Market Intelligence
Biologics South Africa Standards, Regulatory, and Technical Requirements

South Africa Healthcare Biopharmaceutical Production

South Africa’s biopharma production is growing, and the country is positioning itself as a key player on the African continent. Partnerships with U.S. stakeholders and companies are important drivers and offer several opportunities in the following:

  • Biologics and Biosimilars Production. Already well-established in terms of production capacity, U.S. companies can partner with local firms to produce monoclonal antibodies, vaccines, and biosimilars that specifically target the South African and continental African population. This is particularly important, as current medicines on the market have shown not to be as effective for these populations. Additionally, this would also address diseases specific to the continent. An example is the partnership between local biologics company Afrigen and Thermo Fisher Scientific for vaccine development and production. 
     
  • API Manufacturing. There is an urgent need to develop local manufacturing capabilities for Active Pharmaceutical Ingredients (API). The Covid pandemic underscored South Africa’s dependence on imports, which proved challenging at the height of the pandemic. The majority of API is imported from India and China, and can account for up to 70 percent of pharmaceuticals sold in South Africa. 
     
  • Clinical Trials and Research: South Africa has a well-established clinical trials sector, due to its access to a large and diverse population and world-class scientists. Several international companies conduct Phase I, II, and III in-country trials. South Africa aligns itself with international standards – FDA and EMA. There are good opportunities for U.S. companies to partner and collaborate with local CROs, and universities involved in advanced biopharma research, particularly in areas like HIV, TB, non-communicable disease such as CVD, diabetes, as well as emerging diseases.
     
  • Training and Capacity Building: There is a growing demand for capacity-building initiatives in regulatory affairs and quality assurance within South Africa’s biopharma sector. U.S. companies can offer training services or form knowledge-sharing partnerships to enhance local expertise. Some life sciences companies who provide laboratory platforms and solutions already do this as part of their business strategy.
     
  • Green Biopharma Technologies: With an increasing focus on sustainability, U.S. companies specializing in green chemistry, sustainable production methods, and bio-manufacturing can partner with South African firms and provide solutions to reduce the environmental footprint of pharmaceutical production. There are initiatives in place to further develop this field and to support local start-ups such as Synexa Life Sciences and Iraka Biotech, or research stakeholders like CSIR Future Production – a research cluster that focuses on green chemicals, pharmaceuticals, and materials https://www.csir.co.za/future-production-chemicals
     
  • Equipment: While there is some local manufacturing of equipment such as specialized mixing or filtration systems, most equipment used for biopharma production in this country is imported. Regulatory standards are strict, and equipment must meet cGMP requirements.  

For more information, please reach out to Commercial Specialist Felicity Nagel, felicity.nagel@trade.gov 
U.S. Commercial Service, Cape Town South Africa.