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Psoriasis Market and Forecast Analysis to 2025

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    Drug Pipelines

  • 616 Pages
  • July 2018
  • Region: Global
  • Citeline
  • ID: 3797431
Disease Overview
Psoriasis is a chronic inflammatory skin disorder affecting around 2–4% of the world’s population. It is identified as thick scaling red plaques, with variable morphology and distribution, resulting from an unusually high rate of skin cell growth. It usually involves the skin and nails, and lesions cause itching, stinging, and pain. While the main cause of psoriasis remains uncertain, several studies have reported that it is caused by autoimmunity, genetic predisposition, and environmental factors.

Market Snapshot
  • Otezla’s favorable safety profile and lower cost compared to leading anti-TNFs will continue to drive its uptake.

  • Cosentyx is gaining traction, with use increasing with severity and therapy line, but Stelara retains strong market share.

  • Prevalent psoriasis cases are expected to increase overall; however, they will decrease slightly in two countries.

  • Stelara remains the preferred agent in the post-TNF setting but is facing increasing competition from Cosentyx.

  • Product differentiation is critical for new IL inhibitors attempting to enter the psoriasis market.

  • Category carve outs would enable better formulary positioning for interleukin therapies in the US.

Table of Contents

FORECAST: PSORIASIS (Published on 07 April 2017)
Overview
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Brand Forecasts
Cimzia (Certolizumab Pegol)
Cosentyx (Secukinumab)
Enbrel (Etanercept)
Fumaderm (Fumaric Acid Esters)
Guselkumab
Humira (Adalimumab)
Otezla (Apremilast)
Remicade (Infliximab)
Risankizumab
Siliq (Brodalumab)
Stelara (Ustekinumab)
Taltz (Ixekizumab)
Tildrakizumab
Primary Research Methodology
TREATMENT: PSORIASIS (Published on 26 September 2016)
Overview
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Prescribing Trends
Compliance
Unmet Needs In Psoriasis
Prescribing Influences
Future Treatment
Impact Of Biosimilars
EPIDEMIOLOGY: PSORIASIS (Published on 24 July 2018)
Overview
Disease Background
Methodology
Forecast
Bibliography
Appendix: Additional Sources
MARKETED DRUGS: PSORIASIS (Published on 07 April 2017)
Overview
Executive Summary
Product Overview
Product Profile: Cosentyx
Product Profile: Dovobet
Product Profile: Dovonex
Product Profile: Enbrel
Product Profile: Humira
Product Profile: Otezla
Product Profile: Remicade
Product Profile: Siliq
Product Profile: Silkis/Vectical
Product Profile: Sorilux
Product Profile: Stelara
Product Profile: Taltz
PSORIASIS PRICING, REIMBURSEMENT, AND ACCESS (Published on 02 September 2016)
Overview
Executive Summary
Market Context
Global Payer Insights
Us Pricing
Us Payer Insights
Us Reimbursement
Japan
Pricing In The Five Major Eu Markets
Five Major Eu Markets Payer Insights
Biosimilar Tnf-Alpha Inhibitors In The Five Major Eu Markets
France
Germany
Italy
Spain
Uk
Methodology
PIPELINE: PSORIASIS (Published on 07 April 2017)
Overview
Executive Summary
Clinical Pipeline Overview
Comparator Therapies
Clinical Trial Design
Key Opinion Leader Research
Additional Pharma Intelligence Pipeline Resources
Product Profile (Late Stage): Cimzia
Product Profile (Late Stage): Xeljanz
Product Profile (Late Stage): Guselkumab
Product Profile (Late Stage): Risankizumab
Product Profile (Late Stage): Tildrakizumab
LIST OF FIGURES
Figure 1: Psoriasis sales across the US, Japan, and five major EU markets, by country, 2016–25
Figure 2: Systemic psoriasis sales in the US, Japan, and five major EU markets, by class, 2016–25
Figure 3: Sales of Otezla versus established biologics within systemic psoriasis in the US, Japan, and five major EU markets, 2016–25
Figure 4: Sales of Cosentyx versus Stelara within systemic psoriasis in the US, Japan, and five major EU markets, 2016–25
Figure 5: Sales of late-phase interleukin inhibitors versus established biologics within systemic psoriasis in the US, Japan, and five major EU markets, 2016–25
Figure 6: Patient-based forecast methodology for psoriasis
Figure 7: Price sources and calculations, by country
Figure 8: Cimzia sales for psoriasis across the US and five major EU markets, by country, 2016–25
Figure 9: Cosentyx sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 10: Enbrel sales for psoriasis across the US and five major EU markets, by country, 2016–25
Figure 11: Fumaderm sales for psoriasis in France, Germany, and the UK, by country, 2016–25
