Psoriasis Market and Forecast Analysis to 2025

CONTENTS

12 FORECAST: PSORIASIS (Published on 07 April 2017)
12 OVERVIEW
14 EXECUTIVE SUMMARY
16 MARKET OVERVIEW AND TRENDS
24 MARKET DEFINITION AND METHODOLOGY
36 BRAND FORECASTS
37 CIMZIA (CERTOLIZUMAB PEGOL)
40 COSENTYX (SECUKINUMAB)
46 ENBREL (ETANERCEPT)
52 FUMADERM (FUMARIC ACID ESTERS)
55 GUSELKUMAB
58 HUMIRA (ADALIMUMAB)
64 OTEZLA (APREMILAST)
70 REMICADE (INFLIXIMAB)
75 RISANKIZUMAB
79 SILIQ (BRODALUMAB)
83 STELARA (USTEKINUMAB)
87 TALTZ (IXEKIZUMAB)
92 TILDRAKIZUMAB
97 PRIMARY RESEARCH METHODOLOGY

99 TREATMENT: PSORIASIS (Published on 26 September 2016)
99 OVERVIEW
100 EXECUTIVE SUMMARY
101 PRIMARY RESEARCH METHODOLOGY
103 DISEASE DEFINITION AND DIAGNOSIS
109 PATIENT SEGMENTATION
112 CURRENT TREATMENT OPTIONS
115 PRESCRIBING TRENDS
135 COMPLIANCE
139 UNMET NEEDS IN PSORIASIS
144 PRESCRIBING INFLUENCES
147 FUTURE TREATMENT
152 IMPACT OF BIOSIMILARS

158 EPIDEMIOLOGY: PSORIASIS (Published on 24 July 2018)
158 OVERVIEW
159 DISEASE BACKGROUND
161 METHODOLOGY
165 FORECAST
170 BIBLIOGRAPHY
172 APPENDIX: ADDITIONAL SOURCES

173 MARKETED DRUGS: PSORIASIS (Published on 07 April 2017)
173 OVERVIEW
174 EXECUTIVE SUMMARY
175 PRODUCT OVERVIEW
179 PRODUCT PROFILE: COSENTYX
199 PRODUCT PROFILE: DOVOBET
207 PRODUCT PROFILE: DOVONEX
216 PRODUCT PROFILE: ENBREL
229 PRODUCT PROFILE: HUMIRA
244 PRODUCT PROFILE: OTEZLA
257 PRODUCT PROFILE: REMICADE
269 PRODUCT PROFILE: SILIQ
283 PRODUCT PROFILE: SILKIS/VECTICAL
290 PRODUCT PROFILE: SORILUX
295 PRODUCT PROFILE: STELARA
312 PRODUCT PROFILE: TALTZ

330 PSORIASIS PRICING, REIMBURSEMENT, AND ACCESS (Published on 28 March 2019)
330 OVERVIEW
331 REGULATORY LABELS
338 GLOBAL ACCESS LEVERS
354 EVIDENCE AND VALUE
376 ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS
399 PRICING
402 US
403 CANADA
404 JAPAN
406 FRANCE
409 GERMANY
411 ITALY
412 SPAIN
415 UK
417 METHODOLOGY

420 PIPELINE: PSORIASIS (Published on 07 April 2017)
420 OVERVIEW
421 EXECUTIVE SUMMARY
422 CLINICAL PIPELINE OVERVIEW
425 COMPARATOR THERAPIES
433 CLINICAL TRIAL DESIGN
444 KEY OPINION LEADER RESEARCH
445 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES
446 PRODUCT PROFILE (LATE STAGE): CIMZIA
455 PRODUCT PROFILE (LATE STAGE): XELJANZ
463 PRODUCT PROFILE (LATE STAGE): GUSELKUMAB
478 PRODUCT PROFILE (LATE STAGE): RISANKIZUMAB

