Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 6
2.1 Overview 6
2.1.1 Classification of GVHD 6
2.2 Epidemiology 8
2.3 Etiology 9
2.4 Signs and Symptoms 10
2.4.1 Acute GVHD 11
2.4.2 Chronic GVHD 11
2.5 Diagnosis 13
2.5.1 Laboratory Tests 13
2.5.2 Imaging Tests 13
2.5.3 Biopsies 13
2.5.4 Other Tests and Procedures 13
2.6 Prophylaxis 14
2.7 Treatment 14
2.7.1 Primary or First-Line Therapy for aGVHD 14
2.7.2 Secondary or Second-Line Therapy for aGVHD 15
2.7.3 Primary or First-Line Therapy for cGVHD 15
2.7.4 Secondary or Second-Line Therapy for cGVHD 15
2.7.5 Supportive Care 15
2.8 GlobalData Pipeline Report Guidance 16
3 GVHD Therapeutics - Market Characterization 17
3.1 Major Markets, Market Size (2005-2010) 17
3.2 Major Markets, Market Forecast (2010-2018) 19
3.3 US Market Size (2005-2010) 21
3.4 The US Market Forecast (2010-2018) 22
3.5 The UK Market Size (2005-2010) 23
3.6 The UK Market Forecast (2010-2018) 24
3.7 Germany Market Size (2005-2010) 25
3.8 Germany Market Forecast (2010-2018) 26
3.9 Italy Market Size (2005-2010) 27
3.10 Italy Market Forecast (2010-2018) 28
3.11 France Market Size (2005-2010) 29
3.12 France Market Forecast (2010-2018) 30
3.13 Spain Market Size (2005-2010) 31
3.14 Spain Market Forecast (2010-2018) 32
3.15 Japan Market Size (2005-2010) 33
3.16 Japan Market Forecast (2010-2018) 34
3.17 Drivers and Barriers for GVHD Therapeutic Market 35
3.17.1 Drivers for GVHD Market 35
3.17.2 Barriers for GVHD Market 35
3.18 Opportunity and Unmet Need 36
3.19 Key Takeaway 36
4 GVHD Therapeutics Market - Competitive Assessment 37
4.1 Overview 37
4.1.1 Strategic Competitor Assessment 37
4.2 GVHD Market Marketed Products Profile 38
4.2.1 Corticosteroids 38
4.2.2 Cyclosporine 38
4.2.3 Antithymocyte Globulin (ATG) (equine/rabbit) 39
4.2.4 Mycophenolate Mofetil (MMF) 40
4.2.5 Tacrolimus 40
4.3 Key Takeaway 41
5 GVHD - Pipeline Assessment 42
5.1 Overview 42
5.2 Strategic Pipeline Assessment 42
5.3 GVHD Pipeline Analysis - Pipeline by Clinical Phases of Development 43
5.3.1 GVHD Therapeutics - Phase III Clinical Pipeline 43
5.3.2 GVHD Therapeutics - Phase II Clinical Pipeline 44
5.3.3 GVHD Therapeutics - Phase I/II Clinical Pipeline 44
5.3.4 GVHD Therapeutics - Phase I Clinical Pipeline 44
5.3.5 GVHD Therapeutics - Preclinical Pipeline 45
5.4 GVHD Pipeline by Mechanism of Action 45
5.5 GVHD Technology Trends Analytical Framework 47
5.6 GVHD Therapeutics - Promising Drugs under Clinical Development 48
5.7 Molecule Profile for Promising Drugs under Clinical Development 49
5.7.1 ATIR (ANX-530) 49
5.7.2 Budesonide 49
5.7.3 Leukotac (inolimomab) 50
5.7.4 OrBec (Beclomethasone Dipropionate, Oral BDP, Oral Beclomethasone Dipropionate) 50
5.7.5 Prochymal 51
5.8 Key Takeaway 52
6 GVHD Therapeutics - Clinical Trials Mapping
6.1 Overview 53
6.2 Clinical Trials Mapping by Region/Country 53
6.3 Clinical Trials Mapping by Phase 54
6.4 Clinical Trials Mapping by Trial Status 55
6.5 Clinical Trials Mapping by Overall Sponsors 56
6.6 Clinical Trials Mapping by Prominent Sponsors 57
6.7 Participants in Therapeutic Clinical Trials - Companies 58
