Global Immunology Drugs Market to 2022 – Increasing Prevalence, Repositioning Opportunities and Strong Uptake of Interleukin Receptor Inhibitors to Drive Growth

Immunology is a therapy area characterized by disorders of the immune system, specifically an aberrant autoimmune response against healthy tissues in the body, leading to chronic or acute inflammation. Depending on the specific site affected, this can lead to various types of chronic pain and mobility loss, and have a negative impact on quality of life.

A number of therapies have been approved for immunological disorders, including the largely genericized disease-modifying anti-rheumatic drug (DMARD) class of small molecule drugs. 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. There is currently no cure for immunological disorders due to the highly complex nature of the immune system and the fact that many components of the pathophysiological states of these diseases have roles in the healthy immune system.

Autoimmune disorders are currently incurable, and treatment is aimed at managing the disease, in order to reduce the severity of its symptoms and lower the risk of associated co-morbidities. Cytokines and their receptors, such as Tumor Necrosis Factor-α and Interleukin-6 are the most effective and most common therapies used in immunology. This class of compounds has been the most commercially successful in the past decade, particularly in the RA market, with many clinical trials underway across various immunological indications. The market for immunological disorders is largely accounted for by premium products, with only a relatively small revenue share accounted for by generics and biosimilars.

Inflectra, a biosimilar of Remicade was recently approved by the FDA in 2016. However, the gradual uptake of biosimilars such as Inflectra is not expected to act as a strong growth driver for the biosimilar segment within the forecast period. This therefore means existing products such as Remicade are expected to maintain high revenues during the forecast period

Although there is a high degree of failure and uncertainty in R&D of immunological drugs, there are 2,054 drugs in active development in the immunology pipeline. In the long-term, this is expected to drive growth in this market in spite of the anticipated approval of biosimilars for key blockbuster drugs and resultant erosion of revenues. Cytokines and their receptors account for the largest single segment of each of the pipelines which make up the largest individual class.

The report focuses on four key indications within immunology: Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Psoriasis and Inflammatory bowel disease (The two major types of Inflammatory bowel disease covered in this report are Ulcerative colitis and Crohn’s disease). With no curative therapies available, symptomatic medications prescribed off-label are an important part of the treatment paradigm, especially in SLE, increasing the need for extensive R&D within this area.

Scope

– Global revenues for the immunology market are forecast to grow at a compound annual growth rate of 3.63%, from $57.7 billion in 2015 to $74.1 billion in 2022.

– Which drugs will achieve blockbuster status and how will the key player companies perform during the forecast period?

– The immunological disorders pipeline is large and diverse, and contains 2,054 products. How does the composition of the pipeline compare with that of the existing market?

– What molecular targets and molecule types are most commonly being trialed in pipeline products in the key indications?

– Which products will contribute to market growth most significantly, and which will achieve blockbuster status?

– Will the current market leaders retain their dominance over the forecast period, and how is their revenue share of the immunology market set to change?

Reasons to buy

- 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 immunological disorders 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

