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Multiple Myeloma Therapeutics in Major Developed Markets to 2021

Multiple Myeloma Therapeutics in Major Developed Markets to 2021


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Executive Summary

Multiple Myeloma Therapeutics in Major Developed Markets to 2021-Growth Driven by Rising Prevalence, Continued Success of Revlimid and Emerging Supplementary Treatments

Multiple Myeloma (MM) is a hematological malignancy characterized by the proliferation of plasma cells in the bone marrow. It is the second-most frequently diagnosed hematological malignancy, with an annual prevalence in the US of about 45,000. The disease is considered incurable, although the past decade has seen significant improvements in therapy, driven by a greater understanding of pathophysiology. Many of the leading drugs in the market were approved over the past 10-15 years, and have improved median survival rates by about 50%.

The MM pipeline contains 267 products in active development, encompassing a range of molecule types and therapeutic targets. The innovation that has characterized the market over recent years is also clearly present in the current pipeline, with a strong presence of novel, targeted products.

Scope

The MM market landscape has undergone significant change over the past two decades.

Which classes of drug have emerged to dominate the market?

What survival benefits have these drugs produced?

How do the leading marketed therapies compare clinically?

The pipeline contains a range of molecule types and molecular targets not present in the current market, including a strong focus on therapies targeting common oncogenic pathways, such as the Phosphoinositide 3-Kinase/Protein Kinase B (PI3K/Akt) pathway.

Which molecular targets appear most frequently in the pipeline?

How will the new therapies be positioned in the treatment of MM?

How have selected late-stage pipeline therapies performed in clinical trials?

MM clinical trials have an overall attrition rate of 78%.

What are the failure rates for individual Phases of clinical development?

How do MM clinical trial characteristics, including failure rate, duration, and size compare against oncology and industry averages?

The MM market is forecast to rise from a value of USD 7.3 billion in 2014 to USD 8.9 billion in 2021, at a CAGR of 2.9% across the eight major markets assessed.

How much of a role will disease prevalence and new product approvals play in market growth?

Will generic competition have a significant impact on the market over the forecast period?

There have been 39 licensing deals and 22 co-development deals pertaining to MM products since 2006.

Which territories show the most deal activity?

What were the trends in deal completion by product stage of development?

What were the conditions of the key licensing or co-development deals to take place in MM?

Reasons To Buy

Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, diagnosis, prognosis, and the current treatment algorithm used in MM.

Assess the safety and efficacy of current treatment options, with extensive product profiles on prominent marketed therapies and a heatmap directly comparing safety and efficacy data.

Analyze the MM pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.

Predict growth in market size in eight major markets, with in-depth market forecasting from 2014-2021. The forecasts will provide an understanding of how epidemiology trends, new drug entry, and patent expirations will influence market value.

Identify commercial opportunities in the MM deals landscape by analyzing trends in licensing and co-development deals, and by profiling the most significant deals that have occurred in this indication in recent years.