LIST OF FIGURES
16 Figure 1: Psoriasis sales across the US, Japan, and five major EU markets, by country, 2016–25
18 Figure 2: Systemic psoriasis sales in the US, Japan, and five major EU markets, by class, 2016–25
19 Figure 3: Sales of Otezla versus established biologics within systemic psoriasis in the US, Japan, and five major EU markets, 2016–25
21 Figure 4: Sales of Cosentyx versus Stelara within systemic psoriasis in the US, Japan, and five major EU markets, 2016–25
22 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
27 Figure 6: Patient-based forecast methodology for psoriasis
30 Figure 7: Price sources and calculations, by country
38 Figure 8: Cimzia sales for psoriasis across the US and five major EU markets, by country, 2016–25
43 Figure 9: Cosentyx sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
49 Figure 10: Enbrel sales for psoriasis across the US and five major EU markets, by country, 2016–25
53 Figure 11: Fumaderm sales for psoriasis in France, Germany, and the UK, by country, 2016–25
56 Figure 12: Guselkumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
61 Figure 13: Humira sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
67 Figure 14: Otezla sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
72 Figure 15: Remicade sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
77 Figure 16: Risankizumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
80 Figure 17: Siliq sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
85 Figure 18: Stelara sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
89 Figure 19: Taltz sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
94 Figure 20: Tildrakizumab sales for psoriasis across the US, Japan, and five major EU markets, by country, 2016–25
105 Figure 21: Key features of the current understanding of psoriasis pathogenesis, with an illustration of targets for clinical candidates and marketed therapies
110 Figure 22: Severity of diagnosed psoriasis patients, by country (%), 2015
115 Figure 23: Psoriasis patients managed by each type of healthcare professional, by severity
118 Figure 24: Mean percentage of psoriasis patients receiving non-pharma therapy only, pharma therapy, or no treatment, by disease severity (%)
129 Figure 25: Mean percentage of psoriasis patients receiving either monotherapy or combination systemic therapy, by severity and line of therapy (%)
136 Figure 26: Mean compliance rates for psoriasis patients, by formulation type and severity (%)
141 Figure 27: Top treatment challenges in psoriasis
154 Figure 28: Summary of future usage of biosimilar etanercept at one year and three years post-launch (%)
156 Figure 29: Physician confidence in prescribing biosimilars for psoriasis approved on the basis of indication extrapolation, by country (%)
169 Figure 30: Trends in diagnosed prevalent cases of psoriasis in the US, Japan, and five major EU markets, by country, 2017–37
178 Figure 31: Datamonitor Healthcare’s drug assessment summary for psoriasis
193 Figure 32: Cosentyx for psoriasis – SWOT analysis
194 Figure 33: Datamonitor Healthcare’s drug assessment summary of Cosentyx in psoriasis
195 Figure 34: Datamonitor Healthcare’s drug assessment summary of Cosentyx in psoriasis
203 Figure 35: Dovobet for psoriasis – SWOT analysis
204 Figure 36: Datamonitor Healthcare’s drug assessment summary of Dovobet in psoriasis
205 Figure 37: Datamonitor Healthcare’s drug assessment summary of Dovobet in psoriasis
212 Figure 38: Dovonex for psoriasis – SWOT analysis