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 9

2.1 Therapy Area Introduction 9

2.1.1 Rheumatoid Arthritis 9

2.1.2 Systemic Lupus Erythematosus 10

2.1.3 Psoriasis 11

2.1.4 Inflammatory Bowel Disease 12

2.2 Symptoms 13

2.3 Etiology and Pathophysiology 15

2.3.1 Pathophysiology 17

2.4 Epidemiology 21

2.4.1 Rheumatoid Arthritis 22

2.4.2 Systemic Lupus Erythematosus 23

2.4.3 Psoriasis 23

2.4.4 Inflammatory Bowel Disease 24

2.5 Co-morbidities and Complications 25

2.6 Treatment 26

2.6.1 Rheumatoid Arthritis 27

2.6.2 Systemic Lupus Erythematosus 30

2.6.3 Psoriasis 31

2.6.4 Inflammatory Bowel Disease 32

3 Key Marketed Products 34

3.1 Overview 34

3.2 Humira (adalimumab) 34

3.3 Enbrel (etanercept) 36

3.4 Remicade (infliximab) 38

3.5 Rituxan (rituximab) 40

3.6 Stelara (ustekinumab) 42

3.7 Simponi (golimumab) 43

3.8 Prograf (tacrolimus) 45

3.9 Cimzia (certolizumab pegol) 46

3.10 Entyvio (vedolizumab) 47

3.11 Cosentyx (Secukinumab) 49

4 Pipeline Landscape Assessment 51

4.1 Overview 51

4.2 Pipeline Development Landscape 51

4.3 Molecular Targets in the Pipeline 54

4.4 Clinical Trials 56

4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 56

4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 60

4.4.3 Clinical Trial Size 65

4.4.4 Aggregate Clinical Program Size 69

4.4.5 Assessment of Key Pipeline Products 72

4.5 Conclusion 80

5 Multi-scenario Market Forecast to 2022 81

5.1 Overall Market Size 81

5.2 Generic Penetration 83

5.3 Revenue Forecast by Molecular Target 84

5.3.1 Tumor Necrosis Factor-Alpha 84

5.3.2 Interleukin Receptor 86

5.3.3 B and T Lymphocyte Antigens 86

5.3.4 Janus Kinases 87

6 Company Analysis and Positioning 89

6.1 Revenue and Market Share Analysis by Company 90

6.1.1 AbbVie – Will the Patent Expiration of Humira Cause a Loss in Market Size? 94

6.1.2 Pfizer – Xeljanz to Overcome Enbrel Revenue Loss 95

6.1.3 Johnson & Johnson – Steady Market Leader over Forecast Period 96

6.1.4 Amgen – Will the Patent Expiration of Enbrel Have an Effect on Overall Immunology Revenue? 97

6.1.5 Roche – Moderate Revenue Loss Expected due to Biosimilar Competition 98

6.1.6 Eli Lilly – Approval of RA Drug to Drive Revenue 99

6.1.7 Bristol-Myers Squibb – Will Biosimilar Competition Affect Orencia Revenue? 100

6.1.8 Celgene – Otezla and Ozanimod Hydrochloride to Become Blockbuster Drugs 101

6.2 Company Landscape 103

6.3 Marketed and Pipeline Portfolio Analysis 103

7 Strategic Consolidations 106

7.1 Licensing Deals 106

7.1.1 Deals by Region, Year and Value 106

7.1.2 Deals by Stage of Development and Value 108

7.1.3 Deals by Molecule Type, Mechanism of Action and Value 109

7.1.4 Licensing Deals Valued over $100m 111

7.2 Co-development Deals 115

7.2.1 Deals by Region, Year and Value 116

7.2.2 Deals by Stage of Development and Value 117

7.2.3 Deals by Molecule Type, Mechanism of Action and Value 118

7.2.4 Co-development Deals Valued over $100m 120

8 Appendix 124

8.1 References 124

8.2 Table of All Clinical Stage Pipeline Products 132

8.3 Abbreviations 136

8.4 Disease List 137

8.5 Methodology 138

8.5.1 Coverage 138

8.5.2 Secondary Research 138

8.5.3 Market Size and Revenue Forecasts 138

8.5.4 Pipeline Analysis 139

8.5.5 Competitive Landscape 139

8.6 Contact Us 139

8.7 Disclaimer 140

List of Tables

1.1 List of Tables

Table 1: Immunology Therapeutics Market, Symptoms of RA, SLE, Psoriasis and IBD 14

Table 2: Immunology Therapeutics Market, Etiology of RA, SLE, Psoriasis and IBD 16

Table 3: Immunology, Global, Epidemiology of Inflammatory Immunological Disorders, 2017 22

Table 4: Immunology Therapeutics Market, Global, Approved Indications for Humira, 2017 35

Table 5: Immunology Therapeutics Market, Global, Approved Indications for Enbrel, 2017 37

Table 6: Immunology Therapeutics Market, Global, Approved Indications for Remicade, 2017 39