Figure 12: Guselkumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 13: Humira sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 14: Otezla sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 15: Remicade sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Risankizumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: Siliq sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 18: Stelara sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 19: Taltz sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 20: Tildrakizumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 21: Key features of the current understanding of psoriasis pathogenesis, with an illustration of targets for clinical candidates and marketed therapies
Figure 22: Severity of diagnosed psoriasis patients, by country (%), 2015
Figure 23: Psoriasis patients managed by each type of healthcare professional, by severity
Figure 24: Mean percentage of psoriasis patients receiving non-pharma therapy only, pharma therapy, or no treatment, by disease severity (%)
Figure 25: Mean percentage of psoriasis patients receiving either monotherapy or combination systemic therapy, by severity and line of therapy (%)
Figure 26: Mean compliance rates for psoriasis patients, by formulation type and severity (%)
Figure 27: Top treatment challenges in psoriasis
Figure 28: Summary of future usage of biosimilar etanercept at one year and three years post-launch (%)
Figure 29: Physician confidence in prescribing biosimilars for psoriasis approved on the basis of indication extrapolation, by country (%)
Figure 30: Trends in diagnosed prevalent cases of psoriasis in the US, Japan, and five major EU markets, by country, 2017–37
Figure 31: The authors drug assessment summary for psoriasis
Figure 32: Cosentyx for psoriasis – SWOT analysis
Figure 33: The authors drug assessment summary of Cosentyx in psoriasis
Figure 34: The authors drug assessment summary of Cosentyx in psoriasis
Figure 35: Dovobet for psoriasis – SWOT analysis
Figure 36: The authors drug assessment summary of Dovobet in psoriasis
Figure 37: The authors drug assessment summary of Dovobet in psoriasis
Figure 38: Dovonex for psoriasis – SWOT analysis
Figure 39: The authors drug assessment summary of Dovonex in psoriasis
Figure 40: The authors drug assessment summary of Dovonex in psoriasis
Figure 41: Enbrel for psoriasis – SWOT analysis
Figure 42: The authors drug assessment summary of Enbrel in psoriasis
Figure 43: The authors drug assessment summary of Enbrel in psoriasis
Figure 44: Humira for psoriasis – SWOT analysis
Figure 45: The authors drug assessment summary of Humira in psoriasis
Figure 46: The authors drug assessment summary of Humira in psoriasis
Figure 47: Otezla for psoriasis – SWOT analysis
Figure 48: The authors drug assessment summary of Otezla in psoriasis
Figure 49: The authors drug assessment summary of Otezla in psoriasis
Figure 50: Remicade for psoriasis – SWOT analysis
Figure 51: The authors drug assessment summary of Remicade in psoriasis
Figure 52: The authors drug assessment summary of Remicade in psoriasis
Figure 53: Design of Phase II trial of Siliq
Figure 54: Siliq for psoriasis – SWOT analysis
Figure 55: The authors drug assessment summary of Siliq in psoriasis
Figure 56: The authors drug assessment summary of Siliq in psoriasis
Figure 57: Silkis/Vectical for psoriasis – SWOT analysis
Figure 58: The authors drug assessment summary of Silkis/Vectical in psoriasis
Figure 59: The authors drug assessment summary of Silkis/Vectical in psoriasis
Figure 60: Sorilux for psoriasis – SWOT analysis
Figure 61: Stelara for psoriasis – SWOT analysis
Figure 62: The authors drug assessment summary of Stelara in psoriasis
Figure 63: The authors drug assessment summary of Stelara in psoriasis
Figure 64: Taltz for psoriasis – SWOT analysis
Figure 65: The authors drug assessment summary of Taltz in psoriasis
Figure 66: The authors drug assessment summary of Taltz in psoriasis
Figure 67: Typical Phase III clinical trial design in psoriasis of systemic therapies (small molecules and biologics)
Figure 68: Summary of clinical study design of Enbrel’s global Phase III trials for psoriasis
Figure 69: Clinical study design of Humira’s Phase III trial for psoriasis
Figure 70: Psoriasis Area and Severity Index calculation
Figure 71: Cimzia for psoriasis – SWOT analysis
Figure 72: The authors drug assessment summary of Cimzia in psoriasis
Figure 73: The authors drug assessment summary of Cimzia in psoriasis
Figure 74: Guselkumab for psoriasis – SWOT analysis
Figure 75: The authors drug assessment summary of guselkumab in psoriasis
Figure 76: The authors drug assessment summary of guselkumab in psoriasis
Figure 77: Risankizumab for psoriasis – SWOT analysis
Figure 78: The authors drug assessment summary of risankizumab in psoriasis
Figure 79: The authors drug assessment summary of risankizumab in psoriasis
Figure 80: Phase II trial design for tildrakizumab
Figure 81: Tildrakizumab for psoriasis – SWOT analysis
Figure 82: The authors drug assessment summary of tildrakizumab in psoriasis
