Finasteride 59%·dutasteride 61%...generics in the hair loss mkt

In the finasteride·dutasteride market, the market share of generics has surpassed the original

Sales of generics accounted for 88.2% of the total volume of finasteride products

Hanall Biopharma demonstrated outstanding performance in the generic market

When hair loss treatments are reimbursed, domestic pharmaceutical companies are likely to benefit

Generics are demonstrating dominance in the oral prescription hair loss treatment market. In the finasteride market, the market share of generics has surpassed the original brand, while in the dutasteride market, the generic share has surpassed 60%. Because of their low-price competitiveness, finasteride generics captured nearly 90% of the market share on a volume basis. Industry analysis anticipate that if the health authorities approve National Health Insurance (NHI) reimbursement to hair loss treatments, domestic pharmaceutical companies will benefit.

According to data released by pharmaceutical market research firm IQVIA on June 23, sales of finasteride-based hair loss treatments reached KRW 21.4 billion in the first quarter of this year, a 3.0% year-over-year (YoY) increase. Organon Korea’s Propecia is the original 1mg finasteride formulation approved for the treatment of male alopecia in adult males aged 18 to 41. Proscar, which contains 5mg of finasteride, is indicated for benign prostatic hyperplasia (BPH).

The finasteride hair loss treatment market has shown steady expansion, growing by 8.8% over the past three years from KRW 20.7 billion in Q1 2023. 

Quarterly sales trajectory of Propecia and generics (unit: KRW 100 million, source: IQVIA). BLUE: PROPESIA, GRAY: PROPESIA GENERICS, ORANGE LINE: Market share of generic products. AI-generated image

Within the finasteride sector, generic products showed significantly higher growth rates compared to the original brand.   

In Q1, sales of the original Propecia amounted to KRW 8.7 billion, an 8.3% increase compared to the same period last year. However, this represents an 11.8% decline over a three-year period when compared to the KRW 9.9 billion recorded in Q1 2023. Propecia has been on a downward trajectory since peaking at KRW 10.2 billion in Q2 2023. Its Q1 revenue dropped by 14.6% relative to that Q2 2023.

Meanwhile, Q1 revenue for Propecia generics amounted to KRW 12.6 billion, down 0.3% YoY. Although the quarterly growth rate of generics lagged behind the original brand this quarter, generic sales expanded by 17.5% over the past three years, from KRW 10.8 billion in Q1 2023.  

The revenue-based market share of generics in the finasteride hair loss market rose from 52.4% in Q1 2022 to 59.4% in Q1 of this year, climbing 7.0 percentage points over a four-year period.

Quarterly market share of Propecia generic sales (unit: %, source: IQVIA). AI-generated image

Based on prescription volume, the dominance of generics becomes even more pronounced. In Q1, generics accounted for 88.2% of the total volume of finasteride hair loss treatments supplied. Due to their competitive pricing relative to the brand-name original, the volume-based market share significantly outpaced the revenue-based market share.  

The surge of generics was even more significant in the dutasteride market. GlaxoSmithKline's (GSK) Avodart is the original product in this market, indicated for the improvement of symptoms in benign prostatic hyperplasia (BPH) as well as the treatment of male pattern hair loss in adult males aged 18 to 50.

In Q1, total sales in the dutasteride market reached KRW 27.4 billion, rising 12.9% YoY. Compared to the KRW 21.9 billion recorded in Q1 2023, the segment expanded by 24.9% over a three-year period, outpacing the growth rate of the finasteride market.  

In contrast to the overall market growth, the original Avodart generated KRW 10.4 billion in Q1, slipping 1.7% YoY. Avodart's growth has effectively stagnated, registering a 3.0% decline over three years from the KRW 10.7 billion recorded in Q1 2022.

Conversely, generics to Avodart posted Q1 revenues of KRW 17.0 billion, surging 24.2% YoY. This marks an increase of 75.3% over a four-year period from the KRW 9.7 billion recorded in Q1 2022, demonstrating a steep upward trajectory.  

Quarterly sales trajectory of Avodart and generic (unit: KRW 100 million, source; IQVIA). GREEN: AVODART, BLUE: AVODART GENERICS, ORANGE LINE: Market share of generics. AI-generated image

The revenue share of generics in the dutasteride market stood at 45.9% in Q1 2022, crossed the 50% threshold in Q1 2023, and advanced further to 61.0% in Q1 of this year. The expanding footprint of generics is attributed to aggressive market penetration by approximately 70 domestic pharmaceutical manufacturers

In Q1, the volume-based market share of dutasteride generics reached 68.0%, exceeding its revenue-based counterpart by 7.0 percentage points. This gap is analyzed as a direct result of entering the market with low-cost pricing advantages, driving up volume distribution.  

Among domestic companies, Hanall Biopharma demonstrated the most outstanding performance across both the finasteride and dutasteride generic markets. In Q1, Hanall Biopharma generated a combined revenue of KRW 6.2 billion from its Avodart generic, Adamo (KRW 5.4 billion), and its Propecia generic, Hair Gro (KRW 700 million).

Other domestic companies, including Dongkoo Bio & Pharma, The U Pharmaceuticals, Dong-A ST, and Genuone Sciences, each recorded quarterly revenues exceeding KRW 1 billion in their respective Avodart and Propecia generic portfolios.  

Industry insiders anticipate that if hair loss treatments are officially listed for national health insurance reimbursement, high-share generic manufacturers will see a benefit in sales alongside the original brands.

According to data on the "Supply Status of Hair Loss Treatment-related Medicines" submitted by the Health Insurance Review and Assessment Service (HIRA) to Rep. Kim Sunmin’s office (Rebuilding Korea Party), the total supply value of prescription-only hair loss treatments reached KRW 256.8 billion last year. Based on last year's supply data, if the patient co-payment rate for reimbursed hair loss treatments is set at 30%, it is estimated that the National Health Insurance fund would be responsible for an annual fiscal burden of approximately KRW 180 billion.