PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024

PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024

PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0)1300 321501 or Email: reportstore@bioportfolio.com 2

PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 Summary Psoriasis (PsO) is an incurable genetic, systemic, inflammatory, and chronic skin disorder with an overall prevalence of 2-3% worldwide. Specifically, adult plaque psoriasis, the most common form of Psoriasis, is the focus of this report. Although not life-threatening, Psoriasis causes tremendous morbidity and personal angst for patients. GlobalData projects the psoriasis market in 8MM to experience modest growth during the forecast period at a CAGR of 7.26%. This growth will be driven primarily by the highly anticipated arrivals of promising systemic therapies- interleukin-23 (IL-23) inhibitors (guselkumab and tildrakizumab), interleukin-17 (IL-17) inhibitors (Cosentyx, Taltz, and brodalumab) as well as phsophodiesterase (PDE4) inhibitor- Otezla (apremilast). Nevertheless, looming patent expiries of high-grossing branded drugs- especially TNF inhibitors, Humira, Enbrel and Remicade, in the US, 5EU (France, Germany, Italy, Spain, UK), and Japan, along with rapid global developments of biosimilars, are expected to spread the growth throughout the different classes of products, away from the branded TNF inhibitors which have traditionally been the main driver of growth in the prior years. Highlights Key Questions Answered - How good is the management of Psoriasis with marketed therapies? - Which drugs and players are important in the current management landscape? - What are the most promising late-stage pipeline drugs and how will their launch shape the future treatment landscape in the Psoriasis market? - What are the significant unmet needs and remaining opportunities in the Psoriasis market? - What clinical and commercial factors are likely to uptake of Psoriasis therapies in the US, 5EU, Japan and India? Key Findings - The psoriasis market is currently very dynamic, with effective biologic therapies awaiting approval, such as interleukin-17 (IL-17) inhibitor- brodalumab, interleukin-23 (IL-23) inhibitors- guselkumab and tildrakizumab. - Novel biologic therapies will challenge the current anti-tnf biologics in an attempt to dislodge their stronghold, if their safety and efficacy profiles are proven once they enter the market. - The impending patent cliff for biologics will allow for the emergence of biosimilars to all the marketed biologic brands. Patent expiries take place during the forecast period for the current market leaders such as Johnson & Johnson s Remicade (infliximab), AbbVie s Humira (adalimumab), Amgen s Enbrel (etanercept) and Johnson & Johnson s Stelara (ustekinumab). 3

- The drivers for market growth will also include affordable treatments throughout the world, as well as the push for long-term drug efficacy. The main challenge for individual drugs will be to distinguish themselves in a crowded marketplace, comprising a highly diversified field of therapies, with existing drugs struggling to increase their patient share. Scope - Overview of Psoriasis, including epidemiology, etiology, pathophysiology, symptoms and current treatment options - Topline Psoriasis market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included. - Key topics covered include strategic competitor assessment, unmet needs, pipeline assessment, and market outlook for the Psoriasis market. - Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline productsincluding promising IL-17 and IL-23 inhibitors. - Analysis of the current and future market competition in the global Psoriasis market (8MM). Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications. Reasons to buy The report will enable you to - - Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. - Develop business strategies by understanding the trends shaping and driving the global Psoriasis market. - Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Psoriasis market in the future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. - Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. - Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships. Additional Details Publisher : Global Data Reference : GDHC119PIDR Number of Pages : 307 Report Format : PDF Publisher Information : 4

