Donepezil ↑8%, memantine 10%↑…replaces choline alfoscerat

Donepezil-based dementia drug market reaches KRW 162.6 billion in the first half, up 8% year-on-year

Sales of memantine preparations rise from KRW 27.7 billion to KRW 30.4 billion in one year... Nicergoline preparations also up 36%

Amid efficacy controversies, choline alfoscerate formulations maintain prescription sales of KRW 30 billion.

Aricept(donepexil), Ebixa(memantine), Sermion(nicergoline) products that are considered alternatives to choline alfoscerate

Sales of donepezil, memantine, and nicergoline-based dementia treatments, which have emerged as alternatives to choline alfoscerate formulations, are growing.

 

In the first half of this year, donepezil’s sales recorded KRW 162.6 billion, an 8% increase from the previous year.

 

Sales of memantine-based formulation increased by 10% year-on-year, and nicergoline-based formulations also increased by 36%.

 

Prescription market for the choline alfoscerate alternative ‘donepezil’ grows from KRW 151.1 billion to KRW 162.6 billion in one year According to the pharmaceutical market research institution UBIST on the 6th, the outpatient prescription sales of donepezil-based formulations in the first half of this year amounted to KRW 162.6 billion.

 

This represents an 8% increase from the KRW 151.1 billion in the first half of last year.

 

Donepezil is used to treat symptoms of Alzheimer's dementia.

 

The original product is Hanok's Aricept.

 

In August 2000, Daewoong Pharmaceutical imported the finished product from the original developer and began domestic production and supply.

 

Subsequently, the domestic marketing rights were transferred to Hanok.

 

Sales are handled by Eisai Korea.

 

In 2019, the indication for ‘vascular dementia’ was removed following a clinical reevaluation, but it has had little impact on prescription sales.

 

On the contrary, it has continued to grow by around 5-8% annually since 2020.

 

Prescription sales of donepezil-based formulations increased from KRW 243.6 billion in 2020 to KRW 259.8 billion in 2021, KRW 171.5 billion in 2022, KRW 291.9 billion in 2023, and to KRW 313.9 billion last year.

 

Considering the upward trend in prescriptions in the first half of this year, its sales are expected to continue to increase at the same level as previous years.

 

In particular, sales of generic products have shown marked growth.

 

While the sales of the original product Aricept increased by only 2% from KRW 52.2 billion in the first half of last year to KRW 53.4 billion in the first half of this year, sales of generic products increased by 11% from KRW 98.9 billion to KRW 109.3 billion during the same period.

 

Sales of Daewoong Bio's Beacept increased 14% from KRW 14.9 billion to KRW 17 billion, Samjin Pharmaceutical's Neutoin increased 27% to KRW 6.4 billion in a year, and Whan In Pharm’s Donegil increased 88% to KRW 3.8 billion.

 

The rise of donepezil preparations is analyzed to connected to the crisis of choline alfoscerate products.

 

Choline alfoscerate, which were previously the most widely used in the field of dementia prevention, are facing market withdrawal due to reduced reimbursement for their indications and clinical reevaluations.

 

Initially, choline alfoscerate drugs had three indications: ▲secondary symptoms and degenerative or degenerative brain syndrome caused by cerebrovascular defects; ▲emotional and behavioral changes; ▲senile pseudo-depression.

 

During the clinical reevaluation process, two of the three indications were removed, excluding its use as a treatment of ‘secondary symptoms and degenerative or degenerative brain disorders caused by cerebral vascular defects.’ A separate clinical reevaluation to verify the drug’s safety and efficacy is also underway.

 

If pharmaceutical companies fail to prove efficacy in the clinical reevaluation process, their drugs will have to be completely withdrawn from the market.

 

In addition, they must return 20% of the prescription amounts accrued during the clinical trial period to the health authorities.

 

Given this situation, the pharmaceutical industry has been intent on finding alternatives to replace choline alfoscerate.

 

In this process, donepezil, which has similar indications to choline alfoscerate, has emerged as one of the main alternatives.

