Market for montelukast revive…overcomes impurity issue

Cumulative prescriptions in Q3 reach KRW 106.5 bil…to reach over KRW 140 billion by the end of the year

Market stagnation due to side effect issue + COVID-19…starts recovery the past year

The market for asthma treatments containing the ingredient montelukast has succeeded in complete revival.

 

This market shrank significantly in 2020-2021 due to the side effects issue and the COVID-19 outbreak, but made a rebound last year, and is expected to expand to the largest size ever this year.

 

The market which remained stagnant for 2 years...is expected to revive completely after making a market rebound the previous year According to the market industry research institution UBIST on the 13th, the cumulative outpatient prescriptions of asthma treatments containing montelukast in Korea reached KRW 106.5 billion in Q3 this year.

 

This is a 27% increase in 1 year from the KRW 83.6 billion made in the same period in the previous year.

 

Montelukast is one of the most common ingredients used to treat allergic rhinitis and asthma.

 

The original drug is Organon Korea’s ‘Singulair’.

 

In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient.

 

The market was analyzed to have made a complete recovery this year.

 

It had continuously grown until 2019 but then had greatly contracted in 2020-2021.

 

In 2020, the prolonged COVID-19 crisis reduced hospital visits by children and adolescents, reducing prescriptions.

 

During a similar period, the US Food and Drug Administration required a ‘Black box warning’ be attached to montelukast products regarding its neuropsychiatric side effects.

 

Black box warnings are the highest level of warnings issued regarding side effects.

 

Due to the overlapping unfavorable events, the market, which was worth KRW 119.9 billion in 2019, contracted to KRW 97.7 billion in 2020 and KRW 97.6 billion in 2021.

 

Quarterly market size of montelukast asthma treatments

But the market made a rebound last year.

 

The market size expanded again to KRW 118.9 billion last year, which is a similar level to what it made in 2019.

 

The market then continued to grow further this year.

 

By quarter, it sold KRW 31.2 billion in Q1, KRW 34.7 billion in Q2, KRW 29.4 billion in Q3.

 

The analysis is that the rise in influenza and cold patients by Q3 year has increased prescriptions to alleviate related symptoms.

 

This is similar to how prescriptions for pseudoephedrine or cephalosporin-based antibiotics had increased during the same period.

 

In the case of Singulair, the flagship product, the supply of some doses had even become temporarily suspended due to rising demand.

 

In general, prescriptions for this ingredient used to be concentrated in the Q4 each year.

 

For this reason, the industry predicts that the market for treatments with this ingredient will expand to KRW 140 to 150 billion by the end of this year.

 

Unless there are any special issues, it is expected to expand to the largest scale ever.

 

Sales of Singulair generics soar… Lukio 18%, Montezal 44%↑ Prescriptions for major montelukast products also increased at the same time.

 

In the case of the original Singulair, its cumulative sales increased by 8% from KRW 20.2 billion in Q3 last year to KRW 21.9 billion in Q3 this year.

 

Sales of its generic products had risen more rapidly.

 

Sales of HK Inno.N’s Lukio increased by 18% from KRW 6.9 billion to KRW 8.1 billion during the same period.

 

The price of Hanmi Pharmaceuticals Montezal increased by 18% from KRW 4.5 billion to KRW 6.4 billion.

 

Changes in major montelukast asthma treatment prescriptions

Sales of Boryung’s Asluka rose by 44% YoY to KRW 6.4 billion, Hutecs’ Singuldown by 58% to KRW 4.5 billion, Dong Kook’s Singulmon by 23% to KRW 3.7 billion, and Daewoong Bio’s Daewoong Montelukast by 78% to KRW 3.1 billion, respectively.

 

The same goes for montelukast+levocetirizine combination drugs.

 

Hanmi’s Monterizine is the only available combination drug.

 

Monterizine’s cumulative prescriptions in Q3 reached KRW 11.2 billion, up 27% YoY compared with the KRW 8.8 billion raised in Q3 last year.

 

Monterizine is also facing challenges due to the imminent entry of montelukast.

 

10 companies - Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical – won the patent challenges against Hanmi Pharmaceuticals and owns generic exclusivity for Monterizine generics and waiting to release their generics.