Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018 - Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion

Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018 - Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion

Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018 - Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion”. The currently marketed monoclonal antibodies are clinically and commercially highly successful products in the rheumatoid arthritis market, constituting four of the global top 20 best-selling drugs. The unique density of monoclonal antibodies that are approved for this indication, significant market exclusivity expiries in the forecast period and yet more monoclonal antibodies in development will change the dynamics in and this highly lucrative market in the forecast period until 2018.

Scope

- The current therapeutic environment in the treatment of RA across the top seven developed markets, including the US, Germany, France, the UK, Italy, Spain and Japan.
- Analysis of the competitive environment for monoclonal antibodies with strong data and evidence-based profiling of marketed products, including comparative benchmarking and assessment of efficacy and safety profiles as well as differentiating product features.
- A detailed pipeline analysis for monoclonal antibodies in rheumatoid arthritis including individual product profiles, a comparative efficacy and safety profile heat map analysis of the most promising pipeline products as well as analyses on the distribution of molecule types across the RA developmental pipeline, the molecular targets of pipeline mAbs and the developmental program types. In addition, detailed analyses of the clinical trial failure rates, the clinical trial durations by phase and clinical trial sizes by participant numbers are provided.
- Market data on the geographical landscape and therapeutic landscape, including market size, annual cost of therapy, treatment usage patterns such as disease population and prescription populations.
- Market forecasts across the US, the top five countries in Europe (EU5) - Germany, France, the UK, Italy, and Spain- as well as Japan. The multiple scenario forecasts take a range of factors that are likely to vary into account and provide a clear perspective on the level of the potential degree of variance in the market sizes.
- Key market drivers and barriers
- the major deals that have taken place in the monoclonal antibodies market in rheumatoid arthritis in recent years. Coverage includes Mergers and Acquisitions (M&As) as well as co-development and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided.

Reasons to buy

- Understand the competitive environment for monoclonal antibodies
- Develop key strategic repositioning initiatives by studying the repositioning trends and strategies of current competitors
- Understand the clinical and commercial impact of the growing diversification of the molecular targets of monoclonal antibodies in the pipeline and identify potential first-in-class products
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the RA market in the forecast period
- Use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for monoclonal antibodies in RA
- Use key benchmark data to forecast costs of developmental programs for monoclonal antibodies in RA by using proprietary clinical trial size and duration analyses
- Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps
- Use proprietary data analyses to assess the market value of pipeline molecules for in-licensing and out-licensing opportunities

