Losartan prescription market has grown 15% in 3 years

The strike back of losartan containing hypertension drugs that have had impurity issues

Prescriptions for losartan-containing drugs totaled KRW 70.3 billion in Q3...up 5% YoY

Prescription market plummeted in 2021 after exposure to impurity risk

Rebounded since Q2 2022... Prescription market grew 15%p than 3 years ago

The prescription market for the antihypertensive drug losartan has shown an upward trend.

 

Its market plummeted in 2021 following the detection of excess impurities in all losartan products but has since recovered obviously.

 

Prescriptions of both single and combination losartan drugs have risen over 10% from three years ago.

 

Analysts say the recurring impurity issues have diluted fears of impurities in drugs.

 

According to the drug research institution UBIST, outpatient prescriptions for losartan-containing drugs totaled KRW 70.3 billion in the third quarter, up 4.7% year-on-year.

 

Compared to KRW 64.3 billion in the third quarter of 2022, prescriptions have increased 9.4% in two years.

 

Quarterly prescriptions of losartan drugs in Korea (Purple: losartan combination therapy, blue: losartan monotherapy)

This is the first time in 3 years since the fourth quarter of 2021 that quarterly prescriptions for losartan drugs exceeded KRW 70 billion.

 

The prescription market for losartan formulations has been on the rise since 2021, despite a significant decline in prescriptions following the exposure of its impurity issue.

 

In September 2021, 183 lot numbers of 73 products across 3 ingredients - losartan, valsartan, and irbesartan - were recalled for excess impurities.

 

Later in 2021, impurity issues arose in the entire losartan formulation.

 

In 2021, 295 batches of losartan formulations from 98 companies were voluntarily recalled for exceeding or potentially exceeding the standard for ‘losartan azide impurities.’ Of the 306 items from 99 companies on the market, 96.4% were included in the recall.

 

The prescription market for losartan-containing drugs was worth KRW 81 billion in the third quarter of 2021, down 24.6% from KRW 61.1 billion in the second quarter alone.

 

During the same period, sales of losartan monotherapies decreased 33.9% from KRW 24.5 billion to KRW 17.8 billion, and losartan combination drugs decreased 19.9% from KRW 51.9 billion to KRW 44.7 billion.

 

The drop was due to the exposure of impurity issues across all losartan formulations, which led to prescription changes to other drugs in the same angiotensin II receptor blocker (ARB) class.

 

At the end of 2021, 94 of the 295 total losartan products from 34 different manufacturers were available, effectively avoiding the total sales halt of losartan drugs.

 

The prescription market appears to have recovered as many of the losartan formulations have resolved their impurity issues and returned to the market.

 

In the second quarter of 2022, the prescription market for losartan drugs rebounded to KRW 62.7 billion, a 2.6% increase YoY, and the upward trend has continued since.

 

In the third quarter, the total prescription market for losartan formulations expanded by 15.1% compared to the first quarter of 2021.

 

Both losartan monotherapy and combination drugs have seen recent gains.

 

Outpatient prescriptions for losartan monotherapy totaled KRW 20.7 billion in the third quarter, up 16.3% from Q1 2022.

 

This is the first time in three years since the fourth quarter of 2021 that the quarterly prescription volume for losartan monotherapy exceeded KRW 20 billion.

 

Combination losartan prescriptions grew 14.6% from KRW 43.3 billion in Q1 2022 to KRW 49.6 billion in the third quarter of this year.

 

The recurrence of impurity issues across ARBs, starting with valsartan in 2018, has diluted the fears of such impurities in the prescription market.

 

In 2018, the Ministry of Food and Drugs suspended sales of 175 products containing valsartan, an ARB antihypertensive drug.

 

In 2021, impurity issues arose in losartan, valsartan, and irbesartan.

 

Among the ARB class antihypertensives, telmisartan, candesartan, fimasartan, and olmesartan were not affected.

 

Even if impurities above the approved threshold are detected, unless a sales ban or large-scale recall is conducted, some analysts argue that the detection itself is unlikely to affect the prescription market because there is no clear evidence of human harm.