Drug Regulation

PUBLISHER: GlobalData | PRODUCT CODE: 1089651

PUBLISHER: GlobalData | PRODUCT CODE: 1089651

South Africa Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape

PUBLISHED: May 17, 2022

PAGES: 185 Pages

DELIVERY TIME: 1-2 business days

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GlobalData, the industry analysis specialist, has released its latest report: "South Africa Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape". The report is an essential source of information on the 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 South African pharmaceutical market is the drug market with the most potential in Africa, followed by Egypt, Nigeria, and Kenya. The key factors responsible for driving the pharmaceutical market of South Africa are growing and ageing population, larger prevalence of chronic diseases, expanding private health insurance coverage, and increased patient volumes for general practitioners and specialist medical practitioners. In South Africa as of April 2022, approximately 276 companies are licensed by the Department of Health and the Medicine Control Council to manufacture, import, export or distribute pharmaceuticals. Domestic manufacturing pharmaceutical companies almost exclusively produce generic products thus making the pharmaceutical market import dependent. South Africa is the primary business hub for the medical device industry in sub-Saharan Africa. According to pharmaceutical report 2020, nearly every therapeutic class has at least one generic equivalent available and sales of OTC generics also surpass brand name products by almost ZAR1 billion ($6.4 billion) in value and more than 53 million units. The government launched National Development Plan (NDP) 2030 and National Strategic Plan 2017-22 to achieve universal healthcare and improve the healthcare system. These plans also aim to eradicate acquired immunodeficiency syndrome (AIDS), TB, and malaria, and enhance quality of life by reducing disease burden in South Africa.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in South Africa, and 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: Pfizer, Roche, Novartis, Sanofi, and Aspen
Profiles and SWOT analyses of the major players in the medical device market: Abbott, Medtronic, Kimberly Clark, GE healthcare, and Getinge.
An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, Healthtech landscape, 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 healthcare policy highlights, demographics, healthcare infrastructure, and healthcare expenditure.
An overview of the opportunities for and challenges to growth in the South Africa's 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 Africa healthcare market
Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the South Africa 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

Product Code: GDHC0073CHR

1. Table of Contents

1.1 List of Figures
1.2 List of Tables

2. Executive Summary

2.1 Executive Summary
2.2 Key Highlights: Facts about the South Africa Healthcare Market
2.3 Key Highlights: Healthcare Startups in South Africa
2.4 Key Events: South Africa Healthcare Industry, 2015-21
2.5 Key Events: South Africa Pharmaceutical Market
2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2020-22
2.7 Key Events: Top Completed Deals by Value, 2020-22
2.8 Country Profile, South Africa, 2022

3. Overview of the Pharmaceutical Market

3.1 Pharmaceutical Market - Overview
3.2 Pharmaceutical Market - Exports
3.3 Pharmaceutical Market - Imports
3.4 Pharmaceutical Market - Supply Channels, South Africa
3.5 Pharmaceutical Market - Market Segments
3.6 Major Therapeutic Areas, South Africa
3.7 COVID-19 Epidemiology, South Africa
3.8 COVID-19 Impact and Developments, South Africa
3.9 COVID-19 Impact and Developments in the Healthcare Market, South Africa
3.10 COVID-19 Clinical Trials Landscape, South Africa
3.11 Pharmaceutical Market - Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market - Overview
4.2 Medical Devices Market - Major Players

5. Pharmaceutical and Medical Devices Market - Drivers and Barriers

5.1 Drivers
5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, South Africa, 2019-22
6.2 Deal Analysis: Medical Device Market, South Africa, 2019-22

7. HealthTech Landscape

7.1 HealthTech Landscape, South Africa
7.2 Digital Statistics, South Africa
7.3 Adoption of Technology in Healthcare, South Africa
7.4 HealthTech Deals Landscape, South Africa
7.5 Key HealthTech Deals, South Africa
7.6 Digital Regulations, South Africa
7.7 HealthTech Landscape: Benefits and Risks, South Africa