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Table Of Contents for PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 1 Table of Contents1 Table of Contents 91.1 List of Tables 151.2 List of Figures 212 Introduction 222.1 Catalyst 222.2 Related Reports 222.3 Upcoming Related Reports 233 Disease Overview 243.1 Etiology and Pathophysiology 243.1.1 Etiology 243.1.2 Pathophysiology 253.2 Symptoms 284 Epidemiology 304.1 Disease Background 304.2 Risk Factors and Comorbidities 304.3 Global Trends 314.3.1 Prevalence 314.4 Forecast Methodology 334.4.1 Sources Used for One-Year Diagnosed Prevalence of Psoriasis 354.4.2 Sources Not Used 374.4.3 Forecast Assumptions and Methods, One-Year Diagnosed Prevalent Cases of Psoriasis 384.5 Epidemiological Forecast for Psoriasis (2014-2024) 404.5.1 One-Year Diagnosed Prevalent Cases of Psoriasis 404.5.2 Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis 424.5.3 Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis 444.5.4 Age-Standardized One-Year Diagnosed Prevalent Cases of Psoriasis 464.5.5 One-Year Diagnosed Prevalent Cases of Psoriasis by Severity 474.6 Discussion 484.6.1 Epidemiological Forecast Insight 484.6.2 Limitations of the Analysis 494.6.3 Strengths of the Analysis 495 Disease Management 505.1 Diagnosis and Treatment Overview 505.1.1 Diagnosis 505.1.2 Leading Prescribed Drugs and Treatment Guidelines 515.1.3 Clinical Practice 545.2 US 545.3 5EU 595.4 Japan 625.5 India 656 Competitive Assessment 676.1 Overview 676.2 Strategic Competitor Assessment 686.3 Product Profiles - Major Brands 696.3.1 Enbrel (Etanercept) 696.3.2 Humira (Adalimumab) 766.3.3 Remicade (Infliximab) 826.3.4 Stelara (Ustekinumab) 896.3.5 Cosentyx (Secukinumab) 956.3.6 Taltz (Ixekizumab) 1036.3.7 Otezla (Apremilast) 1126.3.8 Taclonex and Enstilar (Calcipotriene and Betamethasone Dipropionate) 1176.3.9 Methotrexate 1236.3.10 Fumaderm (Fumaric Acid Esters) 1286.3.11 Alzumab (Itolizumab) 1336.3.12 Other Therapeutic Drug Classes Used in Psoriasis 1366.3.13 Non-pharmacological Therapy 1377 Unmet Need and Opportunity 1407.1 Overview 1407.2 Limited Patient Access Due to Drug Reimbursement Pattern 1407.2.1 Unmet Need 1407.2.2 Gap Analysis 1417.2.3 Opportunity 1427.3 Improved Drug Safety and Efficacy Profiles 1427.3.1 Unmet Need 1427.3.2 Gap Analysis 1437.3.3 Opportunity 1437.4 Education and Treatment of Psychological Factors Accompanying Psoriasis 1447.4.1 Unmet Need 1447.4.2 Gap Analysis 1457.4.3 Opportunity 1457.5 Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis 1467.5.1 Unmet Need 1467.5.2 Gap Analysis 1467.5.3 Opportunity 1478 Pipeline Assessment 1488.1 Overview 1488.2 Clinical Trial Mapping 1498.2.1 Clinical Trials by Country 1498.3 Clinical Trials by Phase and Trial Status 1508.4 Promising Drugs in Clinical Development 1518.4.1 Xeljanz (Tofacitinib) 1538.4.2 Brodalumab 1608.4.3 Guselkumab (CNTO-1959) 1688.4.4 Tildrakizumab 1738.4.5 Piclidenoson (CF-101) 1808.4.6 Additional Phase III Pipeline Products 1858.4.7 Phase II Pipeline Products 1858.4.8 Phase I Pipeline Products 1878.5 Biosimilar Pipeline Products 1888.5.1 Introduction 1888.5.2 Hospira s Inflectra Versus J&J s Remicade in Key Autoimmune Diseases 1898.5.3 Biosimilars in the Immunology Community 1898.5.4 By the Numbers: Biosimilars in Development 1908.5.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 1948.5.6 Uptake of Biosimilars for Psoriasis is Expected to Vary by Market 1958.5.7 Biosimilars Forecast 1979 Current and Future Players 2029.1 Overview 2029.2 Trends in Corporate Strategy 2059.3 Company Profiles 2079.3.1 Johnson & Johnson 2079.3.2 AbbVie 2099.3.3 Amgen 2119.3.4 Novartis 2139.3.5 Pfizer 2169.3.6 Eli Lilly 2179.3.7 Merck 2199.3.8 LEO Pharma 2219.3.9 Celgene 2249.3.10 Can-Fite Biopharma 22510 Market Outlook 22810.1 Global Markets 22810.1.1 Forecast 22810.1.2 Drivers and Barriers - Global Issues 23310.2 US 23610.2.1 Forecast 23610.2.2 Key Events 24210.2.3 Drivers and Barriers 24210.3 5EU 24410.3.1 Forecast 24410.3.2 Key Events 25010.3.3 Drivers and Barriers 25010.4 Japan 25210.4.1 Forecast 25210.4.2 Key Events 25610.4.3 Drivers and Barriers 25610.5 India 25810.5.1 Forecast 25810.5.2 Key Events 26110.5.3 Drivers and Barriers 26111 Appendix 26411.1 Bibliography 26411.2 Abbreviations 28111.3 Methodology 28611.4 Forecasting Methodology 28611.4.1 Diagnosed Psoriasis Patients 28611.4.2 Percent Drug-Treated Patients 28711.4.3 Drugs Included in Each Therapeutic Class 28711.4.4 Launch and Patent Expiry Dates 28811.4.5 General Pricing Assumptions 28911.4.6 Individual Drug Assumptions 29011.4.7 Generic Erosion 29811.4.8 Pricing of Pipeline agents 29811.5 Physicians and Specialists Included in this Study 29911.6 Primary Research - Prescriber Survey 30211.7 About the Authors 30311.7.1 Author 30311.7.2 Reviewer 30311.7.3 Epidemiologist 30411.7.4 Global Director of Therapy Analysis and Epidemiology 30411.7.5 Global Head of Healthcare 30511.8 About GlobalData 30611.9 Disclaimer 306 6

