Systemic Lupus Erythematosus and Lupus Nephritis – Global Drug Forecast and Market Analysis to 2028

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 incompletely 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, which in turn perpetuate 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.

Key Questions Answered

Novel MOA’s are set to enter the market to help patients with SLE and LN. However, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the SLE and LN market?

The current late-stage SLE and LN pipeline consists of seven different drugs. Will the late-stage drugs make a significant impact on the SLE and LN market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

We have seen a significant increase in the SLE and LN population, in terms of diagnosed prevalence and there is an increase in the amount of patients treated. How will epidemiological changes impact the growth of the future market?

Scope

Overview of SLE and LN, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized SLE and LN therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2018 and forecast for ten years to 2028.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the SLE and LN therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global SLE and LN market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The main driver of the enormous expansion of the SLE and LN market will be the launch of many different novel therapies and an increase in patient shares towards the biologics due to increased efficacy of these therapies.

The major global barrier for the SLE and LN market will be the annual cost of therapy for the new pipeline drugs

The key market opportunities lie in addressing unmet needs through the development of more efficacious drugs for SLE and LN patients with less occurrence of adverse events

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.

Develop business strategies by understanding the trends shaping and driving the global SLE and LN therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SLE and LN therapeutics market in future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the global SLE and LN therapeutics market from 2018-2028.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

GSK

AstraZeneca

Eli Lilly

Novartis

UCB

F. Hoffman-La Roche

Janssen

Aurinia

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 SLE & LN: Executive Summary

2.1 SLE and LN Marketplace to Experience Strong Growth During the Forecast Period, 2018–2028

2.2 R&D or Corporate Strategies for the Lupus Market

2.3 High Level of Unmet Need Persists in the SLE and LN Marketplace

2.4 Despite Intensifying Competition, Opportunities Remain for Firms Seeking to Enter the Marketplace

2.5 The Arrival of Novel Biologics Will Transform the Treatment Paradigm for SLE and LN

2.6 What Do Physicians Think?

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 Prognosis

4.3 Disease Classification and Staging Systems

4.3.1 SLE Classification

4.3.2 LN Classification

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.4.3 Forecast Assumptions and Methods: Diagnosed Incident Cases of SLE

5.4.4 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SLE

5.4.5 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SLE by Severity

5.4.6 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SLE by Comorbidities

5.4.7 Forecast Assumptions and Methods: Diagnosed Incident Cases of LN

5.4.8 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of LN

5.4.9 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of LN by Severity, Based on WHO Classifications

5.4.10 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of LN by Severity, Based on ISN/RPS Classification

5.5 Epidemiological Forecast for SLE and LN (2018–2028)

5.5.1 Diagnosed Incident Cases of SLE

5.5.2 Age-Specific Diagnosed Incident Cases of SLE

5.5.3 Sex-Specific Diagnosed Incident Cases of SLE

5.5.4 Diagnosed Incident Cases of LN

5.5.5 Diagnosed Prevalent Cases of SLE

5.5.6 Age-Specific Diagnosed Prevalent Cases of SLE

5.5.7 Sex-Specific Diagnosed Prevalent Cases of SLE

5.5.8 Diagnosed Prevalent Cases of SLE by Severity

5.5.9 Diagnosed Prevalent Cases of SLE by Comorbidities

5.5.10 Diagnosed Prevalent Cases of LN

5.5.11 Diagnosed Prevalent Cases of LN by Severity, Based on WHO Classifications

5.5.12 Diagnosed Prevalent Cases of LN by Severity, Based on ISN/RPS Classifications

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.2 Treatment Overview

6.3 US

6.4 5EU

6.5 Japan

7 Competitive Assessment

7.1 Overview

7.2 Standard-of-Care Therapies in Lupus

7.3 Biologic Therapies in Lupus

7.3.1 Benlysta

7.3.2 Rituximab

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Superior Efficacy and Safety

8.3 Refined Clinical Trial Design with More Robust Endpoints and Tailored to Heterogeneous Lupus Patient Populations

8.4 Reduction of Cardiovascular Risk in Lupus Patients

8.5 Development of Biomarkers for Lupus Patients

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 GSK’s Portfolio Assessment

10.4 Roche’s Portfolio Assessment

10.5 AstraZeneca’s Portfolio Assessment

10.6 Janssen’s Portfolio Assessment

10.7 Eli Lilly’s Portfolio Assessment

10.8 Novartis’ Portfolio Assessment

10.9 UCB’s Portfolio Assessment

10.10 Aurinia Pharmaceuticals’ Portfolio Assessment

10.11 ImmuPharma Portfolio Assessment

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for This Report

12.4.1 KOLs

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: SLE and LN: Key Metrics in the 7MM

