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

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Published: April 30, 2017 Report Code: GDHC137PIDR-ST

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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.

Scope

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?

GlaxoSmithKline
Roche
Bristol-Myers Squibb
AstraZeneca (MedImmune)
Merck KGaA
Anthera Pharmaceuticals
Aurinia Pharmaceuticals
ImmuPharma
Pfizer

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

Table

Table 1: SLE and LN: Key Metrics in the Seven Major Pharmaceutical Markets

Table 2: Symptoms of SLE

Table 3: The 1982 Revised ACR Criteria For Classification of Systemic Lupus Erythematosus

Table 4: WHO and ISN/RPS Classification Systems for LN

Table 5: Risk Factors for SLE

Table 6: 7MM, Sources Used for Diagnosed Prevalence of SLE

Table 7: 7MM, Sources Used for Diagnosed Prevalence of Mild and Moderate/Severe SLE

Table 8: 7MM, Sources Used for Diagnosed Prevalence of LN

Table 9: 7MM, Sources Used for Diagnosed Prevalent Cases of LN Classified by the WHO Classification

Table 10: 7MM, Sources Used for Classifying LN by the ISN/RPS Classification

Table 11: 7MM, Sources Not Used in Epidemiological Analysis of SLE

Table 12: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Both Sexes, N, Select Years 2015–2025

Table 13: 7MM, Age-Specific Diagnosed Prevalent Cases of SLE, Both Sexes, N, Row (%), 2015

Table 14: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, By Sex, N, Row (%), 2015

Table 15: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Men and Women, By Severity, N, Row (%), 2015

Table 16: 7MM, Diagnosed Prevalent Cases of LN, All Ages, Both Sexes, N, Select Years 2015–2025

Table 17: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by WHO Classification, Row (%), 2015

Table 18: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by ISN/RPS Classification, Row (%), 2015

Table 19: Updated (1997) ACR Criteria for Classification of SLE

Table 20: The SLICC Clinical and Immunologic Criteria for Classification of SLE

Table 21: WHO and ISN/RPS Classifications of LN

Table 22: Treatment Guidelines for SLE and LN

Table 23: Most Prescribed Drugs for SLE and LN by Class in the Global Markets, 2015

Table 24: Country Profile – US

Table 25: Country Profile – France

Table 26: Country Profile – Germany

Table 27: Country Profile – Italy

Table 28: Country Profile – Spain

Table 29: Country Profile – UK

Table 30: Country Profile – Japan

Table 31: Leading Treatments for SLE and LN, 2016

Table 32: Product Profile – Hydroxychloroquine

Table 33: Efficacy of Antimalarial Therapy in Lupus

Table 34: Safety of Antimalarial Therapy in Lupus

Table 35: Antimalarial Therapy SWOT Analysis, 2016

Table 36: Global Sales Forecasts ($m) of Antimalarials* for SLE and LN Therapy, 2015–2025

Table 37: Product Profile – Steroids

Table 38: Efficacy of Steroids in SLE Patients

Table 39: Safety of Long-Term Prednisone Use*

Table 40: Steroids SWOT Analysis, 2016

Table 41: Global Sales Forecasts ($m) of Steroids* for SLE and LN Therapy, 2015–2025

Table 42: Product Profile – Methotrexate

Table 43: Steroid-Sparing Effect of Methotrexate

Table 44: Safety of Methotrexate

Table 45: Methotrexate SWOT Analysis, 2016

Table 46: Global Sales Forecasts ($m) of Methotrexate* for SLE and LN Therapy, 2015–2025

Table 47: Product Profile – Mycophenolate Mofetil

Table 48: Efficacy of Mycophenolate Mofetil

Table 49: Safety of Mycophenolate Mofetil

Table 50: Mycophenolate Mofetil SWOT Analysis, 2016

Table 51: Global Sales Forecasts ($m) of Mycophenolate Mofetil for SLE and LN Therapy, 2015–2025

Table 52: Product Profile – Cyclophosphamide

Table 53: Efficacy of Cyclophosphamide

Table 54: Safety of Cyclophosphamide

Table 55: Cyclophosphamide SWOT Analysis, 2016

Table 56: Global Sales Forecasts ($m) of Cyclophosphamide* for SLE and LN Therapy, 2015–2025

Table 57: Product Profile – Azathioprine

Table 58: Efficacy of Azathioprine

Table 59: Safety of Azathioprine

Table 60: Azathioprine SWOT Analysis, 2016

Table 61: Global Sales Forecasts ($m) of Azathioprine* for SLE and LN Therapy, 2015–2025

Table 62: Product Profile – Calcineurin Inhibitors

Table 63: Efficacy of Calcineurin Inhibitors

Table 64: Safety of Calcineurin Inhibitors

Table 65: Calcineurin Inhibitors SWOT Analysis, 2016

Table 66: Global Sales Forecasts ($m) of Calcineurin Inhibitors* for SLE and LN Therapy, 2015–2025

Table 67: Product Profile – Benlysta

Table 68: Efficacy of Benlysta

Table 69: Safety of Benlysta

Table 70: Benlysta SWOT Analysis, 2016

Table 71: Global Sales Forecasts ($m) of Benlysta for SLE and LN Therapy, 2015–2025

Table 72: Product Profile – Rituxan

Table 73: Efficacy of Rituxan

Table 74: Safety of Rituxan

Table 75: Rituxan SWOT Analysis, 2016

Table 76: Global Sales Forecasts ($m) of Rituxan for SLE and LN Therapy, 2015–2025

Table 77: Summary of Minor Therapeutic Classes for the Treatment of SLE and LN, 2016

