Statin+ezetimibe combo mkt size nears ₩1 tril in KOR

Sales of atorvastatin and pitavastatin soar

Outpatient prescription of statin+ezetimibe combination drugs rise over threefold in 5 years

Rosuvastatin+ezetimibe sales exceed KRW 600 billion…atorvastatin+ezetimibe sales rise twofold in 2 years

Pitavastatin+ezetimibe posts sales of KRW 72 bil in 2 years

The statin and ezetimibe combination continues to dominate the dyslipidemia treatment market.

 

Prescriptions have more than tripled over the past 5 years, with the market size approaching nearly KRW 1 trillion.

 

The rosuvastatin-ezetimibe combination drove market growth, posting more than KRW 600 billion in sales, while the atorvastatin-ezetimibe combination expanded more than threefold after the arrival of its generics.

 

Prescriptions for pitavastatin-ezetimibe combinations also surged.

 

According to the market research institution UBIST, the outpatient prescription market for the statin-ezetimibe combinations totaled at KRW 990 billion ($90.9 million) last year.

 

This is up 24.1% from the KRW 797.6 billion in 2022.

 

The statin-ezetimibe combination market has more than tripled in 5 years from KRW 282.3 billion in 2018.

 

The growth has accelerated recently, more than doubling in the last 3 years from KRW 474.6 billion in 2020.

 

This is because statin-ezetimibe combinations are more effective in lowering low-density lipoprotein cholesterol (LDL-C) and are less expensive than taking two separate drugs.

 

Currently, 4 statin-ezetimibe combinations are available: simvastatin, rosuvastatin, atorvastatin, and pitavastatin.

 

The rosuvastatin-ezetimibe combination owns the largest share of the statin-ezetimibe combination market.

 

Last year, outpatient prescriptions for rosuvastatin-ezetimibe combinations totaled at KRW 616.4 billion, up 18.7% year-on-year.

 

This is a 33.1% rise in 2 years from the KRW 450.6 billion in 2021.

 

Compared to the KRW 197.1 billion it had made in 2018, the market has more than tripled in size in just 5 years.

 

The rosuvastatin-ezetimibe combination accounted for 62.3% of the statin-ezetimibe combination market last year.

 

Hanmi Pharmaceutical was the first to enter the market with the rosuvastatin-ezetimibe combination Rosuzet in 2015.

 

Hanmi entered the market before its competitors by securing the rights to use ezetimibe from the patent holder MSD.

 

Currently, 50 domestic pharmaceutical companies have entered the rosuvastatin-ezetimibe combination market.

 

Prescription sales of Rosuzet amounted to KRW 178.8 billion last year, up 19.3% from the previous year, ranking second among all drugs.

 

This is the third consecutive year it has ranked second since 2021.

 

Rosuzet has boasted its flagship statin-ezetimibe combination drug status, posting outpatient prescription sales in the KRW 100 billion range for 4 consecutive years, after surpassing the KRW 100 billion mark for the first time in 2020.

 

Last year, Rosuzet accounted for 29.0% of the rosuvastatin-ezetimibe combination market.

 

Atorvastatin-ezetimibe combinations have also seen steep growth in recent years.

 

Last year, prescriptions for atorvastatin-ezetimibe combinations totaled at KRW 267.3 billion, up 27.7% year-on-year.

 

Their sales soared 103.4% in 2 years, from KRW 44.2 billion in 2021 to KRW 131.4 billion.

 

The market size has expanded rapidly in a short period of time with the introduction of Atozet generics into the market in bulk.

 

Until 2020, only 1 atorvastatin-ezetimibe combination product – Organon Korea’s Atozet, was available in Korea.

 

However, Since 2021, more than 100 domestic companies have entered the atorvastatin-ezetimibe market simultaneously, expanding the market size.

 

In October 2020, Chong Kun Dang received approval for Lipilouzet, a combination drug that contains the same ingredients as Atozet, after clinical trials.

 

By this time, 22 companies had been approved to produce Lipilouzet-authorized generics and were listed for reimbursement from April 2021.

 

Beginning in February 2021, 88 pharmaceutical companies additionally received authorizations for Atozet generics and were listed for reimbursement in May, one month later than Lipilouzet-authorized generics.

 

In June 2021, two more companies received approval for Atozet generics, bringing the total number of domestic companies entering the Atozet market to 113.

 

The atorvastatin-ezetimibe combination market has expanded by 240.5% in 3 years since the introduction of the generics, up from KRW 82.8 billion in 2020 when only Atozet was available.

 

The atorvastatin-ezetimibe combination's share of the statin-ezetimibe market rose to 43.3% last year from just 22.0% in 2018.

 

Livalozet, the first pitavastatin-ezetimibe combination that was launched by JW Pharmaceuticals in 2021, has recently gained prominence in the statin-ezetimibe combination market.

 

Pitavastatin is the active ingredient in JW Pharmaceutical's flagship hyperlipidemia drug Livalo.

 

After launched in October 2021, Livalozet posted prescription sales of KRW 31.8 billion in 2022, which more than doubled to KRW 72 billion last year.

 

Simvastatin-ezetimibe combinations have been less successful.

 

Last year, prescription of the simvastatin-ezetimibe combinations amounted to KRW 34.3 billion, down 8.0% YoY.

 

It was the third consecutive year of decline after reaching KRW 42.9 billion in 2020.

 

Prescriptions for the simvastatin-ezetimibe combinations were down 20.1% last year compared to 3 years ago.

 

The original simvastatin-ezetimibe combination product, Vytorin from Organon Korea, was the first to enter the statin-ezetimibe combination market.

 

However, its prescription market has gradually shrunk compared to other combinations.

 

The simvastatin-ezetimibe combination accounted for 21.4% of the statin-ezetimibe market in 2017, but its share shrank to 5.6% last year.