8. Market Access

8.8.1 Overview of healthcare system, South Africa
8.8.2 Reimbursement Landscape, South Africa
8.8.3 Overview of Insurance providers, South Africa
8.8.4 Out-of-Pocket Spending and Pharmaceutical Price Index, South Africa
8.8.5 Pricing policies, South Africa
8.8.6 Market Access Timeline, South Africa, 2014-20
8.8.7 Overview of Regulatory Agencies, South Africa
8.8.8 Marketing Authorization for Pharmaceutical Products, South Africa
8.8.9 Marketing Authorization for Medical Devices, South Africa
8.8.10 Medical Device Clinical Trials Landscape, South Africa
8.8.11 IPR, Patents, South Africa
8.8.12 Pharmaceutical Clinical Trials Landscape, South Africa
8.8.13 Medical device Clinical Trials Landscape, South Africa
8.8.14 Pharmaceutical and Medical Device Advertising Regulations, South Africa
8.8.15 Licensing Process for Pharmaceutical and Medical Device Manufacturing, South Africa
8.8.16 Licensing Process for Pharmaceutical Exports and Imports, South Africa
8.8.17 Pharmacy Regulations, South Africa
8.8.18 Labeling and Packaging Regulations, South Africa

9. Country Healthcare Landscape

9.1 South Africa Healthcare Policy Highlights
9.2 Healthcare Facilities, South Africa
9.3 Life Expectancy, South Africa
9.4 Immunization Rate, South Africa
9.5 Environmental Health, South Africa
9.6 Healthcare Personnel, South Africa
9.7 Disease Burden, South Africa
9.8 Healthcare Expenditure, South Africa

10 Trade Associations, South Africa

11 Trade Fairs, South Africa

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology
- 13.1.1 Coverage
- 13.1.2 Secondary Research
- 13.1.3 Forecasts
13.2 Bibliography
13.3 About GlobalData
13.4 Contact Us
13.5 Disclaimer

Product Code: GDHC0073CHR

List of Tables

Table 1: Top five companies in OTC healthcare (value share % by brand), South Africa, 2021
Table 2: COVID-19 indicators, global and South Africa, 2022
Table 3: COVID-19-related travel restrictions, South Africa, 2020-22
Table 4: COVID-19 vaccine doses, immunocompromised adults, South Africa, 2021-22
Table 5: COVID-19 vaccine doses, immunocompromised adults, South Africa, 2021-22
Table 6: Authorized COVID-19 vaccines, South Africa, 2020-22
Table 7: Pipeline COVID-19 vaccines, South Africa, 2020-22
Table 8: Available COVID-19 IVD products, South Africa, 2020-22
Table 9: Pipeline COVID-19 IVD products, South Africa, 2020-22
Table 10: Medical devices market, major segments ($M), South Africa, 2021
Table 11: Hospital supplies market, revenue ($M) and market share (%) of major companies, South Africa, 2021
Table 12: General surgery market, revenue ($M) and market share (%) of major companies, South Africa, 2021
Table 13: Cardiovascular devices market, revenue ($M) and market share (%) of major companies, South Africa, 2021
Table 14: Orthopedic devices market, revenue ($M) and market share (%) of major companies, South Africa, 2021
Table 15: Dental devices market, revenue ($M) and market share (%) of major companies, South Africa, 2021
Table 16: South Africa Government Employees Medical Scheme, South Africa, 2022
Table 17: Maximum price for medicines (excluding VAT), South Africa, 2022
Table 18: Marketing authorization fees, South Africa, 2021
Table 19: Medical device classification, South Africa, 2022
Table 20: Patent fees ($), South Africa, 2022
Table 21: Clinical trial application fee, South Africa, 2022
Table 22: Pharmacy registration/maintenance fees, South Africa, 2022
Table 23: Health strategic plan 2020-21 to 2024-25, key risks, South Africa, 2022
Table 24: Trade fairs, South Africa, 2022

