Market Spotlight: Atopic Dermatitis
Market Spotlight: Atopic Dermatitis
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This Market Spotlight report covers the Atopic Dermatitis market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Publisher: Datamonitor Healthcare
- Description
- Contents
Overview
Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic, relapsing inflammatory dermatological condition. The condition usually begins during early infancy and childhood, but can persist into, or start during, adulthood. AD usually fluctuates between periods of relative flares and quiescence; however, some individuals have chronically active disease. The exact cause of the disease is unknown; however, certain factors such as epigenetic, genetic, immunological, and environmental interactions with overlapping skin barrier defects are indicated in its pathogenesis. The disease significantly affects the quality of life of the patient and their family, which further causes serious socioeconomic consequences. An imbalance of the Th22 and Th2 cytokines which causes the disruption of keratinocytes is thought to be an important contributing factor that drives AD pathogenesis. Furthermore, impaired skin barrier function due to mutations in the epidermal barrier protein, filaggrin, could also play a crucial role in the development of AD by increasing the penetration of microbes and allergens.
Key Takeaways
- The approved drugs in the atopic dermatitis space focus on a wide variety of targets. These drugs are commonly administered via the topical route, with a few select products being available in oral, intramuscular, intravenous, and subcutaneous formulations.
- The majority of industry-sponsored drugs in active clinical development for atopic dermatitis are in Phase II, with one drug in the NDA/BLA phase.
- Pipeline drugs in development for atopic dermatitis focus on a wide variety of targets. The largest proportion of drugs in development are administered via the topical route, with the remainder being oral, subcutaneous, intravenous, and intranasal formulations.
- High-impact upcoming events for drugs in the atopic dermatitis space comprise topline Phase II, Phase IIb, Phase II/III, and Phase III trial results; expected CHMP opinions; and an expected PDUFA date for a BLA.
- The overall likelihood of approval of a Phase I allergy asset is 12%, and the average probability a drug advances from Phase III is 64.7%. Drugs, on average, take 9.4 years from Phase I to approval in the allergy space.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for atopic dermatitis have been in the early and mid-phases of development, with 67% of trials in Phase I–II, and 33% in Phase III–IV.
- The US has a substantial lead in the number of atopic dermatitis clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
- Clinical trial activity in the atopic dermatitis space is dominated by completed trials. Novartis has the highest number of completed clinical trials for atopic dermatitis, with 74 trials.
- Novartis leads the industry sponsors with the highest overall number of clinical trials for atopic dermatitis, followed by Pfizer.
CONTENTS
7 OVERVIEW
8 KEY TAKEAWAYS
9 DISEASE BACKGROUND
9 Disease definition
9 Patient segmentation
9 Symptoms
9 Risk factors
10 Diagnosis
11 TREATMENT
11 Non-pharmacologic interventions
11 Medications
12 Systemic treatment
12 Biologic therapy
12 Phototherapy treatment
12 Adjunctive treatment
