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.
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 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 30
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
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Published By : GBI Research
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