18-05-2025
Access to breakthrough medicines in South Korea among slowest globally, industry report reveals
New drugs account for just 13.5 percent of South Korea's drug spending, less than half the OECD average
New medicines may be hitting global markets at record speed, but for South Korean patients, they remain largely out of reach, often for years after their initial approval overseas.
According to a 2025 report by the Korea Research-based Pharmaceutical Industry Association, only 5 percent of new drugs launched globally are available in South Korea within the first year. That's far below the OECD average of 18 percent, and significantly behind Japan's 32 percent.
Delays are compounded after approval. The same KRPIA analysis, which reviewed 460 drugs approved in the US, Europe and Japan from 2012 to 2021, found that it takes an average of 28 months for South Korean regulators to approve new medicines.
It takes another 18 months on average for those drugs to gain insurance coverage, meaning a total wait of nearly four years before patients can access treatments under the national health system. In contrast, Germany averages just 11 months and Japan 17 months for the same process.
Pricing policy is a key reason. In South Korea, new drug prices are tied to the cost of older, similar treatments. Many older drugs are already priced low, limiting what pharmaceutical companies can charge, even for medications that show superior results.
KRPIA points out that when generics enter the market, prices can drop by over 50 percent, and most new drugs end up priced at or below 90 percent of those benchmarks. Without room to negotiate, many companies choose not to launch their newest drugs in South Korea.
As a result, spending on innovative treatments remains low. A 2024 study by Professor Yoo Seung-rae at Dongduk Women's University found that from 2017 to 2022, only 13.5 percent of South Korea's total health insurance drug budget went toward new medicines. That's 2.5 times lower than the OECD average of 33.9 percent.
In March, the Ministry of Health and Welfare announced a new pricing model to ease this bottleneck. The so-called 'dual pricing' system allows companies to set a higher public list price while refunding the difference to the national insurer. Officials hope this will encourage more drug launches, especially from companies aiming to use Korean prices as export benchmarks.
But challenges remain, particularly for combination therapies, most of which are used in cancer treatment. While such regimens are becoming standard in countries like the United States, they often remain unreimbursed in South Korea, especially when the drugs come from different manufacturers. Between 2020 and 2024, 53 combination therapies applied for expanded reimbursement, but only one cross-company case (Braftovi and Erbitux for colorectal cancer) was approved, according to data from the Health Insurance Review and Assessment Service.
That means even when international studies show major survival benefits, as with recent combinations for bladder and lung cancers, South Korean patients may have no way to access them through the public system.
KRPIA warns that without broader reforms, South Korea risks falling further behind in providing timely access to breakthrough treatments.
