1. Healthcare, Regulatory and Reimbursement Landscape - South
Africa
Report Details:
Published:December 2012
No. of Pages: 172
Price: Single User License – US$1995
Healthcare, Regulatory and Reimbursement Landscape - South Africa
Summary
GlobalData, the industry analysis specialist, has released its new report, “Healthcare, Regulatory
and Reimbursement Landscape - South Africa”. An essential source of information and analysis
on the South African healthcare, regulatory and reimbursement landscape, this report identifies
the 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 the
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.
In 2011, South Africa’s population was 50.5 million, largely due to a positive balance between the
birth rate and mortality rate. The mortality rate is decreasing due to South Africa’s improving
healthcare infrastructure and medical and diagnostic services. The pharmaceutical market was
estimated at $2.5 billion in 2011 and is expected to reach $4.2 billion by 2020 at a projected
CAGR of 5.8%. The medical device market was worth approximately $1.9 billion in 2011 and is
expected 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 medicines
Scope

2. The report provides information on South Africa’s healthcare, regulatory and reimbursement
landscape, including -
- Overview of the pharmaceutical and medical device markets, including size, segmentation, and
key drivers and barriers.
- Profiles and SWOT analyses of the major players in the pharmaceutical and medical device
markets. 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 are
Siemens Healthcare, Essilor International, Johnson & Johnson, F. Hoffmann-La Roche, and B
Braun Melsungen.
- Insightful review of the reimbursement and regulatory landscape, with details of the
reimbursement process, regulatory agencies and market authorization processes for new drug
and medical devices.
- Detailed analysis of South Africa’s political and economic environment, including economic
indicators, demographics, healthcare infrastructure and healthcare expenditure.
- An overview of the opportunities for and challenges to growth in the healthcare market.
Reasons to buy
The report will enhance your decision-making capability and allow you to -
- Develop business strategies by understanding the trends shaping and driving the healthcare
market.
- Drive revenues by understanding the key trends, reimbursement and regulatory policies,
pharmaceutical and medical devices 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 partnerships
- Identify, understand and capitalize on the opportunities and challenges in the healthcare market
Get your copy of this report @
http://www.reportsnreports.com/reports/213160-healthcare-regulatory-and-reimbursement-landscape-south-
africa.html
Major points covered in Table of Contents of this report include
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 9
2.1 Report Guidance 9
3 Overview of the Pharmaceutical and Medical Device Market 10
3.1 Pharmaceutical Market 10

3. 3.1.1 Supply Channels 13
3.1.2 Market Segments 14
3.1.3 Major Disease Areas 16
3.1.4 Major Players 18
3.2 Medical Device Market 43
3.2.1 Market Overview 43
3.2.2 Overview of the Top Five Segments 46
3.2.3 Major Players 57
3.3 Market Drivers and Barriers 77
3.3.1 Drivers 77
3.3.2 Barriers 78
4 Market Access 79
4.1 Reimbursement and Payers Landscape 79
4.1.1 Healthcare System Overview 79
4.1.2 Reimbursement Process 81
4.1.3 Overview of Insurance Providers 83
4.1.4 Patient Share in Healthcare Spending 85
4.1.5 Pricing Policies 86
4.2 Regulatory Landscape 87
4.2.1 Overview of Regulatory Agencies 87
4.2.2 New Drug Approval Process 89
4.2.3 New Medical Device Approval Process 92
4.2.4 Licensing Process for Pharmaceutical Manufacturing 93
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 93
4.2.6 Intellectual Property Rights 95
4.2.7 Clinical Trial Regulations 98
4.2.8 Pharmaceutical Advertising Regulations 99
4.2.9 Pharmacy Regulations 100
4.2.10 Labeling and Packaging Regulations 101
5 Country Analysis 104
5.1 Political Environment 104
5.1.1 Political Structure 104
5.1.2 Analysis of Current Political Environment 105
5.1.3 Healthcare Policy Initiatives 105
5.2 Economic Landscape 106
5.3 Economic Indicators 107
5.3.1 Gross Domestic Product 107
5.3.2 Gross National Income 111
5.3.3 Inflation 112
5.3.4 Currency Exchange Rate 115
5.3.5 Foreign Direct Investment 116
5.3.6 Foreign Exchange Reserves 117

