Oral lung cancer drug market race

Robust sales for Tagrisso·Leclaza·Lorviqua

Analysis of outpatient sales of key lung cancer targeted therapies, such as EGFR·ALK

Sales for Leclaza·Tagrisso…third-generation targeted therapies dominate the market

Alecensa leads the market·Lorviqua is on a chase…competition in the ALK lung cancer market heats up

Late entrants, such as Leclaza and Lorviqua, are expanding their presence in the Korean lung cancer targeted therapy market, continuing rapid growth.

 

While prescription sales for some EGFR and ALK-positive non-small cell lung cancer (NSCLC) treatments are stagnating or declining, newer drugs in these categories are showing a clear upward trend, driven by expanded reimbursement or additional indications.

 

3rd-generation targeted therapies for first-line treatment…distinct growth trend According to market research firm UBIST, on July 16, Leclaza's Q2 outpatient prescription sales reached KRW 20.6 billion, a 92.5% year-over-year (YoY) increase.

 

This marks the first time Leclaza's quarterly prescription sales have surpassed KRW 20 billion.

 

Leclaza is a 3rd-generation tyrosine kinase inhibitor (TKI) developed by Yuhan Corp.

 

EGFR-positive lung cancer treatments are categorized into: first-generation drugs with AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation with Boehringer Ingelheim's Giotrif (afatinib) and Pfizer's Vizimpro (dacomitinib); and third-generation with Leclaza (lazertinib) and Tagrisso (osimertinib).

 

All of these are oral treatment options.

 

Given their oral formulation, outpatient prescriptions are possible.

 

However, considering inpatient prescription sales (which include prescriptions for hospitalized patients), their actual prescription volume is estimated to be even larger.

 

Prescription sales of EGFR-positive lung cancer treatments (unit: KRW 100 million, source: UBIST).

 

Dark Blue-Iressa (gefitinib), Orange-Tarceva (erlotinib), Yellow-Giotrif (afatinib), Gray-Vizimpro (dacomitinib), Sky Blue-Leclaza (lazertinib), Green-Tagrisso (osimertinib).

Leclaza, approved in Korea in January 2021, was officially launched into the market with reimbursement coverage in the same year.

 

Leclaza secured KRW 4.1 billion in prescription sales in just two quarters, recorded KRW 17.4 billion the following year, and successfully surpassed KRW 40 billion last year.

 

Leclaza's outpatient prescription sales in the first half of the year alone reached KRW 38.2 billion, nearing its full-year prescription sales for 2024.

 

Analysis suggests that Leclaza's increase in prescription sales is attributed to its approval as a first-line treatment for EGFR-positive lung cancer in July 2023.

 

Previously, for patients to use Leclaza with reimbursement, they needed to have T790M positivity confirmed through a re-biopsy after using first- or second-generation TKIs.

 

With Leclaza, Tagrisso, and other third-generation TKIs now covered as first-line treatments starting this year, the range of choices for medical professionals and patients has expanded to include the entire spectrum of first- to third-generation targeted therapies.

 

Another strength of Leclaza is its potential for combination with Rybrevant.

 

Recently, combination therapies such as Tagrisso + platinum-based chemotherapy and Rybrevant + platinum-based chemotherapy have obtained approval from overseas regulatory agencies as first-line treatments for lung cancer.

 

Leclaza, which targets EGFR mutations in exons 19 and 21, and Rybrevant, which targets exon 20, are attracting attention as a combination of targeted therapies.

 

Currently, the Leclaza + Rybrevant combination therapy is approved as a first-line treatment for lung cancer in Korea, the U.S., Europe, and Japan.

 

AstraZeneca's Tagrisso maintains its market leadership.

 

Tagrisso's Q2 prescription sales were KRW 47.3 billion, a 46.4% increase from the same period last year.

 

Tagrisso's Q1 prescription sales increased by 53.7% year-on-year to KRW 43 billion, and its Q2 sales expanded by 46.4% to KRW 47.3 billion.

 

Tagrisso is the only TKI that can be used in patients with early-stage lung cancer.

