Systemic Lupus Erythematosus and Lupus Nephritis: Seven-Market Drug Forecast and Market Analysis

Description

List of Tables

This report covers the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). The report provides an overview of the current treatment options, pipeline products in development, as well as current and future R&D trends. Key topics covered include a strategic competitive assessment of current and future drugs, unmet needs, KOL insights, and implications for the Systemic Lupus Erythematosus and Lupus Nephritis market. The base year of the sales forecast model is 2024, and the forecast period is 2024-2034.

GlobalData estimated that the SLE and LN market was $2.4 billion accross the 7MM in 2024, increasing to $5.9 billion by 2034 at a compound annual growth rate (CAGR) of 9.6%. This growth was driven by the launch of ten late-stage pipeline agents entering a market prevouosly dominated by the off-label use of generic immunosuppressants, anti-malarials, and corticosteriods, offering a significant improvement in safety and efficacy. However, the market is expected to face signigicant barriers to its growth, most notably the entry of biosimilars such as belimumab and anifrolumab. And the slow adoption rate of pipeline therapeutics, due to the high annual cost of treatment associated with them.

Scope

Overview of SLE and LN - including epidemiology, disease etiology and management.
Topline SLE and LN drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
Key topics covered include assessment of marketed and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU, and Japan over the 10-year forecast period.
Pipeline analysis: 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 therapeutics market. Insightful review of the key industry drivers and barriers.

Reasons to Buy

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
Develop business strategies by understanding the trends shaping and driving the seven-market systemic lupus erythematosus and lupus nephritis (SLE and LN) therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the seven-market SLE and LN market in the future.
Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 seven-market SLE and LN therapeutics market from 2024-2034.
Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Product Code: GDHC337PIDR-7M

1 Systemic Lupus Erythematosus and Lupus Nephritis: Executive Summary

1.1 SLE market to significantly increase during the forecast period 2024-34
1.2 R&D strategies for the lupus market
1.3 High unmet need for steroid-sparing treatments that can reduce infection risk
1.4 Future SLE and LN players competition
1.5 Pipeline assessment
1.6 What do physicians think?

2 Introduction

2.1 Catalyst
2.2 Related reports
2.3 Upcoming reports

3 Disease Overview

3.1 Etiology and pathophysiology
- 3.1.1 Etiology
- 3.1.2 Pathophysiology
3.2 Prognosis
3.3 Classification or staging systems
- 3.3.1 SLE classification
- 3.3.2 LN classification

4 Epidemiology

4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 7MM forecast methodology
- 4.4.1 Sources
- 4.4.2 Forecast assumptions and methods
- 4.4.3 Forecast assumptions and methods: diagnosed prevalent cases of SLE
- 4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of SLE by severity
- 4.4.5 Forecast assumptions and methods: diagnosed prevalent cases of LN
- 4.4.6 Diagnosed prevalent cases of LN by class
4.5 Epidemiological forecast for diagnosed prevalent cases of SLE (2024-34)
- 4.5.1 Diagnosed prevalent cases of SLE
- 4.5.2 Age-specific diagnosed prevalent cases of SLE
- 4.5.3 Sex-specific diagnosed prevalent cases of SLE
- 4.5.4 Diagnosed prevalent cases of SLE by severity
- 4.5.5 Diagnosed prevalent cases of LN
- 4.5.6 Age-specific diagnosed prevalent cases of LN
- 4.5.7 Sex-specific diagnosed prevalent cases of LN
- 4.5.8 Diagnosed prevalent cases of LN by class
4.6 Discussion
- 4.6.1 Epidemiological forecast insight
- 4.6.2 Limitations of the analysis
- 4.6.3 Strengths of the analysis

5 Disease Management

5.1 Diagnosis and treatment overview
5.2 Treatment overview
5.3 KOL insights on disease management

6 Current Treatment Options

6.1 Overview
6.2 SOC therapies in lupus
- 6.2.1 Antimalarials
- 6.2.2 Steroids
- 6.2.3 Immunosuppressive agents
6.3 Biologic therapies in lupus
- 6.3.1 Benlysta (belimumab)
- 6.3.2 Saphnelo (anifrolumab)
- 6.3.3 Gazyva/Gazyvaro (obinutuzumab)
- 6.3.4 Rituximab

7 Unmet Needs and Opportunity Assessment

7.1 Overview
7.2 More efficacious therapies and steroid-free treatment
7.3 Infection prevention
7.4 Improving patient compliance
7.5 Development of biomarkers for lupus disease activity

8 R&D Strategies

8.1 Overview
- 8.1.1 Novel MoAs
- 8.1.2 Label Expansion and Reformulation
8.2 Clinical trial design
- 8.2.1 Design overview
- 8.2.2 Patient populations
- 8.2.3 CAR-T clinical trials

9 Pipeline Assessment

9.1 Overview
9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

10.1 Overview
10.2 Competitive assessment

11 Current and Future Players

11.1 Overview
11.2 Deal-making trends

12 Market Outlook

12.1 Global markets
- 12.1.1 Forecast
- 12.1.2 Drivers and barriers - global issues
12.2 US
- 12.2.1 Forecast
- 12.2.2 Key events
- 12.2.3 Drivers and barriers
12.3 5EU
- 12.3.1 Forecast
- 12.3.2 Key events
- 12.3.3 Drivers and barriers
12.4 Japan
- 12.4.1 Forecast
- 12.4.2 Key events
- 12.4.3 Drivers and barriers