213 Figure 39: Datamonitor Healthcare’s drug assessment summary of Dovonex in psoriasis
214 Figure 40: Datamonitor Healthcare’s drug assessment summary of Dovonex in psoriasis
223 Figure 41: Enbrel for psoriasis – SWOT analysis
224 Figure 42: Datamonitor Healthcare’s drug assessment summary of Enbrel in psoriasis
225 Figure 43: Datamonitor Healthcare’s drug assessment summary of Enbrel in psoriasis
238 Figure 44: Humira for psoriasis – SWOT analysis
239 Figure 45: Datamonitor Healthcare’s drug assessment summary of Humira in psoriasis
240 Figure 46: Datamonitor Healthcare’s drug assessment summary of Humira in psoriasis
251 Figure 47: Otezla for psoriasis – SWOT analysis
252 Figure 48: Datamonitor Healthcare’s drug assessment summary of Otezla in psoriasis
253 Figure 49: Datamonitor Healthcare’s drug assessment summary of Otezla in psoriasis
262 Figure 50: Remicade for psoriasis – SWOT analysis
263 Figure 51: Datamonitor Healthcare’s drug assessment summary of Remicade in psoriasis
264 Figure 52: Datamonitor Healthcare’s drug assessment summary of Remicade in psoriasis
275 Figure 53: Design of Phase II trial of Siliq
277 Figure 54: Siliq for psoriasis – SWOT analysis
278 Figure 55: Datamonitor Healthcare’s drug assessment summary of Siliq in psoriasis
279 Figure 56: Datamonitor Healthcare’s drug assessment summary of Siliq in psoriasis
286 Figure 57: Silkis/Vectical for psoriasis – SWOT analysis
287 Figure 58: Datamonitor Healthcare’s drug assessment summary of Silkis/Vectical in psoriasis
288 Figure 59: Datamonitor Healthcare’s drug assessment summary of Silkis/Vectical in psoriasis
293 Figure 60: Sorilux for psoriasis – SWOT analysis
306 Figure 61: Stelara for psoriasis – SWOT analysis
307 Figure 62: Datamonitor Healthcare’s drug assessment summary of Stelara in psoriasis
308 Figure 63: Datamonitor Healthcare’s drug assessment summary of Stelara in psoriasis
325 Figure 64: Taltz for psoriasis – SWOT analysis
326 Figure 65: Datamonitor Healthcare’s drug assessment summary of Taltz in psoriasis
327 Figure 66: Datamonitor Healthcare’s drug assessment summary of Taltz in psoriasis
418 Figure 67: Price sources and calculations for the US and EU, by country
434 Figure 68: Typical Phase III clinical trial design in psoriasis of systemic therapies (small molecules and biologics)
437 Figure 69: Summary of clinical study design of Enbrel’s global Phase III trials for psoriasis
438 Figure 70: Clinical study design of Humira’s Phase III trial for psoriasis
439 Figure 71: Psoriasis Area and Severity Index calculation
451 Figure 72: Cimzia for psoriasis – SWOT analysis
452 Figure 73: Datamonitor Healthcare’s drug assessment summary of Cimzia in psoriasis
453 Figure 74: Datamonitor Healthcare’s drug assessment summary of Cimzia in psoriasis
473 Figure 75: Guselkumab for psoriasis – SWOT analysis
474 Figure 76: Datamonitor Healthcare’s drug assessment summary of guselkumab in psoriasis
475 Figure 77: Datamonitor Healthcare’s drug assessment summary of guselkumab in psoriasis
482 Figure 78: Risankizumab for psoriasis – SWOT analysis
483 Figure 79: Datamonitor Healthcare’s drug assessment summary of risankizumab in psoriasis
484 Figure 80: Datamonitor Healthcare’s drug assessment summary of risankizumab in psoriasis
492 Figure 81: Phase II trial design for tildrakizumab
493 Figure 82: Tildrakizumab for psoriasis – SWOT analysis
494 Figure 83: Datamonitor Healthcare’s drug assessment summary of tildrakizumab in psoriasis
495 Figure 84: Datamonitor Healthcare’s drug assessment summary of tildrakizumab in psoriasis

