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(Medical-NewsWire.com, December 04, 2015 ) 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 0.81% 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.
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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 1015 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 20142020 forecast period, the MM market in Australia, China, India and Japan is expected to increase in value at a CAGR of 7.4%, from $1.7 billion to about $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?
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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.
Table of Contents
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
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