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

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


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



Executive Summary

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).

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 products-including 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.

1 Table of Contents

1 Table of Contents 9

1.1 List of Tables 15

1.2 List of Figures 21

2 Introduction 22

2.1 Catalyst 22

2.2 Related Reports 22

2.3 Upcoming Related Reports 23

3 Disease Overview 24

3.1 Etiology and Pathophysiology 24

3.1.1 Etiology 24

3.1.2 Pathophysiology 25

3.2 Symptoms 28

4 Epidemiology 30

4.1 Disease Background 30

4.2 Risk Factors and Comorbidities 30

4.3 Global Trends 31

4.3.1 Prevalence 31

4.4 Forecast Methodology 33

4.4.1 Sources Used for One-Year Diagnosed Prevalence of Psoriasis 35

4.4.2 Sources Not Used 37

4.4.3 Forecast Assumptions and Methods, One-Year Diagnosed Prevalent Cases of Psoriasis 38

4.5 Epidemiological Forecast for Psoriasis (2014-2024) 40

4.5.1 One-Year Diagnosed Prevalent Cases of Psoriasis 40

4.5.2 Age-Specific One-Year Diagnosed Prevalent Cases of Psoriasis 42

4.5.3 Sex-Specific One-Year Diagnosed Prevalent Cases of Psoriasis 44

4.5.4 Age-Standardized One-Year Diagnosed Prevalent Cases of Psoriasis 46

4.5.5 One-Year Diagnosed Prevalent Cases of Psoriasis by Severity 47

4.6 Discussion 48

4.6.1 Epidemiological Forecast Insight 48

4.6.2 Limitations of the Analysis 49

4.6.3 Strengths of the Analysis 49

5 Disease Management 50

5.1 Diagnosis and Treatment Overview 50

5.1.1 Diagnosis 50

5.1.2 Leading Prescribed Drugs and Treatment Guidelines 51

5.1.3 Clinical Practice 54

5.2 US 54

5.3 5EU 59

5.4 Japan 62

5.5 India 65

6 Competitive Assessment 67

6.1 Overview 67

6.2 Strategic Competitor Assessment 68

6.3 Product Profiles-Major Brands 69

6.3.1 Enbrel (Etanercept) 69

6.3.2 Humira (Adalimumab) 76

6.3.3 Remicade (Infliximab) 82

6.3.4 Stelara (Ustekinumab) 89

6.3.5 Cosentyx (Secukinumab) 95

6.3.6 Taltz (Ixekizumab) 103

6.3.7 Otezla (Apremilast) 112

6.3.8 Taclonex and Enstilar (Calcipotriene and Betamethasone Dipropionate) 117

6.3.9 Methotrexate 123

6.3.10 Fumaderm (Fumaric Acid Esters) 128

6.3.11 Alzumab (Itolizumab) 133

6.3.12 Other Therapeutic Drug Classes Used in Psoriasis 136

6.3.13 Non-pharmacological Therapy 137

7 Unmet Need and Opportunity 140

7.1 Overview 140

7.2 Limited Patient Access Due to Drug Reimbursement Pattern 140

7.2.1 Unmet Need 140

7.2.2 Gap Analysis 141

7.2.3 Opportunity 142

7.3 Improved Drug Safety and Efficacy Profiles 142

7.3.1 Unmet Need 142

7.3.2 Gap Analysis 143

7.3.3 Opportunity 143

7.4 Education and Treatment of Psychological Factors Accompanying Psoriasis 144

7.4.1 Unmet Need 144

7.4.2 Gap Analysis 145

7.4.3 Opportunity 145

7.5 Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis 146

7.5.1 Unmet Need 146

7.5.2 Gap Analysis 146

7.5.3 Opportunity 147

8 Pipeline Assessment 148

8.1 Overview 148

8.2 Clinical Trial Mapping 149

8.2.1 Clinical Trials by Country 149

8.3 Clinical Trials by Phase and Trial Status 150

8.4 Promising Drugs in Clinical Development 151

8.4.1 Xeljanz (Tofacitinib) 153

8.4.2 Brodalumab 160

8.4.3 Guselkumab (CNTO-1959) 168

8.4.4 Tildrakizumab 173

8.4.5 Piclidenoson (CF-101) 180

8.4.6 Additional Phase III Pipeline Products 185

8.4.7 Phase II Pipeline Products 185

8.4.8 Phase I Pipeline Products 187

8.5 Biosimilar Pipeline Products 188

8.5.1 Introduction 188

8.5.2 Hospira's Inflectra Versus J&J's Remicade in Key Autoimmune Diseases 189

8.5.3 Biosimilars in the Immunology Community 189

8.5.4 By the Numbers: Biosimilars in Development 190

8.5.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 194

8.5.6 Uptake of Biosimilars for Psoriasis is Expected to Vary by Market 195

8.5.7 Biosimilars Forecast 197

9 Current and Future Players 202

9.1 Overview 202

9.2 Trends in Corporate Strategy 205

9.3 Company Profiles 207

9.3.1 Johnson & Johnson 207

9.3.2 AbbVie 209

9.3.3 Amgen 211

9.3.4 Novartis 213

9.3.5 Pfizer 216

9.3.6 Eli Lilly 217

9.3.7 Merck 219

9.3.8 LEO Pharma 221

9.3.9 Celgene 224

9.3.10 Can-Fite Biopharma 225

