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Global Immunology Market to 2022 - Large pipeline and competitive market to drive long-term market growth

Published By :

GBI Research

Published Date : Dec 2015

Category :

Pharmaceutical

No. of Pages : 133 Pages

Immune-mediated inflammatory diseases are a very common set of chronic disorders that affect 5–7% of western populations. Although they are often disparate in terms of their symptoms and key patient demographics, they are pathophysiologically linked, being characterized by dysregulation of immune pathways and an inappropriate immune response. Generally, disease-modifying anti-rheumatic drugs, a highly genericized class of systemic small-molecule-based agents, are used in the first-line treatment of these diseases. These are supplemented in many cases by shorter-term glucocorticoid therapy, another class of highly genericized systemic agents.

However, as these therapies often fail to elicit an adequate long-term response, a large second-line therapy segment has emerged in these markets, beginning with the approval of Remicade (infliximab) and Enbrel (etanercept) in 1998. This segment consists largely of premium systemic monoclonal Antibodies (mAbs), which are highly commercially successful due to their widespread usage and high cost. Although the patents for many of these mAbs either have already expired or are due to expire during the forecast period, the market is expected to experience continued growth.

Scope

Although the patents for many of these mAbs either have already expired or are due to expire during the forecast period, the market is expected to experience continued growth, from $61.5 billion in 2015 to $74.2 billion in 2022, at a compound annual growth rate of 2.71%.

  • What factors are driving the market growth?
  • How can the factors limiting growth be overcome?

There is a very large pharmaceutical pipeline for immunology, consisting of 1,838 products in active development. However, the commercial performance of the products in the late-stage pipeline is expected to be moderate.

  • What gaps in the market are being addressed by the most promising of these late-stage pipeline products?
  • How does the composition of the pipeline compare with that of the existing market?

Several key commercially successful products, including Humira (adalimumab) and Remicade, are due to lose patent protection in the forecast period.

  • How will this affect their revenues in this period?
  • How are their manufacturers, AbbVie and Johnson & Johnson, responding to this?

The key players in the market, all of which are among the top 20 pharmaceutical companies, are expected to maintain their market lead throughout the forecast period.

  • What is driving this continued market dominance?
  • Who will the new market players be?

Reasons to buy

This report will allow you to 

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis and the treatment options available at each stage of diagnosis
  • Visualize the composition of the immunology market across each indication, in terms of dominant molecule types and targets, highlighting the key commercial assets and players
  • Analyze the immunology pipeline and stratify by stage of development, molecule type and molecular target, with a granular breakdown across key indications
  • Understand the growth in patient epidemiology and market revenues for the immunology market globally and across the key players and product types
  • Stratify the market in terms of the split between generic and premium products and assess the role of these product types in the treatment of the various immunological disorders
  • Identify commercial opportunities in the immunology deals landscape by analyzing trends in licensing and co-development deals

1 Table of Contents
1 Table of Contents 4

1.1 List of Tables 5
1.2 List of Figures 6

2 Introduction 8
2.1 Therapy Area Introduction 8
2.2 Symptoms 8
2.3 Etiology and Pathophysiology 9
2.4 Co-morbidities and Complications 11
2.5 Epidemiology Patterns and Forecasts – Prevalence, Patient Segmentation, Diagnostic and Treatment Usage Rates 11
2.5.1 Rheumatoid Arthritis 12
2.5.2 Psoriasis 13
2.5.3 Systemic Lupus Erythematosus 14
2.6 Treatment 15
2.6.1 Non-Biologic Disease-Modifying Anti-Rheumatic Drugs 16
2.6.2 Glucocorticoids 17
2.6.3 Biologics 17

3 Key Marketed Products 19
3.1 Overview 19
3.2 Humira (adalimumab) 21
3.3 Remicade (infliximab) 22
3.4 Enbrel (etanercept) 24
3.5 Rituxan (rituximab) 26
3.6 Stelara (ustekinumab) 27
3.7 Prograf (tacrolimus) 28
3.8 Cimzia (certolizumab pegol) 30
3.9 Simponi (golimumab) 31
3.10 Conclusion 33

4 Pipeline Landscape Assessment 34
4.1 Overview 34
4.2 Pipeline Development Landscape 34
4.3 Molecular Targets in the Pipeline 37
4.4 Clinical Trials 39
4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 40
4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 43
4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 47
4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 51
4.5 Conclusion 56

