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PharmaPoint: Psoriatic Arthritis - Global Drug Forecast and Market Analysis to 2025
Publication Date Dec 2017
Product Type Report
Pages 235
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PharmaPoint: Psoriatic Arthritis - Global Drug Forecast and Market Analysis to 2025

Summary

Psoriatic arthritis (PsA) is a chronic immune-mediated arthritis typically affecting the large joints, especially those of the lower extremities and distal joints of the fingers and toes as well as the back and sacroiliac joints of the pelvis. In approximately 80% of PsA patients, skin lesions of psoriasis (PsO), an immune-mediated skin disease, manifest prior to the development of PsA, typically by five to 10 years. PsA most commonly develops between the ages of 30 and 50 and affects men and women equally. Although, early diagnosis and intervention are key in preventing irreversible joint damage, many PsA patients are undiagnosed and go untreated for months or years.

GlobalData projects the PsA market in 7MM to experience strong growth during the forecast period at a CAGR of 10.74%. By the forecast's end in 2025, sales will increase to over $12.58 billion from $4.53 billion in 2015. This growth will be driven primarily by the increase in diagnosed prevalent cases from 1,044,022 in 2015 to 1,520,471 in 2025. Further, the launch of the IL-17 inhibitors, including Novartis' Cosentyx, Eli Lilly's Taltz, and AstraZeneca's Lumicef, as well as the launch of Celgene's oral therapy Otezla, will expand the treatment armamentarium for PsA driving growth in the market.

Highlights

Key Questions Answered

- How large an impact will biosimilars have on the PsA market? What do dermatologists, rheumatologists, and key opinion leaders across the 7MM think about the evolving treatment landscape?
- What opportunities remain in the market for new product entrants?
- What are the most promising late-stage pipeline drugs and how will their launch shape the future treatment landscape in the PsA market?
- According to KOLs, what are the most important unmet needs in PsA? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2025?
- What clinical and commercial factors are likely to affect uptake of PsA therapies in the US, 5EU, and Japan?

Key Findings

- The PsA market is currently very dynamic, with effective biologic therapies recently approved, including interleukin-17 (IL-17) inhibitors - Cosentyx, Taltz, and Lumicef - and oral phosphodiesterase-4 (PDE4) - Otezla.
- 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 include the increasing diagnosis rate as well as the recent approval of novel therapies. 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 PsA, including epidemiology, etiology, pathophysiology, symptoms and country-specific diagnosis and treatment recommendations.
- Annualized PsA market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the PsA market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of novel products- including promising IL-17 inhibitors - and biosimilars - such as Celltrion’s Hospira, Sandoz’s Erelzi, Biogen/Samsung Bioepies’ Flixabi and Benepali, and Amgen’s Amjevita.
- Analysis of the current and future market competition in the global PsA market (7MM). 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.
- Track drug sales in the global PsA market from 2015-2025.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


Companies Mentioned

Amgen AbbVie Celgene Eli Lilly Johnson & Johnson UCB Bristol-Myers Squibb Novartis Pfizer AstraZeneca Alder

