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.

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were approximately 624 million prevalent cases of acne worldwide, and forecasts that number to increase to 683 million prevalent cases by 2026.
• Approved drugs in the acne space focus on a wide variety of targets. These drugs 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 one drug in the NDA/BLA phase.
• Therapies in mid-to-late-stage development for acne focus on a wide variety of targets. The majority of the pipeline drugs are administered via the topical route, with the remainder being oral, subcutaneous, intranasal, or intravenous formulations.
• High-impact upcoming events for drugs in the acne space comprise topline Phase II trial results for BTX-1503 and VB 1953, topline Phase III trial results for Winlevi/Breezula and TWIN, and an estimated PDUFA date for FMX101.
• The overall likelihood of approval of a Phase I dermatology-general asset is 28.0%, and the average probability a drug advances from Phase III is 72.4%. Drugs, on average, take 7.8 years from Phase I to approval in both the dermatology-general space and the overall dermatology space.
• There have been 21 licensing and asset acquisition deals involving acne drugs during 2014–19, seven of which occurred in 2014. The largest deal was the $650m agreement in 2018 between Almirall and Allergan for the acquisition of a portfolio of five products from Allergan’s Medical Dermatology unit in the US, which comprises of mature and growth brands Aczone (dapsone), Tazorac (tazarotene), Azelex (azelaic acid), Cordran Tape (fludroxycortide), and Seysara (sarecycline).
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for acne have been in the late phases of development, with 53% of trials in Phase III–IV, and 47% 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.
• Clinical trial activity in the acne space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for acne, with 35 trials.
• GlaxoSmithKline leads industry sponsors with by far the highest number of clinical trials for acne, followed by Allergan