Multiple myeloma therapeutics in major developed markets to 2021 growth driven by rising prevalence, continued success of revlimid and emerging supplementary treatments

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Multiple Myeloma Therapeutics in Major Developed Markets to 2021 - Growth Driven by Rising
Prevalence, Continued Success of Revlimid and Emerging Supplementary Treatments
YRH: Multiple Myeloma Therapeutics in Major Developed Markets to 2021 -
Growth Driven by Rising Prevalence, Continued Success of Revlimid and
Emerging Supplementary Treatments
Overview, Size, Share, Analysis, Technology Developments, Development
Status, Trends, Structure, Production Value and Forecast Research Report
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Multiple Myeloma Therapeutics in Major Developed Markets to 2021 -
Growth Driven by Rising Prevalence, Continued Success of Revlimid and
Emerging Supplementary Treatments
Summary:
Summary
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?

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- 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 $7.3 billion in 2014 to $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
5.5 Japan 74
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
Table of Figures:
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
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Multiple myeloma therapeutics in major developed markets to 2021 growth driven by rising prevalence, continued success of revlimid and emerging supplementary treatments

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Multiple myeloma therapeutics in major developed markets to 2021 growth driven by rising prevalence, continued success of revlimid and emerging supplementary treatments