| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| Historical Data Period | 2019 - 2023 |
| Market Size (2025) | USD 1.53 Billion |
| Market Size (2030) | USD 1.96 Billion |
| CAGR (2025 - 2030) | 5.01 % |
Major Players
*Disclaimer: Major Players sorted in no particular order |
South Africa In-Vitro Diagnostics (IVD) Market Analysis
The South Africa In-Vitro Diagnostics Market size is estimated at USD 1.53 billion in 2025, and is expected to reach USD 1.96 billion by 2030, at a CAGR of 5.01% during the forecast period (2025-2030).
The COVID-19 pandemic turned the spotlight on the IVD market since there was an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV-2 virus infection among the global population. The outbreak of COVID-19 positively impacted the diagnostics industry, as in-vitro diagnostics involved the testing of various biological samples. This aided in the diagnosis of infectious diseases, such as COVID-19. Testing remained a crucial step in controlling the COVID-19 pandemic. Also, the rapid launch of diagnostic kits for the diagnosis of COVID-19 by key players drove the studied market during the pandemic. For instance, according to the data by WHO in February 2022, WHO increased the number of laboratories able to detect COVID-19 from two to more than 900 and bolstered genetic sequencing efforts in Africa through several initiatives including setting up the Regional Centre of Excellence for Genomic Surveillance and Bioinformatics in South Africa in collaboration with South African National Bioinformatics Institute (SANBI) at the University of Western Cape. These efforts led to more than 7,500 samples being sequenced every month in Southern Africa, and led to more than 54% increase in sequencing data on the continent, thereby contributing to the growth of the Africa IVD market. Hence, the COVID-19 pandemic posed a favorable impact on the market initially, and as the pandemic subsided the market lost some traction. However, it is expected to have a stable growth during the forecast period of the study.
The IVD market in South Africa is expected to grow at a good rate over the forecast period. This growth is majorly attributed to the rising burden of chronic and infectious diseases in South Africa, increasing the use of point of care diagnostics in the country, and technological advancements in the IVD industry. According to an article published by PubMed Central in July 2022, the national prevalence of HIV in South Africans was 14.0% across all ages, and it is estimated that around 7.9 million people are affected with the virus. As HIV-affected people are more prone to various chronic and infectious diseases, the demand for in-vitro diagnostics products, including diagnostic testing, is expected to be high in the country for diagnosis and monitoring purposes. In addition, according to the International Diabetes Federation (IDF) 2021 report, the estimated number of South African adults aged 20-79 years with diabetes is expected to increase from 4.2 million in 2021 to 7.5 million by 2045. Therefore, due to the high and increasing burden of diseases, the IVD market is expected to grow over the forecast period with the increase in demand for in-vitro tests and diagnostics products in South Africa.
Additionally, the current market is also growing due to the use of advanced technologies in the IVD market. There has been a paradigm shift from traditional diagnostics to a new generation of diagnostics that work at the gene level. This was made possible by the inclusion of advanced technologies, such as genetic testing, molecular diagnostics, polymerase chain reaction (PCR), and next-generation sequencing (NGS) in the IVD platform.
Also, the increasing product launches with advanced features are expected to drive the studied market. In January 2021, local biotech startup BioCODE, headquartered in Cape Town, started developing a cost-effective test to identify early-stage cancer and cardiovascular disease. In addition, the rapid test will determine an individual's risk for the development of the above-mentioned diseases. By the end of 2022, this test is anticipated to be implemented throughout the nation.
Thus, above mentioned factors are expected to drive the market during study period. However the reimbursement issues and the high cost associated with advanced IVD devices are expected to restrain the growth of the in-vitro diagnostics market in South Africa.
South Africa In-Vitro Diagnostics (IVD) Market Trends
Reagents are Expected to hold a Significant Market Share in the Product Segment Over the Forecast Period
Reagents are an integral part of in vitro diagnostics. They are of a varied range, for different types of disease diagnosis. Due to the increased need for reagents to meet the rising demand worldwide, the diagnosis of COVID-19 infection was anticipated to considerably contribute to the expansion of the researched segment. Few of the market players launched diagnostic reagents for COVID-19 testing. For example, in July 2021, the Health Republic of South Africa released an updated policy and guidelines for SARS-CoV-2 in-vitro diagnostic tests in South Africa.
The reagent segment of the market studied includes chemical, biological, or immunological components, solutions, or preparations intended by the manufacturer to be used during the in-vitro diagnosis process. Given the high cost of many diagnostic platforms, it was common for manufacturers to lease equipment instead of selling technology outright to end-users. In these arrangements, the lease was tied to contracts to purchase associated reagents or assays for the equipment over the life of the contract.
Moreover, South Africa established medical device regulatory structure. For instance, according to an article published by PubMed Central in March 2021, South Africa had a formal regulatory process for medical devices that included all essential regulatory components as recommended by the WHO, this presence of regulatory body for medical devices was expected to increase the usage of reagents used in them and hence it was expected to fuel the segment growth. Furthermore, with the rising cancer burden, the demand for in vitro diagnostics for early diagnosis rose, which was also expected to propel the segment growth over the forecast period.
