Insights

South Korea is a dynamic market for innovators in medical devices, life sciences and biotech. Geographic concentration, advanced healthcare infrastructure, an aggressive business culture and government support combine to make this an attractive entry point for many western players.

While visiting Intralink’s offices in Seoul, I sat down with colleagues and clients in our Medtech & Life Sciences practice to discuss the trends dictating entry into and success in South Korea.

Read on to learn whether this should be your next target market.

Swiftly-growing field

Healthcare in South Korea is a swiftly-growing field, owing to rapidly shifting demographics and lifestyle trends. South Korea is currently the fastest-aging developed country in the world, quickly catching up with the proportion of older people in Japan's population. A quarter of South Korean's are expected to be over 65 by 2025. Meanwhile, Koreans’ sedentary lifestyle, alcohol and tobacco use are driving increases in non-communicable diseases such as diabetes and hypertension. To combat these trends and establish the country as a leader in the biomedical field, the South Korean government has announced strong support for clinical trials, biopharmaceuticals and AI in medtech and life sciences – all of which bring big opportunities for western firms. Further good news is the way entry into South Korea’s healthcare and life sciences markets is simplified by the concentration of healthcare and research. The “Big Five” hospitals – Samsung Medical Center, Asan Medical Center (pictured above), Seoul National University Hospital, Severance Hospital and Seoul St Mary’s Hospital – are all in the capital and dominate research and quality of care. And new entrants should look at the Big Five as clinical evaluation sites as well as customers. The highly concentrated market, a strong domestic healthcare scene and healthy appetite for foreign technologies favor companies with competitive products.

Regulatory approval

The Ministry of Food & Drug Safety (MFDS) is the Korean regulatory body for pharmaceuticals and medical devices. But an important point to know is having approval in the US or EU makes gaining Korean approval much smoother. A Korean-developed genomic test even used FDA approval to secure approval in Korea – after having been rejected by MFDS! In addition, the Korean government has established major initiatives to spur innovation in the medtech and pharma sectors – slashing reviewal times for AI-enabled tech from 90 to 30 days, loosening restrictions on data sharing, providing direct stimulus for the purchase of novel equipment, and even expanding compassionate use cases for pre-approval technology.

If you have an eye on Korea, be sure to evaluate reimbursement categories as part of your regulatory strategy. The country has near-universal healthcare, but a misalignment in pricing can erase other competitive advantages.

So, the overall healthcare market is growing quickly, buoyed by strong government support. Let’s take a closer look at four segments of particular relevance to western companies.

Highly attractive market

South Korea is a vibrant market in which western firms can grow in the biotech, medtech and life sciences fields. And focused government support is further enhancing the opportunities by bolstering clinical and biotech research, as well as the confluence of medtech, biotech and artificial intelligence.

It’s important to understand the macro landscape as well as factors influencing your specific business, but the opportunities are most definitely there for western firms that have innovative products to offer and take a smart approach.