Figure 83: The authors drug assessment summary of tildrakizumab in psoriasis
LIST OF TABLES
Table 1: Summary of key classes and products included in The authors patient-based psoriasis forecast
Table 2: Exchange rates used for calculating prices
Table 3: Patent expiry dates for key marketed brands in psoriasis across the US, Japan, and five major EU markets
Table 4: Forecasted and actual launch dates of biosimilar versions of key marketed brands in psoriasis across the US, Japan, and five major EU markets
Table 5: Forecasted and actual launch dates of key late-phase pipeline products in psoriasis across the US, Japan, and five major EU markets
Table 6: Cimzia sales for psoriasis in the US and five major EU markets, by country ($m), 2016–25
Table 7: The authors price assumptions for Cosentyx
Table 8: Cosentyx sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 9: The authors price assumptions for Enbrel
Table 10: Enbrel sales for psoriasis in the US and five major EU markets, by country ($m), 2016–25
Table 11: The authors price assumptions for Fumaderm
Table 12: Fumaderm sales for psoriasis in France, Germany, and the UK, by country ($m), 2016–25
Table 13: Guselkumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 14: The authors price assumptions for Humira
Table 15: Humira sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 16: The authors price assumptions for Otezla
Table 17: Otezla sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 18: The authors price assumptions for Remicade
Table 19: Remicade sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 20: Risankizumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 21: Siliq sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 22: The authors price assumptions for Stelara
Table 23: Stelara sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 24: The authors price assumptions for Taltz
Table 25: Taltz sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 26: Tildrakizumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 27: Dermatologists surveyed for the psoriasis primary research study, 2016
Table 28: Dermatologists surveyed for the psoriasis primary research study, 2016
Table 29: Summary of key classes and products included in The authors 2016 psoriasis survey
Table 30: Mean percentage of diagnosed mild, moderate, and severe psoriasis patients managed by each type of healthcare professional, by country (%)
Table 31: Patients receiving non-pharma therapy, pharma therapy alone or together with non-pharma therapy, or no treatment, by severity and country (%)
Table 32: Mean percentage of psoriasis patients receiving each drug class, by severity and country (%)
Table 33: Percentage of psoriasis patients receiving systemic agents as monotherapy or combination therapy, by severity, line of therapy, and country (%)
Table 34: Mean compliance rates for psoriasis patients, by formulation type and severity (%)
Table 35: Relative importance of treatment challenges in psoriasis, by country
Table 36: Relative importance of factors that influence dermatologists’ prescribing behavior in psoriasis, by country
Table 37: Expected share of diagnosed psoriasis patients for currently approved and pipeline agents three years after launch, by country and agent (%)
Table 38: Future usage of biosimilar etanercept, according to respondents aware of biosimilars, by country (%)
Table 39: Sources used for the epidemiological analysis of psoriasis in the US, Japan, and five major EU markets, by country
Table 40: Sources used for psoriasis severity data in the US, Japan, and five major EU markets, by country
Table 41: Diagnosed prevalent cases of psoriasis in the US, Japan, and five major EU markets, by country, 2017–37
Table 42: Key marketed drugs for psoriasis
Table 43: Cosentyx drug profile
Table 44: Cosentyx pivotal trial data in psoriasis
Table 45: Cosentyx late-phase trial data in psoriasis
Table 46: Cosentyx ongoing late-phase clinical trials in psoriasis
Table 47: Dovobet drug profile
Table 48: Dovobet pivotal trial data in psoriasis
Table 49: Dovonex drug profile
Table 50: Dovonex pivotal trial data in psoriasis
Table 51: Enbrel drug profile
Table 52: Enbrel pivotal trial data in adult psoriasis
Table 53: Enbrel trial data in pediatric psoriasis
Table 54: Other late-phase trial data for Enbrel in adult psoriasis
Table 55: Humira drug profile
Table 56: Humira pivotal trial data in adult psoriasis
Table 57: Humira pivotal trial data in pediatric psoriasis
Table 58: Humira late-phase trial data in psoriasis
Table 59: Humira ongoing late-phase clinical trials in psoriasis
Table 60: Otezla drug profile
Table 61: Otezla pivotal trial data in psoriasis
Table 62: Pooled exposure-adjusted incidence rates from the ESTEEM 1 and ESTEEM 2 trials of Otezla in psoriasis
Table 63: Otezla late-phase trial data in psoriasis
Table 64: Remicade drug profile