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 10
2 Introduction 12
2.1 Symptoms 12
2.2 Etiology 13
2.3 Pathophysiology 13
2.3.1 Disease Initiation 13
2.3.2 Disease Propagation 14
2.4 Co-Morbidities and Complications 15
2.5 Diagnosis 16
2.5.1 Physical Examination 16
2.5.2 Blood Tests 16
2.5.3 X-Ray Imaging 17
2.6 Classification 17
2.7 Epidemiology 19
2.8 Prognosis and Disease Staging 19
2.9 Measurement of Treatment Effectiveness 20
2.10 Treatment Options 21
2.10.1 Pharmacological 21
2.10.2 Treatment Algorithms and Prescribing Habits 25
2.10.3 Non-Pharmacological Care 28
3 Marketed Products 29
3.1 Therapeutic Landscape 30
3.1.1 Remicade (infliximab) - Johnson and Johnson, Merck 30
3.1.2 Humira (adalimumab) - Abbott Laboratories 32
3.1.3 Enbrel (etanercept) - Amgen Inc., Pfizer Inc. and Takeda Pharmaceutical Co. Ltd. 34
3.1.4 Rituxan (rituximab) - Genentech (Roche Group), Biogen IDEC Inc. 36
3.1.5 Orencia (abatacept) - Bristol-Myers Squibb 38
3.1.6 Actemra (tocilizumab) -F Hoffman La Roche Ltd. 40
3.1.7 Simponi (golimumab) - Johnson and Johnson, Merck 42
3.1.8 Cimzia (certolizumab pegol) - UCB S.A. 43
3.1.9 Remsima (biosimilar infliximab) - Celltrion Inc. 44
3.2 Comparative Efficacy and Safety 44
3.3 Unmet Need 47
4 Pipeline for Rheumatoid Arthritis Monoclonal Antibody Therapeutics 48
4.1 Overall Pipeline 48
4.2 Molecular Targets in the Pipeline 49
4.3 Clinical Trials 52
4.3.1 Failure Rate 52
4.3.2 Patient Enrolment and Clinical Trial Size 56
4.3.3 Duration 59
4.4 Promising Drug Candidates in the Pipeline 61
4.4.1 Arzerra (ofatumumab) - Genmab A/S, GlaxoSmithKline Plc. 61
4.4.2 LY2127399 (tabalumab) - Eli Lily and Company 61
4.4.3 REGN88 (sarilumab) - Regeneron Pharmaceuticals Inc. 62
4.4.4 CNTO 136 (sirukumab) - Johnson and Johnson 62
4.4.5 AIN457 (secukinumab) - Novartis 63
4.4.6 ALD-518 - Alder Biopharmaceuticals Inc. 63
4.4.7 BT-061 (tregalizumab) - Biotest A.G. 63
4.4.8 MLTA3698A (pateclizumab) - Genentech Inc. 64
4.4.9 MOR 103 - MorphoSys A.G. 64
4.5 Heat Map of Safety and Efficacy for Pipeline and Marketed Products 65
4.6 Conclusion 66
5 Market Forecast to 2018 68
5.1 Geographical Markets 68
5.1.1 Global Market 69
5.1.2 US 71
5.1.3 UK 73
5.1.4 France 75
5.1.5 Germany 77
5.1.6 Italy 79
5.1.7 Spain 81
5.1.8 Japan 83
5.2 Drivers and Barriers for the mAbs market in Rheumatoid Arthritis 85
5.2.1 Drivers 85
5.2.2 Barriers 87
6 Deals and Strategic Consolidations 90
6.1 Mergers and Acquisition Deals 91
6.1.1 Amgen Completes Acquisition of Micromet, Inc. 91
6.1.2 Pfizer Inc. Completes Acquisition of Wyeth 92
6.1.3 Bristol-Myers Squibb Completes Acquisition of Medarex Inc. 92
6.1.4 Teva Pharmaceutical Industries Limited Acquires CoGenesys Inc. 92
6.1.5 Biotie Therapies Corp. Terminates Acquisition of Newron Pharmaceuticals S.p.A. 92
6.1.6 Emergent BioSolutions Inc. Completes Acquisition of Trubion Pharmaceuticals Inc. 92
6.1.7 Alexion Pharmaceuticals Inc. completes acquisition of Taligen Therapeutics Inc. 93
6.1.8 Ligand Pharmaceuticals Incorporated Completes Acquisition of Pharmacopeia Inc. 93
6.1.9 Astellas Pharma Inc. Completes Acquisition of Perseid Therapeutics LLC 93
6.1.10 Cypress Bioscience Inc. Completes Acquisition of Proprius Pharmaceuticals Inc. 93
6.1.11 Simcere Pharmaceutical Group Completes Acquisition of Shanghai Celgen Bio-Pharmaceutical Co. Ltd. 93
6.2 Major Co-development Deals 94
6.2.1 Abbott Laboratories Enters Worldwide Agreement with Biotest AG 94
6.2.2 Dynavax Technologies Corporation Expands Worldwide Agreement with GlaxoSmithKline plc 95
6.2.3 Astellas Pharma Inc. Enters into Agreement with Maxygen Inc. 95
6.2.4 Tanabe Research Laboratories Enters Agreement with Anaphore Inc. 95
6.3 Major Licensing Deals 96
6.3.1 Hanwha Chemical Corporation Enter Licensing Agreement with Merck Sharp and Dohme Research Ltd. 99
6.3.2 Alder Biopharmaceuticals Inc. Enter Agreement with Bristol-Myers Squibb Company 99
6.3.3 Immunomedics Inc. Enter Agreement with Nycomed International Management GmbH 99
6.3.4 Sanofi-Aventis Enter Agreement with Kyowa Hakko Kogyo Co. Ltd. 99
6.3.5 EUSA Pharma Inc. Enter Licensing Agreement with GlaxoSmithKline plc 100
7 Appendix 101
7.1 All Pipeline Drugs by Phase 101
7.1.1 Discovery 101
7.1.2 Preclinical 102
7.1.3 IND-Filed and Phase 0 106
7.1.4 Phase I 106
7.1.5 Phase II 108
7.1.6 Phase III 110
7.1.7 Undisclosed 111
7.2 Market Forecasts to 2018 112
7.2.1 Global 112
7.2.2 United States 113
7.2.3 Top Five European Countries (Aggregate) 114
7.2.4 UK 115
7.2.5 France 116
7.2.6 Germany 117
7.2.7 Italy 118
7.2.8 Spain 119
7.2.9 Japan 120
7.3 Market Definitions 121
7.4 Abbreviations 121
7.5 References for Heat Maps (Figure 12 and Figure 23) 123
7.6 Sources 125
7.7 Research Methodology 130
7.7.1 Coverage 130
7.7.2 Secondary Research 130
7.7.3 Primary Research 131
7.7.4 Therapeutic Landscape 131
7.7.5 Geographical Landscape 134
7.7.6 Pipeline Analysis 134
7.8 Expert Panel Validation 134
7.9 Contact Us 134
7.10 Disclaimer 134

