Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process

• Publication date: June 2012
• Report size: 74 pages

Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process Summary GBI Research’s new report, “Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process” provides in-depth analysis of the trends, issues and challenges in S...

Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process



Summary



GBI Research’s new report, “Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process” provides in-depth analysis of the trends, issues and challenges in South Africa’s pharmaceutical market. The report analyzes the overall pharmaceutical and outsourcing market structure, and provides competitive benchmarking for leading companies. It also analyzes the M&A and strategic partnerships that are shaping the pharmaceutical market. The report is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis by GBI Research’s team of industry experts.

South Africa’s pharmaceutical market is one of the most attractive markets in Africa. Some of the main reasons for its rapid growth are the availability of cost-effective and skilled labor, high quality infrastructure, and the introduction of the South African Health Products Regulatory Authority (SAHPRA). Most of the local drug manufacturers and distributors are in the hands of big international pharmaceutical firms. GBI Research valued the South African pharmaceutical market at $3.8 billion in 2011, and expects it to reach $7 billion in 2018 at a Compound Annual Growth Rate (CAGR) of 9.2%. South Africa’s healthcare sector is set to witness a number of new healthcare reform plans in the future, with the primary objective being to reduce the growing drug expenditure by increasing the use of generics. The healthcare system aims to cover the entire population under the National Health Insurance (NHI) scheme, which it will start implementing in a small population of 10 districts by 2012.

GBI Research’s analysis shows that generics accounted for over 60% of the volume of the pharmaceutical market in 2011. Government reforms have encouraged the manufacture and use of generic drugs as a tool to limit drug expenditure and provide low-cost effective public healthcare. The combination of government healthcare policies and numerous active generic manufacturing companies points to an increased generic market share in the forecast period.



Scope


- Overall pharmaceutical and outsourcing market structure in South Africa
- Market characterization, including market size, major regulatory bodies, pricing and reimbursement issues, major distribution channels, and intellectual property rights
- Contract Research Organization (CRO) market growth
- Analysis of the leading segments within the South African pharmaceutical industry
- Key drivers and restraints impacting the market
- Competitive benchmarking of leading companies in the pharmaceutical and CRO markets in South Africa
- Key M&A activities and strategic partnership deals that took place between 2009 and mid-2011



Reasons to buy


- Develop market-entry and market expansion strategies by identifying the leading emerging markets poised for strong growth
- Devise a more tailored country strategy through the understanding of key drivers of and barriers to South Africa’s pharmaceutical market
- Develop key strategic initiatives by understanding the key focus areas of leading companies
- Accelerate and strengthen your market position by identifying key companies for M&A and strategic partnerships

