19% of valsartan Rxs disappear 3 years after impurity issue

Change in prescription performance of valsartan-containing products

Outpatient prescription of valsartan products in 1H 2021 recorded ₩147.3 billion…performance fell 18.5% from 2018

Production and sales suspended due to NDMA detection in July 2018… prescription as monotherapy and combination therapy both decreased

Three years have passed since the valsartan impurity issue swept across the pharmaceutical industry, however, the valsartan market is still showing no signs of recovery.

 

Prescriptions of products containing valsartan as monotherapy and combination therapy both decreased by nearly 20%.

 

Analysts believe that distrust in valsartan after the impurity issue has led to switching prescriptions to similar drugs.

 

According to the pharmaceutical research institution UBIST on the 26th, outpatient prescriptions for valsartan monotherapy products recorded ₩29.9 billion in the first half of this year, a 5.4% decrease from the same period of the previous year.

 

This is the second consecutive year of decline since the 4.1% decrease to ₩31.6 billion last year.

 

Compared to the ₩34.1 billion in 1H of 2018, prescription of valsartan monotherapy products decreased by 12.4% in three years.

 

With losartan, valsartan used to occupy the largest share of the angiotensin II receptor blocker (ARBs) market for the treatment of hypertension.

 

The valsartan market had contracted much since an N-Nitrosodimethylamine (NDMA) impurity was detected in the valsartan active ingredient from China's Zhejiang Huahai Pharamceutical, which led to unprecedented mass recalls and sales suspensions around the world.

 

This incident had delivered a hard blow to the growing domestic prescription market for valsartan products.

 

On July 8th, 2018, the Ministry of Food and Drug Safety had suspended the sale of 209 pharmaceutical products containing valsartan that were being distributed in Korea for using an active ingredient that was found with NDMA.

 

Afterward, the authorities made remedies for products that did not use the active ingredient in question and additionally uncovered products that use NDMA containing active ingredients, resulting in a total of 175 products being suspended from sales.

 

The valsartan combination prescription market, which had a larger market than the monotherapy market, was also unable to escape the aftermath of the impurity crisis.

 

In the first half of this year, the prescription volume for valsartan in combination with a calcium channel blocker (CCB) class amlodipine amounted to ₩98.1 billion.

 

This was a 19.0% decline from the ₩121.1 billion in the first half of 2018, just before the impurity was detected.

 

The market had somewhat recovered – by 6.6% - compared to the first half of 2019 when the valsartan issue just hit the industry.

 

The combination of valsartan and the diuretic hydrochlorothiazide sold ₩19.3 billion in prescriptions in the first half of this year.

 

From the ₩25.5 billion that was recorded in 2018 to ₩21.5 billion in 2019, and to ₩21.1 billion in 2020, the record has continued to fall.

 

Compared to 3 years ago, prescriptions of the valsartan and hydrochlorothiazide combination fell 24.5%.

 

Combined, the monotherapy and combination therapy market for products containing valsartan recorded ₩147.3 billion in the first half of this year.

 

This was an 18.5% decrease from the ₩180.8 billion recorded in 2018.

 

Until the first half of 2018 before the impurity issue broke, the monthly prescription of valsartan monotherapy and combination therapy products exceeded ₩30 billion per month.

 

The monotherapy market by itself had recorded ₩6 billion in prescriptions every month.

 

However, the prescription of valsartan monotherapy and combination therapies that reached ₩30.5 billion in July of 2018, fell immediately after the impurity issue, falling sharply to ₩25.8 billion in August, and ₩22 billion in September.

 

And for three years since then, the monthly prescription has never exceeded ₩30 billion.

 

As of June this year, the prescription for valsartan monotherapy and combination therapy combined recorded ₩24.3 billion.

 

In other words, one-fifth of the prescriptions for valsartan disappeared after the impurity issue.

 

Analysts believe that the distrust built in valsartan after the impurity issue has led to an avoidance of prescriptions containing valsartan.

 

It is highly likely that some of the existing valsartan prescriptions have been switched to similar drugs.

 

In fact, the ARB-based anti-hypertensive drug market itself did not contract after the valsartan impurity issue.

 

The prescription for ARB-class monotherapies in the first half of this year amounted to ₩188.2 billion.

 

As the pharmaceutical market had contracted in general due to the prolonged COVID-19 pandemic, the ARB market had also seen a decrease of 5.1% compared to the same period of the previous year but had increased by 2.9% compared to the ₩182.8 billion in 2018.

 

The dual combination therapy market for the ARB+CCB class of antihypertensive ingredients had grown even more steeply.

 

The accumulated prescription amount for the ARB+CCB combination in the first half of this year was ₩399.5 billion.

 

This was an 0.2% increase from the same period last year and an overwhelming 19.1% increase from the ₩335.5 billion in the first half of 2018.