Dublin, Aug. 25, 2025 (GLOBE NEWSWIRE) -- The "Africa Pharmaceutical Regulatory Affairs Market Size, Share & Trends Analysis Report By Service By Category, By Development Stage, By Indication, By Service Provider, By Company Size, By Country, And Segment Forecasts, 2025 - 2033" report has been added to ResearchAndMarkets.com's offering.
The African pharmaceutical regulatory affairs market size was estimated at USD 161.01 million in 2024 and is projected to reach USD 288.53 million by 2033, growing at a CAGR of 6.73% from 2025 to 2033.
The market is driven by a rising elderly population and the increasing burden of chronic diseases, alongside growing healthcare expenditures and heightened demand for innovative, affordable medicines across the region. Furthermore, there is a significant shift toward strengthening local pharmaceutical manufacturing capabilities, which is drawing greater regulatory attention and driving the need for robust compliance frameworks. 
The market growth is due to a significant transformation in the region's healthcare landscape. The rise in non-communicable diseases such as diabetes, cancer, and cardiovascular conditions is pushing national health systems to adopt tighter regulatory frameworks that ensure the availability of safe and effective treatments. Moreover, expanding health coverage through national insurance schemes and global health partnerships is prompting governments to prioritize streamlined drug approvals and pharmacovigilance systems.
Regulatory bodies are also under pressure to fast-track access to essential medicines, especially in underserved rural areas. This trend has heightened the demand for outsourcing firms with the expertise to navigate evolving regulatory policies, align with harmonized standards, and manage complex approval pathways across multiple countries.
Furthermore, the African governments and regional blocs are increasingly emphasizing the development of local pharmaceutical manufacturing to reduce dependency on imports and improve medicine security. This industrial shift is creating a greater need for well-defined regulatory systems, from GMP certification to dossier submissions and lifecycle management of products. Efforts led by entities such as the African Medicines Agency (AMA), regional harmonization initiatives, and cross-border cooperation are pushing countries to modernize and align their regulatory affairs processes.
This transformation is not only fostering innovation but also opening opportunities for contract regulatory services, consultancy, and training programs focused on building local capacity in regulatory compliance and policy execution.
Africa Pharmaceutical Regulatory Affairs Market Report Segmentation
This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the Africa pharmaceutical regulatory affairs market report based on service providers, services, category, indication, development stage, company size, and country.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 150 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value (USD) in 2024 | $161.01 Million |
| Forecasted Market Value (USD) by 2033 | $288.53 Million |
| Compound Annual Growth Rate | 6.7% |
| Regions Covered | Africa |
Key Topics Covered:
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Africa Pharmaceutical Regulatory Affairs Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Changing Regulatory Landscape
3.2.1.2. Life Sciences Companies Focusing on Their Core Competencies
3.2.1.3. Economic and Competitive Pressures
3.2.1.4. Demand for the Faster Approval Process for Breakthrough Drugs and Devices
3.2.1.5. Entry of Companies into the Global Market
3.2.1.6. Growth in Emerging Areas such as Personalized Medicine, Biosimilars, and Orphan Drugs
3.2.2. Market Restraint Analysis
3.2.2.1. Risk Associated with Data Security
3.2.2.2. Monitoring Issues and Lack of Standardization
3.3. Service Gap Analysis
3.3.1. Market Opportunities