Table 78: Unmet Need and Opportunity in SLE and LN, 2016

Table 79: Key Late-Stage Pipeline Agents for SLE and LN, 2016

Table 80: Product Profile – Atacicept

Table 81: Atacicept SWOT Analysis, 2016

Table 82: Global Sales Forecasts ($m) for Atacicept in SLE and LN, 2015–2025

Table 83: Product Profile – Orencia

Table 84: Orencia SWOT Analysis, 2016

Table 85: Global Sales Forecasts ($m) for Orencia in SLE and LN, 2015–2025

Table 86: AstraZeneca’s Anifrolumab – Key Phase II and Phase III Clinical Trials

Table 87: Product Profile – Anifrolumab

Table 88: Anifrolumab SWOT Analysis, 2016

Table 89: Global Sales Forecasts ($m) for Anifrolumab in SLE and LN, 2015–2025

Table 90: Product Profile – Lupuzor

Table 91: Lupuzor SWOT Analysis, 2016

Table 92: Global Sales Forecasts ($m) for Lupuzor in SLE and LN, 2015–2025

Table 93: Product Profile – Voclosporin

Table 94: Voclosporin SWOT Analysis, 2016

Table 95: Global Sales Forecasts ($m) for Voclosporin in SLE and LN, 2015–2025

Table 96: Other Promising Clinical-Stage Drugs in Development for SLE/LN, 2016

Table 97: Drugs in Development for SLE and LN, 2016

Table 98: Biosimilars Pipeline for RA, 2016

Table 99: Global Sales Forecasts ($m) for Biosimilars (Rituximab and Abatacept) in SLE and LN, 2015–2025

Table 100: Key Companies in the SLE and LN Market in the 7MM, 2016

Table 101: GSK’s SLE and LN Portfolio Assessment, 2016

Table 102: Roche’s SLE and LN Portfolio Assessment, 2016

Table 103: BMS’ SLE and LN Portfolio Assessment, 2016

Table 104: AstraZeneca’s SLE and LN Portfolio Assessment, 2016

Table 105: Merck KGaA’s SLE and LN Portfolio Assessment, 2016

Table 106: Aurinia’s SLE and LN Portfolio Assessment, 2016

Table 107: ImmuPharma’s SLE and LN Portfolio Assessment, 2016

Table 108: Pfizer’s SLE and LN Portfolio Assessment, 2016

Table 109: Global (7MM) Sales Forecasts ($m) for SLE and LN, 2015–2025

Table 110: SLE and LN Market – Global Drivers and Barriers, 2015‒2025

Table 111: Sales Forecasts ($m) for SLE and LN in the US, 2015–2025

Table 112: Key Events Impacting Sales for SLE and LN in the US, 2015–2025

Table 113: SLE and LN Market – Drivers and Barriers in the US, 2015‒2025

Table 114: Sales Forecasts ($m) for SLE and LN in the 5EU, 2015–2025

Table 115: Key Events Impacting Sales for SLE and LN in the 5EU, 2015–2025

Table 116: SLE and LN Market – Drivers and Barriers in the 5EU, 2015‒2025

Table 117: Sales Forecasts ($m) for SLE and LN in Japan, 2015–2025

Table 118: Key Events Impacting Sales for SLE and LN in Japan, 2015–2025

Table 119: SLE and LN Market – Drivers and Barriers in Japan, 2015‒2025

Table 120: Key Historical and Projected Launch Dates for SLE and LN

Table 121: Key Historical and Projected Patent Expiry Dates for SLE and LN

Table 122: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales for SLE and LN by Country/Region, 2015 and 2025

Figure 2: Company Portfolio Gap Analysis in SLE and LN, 2015–2025

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in SLE and LN, 2015–2025

Figure 4: Overview of the Etiology and Pathogenesis of SLE

Figure 5: Integrated Hypothesis for the Pathogenesis of SLE

Figure 6: SLE Forecast Case Flow Map

Figure 7: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Both Sexes, N, 2015–2025

Figure 8: 7MM, Diagnosed Prevalent Cases of SLE, by Age, Both Sexes, N, 2015

Figure 9: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, By Sex, N, 2015

Figure 10: 7MM, Age-Standardized Diagnosed Prevalence (Cases per 100,000 Population) of SLE, All Ages, by Sex, 2015

Figure 11: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Men and Women, By Severity, N, 2015

Figure 12: 7MM, Diagnosed Prevalent Cases of LN, All Ages, Both Sexes, N, 2015‒2025

Figure 13: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by WHO Classification, 2015

Figure 14: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by ISN/RPS Classification, 2015

Figure 15: Overview of the Treatment Management of SLE and LN

Figure 16: SLE and LN Therapeutics – Clinical Trials by Type of Therapy and Development Stage, December 2016

Figure 17: SLE and LN – Key Phase II‒III Clinical Trials, 2016

Figure 18: Competitive Assessment of Late-Stage Pipeline Agents in SLE and LN, 2015–2025

Figure 19: Company Portfolio Gap Analysis in SLE and LN, 2015–2025

Figure 20: Average Annual Cost of Therapy (ACOT) for SLE and LN, 2016

Figure 21: Global (7MM) Sales for SLE and LN by Country/Region, 2015 and 2025

Figure 22: Global (7MM) Sales for SLE and LN by Region, 2015‒2025

Figure 23: Global (7MM) Sales for SLE and LN by Drug, 2015 and 2025

Figure 24: Sales for SLE and LN by Drug Class in the US, 2015

Figure 25: Sales for SLE and LN by Drug Class in the 5EU, 2015 and 2025

Figure 26: Global Sales for SLE and LN by Country in the 5EU, 2015 and 2025

Figure 27: Global Sales for SLE and LN by Country in the 5EU, 2015‒2025

Figure 28: Sales for SLE and LN by Drug Class in Japan, 2015 and 2025

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