Systemic Lupus Erythematosus and Lupus Nephritis – France Drug Forecast and Market Analysis to 2022

Pages: 149 Published: October 01, 2013 Report Code: GDHC161CFR

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 term LN refers to SLE patients with glomerulonephritis, and when the term LN is used, glomerular tissue injury in the kidneys is always involved. Renal injury without any glomerular involvement is classified as nephritis in a patient with SLE.

The growth in the France SLE and LN therapeutics market will be driven by higher uptake of existing biologic drugs and the launch of new biologics and increasing prevalent cases of SLE and LN.

Scope

Overview of SLE-LN including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in France including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in France from 2012-2022.

Analysis of the impact of key events as well the drivers and restraints affecting France SLE-LN market.

Reasons to Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for SLE-LN

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2012-2022 in France

Table of Contents

1Table of Contents1

1.1List of Tables4

1.2List of Figures6

2Executive Summary7

2.1Sales for SLE and LN in France, 2012–20227

2.2What Do the Physicians Think?8

3Introduction10

3.1Catalyst10

3.2Related Reports10

3.3Upcoming Related Reports12

4Disease Overview12

4.1Etiology and Pathophysiology12

4.1.1Etiology12

4.1.2Pathophysiology14

4.2Prognosis15

4.3Quality of Life15

4.4Symptoms16

5Disease Management16

5.1Diagnosis Overview16

5.1.1SLE Diagnosis16

5.1.2LN Diagnosis20

5.2Treatment Overview22

5.3France26

5.3.1Diagnosis26

5.3.2Clinical Practice26

6Competitive Assessment27

6.1Overview27

6.2Strategic Competitor Assessment29

6.3Product Profiles – Major Brands30

6.3.1Antimalarial Therapy (numerous brand names)30

6.3.2Steroids (numerous brand names)34

6.3.3Methotrexate (numerous brand names)38

6.3.4Mycophenolate Mofetil (numerous brand names)42

6.3.5Cyclophosphamide (numerous brand names)46

6.3.6Azathioprine (numerous brand names)49

6.3.7Calcineurin Inhibitors (numerous brand names)52

6.3.8Benlysta (belimumab)56

6.3.9Rituxan (rituximab)63

6.3.10Minor Therapeutic Classes66

7Opportunity and Unmet Need67

7.1Overview67

7.2Unmet Needs69

7.2.1Efficacious Treatments with Reduced Side Effects69

7.2.2Management of LN71

7.2.3Improvement in Patients’ Mortality72

7.2.4Management of Lupus Comorbidities72

7.2.5Sensitive and Reliable Biomarkers73

7.2.6Physicians’ Education and Public Awareness of SLE74

7.2.7Unmet Needs Gap Analysis74

7.3Opportunities75

7.3.1Efficacious and Safe Therapies75

7.3.2Therapies Targeting LN Patients76

7.3.3Treatments for Common Lupus Comorbidities77

7.3.4Discovery of Biomarkers77

8Pipeline Assessment77

8.1Overview77

8.2Promising Drugs in Clinical Development79

8.2.1Blisibimod (A-623)82

8.2.2Tabalumab (LY-2127399)87

8.2.3Atacicept92

8.2.4Epratuzumab96

8.2.5Lupuzor (rigerimod)102

8.2.6Orencia (abatacept)106

9Market Outlook111

9.1France111

9.1.1Forecast111

9.1.2Key Events116

9.1.3Drivers and Barriers116

10Appendix118

10.1Bibliography118

10.2Abbreviations128

10.3Methodology133

10.4Forecasting Methodology133

10.4.1Diagnosed SLE and LN Patients133

10.4.2Percent Drug-Treated Patients134

10.4.3Drugs Included in Each Therapeutic Class134

10.4.4Launch and Patent Expiry Dates134

