Market Spotlight: Acne
Market Spotlight: Acne
$1,318.00
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
- Description
- Contents
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. 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, and Phase III trial results for Winlevi / Breezula.
- 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 23 licensing and asset acquisition deals involving acne drugs during 2013–18, 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.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 TREATMENT
9 Topical therapy
9 Systemic therapy
10 Physical treatments
11 EPIDEMIOLOGY
14 MARKETED DRUGS
19 Approvals by country
24 PIPELINE DRUGS
31 RECENT EVENTS AND ANALYST OPINION
31 FMX101 for Acne (September 11, 2018)
32 Winlevi / Breezula for Acne (July 10, 2018)
34 Olumacostat Glasaretil for Acne (March 5, 2018)
36 Ammonia Oxidizing Bacteria for Acne (October 19, 2017)
37 TWIN for Acne (July 20, 2017)
39 BPX01 for Acne (May 3, 2017)
41 FMX101 for Acne (May 1, 2017)
42 FMX101 for Acne (March 27, 2017)
44 Seysara for Acne (March 27, 2017)
45 SB204 for Acne (January 27, 2017)
48 KEY UPCOMING EVENTS
49 KEY REGULATORY EVENTS
49 Differin Extends With Cleanser, Moisturizer, Biore Adds Foam In OTC Skin Care
50 PROBABILITY OF SUCCESS
51 LICENSING AND ASSET ACQUISITION DEALS
51 Sato licenses Japanese rights to Novan’s acne candidate SB204
52 PARENT PATENTS
53 REVENUE OPPORTUNITY
55 CLINICAL TRIAL LANDSCAPE
56 Sponsors by status
57 Sponsors by phase
58 Recent events
60 BIBLIOGRAPHY
60 Prescription information
62 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of acne, 2017–26
24 Figure 2: Overview of pipeline drugs for acne in the US
24 Figure 3: Pipeline drugs for acne, by company
25 Figure 4: Pipeline drugs for acne, by drug type
25 Figure 5: Pipeline drugs for acne, by classification
32 Figure 6: FMX101 for Acne (September 11, 2018): Phase III – FX2017-22
34 Figure 7: Winlevi / Breezula for Acne (July 10, 2018): Phase III – CB-03-01/25, Phase III – CB-03-01/26
36 Figure 8: Olumacostat Glasaretil for Acne (March 5, 2018): Phase III – CLAREOS-1, Phase III – CLAREOS-2
37 Figure 9: Ammonia Oxidizing Bacteria for Acne (October 19, 2017): Phase IIb/III – AVB244-002
39 Figure 10: TWIN for Acne (July 20, 2017): Phase II – SGT-65-02
41 Figure 11: BPX01 for Acne (May 3, 2017): Phase IIb – OPAL
42 Figure 12: FMX101 for Acne (May 1, 2017): Phase III – FX2014-04, Phase III – FX2014-05
44 Figure 13: FMX101 for Acne (March 27, 2017): Phase III – FX2014-04, Phase III – FX2014-05
45 Figure 14: Seysara for Acne (March 27, 2017): Phase III – 1401, Phase III – 1402
47 Figure 15: SB204 for Acne (January 27, 2017): Phase III – NI-AC301, Phase III – NI-AC302
48 Figure 16: Key upcoming events in acne
50 Figure 17: Probability of success in the acne pipeline
51 Figure 18: Licensing and asset acquisition deals in acne, 2013–18
52 Figure 19: Parent patents in acne
55 Figure 20: Clinical trials in acne
55 Figure 21: Top 10 drugs for clinical trials in acne
56 Figure 22: Top 10 companies for clinical trials in acne
56 Figure 23: Trial locations in acne
57 Figure 24: Acne trials status
58 Figure 25: Acne trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of acne, 2017–26
15 Table 2: Marketed drugs for acne
20 Table 3: Approvals by country for acne
26 Table 4: Pipeline drugs for acne in the US
31 Table 5: FMX101 for Acne (September 11, 2018)
33 Table 6: Winlevi / Breezula for Acne (July 10, 2018)
35 Table 7: Olumacostat Glasaretil for Acne (March 5, 2018)
36 Table 8: Ammonia Oxidizing Bacteria for Acne (October 19, 2017)
38 Table 9: TWIN for Acne (July 20, 2017)
40 Table 10: BPX01 for Acne (May 3, 2017)
41 Table 11: FMX101 for Acne (May 1, 2017)
43 Table 12: FMX101 for Acne (March 27, 2017)
44 Table 13: Seysara for Acne (March 27, 2017)
46 Table 14: SB204 for Acne (January 27, 2017)
53 Table 15: Historical global sales, by drug ($m), 2013–17
54 Table 16: Forecasted global sales, by drug ($m), 2018–22
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