 

Although it has been used consistently for dementia prevention, there has been a series of new product approvals since the threat of choline preparations being withdrawn from the market.

 

In fact, since June 2020, when the Ministry of Food and Drug Safety requested companies with choline alfoscerate-based products to submit clinical trial data, 39 pharmaceutical companies have received new approvals for 50 donepezil preparations.

 

Quarterly prescriptions of donepezil products (Unit: KRW 100 million, Source: UBIST)

The rise in sales of donepezil-based formulations is analyzed as linked to the crisis of choline alfoscerate drugs.

 

Choline alfoscerate-based formulations, which were previously the most widely used ingredient in the field of dementia p #Sales of memantine-based formulations rise from KRW 27.7 billion to KRW 30.4 billion in one year...

 

Sales of nicergoline preparations also jumped 36% The same situation goes for memantine and nisergoline-based products.

 

These two ingredients are considered major alternatives to donepezil and choline alfoscerate.

 

Prescription of memantine-based products increased 10% in the first half of this year, reaching KRW 30.4 billion, compared to the KRW 27,7 billion in the same period last year.

 

Memantine is indicated for the treatment of moderate-to-severe Alzheimer's disease.

 

The original product is Lundbeck's ‘Ebixa,’ which was approved in 2003.

 

Like donepezil-based formulations, new product approvals have skyrocketed since June 2020.

 

Twenty-seven pharmaceutical companies have been approved for 37 products in the last five years.

 

One in three of all memantine products (109) on the market has been approved since the controversy arose over the efficacy of choline preparations.

 

At the end of last year, approvals for new combination products that contain memantine and donepezil followed one after another.

 

After HyundaiPharm received approval for ‘DM Duo,’ eight companies obtained approval for 14 additional products.

 

Related products collectively achieved prescription sales of KRW 500 million in the first half of this year.

 

Among choline esterase inhibitor alternatives, nicergoline-based formulations have had the most new product approvals in the industry.

 

Nicergoline is approved for the ‘primary treatment of dementia symptoms such as memory impairment, concentration disorders, judgment disorders, and lack of initiative associated with primary degenerative vascular dementia and mixed dementia.’ The original product is Ildong Pharmaceutical’s Sermion.

 

Ildong Pharmaceutical received approval for this product in 1997.

 

Until 2022, no subsequent products were approved, excluding those for export.

 

However, since 2023, new product approvals have been granted one after another.

 

Following Hanmi Pharmaceutical's approval of ‘Nicegoline’ in January 2023, 39 companies have received approval for 53 products as of recently.

 

Prescription sales of nicergoline formulations increased by 36% from KRW 3.3 billion in the first half of last year to KRW 4.5 billion in the first half of this year.

 

In particular, the growth of new follow-on products that were recently released to the market has been rapid.

 

The combined prescription sales of the follow on products, which amounted to only KRW 400 million in the first half of last year, increased more than threefold to KRW 1.5 billion in just one year.

 

Sermion’s sales also increased slightly from KRW 2.9 billion to KRW 3 billion.

 

Sales of existing choline preparations recorded KRW 294 billion in the first half of this year.

 

Although this represents a slight decrease from the KRW 301.4 billion in the first half of last year, it still boasts prescription sales of nearly KRW 300 billion, demonstrating its continued popularity.

 

Daewoong Bio and Chong Kun Dang, which hold the top two positions in the existing choline alfoscerate market, are also actively seeking alternatives.

 

Daewoong Bio's ‘Gliatamin’ and Chong Kun Dang's ‘Chongkundang Gliatirin’ accounted for more than half of the total choline preparation market in the first half of the year.

 

In preparation for the withdrawal of its choline alofscerate products, Daewoong Bio has received approval for ‘Beacept,’ which contains donepezil, ‘Glibixa’ containing memantine, and ‘Daewoong Nicergoline’ containing nicergoline.

 

Chong Kun Dang has obtained approval for ‘Neuromanthyn’ containing memantine and ‘Nexcholine’ containing nicergoline.

 

Additionally, at the end of last year, it added ‘Neurocept Duo,’ a combination of donepezil and memantine.