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 marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, 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 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 one drug in the NDA/BLA phase.
- 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.
- High-impact upcoming events for drugs in the acne space comprise topline Phase II trial results for FCD105 and an estimated PDUFA date for Winlevi/Breezula.
- The overall likelihood of approval of a Phase I dermatology-general asset is 25.2%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 8.1 years from Phase I to approval in the dermatology-general space, as well as in the overall dermatology space.
- There have been 14 licensing and asset acquisition deals involving acne drugs during 2015–20. 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 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 51.5% of trials in Phase III–IV, and 48.5% 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 Allergan
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Topical therapy
9 Systemic therapy
10 Physical treatments
14 MARKETED DRUGS
19 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 Twyneo for Acne (December 30, 2019)
28 ANT-1207 for Acne (June 25, 2019)
29 VB 1953 for Acne (May 13, 2019)
30 VB 1953 for Acne (May 13, 2019)
32 Winlevi / Breezula for Acne (March 26, 2019)
33 Aklief for Acne (February 22, 2019)
35 Amzeeq for Acne (September 11, 2018)
38 KEY UPCOMING EVENTS
39 KEY REGULATORY EVENTS
39 Foamix Earns First Approval For Topical Minocycline With Amzeeq
39 FDA Approves Aklief Cream for Acne Treatment
39 Cassiopea Submits Acne Drug With New Mechanism Of Action
39 Keeping Track: Accelerated Approval For Tecentriq And A Burst Of Filings And Submissions
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Menlo And Foamix Merge Into Dermatology Play
42 Deals Shaping The Medical Industry, November 2019
43 Deals Shaping The Medical Industry, November 2019
44 PARENT PATENTS
45 REVENUE OPPORTUNITY
47 CLINICAL TRIAL LANDSCAPE
48 Sponsors by status
49 Sponsors by phase
51 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
20 Figure 3: Pipeline drugs for acne, by company
20 Figure 4: Pipeline drugs for acne, by drug type
21 Figure 5: Pipeline drugs for acne, by classification
28 Figure 6: Twyneo for Acne (December 30, 2019): Phase III – SGT-65-04, Phase III – SGT-65-05
30 Figure 7: VB 1953 for Acne (May 13, 2019): Phase II – Proof-of-Concept (ex. US)
32 Figure 8: VB 1953 for Acne (May 13, 2019): Phase I – First-In-Human
33 Figure 9: Winlevi / Breezula for Acne (March 26, 2019): Phase III – CB-03-01/27 (Long-Term Extension)
35 Figure 10: Aklief for Acne (February 22, 2019): Phase III – Perfect 1, Phase III – Perfect 2
37 Figure 11: Amzeeq for Acne (September 11, 2018): Phase III – FX2017-22
38 Figure 12: Key upcoming events in acne
41 Figure 13: Probability of success in the acne pipeline
42 Figure 14: Licensing and asset acquisition deals in acne, 2015–20
44 Figure 15: Parent patents in acne
47 Figure 16: Clinical trials in acne
47 Figure 17: Top 10 drugs for clinical trials in acne
48 Figure 18: Top 10 companies for clinical trials in acne
48 Figure 19: Trial locations in acne
49 Figure 20: Acne trials status
50 Figure 21: Acne trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of acne, 2017–26
15 Table 2: Marketed drugs for acne
22 Table 3: Pipeline drugs for acne in the US
27 Table 4: Twyneo for Acne (December 30, 2019)
28 Table 5: ANT-1207 for Acne (June 25, 2019)
29 Table 6: VB 1953 for Acne (May 13, 2019)
31 Table 7: VB 1953 for Acne (May 13, 2019)
32 Table 8: Winlevi / Breezula for Acne (March 26, 2019)
34 Table 9: Aklief for Acne (February 22, 2019)
36 Table 10: Amzeeq for Acne (September 11, 2018)
45 Table 11: Historical global sales, by drug ($m), 2014–18
46 Table 12: Forecasted global sales, by drug ($m), 2020–23
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