4. 5.3.7 Trade Balance 118
5.3.8 Government Structural Balance 120
5.3.9 Government Net Debt 121
5.3.10 Major Industries 123
5.4 Demography 124
5.4.1 Population 124
5.4.2 Education and Literacy 140
5.4.3 Employment 142
5.4.4 Disease Burden 143
5.5 Healthcare Infrastructure 145
5.5.1 Healthcare Facilities 145
5.5.2 Healthcare Parameters 147
5.5.3 Healthcare Personnel 149
5.5.4 Environmental Health 151
5.6 Healthcare Expenditure 153
5.6.1 Major Components of Healthcare Spending 154
5.6.2 Share of Public and Private Sector in Healthcare 155
5.6.3 Spending in Pharmaceutical R&D 156
5.7 Trade Associations 158
5.7.1 Pharmaceutical Industry Association of South Africa 158
5.7.2 Pharmaceutical Society of South Africa 158
5.7.3 National Association of Pharmaceutical Manufacturers 158
5.7.4 Hospital Association of South Africa 158
5.8 Trade Fairs 159
6 Opportunities and Challenges 160
6.1 Opportunities 160
6.2 Challenges 161
7 Appendix 163
7.1 Abbreviations 163
7.2 Bibliography 165
7.3 Methodology 170
7.3.1 Coverage 170
7.3.2 Secondary Research 170
7.3.3 Forecasting 171
7.3.4 Primary Research 171
7.3.5 Expert Panel Validation 171
7.4 Contact Us 172
7.5 Disclaimer 172
1.1 List of Tables
Table 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2006-2011 11
Table 2: Pharmaceutical Market, South Africa, Revenue Forecast ($bn), 2012-2020 12

5. Table 3: Price Margins of Distribution Channel (%), South Africa 14
Table 4: Major Disease Areas, South Africa, Treated Patients (‘000), 2011 16
Table 5: Major Products, Aspen, Global, 2011 18
Table 6: Late-stage Pipeline, Aspen, 2012 19
Table 7: Major Products, Adcock, Global, 2011 23
Table 8: Major Products, Sanofi, Global, Revenue ($m), 2011 27
Table 9: Late-stage Pipeline, Sanofi, 2012 28
Table 10: Major Products, Novartis, Global, Revenue ($m), 2011 32
Table 11: Planned Filings, Novartis, 2012 to = 2016 32
Table 12: Major Products, Roche, Global, Revenue ($m), 2011 38
Table 13: Planned Filings, Roche, Global, 2012-2016 39
Table 14: Medical Device Market, South Africa, Revenue ($bn), 2006-2011 44
Table 15: Medical Device Market, South Africa, Revenue Forecast ($bn), 2012-2020 45
Table 16: Medical Device Market, South Africa, Segments, Revenue ($m), 2011 46
Table 17: Ophthalmic Devices Market, South Africa, Revenue ($m), 2006-2011 47
Table 18: Sales Trends for Major Players*, Ophthalmic Devices, South Africa, 2010 48
Table 19: Orthopedic Devices Market, South Africa, Revenue ($m), 2006-2011 49
Table 20: Sales Trends for Major Players*, Orthopedic Devices, South Africa, 2011 50
Table 21: Nephrology and Urology Devices Market, South Africa, Revenue ($m), 2006-2011 51
Table 22: Sales Trends for Major Players*, Nephrology and Urology Devices, South Africa, 2011
52
Table 23: Cardiovascular Devices Market, South Africa, Revenue ($m), 2006-2011 53
Table 24: Sales Trends for Major Players*, Cardiovascular Devices, South Africa, 2011 54
Table 25: In Vitro Diagnostic Market, South Africa, Revenue ($m), 2006-2011 55
Table 26: Sales Trends for Major Players*, In Vitro Diagnostic, South Africa, 2010 56
Table 27: Major Medical Device Companies, South Africa, Revenue ($m), 2010 57
Table 28: Major Products, Siemens, Global, Revenue ($m), 2010 58
Table 29: Major Product Segments, Essilor International, Global, Revenue ($m), 2010 61
Table 30: Major Products, Johnson & Johnson Vision Care, 2011 64
Table 31: Major Products, Roche, Global, Revenue ($m), 2010 70
Table 32: Late-stage Pipeline, Roche, 2012 71
Table 33: Major Product Divisions, B. Braun, Global, Revenue ($m), 2011 74
Table 34: Government Employees Medical Scheme, South Africa, 2012 83
Table 35: Healthcare Spending, South Africa, Patient''s Share (%), 2005-2010 85
Table 36: South Africa, Tiered Pricing System, 2010 86
Table 37: GDP Per Capita ($), South Africa, 2006-2011 107
Table 38: GDP Per Capita ($), South Africa, Forecast, 2012-2020 108
Table 39: GDP, Annual Growth (%), South Africa, 2006-2011 109
Table 40: GDP, Annual Growth (%), South Africa, Forecast, 2012-2020 110
Table 41: GNI Per Capita ($), South Africa, 2006-2011 111
Table 42: Average Consumer Price Index, South Africa, 2006-2011 112
Table 43: Average Consumer Price Index, South Africa, Forecast, 2012-2020 113