14 EPIDEMIOLOGY
15 MARKETED DRUGS
19 PIPELINE DRUGS
29 RECENT EVENTS AND ANALYST OPINION
29 Rinvoq for Atopic Dermatitis (July 21, 2020)
30 Ammonia Oxidizing Bacteria (AOB) for Atopic Dermatitis (June 30, 2020)
32 Rinvoq for Atopic Dermatitis (June 18, 2020)
33 Abrocitinib for Atopic Dermatitis (June 10, 2020)
35 Abrocitinib for Atopic Dermatitis (June 3, 2020)
36 ASN002 for Atopic Dermatitis (June 2, 2020)
38 OPA-15406 for Atopic Dermatitis (March 26, 2020)
39 BTX-1204 for Atopic Dermatitis (March 25, 2020)
41 ASN002 for Atopic Dermatitis (March 10, 2020)
43 Tradipitant for Atopic Dermatitis (February 25, 2020)
44 Ruxolitinib Cream for Atopic Dermatitis (February 19, 2020)
46 Olumiant for Atopic Dermatitis (January 30, 2020)
47 Ruxolitinib Cream for Atopic Dermatitis (January 28, 2020)
49 Olumiant for Atopic Dermatitis (January 24, 2020)
50 ARQ-151 for Atopic Dermatitis (December 16, 2019)
52 Tralokinumab for Atopic Dermatitis (December 11, 2019)
53 Etokimab for Atopic Dermatitis (November 8, 2019)
54 Abrocitinib for Atopic Dermatitis (September 27, 2019)
56 Olumiant for Atopic Dermatitis (August 23, 2019)
58 ATI-502 for Atopic Dermatitis (August 8, 2019)
60 KEY UPCOMING EVENTS
61 KEY REGULATORY EVENTS
61 Leo’s Tralokinumab Poised For US Launch In 2021
61 New China Approvals Include Amgen, Sanofi, Hengrui Drugs, Innovent Biosimilar
61 Pediatric Approvals In TB, Bladder Dysfunction, And Atopic Dermatitis
61 JT Gains World-First Topical JAK Inhibitor Approval
62 Getting A Good Start: Sanofi Extends Dupixent’s Potential To Younger Patients
62 CHMP Delivers More Good News For Sanofi’s Dupixent
63 PROBABILITY OF SUCCESS
64 LICENSING AND ASSET ACQUISITION DEALS
64 Itching To Succeed: UNION Buys LEO Pharma’s PDE4 Inhibitor Series
64 Sanofi Nabs Kymera IRAK4 Protein Degrader As It Continues To Build In I&I
64 Yuhan Partners With GI Innovation On Next-Generation Allergy Treatment
64 Deal Watch: Roche And Vividion Will Investigate E3 Ligases In Cancer, Immunology
65 LEO Pays $40m For Novel Dermatitis, Asthma Candidate
65 Reverse Merger With Tocagen Takes Forte’s Dermatology Ambitions Public
65 Deals Shaping The Medical Industry, February 2020
65 Bayer Harnessing Skin Microbiome In New Product Development
66 Lilly’s Paying $1.1bn For Itch Advantage With Dermira’s Lebrikizumab
66 Janssen Licenses Global Rights To XBiotech’s Bermekimab
66 Seneca Moves Towards Antibody In-Licensing Deal With China’s QYuns
67 Leo Options Two Protein-Degradation Candidates Under Existing Alliance With Ubiquigent
68 REVENUE OPPORTUNITY
70 CLINICAL TRIAL LANDSCAPE
71 Sponsors by status
72 Sponsors by phase
73 Recent events
78 BIBLIOGRAPHY
79 Prescription information
80 APPENDIX
LIST OF FIGURES
19 Figure 1: Overview of pipeline drugs for atopic dermatitis in the US
19 Figure 2: Pipeline drugs for atopic dermatitis, by company
20 Figure 3: Pipeline drugs for atopic dermatitis, by drug type
20 Figure 4: Pipeline drugs for atopic dermatitis, by classification
30 Figure 5: Rinvoq for Atopic Dermatitis (July 21, 2020): Phase III – MEASURE UP 2
32 Figure 6: Ammonia Oxidizing Bacteria (AOB) for Atopic Dermatitis (June 30, 2020): Phase II – 001
33 Figure 7: Rinvoq for Atopic Dermatitis (June 18, 2020): Phase III – MEASURE UP 1
35 Figure 8: Abrocitinib for Atopic Dermatitis (June 10, 2020): Phase III – JADE TEEN
36 Figure 9: Abrocitinib for Atopic Dermatitis (June 3, 2020): Phase III – JADE Mono-2
