Systemic lupus erythematosus (SLE) or lupus is an autoimmune disorder wherein organs and cells experience damage primarily intervened by tissue binding autoantibodies and immune complexes. Lupus nephritis (LN) is a type of kidney disease caused by SLE. It is linked with significant morbidity and mortality in patients with SLE and substantial risk of disease progression to end-stage renal failure.
Lupus nephritis is a potential kidney disease with significant unmet clinical needs regardless of extensive clinical and translational research over the past decade resulting in only drug approval of Benlysta (belimumab) in 2011 for SLE. Although immunosuppression therapy has made it possible to control the disease with improved life expectancy and better quality of life. Current therapeutic options available in lupus nephritis market are off-label therapies that have undesirable side effects which will remain at the forefront of LN market. Increase R&D activity and the launch of new biologic drugs will boost the growth of the global lupus nephritis market. The launch of new pipeline drugs will satisfy the need for improved lupus nephritis medications and effective treatment management. In 2017, there were 560,320 diagnosed prevalent cases of SLE in the US, Japan, and EU5 (France, Germany, Italy, Spain, and the UK). LN accounts for about 20 percent of SLE patients. The US has the highest number of people diagnosed from LN in 2017, followed by Japan and the UK. The prevalence of lupus nephritis in Asian SLE patient population is much higher than in Caucasians. Thus, it represents large and well-defined market opportunity with very less competition and is projected to be worth US$5.89 billion by 2019 at a CAGR of 19 percent. The growing prevalence of LN, awareness among patients, robust healthcare infrastructure, increased R&D activities, and new drug approvals, have propelled the growth of the market. Significant opportunities will remain in the market even after the launch of current pipeline drugs due to lack of disease understanding and specific diagnosis test.
The market is characterized by the presence of a large number of companies. Strong pipeline and inorganic growth strategies will intensify the level of competition among the market players. Companies should embrace the idea of targeting a smaller subset of the larger SLE population to gain market share as this strategy will be the best approach for clinical success of investigational products.The leading players in the market are Roche, GSK, Bristol Myers Squibb, MedImmune and AstraZeneca. The other prominent players in the market are Amgen, Anthera Pharmaceuticals, Aurinia, ImmuPharma, Merck, and Teva Pharmaceuticals.
This report provides strategic insights into the overall CML treatment market, accompanied by the market size and forecast from 2012 to 2022 for major regions, along with approved product sales. The report covers in-depth product profiles of imatinib (Gleevec), nilotinib (Tasigna), dasatinib (Sprycel), bosutinib (Bosulif), ponatinib (Iclusig),and omacetaxine (Synribo) with market sales data for 2014 to 2022. It also provides detailed epidemiology of the CML by major regions (US, the Americas, Europe, and Asia Pacific). Some key players profiled in this report are Novartis, Roche, Teva and Pfizer.