List Of Tables in PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 1.1 List of Tables Table 1: Immune Cells Involved in Lesions 26 Table 2: Symptoms of Psoriasis 29 Table 3: Risk Factors and Comorbidities for Psoriasis 31 Table 4: 8MM, Global Trends for the Diagnosed Prevalence of Psoriasis 33 Table 5: 8MM, Sources of Epidemiological Data Used for the Forecast for Psoriasis One-Year Diagnosed Prevalent Cases 34 Table 6: 8MM, Sources of Epidemiological Data Used for the Segmentation of One-Year Diagnosed Prevalent Cases of Psoriasis by Severity 34 Table 7: 8MM, One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, All Ages, N, 2014-2024 41 Table 8: 8MM, Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, N (Row %), 2014 43 Table 9: 8MM, Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, N (Row %), 2014 45 Table 10: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis 52 Table 11: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, 2014 53 Table 12: Treatment Guidelines for Psoriasis 53 Table 13: Country Profile - US 58 Table 14: Country Profile - 5EU 61 Table 15: Country Profile - Japan 64 Table 16: Country Profile - India 66 Table 17: Leading Treatments for Psoriasis, 2015 69 Table 18: Product Profile - Enbrel 70 Table 19: Enbrel Pivotal Study I Outcomes at 3 and 6 Months 71 Table 20: Enbrel pivotal study II outcomes at 3 Months 72 Table 21: Long-Term Studies on Enbrel Efficacy in Treatment of Psoriasis 73 Table 22: Long-Term Safety Profile of Enbrel in the Treatment of Psoriasis 74 Table 23: Enbrel SWOT Analysis, 2015 75 Table 24: Global Sales Forecast ($m) for Enbrel, 2014-2024 76 Table 25: Product Profile - Humira 78 Table 26: Humira pivotal study outcomes at 16 weeks 79 7

Table 27: Humira SWOT Analysis, 2015 81 Table 28: Global Sales Forecast ($m) for Humira, 2014-2024 82 Table 29: Product Profile - Remicade 84 Table 30: Efficacy Results of RESTORE1 Trial of Remicade vs. MTX at Week 26 86 Table 31: Safety Results and AEs of RESTORE1 Trial of Remicade vs. MTX at Week 16 87 Table 32: Remicade SWOT Analysis, 2015 88 Table 33: Global Sales Forecast ($m) for Remicade, 2014-2024 89 Table 34: Product Profile - Stelara 91 Table 35: Stelara Pivotal Study Outcomes at Week 12 92 Table 36: Stelara SWOT Analysis, 2015 94 Table 37: Global Sales Forecast ($m) for Stelara, 2014-2024 95 Table 38: Product Profile - Cosentyx 97 Table 39: Efficacy Endpoints in Cosentyx Phase III ERASURE Study 98 Table 40: Efficacy End Points in Cosentyx Phase III FIXTURE study 99 Table 41: Cosentyx SWOT Analysis, 2015 102 Table 42: Global Sales Forecast ($m) for Cosentyx, 2014-2024 103 Table 43: Product Profile - Taltz 106 Table 44: Efficacy Results of UNCOVER-2 at Week 12 108 Table 45: Efficacy Results of UNCOVER-3 at Week 12 109 Table 46: Taltz SWOT Analysis, 2015 111 Table 47: Global Sales Forecast ($m) for Taltz, 2014-2024 112 Table 48: Product Profile - Otezla 114 Table 49: Otezla Efficacy Results at Week 16 in Studies ESTEEM-1 and ESTEEM-2 115 Table 50: Otezla SWOT Analysis, 2015 116 Table 51: Global Sales Forecast ($m) for Otezla, 2014-2024 117 Table 52: Product Profile - Taclonex/Enstilar 119 Table 53: Taclonex Efficacy Outcomes from Pivotal Phase III Studies for Adult Scalp and Body Psoriasis. 120 Table 54: Taclonex/Enstilar SWOT Analysis, 2015 122 Table 55: Global Sales Forecast ($m) for Taclonex/Daivobet/Dovobet, 2014-2024 123 Table 56: Product Profile - Methotrexate 125 Table 57: Methotrexate SWOT Analysis, 2015 127 8