 

In February 2021, Tagrisso was approved in Korea for adjuvant treatment after complete tumor resection in EGFR exon 19 and exon 21 mutated non-small cell lung cancer patients.

 

In the Phase 3 ADAURA study, the Tagrisso treatment group showed a 51% reduction in the risk of death compared to conventional treatment.

 

During the same period, the growth of first·second-generation TKIs stagnated.

 

Among them, Boehringer Ingelheim's Giotrif had the highest prescription sales.

 

Giotrif recorded KRW 2.9 billion in outpatient prescription sales in Q2 2025, maintaining the highest performance among first and second-generation drugs.

 

However, its quarterly prescription sales have consistently decreased from KRW 5.2 billion in Q1 2023, falling by half in just over a year.

 

Iressa also showed a downward trend during the same period, falling from KRW 4.5 billion to KRW 2.1 billion.

 

Tarceva's prescription volume decreased to KRW 700 million, and Vizimpro's to KRW 100 million in Q2 last year.

 

The establishment of third-generation targeted therapies as first-line options contributed to the decline in their prescription sales.

 

ALK market also shifting…Lorviqua chases Following the EGFR treatment market, the ALK-positive NSCLC treatment market is also showing signs of change.

 

A generational shift is underway, with second-generation drugs performing well and third-generation treatments expanding their reach.

 

The market leader in this segment is Alecensa.

 

Alecensa's Q2 prescription sales reached KRW 8.4 billion, representing an 18.3% year-over-year increase.

 

Alecensa has shown steady growth since its prescription sales surpassed KRW 5 billion in Q3 2020.

 

This treatment has maintained an average quarterly prescription sales of over KRW 8 billion since 2021.

 

Prescription sales of ALK-positive NSCLC treatment market by quarters (unit: KRW 100 million, source: UBIST).

 

Blue-Xalkori, Gray-Alecensa, Orange-Alunbrig, Yellow-Lorviqua.

Alecensa is a second-generation ALK-positive targeted therapy developed by Roche.

 

Targeted therapies used for ALK-positive lung cancer are categorized into three generations: first-generation, represented by Pfizer's Xalkori; second-generation, including Alecensa and Takeda's Alunbrig; and third-generation, represented by Pfizer's Lorviqua.

 

Alecensa's increasing potential for use in early-stage lung cancer patients has given it the green light to maintain its market-leading position.

 

According to clinical data disclosed at the European Society for Medical Oncology (ESMO 2023) annual meeting, Alecensa showed effectiveness in adjuvant chemotherapy after surgery.

 

Alecensa successfully added the early-stage lung cancer indication in Korea in September of last year.

 

Pfizer's Lorviqua recorded KRW 4.3 billion in Q2 prescription sales, a 53.6% increase year-on-year.

 

Lorbrenda's quarterly prescription performance has steadily increased from KRW 2.3 billion in Q1 2023, nearly doubling in two years.

 

Lorviqua, a third-generation ALK inhibitor, has rapidly expanded its presence due to its excellent ability to control brain metastases and systemic efficacy.

 

Additionally, the expansion of its reimbursement coverage for first-line treatment, starting this year, is also cited as a major factor in its growth.

 

Alunbrig recorded KRW 2.7 billion in outpatient prescription sales in Q2 this year.

 

This is a 22.9% decrease compared to KRW 3.5 billion in the same period last year.

 

Alunbrig initially generated demand by emphasizing its convenience of administration, central nervous system penetration rate, and response rate during its early introduction.

 

However, its competitiveness appears to be weakening recently due to Lorviqua's rapid growth.

 

Xalkori's Q2 prescription sales decreased by 6.6% to KRW 1.4 billion compared to last year.

 

Xalkori, a first-generation ALK inhibitor, has shown a continuous decline in prescriptions since the emergence of subsequent drugs.

 

This is because late entrants have proven superior efficacy and safety compared to Xalkori.

 

Second and third-generation targeted therapies are known to have lower drug toxicity and reduced incidence of adverse reactions compared to first-generation therapies.

 

They are known to demonstrate superior therapeutic efficacy.

 

Additionally, second and third-generation targeted therapies have the advantage of higher CNS penetration, including into the brain.