Key Question Answered:
- Prevalence of Systemic Lupus Erythematosus in US, EU5 and Japan; 2017-2026
- Prevalence ofLupus Nephritis in US, EU5 and Japan; 2017-2026
- Global Prevalence of Systemic Lupus Erythematosus by Severity and Race
- Global Prevalence of Lupus Nephritis by Severity and Race
- Global Lupus NephritisMarket by Value; 2010-2022
- Global Lupus NephritisGenerics/Off-label Drugs Market by Value; 2010-2022
- Global Lupus NephritisNovel Drugs Market by Value; 2010-2022
- Global Average Annual Cost of LN per Patient; 2017
- Lupus NephritisDrugs Cost per Year in the US; 2017
- Clinical Trial Analysis of Lupus Nephritis
- Product Profile of Current Therapies: Benlysta, CellCept, Prograf and HP Acthar
- Product Profile of Pipeline Therapies: Orencia, Lupuzor, Anifrolumab, Orelvo and Blisibimod
- Detailed analysis of growth drivers, challenges and trends in Smart Pills market
- Detailed Company Profiling of Key Market Players: Aurinia, ImmuPharma, Roche, BMS and Anthera
1. Executive Summary
2. Introduction
I. Symptoms
II. Diagnosis
a. Clinical Features
b. Clinical Tests
III. Histologic Classification
IV. Pathogenesis
V. Treatment
VI. Management Strategy
VII. Current Treatment Approach
a. Biological agents in Lupus Nephritis
VIII. Complications
3. Epidemiology
I. Global Prevalence of Systemic Lupus Erythematosus & Lupus Nephritis
II. US Prevalence of Systemic Lupus Erythematosus & Lupus Nephritis
III. Europe Prevalence of Systemic Lupus Erythematosus & Lupus Nephritis
IV. Japan Prevalence of Systemic Lupus Erythematosus & Lupus Nephritis
4. Market Outlook & Forecast
I. Global Lupus Nephritis Market
II. Global Lupus Nephritis Generics/Off-label Drugs Market
III. Global Lupus Nephritis Novel Drugs Market
IV. Global Lupus Nephritis Cost of Therapy
V. US Lupus Nephritis Market
5. Clinical Trial Analysis
I. By Phase
II. By Sponsor
III. By Therapy Type
IV. By Company
a. Indications
V. By Drugs
6. Product Profiles
I. Current Therapies
a. Benlysta (Belimumab)
b. CellCept (Mycophenolatemofetil or MMF)
c. Prograf (Tacrolimus)
d. HP Acthar
II. Emerging Therapies
a. Orencia (Abatacept)
b. Lupuzor (IPP-201101)
c. Anifrolumab
d. Orelvo (Voclosporin)
e. Blisibimod
7. Patent Landscape
I. Overall IP Trends in Lupus Market
II. Patent Trends by Focus Area
III. Key Patents in Lupus Nephritis Market
IV. Lupus Nephritis Market Patent Trend by Key Players
V. RCC Market Patent Trend by Top Inventors
8. Market Dynamics
I. Growth Drivers
a. High Unmet Clinical Need
b. Increasing Black Population
c. Needs for Novel Biomarkers
d. Increasing Research Grants
II. Trends
a. Adoption of Inorganic Growth Strategies
b. Need for Calcineurin Inhibitors (CNIs) in LN
III. Challenges
a. Heterogeneity of Organ Manifestations
b. High Cost of Therapy
9. Company Profiles
I. Aurinia Pharmaceuticals
a. Business Overview
b. Financial Overview
II. ImmuPharma PLC
a. Business Overview
b. Financial Overview
III. Roche
a. Business Overview
b. Financial Overview
IV. Bristol-Myers Squibb
a. Business Overview
b. Financial Overview
V. Anthera Pharmaceuticals
a. Business Overview
b. Financial Overview
10. About EffeMarket
11. Disclaimer
12. Contact US
Figure 1: Algorithm for Kidney Biopsy in Patients with LN
Figure 2: Molecular Pathogenesisof Lupus Nephritis and Potential Therapeutic Targets
Figure 3: Current Induction and Maintenance Treatment Choices for Proliferative Lupus Nephritis
Figure 4: Global Diagnosed Prevalent Cases of SLE; 2017-2026
Figure 5: Global Prevalence of SLE by Regions; 2017
