 159
Table 31: Economic Indicators, South Africa, Gross Domestic Product per Capita ($), 2016-2020 159
Table 32: Economic Indicators, South Africa, Gross Domestic Product Annual Growth (%), 2008-2015 160
Table 33: Economic Indicators, South Africa, Gross Domestic Product Annual Growth (%), 2016-2020 161
Table 34: Economic Indicators, South Africa, Gross National Income per Capita ($), 2008-2015 162
Table 35: Economic Indicators, South Africa, Average Consumer Price Index, 2008-2015 163
Table 36: Economic Indicators, South Africa, Average Consumer Price Index, 2016-2020 164
Table 37: Economic Indicators, South Africa, Average Consumer Price Annual Change (%), 2008-2015 165
Table 38: Economic Indicators, South Africa, Currency Exchange Rate (ZAR/$), 2008-2015 166
Table 39: Economic Indicators, South Africa, Foreign Direct Investment ($bn), 2008-2015 167
Table 40: Economic Indicators, South Africa, Foreign Exchange Reserves ($bn), 2008-2015 168
Table 41: Economic Indicators, South Africa, Imports of Goods and Services ($bn), 2008-2015 169
Table 42: Economic Indicators, South Africa, Exports of Goods and Services ($bn), 2008-2015 171
Table 43: Economic Indicators, South Africa, Government Structural Balance ($bn), 2008-2015 172
Table 44: Economic Indicators, South Africa, General Government Net Debt as Percentage of GDP (%), 2008-2015 173
Table 45: Economic Indicators, South Africa, General Government Net Debt as Percentage of GDP (%), 2016-2020 174
Table 46: Economic Indicators, South Africa, Major Industries by Contribution to GDP, 2015 175
Table 47: Demographics, South Africa, Population (million), 2008-2015 176
Table 48: Demographics, South Africa, Population (million), 2016-2020 177
Table 49: Demographics, South Africa, Urban-Rural Population Share (%), 2008-2015 178
Table 50: Demographics, South Africa, Urban-Rural Population Share (%), 2016-2020 179
Table 51: Demographics, South Africa, Population Distribution by Age Group (%), 2008-2015 180
Table 52: Demographics, South Africa, Population Distribution by Age Group (%), 2016-2020 181
Table 53: Demographics, South Africa, Births (per 1,000 population), 2008-2015 182
Table 54: Demographics, South Africa, Mortality (per 1,000 population), 2008-2015 183
Table 55: Demographics, South Africa, Leading Causes of Mortality, 2014 184
Table 56: Demographics, South Africa, Children under Five, Mortality Rate (%), 2008-2015 185
Table 57: Demographics, South Africa, Immunization Rate (%), 2012 187
Table 58: Demographics, South Africa, Major Causes of Male Mortality (%), 2014 189
Table 59: Demographics, South Africa, Major Causes of Female Mortality (%), 2014 190
Table 60: Demographics, South Africa, Gender Ratio (M/F), 2008-2015 191
Table 61: Demographics, South Africa, Life Expectancy at Birth (years), 2008-2015 192
Table 62: Demographics, South Africa, Enrollments by Level of Education (million), 2013-2014 195
Table 63: Demographics, South Africa, Unemployment Rate (%), 2008-2015 196
Table 64: Demographics, South Africa, Disability-Adjusted Life Years by Disease ('000), 2012 197
Table 65: Healthcare Infrastructure, South Africa, Number of Hospitals, 2008-2015 198
Table 66: Healthcare Infrastructure, South Africa, Hospital Establishments, 2008-2015 199
Table 67: Healthcare Infrastructure, South Africa, Public Hospitals, 2008-2015 201
Table 68: Healthcare Infrastructure, South Africa, Hospital Beds (per 1,000 population), 2008-2015 202
Table 69: Healthcare Infrastructure, South Africa, Hospital Beds by Sector, 2008-2015 203
Table 70: Healthcare Infrastructure, South Africa, Public Hospital Beds, 2008-2015 204
Table 71: Healthcare Infrastructure, South Africa, Doctors (per 1,000 population), 2008-2015 205
Table 72: Healthcare Infrastructure, South Africa, PM2.5 (µg/m3), 2008-2015 207
Table 73: Healthcare Infrastructure, South Africa, CO2 Emissions (metric tons per capita), 2008-2015 208
Table 74: Healthcare Infrastructure, South Africa, Nurses (per 1,000 population), 2008-2015 209
