South Africa Biosimilars Market Overview, 2030

Traditionally, the pharmaceutical market has been known for its production of chemical synthetic medicines generally referred to as originators and generic medicines. However, in the last decade, there has been an increasing interest in more technologically advanced and effective medicines such as biologicals (originator) and biosimilars (equivalent of the biological). From a competition perspective, biosimilars have gained interest due to their positive impact on price competition resulting in more affordable essential medicines. This is particularly pertinent in South Africa given the high disease burden and a constrained healthcare budget. Access to affordable medicines is particularly pertinent in South Africa given the constrained healthcare budget and high disease burden. Moreover, in South Africa, there is a shift in the disease profile from infectious diseases to more chronic conditions. In this regard, biologicals and biosimilars have been gaining significant interest due to their innovative molecular structure that provides high clinical value for non-communicable diseases. The entry of biosimilars in the market for the treatment of complex chronic conditions also plays a crucial role in increasing the access and affordability for essential medicines. This is because biosimilars creates price competition between the biological and biosimilar, which results in lower prices of medicines, thereby increasing access to essential medicines of a biological nature. The price competition between the biological and biosimilars also generate savings for the healthcare system. Therefore, it is imperative that biosimilars enter a market when the patent for the biological has expired to create price competition in the market and increase assess to essential medicines.

According to the research report, “South Africa Biosimilars Market Overview, 2030” published by Bonafide Research, the South Africa Biosimilars market is projected to grow with 19.15% CAGR by 2025-30. Globally and in South Africa, the availability and affordability of medicines are two of the most crucial factors for an effective healthcare system. The availability and affordability of medicines increase access to essential life-saving drugs which has a positive effect on the health outcomes of a country’s citizens. Given the importance of the equitability of medicines for the functioning of national healthcare systems, countries continuously endeavour to improve the affordability and accessibility of medicines for their populations. Until recently, no biosimilars had been registered in South Africa, despite the fact that several biosimilar applications for products containing erythropoietin, filgrastim, and insulin have been received by the Medicines Control Council (MCC). Upon review, none of those candidates had complied with the registration requirements for a biosimilar medicine. However, this may be changing. In October 2019, a global report by the International Generic and Biosimilar Medicines Association identified two biosimilars approved in South Africa (filgrastim-Teva in 2018 and Biocon and Mylan’s trastuzumab Ogivri in 2019), compared to 54 and 23 in Europe and United States, respectively. In North Africa, Celltrion made a licensing agreement for truxima with Jordan-based drug maker Hikma Pharmaceuticals in December 2017. Hikma has exclusive agreements with Celltrion to market three biosimilars: truxima, remsima and herzuma.

The African continent has 54 states, and each country has its own regulatory body. The biosimilar regulatory framework is clearly moving on the continent and is at different stages of maturity. So far, South Africa is the only country that has established a clear regulatory framework for biosimilar approval. Cost-effectiveness, patent expirations of reference biologics, increasing demand for biologic medicines, a supportive regulatory environment, and increased acceptance by healthcare professionals are all main drivers in the biosimilars market. Biosimilars are pharmaceutical medications that are highly similar to an existing biological reference product, known as the originator or reference biologic. Biosimilars are designed to be comparable in quality, safety, and efficacy to the reference product while being less expensive. They are an alternative to costly biologic therapeutics, providing patients with greater access to treatments while potentially saving healthcare systems money. To demonstrate their similarity to the reference product, biosimilars go through a rigorous scientific and regulatory process that includes comparative analytical investigations, and non-clinical and clinical trials.

