Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Etiology 10
2.3 Pathophysiology 11
2.4 Symptoms 12
2.5 Diagnosis and Classification 12
2.6 Epidemiology 15
2.7 Prognosis and Disease Staging 16
2.8 Treatment Options 18
2.8.1 Treatment Algorithm 20
2.8.2 Initial Therapy for Newly Diagnosed Symptomatic Disease 20
2.8.3 Maintenance Therapy 25
2.8.4 Therapy for Relapsed or Refractory Myeloma 26
3 Marketed Products 32
3.1 Overview 32
3.2 Immunomodulatory Agents 32
3.2.1 Thalomid (thalidomide) – Celgene 32
3.2.2 Revlimid (lenalidomide) – Celgene 33
3.2.3 Pomalyst (pomalidomide) – Celgene 33
3.3 Proteasome Inhibitors 34
3.3.1 Velcade (bortezomib) – Millennium Pharmaceuticals/Takeda 34
3.3.2 Kyprolis (carfilzomib) – Onyx 34
3.4 Histone Deacetylase Inhibitors 35
3.4.1 Farydak (panobinostat) – Novartis 35
3.5 Chemotherapy 36
3.5.1 Doxil (doxorubicin HCl liposome injection) – Janssen 36
3.6 Comparative Efficacy and Safety of Marketed Products 36
4 Pipeline Products 40
4.1 Overall Pipeline 40
4.2 Pipeline Analysis by Molecular Target 41
5 Clinical Trials 45
5.1 Failure Rate 45
5.2 Patient Enrolment and Clinical Trial Size 47
5.3 Duration 53
5.4 Competitive Clinical Trials Metrics Analysis 57
5.5 Promising Drug Candidates in the Pipeline 58
5.5.1 Daratumumab – Johnson & Johnson 58
5.5.2 Elotuzumab – AbbVie and Bristol Myers Squibb 59
5.5.3 Ixazomib – Millennium Pharmaceuticals 60
5.5.4 Zolinza (vorinostat) – Merck 62
5.5.5 ARRY-520 (filanesib) – Array Biopharma 63
5.5.6 Aplidin (plitidepsin) – PharmaMar 64
5.6 Heat Map for Pipeline Products 65
6 Market Forecast to 2021 67
6.1 Geographical Markets 67
6.2 Asia-Pacific Market 68
6.3 India 69
6.3.1 Treatment Usage Patterns 69
6.3.2 Annual Cost of Therapy 70
6.3.3 Market Size 70
6.4 China 71
6.4.1 Treatment Usage Patterns 71
6.4.2 Annual Cost of Therapy 72
6.4.3 Market Size 73
6.5 Australia 73
6.5.1 Treatment Usage Patterns 73
6.5.2 Annual Cost of Therapy 74
6.5.3 Market Size 75
6.6 Japan 76
6.6.1 Treatment Usage Patterns 76
6.6.2 Annual Cost of Therapy 77
6.6.3 Market Size 78
7 Drivers and Barriers for the Disease Market 79
7.1 Drivers 79
7.1.1 Rising Prevalence 79
7.1.2 Increasing Therapeutic Options 79
7.1.3 Limited Generic Competition 79
7.2 Barriers 79
7.2.1 Limited Target Patient Population 79
7.2.2 Large Undiagnosed Pool 80
7.2.3 Lower Usage of Costlier Therapies in India and China 80
7.2.4 Costly Drug Development 80
8 Deals and Strategic Consolidations 81
8.1 Licensing Deals 81
8.1.1 PharmaMar Announces Licensing Agreement with TTY Biopharm for Aplidin in Hematological Cancers 87
8.1.2 Genmab Enters into Licensing Agreement with Janssen Biotech for Daratumumab 87
8.1.3 Genentech Enters into Licensing Agreement with Seattle Genetics – Now Terminated 88
8.1.4 OncoPep Enters into Licensing Agreement with Dana-Farber Cancer Institute for Cancer Vaccine Technology 88
8.1.5 PharmaMar Enters into Licensing Agreement with Chugai for Aplidin 88
8.1.6 Onyx Enters into Licensing Agreement with Ono Pharma for Kyprolis and Oprozomib 88
8.2 Co-development Deals 89
8.2.1 Celgene Enters into Co-development Agreement with MedImmune 93
8.2.2 Acetylon Enters into Co-development Agreement with Leukemia & Lymphoma Society 93
8.2.3 Boehringer Ingelheim Enters into Collaboration Agreement with Micromet 94
8.2.4 Multiple Myeloma Research Foundation Enters into Co-development Agreement with Onyx 94
8.2.5 Dana-Farber Cancer Institute Enters into Agreement with MannKind 94
8.2.6 Nordic Nanovector Enters into Co-development Agreement with Affibody 94
9 Appendix 95
9.1 All Pipeline Drugs by Phase of Development 95
9.1.1 Discovery 95
9.1.2 Preclinical 97
9.1.3 Investigational New Drug/Clinical Trial Application-Filed 100
9.1.4 Phase I 101
9.1.5 Phase II 104
9.1.6 Phase III 107
9.1.7 Pre-registration 107
9.2 Market Forecasts to 2021 108
9.2.1 Asia-Pacific 108
9.2.2 India 108
9.2.3 China 109
9.2.4 Australia 109
9.2.5 Japan 110
9.3 Bibliography 110
9.4 Research Methodology 116
9.4.1 Secondary Research 117
9.4.2 Marketed Product Profiles 117
9.4.3 Late-Stage Pipeline Candidates 117
9.4.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 117
9.4.5 Forecasting Model 118
9.4.6 Deals Data Analysis 119
9.5 Expert Panel Validation 120
9.6 Contact Us 120
9.7 Disclaimer 120