Psoriasis – US Drug Forecast and Market Analysis to 2024

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

4Disease Management

4.1Diagnosis and Treatment Overview

4.1.1Diagnosis

4.1.2Leading Prescribed Drugs and Treatment Guidelines

4.1.3Clinical Practice

4.2US

5Competitive Assessment

5.1Overview

5.2Strategic Competitor Assessment

5.3Product Profiles – Major Brands

5.3.1Enbrel (Etanercept)

5.3.2Humira (Adalimumab)

5.3.3Remicade (Infliximab)

5.3.4Stelara (ustekinumab)

5.3.5Cosentyx (Secukinumab)

5.3.6Otezla (Apremilast)

5.3.7Taclonex and Enstilar (Calcipotriene and Betamethasone Dipropionate)

5.3.8Methotrexate

5.3.9Fumaderm (Fumaric Acid Esters)

5.3.10Alzumab (itolizumab)

5.3.11Other Therapeutic Drug Classes Used in Psoriasis

5.3.12Non-pharmacological Therapy

6Unmet Need and Opportunity

6.1Overview

6.2Limited Patient Access Due to Drug Reimbursement Pattern

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Improved Drug Safety and Efficacy Profiles

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Education and Treatment of Psychological Factors Accompanying Psoriasis

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Clinical Trial Mapping

7.2.1Clinical Trials by Country

7.3Clinical Trials by Phase and Trial Status

7.4Promising Drugs in Clinical Development

7.4.1Xeljanz (Tofacitinib)

7.4.2Ixekizumab (LY2439821)

7.4.3Brodalumab

7.4.4Guselkumab (CNTO-1959)

7.4.5Tildrakizumab

7.4.6Piclidenoson (CF-101)

7.4.7Additional Phase III Pipeline Products

7.4.8Phase II Pipeline Products

7.4.9Phase I Pipeline Products

7.5Biosimilar Pipeline Products

7.5.1Introduction

7.5.2Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases

7.5.3Biosimilars in the Immunology Community

7.5.4By the Numbers: Biosimilars in Development

7.5.5The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry

7.5.6Uptake of Biosimilars for Psoriasis is Expected to Vary by Market

7.5.7Biosimilars Forecast

8Market Outlook

8.1US

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Diagnosed Psoriasis Patients

9.4.2Percent Drug-Treated Patients

9.4.3Drugs Included in Each Therapeutic Class

9.4.4Launch and Patent Expiry Dates

9.4.5General Pricing Assumptions

9.4.6Individual Drug Assumptions

9.4.7Generic Erosion

9.4.8Pricing of Pipeline agents

9.5Physicians and Specialists Included in this Study

9.6Primary Research – Prescriber Survey

9.7About the Authors

9.7.1Author

9.7.2Reviewer

9.7.3Epidemiologist

9.7.4Global Director of Therapy Analysis and Epidemiology

9.7.5Global Head of Healthcare

9.8About GlobalData

9.9Disclaimer

Table 1: Immune Cells Involved in Lesions

Table 2: Symptoms of Psoriasis

Table 3: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis

Table 4: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, 2014

Table 5: Treatment Guidelines for Psoriasis

Table 6: Country Profile – US

Table 7: Leading Treatments for Psoriasis, 2015

Table 8: Product Profile – Enbrel

Table 9: Enbrel Pivotal Study I Outcomes at 3 and 6 Months

Table 10: Enbrel pivotal study II outcomes at 3 Months

Table 11: Long-Term Studies on Enbrel Efficacy in Treatment of Psoriasis

Table 12: Long-Term Safety Profile of Enbrel in the Treatment of Psoriasis

Table 13: Enbrel SWOT Analysis, 2015

Table 14: Global Sales Forecast ($m) for Enbrel, 2014–2024

Table 15: Product Profile – Humira

Table 16: Humira pivotal study outcomes at 16 weeks

Table 17: Humira SWOT Analysis, 2015

Table 18: Global Sales Forecast ($m) for Humira, 2014–2024

Table 19: Product Profile – Remicade

Table 20: Efficacy Results of RESTORE1 Trial of Remicade vs. MTX at Week 26

Table 21: Safety Results and AEs of RESTORE1 Trial of Remicade vs. MTX at Week 16

Table 22: Remicade SWOT Analysis, 2015

Table 23: Global Sales Forecast ($m) for Remicade, 2014–2024

Table 24: Product Profile – Stelara

Table 25: Stelara Pivotal Study Outcomes at Week 12

Table 26: Stelara SWOT Analysis, 2015

Table 27: Global Sales Forecast ($m) for Stelara, 2014–2024

Table 28: Product Profile – Cosentyx

Table 29: Efficacy Endpoints in Cosentyx Phase III ERASURE Study

Table 30: Efficacy End Points in Cosentyx Phase III FIXTURE study

Table 31: Cosentyx SWOT Analysis, 2015

Table 32: Global Sales Forecast ($m) for Cosentyx, 2014–2024

Table 33: Product Profile – Otezla

Table 34: Otezla Efficacy Results at Week 16 in Studies ESTEEM-1 and ESTEEM-2

Table 35: Otezla SWOT Analysis, 2015

Table 36: Global Sales Forecast ($m) for Otezla, 2014–2024

Table 37: Product Profile – Taclonex/Enstilar

Table 38: Taclonex Efficacy Outcomes from Pivotal Phase III Studies for Adult Scalp and Body Psoriasis.

