Despite COVID-19 and NDMA metformin prescription surges

31 metformin products banned with NDMA contamination, insignificant impact on the market

Prescription generates KRW 535.7 billion last year growing 10% from 2019

Metformin-based antidiabetic drugs showed exceptional growth in the prescription drug market.

 

Both metformin combination and single agent drugs expanded their prescription volume and maintained the credibility in the clinical scene, regardless of the novel coronavirus disease (COVID-19) outbreak and impurity contamination incident.

 

On Feb.

 

9, a pharmaceutical market research firm UBIST told the outpatient prescription volume in metformin last year marked 535.7 billion won growing 9.5 percent from the previous year.

 

The year 2019 showed a growth of 7.3 percent.

 

Metformin, a type of biguanides, is used vastly on Type 2 diabetic patients as a first-line treatment to control the blood sugar level.

 

Amid COVID-19 pandemic last year, the general prescription drug market fluctuated but the metformin market growth surged.

 

Both metformin and single agent drugs showed definite growth.

 

In last year, metformin single agent drug generated 77.3 billion won, showing a 4.1-percent growth compared to the year before.

 

The growth was increased steeply compared to 2.9 percent growth made in 2019.

 

Meanwhile, the metformin combination drug market had even higher growth.

 

The last year’s metformin combination drug prescription volume grew by 10.5 percent from the year before and made 458.4 billion won.

 

In 2019, the volume grew 8.2 percent compared to previous year.

 

The combination drug market surged by 96.8 percent throughout five years from 2015 making 232.9 billion won.

 

Currently, there are metformin drugs combined with dipeptidyl peptidase 4 (DPP-4) inhibitors, sulfonylureas, glitazone and sodium-glucose co-transporter-2 (SGLT2) inhibitors available in the South Korean market.

 

Among all combination drugs, DPP-4 inhibitor plus metformin drug market had a notable growth.

 

In last year, the DPP-4 inhibitor plus metformin drug prescription volume generated 380.5 billion won, growing by 5.8 percent compared to the year before.

 

In five years from 2015, the market expanded exponentially by 90.5 percent.

 

The DPP-4 inhibitor plus metformin drugs dominates 71.3 percent of the metformin combination drug market share.

 

The SGLT-2 inhibitor plus metformin drug prescription volume also surged by 59.1 percent in last year and made 44.4 billion won.

 

Although metformin drug market suffered a detrimental hit by the impurity contamination, the prescription market firmly consolidated its ground.

 

South Korea’s Ministry of Food and Drug Safety (MFDS) ordered temporary manufacturing and sales suspension and prescription limitation on 31 metformin active pharmaceutical ingredient and complete products supplied in South Korea, as the ministry discovered unacceptable level of N-Nitrosodimethylamine (NDMA) carcinogen in the drugs.

 

The sales ban was imposed on JW Pharmaceutical’s Guardmet, Hanall Biopharma’s Glucodaun OR Tablet and Hutecs Korea Pharmaceutical’s Gluless-M.

 

The order was issued six months after the Singaporean health authority raised an issue of metformin impurity contamination.

 

In December 2019, Singapore’s Health Sciences Authority (HSA) investigated 46 metformin-contained items on sale and recalled three items as they found NDMA exceeding the acceptable daily intake level.

 

Since then, MFDS also started investigating metformin ingredients and complete products in South Korea.

 

The relevant industry was concerned when the South Korean health authority initiated the investigation as it could affect the metformin prescription market.

 

In fact, an anti-hypertension drug valsartan was also found with unacceptable level of impurity and the general market was impacted by the authority’s sales ban order.

 

In July and August 2018, MFDS banned the sales of 175 valsartan single agent drugs and combination drugs using ingredients found with NDMA.

 

Valsartan containing anti-hypertension treatments generated 381.9 billion won in 2017, but the volume continued to slip for two consecutive years in 2018 and 2019 at 376.4 billion won and 332 billion won, respectively.

 

But in last year, the volume increased by 4.0 percent compared to 2019 making a positive growth after three years.

 

Metformin is the only oral antidiabetic drug used for first-line treatment.

 

Basically, the absence of alternative option has protected the drug’s credibility against the impurity incident.

 

Also the sales ban on metformin drugs was limited compared to the overall market.

 

MFDS reported the 31 items banned from sales generated production volume of 22.8 billion won in 2019.

 

It was only 6 percent of the overall production and import volume.

 

And other plenty of options were available, besides the banned items, for the prescription market to have avoided confusion.

 

The industry evaluates the previous experiences of impurity contamination in valsartan, ranitidine and nizatidine have taught the market such incident’s risk is insignificant.

 

When announcing the list of impurity-contaminated metformin items to be banned, MFDS concluded “The harmful risk on human body by long-term exposure to drugs found with unacceptable level of NDMA is miniscule.”