PharmaPoint: Multiple Myeloma – Global Drug Forecast and Market Analysis to 2023

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.

Scope

Overview of multiple myeloma, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized multiple myeloma therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the multiple myeloma therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global multiple myeloma therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The multiple myeloma market is marked by the presence of a number of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of multiple myeloma market?

The late-stage multiple myeloma pipeline has therapies targeting different multiple myeloma populations. Which late-stage drugs will have the biggest impact in each patient population? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

The current multiple myeloma market is dominated by Velcade and Revlimid. How will the advent of new mAbs change the drug treatment landscape for multiple myeloma? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Companies mentioned

Abbvie

Amgen

Array BioPharma

Bristol-Myers Squibb

Celgene

Janssen

Johnson and Johnson

Karyopharm Therapeutics

Merck KGaA

Millennium Pharmaceuticals

Novartis

Onyx

Sanofi

Takeda

Threshold Therapeutics

Triphase Accelerator ...

Abbvie

Amgen

Array BioPharma

Bristol-Myers Squibb

Celgene

Janssen

Johnson and Johnson

Karyopharm Therapeutics

Merck KGaA

Millennium Pharmaceuticals

Novartis

Onyx

Sanofi

Takeda

Threshold Therapeutics

Triphase Accelerator Corporation

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Staging Systems ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Staging Systems

3.3Response and Relapse Criteria

3.4Symptoms

3.5Prognosis

3.6Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Survival Rates for Multiple Myeloma — 8MM

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods, Multiple Myeloma Diagnosed Incident Cases

4.4.4Forecast Assumptions and Methods, Multiple Myeloma Five-Year Diagnosed Prevalent Cases

4.4.5Forecast Assumptions and Methods, Multiple Myeloma Clinical Stages at Diagnosis

4.5Epidemiological Forecast for Multiple Myeloma (2013–2023)

4.5.1Diagnosed Incident Cases of Multiple Myeloma

4.5.2Age-Specific Diagnosed Incident Cases of Multiple Myeloma

4.5.3Sex-Specific Diagnosed Incident Cases of Multiple Myeloma

4.5.4Age-Standardized Diagnosed Incidence of Multiple Myeloma

4.5.5Diagnosed Incident Cases of Multiple Myeloma by Clinical Stage at Diagnosis

4.5.6Five-Year Diagnosed Prevalent Cases of Multiple Myeloma

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Treatment Overview

5.2Diagnosis

5.3Clinical Practice

5.3.1Primary Therapy for SCT-Eligible Patients

5.3.2Primary Therapy for Non-SCT Patients

5.3.3Salvage/Relapse Therapy

5.3.4Leading Prescribed Drugs

5.4US

5.4.1Diagnosis

5.4.2Clinical Practice

5.5France

5.5.1Diagnosis

5.5.2Clinical Practice

5.6Germany

5.6.1Diagnosis

5.6.2Clinical Practice

5.7Italy

5.7.1Diagnosis

5.7.2Clinical Practice

5.8Spain

5.8.1Diagnosis

5.8.2Clinical Practice

5.9UK

5.9.1Diagnosis

5.9.2Clinical Practice

5.10Japan

5.10.1Diagnosis

5.10.2Clinical Practice

5.11China (Urban)

5.11.1Diagnosis

5.11.2Clinical Practice

6Competitive Assessment

6.1Overview

6.2Product Profiles — Proteasome Inhibitors

6.2.1Velcade (Bortezomib)

6.2.2Kyprolis (Carfilzomib)

6.3Product Profiles — Immunomodulators

6.3.1Revlimid (Lenalidomide)

6.3.2Pomalyst/Imnovid (Pomalidomide)

6.4Other Therapeutic Classes

7Unmet Need and Opportunity

7.1Overview

7.2Treatment of High-Risk Patients

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Treatment of Patients with Smoldering Myeloma

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Treatment of Extramedullary Disease

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Farydak (Panobinostat)

8.2.2Ixazomib

8.2.3Empliciti (Elotuzumab)

8.2.4Daratumumab

8.2.5Aplidin (Plitidepsin)

8.3Promising Drugs in Early-Stage Development

8.3.1Oprozomib (ONX-0912)

8.3.2Filanesib

8.3.3SAR650984

8.3.4Marizomib

8.3.5Evofosfamide

8.3.6LGH447

8.3.7Selinexor (KPT-330)

9Current and Future Players

9.1Overview and Trends in Corporate Strategy

9.2Company Profiles

9.2.1Millennium Pharmaceuticals/Takeda

9.2.2Celgene

9.2.3Onyx Pharmaceuticals/Amgen

9.2.4Novartis

9.2.5AbbVie

9.2.6Bristol-Myers Squibb

9.2.7Janssen

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers — Global Issues

10.1.3Barriers — Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers — US

10.2.4Barriers — US

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers — 5EU

10.3.4Barriers — 5EU

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers — Japan

10.4.4Barriers — Japan

10.5China (Urban)