LIST OF TABLES
25 Table 1: Summary of key classes and products included in Datamonitor Healthcare’s patient-based psoriasis forecast
31 Table 2: Exchange rates used for calculating prices
31 Table 3: Patent expiry dates for key marketed brands in psoriasis across the US, Japan, and five major EU markets
32 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
33 Table 5: Forecasted and actual launch dates of key late-phase pipeline products in psoriasis across the US, Japan, and five major EU markets
39 Table 6: Cimzia sales for psoriasis in the US and five major EU markets, by country ($m), 2016–25
42 Table 7: Datamonitor Healthcare’s price assumptions for Cosentyx
44 Table 8: Cosentyx sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
48 Table 9: Datamonitor Healthcare’s price assumptions for Enbrel
50 Table 10: Enbrel sales for psoriasis in the US and five major EU markets, by country ($m), 2016–25
52 Table 11: Datamonitor Healthcare’s price assumptions for Fumaderm
54 Table 12: Fumaderm sales for psoriasis in France, Germany, and the UK, by country ($m), 2016–25
57 Table 13: Guselkumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
60 Table 14: Datamonitor Healthcare’s price assumptions for Humira
62 Table 15: Humira sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
66 Table 16: Datamonitor Healthcare’s price assumptions for Otezla
68 Table 17: Otezla sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
71 Table 18: Datamonitor Healthcare’s price assumptions for Remicade
73 Table 19: Remicade sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
78 Table 20: Risankizumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
81 Table 21: Siliq sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
84 Table 22: Datamonitor Healthcare’s price assumptions for Stelara
86 Table 23: Stelara sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
88 Table 24: Datamonitor Healthcare’s price assumptions for Taltz
90 Table 25: Taltz sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
95 Table 26: Tildrakizumab sales for psoriasis in the US, Japan, and five major EU markets, by country ($m), 2016–25
97 Table 27: Dermatologists surveyed for the psoriasis primary research study, 2016
101 Table 28: Dermatologists surveyed for the psoriasis primary research study, 2016
113 Table 29: Summary of key classes and products included in Datamonitor Healthcare’s 2016 psoriasis survey
116 Table 30: Mean percentage of diagnosed mild, moderate, and severe psoriasis patients managed by each type of healthcare professional, by country (%)
120 Table 31: Patients receiving non-pharma therapy, pharma therapy alone or together with non-pharma therapy, or no treatment, by severity and country (%)
123 Table 32: Mean percentage of psoriasis patients receiving each drug class, by severity and country (%)
130 Table 33: Percentage of psoriasis patients receiving systemic agents as monotherapy or combination therapy, by severity, line of therapy, and country (%)
137 Table 34: Mean compliance rates for psoriasis patients, by formulation type and severity (%)
140 Table 35: Relative importance of treatment challenges in psoriasis, by country
145 Table 36: Relative importance of factors that influence dermatologists’ prescribing behavior in psoriasis, by country
148 Table 37: Expected share of diagnosed psoriasis patients for currently approved and pipeline agents three years after launch, by country and agent (%)
153 Table 38: Future usage of biosimilar etanercept, according to respondents aware of biosimilars, by country (%)
161 Table 39: Sources used for the epidemiological analysis of psoriasis in the US, Japan, and five major EU markets, by country
164 Table 40: Sources used for psoriasis severity data in the US, Japan, and five major EU markets, by country
166 Table 41: Diagnosed prevalent cases of psoriasis in the US, Japan, and five major EU markets, by country, 2017–37
176 Table 42: Key marketed drugs for psoriasis
180 Table 43: Cosentyx drug profile
182 Table 44: Cosentyx pivotal trial data in psoriasis
185 Table 45: Cosentyx late-phase trial data in psoriasis
188 Table 46: Cosentyx ongoing late-phase clinical trials in psoriasis
200 Table 47: Dovobet drug profile
202 Table 48: Dovobet pivotal trial data in psoriasis
208 Table 49: Dovonex drug profile
210 Table 50: Dovonex pivotal trial data in psoriasis