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Introduction 9

2.2 Etiology 9

2.3 Pathophysiology 9

2.4 Symptoms 11

2.5 Diagnosis and Classification 11

2.6 Epidemiology 14

2.7 Prognosis and Disease Staging 15

2.8 Treatment Options 17

2.8.1 Treatment Algorithm 19

2.8.2 Initial Therapy for Newly Diagnosed Symptomatic Disease 19

2.8.3 Maintenance Therapy 22

2.8.4 Therapy for Relapsed or Refractory Myeloma 24

3 Marketed Products 29

3.1 Overview 29

3.2 Immunomodulatory Agents 29

3.2.1 Thalomid (thalidomide)-Celgene 29

3.2.2 Revlimid (lenalidomide)-Celgene 30

3.2.3 Pomalyst (pomalidomide)-Celgene 30

3.3 Proteasome Inhibitors 31

3.3.1 Velcade (bortezomib)-Millennium Pharmaceuticals/Takeda 31

3.3.2 Kyprolis (carfilzomib)-Onyx 31

3.4 Histone Deacetylase Inhibitors 32

3.4.1 Farydak (panobinostat)-Novartis 32

3.5 Chemotherapy 32

3.5.1 Doxil (doxorubicin HCl liposome injection)-Janssen 32

3.6 Comparative Efficacy and Safety of Marketed Products 33

4 Pipeline Products 38

4.1 Overall Pipeline 38

4.2 Pipeline Analysis by Molecular Target 39

4.3 Clinical Trials 42

4.3.1 Failure Rate 43

4.3.2 Patient Enrolment and Clinical Trial Size 45

4.3.3 Duration 50

4.4 Competitive Clinical Trials Metrics Analysis 51

4.5 Promising Drug Candidates in the Pipeline 53

4.5.1 Ixazomib Citrate-Millennium Pharmaceuticals 53

4.5.2 Zolinza (vorinostat)-Merck 54

4.5.3 ARRY-520 (filanesib)-Array Biopharma 56

4.5.4 Aplidin (plitidepsin)-PharmaMar 58

4.5.5 Elotuzumab-AbbVie and Bristol Myers Squibb 58

4.5.6 Daratumumab-Johnson & Johnson 60

4.6 Heat Map for Pipeline Products 62

5 Market Forecast to 2021 64

5.1 Geographical Markets 64

5.2 Global Market 65

5.3 North America 66

5.3.1 Treatment Usage Patterns 66

5.3.2 Annual Cost of Therapy 67

5.3.3 Market Size 68

5.4 Top Five EU Markets 70

5.4.1 Treatment Usage Patterns 70

5.4.2 Annual Cost of Therapy 71

5.4.3 Market Size 72

5.5 Japan 74

5.5.1 Treatment Usage Patterns 74

5.5.2 Annual Cost of Therapy 74

5.5.3 Market Size 75

5.6 Drivers and Barriers for the Disease Market 76

5.6.1 Drivers 76

5.6.2 Barriers 76

6 Deals and Strategic Consolidations 78

6.1 Licensing Deals 78

6.1.1 Genmab Enters into Licensing Agreement with Janssen Biotech for Daratumumab 84

6.1.2 Genentech Enters into Licensing Agreement with Seattle Genetics-Now Terminated 84

6.1.3 OncoPep Enters into Licensing Agreement with Dana-Farber Cancer Institute for Cancer Vaccine Technology 85

6.1.4 PharmaMar Enters into Licensing Agreement with Chugai for Aplidin 85

6.1.5 Onyx Enters into Licensing Agreement with Ono Pharma for Kyprolis and Oprozomib 85

6.2 Co-development Deals 86

6.2.1 Celgene Enters into Co-development Agreement with MedImmune 90

6.2.2 Acetylon Enters into Co-development Agreement with Leukemia & Lymphoma Society 90

6.2.3 Boehringer Ingelheim Enters into Collaboration Agreement with Micromet 90

6.2.4 Multiple Myeloma Research Foundation Enters into Co-development Agreement with Onyx 91

6.2.5 Dana-Farber Cancer Institute Enters into Agreement with MannKind 91

6.2.6 Nordic Nanovector Enters into Co-development Agreement with Affibody 91

7 Appendix 92

7.1 All Pipeline Drugs by Phase of Development 92

7.1.1 Discovery 92

7.1.2 Preclinical 93

7.1.3 IND/CTA-filed 96

7.1.4 Phase I 97

7.1.5 Phase II 100

7.1.6 Phase III 103

7.1.7 Pre-registration 104

7.2 Market Forecasts to 2021 104

7.2.1 Global 104

7.2.2 US 104

7.2.3 Canada 105

7.2.4 UK 105

7.2.5 France 106

7.2.6 Germany 106

7.2.7 Italy 107

7.2.8 Spain 107

7.2.9 Japan 108

7.3 Bibliography 108

7.4 Abbreviations 113

7.5 Research Methodology 115

7.5.1 Secondary Research 116

7.5.2 Marketed Product Profiles 116

7.5.3 Late-Stage Pipeline Candidates 116

7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 117

7.5.5 Forecasting Model 118

7.5.6 Deals Data Analysis 119

7.6 Expert Panel Validation 119

7.7 Contact Us 119

7.8 Disclaimer 119

1.1 List of Tables

Table 1: Multiple Myeloma Therapeutics Market, Global, Initial Screening in Suspected Myeloma Patients 12

Table 2: Multiple Myeloma Therapeutics Market, Global, Diagnostic Criteria for MGUS, Asymptomatic Myeloma and Symptomatic Myeloma 13

Table 3: Multiple Myeloma Therapeutics Market, Global, Myeloma-Related Organ or Tissue Impairment 13

Table 4: Multiple Myeloma Therapeutics Market, Global, Disease Staging, Durie-Salmon Staging System 16

Table 5: Multiple Myeloma Therapeutics Market, Global, Prognostic Factors 17

Table 6: Multiple Myeloma Therapeutics Market, Global, Prognostic Factors 18

Table 7: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Discovery, 2015 92

Table 8: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 93

Table 9: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2015 96

Table 10: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Phase I, 2015 97

Table 11: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Phase II, 2015 100

Table 12: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Phase III, 2015 103

Table 13: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Pre-registration, 2015 104

Table 14: Multiple Myeloma Therapeutics Market, Global, Market Forecast, 2014-2021 104

Table 15: Multiple Myeloma Therapeutics Market, US, Market Forecast, 2014-2021 104

Table 16: Multiple Myeloma Therapeutics Market, Canada, Market Forecast, 2014-2021 105

