South Africa – CountryFocus: Healthcare, Regulatory and Reimbursement Landscape has recently announced the addition of a market study “ CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – South Africa , is a comparative analysis of the global market.

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 countrys 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 GlobalDatas team of industry experts.

The population of South Africa was approximately 53 million in 2013, having grown at a Compound Annual Growth Rate (CAGR) of 1.7% from 2008. In 2011, the government introduced the National Health Insurance (NHI) scheme, although it is still in the early stages of implementation and is not expected to be fully implemented until 2025. In 2013, the government spent $2.2 billion on R&D and exported approximately $198.1m of pharmaceuticals. The pharmaceutical market was worth approximately $2.5 billion in 2008, and is projected to reach approximately $5.6 billion by 2020 at a CAGR of 7.0%. The medical device market was valued at $1.6 billion in 2008 and is projected to grow at a CAGR of 4.1% to an estimated $2.6 billion in 2020. These positive growth trends can be primarily attributed to –

An increasingly elderly population

Government initiatives

Domestic business competitiveness


The report provides information on the healthcare, regulatory, and reimbursement landscape in South Africa, and includes –

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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, Sanofi, Pfizer and Roche; and profiles and SWOT analyses of the major players in the medical device market: Siemens Healthcare, Essilor, B. Braun, Roche, Covidien

Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the countrys healthcare reimbursement process, 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 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 South African healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect the South African 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 best opportunities for consolidation, investment, and strategic partnerships

Identify, understand, and capitalize on the opportunities and challenges in the South African healthcare market

Table of Contents

1 Table of Contents 6

1.1 List of Tables 10

1.2 List of Figures 14

2 Introduction 19

2.1 GlobalData Report Guidance 19

3 Overview of the Pharmaceutical and Medical Device Markets 20

3.1 Pharmaceutical Market 20

3.1.1 Market Overview 20

3.1.2 Pharmaceutical Exports and Imports 22

3.1.3 Supply Channels 24

3.1.4 Market Segments 26

3.1.5 Overview of Top Five Therapeutic Areas 32

3.1.6 Major Players 33

3.2 Medical Device Market 75

3.2.1 Market Overview 75

3.2.2 Overview of Top Five Segments 77

3.2.3 Diagnostic Market 91

3.2.4 Major Players 93

3.3 Market Drivers and Barriers 122

3.3.1 Drivers 122

3.3.2 Barriers 123

4 Market Access 125

4.1 Reimbursement and Payer Landscape 125

4.1.1 Overview of Healthcare System 125

4.1.2 Reimbursement Process 128

4.1.3 Overview of Insurance Providers 131

4.1.4 Patient Share in Healthcare Spending 133

4.1.5 Pricing Policies 134

4.2 Regulatory Landscape 135

4.2.1 Overview of Regulatory Agencies 135

4.2.2 Market Authorization Procedure for Medicines 137

4.2.3 Market Authorization Procedure for Medical Devices 141

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 143

4.2.5 Licensing Process for Pharmaceutical Exports and Imports 144

4.2.6 Intellectual Property Rights 147

4.2.7 Clinical Trial Regulations 152

4.2.8 Pharmaceutical Advertising Regulations 155

4.2.9 Pharmacy Regulations 156

4.2.10 Labeling and Packaging Regulations 158

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