Fierce competition heralded in the hair loss treatment mkt

KOR companies and multinational pharmaceutical companies all join in the competition

Lilly and Pfizer receive FDA approval for their alopecia areata treatments…preoccupies market

Daewoon’s clinical trial for its long-acting injectable formulation in smooth progress…commercialization is imminent

JW Pharmaceutical jointly develops a microneedle formulation with Theraject Asia

Enterobiome confirms the efficacy of akkermansia muciniphila in preclinical trial

The battle between global big pharma and domestic pharma-bio companies is expected to unfold in the field of hair loss treatment.

 

Multinational pharmaceutical companies that have succeeded in commercializing alopecia areata treatments - U.S.

 

companies Eli Lilly and Pfizer - have been leading the market, but local pharmaceutical companies have also been completing their clinical trials, heralding an imminent clash between them in the global market.

 

In terms of U.S.

 

FDA approval, the foreign company at the most advantage is Eli Lilly, whose Olumiant was approved in June 2022 to treat alopecia areata.

 

The drug is a Janus kinase (JAK) inhibitor class drug that contains baricitinib, an immunomodulatory and anti-inflammatory enzyme, and is the first drug that works systemically, unlike existing alopecia areata treatments that work locally on the lesion.

 

Pfizer also received FDA approval in June 2023 for Litfulo, a ritlecitinib-based treatment for alopecia areata.

 

This drug is also a JAK inhibitor class drug.

 

In particular, Pfizer’s drug gained attention as the first hair loss treatment for adolescents aged 12 and older, as previous treatments were only available for adults aged 18 and older.

 

The domestic pharmaceutical industry is focusing on developing new types of hair loss treatments that offer a better effect and convenience in intake.

 

Daewoong Pharmaceutical is making significant progress in developing a long-acting injectable that can be administered only once a month, dramatically reducing the number of doses.

 

In July last year, Daewoong completed a Phase 1 clinical trial of IVL3001, a long-acting injectable drug candidate for the treatment of hair loss, that was conducted in Australia.

 

IVL3001 is being developed as a long-acting injectable version of finasteride, an existing oral drug prescribed for androgenic alopecia in adult men.

 

Patients will be able to see an identical effect to the daily pill with once-monthly injections.

 

The results of the Phase 1 IVL3001 trial showed no evidence of an initial burst, a major weakness of existing long-acting injectables, where a large amount of drug is released into the body immediately after administration.

 

Also, the study showed that a steady level of the drug flowed steadily into the blood for more than a month, and blood levels of DHT, the male hormone that causes hair loss, remained as low as they would have been with an oral drug during the monitoring period.

 

In particular, oral finasteride is strictly off-limits to women of childbearing age because it can suppress male hormones and affect the genitals of an unborn child.

 

The availability of long-acting injectable formulations could be convenient for patients and pharmacists alike, eliminating the need for personal storage of medications due to the reduced risk of human contact.

 

Se-ho Jin, Head of Raw Material Research Center at JW Pharmaceutical, and Kim Kyoung-dong, CEO of Theraject Asia shake hand after signing an agreement this October 

JW Pharmaceutical signed a joint research agreement with Theraject Asia in October and is developing a microneedle hair loss treatment.

 

Microneedle, also known as the "sticker injection," adopts a transdermal drug delivery technology that delivers drugs through the skin with a microscopic needle about one-third the size of a human hair.

 

When a microneedle is applied to the skin, the microneedle pierces the skin and injects the drug, making it a next-generation drug delivery technology that can replace existing injections or oral medications.

 

In addition to the convenience of dosing, it has the advantage of faster recovery compared to injections and the possibility of mass production at low cost.

 

Enterobiome had also recently published the results of its research on hair loss treatment in the International Journal of the Federation of American Societies for Experimental Biology (FASEB), suggesting the possibility of new microbiome drugs.” The research was conducted in collaboration with Dr.

 

Changhwa Jung of the Korea Food Research Institute through R&D support from the Korea Institute for Advancement of Technology.

 

When orally administering the live and killed stains of Enterobiome’s leading strain, akkermansia muciniphila ‘EB-AMDK19’ to animal models with testosterone-induced hair loss for 5 weeks, both models showed a significant increase in the number of hair follicles and improved hair loss by activating beta-catenin protein, which is involved in hair follicle growth and promoting beta-catenin protein proliferation.

 

Furthermore, its hair growth efficacy was equivalent to that of finasteride, the representative hair loss treatment in the field, and the expression of fibroblast growth factor (FGF) and insulin-like growth factor-1 (IGF-1), which are well-known factors for promoting hair growth, was significantly higher in the EB-AMDK19 administered group, indicating the potential for developing innovative hair loss treatments.

 

Meanwhile, according to the Korea Health Insurance Review and Assessment Service, 243,609 patients in Korea received medical treatment for hair loss in 2021, which is an increase of about 15% compared to the 212,041 in 2016.

 

The domestic hair loss treatment market is expected to double from KRW 103.4 billion in 2021 to KRW 200 billion in 2028.

 

The global hair loss treatment market is also expected to grow at an annual rate of 8% from KRW 8 trillion in 2020 to around KRW 15 trillion in 2028, drawing attention to the emergence of new hair loss treatments both in Korea and abroad.