Table 58: Global Sales Forecast ($m) for Methotrexate, 2014-2024 128 Table 59: Product Profile - Fumaderm 130 Table 60: Fumaderm SWOT Analysis, 2015 132 Table 61: Global Sales Forecast ($m) for Fumaderm, 2014-2024 133 Table 62: Product Profile - Alzumab 134 Table 63: Alzumab SWOT Analysis, 2013 135 Table 64: Global Sales Forecast ($m) for Alzumab, 2014-2024 136 Table 65: Summary of Minor Therapeutic Drug Classes for Psoriasis, 2015 137 Table 66: Dosing Guidelines for Broadband Ultraviolet B 139 Table 67: Dosing Guidelines for Narrowband Ultraviolet B 139 Table 68: Overall Unmet Needs in Psoriasis - Current Level of Attainment 140 Table 69: Psoriasis - Clinical Trials by Phase and Status, 2015 151 Table 70: Psoriasis - Phase Pipeline, 2015 151 Table 71: Comparison of Therapeutic Classes in Development for Psoriasis, 2015 153 Table 72: Product Profile - Xeljanz 155 Table 73: Xeljanz SWOT Analysis, 2015 159 Table 74: Global Sales Forecast ($m) for Xeljanz, 2014-2024 160 Table 75: Product Profile - Brodalumab 163 Table 76: Brodalumab SWOT Analysis, 2015 167 Table 77: Global Sales Forecast ($m) for Brodalumab, 2014-2024 168 Table 78: Product Profile - Guselkumab 169 Table 79: Guselkumab SWOT Analysis, 2015 172 Table 80: Global Sales Forecast ($m) for Guselkumab, 2014-2024 173 Table 81: Product Profile - Tildrakizumab 175 Table 82: Tildrakizumab SWOT Analysis, 2015 178 Table 83: Global Sales Forecast ($m) for Tildrakizumab, 2014-2024 179 Table 84: Product Profile - Piclidenoson (CF-101) 181 Table 85: Piclidenoson SWOT Analysis, 2015 184 Table 86: Additional Phase III Psoriasis Pipeline drugs, 2015 185 Table 87: Phase II Psoriasis Pipeline, 2015 185 Table 88: Phase I Psoriasis Pipeline, 2015 187 9