7 GVHD Therapeutics - Implications for Future Competition
7.1 Future Market Competition Scenario 59
8 Global GVHD Therapeutics - Future Players 60
8.1 Introduction 60
8.2 Dr. Falk Pharma GmbH 60
8.2.1 Company Overview 60
8.3 EUSA Pharma, Inc. 61
8.3.1 Company Overview 61
8.4 Kiadis Pharma B.V. 61
8.4.1 Company Overview 61
8.5 Osiris Therapeutics, Inc. 62
8.5.1 Company Overview 62
8.5.2 Business Overview 62
8.6 Soligenix, Inc. 63
8.6.1 Company Overview 63
8.6.2 Business Overview 63
9 Licensing and Partnership Deals
10 Global Graft Versus Host Disease Therapeutics - Appendix
10.1 Definitions 67
10.2 Acronyms 67
10.3 Methodology 69
10.3.1 Coverage 69
10.3.2 Secondary Research 69
10.3.3 Forecasting 70
10.3.4 Primary Research 72
10.3.5 Expert Panel Validation 73
10.4 Contact Us 73
10.5 Disclaimer 73
10.6 Sources 73
List of Tables
Table 1: Clinical Staging and Grading of aGVHD 7
Table 2: Clinicopathologic Classification of cGVHD 7
Table 3: Incidence of GVHD, 2010 8
Table 4: Signs and Symptoms of aGVHD and cGVHD 10
Table 5: GVHD Therapeutics, Global, Market Revenue ($m), 2005-2010 17
Table 6: GVHD Therapeutics, Global, Revenue Forecasts ($m), 2010-2018 19
Table 7: GVHD Therapeutics, The US, Market Historical Revenue ($m), 2005-2010 21
Table 8: GVHD Therapeutics, The US, Historical Revenue Forecasts ($m), 2010-2018 22
Table 9: GVHD Therapeutics, The UK, Market Historical Revenue ($m), 2005-2010 23
Table 10: GVHD Therapeutics, The UK, Revenue Forecasts ($m), 2010-2018 24
Table 11: GVHD Therapeutics, Germany, Market Revenue ($m), 2005-2010 25
Table 12: GVHD Therapeutics, Germany, Revenue Forecasts ($m), 2010-2018 26
Table 13: GVHD Therapeutics, Italy, Market Revenue ($m), 2005-2010 27
Table 14: GVHD Therapeutics, Italy, Revenue Forecasts ($m), 2010-2018 28
Table 15: GVHD Therapeutics, France, Market Revenue ($m), 2005-2010 29
Table 16: GVHD Therapeutics, France, Revenue Forecasts ($m), 2010-2018 30
Table 17: GVHD Therapeutics, Spain, Market Revenue ($m), 2005-2010 31
Table 18: GVHD Therapeutics, Spain, Revenue Forecasts ($m), 2010-2018 32
Table 19: GVHD Therapeutics, Japan, Market Revenue ($m), 2005-2010 33
Table 20: GVHD Therapeutics, Japan, Revenue Forecasts ($m), 2010-2018 34
Table 21: GVHD Therapeutics - Phase III Clinical Pipeline, 2011 43
Table 22: GVHD Therapeutics - Phase II Clinical Pipeline, 2011 44
Table 23: GVHD Therapeutics - Phase I/II Clinical Pipeline, 2011 44
Table 24: GVHD Therapeutics - Phase I Clinical Pipeline, 2011 44
Table 25: GVHD Therapeutics - Preclinical Pipeline, 2011 45
Table 26: Mechanism of Action Constituting Classes in Figure 28 46
Table 27: GVHD Therapeutics - Promising Drugs Under Clinical Development, 2011 48
Table 28: GVHD Clinical Trials by Region – Number, 2011 53
Table 29: GVHD Clinical Trials by Phase, 2011 54
Table 30: GVHD Clinical Trials by Status, 2011 55
Table 31: GVHD Clinical Trials by Overall Sponsors, 2011 56
Table 32: GVHD Clinical Trials by Prominent Sponsors, 2011 57
Table 33: GVHD Therapeutic Clinical Trial - Company Sponsors by Phase, 2011 58
