Pharmaceutical Regulatory Affairs Market to Grow with a CAGR of 5.32% through 2028
Rising post-market surveillance and pharmacovigilance are
expected to drive the South Africa Pharmaceutical Regulatory Affairs Market
growth in the forecast period, 2024-2028.
According to TechSci Research report, “Pharmaceutical
Regulatory Affairs Market – South Africa Industry Size, Share,
Trends, Competition Forecast & Opportunities, 2028”, the South
Africa Pharmaceutical Regulatory Affairs Market stood at USD 3.24 billion in
2022 and is anticipated to grow with a CAGR of 5.32% in the forecast period,
2024-2028. the South Africa Pharmaceutical Regulatory Affairs Market is an
evolving landscape where compliance, safety, and innovation intersect. As the
country aims to position itself as a leader in pharmaceutical regulation on the
African continent, the market's growth and impact on public health and the
healthcare industry remain of paramount importance. The
establishment of the South African Health Products Regulatory Authority
(SAHPRA) in 2018 marked a watershed moment for pharmaceutical regulation in the
country. SAHPRA replaced the Medicines Control Council (MCC) and was created to
streamline regulatory processes, reduce bottlenecks, and enhance the overall
efficiency of product approvals. This reform has significantly expedited the
review and approval of pharmaceuticals, making it easier for manufacturers to
bring new products to market. As SAHPRA continues to refine its processes and
adapt to international regulatory standards, it is attracting increased
attention from both local and international pharmaceutical companies, further
stimulating market growth.
South Africa boasts one of the most developed
pharmaceutical markets in Africa. The nation's pharmaceutical industry is
expanding rapidly, driven by increasing healthcare needs, a growing middle
class, and rising chronic diseases. This growth has resulted in a surge of
research and development activities, clinical trials, and the introduction of
innovative pharmaceutical products. The need for regulatory affairs
professionals to navigate the complex landscape and ensure compliance is higher
than ever, making the regulatory affairs market a crucial part of this growing
sector.
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The importance of post-market surveillance and pharmacovigilance
is on the rise in South Africa. With an increased focus on patient safety, the
regulatory authorities are enhancing their monitoring and oversight of
pharmaceutical products after they are on the market. This ensures that adverse
events, side effects, or any quality issues are promptly identified and
addressed. The need for professionals well-versed in pharmacovigilance and
post-market surveillance has created new opportunities in the regulatory
affairs market.
The South Africa Pharmaceutical Regulatory Affairs Market
is segmented into Services, Category, Indication, Regional Distribution, And
Company. Based
on the Indication, the Oncology segment emerged as the dominant player in the
South Africa market for South Africa Pharmaceutical Regulatory Affairs Market
in 2022. South Africa actively collaborates with international
organizations and pharmaceutical companies in cancer research and clinical
trials. This collaboration necessitates a strong regulatory framework to ensure
that innovative cancer treatments meet the highest safety and efficacy
standards. Despite progress in cancer treatment, unmet medical needs still
exist, particularly for rare or aggressive forms of cancer. Regulatory
professionals play a crucial role in expediting the approval and market access
of novel cancer therapies to address these unmet needs. Clinical trials in
oncology can be complex, involving various phases and diverse patient
populations. Regulatory affairs experts are instrumental in navigating the
intricacies of these trials and ensuring that they align with local and
international regulatory standards. The South African government has
implemented initiatives to improve cancer care and access to innovative
treatments. Regulatory compliance and the successful registration of oncology
drugs and therapies are vital for the success of these initiatives. The safety
and monitoring of cancer treatments are of utmost importance due to their
potential side effects and long-term impact. Regulatory professionals play a
key role in post-market surveillance and pharmacovigilance activities to ensure
patient safety.
Based on the Category, the Infectious
diseases segment emerged as the dominant player in the South Africa market for
South Africa Pharmaceutical Regulatory Affairs Market in 2022. South
Africa has faced significant challenges related to infectious diseases,
including HIV/AIDS and tuberculosis. The prevalence of these diseases has
driven a continuous need for pharmaceutical products, vaccines, and treatments,
resulting in a high demand for regulatory affairs services to ensure that these
products meet safety and efficacy standards. The emergence of new infectious
diseases, such as the COVID-19 pandemic, has emphasized the importance of a
robust and responsive regulatory framework. The demand for rapid approvals,
clinical trials, and the introduction of innovative treatments and vaccines in
the face of infectious disease outbreaks has amplified the need for regulatory
expertise. The development and distribution of vaccines and antiviral
medications for infectious diseases require rigorous regulatory oversight. The
demand for these products in South Africa, along with the necessity for
compliance with international standards, necessitates the services of
regulatory affairs professionals.
Gauteng emerged as the dominant player
in the South Africa Pharmaceutical Regulatory Affairs Market in 2022, holding
the largest market share. Gauteng, as South Africa's economic and industrial
heartland, is home to a significant portion of the country's pharmaceutical
manufacturing and research facilities. It houses numerous pharmaceutical
companies, both local and international, as well as research and development centres.
This concentration of pharmaceutical activity naturally drives a substantial
demand for regulatory affairs services. Gauteng houses prestigious academic and
research institutions that are actively involved in pharmaceutical and
biomedical research. These institutions often collaborate with pharmaceutical
companies, leading to a heightened demand for regulatory support in the
development and approval of pharmaceutical products. The region boasts major
healthcare infrastructure, including numerous hospitals, clinics, and research
institutions. These healthcare facilities are engaged in clinical trials,
healthcare research, and the development of new pharmaceutical products, all of
which require robust regulatory oversight.
Major companies operating in South Africa
Pharmaceutical Regulatory Affairs Market are:
- IQVIA Inc
- ICON plc
- Freyr
- WuXi AppTec
- Charles River Laboratories
- Labcorp Drug Development
- Parexel International Corporation
- Pharmalex GmbH
- Pharmexon
- Genpact
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“The South
Africa Pharmaceutical Regulatory Affairs (NGS) market is poised for significant
growth in the coming years. The country's pharmaceutical industry is
experiencing a surge in research and development, with a focus on innovative treatments
for prevalent diseases. South Africa's commitment to global harmonization and
international collaborations is enhancing its regulatory framework, making it
more attractive to multinational pharmaceutical companies. The strengthening of
intellectual property rights is incentivizing innovation and research,
attracting foreign investments, and stimulating the introduction of advanced
pharmaceutical products. Furthermore, the region's emphasis on infectious
disease treatments and vaccines, as well as its high demand for oncology and
essential medicines, is fueling the demand for regulatory affairs services.” said
Mr. Karan Chechi, Research Director with TechSci Research, a research-based
management consulting firm.
“South Africa Pharmaceutical Regulatory
Affairs Market Segmented By Services (Regulatory Consulting, Legal
Representation, Regulatory Writing & Publishing, Product Registration &
Clinical Trial Applications, Other Services), By Category (Traumatic,
Infectious, Gastrointestinal, Psychiatric, Cardiac, Neurologic, Others), By
Indication (Oncology, Neurology, Cardiology, Immunology, Others) Region and
Competition, Opportunity, and Forecast, 2018-2028”, has evaluated
the future growth potential of South Africa Pharmaceutical Regulatory Affairs
Market and provides statistics & information on market size, structure and
future market growth. The report intends to provide cutting-edge market
intelligence and help decision makers take sound investment decisions. Besides,
the report also identifies and analyzes the emerging trends along with
essential drivers, challenges, and opportunities in South Africa Pharmaceutical
Regulatory Affairs Market.
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