Systemic Lupus Erythematosus – Programs Targeting Cytokine and Growth Factor Signaling Dominate First-In-Class Pipeline

Pages: 53 Published: June 28, 2019 Report Code: GDHC495FP

Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations includes renal (kidney) involvement, known as lupus nephritis (LN). The etiology of SLE is not completely understood, but is thought to be the result of genetic/epigenetic abnormalities, and hormonal and environmental factors. In general, autoimmunity is the result of inadequate regulation of immune cells, which leads to uncontrolled activation of immune cells, such as B and T-cells, and in turn perpetuates chronic inflammatory responses. In SLE, deregulated cellular degradation caused by apoptosis and NETosis appears to play a central role in this process, as it can lead to prolonged exposure to self-antigens and activation of the immune system towards these antigens, causing serious inflammation.

Today, the SLE and LN market is largely dominated by generic products, as the management of patients with lupus is mainly based on the use of antimalarials, steroids, immunosuppressive agents, and hypertension drugs. The competition is high for these therapies and the market is saturated with many suppliers of generic and inexpensive products. GSK’s Benlysta (belimumab) is the only product that has received regulatory approval specifically for SLE is more than 50 years, an event that paved the way for the introduction of new biological therapies into the SLE and LN marketplace. Roche/Biogen’s Rituxan (rituximab) is another biologic drug that is used off-label to treat lupus, mainly in patients with LN. Both biologics are used as add-on therapies to augment the standard of care.


There are 146 pipeline programs in active development for SLE. What proportion of these products are first-in-class? How does first-in-class innovation vary by development stage and molecular target class?

Which molecular target classes are prominently represented in the first-in-class SLE pipeline? Which first-in-class targets have been identified as most promising for the treatment of SLE? How does the distribution of target classes differ in terms of development stage?

Across the SLE landscape, there are 112 active companies. Which companies have formed partnerships? Which companies have first-in-class assets in development with no prior deal involvement?

Reasons to Buy

Understand the current disease landscape with an overview of etiology, pathophysiology, disease classification and staging systems and epidemiology. Visualize the composition of the SLE market in terms of dominant molecule types and molecular targets.

Analyze and compare the SLE pipeline and stratify by stage of development, molecule type, and molecular target.

Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to their clinical potential. Promising first-in-class targets have been reviewed in greater detail.

Recognize commercial opportunities by identifying first-in-class pipeline products for SLE that have not yet been involved in licensing or co-development deals, and by analyzing company strategies in prior deals through case studies of key deals for first-in-class SLE products.

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 SLE: Executive Summary

2.1 Pipeline Holds Potential for the Approval of More Targeted Therapies

2.2 High Levels of First-in-Class Innovation

2.3 High Unmet Need Remains for Disease-Modifying Pharmacotherapies

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Sustained Innovation in SLE

4.4 Epidemiology for SLE

4.5 Overview for Marketed Products

5 Assessment of Pipeline Product Innovation

5.1 Overview

5.2 Pipeline by Stage of Development and Molecule Type

5.3 Pipeline by Molecular Target

5.4 Comparative Distribution of Programs Between SLE Market and Pipeline by Therapeutic Target Family

5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class

5.5.1 Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Programs

5.6 Ratio of First-in-Class Programs to First-in-Class Molecular Targets Within the Pipeline

6 First-in-Class Molecular Target Evaluation

6.1 Overview

6.2 Pipeline Programs Targeting Non Receptor Tyrosine Protein Kinase

6.3 Pipeline Programs Targeting Complement C3

6.4 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5

6.5 Pipeline Programs Targeting Cyclic GMP-AMP Synthase

6.6 Pipeline Programs Targeting Interleukin 2 Receptor Subunit Beta

6.7 Pipeline Programs Targeting Interleukin 1 Receptor Associated Kinase 1

6.8 Pipeline Programs Targeting Mannan-Binding Lectin Serine Protease 2

6.9 Pipeline Programs Targeting Toll-Like Receptor 8

7 Key Players and Deals

7.1 Overview

7.1.1 Eli Lilly Enters into Licensing Agreement with Nektar Therapeutics

7.1.2 Omeros Enters into Licensing Agreement with Helion Biotech

7.1.3 Roivant Sciences Enters into Licensing Agreement with HanAll Biopharma

8 Appendix

8.1 Bibliography

8.2 Abbreviations

8.3 Methodology

8.3.1 Market Analysis

8.3.2 Overall Pipeline Analysis

8.3.3 First-in-Class Pipeline Analysis

8.3.4 First-in-Class Matrix Assessment

8.3.5 First-in-Class Molecular Target Evaluation

8.3.6 Key Players and Deals

8.4 About the Authors

8.4.1 Analyst

8.4.2 Therapy Area Director

8.4.3 Global Director of Therapy Analysis and Epidemiology

8.4.4 Global Head and EVP of Healthcare Operations and Strategy

8.5 About GlobalData

8.6 Contact Us

8.7 Disclaimer

List of Tables

Table 1: SLE Criteria

Table 2: SLE Diagnosed Prevalent Cases, millions (N), 2015–2025

List of Figures

Figure 1: Overview of the Etiology and Pathogenesis of SLE

Figure 2: Integrated Hypothesis for the Pathogenesis of SLE

Figure 3: SLE, Global Market by Molecule Type and Molecular Target, 2019

Figure 4: SLE, Global, Pipeline by Stage of Development and Molecule Type, 2019

Figure 5: SLE, Global, Pipeline by Molecular Target and Stage of Development, 2019

Figure 6: SLE, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2019

Figure 7: SLE, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2019

Figure 8: SLE, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2019

Figure 9: SLE, Global, Ratio of First-in-Class and Non-First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2019

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