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

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

2 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) or 2

3 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

4 - 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 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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6 Table Of Contents for PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to Table of Contents1 Table of Contents 91.1 List of Tables List of Figures 212 Introduction Catalyst Related Reports Upcoming Related Reports 233 Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Symptoms 284 Epidemiology Disease Background Risk Factors and Comorbidities Global Trends Prevalence Forecast Methodology Sources Used for One-Year Diagnosed Prevalence of Psoriasis Sources Not Used Forecast Assumptions and Methods, One-Year Diagnosed Prevalent Cases of Psoriasis Epidemiological Forecast for Psoriasis ( ) One-Year Diagnosed Prevalent Cases of Psoriasis Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis Age-Standardized One-Year Diagnosed Prevalent Cases of Psoriasis One-Year Diagnosed Prevalent Cases of Psoriasis by Severity Discussion Epidemiological Forecast Insight Limitations of the Analysis Strengths of the Analysis 495 Disease Management Diagnosis and Treatment Overview Diagnosis Leading Prescribed Drugs and Treatment Guidelines Clinical Practice US EU Japan India 656 Competitive Assessment Overview Strategic Competitor Assessment Product Profiles - Major Brands Enbrel (Etanercept) Humira (Adalimumab) Remicade (Infliximab) Stelara (Ustekinumab) Cosentyx (Secukinumab) Taltz (Ixekizumab) Otezla (Apremilast) Taclonex and Enstilar (Calcipotriene and Betamethasone Dipropionate) Methotrexate Fumaderm (Fumaric Acid Esters) Alzumab (Itolizumab) Other Therapeutic Drug Classes Used in Psoriasis Non-pharmacological Therapy 1377 Unmet Need and Opportunity Overview Limited Patient Access Due to Drug Reimbursement Pattern Unmet Need Gap Analysis Opportunity Improved Drug Safety and Efficacy Profiles Unmet Need Gap Analysis Opportunity Education and Treatment of Psychological Factors Accompanying Psoriasis Unmet Need Gap Analysis Opportunity Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis Unmet Need Gap Analysis Opportunity 1478 Pipeline Assessment Overview Clinical Trial Mapping Clinical Trials by Country Clinical Trials by Phase and Trial Status Promising Drugs in Clinical Development Xeljanz (Tofacitinib) Brodalumab Guselkumab (CNTO-1959) Tildrakizumab Piclidenoson (CF-101) Additional Phase III Pipeline Products Phase II Pipeline Products Phase I Pipeline Products Biosimilar Pipeline Products Introduction Hospira s Inflectra Versus J&J s Remicade in Key Autoimmune Diseases Biosimilars in the Immunology Community By the Numbers: Biosimilars in Development The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry Uptake of Biosimilars for Psoriasis is Expected to Vary by Market Biosimilars Forecast 1979 Current and Future Players Overview Trends in Corporate Strategy Company Profiles Johnson & Johnson AbbVie Amgen Novartis Pfizer Eli Lilly Merck LEO Pharma Celgene Can-Fite Biopharma Market Outlook Global Markets Forecast Drivers and Barriers - Global Issues US Forecast Key Events Drivers and Barriers EU Forecast Key Events Drivers and Barriers Japan Forecast Key Events Drivers and Barriers India Forecast Key Events Drivers and Barriers Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed Psoriasis Patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Pricing of Pipeline agents Physicians and Specialists Included in this Study Primary Research - Prescriber Survey About the Authors Author Reviewer Epidemiologist Global Director of Therapy Analysis and Epidemiology Global Head of Healthcare About GlobalData Disclaimer 306 6

7 List Of Tables in PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 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, Table 8: 8MM, Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, N (Row %), Table 9: 8MM, Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, N (Row %), 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, 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, 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, Table 24: Global Sales Forecast ($m) for Enbrel, Table 25: Product Profile - Humira 78 Table 26: Humira pivotal study outcomes at 16 weeks 79 7

