Remarks by President Lee Jae-myung on hair loss triggered an immediate reaction across the pharmaceutical and biotech industry. Interpreted as a signal that hair loss treatment, long confined to the realm of "cosmetics," could be brought into the formal medical system, shares of related corporations surged across the board.

According to the Korea Exchange (KRX) on the 17th, shares of pharmaceutical and biotech corporations tied to hair loss treatments rose sharply the previous day.

Withus Pharmaceutical, which is developing the long-acting injectable hair loss treatment "IVL3001" with Inventage Lab, hit the upper price limit, closing at 8,740 won, up to the price cap (29.87%).

JW Shinyak, which has a relatively broad hair loss treatment portfolio ranging from the oral prescription drugs "Monad (ingredient: finasteride)" and "Dutamore (ingredient: dutasteride)" to a topical agent and the next-generation new drug "JW0061," closed at 1,892 won, up 26.13% from the previous day.

Hyundai Pharm, which owns the "Minoxyl" brand containing minoxidil for hair loss treatment, also rose 14.53% to 7,250 won.

President Lee Jae-myung speaks at a briefing by the Ministry of Health and Welfare (Korea Disease Control and Prevention Agency) and the Ministery of Food and Drug Safety held at the Government Sejong Convention Center on the 16th./Courtesy of Presidential Office Press Photographers

The direct trigger for the stock surge was the president's remarks. At a Ministry of Health and Welfare briefing the previous day, the president said, "Isn't hair loss also part of a disease? It's a problem many young people face these days," adding, "It used to be called cosmetics, but these days there's a tendency to see it as a matter of survival." The president also said, "If there is a fiscal burden, we could consider options such as limiting the number of treatments or setting aggregates caps, rather than unlimited coverage."

When the Ministry of Health and Welfare responded that it would comprehensively review medical necessity and other factors, expectations grew that there could be policy changes in the hair loss treatment market.

◇Hair loss outside insurance, global market seen at 23 trillion won by 2030

Under the current national health insurance system, hair loss is treated differently depending on the type. When it is classified as an autoimmune disease, such as alopecia areata, treatment and care are covered by insurance. By contrast, male- and female-pattern hair loss, which are largely genetic, have been excluded from coverage on the grounds that they are closer to cosmetic purposes.

Separate from the policy debate, the market has grown rapidly. According to market research firm Grand View Research, the hair loss treatment market is projected to expand from $8.81 billion (about 12.95 trillion won) in 2023 to $16.0 billion (about 23.5 trillion won) by 2030. Industry watchers say that if hair loss treatment is brought into the formal medical system, market growth could accelerate further.

The main ingredients currently used to treat hair loss are minoxidil and finasteride. Minoxidil is a topical agent that promotes hair growth by improving blood flow, while finasteride is an oral medication that inhibits production of dihydrotestosterone (DHT), a precursor of the male hormone testosterone. A recent catalyst for viewing hair loss not as "cosmetics" but as a "condition requiring treatment" has been the emergence of new drugs in the JAK inhibitor class.

Eli Lilly's "Olumiant (ingredient: baricitinib)" and Pfizer's "Litfulo (ingredient: ritlecitinib)" are representative. These drugs take an approach that treats hair loss as a condition stemming from immune dysfunction. For both, significant regrowth over bald areas was confirmed after six months of dosing. However, they are not yet covered by national health insurance in Korea, and patients are said to shoulder about 7.36 million won per year in treatment costs.

JW Pharmaceutical says that to confirm the efficacy of its investigational hair-loss drug JW0061, it divided a male-pattern hair loss animal model into four groups—JW0061 low dose, JW0061 high dose, standard of care (SoC), and placebo—and, after administering each treatment, found that both the low and high doses of JW0061 accelerate hair growth faster than the standard treatment./Courtesy of JW Pharmaceutical

◇Expectations grow for reevaluation of new hair loss drugs… the key is coverage design

In the market, there is also hope that if the discussion on national health insurance coverage gains momentum, the commercial viability of domestic pipelines for new hair loss treatments could be reassessed.

Chong Kun Dang received approval from the Ministery of Food and Drug Safety in July last year for a phase 3 clinical trial plan for the male-pattern hair loss injection "CKD-843." It is a dutasteride-based injectable administered once every three months.

Epibiotech is conducting a phase 1/2 clinical trial in Korea of "EPI-001," an autologous dermal papilla cell-based cell therapy.

OliX Pharmaceuticals is conducting an Australian phase 1 trial of the RNA interference (RNAi) candidate "OLX104C," and JW Pharmaceutical is preparing to begin clinical trials of the new hair loss treatment "JW0061," which leverages the Wnt signaling pathway.

However, considerable hurdles are expected before any real policy change. Even just looking at ways to recognize hair loss treatments for coverage, the pharmaceutical and medical sectors see multiple options. A relatively simple method would be to change the coverage criteria for specific hair loss treatments by public notice. A more fundamental approach would be to designate "simple hair loss" itself as a reimbursable condition.

The issue is that the ripple effects vary greatly depending on the path chosen. Even if hair loss is included as a reimbursable condition, the specific scope of coverage is to be set by a Ministry of Health and Welfare ordinance, leading to many permutations—such as whether to cover only drugs, or to include consultations and procedures.

Controversy over which drugs qualify for coverage is also inevitable. For example, if only finasteride or dutasteride is recognized for reimbursement as hair loss treatments, adjuncts such as oral minoxidil are likely to be classified as off-label prescriptions and become subject to review and adjustment. Non-covered prescriptions could also be regarded as "arbitrary non-coverage," prompting warnings that confusion in clinical settings would be unavoidable. This could lead not only to patient complaints but also to denials by private insurers.

Lee Jung-gyu, director general of the Health Insurance Policy Bureau at the Ministry of Health and Welfare, said, "It has not been long since the president's remarks, so we cannot know the concrete contours yet. We now need to begin a review, and the impact on national health insurance finances and broad public and social consensus will be the most important issues."

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