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Multiple Myeloma - US Drug Forecast and Market Analysis to 2023
[Published by Global Data]

Published by Global Data: 01 Nov 2015 | 27216 | In Stock
Related Topics: Multiple Myeloma , Myeloma

Introduction

Multiple Myeloma - US Drug Forecast and Market Analysis to 2023

Summary

The Multiple Myeloma (MM) market is currently dominated by Velcade and Revlimid, and the market is set to undergo substantial growth between 2013 and 2023. The main drivers of growth will be the launch of monoclonal antibodies (mAbs) Empliciti and daratumumab, which will not only provide a new treatment option for MM patients, but will also lengthen the time between relapses, meaning that the duration of Revlimid and/or Velcade treatments will also be longer. Furthermore, the relatively mild safety profile of these mAbs and the significant efficacies demonstrated by these agents will mean that more MM patients will ultimately receive drug treatment. Label extensions of these mAbs, as well as of second-generation proteasome inhibitors ixazomib and Kyprolis, will further increase treatment options for these patients. The biggest constrainers of the MM market are the increasing cost-consciousness of healthcare providers, as the launch and subsequent label extensions of these pipeline agents will lead to a significant expense, which may impact uptake of these drugs. The patent expiries of Revlimid and Velcade will somewhat alleviate healthcare spending on multiple myeloma patients, which may assist in the uptake of mAbs and second-generation PIs in the multiple myeloma market.

The US market will remain the largest market, largely due to the rapid acceptance and reimbursement of premium-priced therapies, and although both Velcade and Revlimid will lose market exclusivity during the forecast period, the rapid uptake of Pomalyst and the mAbs will increase market size.

Scope

- Overview of Multiple Myeloma including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in the US from 2014-2024.

- Analysis of the impact of key events as well the drivers and restraints affecting the US Multiple Myeloma market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return

- Stay ahead of the competition by understanding the changing competitive landscape for Multiple Myeloma.

- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

- Make more informed business decisions from insightful and in-depth analysis of drug performance

- Obtain sales forecast for drugs from 2014-2024 in the US.

Table of Contents
for Multiple Myeloma - US Drug Forecast and Market Analysis to 2023 [Published by Global Data]