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers — China (Urban)

10.5.4Barriers — China (Urban)

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Multiple Myeloma Patients

11.4.2Percent of Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Pricing of Pipeline Agents

11.4.8Generic Erosion

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – High-Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Director

11.7.3Epidemiologist

11.7.4Global Head of Healthcare

11.8About GlobalData

11.9Contact Us

11.10Disclaimer

List of Tables

Table 1: Definition of the Classes of Myeloma

Table 2: Staging Systems for Multiple Myeloma

Table 3: MWG Uniform Response Criteria for Multiple Myeloma: Response ...

Table 1: Definition of the Classes of Myeloma

Table 2: Staging Systems for Multiple Myeloma

Table 3: MWG Uniform Response Criteria for Multiple Myeloma: Response

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

Table 5: Symptoms of Multiple Myeloma

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

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

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

Table 9: Multiple Myeloma Clinical Stages at Diagnosis, Using the ISS Criteria

Table 10: Risk Factors and Comorbidities for Multiple Myeloma

Table 11: Trends in the Age-Adjusted Incidence of Multiple Myeloma in the US, Ages =40 Years, 1993–2007

Table 12: Trends in the Age-Adjusted Incidence of Multiple Myeloma in the 5EU, Ages =40 Years, 1993–2007

Table 13: Trends in the Age-Adjusted Incidence of Multiple Myeloma in Japan, Ages =40 Years, 1993–2007

Table 14: Trends in the Age-Adjusted Incidence of Multiple Myeloma in Urban China, Ages =40 Years, 1993–2007

Table 15: Trends in the Five-Year Relative Survival (%) of Multiple Myeloma in the 8MM, Both Sexes, 1993–2009

Table 16: 8MM, Sources of Epidemiological Data Used for the Forecast for Multiple Myeloma Diagnosed Incident Cases

Table 17: 8MM, Sources of Epidemiological Data Used for the Forecast for Multiple Myeloma Diagnosed Five-Year Prevalent Cases

Table 18: 8MM, Sources of Epidemiological Data Used for the Segmentation of Multiple Myeloma Incident Cases by Clinical Stage at Diagnosis

Table 19: 8MM, Diagnosed Incident Cases of Multiple Myeloma, Both Sexes, Ages =40 Years, N, 2013–2023

Table 20: 8MM, Age-Specific Diagnosed Incident Cases of Multiple Myeloma, Both Sexes, N (Row %), 2013

Table 21: 8MM, Sex-Specific Diagnosed Incident Cases of Multiple Myeloma, Ages =40 Years, N (Row %), 2013

Table 22: 8MM, Five-Year Diagnosed Prevalent Cases of Multiple Myeloma, Both Sexes, Ages =40 Years, N, 2013–2023

Table 23: Treatment Guidelines for Multiple Myeloma

Table 24: Definition of the Classes of Myeloma

Table 25: Most Prescribed Drugs for Multiple Myeloma by Class in the Global Markets, 2014

Table 26: Most-Prescribed Drugs for Multiple Myeloma by Segment in the Global Markets, 2013

Table 27: Country Profile — US

Table 28: Country Profile — France

Table 29: Country Profile – Germany

Table 30: Country Profile — Italy

Table 31: Country Profile — Spain

Table 32: Country Profile — UK

Table 33: Country Profile — Japan

Table 34: Country Profile – China (Urban)

Table 35: Product Profile — Velcade

Table 36: Results from the Pivotal Phase III APEX Trial for Velcade

Table 37: Results from the Pivotal Phase III VISTA Trial for Velcade

Table 38 Results from the Subcutaneous versus Intravenous Velcade Phase III trial

Table 39:Common Grade 3 and 4 Adverse Events from Velcade Pivotal Clinical Trials

Table 40: Velcade SWOT Analysis, 2015

Table 41: Global Sales Forecast ($m) for Velcade, 2013–2023

Table 42: Product Profile – Kyprolis

Table 43 Summary of Phase III Pivotal Trial Results for Kyprolis

Table 44: Summary of Phase II Clinical Trial Efficacy Data for Kyprolis

Table 45 Summary of Adverse Events from Key Phase III Pivotal Trials for Kyprolis

Table 46: Kyprolis SWOT Analysis, 2015

Table 47: Global Sales Forecasts ($m) for Kyprolis, 2013–2023

Table 48: Product Profile – Revlimid

Table 49 Summary of Phase III Pivotal Trial Results for Revlimid in NDMM Patients

Table 50 Summary of Phase III Pivotal Trial Results for Revlimid in RRMM Patients