Figure 6: Global Diagnosed Prevalent Cases of LN; 2017-2026
Figure 7: Global Prevalence of LN by Regions; 2017
Figure 8: Global Prevalence of SLE/LN Breakdown; 2017
Figure 9: Global Prevalence of SLE/LN by Race/Ethnicity; 2017
Figure 10: Global Prevalence of SLE/LN Breakdown; 2017
Figure 11: Global Prevalence of SLE/LN by Race/Ethnicity; 2017
Figure 12: Global Prevalence of SLE/LN by Severity; 2011-2015
Figure 13: US Diagnosed Prevalent Cases of SLE; 2017-2026
Figure 14: US Diagnosed Prevalent Cases of LN; 2017-2026
Figure 15: EU5 Diagnosed Prevalent Cases of SLE; 2017-2026
Figure 16: EU5 Diagnosed Prevalent Cases of LN; 2017-2026
Figure 17: Japan Diagnosed Prevalent Cases of SLE; 2017-2026
Figure 18: Japan Diagnosed Prevalent Cases of LN; 2017-2026
Figure 19: Global LN Market by Value; 2010-2022
Figure 20: Global LN Generics/Off-label Drugs Market by Value; 2010-2022
Figure 21: Global LN Novel Drugs Market by Value; 2010-2022
Figure 22: Global Average Annual Cost of LN per Patient; 2017
Figure 23: LN Drugs Cost per Year in the US; 2017
Figure 24: Clinical Trial Analysis by Phase
Figure 25: LN Clinical Trial Analysis by Sponsor
Figure 26: LN Clinical Trial Analysis by Therapy Type
Figure 27: LN Clinical Trial Analysis by Company
Figure 28: LN Clinical Trial Analysis by Drugs
Figure 29: Benlysta Mechanism of Action
Figure 30: CellCept Mechanism of Action
Figure 31: CellCept Market by Number of Patients in the US; 2005-2013
Figure 32: Prograf Mechanism of Action
Figure 33: Prograf Sales in Japan for LN; 2008-2011
Figure 34: Prograf Mechanism of Action
Figure 35: HP Acthar Sales; 2015-2017
Figure 36: Patient Treated with HP Acthar; 2016
Figure 37: Orencia Mechanism of Action
Figure 38: Orencia Sales; 2014-2016
Figure 39: Lupuzor Mechanism of Action
Figure 40: Anifrolumab Mechanism of Action
Figure 41: Voclosporin Sales for LN; 2020
Figure 42: Blisibimod Mechanism of Action
Figure 43: Publication Year Trend
Figure 44: Top Earliest Priority Country Filing Trend
Figure 45: LN- Patent Focus
Figure 46: LN Patent Trend by Composition
Figure 47: LN Patent Trend by Current Therapies
Figure 48: LN Patent Trend by Emerging Therapies
Figure 49: LN Patent Trend by Route of Administration
Figure 50: Lupus Nephritis Patent Trend by Key Patent Holders (Legal Assignees)
Figure 51: LN Patent Trend by Top Inventors
Figure 52: : LN Remission Rates
Figure 53: Black Population Growth; 1990-2016
Figure 54: Aurinia Net Sales; 2013-2017
Figure 55: ImmuPharma Revenue; 2014-2017
Figure 56: ImmuPharma R&D Expenditure; 2013-2017
Figure 57: Roche Net Sales; 2013-2017
Figure 58: Bristol-Myers Squibb Revenue; 2013-2017
Figure 59: Bristol-Myers Squibb Revenue; 2013-2017
Figure 60: AntheraPharmaceuticalsR&D Expenditure; 2013-2017
Table 1: Histologic Classification of Lupus Nephritis
Table 2: Voclosporin Patents
Table 3: Comparison of Immunotherapies in Late-Stage Development for SLE and/or Lupus Nephritis
Table 4:Lupus Nephritis- Patent Focus (2007-2018)
Table 5: Lupus Nephritis Patent Trend by Composition (2007-2018)
Table 6: LN Patent Trend by Current Therapies (2007-2018)
Table 7: Lupus Nephritis Patent Trend by Emerging Therapies
Table 8: Key Patents in Lupus Nephritis Market
Table 9: Key Patent Holder Year Wise Patent Filing in Lupus Nephritis Market; 2007-2018
Table 10: Key Player Patent Filing by Focus area
Table 11: Key Player Patent Filling by Composition
Table 12: Key Player Patent Filling by Current Therapies
Table 13: Top Collaborations of the Assignees
Table 14: Top Inventors Association with Key Players