Disease Analysis: Psoriasis
Publisher: Datamonitor Healthcare
- Description
- Contents
- Enquire
Definition
Psoriasis is a chronic inflammatory skin disorder affecting around 2–3% of the world’s population. It is identified as thick scaling red plaques, resulting from an unusually high rate of skin cell growth. It usually involves the skin and nails, and leads to lesions which cause itching, stinging, and pain. While the main cause of psoriasis remains uncertain, several studies have reported that it is due to autoimmunity, genetic predisposition, and environmental factors. Additionally, psoriasis may be provoked by several triggers, including trauma, obesity, infection, systemic drugs, and stress.
Latest key takeaways
- Datamonitor Healthcare estimates that in 2021, there were 53.4 million prevalent cases of psoriasis worldwide, and forecasts that number to increase to 55.4 million prevalent cases by 2027.
- First-line treatment of milder forms of psoriasis will continue to be with cheaper, topical medications. Use of more expensive, systemic therapies will continue to be relegated to more severe psoriasis.
- While the psoriasis market will see downward pressure from the arrival of biosimilars of the key marketed anti-TNF brands Enbrel and Humira, overall growth will be driven partly by the recent launches of a number of more targeted and efficacious interleukin inhibitors which have expanded the market, as well as by increasing prevalence of the disease.
- Results from head-to-head studies solidly place IL-17 and IL-23 inhibitors ahead of older TNF-alpha inhibitors in terms of efficacy, while differentiating between these newer pathways may come down to speed of disease clearance and safety signals. AbbVie’s IL-23 inhibitor Skyrizi, with strong disease clearance, stands out among competitors with remarkably fast uptake on the market.
- Bimzelx (bimekizumab) received European approval in August 2021, while US approval is expected after UCB addresses minor concerns in a complete response letter it received from the FDA in May 2022. Positive readouts from Bimzelx’s three Phase III psoriasis trials, including head-to-head comparisons against Stelara and Humira, will ensure approval of UCB’s IL-17A/F inhibitor. Unlike Novartis’s Cosentyx and Eli Lilly’s Taltz, which target IL-17A, Bimzelx neutralizes both IL-17A and IL-17F.
- Results from the Phase III POETYK-PSO trials of Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib demonstrate superiority over Otezla, giving deucravacitinib an advantage in the oral treatment market in moderate-to-severe psoriasis. US approval decisions for deucravacitinib and PDE4 inhibitor ARQ-151 are expected during H2 2022.
- The likelihood of approval of a Phase I psoriasis asset is just over 10%. Psoriasis drugs, on average, take 7.7 years from Phase I to approval, which is about two years faster than drugs in the overall autoimmune/immunology space.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Disease definition
9 Symptoms
9 Patient segmentation
10 Subtypes
11 TREATMENT
11 Topical agents remain the gold standard for mild psoriasis
11 Systemic therapies are the mainstay of treatment for moderate-to-severe disease
11 Classes of topical agents to treat psoriasis
14 Key oral systemic classes to treat psoriasis
15 Major biologic classes to treat psoriasis
15 Treatment guidelines
17 EPIDEMIOLOGY
17 Prevalence methodology
20 MARKETED DRUGS
36 PIPELINE DRUGS
46 KEY REGULATORY EVENTS
46 Dermavant Prepares For First Launch, Looking To Build A Blockbuster Psoriasis Brand
46 UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx
46 Shanghai Junshi Announces Chinese Adalimumab Approval
47 Alvotech Reveals Action Date For Interchangeable Adalimumab BLA
47 Amgen: Humira Interchangeability ‘A Nice To Have, Not A Need To Have’
47 Alvotech Eyes Canada Humira Launch As Celltrion Also Bags High-Strength Approval
48 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
48 BI Spesolimab Positioned For FDA Action By August 2022
48 Bristol Submits First-In-Class Psoriasis, Hematology Agents
49 Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan
49 Seventeen And Counting – Bumper Crop Of New EU Filings
49 Scotland’s HTA Body Says Fast-Track Yes To UCB’s Bimzelx
50 Boehringer Targets High Unmet Need With Spesolimab Filing
50 EU Fast-Track Rejected For Boehringer’s Spesolimab
50 UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug
51 Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies
51 FDA Approves Mayne’s Halobetasol Foam For Adolescents