Table 7: Immunology Therapeutics Market, Global, Approved Indications for Rituxan, 2017 41

Table 8: Immunology Therapeutics Market, Global, Approved Indications for Stelara, 2017 43

Table 9: Immunology Therapeutics Market, Global, Approved Indications for Simponi, 2017 44

Table 10: Immunology Therapeutics Market, Global, Approved Indications for Prograf, 2017 45

Table 11: Immunology Therapeutics Market, Global, Approved Indications for Cimzia, 2017 46

Table 12: Immunology Therapeutics Market, Global, Approved Indications for Entyvio, 2017 48

Table 13: Immunology Therapeutics Market, Global, Approved Indications for Cosentyx, 2017 50

Table 14: Immunology, Global, Annual Revenue Forecast for Key Products ($m), 2015–2022 82

Table 15: Immunology, Global, Usage of Generics Across Key Indications, 2017 84

Table 16: Immunology Therapeutics Market, Global, Forecast Revenues by Company, 2015–2022 91

Table 17: Immunology Therapeutics Market, Global, Licensing Deals Valued over $100m, 2006–2016 111

Table 18: Immunology Therapeutics Market, Global, Co-development Deals Valued over $100m, 2006–2017 120

List of Figures

1.2 List of Figures

Figure 1: Immunology, Global, Epidemiology Patterns for Rheumatoid Arthritis (‘000), 2016–2023 22

Figure 2: Immunology, Global, Epidemiology Patterns for Systemic Lupus Erythematosus (‘000), 2016–2023 23

Figure 3: Immunology, Global, Epidemiology Patterns for Psoriasis (‘000), 2016–2023 24

Figure 4: Immunology, Global, Epidemiology Patterns for Inflammatory Bowel Disease (‘000), 2016–2023 25

Figure 5: Immunology, Global, Key Marketed Products and Approved Indications, 2016 34

Figure 6: Immunology Therapeutics Market, Global, Annual Revenues for Humira ($bn), 2006–2022 36

Figure 7: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel ($bn), 2006–2022 38

Figure 8: Immunology Therapeutics Market, Global, Annual Revenues for Remicade ($bn), 2006–2022 40

Figure 9: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel ($bn), 2006–2022 42

Figure 10: Immunology Therapeutics Market, Global, Annual Revenues for Stelara ($bn), 2006–2022 43

Figure 11: Immunology Therapeutics Market, Global, Annual Revenues for Simponi ($bn), 2006–2022 44

Figure 12: Immunology Therapeutics Market, Global, Annual Revenues for Prograf ($bn), 2006–2022 46

Figure 13: Immunology Therapeutics Market, Global, Annual Revenues for Cimzia ($bn), 2006–2022 47

Figure 14: Immunology Therapeutics Market, Global, Annual Revenues for Entyvio ($bn), 2006–2022 49

Figure 15: Immunology Therapeutics Market, Global, Annual Revenues for Cosentyx ($bn), 2006–2022 50

Figure 16: Antibacterial Drug Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 51

Figure 17: Immunology Therapeutics Market, Global, Pipeline for Immunology by Stage of Development, Molecule Type and Program Type, 2017 52

Figure 18: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Stage of Development, 2017 53

Figure 19: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Molecule Type, 2017 54

Figure 20: Immunology Therapeutics Market, Pipeline by Mechanism of Action (%), 2017 55

Figure 21: Immunology Therapeutics Market, Global, Pipeline for Key Immunology Indications by Molecular Target, 2017 56

Figure 22: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006–2017 57

Figure 23: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006–2017 58

Figure 24: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006–2017 59

Figure 25: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006–2017 60

Figure 26: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006–2017 61

Figure 27: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006–2017 62

Figure 28: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006–2017 63

Figure 29: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006–2017 64

Figure 30: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development (patients), 2006–2017 65

Figure 31: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006–2017 66

Figure 32: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006–2017 67

Figure 33: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006–2017 68

Figure 34: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development (months), 2006–2017 69

