Report

The South Africa In-Vitro Diagnostics Market size is estimated at USD 1.46 billion in 2024, and is expected to reach USD 1.87 billion by 2029, growing at a CAGR of 5.01% during the forecast period (2024-2029).

The COVID-19 pandemic turned the spotlight on in-vitro diagnostics since there was an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV2 virus infection among the global population. The outbreak of COVID-19 positively impacted the market studied, 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 is 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 7500 samples being sequenced every month in southern Africa, and led to more than 54% increase in sequencing data on the continent. 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 In-vitro Diagnostics 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 diseases and infectious diseases in South Africa, increasing the use of point-of-care diagnostics in the country, and technological advancements that are being done in the diagnostics market. 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 of in-vitro diagnostics products is expected to be high in the country for the diagnosis and monitoring purpose. In addition, according to the International Diabetes Federation (IDF) 2021 report, the estimated number of South African adults of age 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 in-vitro diagnostics market is expected to grow over the forecast period with the increase in demand for the 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 the 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 diagnostics 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 aunched 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 regaents 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.

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 increasing the adoption of 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.

South Africa In-Vitro Diagnostics (IVD) Industry Overview

The In-vitro Diagnostics 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. 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.

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