38 Figure 10: ASN002 for Atopic Dermatitis (June 2, 2020): Phase II – Severe Chronic Hand Eczema
39 Figure 11: OPA-15406 for Atopic Dermatitis (March 26, 2020): Phase III – Adults (Japan), Phase III – Pediatric (Japan)
41 Figure 12: BTX-1204 for Atopic Dermatitis (March 25, 2020): Phase II – 1204 Study
43 Figure 13: ASN002 for Atopic Dermatitis (March 10, 2020): Phase IIb – RADIANT
44 Figure 14: Tradipitant for Atopic Dermatitis (February 25, 2020): Phase III – EPIONE 1
46 Figure 15: Ruxolitinib Cream for Atopic Dermatitis (February 19, 2020): Phase III – TRuE-AD1
47 Figure 16: Olumiant for Atopic Dermatitis (January 30, 2020): Phase III – BREEZE-AD5 (Mono)
49 Figure 17: Ruxolitinib Cream for Atopic Dermatitis (January 28, 2020): Phase III – TRuE-AD2
50 Figure 18: Olumiant for Atopic Dermatitis (January 24, 2020): Phase III – BREEZE-AD4 (TCS Add-On; Ex-US)
52 Figure 19: ARQ-151 for Atopic Dermatitis (December 16, 2019): Phase IIa – Study 212
54 Figure 20: Etokimab for Atopic Dermatitis (November 8, 2019): Phase IIb – ATLAS
56 Figure 21: Abrocitinib for Atopic Dermatitis (September 27, 2019): Phase III – JADE Mono-2
58 Figure 22: Olumiant for Atopic Dermatitis (August 23, 2019): Phase III – BREEZE-AD7 (TCS Add-On; Ex-US)
59 Figure 23: ATI-502 for Atopic Dermatitis (August 8, 2019): Phase II – AD-201
60 Figure 24: Key upcoming events in atopic dermatitis
63 Figure 25: Probability of success in the atopic dermatitis pipeline
70 Figure 26: Clinical trials in atopic dermatitis
70 Figure 27: Top 10 drugs for clinical trials in atopic dermatitis
71 Figure 28: Top 10 companies for clinical trials in atopic dermatitis
71 Figure 29: Trial locations in atopic dermatitis
72 Figure 30: Atopic dermatitis trials sponsors by status
73 Figure 31: Atopic dermatitis trials sponsors by phase
LIST OF TABLES
16 Table 1: Marketed drugs for atopic dermatitis
21 Table 2: Pipeline drugs for atopic dermatitis in the US
29 Table 3: Rinvoq for Atopic Dermatitis (July 21, 2020)
31 Table 4: Ammonia Oxidizing Bacteria (AOB) for Atopic Dermatitis (June 30, 2020)
32 Table 5: Rinvoq for Atopic Dermatitis (June 18, 2020)
34 Table 6: Abrocitinib for Atopic Dermatitis (June 10, 2020)
35 Table 7: Abrocitinib for Atopic Dermatitis (June 3, 2020)
37 Table 8: ASN002 for Atopic Dermatitis (June 2, 2020)
38 Table 9: OPA-15406 for Atopic Dermatitis (March 26, 2020)
40 Table 10: BTX-1204 for Atopic Dermatitis (March 25, 2020)
42 Table 11: ASN002 for Atopic Dermatitis (March 10, 2020)
43 Table 12: Tradipitant for Atopic Dermatitis (February 25, 2020)
45 Table 13: Ruxolitinib Cream for Atopic Dermatitis (February 19, 2020)
46 Table 14: Olumiant for Atopic Dermatitis (January 30, 2020)
48 Table 15: Ruxolitinib Cream for Atopic Dermatitis (January 28, 2020)
49 Table 16: Olumiant for Atopic Dermatitis (January 24, 2020)
51 Table 17: ARQ-151 for Atopic Dermatitis (December 16, 2019)
52 Table 18: Tralokinumab for Atopic Dermatitis (December 11, 2019)
53 Table 19: Etokimab for Atopic Dermatitis (November 8, 2019)
55 Table 20: Abrocitinib for Atopic Dermatitis (September 27, 2019)
56 Table 21: Olumiant for Atopic Dermatitis (August 23, 2019)
58 Table 22: ATI-502 for Atopic Dermatitis (August 8, 2019)
68 Table 23: Historical global sales, by drug ($m), 2015–19
69 Table 24: Forecasted global sales, by drug ($m), 2020–24
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Non-Alcoholic Steatohepatitis (NASH) KOL Interview – US, Northeast 
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