1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 15
1.2 List of Figures 18
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 20
2.3 Upcoming Related Reports 21
3 Disease Overview 22
3.1 Etiology and Pathophysiology 22
3.1.1 Etiology 22
3.1.2 Pathophysiology 24
3.2 Symptoms 26
3.3 Quality of Life 27
4 Epidemiology 28
4.1 Disease Background 28
4.2 Risk Factors and Comorbidities 30
4.3 Global Trends 31
4.4 Forecast Methodology 32
4.4.1 Sources Used 32
4.4.2 Forecast Assumptions and Methods 33
4.4.3 Sources Not Used 40
4.5 Epidemiological Forecast for PsA (2015-2025) 41
4.5.1 Diagnosed Prevalent Cases of PsA 41
4.5.2 Age-Specific Diagnosed Prevalent Cases of PsA 43
4.5.3 Sex-Specific Diagnosed Prevalent Cases of PsA 45
4.5.4 Age-Standardized Diagnosed Prevalence of PsA 47
4.5.5 Diagnosed Prevalent Cases by Type 49
4.5.6 Diagnosed Prevalent Cases by Joint Involvement 50
4.6 Alternative Forecast of Diagnosed Prevalent Cases of PsA 50
4.7 Discussion 52
4.7.1 Epidemiological Forecast Insight 52
4.7.2 Limitations of the Analysis 53
4.7.3 Strengths of the Analysis 54
5 Disease Management 56
5.1 Diagnosis and Treatment Overview 56
5.1.1 Diagnosis 56
5.1.2 Disease Activity 58
5.1.3 Treatment Guidelines and Leading Prescribed Drugs 59
5.1.4 Clinical Practice 68
5.2 US 70
5.3 5EU 71
5.4 Japan 74
6 Competitive Assessment 76
6.1 Overview 76
6.2 Product Profiles - Major Brands 77
6.2.1 Enbrel (etanercept) 77
6.2.2 Humira (adalimumab) 81
6.2.3 Simponi (golimumab) 85
6.2.4 Remicade (infliximab) 89
6.2.5 Cimzia (certolizumab pegol) 94
6.2.6 Cosentyx (secukizumab) 98
6.2.7 Lumicef (brodalumab) 102
6.2.8 Taltz (ixekizumab) 106
6.2.9 Stelara (ustekinumab) 109
6.2.10 Otezla (apremilast) 113
6.3 Other Therapeutic Classes 117
7 Unmet Needs and Opportunities 118
7.1 Overview 118
7.2 Increased Awareness Among Dermatologists and Primary Care Physicians 119
7.2.1 Unmet Need 119
7.2.2 Gap Analysis 120
7.2.3 Opportunity 121
7.3 Early Diagnosis and Treatment 122
7.3.1 Unmet Need 122
7.3.2 Gap Analysis 122
7.3.3 Opportunity 123
7.4 Improved Drug Safety and Efficacy Profiles 123
7.4.1 Unmet Need 123
7.4.2 Gap Analysis 125
7.4.3 Opportunity 126
7.5 Development of Cost-Effective Therapies 127
7.5.1 Unmet Need 127
7.5.2 Gap Analysis 128
7.5.3 Opportunity 129
8 Pipeline Assessment 130
8.1 Overview 130
8.2 Clinical Trial Mapping 130
8.2.1 Clinical Trials by Class 130
8.3 Promising Drugs in Clinical Development 131
8.3.1 Xeljanz (tofacitinib) 134
8.3.2 Orencia (abatacept) 140
8.3.3 Clazakizumab 146
8.4 Other Drugs in Development 151
8.5 Biosimilars 153
8.5.1 Introduction 153
8.5.2 Biosimilars Versus Branded Biologics in Key Autoimmune Diseases 154
8.5.3 Biosimilars in the Immunology Community 156
8.5.4 By the Numbers: Biosimilars in Development 156
8.5.5 The Impact of Biosimilars Will Be Felt Throughout the Pharmaceutical Industry 162
8.5.6 Uptake of Biosimilars is Expected to Vary by Market 162
9 Current and Future Players 165
9.1 Overview 165
9.2 Trends in Corporate Strategy 168
9.3 Company Profiles 169
9.3.1 Amgen 169
9.3.2 AbbVie 170
9.3.3 Johnson & Johnson 171
9.3.4 UCB 173
9.3.5 Novartis 174
9.3.6 Celgene 175
9.3.7 Pfizer 176
9.3.8 Bristol-Myers Squibb 177
9.3.9 AstraZeneca 178
9.3.10 Eli Lilly 179
9.3.11 Alder 180
10 Market Outlook 182
10.1 Global Markets 182
10.1.1 Forecast 182
10.1.2 Drivers and Barriers - Global Issues 185
10.2 US 187
10.2.1 Forecast 187
10.2.2 Key Events 191
10.2.3 Drivers and Barriers 192
10.3 5EU 192
10.3.1 Forecast 192
10.3.2 Key Events 196
10.3.3 Drivers and Barriers 197
10.4 Japan 197
10.4.1 Forecast 197
10.4.2 Key Events 200
10.4.3 Drivers and Barriers 201
11 Appendix 202
11.1 Bibliography 202
11.2 Abbreviations 213
11.3 Methodology 220
11.4 Forecasting Methodology 220
11.4.1 Diagnosed Psoriatic Arthritis Patients 220
11.4.2 Percent Drug-Treated Patients 220
11.4.3 Drugs Included in Each Therapeutic Class 221
11.4.4 Launch and Patent Expiry Dates 221
11.4.5 General Pricing Assumptions 222
11.4.6 Individual Drug Assumptions 223
11.4.7 Generic Erosion 227
11.4.8 Pricing of Pipeline Agents 228
11.5 Primary Research - Key Opinion Leaders Interviewed for This Report 229
11.6 Primary Research - Prescriber Survey 231
11.7 About the Authors 232
11.7.1 Analyst 232
11.7.2 Therapy Area Director 232
11.7.3 Epidemiologist 232
11.7.4 Global Director of Therapy Analysis and Epidemiology 233
11.8 About GlobalData 234
11.9 Disclaimer 234

