[Plaza] Prerequisite for Success of K-Bio Diagnostic Devices

The new year of the Im-in year has begun alongside the emergence of the COVID-19 Omicron variant. Since the pandemic began in 2020, more than five variants have appeared over the past two years, with several waves of outbreaks recurring.

In the ongoing pandemic situation, not only the public but also many companies are facing difficulties. However, there are places that have used this crisis as a stepping stone for continuous growth. In vitro diagnostic (IVD) companies are exactly such entities. Before the pandemic, most IVD companies were small-scale, but as COVID-19 diagnostic devices were rapidly commercialized and the market expanded during the early stages of the infectious disease outbreak, they grew rapidly. According to Statistics Korea, from January to November last year, South Korea's exports in the in vitro diagnostics sector exceeded 2 trillion won, marking an all-time high, and it is expected that companies entering the global top 10 by sales will emerge, demonstrating remarkable progress.

How was such remarkable growth possible? First, there were capable manufacturers with product development technology. IVD companies that experienced MERS in 2016 accumulated development capabilities for genetic diagnostics, antigen, and antibody diagnostic reagents in preparation for possible future infectious disease outbreaks. That time was not wasted. At the end of January 2020, when most countries had not yet recognized the seriousness of COVID-19, domestic companies decided to develop COVID-19 diagnostic reagents at the ‘MedLab In Vitro Diagnostics Global Exhibition’ held in Dubai. Based on their accumulated capabilities, they quickly developed products, which provided an opportunity to secure overseas markets faster than other countries.

The second reason is the regulatory capacity of South Korea’s regulatory agency, the Ministry of Food and Drug Safety (MFDS). Generally, the image of regulation is negative. However, reasonable regulation and the product support services provided by regulatory agencies based on it become driving forces for industrial development. The ‘Emergency Use Authorization’ introduced by the MFDS is a system that allows the temporary use of unapproved products in situations where a pandemic is feared. Early in the COVID-19 outbreak, companies utilized this system to rapidly commercialize diagnostic devices, and these products were used on the front lines of quarantine to protect the public. Furthermore, as the domestic quarantine model using Emergency Use Authorization spread to other countries, Korean diagnostic companies were able to secure overseas markets. The In Vitro Diagnostic Medical Device Act, which came into effect in May 2020, further solidified the foundation for institutional advancement and innovative growth.

However, no one knows how long this window of opportunity will remain open amid rapid technological and institutional developments. Along with innovative product development capabilities, institutional support and securing expert personnel in regulatory agencies who understand innovative technologies and can support product commercialization are essential. The capacity of regulatory agencies is no longer just the infrastructure of a single organization but the infrastructure of the biohealth industry and, ultimately, national safety.

With the emergence of COVID-19 variants and the possibility of new infectious diseases at any time, the faster the spread, the greater the market demand for rapid and accurate diagnostic products will be. When prepared companies and capable regulatory agencies work together, second and third success models can emerge. I sincerely hope that diagnostic devices that ensure public safety will continue to be developed and that these diagnostic devices will lead the global market in the new year.

/ Son Mijin, Chairperson of the Bio Association In Vitro Diagnostic Companies Council & CEO of SuzenTech

This content was produced with the assistance of AI translation services.