List of Figures

Figure 1: Pharmaceutical market, revenue ($B and ZARB), South Africa, 2013-21
Figure 2: Medical devices market, revenue ($B), South Africa, 2016-21
Figure 3: Healthcare startups in South Africa, 2022
Figure 4: Country profile, South Africa, 2022
Figure 5: Pharmaceutical market, revenue ($B and ZAR), South Africa, 2013-21
Figure 6: Pharmaceutical market, revenue forecast ($B and ZAR), South Africa, 2022-26
Figure 7: Pharmaceutical exports ($M), South Africa, 2011-21
Figure 8: Top export partners, South Africa, 2021
Figure 9: Pharmaceutical imports ($B), South Africa, 2011-21
Figure 10: Top import partners, South Africa, 2021
Figure 11: Pharmaceutical supply chain, South Africa, 2022
Figure 12: Integrated approach to improve efficiency of access to medicines, South Africa, 2022
Figure 13: Central Chronic Medicine Dispensing and Distribution (CCMDD), pharmaceutical market, South Africa, 2022
Figure 14: Causes of supply chain vulnerability, pharmaceutical market, South Africa, 2022
Figure 15: Legislative framework, counterfeiting drugs, South Africa, 2022
Figure 16: Avenues to combat counterfeiters, pharmaceutical market, South Africa, 2022
Figure 17: Number of generics approved, pharmaceutical market, Africa, 2019-20
Figure 18: Generic uptake rate (%) by disease, pharmaceutical market, South Africa, 2017
Figure 19: Top 4 domestic pharmaceutical manufacturers (revenue $M), South Africa, 2021
Figure 20: Key products, domestic pharmaceutical manufacturers (revenue $M), South Africa, 2021
Figure 21: OTC medicines market, market value ($M), South Africa, 2014-22
Figure 22: Major OTC drug classes (share %), South Africa, 2022
Figure 23: OTC medicines sales by channel ($M), South Africa, 2021
Figure 24: OTC drug categories (market value, $M), South Africa, 2022
Figure 25: Number of drugs registered by unique API for top therapeutic area, South Africa, 2021
Figure 26: COVID-19 (cumulative number of cases), South Africa, 2020-22
Figure 27: COVID-19 (cumulative number of deaths), South Africa, 2020-22
Figure 28: COVID-19 fiscal stimulus timeline, South Africa, 2020-22
Figure 29: COVID-19 stringency index, South Africa, 2020-22
Figure 30: COVID-19 containment and health index, South Africa, 2020-22
Figure 31: COVID-19 vaccine dose administration (number of administered vaccine doses), South Africa, 2021-22
Figure 32: Total number of individuals vaccinated (age group), South Africa, 2020-22
Figure 33: Top COVID-19 markets by equipment type (number of available marketed products), South Africa, 2020-22
Figure 34: Top COVID-19 products by product categories (number of available marketed products), South Africa, 2020-22
Figure 35: Companies manufacturing COVID-19 NAATS and POC tests (number of available marketed products), South Africa, 2020-22
Figure 36: Top COVID-19 NAATS (number of available marketed products), South Africa, 2020-22
Figure 37: COVID-19 clinical trials sponsors by count, South Africa, 2020-22
Figure 38: COVID-19 clinical trials count by phase, South Africa, 2020-22
Figure 39: COVID-19 clinical trials count by trial status, South Africa, 2020-22
Figure 40: Medical devices market, revenue ($B), South Africa, 2016-21
Figure 41: Medical devices market, revenue forecast ($B), South Africa, 2022-27
Figure 42: Medical devices market, major segments (%), South Africa, 2021
Figure 43: Hospital supplies market, revenue ($M), South Africa, 2017-25
Figure 44: Hospital supplies market, market share of major players (%), South Africa, 2021
Figure 45: General surgery market, revenue ($M), South Africa, 2017-25
Figure 46: General surgery market, market share of major players (%), South Africa, 2021
Figure 47: Cardiovascular devices market, revenue ($M), South Africa, 2017-25