List of Tables
1.1 List of Tables
Table 1: Symptoms of PsA 26
Table 2: Risk Factors for and Comorbidities of PsA 30
Table 3: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of PsA 32
Table 4: Sources Used to Forecast Proportion of Diagnosed Prevalent Cases of PsA by Type 33
Table 5: 7MM, Diagnosed Prevalent Cases of PsA, Ages ?18 Years, Both Sexes, N, Selected Years 2015-2025 42
Table 6: 7MM, Age-Specific, Diagnosed Prevalent Cases of PsA, Both Sexes, N (Row %), 2015 44
Table 7: 7MM, Sex-Specific Diagnosed Prevalent Cases of PsA, Ages ?18, N (Row %), 2015 46
Table 8: 7MM, Alternative Diagnosed Prevalent Cases of PsA, Ages ?18 Years, Both Sexes, N, Selected Years 2015-2025 51
Table 9: CASPAR Diagnostic Criteria for PsA 57
Table 10: Treatment Guidelines for PsA 60
Table 11: Overarching Principles of PsA GRAPPA Treatment Recommendations, 2015 62
Table 12: GRAPPA Treatment Guidelines for PsA, 2015 63
Table 13: Updated EULAR Overarching Principles for PsA, 2015 64
Table 14: Updated EULAR Recommendations for the Management of PsA, 2015 65
Table 15: Country Profile - US 71
Table 16: Country Profile - 5EU 73
Table 17: Country Profile - Japan 75
Table 18: Leading Branded Treatments for PsA, 2015 76
Table 19: Product Profile - Enbrel 78
Table 20: Enbrel SWOT Analysis, 2015 80
Table 21: Product Profile - Humira 82
Table 22: Humira SWOT Analysis, 2015 84
Table 23: Product Profile - Simponi 86
Table 24: Simponi SWOT Analysis, 2015 88
Table 25: Product Profile - Remicade 91
Table 26: Remicade SWOT Analysis, 2015 93
Table 27: Product Profile - Cimzia 95
Table 28: Cimzia SWOT Analysis, 2015 97
Table 29: Product Profile - Cosentyx 99
Table 30: Cosentyx SWOT Analysis, 2015 101
Table 31: Product Profile - Lumicef 103
Table 32: Lumicef SWOT Analysis, 2015 105
Table 33: Product Profile - Taltz 107
Table 34: Taltz SWOT Analysis, 2015 108
Table 35: Product Profile - Stelara 110
Table 36: Stelara SWOT Analysis, 2015 112
Table 37: Product Profile - Otezla 114
Table 38: Otezla SWOT Analysis, 2015 116
Table 39: Summary of Minor Therapeutic Classes for PsA, 2016 117
Table 40: Unmet Needs and Opportunities in PsA 118
Table 41: Comparison of Therapeutic Classes in Development for PsA, 2016 133
Table 42: Product Profile - Xeljanz 135
Table 43: Clinical Trials Demonstrating Xeljanz as a Potential Treatment for PsA 136
Table 44: Xeljanz SWOT Analysis, 2015 139
Table 45: Product Profile - Orencia 142
Table 46: Orencia SWOT Analysis, 2015 145
Table 47: Product Profile - Clazakizumab 147
Table 48: Clazakizumab SWOT Analysis, 2015 150
Table 49: Drugs in Development for PsA, 2016 152
Table 50: Clinical Trials Demonstrating the Efficacy of Biosimilars to Branded Biologics 155
Table 51: 7MM, Marketed and Pipeline Biosimilars for PsA, 2016 158
Table 52: 7MM, Physician Uptake of Biosimilar Products for PsA, 2016 164
Table 53: 7MM, Key Companies in the PsA Market, 2015 166
Table 54: Amgen’s PsA Portfolio Assessment, 2015 170
Table 55: AbbVie’s PsA Portfolio Assessment, 2015 171
Table 56: J&J’s PsA Portfolio Assessment, 2015 173
Table 57: UCB’s PsA Portfolio Assessment, 2015 174
Table 58: Novartis’ PsA Portfolio Assessment, 2015 175
Table 59: Celgene’s PsA Portfolio Assessment, 2015 176
Table 60: Pfizer’s PsA Portfolio Assessment, 2015 177
Table 61: BMS’ PsA Portfolio Assessment, 2015 178
Table 62: AstraZeneca’s PsA Portfolio Assessment, 2015 179
Table 63: Eli Lilly’s PsA Portfolio Assessment, 2015 180
Table 64: Alder’s PsA Portfolio Assessment, 2015 181
Table 65: PsA Market - Global Drivers and Barriers, 2015?2025 185
Table 66: Key Events Impacting Sales for PsA in the US, 2015-2015 191
Table 67: PsA Market - US Drivers and Barriers, 2015?2025 192
Table 68: Key Events Impacting Sales for PsA in the 5EU, 2015-2015 196
Table 69: PsA Market - 5EU Drivers and Barriers, 2015?2025 197
Table 70: Key Events Impacting Sales for PsA in Japan, 2015-2015 200
Table 71: PsA Market - Japan Drivers and Barriers, 2015?2025 201
Table 72: 7MM, Key Launch Dates 221
Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 231

