Sales of hypertension-hyperlipidemia 4-drug combos grow 41% year-on-year in H1

The market for the hypertension-hyperlipidemia four-drug combo therapies is showing unusually rapid growth.

The year-on-year growth rate in the first half of this year was 40.9 percent. Hanmi Pharm's Amosartan XQ led the growth with a 74.9 percent market share.

According to pharmaceutical market research firm Ubist, the total prescription dispensing value of the four-drug combination therapies for hypertension and hyperlipidemia in the first half of this year reached 8.16 billion won ($6.09 million).

The sales volume remained modest, but the growth pace is significant, considering that it increased by 40.9 percent from the 5.79 billion won in prescriptions dispensed last year.

The hypertension-hyperlipidemia four-drug combination drug market was formed in February 2021 when Hanmi Pharm launched Amosartan XQ (losartan + ezetimibe + amlodipine + rosuvastatin).

Since November 2022, GC Biopharma’s Rozetelpine (telmisartan + ezetimibe + amlodipine + rosuvastatin), Chong Kun Dang's Nuvorozet (telmisartan + ezetimibe + S-amlodipine + rosuvastatin), and Jeil Pharmaceutical's TelmicanQ (telmisartan + ezetimibe + amlodipine + rosuvastatin) have been released.

Among them, Rozetelpine and TelmicanQ are authorized generics of Duowell A Plus Tablet, a four-drug combination drug for hypertension and hyperlipidemia developed by Yuhan Corp. In May 2022, Yuhan obtained a Duowell A Plus Tablet license from the Ministry of Food and Drug Safety. However, instead of launching the product directly, it took charge of commissioned production of the delegated generics. GC Biopharma's Rozetelpine and Jeil Pharmaceutical’s TelmicanQ are manufactured at Yuhan Corp.’s Plant 1.

The hypertension-hyperlipidemia four-drug combination market has been growing rapidly since the launch of Amosartan XQ.

In 2021, the first year of Amosartan XQ's launch, the market size of the hypertension-hyperlipidemia four-drug combination was 2.28 billion won. In 2022, it nearly tripled to 6.71 billion won. In 2023, when the prescriptions of latecomers were fully counted, the market size grew to 12.74 billion won.

Amosartan XQ of Hanmi Pharm currently tops the list of the four-drug combination drugs for hypertension and hyperlipidemia. In the first half of this year, Amosaltan XQ recorded prescription sales of 6.11 billion won (up 23.4 percent year-on-year), accounting for 74.9 percent of the market for four-drug combination drugs for hypertension and hyperlipidemia.

GC Biopharma's Rozetelpine and Chong Kun Dang's Nuvorozet also showed steep growth.

Rozetelpine, launched in November 2022, generated 1.05 billion in prescription sales in the first half of this year. This represented an increase of about 126.7 percent from 460.2 million won in prescriptions dispensed in the same period last year. Rozetelpine's market share in the first half of this year was 12.9 percent, ranking second among four drug combinations for hypertension and hyperlipidemia.

Chong Kun Dang's Nuvorozet, launched in January last year, achieved prescription sales of 365 million won in the first half of last year and 790 million won in the first half of this year, an increase of 116.4 percent year-on-year. Nuvorozet's market share in the hypertension-hyperlipidemia four-drug combination market was 9.7 percent in the first half of this year.

Jeil Pharmaceutical’s TelmicanQ, whose prescription volume started to be counted in June last year, recorded prescription dispensing valued at 205 million won in the first half of this year alone. Although the amount is insignificant, it represents a 1,742.4 percent year-on-year growth. TelmicanQ's market share of the hypertension-hyperlipidemia four-drug combination market in the first half of this year was 2.5 percent, compared to a 0.19 percent share in its first year in the market.

It is also interesting to see when Boryung and Daewoong Pharmaceutical, which are conducting clinical trials for a four-drug combination for hypertension and hyperlipidemia, will enter the market.

Boryung is conducting the study after receiving approval for a phase 3 protocol for BR1018 in September last year. The drug is a four-drug combination of Boryung's Kanarb (fimasartan) plus amlodipine, atorvastatin, and ezetimibe. Clinical completion of BR1018 is scheduled for December 2025.

Daewoong Pharmaceutical is developing DWJ1451, a four-drug combination product that adds ezetimibe to the existing three-drug combination product Olomax (olmesartan + rosuvastatin + amlodipine). It has already completed four phase 1 and one phase 3 clinical trials. However, it received approval for a new phase 1 clinical trial in June last year.

As the market for four-drug combination drugs for hypertension and hyperlipidemia continues to grow, industry officials are watching how the market will change with the addition of these products.