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Multiple Myeloma Therapeutics in Asia-Pacific Markets to 2021

Multiple Myeloma Therapeutics in Asia-Pacific Markets to 2021


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Executive Summary

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

Multiple Myeloma (MM) is a hematological malignancy characterized by the proliferation of plasma cells in the bone marrow. The disease is incurable; although over the past decade there have been significant improvements in therapy, driven by a greater understanding of pathophysiology. MM represents about 0.8-1% of all cancer cases worldwide and approximately 10% of all hematological cancers, with incidence rates ranging from 0.4 to 5 per 100,000 persons in different parts of the world.

Without any treatment, the median survival of a myeloma patient is about six months, but this can be extended with the use of various forms of treatment. There are now five classes of drugs used in the treatment of myeloma: immunomodulatory drugs, chemotherapy, proteasome drugs, Histone Deacetylase (HDAC) inhibitors and steroids. Many of the notable drugs in these classes were approved over the past 10-15 years. Treatment using these novel drugs and high-dose chemotherapy with hematopoietic Stem-Cell Transplant (SCT) has been shown to improve median survival to five years, which makes this the current standard therapy. However, many patients suffer relapse or develop treatment resistance, leaving a need to develop safe and effective treatments that prolong the duration of remission and improve survival.

Scope

The different segments of patients with MM are based on their eligibility for an SCT

-What combination therapies are used for various segments?

-What are the treatment options available for myeloma, providing an overview of the front-line, second-line and third-line therapies available?

There are seven main marketed products for MM, with most of the novel drugs being approved in the last decade.

-What are the dominant mechanisms of action across marketed products?

-Which products are approved currently in each country and which ones are likely to be launched within the forecast period?

-Which product is used more in each country?

-Will there be any label expansions of existing market leaders in any of the countries?

Epidemiology of MM is significantly different in Asia-Pacific countries from that in the major markets.

-What are the various epidemiology trends in each country?

-What factors contribute to the overall epidemiology?

The MM pipeline consists of more than 250 products in active development. Small molecules are the most abundant molecule type in the pipeline, accounting for 48% of all products.

-What are the various pipeline products based on molecule type, mechanism of action and stage of development?

-Which class is most prominent within the pipeline?

-Do the pipeline molecules offer an advantage over commercially proven mechanisms?

-What are the late-pipeline products expected to be launched in each country in the near future?

Analysis of clinical trials since 2006 identified that MM products have a high rate of attrition.

-How do failure rates vary by product stage of development, molecule type, and mechanism of action?

-How do other factors such as average trial duration and trial size influence the costs and risks associated with product development?

-What are the current promising pipeline drugs and their efficacy data?

Over the 2014-2020 forecast period, the MM market in Australia, China, India and Japan is expected to increase in value at a CAGR of 7.4%, from USD 1.7 billion to about USD 2.8 billion.

-Which markets make the most significant contribution to the current market size?

-What are the incidence, diagnosis and treatment trends in these markets?

-What are the factors responsible for difference in the treatment patterns within the four markets?

-Which factors will influence growth rates?

-Will new market entrants lead to substantial changes in annual therapy costs?

Some key marketed products are expected to expire in the forecast period, and promising pipeline molecules are likely to be launched in the near future.

-Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?

-Will the patent expiration be offset by the approval of new therapies?

Reasons To Buy

This report will enable you to

Understand the clinical context of MM by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.

Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.

Appreciate key pipeline trends in molecule type, administration route, mechanism of action, and novelty.

Consider market opportunities and potential risks by examining trends in clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.

Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential by examining clinical trial data and multi-scenario product forecast projections.

Compare treatment usage patterns, annual therapy costs, and market growth projections for India, China, Australia and Japan.

Discover trends in licensing and co-development deals concerning MM products and identify the major strategic consolidations that have shaped the commercial landscape.

