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

Summary

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- 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 Crohns 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

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

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), 20152022 82 Table 15: Immunology, Global, Usage of Generics Across Key Indications, 2017 84 Table 16: Immunology Therapeutics Market, Global, Forecast Revenues by Company, 20152022 91 Table 17: Immunology Therapeutics Market, Global, Licensing Deals Valued over $100m, 20062016 111 Table 18: Immunology Therapeutics Market, Global, Co-development Deals Valued over $100m, 20062017 120

1.2 List of Figures Figure 1: Immunology, Global, Epidemiology Patterns for Rheumatoid Arthritis (000), 20162023 22 Figure 2: Immunology, Global, Epidemiology Patterns for Systemic Lupus Erythematosus (000), 20162023 23 Figure 3: Immunology, Global, Epidemiology Patterns for Psoriasis (000), 20162023 24 Figure 4: Immunology, Global, Epidemiology Patterns for Inflammatory Bowel Disease (000), 20162023 25 Figure 5: Immunology, Global, Key Marketed Products and Approved Indications, 2016 34 Figure 6: Immunology Therapeutics Market, Global, Annual Revenues for Humira ($bn), 20062022 36 Figure 7: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel ($bn), 20062022 38 Figure 8: Immunology Therapeutics Market, Global, Annual Revenues for Remicade ($bn), 20062022 40 Figure 9: Immunology Therapeutics Market, Global, Annual Revenues for Enbrel ($bn), 20062022 42 Figure 10: Immunology Therapeutics Market, Global, Annual Revenues for Stelara ($bn), 20062022 43 Figure 11: Immunology Therapeutics Market, Global, Annual Revenues for Simponi ($bn), 20062022 44 Figure 12: Immunology Therapeutics Market, Global, Annual Revenues for Prograf ($bn), 20062022 46 Figure 13: Immunology Therapeutics Market, Global, Annual Revenues for Cimzia ($bn), 20062022 47 Figure 14: Immunology Therapeutics Market, Global, Annual Revenues for Entyvio ($bn), 20062022 49 Figure 15: Immunology Therapeutics Market, Global, Annual Revenues for Cosentyx ($bn), 20062022 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 (%), 20062017 57 Figure 23: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 20062017 58 Figure 24: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 20062017 59 Figure 25: Immunology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 20062017 60 Figure 26: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 20062017 61 Figure 27: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 20062017 62 Figure 28: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 20062017 63 Figure 29: Immunology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 20062017 64 Figure 30: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development (patients), 20062017 65 Figure 31: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 20062017 66 Figure 32: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 20062017 67 Figure 33: Immunology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 20062017 68 Figure 34: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development (months), 20062017 69 Figure 35: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 20062017 70 Figure 36: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 20062017 71 Figure 37: Immunology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 20062017 72 Figure 38: Immunology Therapeutics Market, Global, Revenue Forecast for sarilumab ($bn), 20162022 74 Figure 39: Immunology Therapeutics Market, Global, Revenue Forecast for sirukumab ($m), 20152022 75 Figure 40: Immunology, Global, Annual Revenue Forecast for baricitinib ($bn), 20152022 77 Figure 41: Immunology, Global, Annual Revenue Forecast for upadacitinib ($m), 20152022 78 Figure 42: Immunology, Global, Annual Revenue Forecast for ozanimod ($bn), 20192022 79 Figure 43: Immunology, Global, Market Size ($m), 20152022 81 Figure 44: Immunology, Global, Annual Revenue Forecast for Key Products ($m), 20152022 83 Figure 45: Immunology, Global, Annual Revenue Forecast for Tumor Necrosis Factor-Alpha Inhibitors ($bn), 20152022 85 Figure 46: Immunology, Global, Annual Revenue Forecast for Interleukin Inhibitors ($bn), 20152022 86 Figure 47: Immunology, Global, Annual Revenue Forecast for B and T Lymphocyte Antigens ($bn), 20152022 87 Figure 48: Immunology, Global, Annual Revenue Forecast for Janus Kinases ($bn), 20152022 88 Figure 49: Immunology Therapeutics Market, Global, Cluster by Growth and Market Share, 20152022 89 Figure 50: Immunology Therapeutics Market, Global, Forecast Market Share by Company (%), 20152022 92 Figure 51: Immunology, Global, Companies by Compound Annual Growth Rate (%), 20142022 93 Figure 52: Immunology, Global, Revenues by Product Type, 20152022 94 Figure 53: Immunology, Global, AbbVie Annual Revenue Forecast ($bn), 20152022 95 Figure 54: Immunology, Global, Pfizer Annual Revenue Forecast ($bn), 20152022 96 Figure 55: Immunology, Global, Johnson & Johnson Annual Revenue Forecast ($bn), 20152022 97 Figure 56: Immunology, Global, Amgen Annual Revenue Forecast ($bn), 20152022 98 Figure 57: Immunology, Global, Roche Annual Revenue Forecast ($bn), 20152022 99 Figure 58: Immunology, Global, Eli Lilly Annual Revenue Forecast ($bn), 20152022 100 Figure 59: Immunology, Global, Bristol-Myers Squib Annual Revenue Forecast ($bn), 20152022 101 Figure 60: Immunology, Global, Celgene Annual Revenue Forecast ($bn), 20152022 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, 20152022 105 Figure 64: Immunology, Global, Licensing Deals, 20062017 107 Figure 65: Immunology, Global, Licensing Deals by Indication and Value, 20062017 108 Figure 66: Immunology, Global, Licensing Deals, 20062017 109 Figure 67: Immunology, Global, Licensing Deals by Molecule Type and Mechanism of Action, 20062017 110 Figure 68: Immunology, Global, Co-development Deals, 20062017 116 Figure 69: Immunology, Global, Co-development Deals by Indication and Value, 20062017 117 Figure 70: Immunology, Global, Co-development Deals, 20062017 118 Figure 71: Immunology, Global, Co-development Deals by Molecule Type and Mechanism of Action, 20062017 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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Global Immunology Drugs Market to 2022 - Increasing ...