Table 75: Healthcare Infrastructure, South Africa, Pharmacists (per 100,000 population), 2008-2015 210
Table 76: Healthcare Infrastructure, South Africa, Dentists (per 100,000 population), 2008-2015 211
Table 77: Healthcare Expenditure, South Africa, Healthcare Expenditure as Percentage of GDP (%), 2008-2015 212
Table 78: Healthcare Expenditure, South Africa, Primary Healthcare Expenditure, Current Health Expenditure by Program (%), 2014-2015 213
Table 79: Healthcare Expenditure, South Africa, Public-Private Share (%), 2008-2015 215
Table 80: Healthcare Expenditure, South Africa, Gross Domestic Expenditure on RandD as Percentage of GDP (%), 2008-2015 216
Table 81: Healthcare Expenditure, South Africa, Major Healthcare Trade Fairs, 2017 218

1.2 List of Figures
Figure 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2008-2015 20
Figure 2: Pharmaceutical Market, South Africa, Revenue ($bn), 2016-2020 21
Figure 3: Pharmaceutical Market, South Africa, Pharmaceutical Exports and Imports ($bn), 2008-2015 22
Figure 4: Pharmaceutical Market, South Africa, Supply Chain, 2016 23
Figure 5: Pharmaceutical Market, South Africa, Top Therapeutic Areas by Prevalence Rate (per 1,000), 2015 28
Figure 6: Medical Device Market, South Africa, Revenue ($bn), 2008-2015 72
Figure 7: Medical Device Market, South Africa, Revenue ($bn), 2016-2020 73
Figure 8: Medical Device Market, South Africa, Revenue by Segment ($m), 2015 74
Figure 9: Ophthalmic Devices, South Africa, Revenue ($m), 2008-2015 75
Figure 10: Ophthalmic Devices, South Africa, Market Share (%) of Major Players, 2012 76
Figure 11: Orthopedic Devices, South Africa, Revenue ($m), 2008-2015 77
Figure 12: Orthopedic Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2015 78
Figure 13: Cardiovascular Devices, South Africa, Revenue ($m), 2008-2015 79
Figure 14: Cardiovascular Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2015 80
Figure 15: Nephrology and Urology Devices, South Africa, Revenue ($m), 2008-2015 81
Figure 16: Nephrology and Urology Devices, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 82
Figure 17: ENT Device Market, South Africa, Revenue ($m), 2008-2015 83
Figure 18: ENT Device Market, South Africa, Revenue ($m) and Market Share (%) of Major Players, 2012 84
Figure 19: Medical Device Market, South Africa, Revenue of Major Players ($m), 2012 85
Figure 20: Healthcare Market, South Africa, Drivers and Barriers, 2016 113
Figure 21: Healthcare System, South Africa, Major Healthcare Financing Reforms, 1994-2016 115
Figure 22: Healthcare System, South Africa, Process of Addition to Essential Drugs List, 2016 118
Figure 23: Healthcare Spending, South Africa, Patient Share in Healthcare Spending (%), 2008-2015 121
Figure 24: Regulatory Landscape, South Africa, Medicines Control Council Structure, 2016 123
Figure 25: Regulatory Landscape, South Africa, New Drug Approval Process, 2015 127
Figure 26: Market Access, South Africa, Patent Approval Process, 2016 136
Figure 27: Market Access, South Africa, Trademark Registration Process, 2016 137
Figure 28: Economic Indicators, South Africa, Gross Domestic Product per Capita ($), 2008-2015 158
Figure 29: Economic Indicators, South Africa, Gross Domestic Product per Capita ($), 2016-2020 159
Figure 30: Economic Indicators, South Africa, Gross Domestic Product Annual Growth (%), 2008-2015 160
Figure 31: Economic Indicators, South Africa, Gross Domestic Product Annual Growth (%), 2016-2020 161
Figure 32: Economic Indicators, South Africa, Gross National Income per Capita ($), 2008-2015 162
Figure 33: Economic Indicators, South Africa, Average Consumer Price Index, 2008-2015 163
Figure 34: Economic Indicators, South Africa, Average Consumer Price Index, 2016-2020 164
Figure 35: Economic Indicators, South Africa, Average Consumer Price Annual Change (%), 2008-2015 165
Figure 36: Economic Indicators, South Africa, Currency Exchange Rate (ZAR/$), 2008-2015 166
Figure 37: Economic Indicators, South Africa, Foreign Direct Investment ($bn), 2008-2015 167