1.1 List of Tables
Table 1: American College of Rheumatology Classification Guidelines for Rheumatoid Arthritis, 2010–2012 18
Table 2: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Discovery), 2012 101
Table 3: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Preclinical), 2012 102
Table 4: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (IND-Filed and Phase 0), 2012 106
Table 5: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Phase I), 2012 106
Table 6: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Phase II), 2012 108
Table 7: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Phase III), 2012 110
Table 8: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Filed), 2007-2012 110
Table 9: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pharmaceutical Pipeline (Undisclosed Developmental Phase), 2012 111
Table 10: Monoclonal Antibodies Market for Rheumatoid Arthritis, Global, Market Forecast, 2004-2018 112
Table 11: Monoclonal Antibodies Market for Rheumatoid Arthritis, Global, Market Forecast, 2004-2018 112
Table 12: Monoclonal Antibodies Market for Rheumatoid Arthritis, US, Market Forecast, 2004-2018 113
Table 13: Monoclonal Antibodies Market for Rheumatoid Arthritis, Top Five European Countries, Market Forecast, 2004-2018 114
Table 14: Monoclonal Antibodies Market for Rheumatoid Arthritis, UK, Market Forecast, 2004–2018 115
Table 15: Monoclonal Antibodies Market for Rheumatoid Arthritis, France, Market Forecast, 2004–2018 116
Table 16: Monoclonal Antibodies Market for Rheumatoid Arthritis, Germany, Market Forecast, 2004–2018 117
Table 17: Monoclonal Antibodies Market for Rheumatoid Arthritis, Italy, Market Forecast, 2004–2018 118
Table 18: Monoclonal Antibodies Market for Rheumatoid Arthritis, Spain, Market Forecast, 2004–2018 119
Table 19: Monoclonal Antibodies Market for Rheumatoid Arthritis, Japan, Market Forecast, 2004–2018 120
Table 20: Monoclonal Antibodies Market for Rheumatoid Arthritis, Heat Maps for Efficacy and Safety of Marketed and Pipeline Products, References 123