Monoclonal antibodies (mAbs) are leading the biosimilars industry in South Africa due to their critical role in treating a wide range of prevalent and serious diseases such as cancer, autoimmune disorders, and infectious diseases, which impose a significant health burden on the population. The rising incidence of cancers like breast, lung, and colorectal cancer, along with autoimmune conditions such as rheumatoid arthritis and Crohn’s disease, has intensified demand for effective biologic therapies, many of which are based on monoclonal antibodies. However, the high cost of originator biologics has historically limited access, particularly in emerging economies like South Africa, where healthcare resources and insurance coverage may be constrained. Biosimilar mAbs provide a more affordable yet equally effective alternative, enabling wider patient access and easing the financial pressure on both public and private healthcare sectors. South Africa’s healthcare system, comprising a large public sector serving the majority of the population and a private sector with advanced capabilities, has shown increasing acceptance of biosimilars, especially monoclonal antibodies, as a means to improve treatment accessibility and outcomes. Regulatory frameworks are evolving, with the South African Health Products Regulatory Authority (SAHPRA) adopting clearer guidelines for biosimilar approval, which has encouraged local and multinational pharmaceutical companies to invest in mAb biosimilar development and commercialization. Moreover, partnerships and collaborations with global biosimilar manufacturers have facilitated technology transfer and local production initiatives, strengthening supply chains and reducing dependency on costly imports.

Oncology is leading the biosimilars industry in South Africa due to the escalating burden of cancer within the country and the urgent need for accessible, cost-effective treatment options. Cancer incidence in South Africa has been rising steadily, driven by factors such as population growth, aging demographics, lifestyle changes, and the high prevalence of HIV/AIDS, which increases vulnerability to certain cancers like Kaposi’s sarcoma and cervical cancer. Traditional biologic therapies used in oncology, while highly effective, are often prohibitively expensive for many patients and healthcare providers in South Africa’s mixed healthcare system, which includes a resource-limited public sector serving the majority of the population. Biosimilars offer a more affordable alternative without compromising efficacy or safety, making them a vital tool in expanding access to life-saving cancer treatments. The South African Health Products Regulatory Authority (SAHPRA) has implemented clearer regulatory pathways and expedited approval processes for biosimilars, particularly those targeting oncology indications, fostering a more favorable environment for biosimilar adoption. This regulatory support, combined with growing awareness and confidence among oncologists and healthcare providers about biosimilars’ clinical equivalence to originator biologics, has accelerated their uptake in hospitals and cancer treatment centers across the country. Moreover, government and private sector initiatives aimed at enhancing cancer care infrastructure and improving patient coverage through insurance schemes have further stimulated demand for biosimilar oncology drugs.

Pharmaceutical companies have responded to this growing market opportunity by investing in the development and distribution of biosimilar oncology products, often collaborating with local partners to optimize supply chains and meet specific regional needs. These efforts align with national healthcare goals to reduce treatment costs while improving patient outcomes, particularly in underserved areas where access to advanced cancer therapies was previously limited. In-house manufacturing is leading the biosimilars industry in South Africa due to a combination of strategic, economic, and regulatory factors that emphasize local production capabilities to meet rising healthcare demands. South Africa’s growing biosimilars market, fueled by increasing prevalence of chronic diseases and cancers requiring biologic therapies, has highlighted the need for sustainable and cost-effective drug supply solutions. In-house manufacturing allows pharmaceutical companies to have greater control over the entire production process—from development and quality assurance to distribution—ensuring timely availability of biosimilars while reducing dependency on imports, which can be subject to delays, price fluctuations, and supply chain disruptions. This self-reliance is particularly important in a market where healthcare budgets are constrained and patients’ access to affordable medicines is a priority.

The South African government’s commitment to strengthening local pharmaceutical manufacturing under initiatives such as the Pharmaceutical Industry Strategy for South Africa (PISA) has provided policy support, incentives, and infrastructure development aimed at boosting domestic production. This environment encourages companies to invest in advanced biotechnological manufacturing facilities within the country, enabling them to produce complex biosimilars like monoclonal antibodies and erythropoietins that require specialized technology and expertise. Additionally, in-house production facilitates compliance with South African Health Products Regulatory Authority (SAHPRA) standards and expedites regulatory approvals, as manufacturers are better positioned to quickly adapt processes and provide detailed data required for biosimilar registration. Furthermore, local manufacturing promotes cost efficiencies by minimizing import tariffs, logistics expenses, and currency exchange risks, ultimately translating into more competitive pricing and increased market penetration. It also creates employment opportunities and builds technical expertise within the country, aligning with national economic development goals. The strategic importance of in-house manufacturing is amplified by increasing partnerships between South African firms and international biotechnology companies, enabling technology transfer and knowledge sharing that enhance local capabilities.