3.3.1.1. Service Upgrade
3.3.1.2. Technological Advancements
3.3.1.3. Latest Trends
3.3.2. Market Challenges Analysis
3.3.2.1. Analysis Pertaining to Existing Gaps & Shortcomings in the Regulatory Services
3.3.2.2. Bottlenecks Faced by Companies Seeking Regulatory Approvals or Maintaining Compliance
3.4. Technology Landscape
3.5. Pricing Model Analysis
3.6. Clinical Trials Volume Analysis, 2024
3.7. Market Analysis Tools
3.8. Best Practices and Case Study Pertaining to Regulatory Affairs Services
Chapter 4. Africa Pharmaceutical Regulatory Affairs Market: Service Provider Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
4.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service Provider
4.4. In-house
4.5. Outsourcing
Chapter 5. Africa Pharmaceutical Regulatory Affairs Market: Service Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
5.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service
5.4. Regulatory Consulting
5.5. Legal Representation
5.6. Regulatory Writing & Publishing
5.6.1. Regulatory Writing & Publishing Market Estimates and Forecasts
5.6.2. Writing
5.6.3. Publishing
5.7. Product Registration & Clinical Trial Applications
5.8. Other Services
Chapter 6. Africa Pharmaceutical Regulatory Affairs Market: Category Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
6.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Category
6.4. Drugs
6.4.1. Drugs Market Estimates and Forecasts, 2021 - 2033
6.4.2. Innovator
6.4.2.2. Preclinical
6.4.2.3. Clinical
6.4.2.4. Post Market Approval (PMA)
6.4.3. Generics
6.4.3.1. Generics Market Estimates and Forecasts, 2021 - 2033
6.4.3.2. Preclinical
6.4.3.3. Clinical
6.4.3.4. Post Market Approval (PMA)
6.5. Biologics
6.5.1. Biologics Market Estimates and Forecasts, 2021 - 2033
6.5.2. Biotech
6.5.2.1. Biotech Market Estimates and Forecasts, 2021 - 2033
6.5.2.2. Preclinical
6.5.2.3. Clinical
6.5.2.4. Post Market Approval (PMA)
6.5.3. ATMP
6.5.3.1. ATMP Market Estimates and Forecasts, 2021 - 2033
6.5.3.2. Preclinical
6.5.3.3. Clinical
6.5.3.4. Post Market Approval (PMA)
6.5.4. Biosimilars
6.5.4.1. Biosimilars Market Estimates and Forecasts, 2021 - 2033
6.5.4.2. Preclinical
6.5.4.3. Clinical
6.5.4.4. Post Market Approval (PMA)
Chapter 7. Africa Pharmaceutical Regulatory Affairs Market: Indication Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
7.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Indication
7.4. Oncology
7.5. Neurology
7.6. Cardiology
7.7. Immunology
7.8. Others
Chapter 8. Africa Pharmaceutical Regulatory Affairs Market: Development Stage Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
8.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Development Stage, 2021 - 2033
8.4. Preclinical
8.5. Clinical studies
8.6. Post Market Approval (PMA)
Chapter 9. Africa Pharmaceutical Regulatory Affairs Market: Company Size Estimates & Trend Analysis
9.1. Segment Dashboard
9.2. Africa Pharmaceutical Regulatory Affairs Market Movement Analysis
9.3. Africa Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Company Size, 2021 - 2033
9.4. Small
9.5. Medium
9.6. Large
Chapter 10. Africa Pharmaceutical Regulatory Affairs Market: Country Estimates & Trend Analysis
10.1. Country Market Dashboard
10.2. Market Size & Forecasts Trend Analysis, 2021 to 2033:
10.3. Africa
10.4. South Africa
10.5. Botswana
10.6. Namibia
10.7. Zimbabwe
10.8. Zambia
10.9. Tanzania
10.10. Rwanda
10.11. Ghana
10.12. Nigeria
10.13. Uganda
10.14. Mauritius
10.15. Kenya
Chapter 11. Competitive Landscape
11.1. Market Participant Categorization
11.2. Competitive Market Assessment Analysis (2024)
11.3. Company Profiles
- Freyr
- IQVIA Inc.
- ICON plc
- WuXi AppTec
- Charles River Laboratories Inc.
- LabCorp
- Parexel International Corporation
- Pharmalex GmbH
- Pharmexon
- Genpact
For more information about this report visit https://www.researchandmarkets.com/r/wr09hs
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Attachment