5 Multi-Scenario Market Forecast to 2022 57
5.1 Overall Market Size 57
5.2 Generic Penetration 60
5.3 Revenue Forecast by Molecular Target 61
5.3.1 Tumor Necrosis Factor-Alpha 62
5.3.2 Interleukin-6 and Interleukin-6 Receptor 63
5.3.3 Interleukins-1, 2, 5, 12, 17 and 23 and Receptors 63
5.3.4 Janus Kinases 64
5.3.5 Revenue and Market Share Analysis by Company 65
5.3.6 Assessment of Key Pipeline Products 74

6 Company Analysis and Positioning 81
6.1 Company Landscape 81
6.2 Marketed and Pipeline Portfolio Analysis 82

7 Strategic Consolidations 84
7.1 Licensing Deals 84
7.1.1 Deals by Region, Year and Value 84
7.1.2 Deals by Stage of Development and Value 86
7.1.3 Deals by Molecule Type, Mechanism of Action and Value 87
7.1.4 Table for Licensing Deals Valued Above $100m 89
7.2 Co-development Deals 91
7.2.1 Deals by Region, Year and Value 91
7.2.2 Deals by Stage of Development and Value 92
7.2.3 Deals by Molecule Type, Mechanism of Action and Value 93
7.2.4 Table for Co-development Deals Valued Above $100m 95

8 Appendix 97
8.1 References 97
8.2 Table of All Clinical Stage Pipeline Products 101
8.3 Abbreviations 130
8.4 Disease List 130
8.5 Methodology 131
8.5.1 Coverage 131
8.5.2 Secondary Research 131
8.5.3 Market Size and Revenue Forecasts 131
8.5.4 Pipeline Analysis 132
8.5.5 Competitive Landscape 132
8.6 Contact Us 133
8.7 Disclaimer 133

List of Table

Table 1: Immunology, Global, Epidemiology of Inflammatory Immunological Disorders, 2015 12
Table 2: Immunology Therapeutics Market, Global, Approved Indications for Humira, 2015 21
Table 3: Immunology Therapeutics Market, Global, Approved Indications for Remicade, 2015 23
Table 4: Immunology Therapeutics Market, Global, Approved Indications for Enbrel, 2015 25
Table 5: Immunology Therapeutics Market, Global, Approved Indications for Rituxan, 2015 27
Table 6: Immunology Therapeutics Market, Global, Approved Indications for Stelara, 2015 28
Table 7: Immunology Therapeutics Market, Global, Approved Indications for Prograf, 2015 29
Table 8: Immunology Therapeutics Market, Global, Approved Indications for Cimzia, 2015 30
Table 9: Immunology Therapeutics Market, Global, Approved Indications for Simponi, 2015 32
Table 10: Immunology, Global, Annual Revenue Forecast for Key Products ($m), 2014–2022 59
Table 11: Immunology, Global, Usage of Generics Across Key Indications, 2015 61
Table 12: Immunology Therapeutics Market, Global, Forecast Revenues by Company, 2014–2022 66
Table 13: Immunology Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006–2015 89
Table 14: Immunology Therapeutics Market, Global, Co-Development Deals Valued Above $100m, 2006–2015 95
Table 15: Immunology, Global, Table of all Clinical Stage Pipeline Products, 2015 101