Figure 48: Cardiovascular devices market, market share of major players (%), South Africa, 2021
Figure 49: Orthopedic devices market, revenue ($M), South Africa, 2017-25
Figure 50: Orthopedic devices market, market share of major players (%), South Africa, 2021
Figure 51: Dental devices market, revenue ($M), South Africa, 2017-25
Figure 52: Dental devices market, market share of major players (%), South Africa, 2021
Figure 53: Diagnostic market, revenue ($M), South Africa, 2016-21
Figure 54: Diagnostic market, revenue ($B), South Africa, 2022-27
Figure 55: Medical devices market, revenue ($B) of major companies, South Africa, 2021
Figure 56: Deals value and deal count, pharmaceutical market, South Africa, 2019-22
Figure 57: Deals value and deal count, quarterly, pharmaceutical market, South Africa, 2019-22
Figure 58: Deals value and deal count, subtypes, pharmaceutical market, South Africa, 2019-22
Figure 59: Top therapy areas by deal value ($M), pharmaceutical market, South Africa, 2019-22
Figure 60: Top therapy areas by deal count, pharmaceutical market, South Africa, 2019-22
Figure 61: M&A deals by quarter (by value and by number), pharmaceutical market, South Africa, 2019-22
Figure 62: VC deals by quarter (by value and by number), pharmaceutical market, South Africa, 2019-22
Figure 63: Deals value and deal count, medical devices market, South Africa, 2019-22
Figure 64: Deals value and deal count, quarterly, medical devices market, South Africa, 2019-22
Figure 65: Deals value and deal count, subtypes, medical devices market, South Africa, 2019-22
Figure 66: Top equipment sectors by deal value ($M), medical devices market, South Africa, 2019-22
Figure 67: Top equipment sectors by deal count, medical devices market, South Africa, 2019-22
Figure 68: M&A deals by quarter (by value and by number), medical devices market, South Africa, 2019-22
Figure 69: Healthtech ecosystem, South Africa, 2022
Figure 70: Digital Health Strategy, mission and vision, South Africa, 2022
Figure 71: Nine strategic objectives, Digital Health Strategy, South Africa, 2022
Figure 72: Key stakeholders, Digital Health Strategy, South Africa, 2022
Figure 73: Government-sponsored schemes promoting startups, South Africa, 2022
Figure 74: Deals value ($M), Healthtech, South Africa, 2019-22
Figure 75: Deal count (number of deals), Healthtech, South Africa, 2019-22
Figure 76: Organization of public healthcare system, South Africa, 2022
Figure 77: Statutory bodies for the health-service professionals, South Africa, 2022
Figure 78: Organizational structure of drugs regulatory authorities, South Africa, 2022
Figure 79: Process of addition to essential drugs list, healthcare system, South Africa, 2022
Figure 80: Determining analysis required for a health technology assessment, South Africa, 2022
Figure 81: Out-of-pocket spending ($ per capita), South Africa, 2011-21
Figure 82: Annual rate of change (%), health price index, South Africa, 2012-21
Figure 83: Pre-evaluation screening process, SAHPRA, regulatory landscape, South Africa, 2022

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South Africa Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape

Description

Table of Contents

List of Tables

Scope

Reasons to Buy

Table of Contents

1. Table of Contents

2. Executive Summary

3. Overview of the Pharmaceutical Market

4. Overview of Medical Devices Market

5. Pharmaceutical and Medical Devices Market - Drivers and Barriers

6. Deal Analysis

7. HealthTech Landscape

8. Market Access

9. Country Healthcare Landscape

10 Trade Associations, South Africa

11 Trade Fairs, South Africa

12 Opportunities and Challenges

13 Appendix

List of Tables

List of Tables

List of Figures

List of Figures