₩200 bil schizophrenia treatment market is changing

with the introduction of new drugs and licensing deals

Korean companies secure originals to catch up in the global pharmaceutical company-led market.

Boryung acquires rights to sell and license Zyprexa in Korea… Whanin to introduce ‘Cariprazine’

Korea Otsuka Pharmaceutical prepares defense strategy by receiving approval for the ultra-low-dose formulation of Abilify

Change is in the air in the schizophrenia treatment market that was once led by global pharmaceutical companies such as Otsuka Pharmaceutical and Janssen.

 

Domestic companies are acquiring rights of originals and introducing new products to chase the multinational leaders in the market.

 

In response to the change, the global pharmaceutical companies are also preparing strategies such as adding a new dose to their product line for the first time in 6 years.

 

◆ Boryung rises to the rank as No.3 after securing ‘Zyprexa’ According to industry sources on the 13th, the schizophrenia treatment market in Korea is estimated to be around ₩200 billion.

 

The market had been led primarily by multinational pharmaceutical companies, with Korea Otsuka Pharmaceutical, Janssen Korea, and Lilly Korea owning the top 3 items in the market.

 

Pic of Zyprexa.

 

Boryung acquired the rights, including sales and licensing for Zyprexa from Lilly in October last year

However, a change has been forewarned in the market with Boryung’s acquisition of ‘Zyprexa (olanzapine).’ Boryung Pharmaceutical had acquired all sales and licensing rights for Zyprexa in Korea from Lilly in October last year.

 

At the same time, the company announced its plans to reinforce its CNS (central nervous system) treatment portfolio around Zyprexa.

 

The company’s goal is to raise its CNS sales, which are currently around ₩30 billion to ₩50 billion by 2025.

 

Boryung’s confidence in setting such an aggressive sales goal lies in its securement of an original drug.

 

Preference for originals is very high in the CNS treatment market that includes schizophrenia treatments.

 

In the case of olanzapine, Whanin Pharm, Myung In, Hanlim Pharm own generic versions of olanzapine, but the companies had earned very little.

 

In 2020, Whanin’s ‘Zyrepin’ earned ₩5.9 billion, Myung In’s ‘Neurozapine’ ₩3.1 billion, and Hanlim’s ‘Zyzapine’ ₩2.7 billion.

 

In other words, the original drug that has been in the country for 25 years since its approval in 1997 holds an overwhelming influence over the market.

 

This is why Boryung Pharmaceutical also made the decision to acquire the license of Zyprexa rather than release a generic version.

 

◆ Whanin plans to introduce ‘Cariprazine’…first new drug to be introduced in 11 years

After acquiring original schizophrenia drugs, Boryung and Whanin are preparing to chase its leaders in the market

This is why other Korean companies are also intent on securing their own originals.

 

In this sense, Whanin Pharm set a strategy to introduce a new drug for schizophrenia to Korea.

 

For the past decade, no new drugs had been introduced in the schizophrenia treatment market.

 

‘Abilify(aripiprazole),’ the No.1 leader in the market, was approved in 2002, and the No.2 ‘Invega (paliperidone) was also first approved in 2010.

 

Whanin’s new drug ‘Cariprazine’ therefore is the first new drug to be introduced to the Korean market in a decade.

 

Cariprazine is an atypical antipsychotic developed by the Hungarian company Gedeon Richter.

 

The drug is being sold under the brand names Vraylar in the United States and Reagila in the European Union Whanin Pharm received approval to conduct a bridging study for the introduction of the drug to Korea in April last year.

 

The trial is being conducted on 342 patients who have acute-phase schizophrenia at 30 institutions including the Seoul National University Hospital.

 

Considering that it takes around a year for a bridging study to be complete, it is expected that the company will be completing the study within the year and receive marketing authorization for the drug.

 

Samil Pharm has also jumped into the schizophrenia treatment market with an original of its own.

 

In December last year, Samil Pharm had entered into a co-promotion agreement with Viatris Korea for the sale of three drugs - schizophrenia treatment ‘Zeldox (ziprasidone),’ antidepressant ‘Zoloft,’ and anxiolytic ‘Xanax’- to expand its CNS business.

 

Dong Wha Pharmaceutical had previously been selling and distributing the drugs for the past 6 years.

 

Samil is known to have set up a team dedicated to CNS to increase the influence of the three drugs.

 

◆MNCs in defense…Otsuka receives approval for a new dosage for the first time in 6 years With the entry of such new contestants companies that are already in the lead are preparing measures to defend their ranks in the market.

 

Korea Otsuka Pharmaceutical newly received approval for its ‘Abilify 1mg’ in December last year.

 

Previously, the company had 2mg, 5mg, 10mg, 15mg dosages of Abilify in the market.

 

This is the first change made to the pipeline in 6 years since ‘Abilify Maintena Inj.’ was introduced in 2015.

 

When limiting the product to the table formulations, it is the first new dosage to be introduced in 13 years, since the company received approval for the 2mg product in 2008.

 

The industry believes this move was made conscious of the competition with domestic pharmaceutical companies that entered with original drugs at their forefront.

 

Otsuka expects the ultra-low-dose product to play a positive role in securing their lead in the market as prescriptions of low-dose products are increasing in practice.

 

No.1 and 2 in the schizophrenia treatment market, Abilify(left), Invega(right)

According to the market research institution IQVIA, Korea Otsuka Pharmaceutical’s Abilify series makes the most sales among all domestic schizophrenia treatments.

 

It recorded sales of ₩50.9 billion in 2020 with its three products -Abilify Tab, Abilify OD Tab, and Abilify Maintena Inj.

 

Last year, in the first half year alone, the company had made ₩27.4 billion with the product line.

 

The runner-up in the ranks is Janssen Korea’s Invega series.

 

Janssen Korea recorded sales of ₩25.3 billion with Invega ER Tab, Invega Sustenna Inj, and Invega Trinza Inj in 2020.

 

The company had sold ₩13.1 billion in the first half of last year.

 

The third-most sold is Zyprexa, which sold ₩14.2 billion in 2020.