PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis – Global Drug Forecast and Market Analysis to 2025

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Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. As a multisystem disorder, SLE is heterogeneous in nature—no two cases of lupus are alike—and 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 and LN remains incompletely understood, but genetic and environmental factors have been shown to play pivotal roles in the development of the disease.

To date, the cornerstone of lupus therapy still relies on generic steroids and unspecific immunosuppressive agents; both of which are associated with severe adverse events (SAEs) and contribute significantly to the morbidity and mortality in lupus. The much anticipated approval of Benlysta (belimumab) in 2011 had only a small impact on the treatment paradigm, and off-label Rituxan/MabThera (rituximab) remains the market leader in terms of sales. R&D efforts in lupus are high, however late-stage clinical failure remains a major barrier to market entry. The anticipated release of six new pipeline agents for SLE and LN will have the potential to revolutionize the lupus treatment. GlobalData expects the global SLE and LN market—which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan)—to expand during the next decade at an astonishing CAGR of 10.6%, reaching total sales of $3.2 billion by 2025.


Overview of SLE and LN, including epidemiology, etiology, pathophysiology, as well current routine SLE and LN recommendations of all 7MM covered.

Top-line SLE and LN market revenue from 2015–2025. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the SLE and LN market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.

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

Key Highlights

Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the SLE and LN marketplace.

What will be the effect of recent and upcoming biologics on the SLE and LN treatment landscape?

How will the upcoming first-in-class and me-too pipeline agents be received in the different markets?

What research and development (R&D) strategies will companies leverage to compete in the future SLE and LN marketplace?

Which patient population(s) are most likely to be targeted by newly introduced pipeline agents?

Bristol-Myers Squibb
AstraZeneca (MedImmune)
Merck KGaA
Anthera Pharmaceuticals
Aurinia Pharmaceuticals

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 SLE and LN Marketplace to Experience Strong Growth During the Forecast Period, 2015–2025

2.2 Partnerships among Big Pharma and Small Biotech Dominate Current and Future R&D Landscape

2.3 A 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, Headlined by AstraZeneca’s Anifrolumab, 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 Symptoms

4.3 Prognosis

4.4 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global Trends

5.3.1 SLE and LN Prevalence

5.3.2 LN Classification

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.4.3 Sources Not Used

5.5 Epidemiological Forecast for SLE and LN (2015–2025)

5.5.1 Diagnosed Prevalent Cases of SLE

5.5.2 Age-Specific Diagnosed Prevalent Cases of SLE

5.5.3 Sex-Specific Diagnosed Prevalent Cases of SLE

5.5.4 Age-Standardized Diagnosed Prevalence of SLE

5.5.5 Diagnosed Prevalent Cases of SLE Segmented by Severity

5.5.6 Diagnosed Prevalent Cases of LN

5.5.7 Diagnosed Prevalent Cases of LN Segmented by Class

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 Overview

6.1.1 SLE Diagnosis

6.1.2 LN Diagnosis

6.2 Treatment Overview

6.2.1 Treatment Guidelines and Leading Prescribed Drugs

6.3 US

6.3.1 Diagnosis

6.3.2 Clinical Practice

6.4 France

6.4.1 Diagnosis

6.4.2 Clinical Practice

6.5 Germany

6.5.1 Diagnosis

6.5.2 Clinical Practice

6.6 Italy

6.6.1 Diagnosis

6.6.2 Clinical Practice

6.7 Spain

6.7.1 Diagnosis

6.7.2 Clinical Practice

6.8 UK

6.8.1 Diagnosis

6.8.2 Clinical Practice

6.9 Japan

6.9.1 Diagnosis

6.9.2 Clinical Practice

7 Competitive Assessment

7.1 Overview

7.2 Strategic Competitor Assessment

7.3 Product Profiles – Major Brands, Small Molecules

7.3.1 Antimalarials (numerous brand names)

7.3.2 Steroids (numerous brand names)

7.3.3 Methotrexate (numerous brand names)

7.3.4 Mycophenolate Mofetil (numerous brand names)

7.3.5 Cyclophosphamide (numerous brand names)

7.3.6 Azathioprine (numerous brand names)

7.3.7 Calcineurin Inhibitors (numerous brand names)

7.4 Product Profiles – Major Brands, Biologics

7.4.1 Benlysta (belimumab)

7.4.2 Rituxan (rituximab)

7.5 Minor Therapeutic Classes

8 Unmet Needs Assessment and Opportunity Analysis

8.1 Overview

8.2 Drugs with Superior Efficacy and Safety Profiles, Particularly for LN

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Refined Clinical Trial Design Tailored to Heterogeneous Lupus Patient Populations

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Reduced Morbidity and Mortality in Lupus Patients

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Improved Physician Education

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

8.6 Sensitive and Reliable Biomarkers for Diagnosis and Disease Management

8.6.1 Unmet Need

8.6.2 Gap Analysis

8.6.3 Opportunity

8.7 Increased Compliance Rates for SOC SLE and LN Therapies

8.7.1 Unmet Need

8.7.2 Gap Analysis

8.7.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Clinical Trial Mapping

9.2.1 Clinical Trials by Therapy Type

9.3 Promising Drugs in Late-Stage Clinical Development

9.3.1 Atacicept

9.3.2 Orencia (abatacept)

9.3.3 Anifrolumab

9.3.4 Lupuzor (IPP-201101, P-140)

9.3.5 Voclosporin

9.4 Promising Drugs in Early-Stage Clinical Development

9.4.1 Overview

9.5 Other Drugs in Clinical Development

9.6 Biosimilars

9.6.1 Overview

9.6.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases

9.6.3 Biosimilars in the Immunology Community

9.6.4 By the Numbers: Biosimilars in Development for Potential Off-Label Use in SLE and LN

9.6.5 The Impact of Biosimilars Will Be Felt Throughout the Pharmaceutical Industry

9.6.6 Uptake of Biosimilars for SLE and LN Is Expected to Vary by Country/Region

9.6.7 Biosimilars Forecast for SLE and LN

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 GlaxoSmithKline

10.3.2 Roche

10.3.3 Bristol-Myers Squibb

10.3.4 AstraZeneca

10.3.5 Merck KGaA

10.3.6 Aurinia Pharmaceuticals

10.3.7 ImmuPharma

10.3.8 Pfizer

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

12.4 Forecasting Methodology

12.4.1 Diagnosed SLE and LN Patients

12.4.2 Percent Drug-Treated Patients

12.4.3 Drugs Included in Each Therapeutic Class

12.4.4 Launch and Patent Expiry Dates

12.4.5 General Pricing Assumptions

12.4.6 Individual Drug Assumptions

12.4.7 Generic Erosion

12.4.8 Pricing of Pipeline Agents

12.5 Primary Research – KOLs Interviewed for this Report

12.6 Primary Research – Prescriber Survey

12.7 About the Authors

12.7.1 Analyst

12.7.2 Therapy Area Directors

12.7.3 Epidemiologists

12.7.4 Global Director of Therapy Analysis and Epidemiology

12.7.5 Global Head and EVP of Healthcare Operations and Strategy

12.8 About GlobalData

12.9 Disclaimer

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