8 Table 27: Humira SWOT Analysis, Table 28: Global Sales Forecast ($m) for Humira, Table 29: Product Profile - Remicade 84 Table 30: Efficacy Results of RESTORE1 Trial of Remicade vs. MTX at Week Table 31: Safety Results and AEs of RESTORE1 Trial of Remicade vs. MTX at Week Table 32: Remicade SWOT Analysis, Table 33: Global Sales Forecast ($m) for Remicade, Table 34: Product Profile - Stelara 91 Table 35: Stelara Pivotal Study Outcomes at Week Table 36: Stelara SWOT Analysis, Table 37: Global Sales Forecast ($m) for Stelara, Table 38: Product Profile - Cosentyx 97 Table 39: Efficacy Endpoints in Cosentyx Phase III ERASURE Study 98 Table 40: Efficacy End Points in Cosentyx Phase III FIXTURE study 99 Table 41: Cosentyx SWOT Analysis, Table 42: Global Sales Forecast ($m) for Cosentyx, Table 43: Product Profile - Taltz 106 Table 44: Efficacy Results of UNCOVER-2 at Week Table 45: Efficacy Results of UNCOVER-3 at Week Table 46: Taltz SWOT Analysis, Table 47: Global Sales Forecast ($m) for Taltz, Table 48: Product Profile - Otezla 114 Table 49: Otezla Efficacy Results at Week 16 in Studies ESTEEM-1 and ESTEEM Table 50: Otezla SWOT Analysis, Table 51: Global Sales Forecast ($m) for Otezla, 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, Table 55: Global Sales Forecast ($m) for Taclonex/Daivobet/Dovobet, Table 56: Product Profile - Methotrexate 125 Table 57: Methotrexate SWOT Analysis,

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

10 Table 89: Marketed and Pipeline Biosimilars for Psoriasis in the 8MM, Table 90: Physician Uptake of Biosimilar Products for Psoriasis Across the 8MM, Table 91: Global Sales Forecast ($m) for Etanercept Biosimilars, Table 92: Global Sales Forecast ($m) for Adalimumab Biosimilars, Table 93: Global Sales Forecast ($m) for Infliximab Biosimilars, Table 94: Key Companies in the Psoriasis Market, Table 95: J&J s Psoriasis Portfolio Assessment, Table 96: J&J s Psoriasis Portfolio SWOT Analysis, Table 97: AbbVie s Psoriasis Portfolio Assessment, Table 98: AbbVie s Psoriasis SWOT Analysis, Table 99: Amgen s Psoriasis Portfolio Assessment, Table 100: Amgen s Psoriasis SWOT Analysis, Table 101: Novartis s Psoriasis Portfolio Assessment, Table 102: Novartis Psoriasis SWOT Analysis, Table 103: Pfizer s Psoriasis Portfolio Assessment, Table 104: Pfizer s Psoriasis Portfolio SWOT Analysis, Table 105: Eli Lilly s Psoriasis Portfolio Assessment, Table 106: Eli Lilly s Psoriasis Portfolio SWOT Analysis, Table 107: Merck s Psoriasis Portfolio Assessment, Table 108: Merck s Psoriasis Portfolio SWOT Analysis, Table 109: LEO Pharma s Psoriasis Portfolio Assessment, Table 110: LEO Pharma s Psoriasis Portfolio SWOT Analysis, Table 111: Celgene s Psoriasis Portfolio Assessment, Table 112: Celgene s Psoriasis Portfolio SWOT Analysis, Table 113: Can-Fite s Psoriasis Portfolio Assessment, Table 114: Celgene s Psoriasis Portfolio SWOT Analysis, Table 115: Global Sales Forecast ($m) for Psoriasis, Table 116: Global Psoriasis Market - Drivers and Barriers, Table 117: Sales Forecast ($) for Psoriasis in the US, Table 118: Key Events Impacting Sales for Psoriasis in the US, Table 119: Psoriasis Market in the US - Drivers and Barriers,

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

12 List Of Figures, Charts and Diagrams in PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 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, Figure 5: 8MM, Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, Both Sexes, N, Figure 6: 8MM, Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, N, Figure 7: 8MM, Age-Standardized One-Year Diagnosed Prevalent Cases of Psoriasis (%), All Ages, by Sex, Figure 8: 8MM, Severity Profile of One-Year Diagnosed Prevalent Cases of Psoriasis, All Ages, Both Sexes, N, Figure 9: Psoriasis Therapeutics - Ongoing Clinical Trial Sites by Country, Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis, Figure 11: Biosimilar Prescribing Habits in Psoriasis Across the 8MM, Figure 12: Global Sales Forecast ($m) for Enbrel vs. Etanercept Biosimilars, Figure 13: Global Sales Forecast ($m) for Humira vs. Adalimumab Biosimilars, Figure 14: Global Sales Forecast ($m) for Remicade vs. Infliximab Biosimilars, Figure 15: Company Portfolio Gap Analysis in Psoriasis, Figure 16: Global Sales for Psoriasis by Region, Figure 17: Sales for Psoriasis in the US by Drug Class, Figure 18: Sales for Psoriasis in the 5EU by Drug Class, Figure 19: Sales for Psoriasis in the 5EU by Region, Figure 20: Sales for Psoriasis in Japan by Drug Class, Figure 21: Sales for Psoriasis in India by Drug Class,

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