Table 51: Summary of Frequent Grade 3 and 4 AEs in a Phase III Trial for Revlimid

Table 52: Revlimid SWOT Analysis, 2015

Table 53: Global Sales Forecast ($m) for Revlimid, 2013–2023

Table 54: Product Profile — Pomalyst

Table 55: Summary of PFS, OS, and ORR from Phase II Trial Data for Pomalyst

Table 56: Summary of Phase III Trial Data for Pomalyst

Table 57: Pomalyst SWOT Analysis, 2015

Table 58: Global Sales Forecasts ($m) for Pomalyst, 2013–2023

Table 59: Summary of Other Therapeutic Classes, 2015

Table 60: Pipeline Product Profile — Farydak

Table 61: Summary of the Phase III PANORAMA 1 Trial of Farydak

Table 62: 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)

Table 63: Summary of the Phase II PANORAMA 2 Trial of Farydak

Table 64: Grade 3–4 Adverse Events in the Phase III PANORAMA 1 Trial of Farydak

Table 65: Farydak SWOT Analysis, 2015

Table 66: Global Sales Forecast ($m) for Farydak, 2013–2023

Table 67: Pipeline Product Profile — Ixazomib

Table 68: Response Results from the Phase II Study of Ixazomib

Table 69: Ixazomib SWOT Analysis, 2015

Table 70: Global Sales Forecast ($m) for Ixazomib, 2013–2023

Table 71: Pipeline Product Profile — Empliciti

Table 72: Summary of the Phase III ELOQUENT 2 trial of Empliciti

Table 73: Efficacy Results from the Phase II Study of Empliciti with Velcade and Dexamethasone

Table 74: Empliciti SWOT Analysis, 2015

Table 75: Global Sales Forecast ($m) for Empliciti, 2013–2023

Table 76: Pipeline Product Profile — Daratumumab

Table 77: Response Results from the Phase II Study of Daratumumab

Table 78: Daratumumab SWOT Analysis, 2015

Table 79: Global Sales Forecast ($m) for Ddaratumumab, 2013–2023

Table 80: Pipeline Product Profile — Aplidin

Table 81: Summary of Phase II Clinical Trial Results for Aplidin

Table 82: Summary of Grade 3 and 4 Adverse Events of Aplidin

Table 83: Aplidin SWOT Analysis, 2015

Table 84: Global Sales Forecast ($m) for Aplidin, 2013–2023

Table 85: Summary of Efficacy Data from the Phase Ib/II Clinical Trial of Oprozomib

Table 86: Summary of the Phase I Efficacy Results of SAR650984

Table 87: Summary of the Phase I Efficacy Results of Evofosfamide

Table 88: Key Companies in the Multiple Myeloma Market Across the 8MM, 2013–2023

Table 89: Millennium Pharmaceuticals Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 90: Celgene’s Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 91: Onyx Pharmaceuticals Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 92: Novartis’ Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 93: AbbVie’s Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 94: BMS’ Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 95: Janssen’s Multiple Myeloma Therapy Portfolio Assessment, 2015

Table 96: Annual Global Sales ($m) for Multiple Myeloma by Region, 2013–2023

Table 97: Annual Global Sales ($m) for Multiple Myeloma by Drug, 2013–2023

Table 98: Global Multiple Multiple Myeloma — Drivers, 2013–2023

Table 99: Global Multiple Multiple Myeloma — Barriers, 2013–2023

Table 100: US Sales Forecast, Multiple Myeloma, 2013–2023 ($m)

Table 101: Key Events Impacting Sales for Multiple Myeloma in the US, 2013–2023

Table 102: US Multiple Myeloma — Drivers, 2013–2023

Table 103: US Multiple Myeloma — Barriers, 2013–2023

Table 104: 5EU Sales Forecast, Multiple Myeloma, 2013–2023 ($m)

Table 105: Key Events Impacting Sales for Multiple Myeloma in the 5EU, 2013–2023

Table 106: 5EU Multiple Myeloma — Drivers and Barriers, 2013–2023

Table 107: 5EU Multiple Myeloma — Barriers, 2013–2023

Table 108: Japan Sales Forecasts, Multiple Myeloma, 2013–2023 ($m)

Table 109: Key Events Impacting Sales for Multiple Myeloma in Japan, 2013–2023

Table 110: Japanese Multiple Myeloma — Drivers, 2013–2023

Table 111: Japanese Multiple Myeloma — Barriers, 2013–2023

Table 112: China (Urban) Sales Forecast, Multiple Myeloma, 2013–2023 ($m)

