Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 Strong Unmet need for Prevention of Chronic Rejection 5
2.2 Moderately-Sized by Highly Innovative Pipeline 5
2.3 Chemokines and Immune Surface Antigens Appear to Hold Promise as Novel Targets 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 9
4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Symptoms 11
4.2.1 Transplant Rejection 11
4.2.2 Graft-Versus-Host Disease 12
4.3 Diagnosis 12
4.4 Etiology and Pathophysiology 13
4.4.1 Major Histocompatibility Complex 13
4.4.2 Allogeneic Immune Response 13
4.4.3 Innate Immunity 15
4.4.4 The Role of Cytokines 15
4.4.5 Types of Rejection 15
4.5 Epidemiology and Prognosis 17
4.5.1 Transplant Rejection 17
4.5.2 Graft-Versus-Host Disease 18
4.6 Treatment Options 18
4.6.1 Antibody Therapies 19
4.6.2 Calcineurin Inhibitors 19
4.6.3 Anti-Proliferative Agents 19
4.6.4 mTOR Inhibitors 20
4.6.5 Corticosteroids 20
4.7 Overview of Marketed Products 21
4.8 Current Unmet Needs 23
5 Assessment of Pipeline Product Innovation 24
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 24
5.2 First-in-Class Programs Targeting Novel Molecular Targets 28
6 Transplant Rejection Signaling Network, Disease Causation and Innovation Alignment 36
6.1 Complexity of Signaling Networks 36
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 36
6.3 First-in-Class Matrix Assessment 36
7 First-in-Class Target and Pipeline Program Evaluation 39
7.1 Pipeline Programs Targeting XXX 39
7.2 Pipeline Programs Targeting XXX 41
7.3 Pipeline Programs Targeting XXX 43
7.4 Pipeline Programs Targeting XXX 44
7.5 Pipeline Programs Targeting XXX 46
7.6 Pipeline Programs Targeting XXX 48
8 Strategic Consolidations 50
8.1 Industry-Wide First-in-Class Deals 50
8.2 Licensing Deals 52
8.2.1 Deals by Region, Year and Value 52
8.2.2 Deals by Stage of Development and Value 53
8.2.3 Deals by Molecule Type, Molecular Target and Value 54
8.2.4 List of Deals with Disclosed Deal Values 56
8.3 Co-development Deals 57
8.3.1 Deals by Region, Year and Value 57
8.3.2 Deals by Stage of Development and Value 59
8.3.3 Deals by Molecule Type, Molecular Target and Value 59
8.3.4 List of Deals with Disclosed Deal Values 61
8.4 List of First-in-Class Pipeline Products with and without Prior Deal Involvement 62
9 Appendix 64
9.1 Abbreviations 64
9.2 Disease List 64
9.3 References 65
9.4 Research Methodology 70
9.4.1 Data integrity 70
9.4.2 Innovative and meaningful analytical techniques and frameworks 70
9.4.3 Evidence based analysis and insight 70
9.5 Secondary Research 70
9.5.1 Market Analysis 70
9.5.2 Pipeline Analysis 70
9.5.3 Licensing and Co-development Deals 71
9.6 Contact Us 71
9.7 Disclaimer 72