List of Chart

Figure 1: Immunology, Global, Epidemiology Patterns for Rheumatoid Arthritis (million), 2015–2022 13
Figure 2: Immunology, Global, Epidemiology Patterns for Psoriasis, Patients (million), 2015–2022 14
Figure 3: Immunology, Global, Epidemiology for Systemic Lupus Erythematosus (‘000), 2015–2022 15
Figure 4: Immunology, Global, Key Marketed Products and Approved Indications, 2015 20
Figure 5: Immunology Therapeutics Market, Global, Annual Revenues for Humira ($bn), 2006–2022 22
Figure 6: Immunology Therapeutics Market, Global, Annual Revenues for Remicade ($bn), 2006–2022 24
Figure 7: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel ($bn), 2006–2022 26
Figure 8: Immunology Therapeutics Market, Global, Annual Revenues for Rituxan ($bn), 2006–2022 27
Figure 9: Immunology Therapeutics Market, Global, Annual Revenues for Stelara ($bn), 2010–2022 28
Figure 10: Immunology Therapeutics Market, Global, Annual Revenues for Prograf ($bn), 2006–2022 30
Figure 11: Immunology Therapeutics Market, Global, Annual Revenues for Cimzia ($bn), 2006–2022 31
Figure 12: Immunology Therapeutics Market, Global, Annual Revenues for Simponi ($bn), 2006–2022 32
Figure 13: Immunology Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2015 34
Figure 14: Immunology Therapeutics Market, Global, Pipeline for Immunology by Stage of Development, Molecule Type and Program Type, 2015 35
Figure 15: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Stage of Development, 2015 36
Figure 16: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Molecule Type, 2015 37
Figure 17: Immunology Therapeutics Market, Global, Pipeline for Immunology by Molecular Target, 2015 38
Figure 18: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Molecular Target, 2015 39
Figure 19: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006–2015 40
Figure 20: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006–2015 41
Figure 21: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006–2015 42
Figure 22: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006–2015 43
Figure 23: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006–2015 44
Figure 24: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006–2015 45
Figure 25: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006–2015 46
Figure 26: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006–2015 47
Figure 27: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development (patients), 2006–2015 48
Figure 28: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006–2015 49
Figure 29: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006–2015 50
Figure 30: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006–2015 51
Figure 31: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development (months), 2006–2015 52
Figure 32: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006–2015 53
Figure 33: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006–2015 54
Figure 34: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006–2015 55
Figure 35: Immunology, Global, Market Size ($m), 2015–2022 58
Figure 36: Immunology, Global, Annual Revenue Forecast for Key Products ($m), 2014–2022 60
Figure 37: Immunology, Global, Annual Revenue Forecast for Tumor Necrosis Factor-Alpha Inhibitors ($bn), 2014–2022 62
Figure 38: Immunology, Global, Annual Revenue Forecast for Interleukin-6 Inhibitors ($bn), 2014–2022 63
Figure 39: Immunology, Global, Annual Revenue Forecast for Interleukin Inhibitors ($bn), 2015–2022 64
Figure 40: Immunology, Global, Annual Revenue Forecast for Janus Kinase Inhibitors ($bn), 2014–2022 65
Figure 41: Immunology Therapeutics Market, Global, Forecast Market Share by Company (%), 2014–2022 67
Figure 42: Immunology, Global, Companies by Compound Annual Growth Rate (%), 2014–2022 68
Figure 43: Immunology, Global, Revenues by Product Type, 2014–2022 69
Figure 44: Immunology, Global, AbbVie Annual Revenue Forecast ($bn), 2014–2022 70
Figure 45: Immunology, Global, Johnson & Johnson Annual Revenue Forecast ($m), 2014–2022 71
Figure 46: Immunology, Global, Roche Annual Revenue Forecast ($m), 2014–2022 72
Figure 47: Immunology, Global, Amgen Annual Revenue Forecast ($m), 2014–2022 73
Figure 48: Immunology, Global, Novartis Annual Revenue Forecast ($m), 2014–2022 74
Figure 49: Immunology Therapeutics Market, Global, Revenue Forecast for baricitinib ($m), 2015–2022 75
Figure 50: Immunology Therapeutics Market, Global, Revenue Forecast for ABP-501 ($m), 2015–2022 76
Figure 51: Immunology Therapeutics Market, Global, Revenue Forecast for ixekizumab ($m), 2015–2022 77
Figure 52: Immunology Therapeutics Market, Global, Revenue Forecast for sarilumab ($m), 2015–2022 78
Figure 53: Immunology Therapeutics Market, Global, Revenue Forecast for AMG-827 ($m), 2015–2022 79
Figure 54: Immunology, Global, Companies by Type, 2015 81
Figure 55: Immunology, Global, Pipeline, High-Activity and Late-Stage Developers by Level of Immunology Specialization, 2015 82
Figure 56: Immunology, Global, Proportion of Total Company Revenue Attributed to Immunology, 2014–2022 83
Figure 57: Immunology, Global, Licensing Deals, 2006–2015 85
Figure 58: Immunology, Global, Licensing Deals by Indication and Value, 2006–2015 86
Figure 59: Immunology, Global, Licensing Deals, 2006–2015 87
Figure 60: Immunology, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006–2015 88
Figure 61: Immunology, Global, Co-development Deals, 2006–2015 91
Figure 62: Immunology, Global, Co-development Deals by Indication and Value, 2006–2015 92
Figure 63: Immunology, Global, Co-development Deals, 2006–2015 93
Figure 64: Immunology, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006–2015 94

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