Pharmaceutical Industry in South Africa

Table of Contents
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
3 Emerging Pharmaceutical Market: South Africa – Industry Characteristics 11
3.1 Pharmaceutical Market Size and Growth in South Africa 11
3.2 Environmental Disease Burden 12
3.2.1 HIV/AIDS 15
3.2.2 Tuberculosis 17
3.3 Patented and Generic Drugs Market Share 18
3.4 Imports and Exports 20
3.4.1 Imports 20
3.4.2 Exports 21
3.4.3 Balance of Trade 22
3.5 Key Domestic Players in South Africa 23
3.5.1 Aspen Pharmacare 23
3.5.2 Adcock Ingram 24
3.5.3 Cipla Medpro 25
3.6 Key Foreign Players in South Africa 26
3.6.1 Sanofi 26
3.6.2 Pfizer 27
3.6.3 Roche 28
3.6.4 Ranbaxy 29
3.6.5 GlaxoSmithKline 30
3.6.6 Merck & Co 31
3.6.7 Novartis 32
3.7 Market Drivers and Restraints 33
3.7.1 Drivers 33
3.7.2 Restraints 34
3.8 PESTLE Analysis 36
4 Emerging Pharmaceutical Market: South Africa – Macroeconomic Environment 37
4.1 Demographic Analysis 37
4.1.1 Introduction 37
4.1.2 Population Size, Growth and Structure 38
4.1.3 Changes in Life Expectancy at Birth 39
4.1.4 Infant Mortality Rate 40
4.1.5 Rural/Urban Distribution 41
4.1.6 Population by Gender 42
4.2 Gross Domestic Product 42
4.3 Healthcare Expenditure 43
4.4 Healthcare System 46
4.4.1 Health Workforce and Infrastructure in South Africa 46
5 Emerging Pharmaceutical Market: South Africa – Healthcare Regulation 52
5.1 Pharmaceutical Regulation in South Africa 52
5.2 Intellectual Property Rights 53
5.3 Health Insurance Coverage 53
5.4 Pricing and Reimbursement 54
5.4.1 Pricing 54
5.4.2 Reimbursement 55
5.5 Clinical Trials 55
6 Emerging Pharmaceutical Market: South Africa – Industry Trends 57
6.1 Strategic Consolidations 57
6.2 Mergers and Acquisitions 59
6.2.1 Deals by Year 59
6.2.2 Deals by Type 60
6.2.3 Deals by Value 61
6.2.4 Top M&A Deals 62
6.3 Licensing Agreements 63
6.3.1 Top Licensing Deals 63
7 Emerging Pharmaceutical Market: South Africa – Contract Research Organization Industry 64
7.1 Contract Research Organizations 64
7.2 Key International Contract Research Organization Players in South Africa 64
7.2.1 Quintiles 64
7.2.2 Pharmaceutical Product Development 65
7.2.3 Inc Research 66
7.2.4 Parexel 67
7.2.5 Icon plc. 68
7.2.6 PRA International 69
7.3 Key Domestic Contract Research Organization Players in South Africa 70
7.3.1 African Clinical Research Organization 70
7.3.2 OnQ 71
8 Emerging Pharmaceutical Market: South Africa - Appendix 72
8.1 Market Definitions 72
8.2 Abbreviations 72
8.3 Sources 73
8.4 Research Methodology 73
8.4.1 Industry Performance 73
8.4.2 Macroeconomic Environment 73
8.4.3 Healthcare Regulations 74
8.4.4 Industry Trends 74
8.5 Contact Us 74
8.6 Disclaimer 74



List of Tables

Table 1: Emerging Pharmaceutical Market: South Africa, Market Forecast, 2007–2018 11
Table 2: Emerging Pharmaceutical Market: South Africa, Causes of Death, 2008 13
Table 3: Emerging Pharmaceutical Market: South Africa, Causes of Death due to Infectious Diseases, 2008 14
Table 4: Emerging Pharmaceutical Market: South Africa, HIV/AIDS Population (million), (%), 2001–2011 15
Table 5: Emerging Pharmaceutical Market: South Africa, Tuberculosis Population, 2001–2011 17
Table 6: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Imports, 2007–2018 20
Table 7: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Exports, 2007–2018 21
Table 8: Revised Timelines for Drug Approval Process by South African Health Products Regulatory Authority 34
Table 9: Emerging Pharmaceutical Market: South Africa, Population Structure in South Africa, (million), 2000–2025 38
Table 10: Emerging Pharmaceutical Market: South Africa, Population Parameters, 2009 39
Table 11: Emerging Pharmaceutical Market: South Africa, BRICS, Rural/Urban Distribution of Population, 2011 41
Table 12: Emerging Pharmaceutical Market: South Africa, Population by Gender(%), 1990–2025 42
Table 13: Emerging Pharmaceutical Market: South Africa, Macroeconomic Indicators, 2010 and 2015 42
Table 14: Emerging Pharmaceutical Market: South Africa, National Healthcare Coverage and Expenditure, 2007 43
Table 15: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Physicians, 2010 47
Table 16: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Nursing and Midwifery Personnel, 2010 48
Table 17: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Dentistry Personnel, 2010 49
Table 18: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Pharmaceutical Personnel, 2010 50
Table 19: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Hospital Beds per 10,000 Population, 2009 51
Table 20: Emerging Pharmaceutical Market: South Africa, Medicines Control Council Registration Fees for New Medicines, South Africa 52
Table 21: Emerging Pharmaceutical Market: South Africa, Revised Timelines for Drug Approval Process by South African Health Products Regulatory Authority, South Africa 52
Table 22: Emerging Pharmaceutical Market: South Africa, Government Employees Medical Scheme, South Africa 54
Table 23: Emerging Pharmaceutical Market: South Africa, Tiered Pricing System, 2010 54
Table 24: Emerging Pharmaceutical Market: South Africa, Number of Clinical Trials, 2007–2011 56
Table 25: Emerging Pharmaceutical Market: South Africa, Strategic Consolidations, Deals by Year, 2009–2011 58
Table 26: Emerging Pharmaceutical Market: South Africa, Recent M&A Deals, 2009–2011 62
Table 27: Emerging Pharmaceutical Market: South Africa, Recent Licensing Agreements, 2009–2011 63