Table 2: Updated (1997) ACR Criteria for Classification of SLE

Table 3: The SLICC Clinical and Immunologic Criteria for Classification of SLE

Table 4: WHO and ISN/RPS Classifications of LN

Table 5: Risk Factors and Comorbidities for SLE

Table 6: Disease Classification Definitions SLE and LN

Table 7: BILAG 2004 Index

Table 8: Treatment Guidelines for SLE and LN

Table 9: Country Profile – US

Table 10: Country Profile – 5EU

Table 11: Country Profile – Japan

Table 12: Leading Treatments for SLE and LN, 2020

Table 13: GSK’s SLE and LN Portfolio Assessment, 2020

Table 14: Roche’s SLE and LN Portfolio Assessment, 2020

Table 15: AstraZeneca SLE and LN Portfolio Assessment, 2020

Table 16: Janssen’s SLE and LN Portfolio Assessment, 2020

Table 17: Eli Lilly’s SLE and LN Portfolio Assessment, 2020

Table 18: Novartis’ SLE and LN Portfolio Assessment, 2020

Table 19: UCB’s SLE and LN Portfolio Assessment, 2020

Table 20: Aurinia’s SLE and LN Portfolio Assessment, 2020

Table 21: ImmuPharma’s SLE and LN Portfolio Assessment, 2016

Table 22: SLE and LN Market – Global Drivers and Barriers, 2018–2028

Table 23: Key Events Impacting Sales for SLE and LN in the US, 2018–2028

Table 24: SLE and LN Market – Drivers and Barriers in the US, 2018–2028

Table 25: Key Events Impacting Sales for SLE and LN in the 5EU, 2018–2028

Table 26: SLE and LN Market – Drivers and Barriers in the 5EU, 2018–2028

Table 27: Key Events Impacting Sales for SLE and LN in Japan, 2018–2028

Table 28: SLE and LN Market – Global Drivers and Barriers in Japan, 2018–2028

Table 29: Key Historical and Projected Launch Dates for SLE and LN

Table 30: Key Historical and Projected Patent Expiry Dates for SLE and LN

Table 31: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for SLE and LN in 2018 and 2028

Figure 2: Analysis of the Company Portfolio Gap in SLE and LN During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of SLE and LN During the Forecast Period

Figure 4: Overview of the Etiology and Pathogenesis of SLE

Figure 5: Integrated Hypothesis for the Pathogenesis of SLE

Figure 6: 7MM, Diagnosed Prevalence of SLE, Men and Women, %, All Ages, 2018

Figure 7: 7MM, Diagnosed Prevalence of LN, Men and Women, %, All Ages, 2018

Figure 8: 7MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of SLE

Figure 9: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of SLE

Figure 10: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of LN

Figure 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of LN

Figure 12: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of LN by Severity, Based on WHO Classification

Figure 13: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of LN by Severity, Based on ISN/RPS Classification

Figure 14: 7MM, Diagnosed Incident Cases of SLE, N, Both Sexes, All Ages, 2018

Figure 15: 7MM, Diagnosed Incident Cases of SLE by Age, N, Both Sexes, 2018

Figure 16: 7MM, Diagnosed Incident Cases of SLE by Sex, N, All Ages, 2018

Figure 17: 7MM, Diagnosed Incident Cases of LN, N, Both Sexes, All Ages, 2018

Figure 18: 7MM, Diagnosed Prevalent Cases of SLE, N, Both Sexes, All Ages, 2018

Figure 19: 7MM, Diagnosed Prevalent Cases of SLE by Age, N, Both Sexes, 2018

Figure 20: 7MM, Diagnosed Prevalent Cases of SLE by Sex, N, All Ages, 2018

Figure 21: 7MM, Diagnosed Prevalent Cases of SLE by Severity, N, All Ages, 2018

Figure 22: 7MM, Diagnosed Prevalent Cases of SLE by Comorbidities, N, All Ages, 2018

Figure 23: 7MM, Diagnosed Prevalent Cases of LN, N, Both Sexes, All Ages, 2018

Figure 24: 7MM, Diagnosed Prevalent Cases of LN by Severity Based on WHO Classification, N, Both Sexes, All Ages, 2018

Figure 25: 7MM, Diagnosed Prevalent Cases of LN by Severity Based on ISN/RPS Classification, N, Both Sexes, All Ages, 2018

Figure 26: Overview of the Treatment Management of SLE and LN

Figure 27: Unmet Needs and Opportunities in SLE and LN

Figure 28: Overview of the Development Pipeline in SLE and LN

Figure 29: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for SLE and LN in the 7MM During the Forecast Period

Figure 30: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of SLE and LN During the Forecast Period

Figure 31: Analysis of the Company Portfolio Gap in Lupus During the Forecast Period

Figure 32: Global (7MM) Sales Forecast by Country for SLE and LN in 2018 and 2028

Figure 33: Sales Forecast by Class for SLE and LN in the US in 2018 and 2028

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