Alopecia
Hair loss (alopecia) can affect just the scalp or the entire body, and it can be either temporary or permanent. It may result from genetics, hormonal changes, medical conditions, or simply the natural aging process. While anyone can experience hair loss on the scalp, it is more common in men. Baldness generally refers to significant hair loss from the scalp, with hereditary hair loss due to aging being the most frequent cause. Some individuals may choose to let their hair loss progress without treatment or concealment, while others may use hairstyles, makeup, hats, or scarves to cover it up. Additionally, some people opt for treatments to prevent further hair loss or promote regrowth.
Symptoms:
Hair loss can manifest in various ways, depending on its underlying cause. It may develop suddenly or gradually and affect just the scalp or the entire body.
Common signs and symptoms of hair loss include:
• Gradual thinning on the top of the head: This is the most typical form of hair loss, especially as people age. In men, it often starts with a receding hairline at the forehead. In women, it usually presents as a widening part in the hair. A common pattern in older women is frontal fibrosing alopecia, where the hairline recedes.
• Circular or patchy bald spots: Some people experience hair loss in distinct, round patches on the scalp, beard, or eyebrows. The affected skin may become itchy or painful before the hair falls out.
• Sudden hair loss: Physical or emotional stress can trigger hair to loosen rapidly. The patient may notice a handful of hair coming out when combing or washing or even with gentle tugging. This hair loss typically leads to overall thinning but is usually temporary.
• Full-body hair loss: Certain conditions or medical treatments, like chemotherapy, can result in hair loss across the entire body. In most cases, the hair regrows once the treatment is over.
• Scaly patches on the scalp: This may indicate a fungal infection, such as ringworm. It can be accompanied by broken hair, redness, swelling, and sometimes oozing
Drug Class Distribution and Development Phases
According to the AdisInsight database, the following is a detailed overview of drugs organized into nine major drug classes, along with their respective development phases. The small molecule category dominates the market, with the highest number of drugs in both early-stage and late-stage clinical development, as well as eight drugs already launched.
Drug development phases Vs drug class
Fig 10: Development phases of drugs versus drug class distribution
The graph clearly illustrates that small molecules are dominating the development phase, with four drugs in the registered phase set for imminent market launch— Baricitinib (Olumiant®), Ritlecitinib (Litfulo®), Deuruxolitinib (LEQSELVI™), Finasteride (Finjuve™).
Analysis of Development Phases and Routes of Administration
As shown in the graph, according to the AdisInsight database, the topical route of administration is leading, with one drug in the registered phase, three in the preregistration phase, three in late-stage clinical development and four in early-stage clinical development. Finasteride (Finjuve™) (topical/spray) is in the registered phase and is currently under approval in Italy, Germany, Luxembourg, and Portugal for the treatment of androgenetic alopecia.
Drug development phases Vs RoA
Fig 11: Development phases of drugs versus RoA distribution
Drug development phases Vs formulation of drugs
Fig 12: Development phases of drugs versus formulation
Overview of Development Stages and Formulations
Based on the AdisInsight database, tablet formulations are leading in development, with three drugs in the registered phase and one in early-stage development.
Drugs Available for Licensing
Drugs for alopecia have proven to be a significant revenue generator for pharmaceutical companies. For example, Sun Pharma acquired Leqselvi (deuruxolitinib) through its purchase of Concert Pharmaceuticals in January 2023. The USFDA approved Leqselvi in July 2024 for the treatment of adults with severe alopecia areata. It is projected to generate approximately $200 million in sales for Sun Pharma over the next three to four years. According to the AdisInsight database, the following drugs are available for licensing: one in the preregistration phase, one in late-stage clinical development, and six in early-stage clinical development.
Table 19- Drugs available for licensing for Alopecia