List of Figures

Figure 1: Emerging Pharmaceutical Market: South Africa, Market Forecast, 2007–2018 11
Figure 2: Emerging Pharmaceutical Market: South Africa, Top 10 Causes of Death (%), 2008 12
Figure 3: Emerging Pharmaceutical Market: South Africa, Causes of Death due to Infectious Diseases (%), 2008 14
Figure 4: Emerging Pharmaceutical Market: South Africa, HIV/AIDS Population (million), 2001–2011 15
Figure 5: Emerging Pharmaceutical Market: South Africa, Deaths due to AIDS, 2001–2011 16
Figure 6: Emerging Pharmaceutical Market: South Africa, Transmission of HIV/AIDS, (%), 2011 16
Figure 7: Emerging Pharmaceutical Market: South Africa, Tuberculosis Population, 2001–2011 17
Figure 8: Emerging Pharmaceutical Market: South Africa, Patented vs. Generic Drugs, by Value, 2011 18
Figure 9: Emerging Pharmaceutical Market: South Africa, Patented vs. Generic Drugs Market Share %, by Volume, 2011 19
Figure 10: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Imports, 2007–2018 20
Figure 11: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Exports, 2007–2018 21
Figure 12: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Exports and Imports, 2007–2018 22
Figure 13: Emerging Pharmaceutical Market: South Africa, Aspen Pharmacare, SWOT Analysis, 2011 23
Figure 14: Emerging Pharmaceutical Market: South Africa, Adcock Ingram, SWOT Analysis, 2011 24
Figure 15: Emerging Pharmaceutical Market: South Africa, Cipla Medpro, SWOT Analysis, 2011 25
Figure 16: Emerging Pharmaceutical Market: South Africa, Sanofi, SWOT Analysis, 2011 26
Figure 17: Emerging Pharmaceutical Market: South Africa, Pfizer, SWOT Analysis, 2011 27
Figure 18: Emerging Pharmaceutical Market: South Africa, Roche, SWOT Analysis, 2011 28
Figure 19: Emerging Pharmaceutical Market: South Africa, Ranbaxy, SWOT Analysis, 2011 29
Figure 20: Emerging Pharmaceutical Market: South Africa, GlaxoSmithKline, SWOT Analysis, 2011 30
Figure 21: Emerging Pharmaceutical Market: South Africa, Merck and Co., SWOT Analysis, 2011 31
Figure 22: Emerging Pharmaceutical Market: South Africa, Novartis, SWOT Analysis, 2011 32
Figure 23: Emerging Pharmaceutical Market: South Africa, Market Drivers, 2011 33
Figure 24: Emerging Pharmaceutical Market: South Africa, Market Restraints, 2011 34
Figure 25: Emerging Pharmaceutical Market: South Africa, PESTLE Analysis, 2011 36
Figure 26: Emerging Pharmaceutical Market: South Africa, Population of BRICS Nations, 2010 37
Figure 27: Emerging Pharmaceutical Market: South Africa, Population Structure, (million), 2000–2025 38
Figure 28: Emerging Pharmaceutical Market: South Africa, Life Expectancy at Birth, 1950–2010 39
Figure 29: Emerging Pharmaceutical Market: South Africa, Infant Mortality Rate, 2001–2011 40
Figure 30: Emerging Pharmaceutical Market: South Africa, Rural/Urban Distribution of Population, 1990–2009 41
Figure 31: Emerging Pharmaceutical Market: South Africa, National Healthcare Expenditure, 2008 43
Figure 32: Emerging Pharmaceutical Market: South Africa, Private Healthcare Expenditure (%), 2010 44