Hence, due to the aforementioned factors, the reagents segment was expected to hold a large market share during the forecast period of the study.
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Molecular Diagnostics Segment is Expected to hold a Significant Market Share Over the Forecast Period
The major factors driving the growth of the segment are rising developments in the molecular diagnostics field, increasing prevalence of infectious diseases, and rising adoption of molecular diagnostic tests.
The increasing prevalence of infectious diseases like influenza and HIV is boosting the adoption of rapid influenza diagnostic tests and molecular diagnostic tests in the region. For instance, according to the data from The National Institute for Communicable Diseases of South Africa in November 2022, 1,149 influenza cases have been detected and 95 cases of Bordetella pertussis have been detected in South Africa in 2022.
Furthermore, the development of new technologies in the molecular diagnostic field will also enhance the growth of the segment. For instance, according to an article published by Frontiers in October 2022, pathogenic microorganisms have major impacts on human lives, and rapid and sensitive molecular diagnostic tools are urgently needed to facilitate the early treatment of microbial infections and the effective control of microbial transmission. CRISPR-Cas13 is a new molecular diagnostic technology that employs programmable RNA to produce a sensitive and specific method with high base resolution and thus provides a novel tool for the rapid detection of microorganisms.
Hence, due to the factors such as increasing prevalence of infectious diseases like influenza and HIV, and development of new technologies in the molecular diagnostic field are expected to enhance the segment growth.
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South Africa In-Vitro Diagnostics (IVD) Industry Overview
The IVD market in South Africa is fragmented in nature. This is majorly due to the rising investment of global companies in South Africa as this country shows several opportunities for growth in the diagnostics industry. With the rising expansion strategies that are being implemented by the companies, it is expected that in the future, several small and mid-sized companies will penetrate the market and hold a substantial share. The major players in the market are Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Thermo Fisher Scientific, and Nihon Kohden Corporation among others.
South Africa In-Vitro Diagnostics (IVD) Market Leaders
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Nihon Kohden Corporation
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Siemens Healthineers
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Thermo Fisher Scientific
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Abbott Laboratories
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F. Hoffmann-La Roche Ltd
- *Disclaimer: Major Players sorted in no particular order
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South Africa In-Vitro Diagnostics (IVD) Market News
- March 2022: Audere entered into a partnership with Medical Diagnostech, headquartered in South Africa, a developer, and manufacturer of lateral flow rapid diagnostic test kits. This partnership will pair Medical Diagnostech's MD SARS-nCoV-2 Antigen Device with Audere's HealthPulse digital companion app.
- February 2022: Datar Cancer Genetics launched the Blood-based Trucheck cancer screening test in South Africa.
South Africa In-Vitro Diagnostics (IVD) Industry Segmentation
As per the scope of this report, in-vitro diagnostics involves medical devices and consumables that are utilized to perform in-vitro tests on various biological samples. They are used for the diagnosis of various medical conditions, such as diabetes and cancer. The South Africa In-Vitro Diagnostics Market is segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Hematology, and Other Test Types), Product (Instruments, Reagents, and Other Products), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Diseases, Nephrology, and Other Applications), and End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users). The report offers the value (in USD million) for the above segments.
| By Test Type | Clinical Chemistry |
| Molecular Diagnostics | |
| Immuno Diagnostics | |
| Haematology | |
| Other Test Types | |
| By Product | Instrument |
| Reagent | |
| Other Products | |
| By Usability | Disposable IVD Device |
| Reusable IVD Device | |
| By Application | Infectious Disease |
| Diabetes | |
| Cancer/Oncology | |
| Cardiology | |
| Autoimmune Disease | |
| Nephrology | |
| Other Applications | |
| By End-User | Diagnostic Laboratories |
| Hospitals and Clinics | |
| Other End-users |
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South Africa In-Vitro Diagnostics (IVD) Market Research FAQs
How big is the South Africa In-Vitro Diagnostics Market?
The South Africa In-Vitro Diagnostics Market size is expected to reach USD 1.53 billion in 2025 and grow at a CAGR of 5.01% to reach USD 1.96 billion by 2030.
What is the current South Africa In-Vitro Diagnostics Market size?
In 2025, the South Africa In-Vitro Diagnostics Market size is expected to reach USD 1.53 billion.
Who are the key players in South Africa In-Vitro Diagnostics Market?
Nihon Kohden Corporation, Siemens Healthineers, Thermo Fisher Scientific, Abbott Laboratories and F. Hoffmann-La Roche Ltd are the major companies operating in the South Africa In-Vitro Diagnostics Market.
What years does this South Africa In-Vitro Diagnostics Market cover, and what was the market size in 2024?
In 2024, the South Africa In-Vitro Diagnostics Market size was estimated at USD 1.45 billion. The report covers the South Africa In-Vitro Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the South Africa In-Vitro Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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South Africa In-Vitro Diagnostics Industry Report
Statistics for the 2025 South Africa In-Vitro Diagnostics market share, size and revenue growth rate, created by Mordor Intelligenceā¢ Industry Reports. South Africa In-Vitro Diagnostics analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