Figure 35: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006–2017 70

Figure 36: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006–2017 71

Figure 37: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006–2017 72

Figure 38: Immunology Therapeutics Market, Global, Revenue Forecast for sarilumab ($bn), 2016–2022 74

Figure 39: Immunology Therapeutics Market, Global, Revenue Forecast for sirukumab ($m), 2015–2022 75

Figure 40: Immunology, Global, Annual Revenue Forecast for baricitinib ($bn), 2015–2022 77

Figure 41: Immunology, Global, Annual Revenue Forecast for upadacitinib ($m), 2015–2022 78

Figure 42: Immunology, Global, Annual Revenue Forecast for ozanimod ($bn), 2019–2022 79

Figure 43: Immunology, Global, Market Size ($m), 2015–2022 81

Figure 44: Immunology, Global, Annual Revenue Forecast for Key Products ($m), 2015–2022 83

Figure 45: Immunology, Global, Annual Revenue Forecast for Tumor Necrosis Factor-Alpha Inhibitors ($bn), 2015–2022 85

Figure 46: Immunology, Global, Annual Revenue Forecast for Interleukin Inhibitors ($bn), 2015–2022 86

Figure 47: Immunology, Global, Annual Revenue Forecast for B and T Lymphocyte Antigens ($bn), 2015–2022 87

Figure 48: Immunology, Global, Annual Revenue Forecast for Janus Kinases ($bn), 2015–2022 88

Figure 49: Immunology Therapeutics Market, Global, Cluster by Growth and Market Share, 2015–2022 89

Figure 50: Immunology Therapeutics Market, Global, Forecast Market Share by Company (%), 2015–2022 92

Figure 51: Immunology, Global, Companies by Compound Annual Growth Rate (%), 2014–2022 93

Figure 52: Immunology, Global, Revenues by Product Type, 2015–2022 94

Figure 53: Immunology, Global, AbbVie Annual Revenue Forecast ($bn), 2015–2022 95

Figure 54: Immunology, Global, Pfizer Annual Revenue Forecast ($bn), 2015–2022 96

Figure 55: Immunology, Global, Johnson & Johnson Annual Revenue Forecast ($bn), 2015–2022 97

Figure 56: Immunology, Global, Amgen Annual Revenue Forecast ($bn), 2015–2022 98

Figure 57: Immunology, Global, Roche Annual Revenue Forecast ($bn), 2015–2022 99

Figure 58: Immunology, Global, Eli Lilly Annual Revenue Forecast ($bn), 2015–2022 100

Figure 59: Immunology, Global, Bristol-Myers Squib Annual Revenue Forecast ($bn), 2015–2022 101

Figure 60: Immunology, Global, Celgene Annual Revenue Forecast ($bn), 2015–2022 102

Figure 61: Immunology, Global, Companies by Type, 2017 103

Figure 62: Immunology, Global, High-Activity and Late-Stage Pipeline Developers by Level of immunology specialization, 2017 104

Figure 63: Immunology, Global, Proportion of Company Revenue Attributed to immunology, 2015–2022 105

Figure 64: Immunology, Global, Licensing Deals, 2006–2017 107

Figure 65: Immunology, Global, Licensing Deals by Indication and Value, 2006–2017 108

Figure 66: Immunology, Global, Licensing Deals, 2006–2017 109

Figure 67: Immunology, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006–2017 110

Figure 68: Immunology, Global, Co-development Deals, 2006–2017 116

Figure 69: Immunology, Global, Co-development Deals by Indication and Value, 2006–2017 117

Figure 70: Immunology, Global, Co-development Deals, 2006–2017 118

Figure 71: Immunology, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006–2017 119

Figure 72: Immunology, Global, Table of all Clinical Stage Pipeline Products, Part I, 2017 132

Figure 73: Immunology, Global, Table of all Clinical Stage Pipeline Products, Part II, 2017 133

Figure 74: Immunology, Global, Table of all Clinical Stage Pipeline Products, Part III, 2017 134

Figure 75: Immunology, Global, Table of all Clinical Stage Pipeline Products, Part IV, 2017 135

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