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Multiple Myeloma Treatments: World Drug Industry and Market

2013-2023

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Contents

1.1 What This Report Covers

1.2 Multiple Myeloma: World Drug Market Overview 2013-2023

1.3 Chapter Outlines

1.4 Research and Analysis Methods

2.1 What is Multiple Myeloma?

2.2 What Are Plasma Cells?

2.3 What Causes Multiple Myeloma?

2.4 Signs and Symptoms of the Disease

2.5 Demographic Risk Variation in Multiple Myeloma

2.6 Stages of the Disease

2.6.1 The Durie-Salmon Staging System and the International Staging System

2.7 Treatment of Multiple Myeloma

2.7.1 Induction Therapy

2.7.2 Maintenance Therapy

2.7.3 Salvage Therapy

2.8 Present and Future Options for Treating Multiple Myeloma: Summary

3.1 The World Multiple Myeloma Drug Treatment Market in 2012

3.2 Multiple Myeloma Drug Treatment: Overarching Market Forecast 2013-2023

3.3 World Multiple Myeloma Drug Treatment Market by Therapeutic Subclass:

Comparison of Revenue and Market Share, 2018 and 2023

3. The World Multiple Myeloma Drug Treatment Market, 2013-2023

2. Introduction to Multiple Myeloma and its Treatment

1. Executive Summary

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Contents 3.4 The World Multiple Myeloma Drug Treatment Market by Therapeutic Subclass:

Grouped Revenue Forecasts, 2013-2023

3.5 Immunomodulators for Multiple Myeloma: Dominating the Market Throughout the

Forecast Period

3.5.1 Immunomodulators: Revenue Forecast 2013-2023

3.6 Proteasome Inhibitors: A Cornerstone in Multiple Myeloma Drug Treatment

3.6.1 Proteasome Inhibitors: Revenue Forecast 2013-2023

3.7 Monoclonal Antibodies: Market Launch Anticipated in 2015

3.7.1 Monoclonal Antibodies: Revenue Forecast 2013-2023

3.8 Kinase Inhibitors: A Class of Advanced Cancer Medications

3.8.1 Kinase Inhibitors: Revenue Forecast 2013-2023

3.9 Summary: Growth of the Multiple Myeloma Drug Treatment Market, 2013-2023

4.1 The Leading National Markets in 2012

4.2 The Leading National Markets: Comparison of Revenue and Market Share, 2018 and

2023

4.3 The Leading National Markets for Multiple Myeloma Drug Treatment: Grouped

Revenue Forecasts, 2013-2023

4.4 The US Will Continue to Dominate the Multiple Myeloma Drug Treatment Market from

2013-2023

4.5 The EU5 Countries

4.5.1 Germany: The Largest EU5 Market Will Have the Lowest Levels of Growth

4.5.2 France: Steadily Decreasing Market Share

4.5.3 Italy: High Growth Between 2013 and 2016

4. Leading National Markets for Multiple Myeloma Drug Treatment, 2013-2023

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Contents 4.5.4 The UK: Strongest Growth of the EU5 from 2018-2023

4.5.5 Spain: The Smallest Market of the EU5

4.6 Japan: Delays in Regulatory Approval

4.7 China: Pursuing Domestic Oncology R&D

4.8 Brazil: Governmental Healthcare Investments Support Growth

4.9 Russia: Poor Treatment Outcomes Mean Demand for More-Effective Therapy is High

4.10 India: A Strong Domestic Drug Industry Limits Market Share

5.1 Immunomodulators and Proteasome Inhibitors Dominate the Market in 2012

5.2 Leading Multiple Myeloma Drugs: Comparison of Revenue and Market Share, 2018

and 2023

5.3 Leading Multiple Myeloma Drugs: Grouped Revenue Forecasts, 2013-2023

5.4 Revlimid: Market Domination Will Continue

5.4.1 Revlimid: Driving and Restraining Forces

5.4.2 Revlimid: Revenue Forecast 2013-2023

5.5 Velcade: Generic Competition Expected

5.5.1 The Driving and Restraining Factors for Velcade

5.5.2 Velcade: Revenue Forecast 2013-2023

5.6 Thalomid: A 1st Line Treatment, But Revenue is Declining

5.6.1 Driving and Restraining Factors for Thalomid

5.6.2 Thalomid: Revenue Forecast, 2013-2023

5.7 Zometa: Facing Generic Competition

5.7.1 Driving and Restraining Factors for Zometa

5. The Leading Drugs of the World Multiple Myeloma Market, 2013-2023

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Contents 5.7.2 Zometa: Revenue Forecast, 2013-2023