1.2 List of Figures
Figure 1: American College of Rheumatology Treatment Guidelines, Early Rheumatoid Arthritis, 2012 26
Figure 2: American College of Rheumatology Treatment Guidelines, Established Rheumatoid Arthritis, 2012 27
Figure 3: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Annual Sales ($m), 2011 29
Figure 4: Remicade (infliximab), Global, Annual Sales ($m), 2003-2011 31
Figure 5: Humira (adalimumab), Global, Annual Sales ($m), 2003-2011 32
Figure 6: Enbrel (etanercept), Global, Annual Sales ($m), 2003-2011 34
Figure 7: Rituxan (rituximab), Global, Annual Sales ($m), 2002-2011 36
Figure 8: Orencia (abatacept), Global, Annual Sales ($m), 2006-2011 38
Figure 9: Actemra (tocilizumab), Global, Annual Sales ($m), 2008-2011 40
Figure 10: Simponi (golimumab), Global, Annual Sales ($m), 2009-2011 42
Figure 11: Cimzia (certolizumab pegol), Global, Annual Sales ($m), 2008-2011 43
Figure 12: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Comparative Safety and Efficacy of Marketed Products (Heat Map), 2012 45
Figure 13: Rheumatoid Arthritis Market, Global, Pipeline, 2012 48
Figure 14: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Pipeline by Molecular Target, 2012 49
Figure 15: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Novel Pipeline by Molecular Target, 2012 50
Figure 16: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Clinical Trial Failure Rates (%), 1999-2012 53
Figure 17: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Proportion of Inferred Clinical Trial Failure and Success Rates (%), 1999-2012 54
Figure 18: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Reasons for Clinical Trial Failure (All Phases) (%), 1999-2012 55
Figure 19: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mean Clinical Trial Sizes (n), 1999-2012 56
Figure 20: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Estimated Cumulative Clinical Trial Size (‘000), 1999-2012 58
Figure 21: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mean Clinical Trial Duration (Months), 1999-2012 59
Figure 22: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mean Number of Clinical Trials Per Pipeline Drug, With Sample Size (n), 1999-2012 60
Figure 23: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Comparative Safety and Efficacy of Marketed and Late-Stage Pipeline Products (Heat Map), 2012 65
Figure 24: Monoclonal Antibodies Market for Rheumatoid Arthritis, Global, Annual Sales ($bn), 2004-2018 70
Figure 25: Rheumatoid Arthritis Therapeutic Monoclonal Antibodies Market, US, Treatment Patterns, 2004-2018 72
Figure 26: Monoclonal Antibodies Market in Rheumatoid Arthritis, UK, Treatment Usage Patterns (‘000), 2004-2018 74
Figure 27: Monoclonal Antibodies Market in Rheumatoid Arthritis, France, Treatment Usage Patterns (‘000), 2004-2018 76
Figure 28: Monoclonal Antibodies Market in Rheumatoid Arthritis, Germany, Treatment Usage Patterns (‘000), 2004-2018 78
Figure 29: Monoclonal Antibodies Market in Rheumatoid Arthritis, Italy, Treatment Usage Patterns (‘000), 2004-2018 80
Figure 30: Monoclonal Antibodies Market in Rheumatoid Arthritis, Spain, Treatment Usage Patterns (‘000), 2004-2018 82
Figure 31: Rheumatoid Arthritis Therapeutic Monoclonal Antibodies Market, Japan, Treatment Patterns (‘000), 2004-2018 84
Figure 32: Monoclonal Antibodies Market in Rheumatoid Arthritis, US, Indications for Marketed RA Antibodies (Chronology of FDA Approvals), 1997-2012 86
Figure 33: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mean Clinical Trial Duration for Novel and Biosimilar Products (Months), with Sample Size (n), 1999-2012 89
Figure 34: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mergers and Acquisition Deals, 2007-2012 90
Figure 35: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Mergers and Acquisition Deals, 2007-2012 91
Figure 36: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Co-Development Deals, 2004-2012 94
Figure 37: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Licensing Deals 2004-2012 96
Figure 38: Monoclonal Antibodies Market in Rheumatoid Arthritis, Global, Licensing Deals, 2004-2012 97
Figure 39: Rheumatoid Arthritis, Global, Licensing Deals (Acquirer Companies), 2004-2012 98
Figure 40: GBI Research Market Forecasting Model 133