51 UK Warns Of Withdrawal Reactions Linked To Topical Corticosteroids
52 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
52 Potential ‘Mega-Blockbuster’ Bimzelx Heading For Psoriasis Market In UK & EU
52 UCB’s Bimekizumab Gets Fast-Track Funding For Severe Psoriasis In England
53 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
53 UCB’s Bimzelx Close To Challenging Major Psoriasis Players
53 Dermavant Sees PSOARING Prospects For Tapinarof
55 PROBABILITY OF SUCCESS
56 LICENSING AND ASSET ACQUISITION DEALS
56 Henlius Partners With Getz To Commercialize Adalimumab Biosimilar
56 Hikma Adds Remsima SC To Celltrion MENA Collaboration
56 Xbrane And Biogen Ally On Certolizumab Pegol Biosimilar
57 Assertio Acquires Otrexup From Antares Pharma
57 KoBioLabs, SPH Sine Ink $107.25m Microbiome Therapeutics Deal
57 Union Inks China Deal For Promising Skin Drug Orismilast
57 Intas Picks Up Global Rights To Meiji And Dong-A’s Stelara Biosimilar
58 Lipidor Licenses Two Psoriasis Candidates To Menarini Subsidiary
59 CLINICAL TRIAL LANDSCAPE
60 Sponsors by status
61 Sponsors by phase
62 Recent events
66 DRUG ASSESSMENT MODEL
66 Biologics
71 Oral small molecules
71 Topicals
73 MARKET DYNAMICS
74 FUTURE TRENDS
74 Market access drives prescribing trends in a crowded market
74 Biosimilar prospects safeguard the relevance of older classes
74 Oral treatments will become increasingly attractive
75 CONSENSUS FORECASTS
81 RECENT EVENTS AND ANALYST OPINION
81 Bimzelx for Psoriasis (May 13, 2022)
81 Deucravacitinib for Psoriasis (May 12, 2022)
82 EDP1815 for Psoriasis (September 27, 2021)
84 BMS-986165 for Psoriasis (April 23, 2021)
86 Imsidolimab for Psoriasis (March 8, 2021)
88 Bimekizumab for Psoriasis (February 4, 2021)
90 BMS-986165 for Psoriasis (February 2, 2021)
91 ARQ-151 for Psoriasis (February 1, 2021)
94 KEY UPCOMING EVENTS
95 KEY OPINION LEADER INSIGHTS
98 UNMET NEEDS
98 More effective oral treatments
98 Safe topical treatments that enable compliance
98 Additional data on co-morbidities and options for patient subsets
100 BIBLIOGRAPHY
101 APPENDIX
LIST OF FIGURES
19 Figure 1: Trends in prevalent cases of psoriasis, 2018–27
36 Figure 2: Overview of pipeline drugs for psoriasis in the US
36 Figure 3: Pipeline drugs for psoriasis, by company
37 Figure 4: Pipeline drugs for psoriasis, by drug type
37 Figure 5: Pipeline drugs for psoriasis, by classification
55 Figure 6: Probability of success in the psoriasis pipeline
59 Figure 7: Clinical trials in psoriasis
59 Figure 8: Top 10 drugs for clinical trials in psoriasis
60 Figure 9: Top 10 companies for clinical trials in psoriasis
60 Figure 10: Trial locations in psoriasis
61 Figure 11: Psoriasis trials status
62 Figure 12: Psoriasis trials sponsors, by phase
66 Figure 13: Datamonitor Healthcare’s drug assessment summary for psoriasis
73 Figure 14: Market dynamics in psoriasis
74 Figure 15: Future trends in psoriasis
84 Figure 16: EDP1815 for Psoriasis (September 27, 2021): Phase II – 201
86 Figure 17: BMS-986165 for Psoriasis (April 23, 2021): Phase III – POETYK-PSO-1, Phase III – POETYK-PSO-2
88 Figure 18: Imsidolimab for Psoriasis (March 8, 2021): Phase II – Palmoplantar Pustulosis (POPLAR)
90 Figure 19: Bimekizumab for Psoriasis (February 4, 2021): Phase III – BE VIVID
91 Figure 20: BMS-986165 for Psoriasis (February 2, 2021): Phase III – POETYK-PSO-2
93 Figure 21: ARQ-151 for Psoriasis (February 1, 2021): Phase III – Study 301 (DERMIS-1), Phase III – Study 302 (DERMIS-2)
94 Figure 22: Key upcoming events in psoriasis
LIST OF TABLES
13 Table 1: Topical corticosteroids for psoriasis – ultra-high and high potency
14 Table 2: Topical corticosteroids for psoriasis – moderate and low potency
16 Table 3: Psoriasis treatment guidelines
18 Table 4: Prevalent cases of psoriasis, 2018–27
21 Table 5: Marketed drugs for psoriasis
38 Table 6: Pipeline drugs for psoriasis in the US
76 Table 7: Historical global sales, by drug ($m), 2017–21
79 Table 8: Forecasted global sales, by drug ($m), 2022–26
81 Table 9: Bimzelx for Psoriasis (May 13, 2022)
82 Table 10: Deucravacitinib for Psoriasis (May 12, 2022)
83 Table 11: EDP1815 for Psoriasis (September 27, 2021)
85 Table 12: BMS-986165 for Psoriasis (April 23, 2021)
87 Table 13: Imsidolimab for Psoriasis (March 8, 2021)
89 Table 14: Bimekizumab for Psoriasis (February 4, 2021)
90 Table 15: BMS-986165 for Psoriasis (February 2, 2021)
92 Table 16: ARQ-151 for Psoriasis (February 1, 2021)
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Molecular Diagnostics 
Sign up to the