Figure 38: Economic Indicators, South Africa, Foreign Exchange Reserves ($bn), 2008-2015 168
Figure 39: Economic Indicators, South Africa, Imports of Goods and Services ($bn), 2008-2015 169
Figure 40: Economic Indicators, South Africa, Exports of Goods and Services ($bn), 2008-2015 170
Figure 41: Economic Indicators, South Africa, Government Structural Balance ($bn), 2008-2015 172
Figure 42: Economic Indicators, South Africa, General Government Net Debt as Percentage of GDP (%), 2008-2015 173
Figure 43: Economic Indicators, South Africa, General Government Net Debt as Percentage of GDP (%), 2016-2020 174
Figure 44: Economic Indicators, South Africa, Major Industries by Contribution to GDP, 2015 175
Figure 45: Demographics, South Africa, Population (million), 2008-2015 176
Figure 46: Demographics, South Africa, Population (million), 2016-2020 177
Figure 47: Demographics, South Africa, Urban-Rural Population Share (%), 2008-2015 178
Figure 48: Demographics, South Africa, Urban-Rural Population Share (%), 2016-2020 179
Figure 49: Demographics, South Africa, Population Distribution by Age Group (%), 2008-2015 180
Figure 50: Demographics, South Africa, Population Distribution by Age Group (%), 2016-2020 181
Figure 51: Demographics, South Africa, Births (per 1,000 population), 2008-2015 182
Figure 52: Demographics, South Africa, Mortality (per 1,000 population), 2008-2015 183
Figure 53: Demographics, South Africa, Major Causes of Mortality, 2014 184
Figure 54: Demographics, South Africa, Children under Five, Mortality Rate (%), 2008-2015 185
Figure 55: Demographics, South Africa, Immunization Rate (%), 2012 187
Figure 56: Demographics, South Africa, Major Causes of Male Mortality (%), 2014 188
Figure 57: Demographics, South Africa, Major Causes of Female Mortality (%), 2014 189
Figure 58: Demographics, South Africa, Gender Ratio (M/F), 2008-2015 191
Figure 59: Demographics, South Africa, Life Expectancy at Birth (years), 2008-2015 192
Figure 60: Demographics, South Africa, Enrollment by Level of Education (million), 2013-2014 194
Figure 61: Demographics, South Africa, Unemployment Rate (%), 2008-2015 195
Figure 62: Demographics, South Africa, Disability-Adjusted Life Years by Disease ('000), 2012 197
Figure 63: Healthcare Infrastructure, South Africa, Number of Hospitals, 2008-2015 198
Figure 64: Healthcare Infrastructure, South Africa, Hospital Establishments, 2008-2015 199
Figure 65: Healthcare Infrastructure, South Africa, Public Hospitals, 2008-2015 200
Figure 66: Healthcare Infrastructure, South Africa, Hospital Beds (per 1,000 population), 2008-2015 202
Figure 67: Healthcare Infrastructure, South Africa, Hospital Beds by Sector, 2008-2015 203
Figure 68: Healthcare Infrastructure, South Africa, Public Hospital Beds, 2008-2015 204
Figure 69: Healthcare Infrastructure, South Africa, Doctors (per 1,000 population), 2008-2015 205
Figure 70: Healthcare Infrastructure, South Africa, PM2.5 (µg/m3), 2008-2015 207
Figure 71: Healthcare Infrastructure, South Africa, CO2 Emissions (metric tons per capita), 2008-2015 208
Figure 72: Healthcare Infrastructure, South Africa, Nurses (per 1,000 population), 2008-2015 209
Figure 73: Healthcare Infrastructure, South Africa, Pharmacists (per 100,000 population), 2008-2015 210
Figure 74: Healthcare Infrastructure, South Africa, Dentists (per 100,000 population), 2008-2015 211
Figure 75: Healthcare Expenditure, South Africa, Healthcare Expenditure as Percentage of GDP (%), 2008-2015 212
Figure 76: Healthcare Expenditure, South Africa, Primary Healthcare Expenditure by Program (%), 2014-2015 213
Figure 77: Healthcare Expenditure, South Africa, Healthcare Expenditure as Percentage of GDP by Sector (%), 2008-2015 214
Figure 78: Healthcare Expenditure, South Africa, Gross Domestic Expenditure on RandD as Percentage of GDP (%), 2008-2015 215
Figure 79: Healthcare Market, South Africa, Opportunities and Challenges, 2016 221

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