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

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


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Executive Summary

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

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 USD 61.5 billion in 2015 to USD 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 USD 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 USD 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

1.1 List of Tables

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 (USD 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 USD 100m, 2006-2015 89

Table 14: Immunology Therapeutics Market, Global, Co-Development Deals Valued Above USD 100m, 2006-2015 95

Table 15: Immunology, Global, Table of all Clinical Stage Pipeline Products, 2015 101

1.2 List of Figures

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 (USD bn), 2006-2022 22

Figure 6: Immunology Therapeutics Market, Global, Annual Revenues for Remicade (USD bn), 2006-2022 24

Figure 7: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel (USD bn), 2006-2022 26

Figure 8: Immunology Therapeutics Market, Global, Annual Revenues for Rituxan (USD bn), 2006-2022 27

Figure 9: Immunology Therapeutics Market, Global, Annual Revenues for Stelara (USD bn), 2010-2022 28

Figure 10: Immunology Therapeutics Market, Global, Annual Revenues for Prograf (USD bn), 2006-2022 30

Figure 11: Immunology Therapeutics Market, Global, Annual Revenues for Cimzia (USD bn), 2006-2022 31

Figure 12: Immunology Therapeutics Market, Global, Annual Revenues for Simponi (USD 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 (USD m), 2015-2022 58

Figure 36: Immunology, Global, Annual Revenue Forecast for Key Products (USD m), 2014-2022 60

Figure 37: Immunology, Global, Annual Revenue Forecast for Tumor Necrosis Factor-Alpha Inhibitors (USD bn), 2014-2022 62

Figure 38: Immunology, Global, Annual Revenue Forecast for Interleukin-6 Inhibitors (USD bn), 2014-2022 63

Figure 39: Immunology, Global, Annual Revenue Forecast for Interleukin Inhibitors (USD bn), 2015-2022 64

Figure 40: Immunology, Global, Annual Revenue Forecast for Janus Kinase Inhibitors (USD 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 (USD bn), 2014-2022 70

Figure 45: Immunology, Global, Johnson & Johnson Annual Revenue Forecast (USD m), 2014-2022 71

Figure 46: Immunology, Global, Roche Annual Revenue Forecast (USD m), 2014-2022 72

Figure 47: Immunology, Global, Amgen Annual Revenue Forecast (USD m), 2014-2022 73

Figure 48: Immunology, Global, Novartis Annual Revenue Forecast (USD m), 2014-2022 74

Figure 49: Immunology Therapeutics Market, Global, Revenue Forecast for baricitinib (USD m), 2015-2022 75

Figure 50: Immunology Therapeutics Market, Global, Revenue Forecast for ABP-501 (USD m), 2015-2022 76

Figure 51: Immunology Therapeutics Market, Global, Revenue Forecast for ixekizumab (USD m), 2015-2022 77

Figure 52: Immunology Therapeutics Market, Global, Revenue Forecast for sarilumab (USD m), 2015-2022 78

Figure 53: Immunology Therapeutics Market, Global, Revenue Forecast for AMG-827 (USD 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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