Table 89: Marketed and Pipeline Biosimilars for Psoriasis in the 8MM, 2015 192 Table 90: Physician Uptake of Biosimilar Products for Psoriasis Across the 8MM, 2015 197 Table 91: Global Sales Forecast ($m) for Etanercept Biosimilars, 2014-2024 197 Table 92: Global Sales Forecast ($m) for Adalimumab Biosimilars, 2014-2024 198 Table 93: Global Sales Forecast ($m) for Infliximab Biosimilars, 2014-2024 200 Table 94: Key Companies in the Psoriasis Market, 2015 204 Table 95: J&J s Psoriasis Portfolio Assessment, 2015 208 Table 96: J&J s Psoriasis Portfolio SWOT Analysis, 2015 209 Table 97: AbbVie s Psoriasis Portfolio Assessment, 2015 211 Table 98: AbbVie s Psoriasis SWOT Analysis, 2015 211 Table 99: Amgen s Psoriasis Portfolio Assessment, 2015 213 Table 100: Amgen s Psoriasis SWOT Analysis, 2015 213 Table 101: Novartis s Psoriasis Portfolio Assessment, 2015 215 Table 102: Novartis Psoriasis SWOT Analysis, 2015 215 Table 103: Pfizer s Psoriasis Portfolio Assessment, 2015 217 Table 104: Pfizer s Psoriasis Portfolio SWOT Analysis, 2015 217 Table 105: Eli Lilly s Psoriasis Portfolio Assessment, 2015 219 Table 106: Eli Lilly s Psoriasis Portfolio SWOT Analysis, 2015 219 Table 107: Merck s Psoriasis Portfolio Assessment, 2015 220 Table 108: Merck s Psoriasis Portfolio SWOT Analysis, 2015 221 Table 109: LEO Pharma s Psoriasis Portfolio Assessment, 2015 223 Table 110: LEO Pharma s Psoriasis Portfolio SWOT Analysis, 2015 223 Table 111: Celgene s Psoriasis Portfolio Assessment, 2015 224 Table 112: Celgene s Psoriasis Portfolio SWOT Analysis, 2015 225 Table 113: Can-Fite s Psoriasis Portfolio Assessment, 2015 226 Table 114: Celgene s Psoriasis Portfolio SWOT Analysis, 2015 227 Table 115: Global Sales Forecast ($m) for Psoriasis, 2014-2024 230 Table 116: Global Psoriasis Market - Drivers and Barriers, 2014-2024 233 Table 117: Sales Forecast ($) for Psoriasis in the US, 2014-2024 239 Table 118: Key Events Impacting Sales for Psoriasis in the US, 2014-2024 242 Table 119: Psoriasis Market in the US - Drivers and Barriers, 2014-2024 242 10

Table 120: Sales Forecast ($) for Psoriasis in the 5EU, 2014-2024 247 Table 121: Key Events Impacting Sales for Psoriasis in the 5EU, 2014-2024 250 Table 122: Psoriasis Market in the 5EU - Drivers and Barriers, 2014-2024 250 Table 123: Sales Forecast ($) for Psoriasis in Japan, 2014-2024 254 Table 124: Key Events Impacting Sales for Psoriasis in Japan, 2014-2024 256 Table 125: Psoriasis Market in Japan - Drivers and Barriers, 2014-2024 256 Table 126: Sales Forecast ($) for Psoriasis in India, 2014-2024 259 Table 127: Key Events Impacting Sales for Psoriasis in India, 2014-2024 261 Table 128: Psoriasis Market in India - Drivers and Barriers, 2014-2024 261 Table 129: Key Launch Dates 288 Table 130: Key Patent Expiries 288 Table 131: Key Launch Dates 289 Table 132: Physicians Surveyed, by Country 302 11

List Of Figures, Charts and Diagrams in PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 1.2 List of Figures Figure 1: Psoriatic Plaque on Elbow of Patient 25 Figure 2: The Three Layers of the Skin and Associated Structures 27 Figure 3: Healthy Skin Versus Psoriatic Skin 28 Figure 4: 8MM, One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, All Ages, N, 2014-2024 41 Figure 5: 8MM, Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, N, 2014 44 Figure 6: 8MM, Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, N, 2014 46 Figure 7: 8MM, Age-Standardized One-Year Diagnosed Prevalent Cases of Psoriasis (%), All Ages, by Sex, 2014 47 Figure 8: 8MM, Severity Profile of One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, Both Sexes, N, 2014 48 Figure 9: Psoriasis Therapeutics - Ongoing Clinical Trial Sites by Country, 2015 150 Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis, 2014-2024 152 Figure 11: Biosimilar Prescribing Habits in Psoriasis Across the 8MM, 2015 196 Figure 12: Global Sales Forecast ($m) for Enbrel vs. Etanercept Biosimilars, 2014-2024 198 Figure 13: Global Sales Forecast ($m) for Humira vs. Adalimumab Biosimilars, 2014-2024 199 Figure 14: Global Sales Forecast ($m) for Remicade vs. Infliximab Biosimilars, 2014-2024 201 Figure 15: Company Portfolio Gap Analysis in Psoriasis, 2014-2024 205 Figure 16: Global Sales for Psoriasis by Region, 2014-2024 232 Figure 17: Sales for Psoriasis in the US by Drug Class, 2014-2024 241 Figure 18: Sales for Psoriasis in the 5EU by Drug Class, 2014-2024 248 Figure 19: Sales for Psoriasis in the 5EU by Region, 2014-2024 249 Figure 20: Sales for Psoriasis in Japan by Drug Class, 2014-2024 255 Figure 21: Sales for Psoriasis in India by Drug Class, 2014-2024 260 12

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