Table 34: Dr. Falk Pharma GmbH- GVHD Therapeutics Pipeline 60
Table 35: EUSA Pharma, Inc. - GVHD Therapeutics Pipeline 61
Table 36: Kiadis Pharma B.V. - GVHD Therapeutics Pipeline 61
Table 37: Osiris Therapeutics, Inc.- GVHD Therapeutics Pipeline 63
Table 38: Soligenix, Inc. - GVHD Therapeutics Pipeline 64
Table 39: GVHD Therapeutics, Licensing and Partnership Deals 65
List of Figures
Figure 1: Stages of GVHD after Allogeneic HCT 9
Figure 2: Mechanisms of Injury by Tissue-Infiltrating Alloreactive T-Cells 10
Figure 3: Skin Affected by GVHD (Stage 3) 12
Figure 4: Oral Mucosal Changes in Patients with cGVHD 12
Figure 5: GVHD Therapeutics, Global, Market Revenue ($m), 2005-2010 17
Figure 6: GVHD Therapeutics, Market Share ($m, %), 2010 18
Figure 7: GVHD Therapeutics, Global, Revenue Forecasts ($m), 2010-2018 19
Figure 8: GVHD Therapeutics, Forecast Market Share ($m, %), 2018 20
Figure 9: GVHD Therapeutics, The US, Market Revenue ($m), 2005-2010 21
Figure 10: GVHD Therapeutics, The US, Revenue Forecasts ($m), 2010-2018 22
Figure 11: GVHD Therapeutics, The UK, Market Revenue ($m), 2005-2010 23
Figure 12: GVHD Therapeutics, The UK, Revenue Forecasts ($m), 2010-2018 24
Figure 13: GVHD Therapeutics, Germany, Market Revenue ($m), 2005-2010 25
Figure 14: GVHD Therapeutics, Germany, Revenue Forecasts ($m), 2010-2018 26
Figure 15: GVHD Therapeutics, Italy, Market Revenue ($m), 2005-2010 27
Figure 16: GVHD Therapeutics, Italy, Revenue Forecasts ($m), 2010-2018 28
Figure 17: GVHD Therapeutics, France, Market Revenue ($m), 2005-2010 29
Figure 18: GVHD Therapeutics, France, Revenue Forecasts ($m), 2010-2018 30
Figure 19: GVHD Therapeutics, Spain, Market Revenue ($m), 2005-2010 31
Figure 20: GVHD Therapeutics, Spain, Revenue Forecasts ($m), 2010-2018 32
Figure 21: GVHD Therapeutics, Japan, Market Revenue ($m), 2005-2010 33
Figure 22: GVHD Therapeutics, Japan, Revenue Forecasts ($m), 2010-2018 34
Figure 23: GVHD Therapeutic Market - Drivers and Barriers 35
Figure 24: Opportunity and Unmet Need in the GVHD Therapeutic Market 36
Figure 25: Strategic Competitor Assessment of Marketed Products for GVHD, 2010 37
Figure 26: Pipeline Products by Phase of Clinical Development, 2011 42
Figure 27: GVHD Therapeutics Pipeline by Phase of Clinical Development, 2011 43
Figure 28: GVHD Therapeutics Market - Clinical Pipeline by Mechanism of Action, 2011 45
Figure 29: Technology Trends Analytical Framework of GVHD Pipeline, 2011 47
Figure 30: Technology Trends Analytical Framework of GVHD Pipeline - Description, 2011 48
Figure 31: GVHD Clinical Trials by Region, 2011 53
Figure 32: GVHD Clinical Trials by Phase, 2011 54
Figure 33: GVHD Clinical Trials by Status, 2011 55
Figure 34: GVHD Clinical Trials by Sponsors, 2011 56
Figure 35: GVHD Clinical Trials by Prominent Sponsors, 2011 57
Figure 36: GVHD Therapeutic Clinical Trial - Company Sponsors by Phase, 2011 58
Figure 37: Implications for Future Market Competition in the GVHD Market, 2011 59
Figure 38: GVHD Therapeutics, Clinical Pipeline by Company, 2011 60
Figure 39: GlobalData Market Forecasting Model 72