PharmaPoint: Rheumatoid Arthritis - United Kingdom Drug Forecast and Market Analysis Event-Driven Update



Summary



GlobalData has released its new Country report, “PharmaPoint: Rheumatoid Arthritis - United Kingdom Drug Forecast and Market Analysis Event-Driven Update”. The RA market is currently very dynamic, with the November 6, 2012 FDA approval of Pfizer’s Xeljanz (tofacitinib) and novel oral therapies awaiting approval such as: Eli Lilly’s anti-BAFF, tabalumab and JAK1,2 inhibitor, baricitinib, and Rigel/AZ’s SYK inhibitor, fostamatinib. These compounds will challenge the current biologics in the attempt to dislodge the stronghold of the TNF inhibitors, if their safety and efficacy profiles are proven once they enter the market.

UK physicians surveyed for this report typically follow guidelines such as NICE or BSR (British Society for Rheumatology), but also follow their own clinical experience as no two patients are the same. In the UK, about 65% of patient referrals at any stage come from PCPs. As in the US, most people seeking treatment are 55 years and older; however within this age group, males outnumber females by a small margin compared with the younger age groups.



Scope


- Overview of RA, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the United Kingdom including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in United Kingdom from 2011 to 2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the United Kingdom rheumatoid arthritis market.



Reasons to buy


- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for rheumatoid arthritis
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of rheumatoid arthritis drug performance in the United Kingdom
- Obtain sales forecast from 2011-2022 in the United Kingdom

Table Of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 13
3.1.3 Prognosis 16
3.1.4 Quality of Life 16
3.2 Symptoms 17
4 Disease Management 18
4.1 Treatment Overview 21
4.2 UK 24
4.2.1 Diagnosis 24
4.2.2 Clinical Practice 24
5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 26
5.3 Product Profiles - Major Brands 27
5.3.1 Enbrel (etanercept) 27
5.3.2 Humira (adalimumab) 33
5.3.3 Remicade (infliximab) 36
5.3.4 Simponi (golimumab) 40
5.3.5 Cimzia (certolizumab pegol) 44
5.3.6 Orencia (abatacept) 47
5.3.7 Actemra/RoActemra (tocilizumab) 51
5.3.8 Rituxan/MabThera (rituximab) 55
5.3.9 Methotrexate Sodium (numerous generic names) 59
5.3.10 DMARDs 62
6 Opportunity and Unmet Need 63
6.1 Overview 63
6.2 Unmet Needs 64
6.2.1 More rheumatologists in the field and physician knowledge of the disease 64
6.2.2 More cost-effective therapies through oral formulation and biosimilars 64
6.2.3 The development of predictive tests and discovery of biomarkers 64
6.2.4 The discovery of curative therapies 64
6.2.5 Improved drug safety and efficacy profiles 65
6.3 Gap Analysis 65
6.4 Opportunities 66
6.4.1 Predictive Tools for Diagnosis and Treatment 66
6.4.2 Target Specificity 66
7 Pipeline Assessment 67
7.1 Overview 67
7.2 Promising Drugs in Clinical Development 68
7.2.1 Tofacitinib (CP-690550) 69
7.2.2 Tabalumab (LY2127399) 76
7.2.3 Fostamatinib (previously R788) 79
7.2.4 RAVAX 83
7.2.5 Secukinumab (AIN457) 87
7.2.6 Masitinib (AB101) 91
7.2.7 Baricitinib (formerly LY3009104/INCB28050) 96
7.2.8 Sarilumab (REGN88/SAR153191) 100
7.2.9 Sirukumab (CNTO 136) 103
8 Market Outlook 106
8.1 United Kingdom 106
8.1.1 Forecast 106
8.1.2 Key Events 109
8.1.3 Drivers and Barriers 109
9 Appendix 112
9.1 Abbreviations 112
9.2 Bibliography 114
9.3 Methodology 122
9.4 Forecasting Methodology 122
9.4.1 Diagnosed Rheumatoid Arthritis Patients 122
9.4.2 Percent Drug-treated Patients 123
9.4.3 Drugs Included in Each Therapeutic Class 123
9.4.4 Launch and Patent Expiry Dates 124
9.4.5 General Pricing Assumptions 124
9.4.6 Individual Drug Assumptions 125
9.4.7 Generic Erosion 131
9.4.8 Pricing of Pipeline agents 131
9.5 Physicians and Specialists Included in this Study 132
9.6 Primary Research - Prescriber Survey 132
9.7 About the Authors 133
9.7.1 Analysts 133
9.7.2 Global Head of Healthcare 134
9.8 About GlobalData 135
9.9 Contact Us 135
9.10 Disclaimer 135



