This Market Spotlight report covers the Acne market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- The report estimates that in 2016, there were approximately 615 million prevalent cases of acne worldwide, and forecasts that number to increase to 673 million prevalent cases by 2025.
- Approved drugs in the acne space target retinoic acid receptor, bacterial ribosome, bacterial protein synthesis, dihydropteroate synthetase, steroid 5a-reductase, estrogen receptor alpha, estrogen receptor beta, folate receptor, mineralocorticoid receptor, and progesterone receptor. These are commonly administered via the oral and topical routes.
- The majority of industry-sponsored drugs in active clinical development for acne are in Phase II, with only two drugs in NDA/BLA phase.
- Therapies in mid-to-late-stage development for acne focus on a variety of targets. The majority of the drugs in mid-to-late-stage development for acne are administered via the topical route, with the remainder being oral, subcutaneous, or intravenous formulations.
- High-impact upcoming events for drugs in the acne space include topline Phase II and Phase III trial results for BTX-1503 and olumacostat glasaretil, respectively, an estimated PDUFA date for Seysara, and Altreno's NDA.
- There were 19 licensing and asset acquisition activities involving acne drugs during 2013-18, seven of which occurred in 2014. The exclusive 2017 license agreement between XOMA and Novartis, worth $454m for the global rights to XOMA's program relating to gevokizumab, was the largest deal during the 2013-18 period.
- Yaz's sales ranked highest among drugs available for acne during 2012-16. The clinical trials distribution across Phase I-IV indicates that the majority of trials for acne have been in late phases of development, with 57% of trials in Phase III-IV, and 43% in Phase I-II.
- The US has a substantial lead in the number of acne clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- GlaxoSmithKline has the highest number of completed clinical trials for acne.
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