Table 17: Multiple Myeloma Therapeutics Market, UK, Market Forecast, 2014-2021 105

Table 18: Multiple Myeloma Therapeutics Market, France, Market Forecast, 2014-2021 106

Table 19: Multiple Myeloma Therapeutics Market, Germany, Market Forecast, 2014-2021 106

Table 20: Multiple Myeloma Therapeutics Market, Italy, Market Forecast, 2014-2021 107

Table 21: Multiple Myeloma Therapeutics Market, Spain, Market Forecast, 2014-2021 107

Table 22: Multiple Myeloma Therapeutics Market, Japan, Market Forecast, 2014-2021 108

1.2 List of Figures

Figure 1: Multiple Myeloma Therapeutics Market, Global, Average Number of New Cases per Year and Age Specific Incidence Rates, UK, 2009-2011 14

Figure 2: Multiple Myeloma Therapeutics Market, Global, Treatment Algorithm for Myeloma 19

Figure 3: Multiple Myeloma Therapeutics Market, Global, Heat Map for Initial Treatment-Efficacy 34

Figure 4: Multiple Myeloma Therapeutics Market, Global, Heat Map for Initial Treatment-Safety 35

Figure 5: Multiple Myeloma Therapeutics Market, Global, Heat Map for Maintenance Treatment 35

Figure 6: Multiple Myeloma Therapeutics Market, Global, Heat Map for Relapsed or Refractory Multiple Myeloma-Efficacy 36

Figure 7: Multiple Myeloma Therapeutics Market, Global, Heat Map for Relapsed or Refractory Multiple Myeloma-Safety 37

Figure 8: Multiple Myeloma Therapeutics Market, Global, Overview of Pipeline Products 39

Figure 9: Multiple Myeloma Therapeutics Market, Global, Target Families in the Pipeline 42

Figure 10: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase, 2006-2015 43

Figure 11: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase and Molecule Type, 2006-2015 44

Figure 12: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Attrition Rate and Failure Rate by Phase and Molecular Target, 2006-2015 45

Figure 13: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type, 2006-2015 46

Figure 14: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type, 2006-2015 47

Figure 15: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target, 2006-2015 48

Figure 16: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target, 2006-2015 49

Figure 17: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, 2006-2015 50

Figure 18: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target, 2006-2015 51

Figure 19: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 52

Figure 20: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 52

Figure 21: Multiple Myeloma Therapeutics Market, Global, Ixazomib Citrate Market Forecast, 2020-2021 54

Figure 22: Multiple Myeloma Therapeutics Market, Global, Zolinza Market Forecast, 2019-2021 56

Figure 23: Multiple Myeloma Therapeutics Market, Global, ARY-520 Market Forecast, 2020-2021 57

Figure 24: Multiple Myeloma Therapeutics Market, Global, Elotuzumab Market Forecast, 2017-2021 60

Figure 25: Multiple Myeloma Therapeutics Market, Global, Daratumumab Market Forecast, 2017-2021 61

Figure 26 : Multiple Myeloma Therapeutics Market, Global, Pipeline Heat Map, 2015 62

Figure 27: Multiple Myeloma Therapeutics Market, Global, Treatment Patterns ('000) and Market Size (USD bn), 2014-2021 65

Figure 28: Multiple Myeloma Therapeutics Market, North America, Treatment Patterns, 2014-2021 67

Figure 29: Multiple Myeloma Therapeutics Market, North America, Annual Cost of Therapy (USD ), 2014-2021 68

Figure 30: Multiple Myeloma Therapeutics Market, North America, Market Size, 2014-2021 69

Figure 31: Multiple Myeloma Therapeutics Market, EU, Treatment Patterns, 2014-2021 71

Figure 32: Multiple Myeloma Therapeutics Market, EU, Annual Cost of Therapy (USD ), 2014-2021 72

Figure 33: Multiple Myeloma Therapeutics Market, EU, Market Size, 2014-2021 73

Figure 34: Multiple Myeloma Market, Japan, Treatment Usage Patterns ('000), 2014-2021 74

Figure 35: Multiple Myeloma Market, Japan, Annual Cost of Therapy (USD ), 2014-2021 74

Figure 36: Multiple Myeloma Therapeutics Market, Japan, Market Size (USD m), 2014-2021 75

Figure 37: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 78

Figure 38: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), 2006-2015 79

Figure 39: Multiple Myeloma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Payment Value (USD m), 2006-2015 80

Figure 40: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 81

Figure 41: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 82

Figure 42: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Molecular Target, 2006-2015 84

Figure 43: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Region, 2006-2015 86

Figure 44: Multiple Myeloma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, 2006-2015 87

Figure 45: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2015 88

Figure 46: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2015 89

Figure 47: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015 90

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