Figure 33: Emerging Pharmaceutical Market: South Africa, Increase in Government Healthcare Expenditure over the Previous Year (%), 2011 45
Figure 34: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Physicians per 10,000 Population, 2010 46
Figure 35: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Nursing and Midwifery Personnel per 10,000 Population, 2010 48
Figure 36: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Dentistry Personnel per 10,000 Population, 2010 49
Figure 37: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Pharmaceutical Personnel per 10,000 Population, 2010 50
Figure 38: Emerging Pharmaceutical Market: South Africa, BRICS, Number of Hospital Beds per 10,000 Population, 2009 51
Figure 39: Emerging Pharmaceutical Market: South Africa, Number of Clinical Trials, 2007–2011 55
Figure 40: Emerging Pharmaceutical Market: South Africa, Strategic Consolidation, Deals by Type, (%), 2009–2011 57
Figure 41: Emerging Pharmaceutical Market: South Africa, Strategic Consolidations, Deals by Year, 2009–2011 58
Figure 42: Emerging Pharmaceutical Market: South Africa, M&A Deals by Year, 2009–2011 59
Figure 43: Emerging Pharmaceutical Market: South Africa, M&A Deals by Type, (%), 2009–2011 60
Figure 44: Emerging Pharmaceutical Market: South Africa, M&A Deals by Value, %, 2009–2011 61
Figure 45: Emerging Pharmaceutical Market: South Africa, Quintiles, Company Profile, 2011 64
Figure 46: Emerging Pharmaceutical Market: South Africa, Pharmaceutical Product Development, Company Profile, 2011 65
Figure 47: Emerging Pharmaceutical Market: South Africa, Inc Research, Company Profile, 2011 66
Figure 48: Emerging Pharmaceutical Market: South Africa, Parexel, Company Profile, 2011 67
Figure 49: Emerging Pharmaceutical Market: South Africa, Icon plc, Company Profile, 2011 68
Figure 50: Emerging Pharmaceutical Market: South Africa, PRA International, Company Profile, 2011 69
Figure 51: Emerging Pharmaceutical Market: South Africa, African Clinical Research Organization, Company Profile, 2011 70
Figure 52: Emerging Pharmaceutical Market: South Africa, OnQ, Company Profile, 2011 71



Companies Mentioned

Aspen Pharmacare
Adcock Ingram
Cipla Medpro
Sanofi
Pfizer
Roche
Ranbaxy
GlaxoSmithKline
Merck & Co
Novartis

Pharmaceutical in South Africa

South Africa Poisonings, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pharmaceutical
• Countries : South Africa

South Africa Poisonings, 0-4 Yrs, Total, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pharmaceutical
• Countries : South Africa

South Africa Poisonings, 70+ Yrs, Female, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pharmaceutical
• Countries : South Africa

South Africa Poisonings, 60-69 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pharmaceutical
• Countries : South Africa

South Africa Poisonings, Total, Female, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pharmaceutical
• Countries : South Africa