South Korea In Vitro Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Market Overview

The South Korea in vitro diagnostics market was valued at approximately USD 1,650 million in 2020, and it is expected to reach USD 2,200 million in 2026, witnessing a CAGR of 5.20% over the forecast period, 2021-2026.

The market studied has observed a positive impact of COVID-19 with the rising number of cases of COVID-19 and product launches related to the diagnosis of COVID-19. In April 2020, Seasun Biomaterials announced the launch of the ''AQ-TOP COVID-19 Rapid Detection Kit'' for the diagnosis of COVID-19. Hence, such developments are expected to positively impact the market due to the growing need for the diagnosis of COVID-19.

In addition, in March 2020, the Ministry of Food and Drug Safety (MFDS), South Korea, approved urgent-use licenses to four COVID-19 diagnostic kits to ramp up the diagnostic procedures in the country and curb the transmission of the disease. Hence, IVD has played a crucial role in the pandemic scenario, and hence, a significant positive impact can be expected on the market growth.

Some of the major factors driving the market growth include the high prevalence of chronic diseases, increasing use of point-of-care (POC) diagnostics, advanced technologies, and increasing awareness and acceptance of personalized medicines and companion diagnostics. The World Health Organization (WHO) has identified chronic diseases as one of the world’s most pressing health problems. According to Globocan, 2020, about 230,317 new cases of cancer were reported in South Korea.

Furthermore, as per the International Diabetes Federation, in 2020, about 3,689,400 adults in South Korea were suffering from diabetes, constituting around 9.2% of the population. In vitro diagnostics played a crucial role in the detection of these diseases. Hence, with such factors taken into consideration, the growing burden of chronic diseases is expected to accelerate the market growth.

Also, advantages associated with point-of-care testing have increased the demand for in vitro diagnostics products in South Korea. Point-of-care testing helps bring testing closer to the patients and obtain results quickly for the healthcare providers to expedite diagnoses and subsequent treatment. Hence, this is likely to increase the adoption of in vitro diagnostics in the country.

Scope of the Report

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 chronic diseases. The South Korea in vitro diagnostics market is segmented by test type (clinical chemistry, molecular diagnostics, immunodiagnostics, hematology, and other types), product (instrument, reagent, and other products), application (infectious disease, diabetes, cancer/oncology, cardiology, nephrology, and other applications), and end user (diagnostic laboratories, hospitals and clinics, and other end users). The report offers the market size and forecasts in value (USD million) for the above segments.

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Key Market Trends

Reagents are Expected to Hold the Major Share Over the Forecast Period

The reagents segment of the market studied includes chemical, biological, or immunological components, solutions, or preparations intended by the manufacturers to be used during the in vitro diagnosis process. The outbreak of COVID-19 has fueled the demand for IVD reagents. For instance, in February 2020, Seegene Inc. received approval from the Korea Centers for Disease Control & Prevention for its product, "Allplex 2019-nCoV Assay", a real-time PCR assay. Furthermore, in March 2020, Gencurix introduced its new COVID-19 rapid immunodiagnostic kit in South Korea and the European Union.

Because of the high cost of many diagnostic platforms, it is common for manufacturers to lease equipment instead of selling technology outright to end users. In these arrangements, the lease is tied to contracts to purchase associated reagents or assays for the equipment over the life of the contract. Companies are adopting growth strategies to expand their presence in the market. For instance, Celltrion and BBB, a South Korea-based healthcare company, entered a partnership to develop point-of-care antigen testing (POCT) kit for the detection of COVID-19. Thus, with the above-mentioned factors, the market studied is expected to show significant growth in this segment.

However, in May 2020, the Medical Device Policy Division of the Ministry of Food and Drug Safety (MFDS), South Korea, reformed its regulations related to in vitro diagnostics. The new guidelines issued by the regulatory authority will primarily focus on the manufacturing and importing of IVD products, including reagents, to ensure that the IVD products are compliant with the applicable safety and performance requirements. Such a stringent regulatory framework may obstruct the market growth.

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