217 Table 51: Enbrel drug profile
219 Table 52: Enbrel pivotal trial data in adult psoriasis
221 Table 53: Enbrel trial data in pediatric psoriasis
222 Table 54: Other late-phase trial data for Enbrel in adult psoriasis
230 Table 55: Humira drug profile
232 Table 56: Humira pivotal trial data in adult psoriasis
233 Table 57: Humira pivotal trial data in pediatric psoriasis
234 Table 58: Humira late-phase trial data in psoriasis
237 Table 59: Humira ongoing late-phase clinical trials in psoriasis
245 Table 60: Otezla drug profile
247 Table 61: Otezla pivotal trial data in psoriasis
248 Table 62: Pooled exposure-adjusted incidence rates from the ESTEEM 1 and ESTEEM 2 trials of Otezla in psoriasis
249 Table 63: Otezla late-phase trial data in psoriasis
258 Table 64: Remicade drug profile
260 Table 65: Remicade pivotal trial data in psoriasis
261 Table 66: Remicade ongoing late-phase clinical trials in psoriasis
270 Table 67: Siliq drug profile
272 Table 68: Siliq pivotal trial data in psoriasis
274 Table 69: Siliq late-phase trial data in psoriasis
275 Table 70: Clinical efficacy results for a Phase II open-label extension study of Siliq in psoriasis, 2013
276 Table 71: Results for Phase II trial of Siliq in psoriasis, 2012
284 Table 72: Silkis/Vectical drug profile
285 Table 73: Silkis/Vectical pivotal trial data in psoriasis
291 Table 74: Sorilux drug profile
292 Table 75: Sorilux pivotal trial data in psoriasis
296 Table 76: Stelara drug profile
298 Table 77: Stelara pivotal trial data in adult psoriasis
301 Table 78: Stelara pivotal trial data in adolescent psoriasis
302 Table 79: Stelara late-phase trial data in psoriasis
304 Table 80: Cumulative rates of adjudicated major adverse cardiovascular events in five-year follow-up study on Stelara patients
304 Table 81: Treatment-emergent infections in patients treated with Stelara through up to five-year follow-up
313 Table 82: Taltz drug profile
315 Table 83: Taltz pivotal trial data in psoriasis
323 Table 84: Taltz ongoing late-phase clinical trials in psoriasis
332 Table 85: Marketed products and approved indications for psoriasis in the US, Japan, and five major EU markets
343 Table 86: Biosimilar access levers in the US and five major EU markets
351 Table 87: Levers impacting access to psoriasis drugs in the US and five major EU markets
356 Table 88: Summary of important key endpoints in psoriasis clinical trial design
380 Table 89: National reimbursement decisions for marketed and assessed ILs
385 Table 90: Contracting and financial agreements for interleukins
391 Table 91: Likely reimbursement for Ilumya in psoriasis
394 Table 92: Likely reimbursement for risankizumab in psoriasis
400 Table 93: Pricing of key psoriasis drugs in the US, Japan, and five major EU markets, by country, 2019
405 Table 94: Pricing premiums given to medicines in Japan that can demonstrate benefit over comparators
407 Table 95: Transparency Committee’s ASMR ratings and pricing implications
408 Table 96: Transparency Committee’s SMR ratings and pricing implications
413 Table 97: Spanish Society of Hospital Pharmacy ratings
419 Table 98: Exchange rates used for calculating drug prices
423 Table 99: Late-phase pipeline products in development for psoriasis
427 Table 100: Humira drug profile
429 Table 101: Dovonex drug profile
431 Table 102: Methotrexate drug profile
435 Table 103: Typical Phase III clinical trial design in psoriasis of systemic therapies
436 Table 104: Typical Phase III clinical trial design in psoriasis of topical therapies
447 Table 105: Cimzia drug profile
449 Table 106: Cimzia’s pivotal late-phase trials in psoriasis
456 Table 107: Xeljanz drug profile
458 Table 108: Xeljanz pivotal late-phase trials in psoriasis
464 Table 109: Guselkumab drug profile
465 Table 110: Guselkumab late-phase trials in psoriasis
471 Table 111: Results for Phase IIb X-PLORE trial of guselkumab in psoriasis
472 Table 112: Safety results for Phase IIb X-PLORE trial of guselkumab in psoriasis
479 Table 113: Risankizumab drug profile
480 Table 114: Risankizumab late-phase trials in psoriasis
481 Table 115: Phase II results from risankizumab’s head-to-head trial against Stelara
487 Table 116: Tildrakizumab drug profile
489 Table 117: Tildrakizumab pivotal late-phase trials in psoriasis
492 Table 118: Week 16 results for Phase II trial of tildrakizumab in psoriasis