Market Spotlight: Acne
Market Spotlight: Acne
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.e forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- 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
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Topical therapy
9 Systemic therapy
10 Physical treatments
14 MARKETED DRUGS
19 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 FMX101 for Acne (September 11, 2018)
27 Winlevi / Breezula for Acne (July 10, 2018)
29 Olumacostat Glasaretil for Acne (March 5, 2018)
31 Ammonia Oxidizing Bacteria for Acne (October 19, 2017)
33 KEY UPCOMING EVENTS
34 KEY REGULATORY EVENTS
34 Foamix Submits First Topical Minocycline For Acne
34 Differin Extends With Cleanser, Moisturizer, Biore Adds Foam In OTC Skin Care
35 PROBABILITY OF SUCCESS
36 LICENSING AND ASSET ACQUISITION DEALS
37 PARENT PATENTS
38 REVENUE OPPORTUNITY
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
43 Recent events
44 Prescription information
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of acne, 2017–26
19 Figure 2: Overview of pipeline drugs for acne in the US
19 Figure 3: Pipeline drugs for acne, by company
20 Figure 4: Pipeline drugs for acne, by drug type
20 Figure 5: Pipeline drugs for acne, by classification
27 Figure 6: FMX101 for Acne (September 11, 2018): Phase III – FX2017-22
29 Figure 7: Winlevi / Breezula for Acne (July 10, 2018): Phase III – CB-03-01/25, Phase III – CB-03-01/26
31 Figure 8: Olumacostat Glasaretil for Acne (March 5, 2018): Phase III – CLAREOS-1, Phase III – CLAREOS-2
32 Figure 9: Ammonia Oxidizing Bacteria for Acne (October 19, 2017): Phase IIb/III – AVB244-002
33 Figure 10: Key upcoming events in acne
35 Figure 11: Probability of success in the acne pipeline
36 Figure 12: Licensing and asset acquisition deals in acne, 2014–19
37 Figure 13: Parent patents in acne
40 Figure 14: Clinical trials in acne
40 Figure 15: Top 10 drugs for clinical trials in acne
41 Figure 16: Top 10 companies for clinical trials in acne
41 Figure 17: Trial locations in acne
42 Figure 18: Acne trials status
43 Figure 19: Acne trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of acne, 2017–26
15 Table 2: Marketed drugs for acne
21 Table 3: Pipeline drugs for acne in the US
26 Table 4: FMX101 for Acne (September 11, 2018)
28 Table 5: Winlevi / Breezula for Acne (July 10, 2018)
30 Table 6: Olumacostat Glasaretil for Acne (March 5, 2018)
31 Table 7: Ammonia Oxidizing Bacteria for Acne (October 19, 2017)
38 Table 8: Historical global sales, by drug ($m), 2013–17
39 Table 9: Forecasted global sales, by drug ($m), 2019–23
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