13 Appendix

13.1 Bibliography
13.2 Abbreviations
13.3 Methodology
- 13.3.1 Forecasting methodology
13.4 Primary research - KOLs interviewed for this report
- 13.4.1 KOLs
13.5 Primary research - prescriber survey
13.6 About the Authors
- 13.6.1 Analyst
- 13.6.2 Managing Analyst
- 13.6.3 Therapy Area Director
- 13.6.4 Epidemiologist/Managing Epidemiologist
- 13.6.5 Vice President of Disease Intelligence and Epidemiology
- 13.6.6 Global Head of Pharma Research, Analysis, and Competitive Intelligence
About GlobalData
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Product Code: GDHC337PIDR-7M

List of Table

List of Tables

Table 1: SLE and LN: key metrics in the 7MM
Table 2 EULAR/ACR 2019 criteria for SLE classification
Table 3: Disease classification definitions in SLE
Table 4: BILAG=2004 index
Table 5 ISN/RPS 2018 classification of LN
Table 6: Risk factors and comorbidities for SLE
Table 7: 7MM, diagnosed prevalent cases of LN by class on the ISN/RPS classification, N, both sexes, all ages, 2024
Table 8 Treatment guidelines for SLE and LN
Table 9 Leading treatments for SLE and LN, 2025
Table 10 Clinical endpoints for recent and current Phase III SLE and LN pipeline assets
Table 11: Top 10 deals by value, 2020-25
Table 12 SLE and LN market - drivers and barriers in the US, 2024-34
Table 13: Key events impacting sales for SLE and LN in the US, 2024-34
Table 14: SLE and LN Market - drivers and barriers in the US, 2024-34
Table 15: Key events impacting sales for SLE and LN in the 5EU, 2024-34
Table 16: SLE and LN market - drivers and barriers in the 5EU, 2024-34
Table 17: Key events impacting sales for SLE and LN in Japan, 2024-34
Table 18: SLE and LN market - drivers and barriers in Japan, 2024-34
Table 20: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figure

List of Figures

Figure 1: Global sales forecast by country for SLE and LN in 2024 and 2034
Figure 2: Analysis of the company portfolio gap in SLE/LN during the forecast period
Figure 3 Competitive assessment of the marketed and pipeline complex molecules benchmarked against the SOC, Benlysta
Figure 4 Competitive assessment of the marketed and pipeline small molecules benchmarked against the SOC, mycophenolate mofetil
Figure 5 Overview of the etiology and pathogenesis of SLE
Figure 6 Integrated hypothesis for the pathogenesis of SLE
Figure 7: 7MM, diagnosed prevalence of SLE, men, women, %, all ages, 2024
Figure 8: 7MM, diagnosed prevalence of LN, men, women, %, all ages, 2024
Figure 9: 7MM, sources used to forecast the diagnosed prevalent cases of SLE
Figure 10: 7MM, sources used to forecast the diagnosed prevalent cases of SLE by severity
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 class
Figure 13: 7MM, diagnosed prevalent cases of SLE, N, both sexes, all ages, 2024
Figure 14: 7MM, diagnosed prevalent cases of SLE by age, N, both sexes, 2024
Figure 15: 7MM, diagnosed prevalent cases of SLE by sex, N, all ages, 2024
Figure 16: 7MM, diagnosed prevalent cases of SLE by severity, N, both sexes, all ages, 2024
Figure 17: 7MM, diagnosed prevalent cases of LN, N, both sexes, all ages, 2024
Figure 18: 7MM, diagnosed prevalent cases of LN by age, N, both sexes, all ages, 2024
Figure 19: 7MM, diagnosed prevalent cases of LN by sex, N, men, women, all ages, 2024
Figure 20 Overview of the treatment management of SLE and LN
Figure 21: Unmet needs and opportunities in SLE and LN
Figure 22: Overview of the development pipeline in SLE in the 7MM
Figure 23: Overview of the development pipeline in LN in the 7MM
Figure 24 Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for SLE and LN in the 7MM during the forecast period
Figure 25 Competitive assessment of the marketed and pipeline small molecules benchmarked against the SOC, mycophenolate mofetil
Figure 26 Competitive assessment of the marketed and pipeline complex molecules benchmarked against the SOC, Benlysta
Figure 27: Analysis of the company portfolio gap in SLE/LN during the forecast period
Figure 28: Global (7MM) sales forecast by country for SLE and LN in 2024 and 2034
Figure 29 Global (7MM) sales forecast by drug class for SLE and LN in 2024 and 2034
Figure 30 Sales forecast by drug class for SLE and LN in the US in 2024 and 2034
Figure 31 Sales forecast by drug class for SLE and LN in the 5EU in 2024 and 2034
Figure 32 Sales forecast by drug class for SLE and LN in Japan in 2024 and 2034

Systemic Lupus Erythematosus and Lupus Nephritis: Seven-Market Drug Forecast and Market Analysis

Description

Table of Contents

List of Tables

Scope

Reasons to Buy

Table of Contents

Table of Contents

1 Systemic Lupus Erythematosus and Lupus Nephritis: Executive Summary

2 Introduction

3 Disease Overview

4 Epidemiology

5 Disease Management

6 Current Treatment Options

7 Unmet Needs and Opportunity Assessment

8 R&D Strategies

9 Pipeline Assessment

10 Pipeline Valuation Analysis

11 Current and Future Players

12 Market Outlook

13 Appendix

List of Table

List of Tables

List of Figure

List of Figures