This Market Spotlight report covers the Acne market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways The analyst estimates that in 2019, there were approximately 612.5 million prevalent cases of acne worldwide, and forecasts that number to increase to 658.6 million prevalent cases by 2028.
Approved drugs in the acne space focus on a wide variety of targets. These drugs are administered via the oral and topical routes.
The majority of industry-sponsored drugs in active clinical development for acne are in Phase II, with just a single product in the NDA/BLA stage.
Therapies in 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.
The only high-impact upcoming event for drugs in the acne space is an expected PDUFA date for Twyneo. The overall likelihood of approval of a Phase I dermatology-general asset is 20.2%, and the average probability a drug advances from Phase III is 68%. Drugs, on average, take 8.8 years from Phase I to approval in the dermatology-general space, as well as in the overall dermatology space.
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 52% of trials in Phase III–IV, and 48% in Phase I–II.
The US has a substantial lead in the number of acne clinical trials globally. Germany leads the major European 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 overall number of clinical trials for acne, followed by AbbVie.
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