  • 1 Table of Contents

    1 Table of Contents 2

    1.1 List of Tables 6

    1.2 List of Figures 10

    2 Introduction 11

    2.1 Catalyst 11

    2.2 Related Reports 12

    2.3 Upcoming Related Reports 12

    3 Disease Overview 13

    3.1 Etiology and Pathophysiology 13

    3.1.1 Etiology 13

    3.1.2 Pathophysiology 13

    3.2 Staging Systems 16

    3.3 Response and Relapse Criteria 17

    3.4 Symptoms 19

    3.5 Prognosis 20

    3.6 Quality of Life 21

    4 Disease Management 24

    4.1 Treatment Overview 24

    4.2 Diagnosis 25

    4.3 Clinical Practice 26

    4.3.1 Primary Therapy for SCT-Eligible Patients 27

    4.3.2 Primary Therapy for Non-SCT Patients 29

    4.3.3 Salvage/Relapse Therapy 30

    4.3.4 Leading Prescribed Drugs 31

    4.4 US 33

    4.4.1 Diagnosis 34

    4.4.2 Clinical Practice 35

    5 Competitive Assessment 37

    5.1 Overview 37

    5.2 Product Profiles - Proteasome Inhibitors 37

    5.2.1 Velcade (Bortezomib) 37

    5.2.2 Kyprolis (Carfilzomib) 44

    5.3 Product Profiles - Immunomodulators 52

    5.3.1 Revlimid (Lenalidomide) 52

    5.3.2 Pomalyst/Imnovid (Pomalidomide) 59

    5.4 Other Therapeutic Classes 64

    6 Unmet Need and Opportunity 65

    6.1 Overview 65

    6.2 Treatment of High-Risk Patients 65

    6.2.1 Unmet Need 65

    6.2.2 Gap Analysis 66

    6.2.3 Opportunity 67

    6.3 Treatment of Patients with Smoldering Myeloma 67

    6.3.1 Unmet Need 67

    6.3.2 Gap Analysis 69

    6.3.3 Opportunity 69

    6.4 Treatment of Extramedullary Disease 70

    6.4.1 Unmet Need 70

    6.4.2 Gap Analysis 70

    6.4.3 Opportunity 71

    7 Pipeline Assessment 72

    7.1 Overview 72

    7.2 Promising Drugs in Clinical Development 72

    7.2.1 Farydak (Panobinostat) 72

    7.2.2 Ixazomib 79

    7.2.3 Empliciti (Elotuzumab) 84

    7.2.4 Daratumumab 90

    7.2.5 Aplidin (Plitidepsin) 95

    7.3 Promising Drugs in Early-Stage Development 99

    7.3.1 Oprozomib (ONX-0912) 99

    7.3.2 Filanesib 100

    7.3.3 SAR650984 100

    7.3.4 Marizomib 102

    7.3.5 Evofosfamide 102

    7.3.6 LGH447 103

    7.3.7 Selinexor (KPT-330) 103

    8 Market Outlook 105

    8.1 US 105

    8.1.1 Forecast 105

    8.1.2 Key Events 109

    8.1.3 Drivers - US 109

    8.1.4 Barriers - US 111

    9 Appendix 113

    9.1 Bibliography 113

    9.2 Abbreviations 135

    9.3 Methodology 139

    9.4 Forecasting Methodology 139

    9.4.1 Diagnosed Multiple Myeloma Patients 139

    9.4.2 Percent of Drug-Treated Patients 140

    9.4.3 Drugs Included in Each Therapeutic Class 140

    9.4.4 Launch and Patent Expiry Dates 141

    9.4.5 General Pricing Assumptions 142

    9.4.6 Individual Drug Assumptions 143

    9.4.7 Pricing of Pipeline Agents 150

    9.4.8 Generic Erosion 157

    9.5 Primary Research - KOLs Interviewed for this Report 158

    9.6 Primary Research - High-Prescriber Survey 160

    9.7 About the Authors 161

    9.7.1 Analyst 161

    9.7.2 Therapy Director 161

    9.7.3 Epidemiologist 162

    9.7.4 Global Head of Healthcare 162

    9.8 About GlobalData 163

    9.9 Disclaimer 163

List Of Tables
in Multiple Myeloma - US Drug Forecast and Market Analysis to 2023 [Published by Global Data]

1.1 List of Tables

Table 1: Definition of the Classes of Myeloma 15

Table 2: Staging Systems for Multiple Myeloma 17

Table 3: IMWG Uniform Response Criteria for Multiple Myeloma: Response 18

Table 4: IMWG Uniform Response Criteria for Multiple Myeloma: Progression 18

Table 5: Symptoms of Multiple Myeloma 19

Table 6: Median Survival for Each Stage at Diagnosis of Multiple Myeloma 20

Table 7: Potential Diagnostic Markers that Predict Two-Year Disease Progression 21

Table 8: Summary of Prevalence and Clinical Outcomes of Translocations in Multiple Myeloma 21

Table 9: Treatment Guidelines for Multiple Myeloma 25

Table 10: Definition of the Classes of Myeloma 26

Table 11: Most Prescribed Drugs for Multiple Myeloma by Class in the Global Markets, 2014 31

Table 12: Most-Prescribed Drugs for Multiple Myeloma by Segment in the Global Markets, 2013 32

Table 13: Country Profile - US 34

Table 14: Product Profile - Velcade 38

Table 15: Results from the Pivotal Phase III APEX Trial for Velcade 40

Table 16: Results from the Pivotal Phase III VISTA Trial for Velcade 41

Table 17 Results from the Subcutaneous versus Intravenous Velcade Phase III trial 41

Table 18: Common Grade 3 and 4 Adverse Events from Velcade Pivotal Clinical Trials 42

Table 19: Velcade SWOT Analysis, 2015 43

Table 20: Global Sales Forecast ($m) for Velcade, 2013-2023 43

Table 21: Product Profile - Kyprolis 45

Table 22 Summary of Phase III Pivotal Trial Results for Kyprolis 48

Table 23: Summary of Phase II Clinical Trial Efficacy Data for Kyprolis 49

Table 24 Summary of Adverse Events from Key Phase III Pivotal Trials for Kyprolis 50

Table 25: Kyprolis SWOT Analysis, 2015 51

Table 26: Global Sales Forecasts ($m) for Kyprolis, 2013-2023 52

Table 27: Product Profile - Revlimid 53

Table 28 Summary of Phase III Pivotal Trial Results for Revlimid in NDMM Patients 55

Table 29 Summary of Phase III Pivotal Trial Results for Revlimid in RRMM Patients 56

Table 30: Summary of Frequent Grade 3 and 4 AEs in a Phase III Trial for Revlimid 57

Table 31: Revlimid SWOT Analysis, 2015 58

Table 32: Global Sales Forecast ($m) for Revlimid, 2013-2023 58

Table 33: Product Profile - Pomalyst 59

Table 34: Summary of PFS, OS, and ORR from Phase II Trial Data for Pomalyst 61

Table 35: Summary of Phase III Trial Data for Pomalyst 62

Table 36: Pomalyst SWOT Analysis, 2015 63

Table 37: Global Sales Forecasts ($m) for Pomalyst, 2013-2023 63

Table 38: Summary of Other Therapeutic Classes, 2015 64

Table 39: Pipeline Product Profile - Farydak 73

Table 40: Summary of the Phase III PANORAMA 1 Trial of Farydak 76

Table 41: Summary of the Phase III PANORAMA 1 Trial of Farydak in Patients Who Recived at Least Two Prior Lines of Therapy (Including Velcade and an IMiD) 76

Table 42: Summary of the Phase II PANORAMA 2 Trial of Farydak 77

Table 43: Grade 3-4 Adverse Events in the Phase III PANORAMA 1 Trial of Farydak 77

