Acne Vulgaris (AV) is one of the most common dermatological conditions worldwide and is a chronic skin disease/disorder of pilosebaceous follicles. The androgens increase the production of sebum, which causes an inflammatory reaction. The disease is characterized by blockage of hair follicles and the accompanying sebaceous gland and is observed mostly in adolescence. The infection is characterized by non-inflammatory, open or closed comedones and by inflammatory papules, pustules, and nodules. It typically affects the face, upper chest and back. Based on the extent of severity of acne, this disorder is classified as Mild, Moderate and Severe.
Acne Vulgaris Epidemiology
As per DelveInsight’s estimation, the United States accounted for the highest number of cases of Acne Vulgaris wit h approximately 47 million diagnosed prevalent cases in 2017. However, in the EU5, the United Kingdom showed the highest number of Diagnosed Prevalent Cases of Acne Vulgaris in 2017, whereas Spain showed the lowest number of diagnosed cases. Acne vulgaris Epidemiology is not limited to adolescence. In fact, twelve per cent of women and five per cent of men aged 25 years have acne vulgaris. By the age of 45 years, 5% of both men and women still have acne vulgaris.
During adolescence, acne vulgaris is more prevalent in males. In adulthood, acne vulgaris is more common in women than in men.
According to a study conducted by K. Bhate et. al. 2012, moderate-to-severe acne affects around 20% of young people in the UK. In the U.S. Acne Vulgaris is known to affect around 80% of Americans.
Out of these, twenty per cent have severe acne, which can result in permanent physical scarring and mental anguish.
Acne Vulgaris Therapies
The Acne Vulgaris therapeutic market is designed based on a better understanding of the pathogenesis of acne. Acne Vulgaris market is segmented into topical and oral combination treatments. In topical therapy, various agents, such as benzoyl peroxide, antibiotics, topical retinoid, etc. can be used as combination medications. On the other hand, systemic therapy includes oral antibiotics, hormonal therapy, isotretinoin, and others. The advice on the therapy to be administered is based on the severity of the acne. Phototherapy and lesion removal are also found to be effective in a few cases. The current Acne Vulgaris market is dependent on both the marketed as well as generic products. The branded marketed drugs such as Acanya (Valeant Pharmaceuticals), Tazorac (Allergan), Veltin (Almirall), Duac (GlaxoSmithKline), Epiduo and Epiduo Forte (Galderma), BenzaClin Topical Gel (Dermik Laboratories a business of Sanofi-Aventis) etc., along with antimicrobial and anti-inflammatory drugs hold the major position in the acne market. On the flip side, patent expiry of the marketed drugs is also set to impact the overall market size of Acne Vulgaris. On the pipeline front, there are multiple clinical trials assessing new formulations or combinations of established acne treatments, and novel uses of antimicrobials.
Acne Vulgaris Therapeutic Market
Acne Vulgaris current treatments are effective, however, regimens are complex and side effects are common. A better understanding of the pathology of acne is leading to the identification of new and safer therapeutic targets. There are many products in the final phase of the pipeline, all of which are in topical therapy area and targets various mechanisms such as IDP-120 (Valeant Pharmaceuticals), ASC-J9 (AndroScience), DRM01 (DRM01), BPX-01 (BioPharmX), and AOB101 (AOBiome).
BPX-01, a novel topical gel formulation of minocycline for the treatment of inflammatory acne, is the most promising clinical compound based on the patented HyantX delivery system. In July 2018, FDA waived its requirement for a dermal carcinogenicity study for BPX-01, eliminating several years of non-clinical research normally required for FDA review, leading to the compound’s acceleration towards regulatory schedule. Furthermore, it has been observed that the novel therapies in the pipeline, such as live bacterial therapy, are also gaining importance through better efficacy and safety results and less adverse events. An example of this is AOBiome, which has its live bacteria therapy in Phase IIb stage of clinical development. Some candidates, however, have recently failed clinical trials. Notably, Xenon’s phase II small-molecule inhibitor of sebum production XEN801 and Novan’s SB204, a NO-releasing topical gel, are two such candidates. Even though these candidates are more effective than placebo in phase II, however, they failed to meet one of its phase III endpoints. The biggest hurdle identified during their studies was the requirement of both objective and subjective testing in clinical trials. DelveInsight predicts that the promising key candidates in the late phase of clinical development will impact the Acne Vulgaris market during the forecast period (2018-2028).
There are huge numbers of new treatments currently being considered for acne vulgaris, some of which target the inflammatory cascade of acne pathogenesis. With the advancements in the prognosis, diagnosis and pipeline therapies, DelveInsight estimates further evolution of the market of Acne Vulgaris.
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