1 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 31

3.1 Overview 31

3.2 Immunomodulatory Agents 31

3.2.1 Thalomid (thalidomide)-Celgene 31

3.2.2 Revlimid (lenalidomide)-Celgene 32

3.2.3 Pomalyst (pomalidomide)-Celgene 32

3.3 Proteasome Inhibitors 33

3.3.1 Velcade (bortezomib)-Millennium Pharmaceuticals/Takeda 33

3.3.2 Kyprolis (carfilzomib)-Onyx 33

3.4 Histone Deacetylase Inhibitors 34

3.4.1 Farydak (panobinostat)-Novartis 34

3.5 Chemotherapy 35

3.5.1 Doxil (doxorubicin HCl liposome injection)-Janssen 35

3.6 Comparative Efficacy and Safety of Marketed Products 35

4 Pipeline Products 38

4.1 Overall Pipeline 38

4.2 Pipeline Analysis by Molecular Target 39

5 Clinical Trials 43

5.1 Failure Rate 43

5.2 Patient Enrolment and Clinical Trial Size 45

5.3 Duration 51

5.4 Competitive Clinical Trials Metrics Analysis 54

5.5 Promising Drug Candidates in the Pipeline 55

5.5.1 Daratumumab-Johnson & Johnson 55

5.5.2 Elotuzumab-AbbVie and Bristol Myers Squibb 56

5.5.3 Ixazomib-Millennium Pharmaceuticals 57

5.5.4 Zolinza (vorinostat)-Merck 59

5.5.5 ARRY-520 (filanesib)-Array Biopharma 60

5.5.6 Aplidin (plitidepsin)-PharmaMar 60

5.6 Heat Map for Pipeline Products 62

6 Market Forecast to 2021 64

6.1 Geographical Markets 64

6.2 Asia-Pacific Market 65

6.3 India 66

6.3.1 Treatment Usage Patterns 66

6.3.2 Annual Cost of Therapy 67

6.3.3 Market Size 67

6.4 China 68

6.4.1 Treatment Usage Patterns 68

6.4.2 Annual Cost of Therapy 68

6.4.3 Market Size 69

6.5 Australia 70

6.5.1 Treatment Usage Patterns 70

6.5.2 Annual Cost of Therapy 71

6.5.3 Market Size 71

6.6 Japan 73

6.6.1 Treatment Usage Patterns 73

6.6.2 Annual Cost of Therapy 74

6.6.3 Market Size 75

7 Drivers and Barriers for the Disease Market 76

7.1 Drivers 76

7.1.1 Rising Prevalence 76

7.1.2 Increasing Therapeutic Options 76

7.1.3 Limited Generic Competition 76

7.2 Barriers 76

7.2.1 Limited Target Patient Population 76

7.2.2 Large Undiagnosed Pool 76

7.2.3 Lower Usage of Costlier Therapies in India and China 77

7.2.4 Costly Drug Development 77

8 Deals and Strategic Consolidations 78

8.1 Licensing Deals 78

8.1.1 PharmaMar Announces Licensing Agreement with TTY Biopharm for Aplidin in Hematological Cancers 84

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

8.1.3 Genentech Enters into Licensing Agreement with Seattle Genetics-Now Terminated 85

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

8.1.5 PharmaMar Enters into Licensing Agreement with Chugai for Aplidin 85

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

8.2 Co-development Deals 86

8.2.1 Celgene Enters into Co-development Agreement with MedImmune 90

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

8.2.3 Boehringer Ingelheim Enters into Collaboration Agreement with Micromet 91

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

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

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

9 Appendix 92

9.1 All Pipeline Drugs by Phase of Development 92

9.1.1 Discovery 92

9.1.2 Preclinical 94

9.1.3 Investigational New Drug/Clinical Trial Application-Filed 97

9.1.4 Phase I 97

9.1.5 Phase II 101

9.1.6 Phase III 104

9.1.7 Pre-registration 104

9.2 Market Forecasts to 2021 105

9.2.1 Asia-Pacific 105

9.2.2 India 105

9.2.3 China 106

9.2.4 Australia 106

9.2.5 Japan 107

9.3 Bibliography 107

9.4 Research Methodology 113

9.4.1 Secondary Research 113

9.4.2 Marketed Product Profiles 114

9.4.3 Late-Stage Pipeline Candidates 114

9.4.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 114

9.4.5 Forecasting Model 115

9.4.6 Deals Data Analysis 116

9.5 Expert Panel Validation 116

9.6 Contact Us 117

9.7 Disclaimer 117

1.1 List of Tables

Table 1: Multiple Myeloma Therapeutics Market, Initial Screening in Suspected Myeloma Patients 13

Table 2: Multiple Myeloma Therapeutics Market, Diagnostic Criteria for MGUS, Asymptomatic Myeloma and Symptomatic Myeloma 14

