Africa Pharmaceutical Regulatory Affairs Analysis Report 2023


Dublin, Jan. 24, 2024 (GLOBE NEWSWIRE) -- The "Africa Pharmaceutical Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Category, By Indication, By Product Stage, By Service Provider, By Company Size, By Country, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

The Africa pharmaceutical regulatory affairs market size is expected to reach USD 213.06 million by 2030, registering a CAGR of 6.81% from 2023 to 2030

The market is driven by increasing demand for pharmaceutical products across the Africa region coupled with the growing need for safe and effective drugs, which requires stringent regulatory oversight. Moreover, the rise in the prevalence of various diseases, including communicable and non-communicable diseases, propels the demand for pharmaceuticals.



The COVID-19 pandemic had a significant impact on the market. The pandemic highlighted the importance of a robust regulatory framework to expedite the approval process for important drugs and vaccines, and African regulatory authorities responded by streamlining emergency authorization procedures.

Moreover, COVID-19 emphasized the importance of strengthening pharmaceutical manufacturing capabilities within the region. Several countries have reduced their dependence on imports and are now investing in local production to enhance supply chain resilience. These factors have contributed to market growth.

The increasing number of clinical trials conducted in Africa is impacting the regulatory landscape. Many global pharmaceutical companies are conducting trials in the region due to the diverse patient populations and lower costs. As a result, stringent regulatory oversight is essential to safeguarding trial participants and ensuring the validity of research outcomes, bolstering the role of regulatory affairs.

Moreover, the ongoing efforts to improve healthcare access and infrastructure in Africa are driving the demand for pharmaceutical products. As healthcare systems continue to evolve, regulatory affairs play an important role in assuring the quality and efficacy of medicines, thus driving the market growth.

Africa Pharmaceutical Regulatory Affairs Market Report Highlights

  • By services, the regulatory writing & publishing segment dominated the market with a share of over 36% in 2022. The legal representation segment is projected to witness the fastest growth rate in the coming years
  • By category, the drugs segment dominated the market in 2022. Regulatory affairs play a very important role in the entire drug development, manufacturing, and commercialization continuum
  • By indication, the oncology segment held the highest share of the market in 2022. This can be attributed to the high prevalence of cancer, which is boosting the need for safe and effective treatment options
  • By product stage, the clinical studies segment held the highest share of the market in 2022. This can be attributed to the increasing number of clinical trial registrations over the past few years
  • By service provider, the outsourcing segment dominated the market in 2022. This can be attributed to the increasing popularity of these services as outsourcing enables healthcare companies to reduce costs and prioritize strategic projects
  • By company size, the medium segment dominated the market in 2022. These companies have a broader product portfolio and a wider geographic presence, allowing them to serve a larger customer base across different African countries

Company Profiles

  • Freyr
  • IQVIA Inc
  • ICON plc
  • WuXi AppTec
  • Charles River Laboratories
  • Labcorp Drug Development
  • Parexel International Corporation
  • Pharmalex GmbH
  • Pharmexon
  • Genpact

Key Attributes:

Report AttributeDetails
No. of Pages150
Forecast Period2022 - 2030
Estimated Market Value (USD) in 2022$126.04 Million
Forecasted Market Value (USD) by 2030$213.06 Million
Compound Annual Growth Rate6.8%
Regions CoveredAfrica

Key Topics Covered:

Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Research Methodology
1.3. Information Procurement
1.4. Information or Data Analysis
1.5. Market Formulation & Validation
1.6. Model Details
1.7. List of Data Sources

Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights

Chapter 3. Africa Pharmaceutical Regulatory Affairs Market Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market 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 focus on their core competencies.
3.2.1.3. Economic and competitive pressures
3.2.1.4. Demand for 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. Africa Pharmaceutical Regulatory Affairs Market Analysis Tools
3.3.1. Industry Analysis - Porter's
3.3.2. PESTEL Analysis
3.3.3. COVID-19 Impact Analysis
3.3.4. Service Gap Analysis
3.3.5. Africa Market Composition
3.3.6. Qualitative Analysis of Primary Factors Driving Market Demand for Pharmaceutical Products and Healthcare Services across the African Countries

Chapter 4. Africa Pharmaceutical Regulatory Affairs Market: Services Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Africa Pharmaceutical Regulatory Affairs Market: Services Movement Analysis & Market Share, 2022 & 2030
4.3. Regulatory Consulting
4.4. Legal Representation
4.5. Regulatory Writing & Publishing
4.5.1. Regulatory Writing & Publishing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.2. Writing
4.5.3. Publishing
4.6. Product Registration & Clinical Trial Applications

Chapter 5. Africa Pharmaceutical Regulatory Affairs Market: Category Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Africa Pharmaceutical Regulatory Affairs Market: Category Movement Analysis & Market Share, 2022 & 2030
5.3. Drugs
5.3.1. Drugs Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3.2. Innovator
5.3.2.1. Innovator Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3.2.2. Preclinical Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3.2.3. Clinical Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3.2.4. Pre-Market Approval (PMA) Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3.3. Generics
5.4. Biologics
5.4.1. Biologics Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4.2. Biotech
5.4.3. ATMP
5.4.4. Biosimilars

Chapter 6. Africa Pharmaceutical Regulatory Affairs Market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Africa Pharmaceutical Regulatory Affairs Market: Indication Movement Analysis & Market Share, 2022 & 2030
6.3. Oncology
6.4. Neurology
6.5. Cardiology
6.6. Immunology

Chapter 7. Africa Pharmaceutical Regulatory Affairs Market: Product Stage Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Africa Pharmaceutical Regulatory Affairs Market: Product Stage Movement Analysis & Market Share, 2022 & 2030
7.3. Preclinical
7.4. Clinical studies
7.5. PMA

Chapter 8. Africa Pharmaceutical Regulatory Affairs Market: Service Provider Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Africa Pharmaceutical Regulatory Affairs Market: Service Provider Movement Analysis & Market Share, 2022 & 2030
8.3. In-house
8.4. Outsourcing

Chapter 9. Africa Pharmaceutical Regulatory Affairs Market: Company Size Estimates & Trend Analysis
9.1. Segment Dashboard
9.2. Africa Pharmaceutical Regulatory Affairs Market: Company Size Movement Analysis & Market Share, 2022 & 2030
9.3. Small
9.4. Medium
9.5. Large

Chapter 10. Africa Pharmaceutical Regulatory Affairs Market: Regional Estimates & Trend Analysis
10.1. Regional Outlook
10.2. Africa Pharmaceutical Regulatory Affairs Market: Regional Movement Analysis & Market Share, 2022 & 2030

Chapter 11. Competitive Landscape
11.1. Key Company Profiles
11.1.1. Participant's Overview
11.1.2. Product/ Software & Services Benchmarking
11.1.3. Financial Performance
11.1.4. Strategic Initiatives
11.2. Participant Categorization
11.3. Heat Map Analysis/ Company Market Position Analysis
11.4. Strategy Mapping

For more information about this report visit https://www.researchandmarkets.com/r/6bekx9

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African Pharmaceutical Regulatory Affairs Market

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