Table 39: Taclonex/Enstilar SWOT Analysis, 2015

Table 40: Global Sales Forecast ($m) for Taclonex/Daivobet/Dovobet, 2014–2024

Table 41: Product Profile – Methotrexate

Table 42: Methotrexate SWOT Analysis, 2015

Table 43: Global Sales Forecast ($m) for Methotrexate, 2014–2024

Table 44: Product Profile – Fumaderm

Table 45: Fumaderm SWOT Analysis, 2015

Table 46: Global Sales Forecast ($m) for Fumaderm, 2014–2024

Table 47: Product Profile – Alzumab

Table 48: Alzumab SWOT Analysis, 2013

Table 49: Global Sales Forecast ($m) for Alzumab, 2014–2024

Table 50: Summary of Minor Therapeutic Drug Classes for Psoriasis, 2015

Table 51: Dosing Guidelines for Broadband Ultraviolet B

Table 52: Dosing Guidelines for Narrowband Ultraviolet B

Table 53: Overall Unmet Needs in Psoriasis – Current Level of Attainment

Table 54: Psoriasis – Clinical Trials by Phase and Status, 2015

Table 55: Psoriasis – Phase Pipeline, 2015

Table 56: Comparison of Therapeutic Classes in Development for Psoriasis, 2015

Table 57: Product Profile – Xeljanz

Table 58: Xeljanz SWOT Analysis, 2015

Table 59: Global Sales Forecast ($m) for Xeljanz, 2014–2024

Table 60: Product Profile – Ixekizumab

Table 61: Efficacy Results of UNCOVER-2 at Week 12

Table 62: Efficacy Results of UNCOVER-3 at Week 12

Table 63: Ixekizumab SWOT Analysis, 2015

Table 64: Global Sales Forecast ($m) for Ixekizumab, 2014–2024

Table 65: Product Profile – Brodalumab

Table 66: Brodalumab SWOT Analysis, 2015

Table 67: Global Sales Forecast ($m) for Brodalumab, 2014–2024

Table 68: Product Profile – Guselkumab

Table 69: Guselkumab SWOT Analysis, 2015

Table 70: Global Sales Forecast ($m) for Guselkumab, 2014–2024

Table 71: Product Profile – Tildrakizumab

Table 72: Tildrakizumab SWOT Analysis, 2015

Table 73: Global Sales Forecast ($m) for Tildrakizumab, 2014–2024

Table 74: Product Profile – Piclidenoson (CF-101)

Table 75: Piclidenoson SWOT Analysis, 2015

Table 76: Additional Phase III Psoriasis Pipeline drugs, 2015

Table 77: Phase II Psoriasis Pipeline, 2015

Table 78: Phase I Psoriasis Pipeline, 2015

Table 79: Marketed and Pipeline Biosimilars for Psoriasis in the 8MM, 2015

Table 80: Physician Uptake of Biosimilar Products for Psoriasis Across the 8MM, 2015

Table 81: Global Sales Forecast ($m) for Etanercept Biosimilars, 2014–2024

Table 82: Global Sales Forecast ($m) for Adalimumab Biosimilars, 2014–2024

Table 83: Global Sales Forecast ($m) for Infliximab Biosimilars, 2014–2024

Table 84: Sales Forecast ($) for Psoriasis in the US, 2014–2024

Table 85: Key Events Impacting Sales for Psoriasis in the US, 2014–2024

Table 86: Psoriasis Market in the US – Drivers and Barriers, 2014–2024

Table 87: Key Launch Dates

Table 88: Key Patent Expiries

Table 89: Key Launch Dates

Table 90: Physicians Surveyed, by Country

Figure 1: Psoriatic Plaque on Elbow of Patient

Figure 2: The Three Layers of the Skin and Associated Structures

Figure 3: Healthy Skin Versus Psoriatic Skin

Figure 4: Psoriasis Therapeutics – Ongoing Clinical Trial Sites by Country, 2015

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis, 2014–2024

Figure 6: Biosimilar Prescribing Habits in Psoriasis Across the 8MM, 2015

Figure 7: Global Sales Forecast ($m) for Enbrel vs. Etanercept Biosimilars, 2014–2024

Figure 8: Global Sales Forecast ($m) for Humira vs. Adalimumab Biosimilars, 2014–2024

Figure 9: Global Sales Forecast ($m) for Remicade vs. Infliximab Biosimilars, 2014–2024

Figure 10: Sales for Psoriasis in the US by Drug Class, 2014–2024