Table 3: Multiple Myeloma Therapeutics Market, Myeloma-Related Organ or Tissue Impairment 14

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

Table 5: Multiple Myeloma Therapeutics Market, Prognostic Factors 17

Table 6: Multiple Myeloma Therapeutics Market, Prognostic Factors 19

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

Table 8: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 94

Table 9: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2015 97

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 101

Table 12: Multiple Myeloma Therapeutics Market, Global, Pipeline Products, Phase III, 2015 104

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

Table 14: Multiple Myeloma Therapeutics Market, Asia-Pacific, Market Forecast, 2014-2021 105

Table 15: Multiple Myeloma Therapeutics Market, India, Market Forecast, 2014-2021 105

Table 16: Multiple Myeloma Therapeutics Market, China, Market Forecast, 2014-2021 106

Table 17: Multiple Myeloma Therapeutics Market, Australia, Market Forecast, 2014-2021 106

Table 18: Multiple Myeloma Therapeutics Market, Japan, Market Forecast, 2014-2021 107

1.2 List of Figures

Figure 1: Multiple Myeloma Therapeutics Market, Australia, Age-Specific Incidence Rate and Average Number of Cases, 2007-2011 15

Figure 2: Multiple Myeloma Therapeutics Market, Treatment Algorithm for Myeloma 20

Figure 3: Multiple Myeloma Therapeutics Market, Global, Heat Map for Initial Treatment-Efficacy 36

Figure 4: Multiple Myeloma Therapeutics Market, Global, Heat Map for Initial Treatment-Safety 36

Figure 5: Multiple Myeloma Therapeutics Market, Global, Heat Map for Maintenance Treatment 37

Figure 6: Multiple Myeloma Therapeutics Market, Global, Heat Map for Relapsed or Refractory Multiple Myeloma-Efficacy 37

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 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 (participants), 2006-2015 46

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

Figure 15: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2015 49

Figure 16: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-2015 50

Figure 17: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2015 52

Figure 18: Multiple Myeloma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2015 53

Figure 19: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 54

Figure 20: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 55

Figure 21: Multiple Myeloma Therapeutics Market, Global, Pipeline Heat Map, 2015 62

Figure 22: Multiple Myeloma Therapeutics Market, Asia-Pacific, Treatment Patterns ('000) and Market Size (USD bn), 2014-2021 65

Figure 23: Multiple Myeloma Therapeutics Market, India, Treatment Patterns ('000), 2014-2021 66

Figure 24: Multiple Myeloma Therapeutics Market, India, Annual Cost of Therapy (USD ), 2014-2021 67

Figure 25: Multiple Myeloma Therapeutics Market, India, Market Size (USD m), 2014-2021 67

Figure 26: Multiple Myeloma Therapeutics Market, China, Treatment Patterns ('000), 2014-2021 68

Figure 27: Multiple Myeloma Therapeutics Market, China, Annual Cost of Therapy (USD ), 2014-2021 69

Figure 28: Multiple Myeloma Therapeutics Market, China, Market Size (USD m), 2014-2021 70

Figure 29: Multiple Myeloma Market, Australia, Treatment Usage Patterns ('000), 2014-2021 70

Figure 30: Multiple Myeloma Market, Australia, Annual Cost of Therapy (USD ), 2014-2021 71

Figure 31: Multiple Myeloma Therapeutics Market, Australia, Market Size (USD m), 2014-2021 71

Figure 32: Multiple Myeloma Market, Japan, Treatment Usage Patterns ('000), 2014-2021 73

Figure 33: Multiple Myeloma Market, Japan, Annual Cost of Therapy (USD ), 2014-2021 74

Figure 34: Multiple Myeloma Therapeutics Market, Japan, Market Size (USD m), 2014-2021 75

Figure 35: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 78

Figure 36: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), 2006-2015 79

Figure 37: Multiple Myeloma Therapeutics Market, Global, Number of Deals and Aggregate Deal Value (USD m), 2006-2015 80

Figure 38: 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 39: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 82

Figure 40: Multiple Myeloma Therapeutics Market, Global, Licensing Deals by Molecular Target, 2006-2015 84

Figure 41: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Region, 2006-2015 86

Figure 42: Multiple Myeloma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, 2006-2015 87

Figure 43: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2015 88

Figure 44: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2015 89

Figure 45: Multiple Myeloma Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015 90

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