Africa Pharmaceutical Regulatory Affairs Market (By Services; By Category; By Indication; By Product Stage; By Service Provider; By Company Size) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2023-2032

The Africa pharmaceutical regulatory affairs market was estimated at USD 126.09 million in 2022 and it is expected to surpass around USD 245.04 million by 2032, poised to grow at a CAGR of 6.87% from 2023 to 2032.

Key Pointers

• By services, the regulatory writing & publishing segment dominated the market with a share of over 37% in 2022. 
• By category, the drugs segment dominated the market in 2022 with a market share of 59%.

Report Scope of the Africa Pharmaceutical Regulatory Affairs Market

The market is driven by several factors such as the increasing prevalence of chronic diseases, a growing elderly population, rising healthcare expenditure, and the demand for innovative and cost-effective medicines across the continent. Additionally, there has been an increasing focus on promoting local pharmaceutical manufacturing in Africa. The government and international organizations have been supporting domestic production to reduce dependence on imports and improve access to affordable medicines. This would further create opportunities for local pharmaceutical companies, leading to a positive impact on the market.

The COVID-19 pandemic of 2020-21 and the macroeconomic headwinds of 2022-23 had a notable impact on the market. The pandemic highlighted the need for robust regulatory systems to expedite the approval and distribution of vaccines, therapeutics, and medical devices. Regulatory agencies in various African countries had to adapt quickly to expedite emergency approvals while ensuring safety and efficacy. These factors have led to potential advancements in the regulatory framework and have brought about collaborative efforts between regulatory authorities and pharmaceutical companies.

Furthermore, there have been notable advancements in the regulatory landscape in Africa. Several countries have been strengthening their regulatory capabilities and implementing reforms to harmonize their processes with international standards. The African Medicines Agency (AMA), launched in 2019, is a notable development aimed at promoting access to safe, effective, and quality medicines across the continent. Such initiatives are expected to streamline the regulatory pathway, encourage innovation, and enhance healthcare outcomes.

The increasing focus on clinical research and development in Africa is also contributing to boosting the demand for a robust regulatory framework. Many countries in the region are participating in clinical trials for various diseases, including infectious diseases, oncology, and tropical illnesses. This shift towards clinical research is attributed to the availability of diverse patient populations, relatively lower costs, and increasing partnerships between global research organizations and African institutions.

Services Insights

By services, the regulatory writing & publishing segment dominated the market with a share of over 37% in 2022. The growth is attributed to factors such as increased outsourcing of these services by large- and mid-size biopharmaceutical and medical device companies. Regulatory writing and publishing services are offered from the early stages of development to the post-marketing authorization phase. Various functions performed under this segment include submission management services such as writing and publishing applications for various regulatory agencies across the globe. Some organizations also provide nonclinical writing and publishing services such as product labeling, aggregate reporting, patient narratives, & investigator brochures.

The legal representation segment is projected to witness the fastest growth rate in the coming years. These services are provided by CROs to biopharmaceutical companies that require regulatory support services for their medicinal products. Different countries require in-house representatives as regulations are very complex and ever-changing. CROs provide legal representatives who can handle regulatory requirements pertaining to the commercialization of their medicinal products. The demand for legal representatives has considerably increased over the years owing to complex and changing healthcare regulations.

Category Insights

By category, the drugs segment dominated the market in 2022 with a market share of 59%. Regulatory affairs play a very important role in the entire drug development, manufacturing, and commercialization continuum. This can be attributed to various regulations and related regulatory submissions/documentation at each of the steps involved in the process. A clear understanding of these regulations enables timely and cost-effective product launches in the market and can also help pharmaceutical companies gain the first-mover advantage.

The biologics segment is projected to witness considerable growth during the forecasted period. Increasing healthcare needs, coupled with increasing investments in healthcare infrastructure and improving regulatory frameworks, are driving the demand for biologics in the region. The region’s increasing middle-class population and expanding access to healthcare services contribute to the growing demand for advanced and innovative therapies.

Indication Insights

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. Africa is expected to experience the most significant increase in cancer cases and deaths compared to other regions. According to data published by GLOBOCAN, the number of cancer cases in Africa is estimated to increase from 1.1 million new cases in 2020 to 2.1 million cases in 2040. Furthermore, oncology is one of the most profitable markets for pharmaceutical & biotechnology companies, thereby increasing the R&D projects undertaken by these players.

The immunology segment is projected to witness considerable growth during the forecasted period. The robust immunology pipeline of pharmaceutical and biopharmaceutical companies is anticipated to further boost segment growth. For instance, as of 2022, Novartis had nearly 33 drugs in the pipeline for treating immunological conditions. The high number of drugs in the pipeline for immunological drugs is expected to support the demand for regulatory services during the forecast period.

Product Stage Insights

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. The COVID-19 pandemic has increased the number of clinical trials in the region, due to the urgency to identify and commercialize an effective cure and/or vaccine for the disease. Furthermore, supportive regulatory actions, such as shortening trial approval time, waiving the waiting period, release of industry guidance documents, and funding clinical trials undertaken by regulatory authorities, are anticipated to boost this segment in the pharmaceutical regulatory affairs market.

The preclinical segment is projected to witness considerable growth during the forecasted period. This can be attributed to the increasing demand for novel disease treatments, such as COVID-19, the Zika virus, & Ebola, and the increasing prevalence of existing diseases such as CVDs, cancer, & neurological diseases. The main goals of preclinical studies are to determine a molecule’s safety profile, bioanalysis, pharmacodynamics, and ADME & DMPK analysis.

Service Provider Insights

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, prioritize strategic projects, reduce staff training time, and improve overall efficiency as well as provide greater flexibility. The availability of various outsourcing models suitable for different company sizes is also anticipated to boost the outsourcing market.

The in-house segment is projected to witness slow growth during the forecasted period. The slow growth is due to an increasing number of small- and medium-scale pharma/biotech/medical device companies, which lack funds and infrastructure to support an in-house regulatory affairs department. Furthermore, these firms find it difficult to hire experienced and technically sound full-time employees as they are emerging companies & have budget constraints. Hence, in-house regulatory affairs department is not preferred by small-scale companies, and they outsource nearly 90% of their regulatory solutions.

Company Size Insights

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. They can invest in R&D, clinical trials, and regulatory compliance, ensuring that their products meet the necessary standards and regulations. Moreover, medium-sized companies can establish strategic partnerships with local stakeholders, including regulatory authorities and healthcare providers, to streamline the regulatory process & enhance market access.

The large-size segment is projected to witness considerable growth during the forecasted period. Large companies have extensive resources, global presence, and expertise in navigating complex regulatory frameworks. These companies often have established relationships with regulatory authorities, enabling them to influence policy and shape regulatory standards. Large companies have the financial strength to invest in extensive clinical trials, advanced manufacturing facilities, and robust regulatory compliance systems. This allows them to bring innovative and high-quality pharmaceutical products to the African market while meeting stringent regulatory requirements.

Africa Pharmaceutical Regulatory Affairs Market Segmentations:

By Services 

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
  • Writing
  • Publishing
• Product Registration & Clinical Trial Applications
• Other Services  

By Category 

• 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)

By Indication 

• Oncology
• Neurology
• Cardiology
• Immunology
• Others  

By Product Stage 

• Preclinical
• Clinical studies
• PMA

By Service Provider 

• In-house
• Outsourcing

By Company Size 

• Small
• Medium
• Large