10.4.5General Pricing Assumptions135

10.4.6Individual Drug Assumptions135

10.4.7Generic Erosion138

10.4.8Pricing of Pipeline Agents138

10.5Physicians and Specialists Included in this Study140

10.6Primary Research – Prescriber Survey142

10.7About the Authors143

10.7.1Analysts143

10.7.2Global Head of Healthcare143

10.8About GlobalData145

10.9Contact Us145

10.10Disclaimer145

List of Tables

Table 1: Symptoms of SLE16

Table 2: 1997 Updated ACR Criteria for Classification of SLE18

Table 3: The SLICC Clinical and Immunologic Criteria for Classification of SLE19

Table 4: WHO and ISN/RPS classifications of LN21

Table 5: Treatment Guidelines for SLE and LN24

Table 6: Most Prescribed Drugs for SLE and LN by Class in the Global Markets, 201325

Table 7: Leading Treatments for SLE and LN, 201329

Table 8: Product Profile – Hydroxychloroquine31

Table 9: Antimalarial Therapy SWOT Analysis, 201333

Table 10: Product Profile – Steroids36

Table 11: Steroids SWOT Analysis, 201338

Table 12: Product Profile – Methotrexate40

Table 13: Methotrexate SWOT Analysis, 201341

Table 14: Product Profile – Mycophenolate Mofetil43

Table 15: Mycophenolate Mofetil SWOT Analysis, 201345

Table 16: Product Profile – Cyclophosphamide47

Table 17: Cyclophosphamide SWOT Analysis, 201349

Table 18: Product Profile – Azathioprine50

Table 19: Azathioprine SWOT Analysis, 201352

Table 20: Product Profile – Calcineurin Inhibitors54

Table 21: Calcineurin Inhibitors SWOT Analysis, 201355

Table 22: Product Profile – Benlysta57

Table 23: Benlysta SWOT Analysis, 201362

Table 24: Product Profile – Rituxan64

Table 25: Rituxan SWOT Analysis, 201366

Table 26: Summary of Minor Therapeutic Classes in SLE and LN, 201367

Table 27: Overall Unmet Needs in SLE and LN – Current Level of Attainment69

Table 28: Clinical Unmet Needs in SLE and LN – Gap Analysis, 201374

Table 29: SLE and LN – Phase Pipeline, 201379

Table 30: Comparison of Therapeutic Classes in Development for SLE and LN, 201381

Table 31: Product Profile – Blisibimod83

Table 32: Blisibimod SWOT Analysis, 201387

Table 33: Product Profile – Tabalumab (LY-2127399)88

Table 34: Tabalumab SWOT Analysis, 201391

Table 35: Product Profile – Atacicept93

Table 36: Atacicept SWOT Analysis, 201395

Table 37: Product Profile – Epratuzumab97

Table 38: Epratuzumab SWOT Analysis, 2013101

Table 39: Product Profile – Lupuzor102

Table 40: Lupuzor SWOT Analysis, 2013106

Table 41: Product Profile – Orencia107

Table 42: Orencia SWOT Analysis, 2013111

Table 43: Sales Forecasts ($m) for SLE in France, 2012–2022113

Table 44: Sales Forecasts ($m) for LN in France, 2012–2022114

Table 45: Key Events Impacting Sales for SLE and LN in France, 2012–2022116

Table 46: SLE and LN Market in France – Drivers and Barriers, 2012–2022116

Table 47: Key Launch Dates134

Table 48: Key Patent Expiries134

Table 49: Number of Physicians Surveyed by Country142

List of Figures

Figure 1: Sales for SLE and LN in France by Drug Class, 2012–20228

Figure 2: Overview of the Etiology and Pathogenesis of SLE13

Figure 3: Overview of the BAFF/APRIL Ligand and Receptor System15

Figure 4: Overview of the Treatment Management of SLE22

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in SLE and LN, 2012–202280

Figure 6: Sales for SLE and LN in France by Drug Class, 2012–2022115

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