
The immuno-oncology drug Keytruda has strengthened its dominance in the domestic drug market, maintaining quarterly sales in the KRW 100 billion range.
After being granted reimbursement expansion as a first-line treatment, Keytruda’s sales surged even greater, tripling the sales gap with the runner-up in the market.
Also, other new anticancer drugs from multinational pharmaceutical companies like Tagrisso and Imfinzi showed strong growth.
According to the market research institution IQVIA on the 24th, sales of MSD Korea’s Keytruda led the market with sales of KRW 116.8 billion in Q1, up 33.1% YoY.
This marks the 17th consecutive quarter that Keytruda has held the top spot in the domestic drug market since taking the top spot in Q1 2020.
Keytruda, which was introduced to Korea in 2015, is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activates the immune system to treat cancer.
The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head and neck cancer, ▲ Hodgkin’s lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer.
It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea.
It is reimbursed for 7 indications in 4 types of cancer – non-small-cell lung cancer, melanoma, urothelial carcinoma, and Hodgkin’s lymphoma.
It is also reimbursed as a first-line treatment for melanoma and non-small-cell lung cancer.
It has shown accelerated performance since its reimbursement was extended to the first line in 2022.
In March 2022, Keytruda’s reimbursement was extended to cover first-line treatment for non-small cell lung cancer.
Keytruda’s sales jumped 117.1% in one year, from KRW 40.4 billion in Q1 2022 to KRW 87.8 billion in Q1 last year.
Its Q1 sales this year tripled compared to 2 years ago.
Since exceeding sales of KRW 100 billion in Q3 last year, the drug has posted sales of over KRW 100 billion for 3 consecutive quarters.
This is the first time a drug’s quarterly sales have surpassed KRW 100 billion in the domestic pharmaceutical market.
Keytruda’s sales are nearly three times higher than the second place, Prolia.
Keytruda's insurance ceiling price was lowered by 25.6% with the reimbursement expansion.
Considering how sales had increased by twofold in Q1 compared to Q4 2021, before the reimbursement expansion, it is calculated that Keytruda’s prescriptions increased by over threefold during the period.
Also, AstraZeneca’s anticancer drug Tagrisso has benefited from the reimbursement expansions this year.
Q1 sales of Tagrisso were KRW 39.9 billion, up 46.0% YoY.
Tagrisso is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
EGFR-TKIs are targeted anticancer drugs prescribed to patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutations.
Tagrisso’s quarterly sales surpassed KRW 20 billion in Q1 2020 and remained in the KRW 20 billion range until Q4 last year.
Beginning this year, Tagrisso, along with Yuhan Corp’s Leclaza, were granted reimbursement expansions as were covered as a first-line treatment for locally advanced or metastatic NSCLC with certain genetic mutations.’ Tagrisso reported sales of KRW 26.9 billion in Q4 last year, and sales jumped 47.9% in a single quarter after the reimbursement expansion.
Health authorities estimate that Tagrisso's coverage as a first-line treatment will cost an additional KRW 92 billion, according to the Ministry of Health and Welfare.
Yuhan Corp’s Leclaza’s sales more than tripled to KRW 18.9 billion in Q1 from KRW 6.2 billion in sales in Q4 last year.
The MOHW analyzed that the reimbursement coverage of Leclaza as a first-line treatment will cost the nation an additional KRW 88.1 billion.
New products recently launched by multinational pharmaceutical companies have also risen to prominence at the top of the domestic drug market.
Amgen's Prolia ranked second overall with Q1 sales of KRW 41.2 billion, up 16.2% from the previous year.
This is a 64.7% increase in 2 years from KRW 25 billion in Q1 2022.
Launched in Korea in November 2016, Prolia is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone.
Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017.
After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively.
Prolia is copromoted by Chong Kun Dang in Korea.
Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 30.9% YoY to record KRW 40.5 billion in Q1.
Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with topical therapies or who cannot use topical therapies.
Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020.
Sales of the immuno-oncology drug Imfinzi increased 107.1% YoY to reach KRW 31.5 billion in Q1 this year.
Imfinzi is a PD-1-targeted immuno-oncology drug developed by AstraZeneca.
Imfinzi was the first immuno-oncology drug to demonstrate efficacy in biliary tract cancer.
In 2022, AstraZeneca received approval for the combination of Imfinzi+gemcitabine+cisplatin in South Korea.
The combination became the new standard of care for biliary tract cancer in 12 years.
AstraZeneca is currently in the process of expanding reimbursement to the biliary tract cancer indication.
Among domestically developed new drugs, HK Inno.N’s gastroesophageal reflux disease treatment K-CAB’s sales had risen 21.6% YoY in 1H to record KRW 32.2 billion, and rose to 6th place.
K-CAB, was released in March 2019.
It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion.
Hanmi Pharmaceutical's hyperlipidemia combination drug Rosuzet ranked 10th overall with sales of KRW 29.3 billion in Q1.
Rosuzet is a combination drug that contains rosuvastatin and ezetimibe.
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