Summary
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.
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
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.
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.
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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
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
11 Market Outlook
12 Appendix
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: SLE and LN Market - Global Drivers and Barriers, 2018-2028
Table 22: Key Events Impacting Sales for SLE and LN in the US, 2018-2028
Table 23: SLE and LN Market - Drivers and Barriers in the US, 2018-2028
Table 24: Key Events Impacting Sales for SLE and LN in the 5EU, 2018-2028
Table 25: SLE and LN Market - Drivers and Barriers in the 5EU, 2018-2028
Table 26: Key Events Impacting Sales for SLE and LN in Japan, 2018-2028
Table 27: SLE and LN Market - Global Drivers and Barriers in Japan, 2018-2028
Table 28: Key Historical and Projected Launch Dates for SLE and LN
Table 29: Key Historical and Projected Patent Expiry Dates for SLE and LN
Table 30: 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 i 2018 and 2028
Figure 33: Sales Forecast by Class for SLE and LN in the US in 2018 and 2028