List of Tables

1.1 List of Tables
Table 1: Symptoms of Rheumatoid Arthritis 17
Table 2: Treatment Guidelines for Rheumatoid Arthritis 21
Table 3: Top Three Biologics Prescribed for Moderate-Severe Rheumatoid Arthritis by Market 23
Table 4: Treatment Guidelines for Rheumatoid Arthritis 27
Table 5: Product Profile - Enbrel 28
Table 6: 10 year Open-label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 years for Completers 29
Table 7: 10 year Open-label Safety and Efficacy Trial of Enbrel: Safety Results Overall 30
Table 8: Enbrel SWOT Analysis, 2012 32
Table 9: Product Profile - Humira 33
Table 10: Humira SWOT Analysis, 2012 35
Table 11: Product Profile - Remicade 37
Table 12: Remicade SWOT Analysis, 2012 39
Table 13: Product Profile - Simponi 41
Table 14: Simponi SWOT Analysis, 2012 43
Table 15: Product Profile - Cimzia 45
Table 16: Cimzia SWOT Analysis, 2012 47
Table 17: Product Profile - Orencia 48
Table 18: Orencia SWOT Analysis, 2012 50
Table 19: Product Profile - Actemra/RoActemra 52
Table 20: Actemra/RoActemra SWOT Analysis, 2012 54
Table 21: Product Profile - Rituxan 56
Table 22: Rituxan SWOT Analysis, 2012 58
Table 23: Product Profile - Methotrexate 60
Table 24: Methotrexate SWOT Analysis, 2012 61
Table 25: Summary of Minor Therapeutic Classes, 2012 62
Table 26: Overall Unmet Needs - Current Level of Attainment 63
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 66
Table 28: Rheumatoid Arthritis - Phase Pipeline, 2012 68
Table 29: Comparison of Therapeutic Classes in Development for RA, 2012 69
Table 30: Product Profile - Tofacitinib 70
Table 31: Clinical Trial Locations by Country for Tofacitinib 71
Table 32: ORAL Standard ACR 20 Responses for Tofacitinib vs. Placebo vs. Humira at Month 6 71
Table 33: ORAL Step ACR 20, 50, 70 Responses for Tofacitinib vs. Placebo at Month Six 72
Table 34: Efficacy Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 72
Table 35: Safety Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 73
Table 36: Tofacitinib Clinical Trial Mortalities as of September 29, 2011 74
Table 37: Tofacitinib SWOT Analysis, 2012 75
Table 38: Product Profile - Tabalumab 76
Table 39: ACR Responses and DAS28 Scores for Tabalumab vs. Placebo at Week 16 77
Table 40: Tabalumab SWOT Analysis, 2012 78
Table 41: Product Profile - Fostamatinib 79
Table 42: ACR Responses and DAS28 Scores for Fostamatinib vs. Placebo at Month Three 80
Table 43: Fostamatinib SWOT Analysis, 2012 82
Table 44: Product Profile - RAVAX 83
Table 45: RAVAX SWOT Analysis, 2012 86
Table 46: Product Profile - Secukinumab 87
Table 47: Secondary Endpoint Results for Secukinumab vs. Placebo at Weeks 24 and 52 88
Table 48: Secukinumab SWOT Analysis, 2012 90
Table 49: Product Profile - Masitinib 91
Table 50: ACR Responses for Masitinib in the ITT Population (12 Weeks) 92
Table 51: ACR Responses for Masitinib in the ITT Population (12-82 Weeks) 93
Table 52: Masitinib SWOT Analysis, 2012 95
Table 53: Product Profile - Baricitinib 96
Table 54: ACR Responses for Baricitinib + MTX vs. Placebo + MTX at Week 12 97
Table 55: Safety of 4 and 8mg Baricitinib at Week 12 98
Table 56: Laboratory Values of 4 and 8mg Baricitinib at Week 12 98
Table 57: Baricitinib SWOT Analysis, 2012 99
Table 58: Product Profile - Sarilumab 100
Table 59: MOBILITY Study Results for Sarilumab at Week 12 101
Table 60: Sarilumab SWOT Analysis, 2012 102
Table 61: Product Profile - Sirukumab 103
Table 62: Sirukumab SWOT Analysis, 2012 105
Table 63: Sales Forecasts ($m) for Rheumatoid Arthritis in the United Kingdom 107
Table 64: Key Events Impacting Sales for Rheumatoid Arthritis in the United Kingdom, 2012 109
Table 65: Rheumatoid Arthritis Market - Drivers and Barriers in the United Kingdom, 2012 109
Table 66: Key Launch Dates 124
Table 67: Key Patent Expiries 124
Table 68: Physicians Surveyed, By Country 132



List of Figures

1.2 List of Figures
Figure 1: Healthy and Arthritic Joint with Rheumatoid Arthritis 13
Figure 2: Rheumatoid Arthritis Biologic Drug Targets 15
Figure 3: Diagnosis Criteria for Rheumatoid Arthritis Based on 2010 ACR/EULAR Criteria Point System 19
Figure 4: Severity of Rheumatoid Arthritis 20
Figure 5: Biologic Treatment Flow Based on Updated 2012 ACR Treatment Recommendations* 22
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2012-2022 68
Figure 7: Sales for Rheumatoid Arthritis in the United Kingdom by Drug Class 108

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