10 years since stem cell therapy was introduced

CARTISTEM has sold 10 billion won for 5 years in a row since 2017

Sales of the remaining three types of Cellgram, Cupistem, and Neuronata are insignificant

No approval for stem cell therapy since 2014

4 types of domestic approved stem cell therapy

Ten years have passed since stem cell treatments appeared in Korea, but they have yet to produce commercial results.

 

Medipost's CARTISTEM is recording annual sales of 10 billion won in Korea, but there is virtually no overseas sales.

 

According to the Financial Supervisory Service on the 2nd, Medipost's sales of stem cell treatments in the first quarter were 4.5 billion won, up 3.5% from a year earlier.

 

Medipost's stem cell therapy is the only treatment for osteoarthritis, CARTISTEM.

 

CARTISTEM is a drug mainly composed of stem cells derived from cord blood of the same kind.

 

Medipost succeeded in developing the world's first cord blood-derived stem cell therapy using cord blood stem cells from others, and received an item approval from the MFDS in January 2012.

 

It is used for the treatment of knee cartilage defects in ICRS grade IV.

 

After surpassing 10 billion won in sales for the first time in 2017, CARTISTEM posted 10 billion won in sales for five consecutive years until last year.

 

Last year, CARTISTEM's sales reached 17.2 billion won.

 

However, the recent growth has slowed down somewhat.

 

CARTISTEM's sales grew 36.1% and 16.6% year-on-year in 2018 and 2019, respectively, but in 2020 and 2021, they increased only 3.2% and 3.8% year-on-year, respectively.

 

Looking at sales in the first quarter, CARTISTEM increased 95.1% and 40.1% year-on-year in the first quarter of 2018 and 2019.

 

However, CARTISTEM's sales in the first quarter of 2020 and 2021 grew less than 1% year-on-year and recorded 3% growth this year.

 

Medipost is seeking to enter the global market of CARTISTEM, but no overseas sales have occurred yet.

 

The sales performance of other stem cell treatments other than CARTISTEM is even lower than expected.

 

Currently, there are a total of four types of stem cell treatments approved in Korea.

 

After Pharmicell's acute myocardial infarction treatment Hearticellgram-AMI was approved in Korea as the world's first stem cell treatment in 2011, CARTISTEM and Antrogen's Crohnistem were approved for market in 2012, and CORESTEM's Lou Gehrig's fourth stem cell treatment in 2014.

 

In the first quarter of last year, Pharmicell's bio business sales were only 572 million won.

 

Pharmicell's bio business includes cosmetics along with Hearticellgram-AMI.

 

Last year, Pharmicell's bio business sales were only 800 million won.

 

Cupistem posted 700 million won in sales in 2020, including stem cell culture.

 

It recorded 359 million won in sales in the first quarter of last year.

 

Antrogen has not disclosed sales by business units since the second quarter of last year.

 

Total sales of anthrogen in the first quarter were 1.7 billion won.

 

CORESTEM's Neuronata recorded sales of 1.9 billion won and 1.2 billion won, respectively, in 2020 and last year.

 

It made 300 million won in sales in the first quarter.

 

Although it received great attention at the time of domestic approval, it is not in high demand due to the characteristics of rare diseases, and its preference is rarely increasing at the prescription site.

 

Stem cell therapy was once in the spotlight as a next-generation growth engine, but news of the recent emergence of new products is also far from clear.

 

Since Neuronata's approval in 2014, there are no stem cell treatments approved for eight years.

 

In 2016, the Ministry of Food and Drug Safety revised the regulations for product licensing screening such as biological drugs, allowing cell therapy used for life-threatening diseases or severe irreversible diseases to receive conditional approval only with the results of phase 2 clinical trials.

 

The intention is to shorten the time to enter the market for cell therapy products whose safety has been confirmed and treatment effects have been searched.

 

A life-threatening disease is a disease that is likely to die if it is not accompanied by appropriate treatment and is defined as a disease in which there is no alternative to treatment.

 

Serious irreversible disease refers to a disease or condition in which irreversible pathological conditions deteriorate for functions necessary for daily life if appropriate treatment is not accompanied.

 

After easing regulations on cell therapy approval, bio companies such as Kang Stem Biotech, Naturecell, and Pharmicell attempted conditional approval of stem cell treatments, but all failed.