10 Market Outlook 228

10.1 Global Markets 228

10.1.1 Forecast 228

10.1.2 Drivers and Barriers-Global Issues 233

10.2 US 236

10.2.1 Forecast 236

10.2.2 Key Events 242

10.2.3 Drivers and Barriers 242

10.3 5EU 244

10.3.1 Forecast 244

10.3.2 Key Events 250

10.3.3 Drivers and Barriers 250

10.4 Japan 252

10.4.1 Forecast 252

10.4.2 Key Events 256

10.4.3 Drivers and Barriers 256

10.5 India 258

10.5.1 Forecast 258

10.5.2 Key Events 261

10.5.3 Drivers and Barriers 261

11 Appendix 264

11.1 Bibliography 264

11.2 Abbreviations 281

11.3 Methodology 286

11.4 Forecasting Methodology 286

11.4.1 Diagnosed Psoriasis Patients 286

11.4.2 Percent Drug-Treated Patients 287

11.4.3 Drugs Included in Each Therapeutic Class 287

11.4.4 Launch and Patent Expiry Dates 288

11.4.5 General Pricing Assumptions 289

11.4.6 Individual Drug Assumptions 290

11.4.7 Generic Erosion 298

11.4.8 Pricing of Pipeline agents 298

11.5 Physicians and Specialists Included in this Study 299

11.6 Primary Research-Prescriber Survey 302

11.7 About the Authors 303

11.7.1 Author 303

11.7.2 Reviewer 303

11.7.3 Epidemiologist 304

11.7.4 Global Director of Therapy Analysis and Epidemiology 304

11.7.5 Global Head of Healthcare 305

11.8 About GlobalData 306

11.9 Disclaimer 306

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

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 (USD m) for Enbrel vs. Etanercept Biosimilars, 2014-2024 198

Figure 13: Global Sales Forecast (USD m) for Humira vs. Adalimumab Biosimilars, 2014-2024 199

Figure 14: Global Sales Forecast (USD 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

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 (USD m) for Enbrel, 2014-2024 76

Table 25: Product Profile-Humira 78

Table 26: Humira pivotal study outcomes at 16 weeks 79

Table 27: Humira SWOT Analysis, 2015 81

Table 28: Global Sales Forecast (USD 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 (USD 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 (USD 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 (USD 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 (USD 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 (USD 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 (USD m) for Taclonex/Daivobet/Dovobet, 2014-2024 123

Table 56: Product Profile-Methotrexate 125

Table 57: Methotrexate SWOT Analysis, 2015 127

Table 58: Global Sales Forecast (USD m) for Methotrexate, 2014-2024 128

Table 59: Product Profile-Fumaderm 130

Table 60: Fumaderm SWOT Analysis, 2015 132

Table 61: Global Sales Forecast (USD m) for Fumaderm, 2014-2024 133

Table 62: Product Profile-Alzumab 134

Table 63: Alzumab SWOT Analysis, 2013 135

Table 64: Global Sales Forecast (USD 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 (USD m) for Xeljanz, 2014-2024 160

Table 75: Product Profile-Brodalumab 163

Table 76: Brodalumab SWOT Analysis, 2015 167

Table 77: Global Sales Forecast (USD m) for Brodalumab, 2014-2024 168

Table 78: Product Profile-Guselkumab 169

Table 79: Guselkumab SWOT Analysis, 2015 172

Table 80: Global Sales Forecast (USD m) for Guselkumab, 2014-2024 173

Table 81: Product Profile-Tildrakizumab 175

Table 82: Tildrakizumab SWOT Analysis, 2015 178

Table 83: Global Sales Forecast (USD 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

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 (USD m) for Etanercept Biosimilars, 2014-2024 197

Table 92: Global Sales Forecast (USD m) for Adalimumab Biosimilars, 2014-2024 198

Table 93: Global Sales Forecast (USD 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 (USD m) for Psoriasis, 2014-2024 230

Table 116: Global Psoriasis Market-Drivers and Barriers, 2014-2024 233

Table 117: Sales Forecast (USD ) 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

Table 120: Sales Forecast (USD ) 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 (USD ) 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 (USD ) 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

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Johnson & Johnson

AbbVie

Amgen

Novartis

Pfizer

Eli Lilly

Merck

LEO Pharma

Celgene

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