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

NEW YORK, Feb. 7, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

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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

Table of Contents

1 Table of Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 82 Introduction 103 Emerging Pharmaceutical Market: South Africa – Industry Characteristics 113.1 Pharmaceutical Market Size and Growth in South Africa 113.2 Environmental Disease Burden 123.2.1 HIV/AIDS 153.2.2 Tuberculosis 173.3 Patented and Generic Drugs Market Share 183.4 Imports and Exports 203.4.1 Imports 203.4.2 Exports 213.4.3 Balance of Trade 223.5 Key Domestic Players in South Africa 233.5.1 Aspen Pharmacare 233.5.2 Adcock Ingram 243.5.3 Cipla Medpro 253.6 Key Foreign Players in South Africa 263.6.1 Sanofi 263.6.2 Pfizer 273.6.3 Roche 283.6.4 Ranbaxy 293.6.5 GlaxoSmithKline 303.6.6 Merck & Co 313.6.7 Novartis 323.7 Market Drivers and Restraints 333.7.1 Drivers 333.7.2 Restraints 343.8 PESTLE Analysis 364 Emerging Pharmaceutical Market: South Africa – Macroeconomic Environment 374.1 Demographic Analysis 374.1.1 Introduction 374.1.2 Population Size, Growth and Structure 384.1.3 Changes in Life Expectancy at Birth 394.1.4 Infant Mortality Rate 404.1.5 Rural/Urban Distribution 414.1.6 Population by Gender 424.2 Gross Domestic Product 424.3 Healthcare Expenditure 434.4 Healthcare System 464.4.1 Health Workforce and Infrastructure in South Africa 465 Emerging Pharmaceutical Market: South Africa – Healthcare Regulation 525.1 Pharmaceutical Regulation in South Africa 525.2 Intellectual Property Rights 535.3 Health Insurance Coverage 535.4 Pricing and Reimbursement 545.4.1 Pricing 545.4.2 Reimbursement 555.5 Clinical Trials 556 Emerging Pharmaceutical Market: South Africa – Industry Trends 576.1 Strategic Consolidations 576.2 Mergers and Acquisitions 596.2.1 Deals by Year 596.2.2 Deals by Type 606.2.3 Deals by Value 616.2.4 Top M&A Deals 626.3 Licensing Agreements 636.3.1 Top Licensing Deals 637 Emerging Pharmaceutical Market: South Africa – Contract Research Organization Industry 647.1 Contract Research Organizations 647.2 Key International Contract Research Organization Players in South Africa 647.2.1 Quintiles 647.2.2 Pharmaceutical Product Development 657.2.3 Inc Research 667.2.4 Parexel 677.2.5 Icon plc. 687.2.6 PRA International 697.3 Key Domestic Contract Research Organization Players in South Africa 707.3.1 African Clinical Research Organization 707.3.2 OnQ 718 Emerging Pharmaceutical Market: South Africa - Appendix 728.1 Market Definitions 728.2 Abbreviations 728.3 Sources 738.4 Research Methodology 738.4.1 Industry Performance 738.4.2 Macroeconomic Environment 738.4.3 Healthcare Regulations 748.4.4 Industry Trends 748.5 Contact Us 748.6 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

To order this report:Pharmaceutical Industry: Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process

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