Frontier Pharma: Systemic Lupus Erythematosus – Identifying and Commercializing First-in-Class Innovation...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 The Case for Innovation in Systemic Lupus Erythematosus 7
2.2 Growing Opportunities for Biologic Products 7
2.3 Diversification of Molecular Targets 7
2.4 Innovative First-in-Class Product Developments Remain Attractive 8
2.5 Changes in the Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications 8
2.6 Sustained Innovation 8
3 Systemic Lupus Erythematosus 9
3.1 Disease Overview 9
3.2 Epidemiology 9
3.3 Disease Pathophysiology 10
3.4 Disease Symptoms 10
3.5 Environmental and Genetic Predisposition 11
3.6 Diagnosis 11
3.7 Disease Severity Assessments 12
3.7.1 PGA 12
3.7.2 SLEDAI 12
3.7.3 BILAG 13
3.7.4 SRI 13
3.8 Lupus Nephritis 13
3.9 Pharmacotherapy Algorithm 14
4 Clinical and Commercial Landscape 16
4.1 Corticosteroids 16
4.2 Antimalarials 16
4.3 Cytotoxic Chemotherapy 16
4.4 Biologics 17
4.4.1 Benlysta (belimumab) 17
4.5 Comparative Strengths and Weaknesses of Traditional Therapeutics 19
4.5.1 Corticosteroids vs Cytotoxic Therapeutics 19
4.5.2 Comparison of Immunosuppressants: Cyclosporine vs Azathioprine or Cyclophosphamide 21
4.5.3 Cyclophosphamide vs Azathioprine 23
4.5.4 Cyclophosphamide vs Mycophenolate Mofetil 23
4.5.5 Mycophenolate Mofetil vs Azathioprine 23
4.5.6 Biologics vs Immunosuppressants 25
4.6 Current Unmet Needs in the Systemic Lupus Erythematosus Market 27
5 Assessment of Pipeline Product Innovation 28
5.1 Overview of Pipeline Products for Systemic Lupus Erythematosus 28
5.2 Frequently Targeted Molecular Target Families 29
5.3 Comparative Distribution of Programs between the Systemic Lupus Erythematosus Market and Pipeline by Therapeutic Target Family 30
5.4 Comparative Efficacy and Safety of Pipeline Programs 31
5.5 Comparative Distribution of Programs with First-in-Class and Established Targets 33
5.6 Pipeline Programs Targeting Established Molecular Targets 35
5.7 First-in-class Pipeline Programs with Novel Molecular Targets 37
6 First-in-Class Target and Pipeline Program Evaluation 39
6.1 Cytokines and Receptors 39
6.1.1 Pipeline Programs Targeting IFN-α 39
6.1.2 Pipeline Programs Targeting CD74 43
6.1.3 Pipeline Programs Targeting B7 Related Protein 44
6.1.4 Pipeline Programs Targeting IL-21 46
6.1.5 Pipeline Programs Targeting IL-17 49
6.1.6 Pipeline Programs Targeting High Mobility Protein Box 1 51
6.1.7 Pipeline Programs Targeting APRIL 53
6.2 B and T Cell Antigens 55
6.2.1 Pipeline Programs Targeting CD4 55
6.2.2 Pipeline Programs Targeting CD40L 57
6.2.3 Pipeline Programs which Target FcγR2b (CD32b) 60
6.2.4 Pipeline Programs which Target CD19 62
6.2.5 Pipeline Programs which Target CD22 64
6.3 Intracellular Kinase 67
6.3.1 Pipeline Programs which Target Spleen Tyrosine Kinase 67
6.4 Others 70
6.4.1 Pipeline Programs which Target Immunoproteasome subunit 7 (IMP7) 70
6.4.2 Pipeline Programs which Target ILT-7 71
7 Conclusions 72
8 Deals and Strategic Consolidations 74
8.1 Licensing Agreements 74
8.2 Co-development Deals 76
8.2.1 First-in-Class Developmental Programs Not Involved in Co-development Deals or Licensing Deals 78
9 Appendix 79
9.1 References 79
9.2 Abbreviations 88
9.3 Methodology 89
9.4 Contact Us 89
9.5 Disclaimer 89