Table 65: Remicade pivotal trial data in psoriasis
Table 66: Remicade ongoing late-phase clinical trials in psoriasis
Table 67: Siliq drug profile
Table 68: Siliq pivotal trial data in psoriasis
Table 69: Siliq late-phase trial data in psoriasis
Table 70: Clinical efficacy results for a Phase II open-label extension study of Siliq in psoriasis, 2013
Table 71: Results for Phase II trial of Siliq in psoriasis, 2012
Table 72: Silkis/Vectical drug profile
Table 73: Silkis/Vectical pivotal trial data in psoriasis
Table 74: Sorilux drug profile
Table 75: Sorilux pivotal trial data in psoriasis
Table 76: Stelara drug profile
Table 77: Stelara pivotal trial data in adult psoriasis
Table 78: Stelara pivotal trial data in adolescent psoriasis
Table 79: Stelara late-phase trial data in psoriasis
Table 80: Cumulative rates of adjudicated major adverse cardiovascular events in five-year follow-up study on Stelara patients
Table 81: Treatment-emergent infections in patients treated with Stelara through up to five-year follow-up
Table 82: Taltz drug profile
Table 83: Taltz pivotal trial data in psoriasis
Table 84: Taltz ongoing late-phase clinical trials in psoriasis
Table 85: Marketed psoriasis products and approved indications for psoriasis in the US, Japan, and five major EU markets
Table 86: Late-stage candidates in development for psoriasis
Table 87: Key endpoints in active comparator Phase III trials for ABBV-066, guselkumab, tildrakizumab, and Taltz with active comparator arms lasting beyond 16 weeks
Table 88: US pricing of key marketed drugs
Table 89: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2014
Table 90: Specialty drug spend by Express Scripts members (inflammatory diseases market), 2015
Table 91: CVS Caremark’s and Express Scripts’ formulary exclusions for psoriasis and psoriatic arthritis drugs, 2014–16
Table 92: Formulary placement of psoriasis medications in selected commercial formularies
Table 93: Formulary placement of psoriasis medications in selected Medicare formularies
Table 94: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage drugs: psoriasis and psoriatic arthritis
Table 95: Formulary placement of psoriasis drugs in selected Medicaid programs
Table 96: Prior authorization criteria for psoriasis drugs in major health insurers and pharmacy benefit managers
Table 97: Japan – pricing premiums given to medicines that can demonstrate benefit over comparators
Table 98: Price calculation methodologies for psoriasis drugs in Japan launched after 2008
Table 99: Pricing of key marketed psoriasis drugs in Japan
Table 100: Pricing of key psoriasis drugs in the five major EU markets, by country
Table 101: Access controls for psoriasis medications in the five major EU markets, by country
Table 102: Market access tools used to promote biosimilar uptake in the five major EU markets, by country
Table 103: Transparency Committee’s ASMR ratings and pricing implications
Table 104: Transparency Committee's SMR ratings and pricing implications
Table 105: Transparency Committee’s assessment of psoriasis treatments
Table 106: G-BA assessment of key psoriasis therapies
Table 107: Reimbursement conditions for psoriasis treatments in Italy
Table 108: Italian regional formulary decisions for psoriasis drugs
Table 109: Therapeutic positioning reports for psoriasis drugs in Spain
Table 110: Spanish Society of Hospital Pharmacy ratings
Table 111: NICE assessments of key psoriasis therapies
Table 112: UK regional formulary decisions for psoriasis drugs
Table 113: SMC decisions on key psoriasis therapies
Table 114: Price sources and calculations for the US
Table 115: Price sources and calculations for the EU
Table 116: Exchange rates used for calculating branded drug prices
Table 117: Late-phase pipeline products in development for psoriasis
Table 118: Humira drug profile
Table 119: Dovonex drug profile
Table 120: Methotrexate drug profile
Table 121: Typical Phase III clinical trial design in psoriasis of systemic therapies
Table 122: Typical Phase III clinical trial design in psoriasis of topical therapies
Table 123: Cimzia drug profile
Table 124: Cimzia’s pivotal late-phase trials in psoriasis
Table 125: Xeljanz drug profile
Table 126: Xeljanz pivotal late-phase trials in psoriasis
Table 127: Guselkumab drug profile
Table 128: Guselkumab late-phase trials in psoriasis
Table 129: Results for Phase IIb X-PLORE trial of guselkumab in psoriasis
Table 130: Safety results for Phase IIb X-PLORE trial of guselkumab in psoriasis
Table 131: Risankizumab drug profile
Table 132: Risankizumab late-phase trials in psoriasis
Table 133: Phase II results from risankizumab's head-to-head trial against Stelara
Table 134: Tildrakizumab drug profile
Table 135: Tildrakizumab pivotal late-phase trials in psoriasis
Table 136: Week 16 results for Phase II trial of tildrakizumab in psoriasis