Generation shift of ALK targeted drugs... rise of Alecensa

Alecensa occupies 60% of market

1st generation Xalkori's sales fall… market share falls from 86%→24% in 4 years

'Alecensa' occupies over half of the market…latecomer ‘Alunbrig’ is on a fierce chase

First 3rd generation ‘Lorviqua’ introduced to the market… rises as a new alternative in the second-line

The targeted cancer therapy market for patients with ALK mutations has been restructured around second-generation drugs.

 

The share of the first-generation drug Xalkori, which used to occupy 2/3 of the market fell to 20%, and the representative second-generation drug ‘Alecensa' took over the market.

 

However, Alunbrig, a latecomer into the second-generation treatment market, has been rapidly chasing the market leader Alecensa that has currently occupied over half of the market.

 

According to the pharmaceutical research institution IQVIA on the 8th, the Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) market recorded ₩54.4 billion last year, which was an 11.9% and ₩48.6 billion increase from the previous year.

 

The ALK TKI market, whose doors were first opened by ‘Xalkori (crizotinib),’ is used to treat patients with ALK-positive non-small-cell lung cancer (NSCLC).

 

With the introduction of next-generation drugs that have demonstrated improved efficacy, a total of 5 drugs are currently present in the market.

 

In addition to second-generation drugs ‘Zykadia (ceritinib),’ ‘Alecensa (alectinib),’ ‘Alunbrig (brigatinib),’ a third-generation drug ‘Lorviqua (lorlatinib)’ has also entered the market last year.

 

Compared to 2017, the market transition from first-generation to second-generation drugs is quite clear.

 

In 2017, Xalkori had an oligopoly over the market as the only ALK TKI option and accounted for 86% of the market.

 

Its sales had recorded nearly ₩36.5 billion that year, followed by the first second-generation drug, ‘Zykadia,' which made ₩5.1 billion, then Alecensa's ₩1.1 billion.

 

However, in 4 years in 2021, the landscape had completely shifted with the proof that second-generation drugs have a better effect in patients with brains metastasis.

 

With doctors opting for second-generation drugs in the first line, Alecensa’s market share rose to 60%.

 

Shares of another second-generation drug, Alunbrig, took over 15% of the market, making ₩8 billion in sales.

 

Xalkori’s sales fell to 24%, making ₩13.1 billion.

 

Roche’s Alecensa and Takeda’s Alunbrig are representative second-generation ALK TKIs.

 

By market entry, Alecensa entered the market 2 years earlier than Alunbrig.

 

Alecensa expanded its indication to the first-line in 2018 and was granted reimbursement in December of the same year to quickly replace Xalkori.

 

In 2018, Alecensa sold ₩10.4 billion, which was 1/4 of the sales made by Xalkori (₩49.6 billion).

 

After receiving reimbursement in 2019, Alecensa sold ₩22.1 billion and exceeded the Xalkori's ₩20.3 billion in sales.

 

Alecensa's sales increased to ₩29.3 billion in 2020 and ₩32.7 billion in 2021.

 

Alunbrig, which was approved in December 2018, aimed to rapidly enter the market and catch up with Alecensa.

 

As soon as it was approved for the first linein August 2020, the company applied for its reimbursement and succeeded in expanding its reimbursement in only 7 months.

 

With the reimbursement approval as a first-line treatment that was granted in April last year, the company is working to expand its share in the market.

 

Sales in 2020 were ₩3.9 billion won, far short of that of Alecensa and Xalkori, sales increased 102.9% to ₩8 billion after the reimbursement expansion.

 

On the other hand, the first second-generation drug, Novartis’s Zykadia, has been going down a completely different path.

 

Zykadia’s sales which had surged to ₩5.1 billion in the past had started to fall sharply with the introduction of Alecensa.

 

It sold ₩2.2 billion in 2018, ₩0.9 billion in 2019, and only ₩0.5 billion last year.

 

The anlaysis is that this rapid drop in sales is due to the relatively higher instance of side effects compared to Alecensa or Alunbrig.

 

The first third-generation ALK TKI was introduced last year.

 

Xalkori’s developer Pfizer had introduced the first-ever third-generation drug Lorviqua.

 

Lorviqua was first to be approved as a second-line treatment for ALK-positive NSCLC in July last year and rose as a new alternative due to its ability to manage the resistance developed after first-line treatment.

 

Lorviqua can manage the resistance caused by G1202R mutation, as well as those by F1174L (Zykadia), I1171T/N/S (Alecensa), E1210K (Alunbrig).

 

Lorviqua is not listed for reimbursement yet and is expected to generate sales in earnest after passing the National Health Insurance Service’s Drug Reimbursement Evaluation Committee and drug negotiations with the authorities.

 

In particular, as Lorviqua is attempting to expand its territory into first-line treatment for ALK-positive patients, its its competition with second-generation drugs are also being expected to arise soon.

 

The drug already owns a first-line indication for ALK-positive NSCLC in the US and Euope.