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

7. Table 87: Medical and Health Sciences R&D Expenditure by Sector ($bn), South Africa, 2008 157
Table 88: Major Healthcare Trade Fairs, South Africa, 2012 159
1.2 List of Figures
Figure 1: Pharmaceutical Market, South Africa, Revenue ($bn), 2006-2011 11
Figure 2: Pharmaceutical Market, South Africa, Revenue Forecast ($bn), 2012-2020 12
Figure 3: Pharmaceutical Supply Chain, South Africa, 2012 13
Figure 4: Major Disease Areas, South Africa, Treated Patients (‘000), 2011 16
Figure 5: Medical Device Market, South Africa, Revenue ($bn), 2006-2011 44
Figure 6: Medical Device Market, South Africa, Revenue Forecast ($bn), 2012-2020 45
Figure 7: Medical Device Market, South Africa, Segments, Revenue ($m), 2011 46
Figure 8: Ophthalmic Devices Market, South Africa, Revenue ($m), 2006-2011 47
Figure 9: Sales Trends for Major Players*, Ophthalmic Devices, South Africa, 2006-2010 48
Figure 10: Orthopedic Devices Market, South Africa, Revenue ($m), 2006-2011 49
Figure 11: Sales Trends for Major Players*, Orthopedic Devices, South Africa, 2006-2011 50
Figure 12: Nephrology and Urology Devices Market, South Africa, Revenue ($m), 2006-2011 51
Figure 13: Sales Trends for Major Players*, Nephrology and Urology Devices, South Africa, 2006-
2011 52
Figure 14: Cardiovascular Devices Market, South Africa, Revenue ($m), 2006-2011 53
Figure 15: Sales Trends for Major Players*, Cardiovascular Devices, South Africa, 2006-2011 54
Figure 16: In Vitro Diagnostic Market, South Africa, Revenue ($m), 2006-2011 55
Figure 17: Sales Trends for Major Players*, In Vitro Diagnostic, South Africa, 2006-2010 56
Figure 18: Major Medical Device Companies, South Africa, Revenue ($m), 2010 57
Figure 19: Drivers and Barriers, Healthcare Market, South Africa, 2012 78
Figure 20: Major Healthcare Financing Reforms, South Africa, 1994-2012 80
Figure 21: Drug Reimbursement Process, South Africa, 2012 82
Figure 22: Healthcare Spending, South Africa, Patient''s Share (%), 2005-2010 85
Figure 23: Medicines Control Council Structure, 2012 88
Figure 24: New Drug Approval Process, South Africa, 2012 91
Figure 25: Patent Approval Process, South Africa, 2012 96
Figure 26: Trademark Registration Process, South Africa, 2012 97
Figure 27: GDP Per Capita ($), South Africa, 2006-2011 107
Figure 28: GDP Per Capita ($), South Africa, Forecast, 2012-2020 108
Figure 29: GDP, Annual Growth (%), South Africa, 2006-2011 109
Figure 30: GDP, Annual Growth (%), South Africa, Forecast, 2012-2020 110
Figure 31: GNI Per Capita ($), South Africa, 2006-2011 111
Figure 32: Average Consumer Price Index, South Africa, 2006-2011 112
Figure 33: Average Consumer Price Index, South Africa, Forecast, 2012-2020 113
Figure 34: Average Consumer Price, South Africa, Annual Change (%), 2006-2011 114
Figure 35: Currency Exchange Rate (ZAR/$), South Africa, 2006-2011 115
Figure 36: Foreign Direct Investment ($bn), South Africa, 2006-2011 116
Figure 37: Foreign Exchange Reserves ($bn), South Africa, 2006-2011 117

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