Table 113: Key Events Impacting Sales for Multiple Myeloma in China 2013–2023

Table 114: Chinese (Urban) Multiple Myeloma — Drivers, 2013–2023

Table 115: Chinese (Urban) Multiple Myeloma — Barriers, 2013–2023

Table 116: Multiple Myeloma Diagnosed Incidence, 2013–2023

Table 117: Multiple Myeloma Drugs and Pipeline agents, Launch Dates

Table 118: Multiple Myeloma Drugs and Pipeline agents, Anticipated Patent Expiries

Table 119: Average Cost of Therapy for Velcade

Table 120: Average Duration of Treatment (Weeks) for Velcade

Table 121: Average Cost of Therapy for Kyprolis ($)

Table 122: Average Duration of Treatment (Weeks) for Kyprolis

Table 123: Average Cost of Therapy for Revlimid ($)

Table 124: Average Duration of Treatment (Weeks) for Revlimid

Table 125: Average Cost of Therapy for Pomalyst/Imnovid ($)

Table 126 Average Duration of Treatment (Weeks) for Pomalyst/Imnovid

Table 127:Average Cost of Therapy for Farydak ($)

Table 128: Duration of Treatment (Weeks) for Farydak

Table 129: Average Cost of Therapy for Ixazomib ($)

Table 130: Duration of Treatment (Weeks) for Ixazomib

Table 131: Average Cost of Therapy for Empliciti ($)

Table 132: Duration of Treatment (Weeks) for Empliciti

Table 133: Average Cost of Therapy for Daratumumab ($)

Table 134: Duration of Treatment (Weeks) for Daratumumab

Table 135: Average Cost of Therapy for Daratumumab ($)

Table 136: Duration of Treatment (Weeks) for Daratumumab

Table 137: Numbers of Prescribers Surveyed in Each Country

List of Figures

Figure 1: 8MM, Diagnosed Incident Cases of Multiple Myeloma, Both Sexes, Ages =40 Years, N, 2013–2023

Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of Multiple ...

Figure 1: 8MM, Diagnosed Incident Cases of Multiple Myeloma, Both Sexes, Ages =40 Years, N, 2013–2023

Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of Multiple Myeloma, Both Sexes, N, 2013

Figure 3: 8MM, Sex-Specific Diagnosed Incident Cases of Multiple Myeloma, Ages =40 Years, N, 2013

Figure 4: 8MM, Age-Standardized Diagnosed Incidence of Multiple Myeloma (Cases per 100,000 Population), Ages =40 Years, by Sex, 2013

Figure 5: 8MM, Diagnosed Incident Cases of Multiple Myeloma by Clinical Stage at Diagnosis, Ages =40 Years, N, 2013

Figure 6: 8MM, Five-Year Diagnosed Prevalent Cases of Multiple Myeloma, Both Sexes, Ages =40 Years, N, 2013–2023

Figure 7: SCT-Eligible Typical Patient Journey

Figure 8: Non-SCT-Eligible Typical Patient Journey

Figure 9: Velcade’s Phase III Development in Multiple Myeloma

Figure 10: Kyprolis’s Phase III Development in Multiple Myeloma

Figure 11: Revlimid’s Phase III Development in Multiple Myeloma

Figure 12: Pomalyst/Imnovid’s Phase III Development in Multiple Myeloma

Figure 13: Farydak’s Development in Multiple Myeloma

Figure 14: Dosing Schedule for Farydak

Figure 15: Ixazomib’s Development in Multiple Myeloma

Figure 16: Empliciti's Development in Multiple Myeloma

Figure 17: Daratumumab’s Development in Multiple Myeloma

Figure 18: Global Sales ($m) of Branded Products for Multiple Myeloma by Company, 2013 - 2023

Figure 19: Company Portfolio Gap Analysis in Multiple Myeloma, 2013–2023

Figure 20: Annual Global Sales for Multiple Myeloma by Region, 2013–2023

Figure 21: Annual Global Sales for Multiple Myeloma by Region — 2013, 2023

Figure 22: Annual Global Sales for Multiple Myeloma by Drug, 2013–2023

Figure 23: Global Sales for Multiple Myeloma by Drug, 2013 - 2023

Figure 24: Annual US Sales for Multiple Myeloma by Drug, 2013–2023

Figure 25: US Sales for Multiple Myeloma by Drug, 2013 and 2023

Figure 26: Annual 5EU Sales for Multiple Myeloma by Region, 2013–2023

Figure 27: Annual 5EU Sales for Multiple Myeloma by Drug, 2013–2023

Figure 28: 5EU Sales for Multiple Myeloma by Drug, 2013 and 2023

Figure 29: Annual Japanese Sales for Multiple Myeloma by Drug, 2013–2023

Figure 30: Japanese Sales for Multiple Myeloma by Drug, 2013 and 2023

Figure 31: Annual Chinese (Urban) Sales for Multiple Myeloma by Drug, 2013–2023

Figure 32: Chinese (Urban) Sales for Multiple Myeloma by Drug, 2013 and 2023

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