List of Figures
1.2 List of Figures
Figure 1: 7MM, Diagnosed Prevalent Cases of PsA, Ages ?18 Years, Both Sexes, N, 2015-2025 43
Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of PsA, Both Sexes, N, 2015 45
Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of PsA, Ages ?18, 2015 47
Figure 4: 7MM, Age-Standardized Diagnosed Prevalence Rate of PsA, Ages ?18, N, 2015 48
Figure 5: 7MM, Diagnosed Prevalent Cases of PsA by Type, Both Sexes, Ages ?18, 2015 49
Figure 6: 7MM, Diagnosed Prevalent Cases of PsA by Joint Involvement, Both Sexes, Ages ?18, 2015 50
Figure 7: 7MM, Alternative Diagnosed Prevalent Cases of PsA, Ages ?18 Years, Both Sexes, N, Selected Years 2015-2025 52
Figure 8: Original GRAPPA Treatment Guidelines for PsA, 2009 61
Figure 9: EULAR 2015 Recommendations for the Management of PsA, Phase I 66
Figure 10: EULAR 2015 Recommendations for the Management of PsA, Phase II 67
Figure 11: EULAR 2015 Recommendations for the Management of PsA, Phase III 67
Figure 12: EULAR 2015 Recommendations for the Management of PsA, Phase IV 68
Figure 13: PsA Clinical Trials by Drug Class, 2016 131
Figure 14: PsA - Phase IIb-III Pipeline, 2016 132
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in PsA, 2015-2025 133
Figure 16: Clinical and Commercial Positioning of Xeljanz 139
Figure 17: Clinical and Commercial Positioning of Orencia 144
Figure 18: Clinical and Commercial Positioning of Clazakizumab 150
Figure 19: Biosimilar Prescribing Habits in PsA Across the 7MM, 2016 164
Figure 20: Global Sales of Branded Products for PsA by Company, 2015-2025 167
Figure 21: Company Portfolio Gap Analysis in PsA, 2015-2025 168
Figure 22: Global Sales for PsA by Region, 2015-2025 184
Figure 23: US Sales for PsA by Drug Class, 2015-2025 190
Figure 24: 5EU Sales for PsA by Drug Class, 2015-2025 195
Figure 25: Japan Sales for PsA by Drug Class, 2015-2025 199

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