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, according to a new report by Grand View Research, Inc. 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.
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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
Grand View Research has segmented the Africa pharmaceutical regulatory affairs market based on services, category, indication, product stage, service provider, company size, and country:
Africa Pharmaceutical Regulatory Affairs Services Outlook (Revenue, USD Million, 2018 - 2030)
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Writing
Publishing
Product Registration & Clinical Trial Applications
Other Services
Africa Pharmaceutical Regulatory Affairs Category Outlook (Revenue, USD Million, 2018 - 2030)
Drugs
Innovator
Preclinical
Clinical
Pre-Market Approval (PMA)
Generics
Preclinical
Clinical
Pre-Market Approval (PMA)
Biologics
Biotech
Preclinical
Clinical
Pre-Market Approval (PMA)
ATMP
Preclinical
Clinical
Pre-Market Approval (PMA)
Biosimilars
Preclinical
Clinical
Pre-Market Approval (PMA)
Africa Pharmaceutical Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
Neurology
Cardiology
Immunology
Others
Africa Pharmaceutical Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018 - 2030)
Preclinical
Clinical studies
PMA
Africa Pharmaceutical Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2018 - 2030)
In-house
Outsourcing
Africa Pharmaceutical Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018 - 2030)
Small
Medium
Large
Africa Pharmaceutical Regulatory Affairs Country Outlook (Revenue, USD Million, 2018 - 2030)
Africa
South Africa
Botswana
Namibia
Zimbabwe
Algeria
Zambia
Tanzania
Rwanda
Ghana
Nigeria
Uganda
Mauritius
Kenya
Rest of Africa
List of Key Players in the Africa Pharmaceutical Regulatory Affairs Market
Freyr
IQVIA Inc
ICON plc
WuXi AppTec
Charles River Laboratories
Labcorp Drug Development
Parexel International Corporation
Pharmalex GmbH
Pharmexon
Genpact
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