Table 44: Farydak SWOT Analysis, 2015 79

Table 45: Global Sales Forecast ($m) for Farydak, 2013-2023 79

Table 46: Pipeline Product Profile - Ixazomib 80

Table 47: Response Results from the Phase II Study of Ixazomib 82

Table 48: Ixazomib SWOT Analysis, 2015 83

Table 49: Global Sales Forecast ($m) for Ixazomib, 2013-2023 84

Table 50: Pipeline Product Profile - Empliciti 85

Table 51: Summary of the Phase III ELOQUENT 2 trial of Empliciti 87

Table 52: Efficacy Results from the Phase II Study of Empliciti with Velcade and Dexamethasone 88

Table 53: Empliciti SWOT Analysis, 2015 89

Table 54: Global Sales Forecast ($m) for Empliciti, 2013-2023 89

Table 55: Pipeline Product Profile - Daratumumab 90

Table 56: Response Results from the Phase II Study of Daratumumab 92

Table 57: Daratumumab SWOT Analysis, 2015 94

Table 58: Global Sales Forecast ($m) for Ddaratumumab, 2013-2023 94

Table 59: Pipeline Product Profile - Aplidin 95

Table 60: Summary of Phase II Clinical Trial Results for Aplidin 97

Table 61: Summary of Grade 3 and 4 Adverse Events of Aplidin 97

Table 62: Aplidin SWOT Analysis, 2015 98

Table 63: Global Sales Forecast ($m) for Aplidin, 2013-2023 98

Table 64: Summary of Efficacy Data from the Phase Ib/II Clinical Trial of Oprozomib 100

Table 65: Summary of the Phase I Efficacy Results of SAR650984 101

Table 66: Summary of the Phase I Efficacy Results of Evofosfamide 103

Table 67: US Sales Forecast, Multiple Myeloma, 2013-2023 ($m) 106

Table 68: Key Events Impacting Sales for Multiple Myeloma in the US, 2013-2023 109

Table 69: US Multiple Myeloma - Drivers, 2013-2023 109

Table 70: US Multiple Myeloma - Barriers, 2013-2023 111

Table 71: Multiple Myeloma Diagnosed Incidence, 2013-2023 140

Table 72: Multiple Myeloma Drugs and Pipeline agents, Launch Dates 141

Table 73: Multiple Myeloma Drugs and Pipeline agents, Anticipated Patent Expiries 142

Table 74: Average Cost of Therapy for Velcade 144

Table 75: Average Duration of Treatment (Weeks) for Velcade 144

Table 76: Average Cost of Therapy for Kyprolis ($) 146

Table 77: Average Duration of Treatment (Weeks) for Kyprolis 146

Table 78: Average Cost of Therapy for Revlimid ($) 147

Table 79: Average Duration of Treatment (Weeks) for Revlimid 148

Table 80: Average Cost of Therapy for Pomalyst/Imnovid ($) 149

Table 81 Average Duration of Treatment (Weeks) for Pomalyst/Imnovid 149

Table 82: Average Cost of Therapy for Farydak ($) 150

Table 83: Duration of Treatment (Weeks) for Farydak 151

Table 84: Average Cost of Therapy for Ixazomib ($) 152

Table 85: Duration of Treatment (Weeks) for Ixazomib 152

Table 86: Average Cost of Therapy for Empliciti ($) 153

Table 87: Duration of Treatment (Weeks) for Empliciti 154

Table 88: Average Cost of Therapy for Daratumumab ($) 155

Table 89: Duration of Treatment (Weeks) for Daratumumab 156

Table 90: Average Cost of Therapy for Daratumumab ($) 157

Table 91: Duration of Treatment (Weeks) for Daratumumab 157

Table 92: Numbers of Prescribers Surveyed in Each Country 160

List Of Figures, Charts and Diagrams
in Multiple Myeloma - US Drug Forecast and Market Analysis to 2023 [Published by Global Data]

1.2 List of Figures

Figure 1: SCT-Eligible Typical Patient Journey 27

Figure 2: Non-SCT-Eligible Typical Patient Journey 29

Figure 3: Velcade’s Phase III Development in Multiple Myeloma 39

Figure 4: Kyprolis’s Phase III Development in Multiple Myeloma 46

Figure 5: Revlimid’s Phase III Development in Multiple Myeloma 53

Figure 6: Pomalyst/Imnovid’s Phase III Development in Multiple Myeloma 60

Figure 7: Farydak’s Development in Multiple Myeloma 75

Figure 8: Dosing Schedule for Farydak 78

Figure 9: Ixazomib’s Development in Multiple Myeloma 81

Figure 10: Empliciti's Development in Multiple Myeloma 85

Figure 11: Daratumumab’s Development in Multiple Myeloma 92

Figure 12: Annual US Sales for Multiple Myeloma by Drug, 2013-2023 107

Figure 13: US Sales for Multiple Myeloma by Drug, 2013 and 2023 108

Additional Details

Publisher

Global Data

Publisher Information

Reference

27216 | GDHC304CFR

Number of Pages

164

Report Format

PDF

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