Keytruda leads mkt for 4 consecutive years

Power of innovative new drug designation and reimbursement expansion

Last year's sales of Keytruda reach KRW 39.87 billion, twofold difference from runner-up product… sales surge after reimbursement expansion

Sales of new drugs from multinational pharmaceutical companies such as Prolia, Dupixent, and Opdivo surge

The immuno-oncology drug Keytruda has taken the lead in the domestic market for the 4th consecutive year.

 

Its quarterly sales exceeded KRW 100 billion for the first time in the domestic market after being expanded reimbursement to the first line.

 

The gap with the runner-up had more than doubled, reinforcing Keytruda’s leadership in the market.

 

According to the market research institution IQVIA on the 21st, MSD’s Keytruda topped the list of drugs sold in Korea last year with sales of KRW 398.7 billion.

 

The drug had continued to show high growth, rising 66.4% from the previous year.

 

This is the fourth consecutive year that Keytruda has kept the lead, having first topped the list in 2020 with sales of KRW 155.7 billion.

 

Released in 2015, Keytruda 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 activating the immune system to treat cancer.

 

Currently, Keytruda is indicated to treat▲Lung cancer, ▲head and neck cancer, ▲ Hodgkin 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.

 

The drug is currently reimbursed for 7 indications in 4 types of cancer - non-small cell lung cancer, melanoma, urothelial carcinoma, and Hodgkin's lymphoma.

 

Keytruda is also reimbursed for first-line use in melanoma and NSCLC.

 

In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion.

 

However, its sales started to surge with reimbursement approval.

 

After being reimbursed as a second-line treatment for non-small-cell lung cancer in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018 and then exceeded KRW 100 billion by 2019.

 

In 2020, the drug outsold the then-lead Lipitor and rose to the lead.

 

Keytruda’s sales grew 28.5% and 19.7% year-on-year in 2021 and 2022, respectively, and the growth rate accelerated further last year with its reimbursement expansion.

 

In March 2022, Keytruda’s reimbursement was extended to cover its use as a first-line treatment for non-small cell lung cancer.

 

Keytruda's sales then increased 33.4% from KRW 40.4 billion in Q1 2022 to KRW 53.9 billion in Q2 2022.

 

In Q3 and Q4, the drug’s sales rose to reach KRW 67.2 billion and KRW 78 billion, respectively Keytruda’s sales exceeded KRW 80 billion and KRW 90 billion in Q1 and Q2 last year, respectively, then exceeded KRW 100 billion in Q3.

 

In Q4 its sales reached KRW 108.9 billion, renewing its record for the 6th consecutive quarter since Q3 2022.

 

Despite a 25.6% reduction in its price ceiling that was applied in March 2022 with the reimbursement expansion, Keytruda’s Q4 sales increased 99.3% compared to Q4 2021, before the reimbursement expansion.

 

As such, Keytruda has again solidified its market lead, with its sales more than double what was posted by the runner-up in the market, Prolia.

 

New drugs from multinational pharmaceutical companies have also shown strong sales last year.

 

Amgen's Prolia ranked second overall with sales of KRW 151.1 billion last year, up 30.6% from the previous year.

 

Its sales increased 64.0% in 2 years from KRW 92.1 billion in 2021.

 

Prolia, which was released in November 2016 in Korea, 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 for first-line use in April 2019, Prolia’s sales rose explosively.

 

In 2022, Prolia’s sales exceeded KRW 100 billion for the first time in 6 years and continued strong growth last year as well.

 

Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.1% YoY to record ₩143.2 billion last year.

 

Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription 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.

 

After posting sales of KRW 77.2 billion in 2021, its sales grew 85.4% in 2 years.

 

Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 18.7% YoY to record ₩130.4 billion this year.

 

Sales of Opdivo, which was approved in 2015, grew greatly after being listed for reimbursement in 201 It exceeded annual sales of KRW 100 billion for the first time in 2022 with sales of KRW 109.9 billion, and sales grew even further last year.

 

Its sales had grown 85.4% over the 2 years.

 

Also, other new drugs from multinational pharmaceutical companies, such as Lipitor, Perjeta, Tagrisso, and Gardasil, surpassed the KRW 100 billion mark in sales last year.

 

Among drugs developed by domestic companies, HK Inno.N’s K-Cab and Hanmi Pharmaceutical's Rosuzet topped the list with sales in the KRW 100 billion range.