Who will take over the Forxiga market worth 50 bil?

AstraZeneca to withdraw Forxiga from Korea…First-half year’s supply is secured

SLT-2 inhibitor class market likely to benefit from Forxiga’s withdrawal

Daewoong Pharmaceutical's new drug Envlo may rise and become a viable competitor

The pharmaceutical industry is closely monitoring the potential withdrawal of the diabetes drug Forxiga from the market in Korea.

 

This withdrawal is expected to intensify competition among companies aiming to fill the market gap left by Forxiga.

 

Companies that have recently introduced generics of Forxiga are predicted to enter intense market competition.

 

Furthermore, there is speculation that Daewoong Pharmaceutical, having launched a new medication from the same class this year, could benefit from these developments.

 

According to the industry, AstraZeneca Korea has officially declared on the 14th its exit from the Korean market with its diabetes treatment Forxiga.

 

This decision by AstraZeneca to withdraw from the market is attributed to increased competition arising from the introduction of generics, drug price cuts, and restructuring of their portfolio.

 

Forxiga is a SGLT-2 inhibitor class treatment for diabetes and contains dapagliflozin as its active ingredient.

 

SGLT-2 inhibitors function by preventing the reabsorption of glucose in the kidneys, which leads to the excretion of glucose via urine and consequently lowers blood sugar levels.

 

According to the data from UBIST, a market research firm, Forxiga’s prescription totaled to 51 billion won in the previous year.

 

Therefore, pharmaceutical companies already in the SGLT-2 inhibitor market may likely benefit from the Forxiga's withdrawal.

 

SGLT-2 inhibitors, which are used as diabetes treatments, has recently shown rapid growth in sales.

 

In Q3 of this year, SGLT-2 inhibitors monotherapy achieved outpatient prescription sales of 37.7 billion won.

 

This reflects a 41.0% increase compared to the previous year.

 

From Q3 of 2020, where it reached 20.1 billion won in sales, there has been a remarkable 87.2% growth over three years.

 

SGLT-2 inhibitors, unlike DPP-4 inhibitors which are another class of diabetes treatments, offer an insulin-independent mechanism of action; therefore, they are not affected by insulin resistance.

 

Additionally, clinical studies that demonstrate benefits in weight loss are seen as a positive factor contributing to the market expansion of SGLT-2 inhibitors.

 

The recent sales for dapagliflozin monotherapy, including Forxiga, have shown a steep increase in growth.

 

Q3’s prescription sales of dapagliflozin monotherapy reached 20.5 billion won, up 56.0% YoY compared to the last year.

 

The market size has approximately doubled from the 10.9 billion won in Q3 of 2021, demonstrating substantial expansion over just two years.

 

The market has significantly expanded recently with the introduction of Forxiga generics.

 

Following the expiration of Forxiga's substance patent in April, numerous pharmaceutical companies in Korea rushed to release generics containing the dapagliflozin.

 

Currently, there are approximately 60 companies that have introduced generics of Forxiga monotherapy.

 

Dapagliflozin’s prescription sales was recorded at 14.5 billion won in Q1, and it increased to 17.9 billion won in Q2, up 23.4%.

 

Compared to Q1, the prescription sales in Q3 increased by 40.8%.

 

For pharmaceutical companies, Forxiga's market exit is seen as an opportunity to grow through the substitution of generics that contain the same active ingredient.

 

In the early stage of the Forxiga generic market, Boryung Pharmaceutical and Hanmi Pharmaceutical are emerging as key players.

 

Boryung's Trudapa has achieved prescription sales of 1.2 billion won since its introduction, while Hanmi's Daparon has recorded a prescription amount of 1.1 billion won in the past six months.

 

Additionally, other companies like Chong Kun Dang, Aju Pharm, KyugDong Pharmaceutical, and Daewon Pharmaceutical have also seen prescription figures exceeding 500 million won.

 

Following Forxiga's withdrawal, prescriptions of other for-2 inhibitors like empagliflozin, ipragliflozin, ertugliflozin, and enavogliflozin may also rise.

 

Empagliflozin, already a significant player in the SGLT-2 inhibitor market alongside dapagliflozin, is expected to potentially benefit from this market shift.

 

Empagliflozin monotherapy’s sales from prescription reached 14.6 billion won in the Q3, a YoY 53.0% increase from 9.5 billion won in the Q3 of 2020, demonstrating a strong growth.

 

As for Empagliflozin-class monotherapy, Boehringer Ingelheim's Jardiance is currently the only product.

 

Daewoong Pharmaceutical's new drug Envlo may rise to become a viable competitor in the SGLT-2 inhibitor market.

 

Envlo, which contains the active ingredient Enavogliflozin, is Daewoong Pharmaceutical’s SGLT-2 class inhibitor, which was developed for the first time among domestic pharmaceutical companies.

 

It received domestic approval last year and was launched in May.

 

Envlo demonstrated superior efficacy with just 0.3 mg, which is less than one-thirtieth of the dose required by existing SGLT-2 inhibitors.

 

In phase 3 clinical trials involving patients with type 2 diabetes, it proved superior in lowering glycated hemoglobin (HbA1c) and fasting blood sugar levels, as well as in safety, compared to existing drugs.

 

Since its introduction, Envlo has achieved a prescription sales of 1.6 billion won.

 

In Q2, it reached 400 million won in prescriptions, which then increased to 1.1 billion won in Q3.

 

Despite being relatively new to the market and thus having a smaller prescription volume, Envlo has already outperformed the sales performance of ipragliflozin and etugliflozin, making it the third most prescribed drug in its class.

 

In this sense, Envlo is beginning to establish a significant presence in the market, outshining Forxiga's generics.

 

Daewoong Pharmaceutical’s past experience in marketing is postulated for the background of Envlo's market expansion.

 

Since 2018, Daewoong Pharmaceutical has been a co-distributer of Forxiga, and had led its market expansion.

 

Daewoong Pharmaceutical has proven its sales power in the anti-ulcer drug market.

 

The company distributed AstraZeneca's PPI class anti-ulcer drug Nexium for 13 years, from 2008 to last year.

 

This year, they have focused on selling self-developed gastroesophageal reflux disease drug, Fexuclue.

 

Fexuclue has successfully penetrated the market, recording a prescription amount of 37.4 billion won in its second year until the Q3 of this year.

 

Last year, Daewoong Pharmaceutical launched Nexierd, containing the active ingredient Esomeprazole, and its cumulative prescription sales in Q3 of this year reached 4.8 billion won, ranking it among the top in its class.

 

AstraZeneca has secured the domestic supply of Forxiga until the first half of next year and is discussing patient protection measures with the Ministry of Food and Drug Safety (MFDS).