5.8 Kyprolis: The 2nd Generation Proteasome Inhibitor Will Capture a Large Market Share

5.8.1 The Driving and Restraining Factors for Kyprolis

5.8.2 Kyprolis: Revenue Forecast, 2013-2023

5.9 Pomalyst: Celgene’s 3rd Immunomodulator, But Will it Supersede its Predecessors?

5.9.1 Driving and Restraining Factors for Pomalyst

5.9.2 Pomalyst: Revenue Forecast 2013-2023

5.10 Promising Drugs in the R&D Pipeline

5.10.1 Elotuzumab: The 1st Monoclonal Antibody For MM?

5.10.1.1 Elotuzumab: Driving and Restraining Forces

5.10.1.2 Elotuzumab: Revenue Forecast, 2013-2023

5.10.2 MLN9708: A Game Changing Proteasome Inhibitor?

5.10.2.1 MLN9708: Driving and Restraining Factors

5.10.2.2 MLN9708: Revenue Forecast, 2013-2023

5.10.3 Panobinostat: A First-in-Class Therapy

5.10.3.1 Panobinostat: Driving and Restraining Factors

5.10.3.2 Panobinostat: Revenue Forecast, 2013-2023

5.10.4 Aplidin: A Marine-Derived Compound for the Treatment of Multiple Myeloma

5.10.4.1 Aplidin: Driving and Restraining Factors

5.10.4.2 Aplidin: Revenue Forecast, 2013-2023

5.11 Late-Stage Product Candidates

6.1 The Small-Molecule Drug Pipeline

6.1.1 Five Candidates in Phase III Development

6. Multiple Myeloma: R&D Pipeline, 2013

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Contents 6.1.1.1 Novartis’ Panobinostat

6.1.1.2 AB Science’s Masitinib

6.1.1.3 Millennium Pharmaceuticals’ MLN9708 (ixazomib)

6.1.1.4 PharmaMar’s Aplidin

6.1.1.5 Otsuka America Pharmaceutical’s Busulfex

6.1.2 Candidates in Phase II Development: An Abundance of Kinase Inhibitors

6.1.2.1 Oncopeptides’ Melflufen

6.1.2.2 Merck’s Dinaciclib

6.1.2.3 Astra Zeneca’s Selumetinib

6.1.2.4 Pharmacyclics’ Ibrutinib

6.1.2.5 Geron Corporation’s Imetelstat

6.1.2.6 Celgene’s Istodax

6.1.2.7 Bristol-Myers Squibb’s Dasatinib

6.1.2.8 Cephalon’s Treanda

6.1.2.9 Pfizer’s Torisel

6.1.2.10 Novartis’ Everolimus

6.1.2.11 Millennium Pharmaceuticals’ MLN8237

6.1.2.12 Bayer and Onyx Pharmaceuticals’ Nexavar

6.1.3 Candidates in Phase I Development

6.1.3.1 GlaxoSmithKline’s GSK2110183 (afuresertib): Development Apparently

Suspended

6.1.3.2 Array BioPharma’s Arry-520

6.1.3.3 Arno Therapeutics’ AR-42

6.1.3.4 EntreMed’s ENMD-2076

6.1.3.5 Genentech’s Erivedge

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Contents 6.1.3.6 Allos Therapeutics’ Folotyn

6.1.3.7 Synta Pharmaceuticals’ Ganetespib

6.2 The Biologic Drug Pipeline: Monoclonal Antibodies Dominate

6.2.1 Three Monoclonal Antibodies Dominate the Phase III Developmental Pipeline

6.2.1.1 Elotuzumab Being Developed Under a Collaboration Between Bristol-Myers

Squibb and AbbVie

6.2.1.2 Amgen’s Xgeva: Could it Supersede Zometa?

6.2.1.3 Janssen Biotech and Genmab’s Daratumumab

6.2.2 Candidates in Phase II Development

6.2.2.1 Novartis’ HCD122 (Lucatumumab): Development Appears to Have Stalled

6.2.2.2 Senesco Technologies’ SNS01-T

6.2.2.3 Gliknik’s GL-0817

6.2.2.4 Celldex Therapeutics’ CDX-1401

6.2.2.5 Janssen’s Siltuximab

6.2.2.6 Roche’s Avastin

6.2.2.7 GlaxoSmithKline’s Bexxar

6.2.2.8 Novartis’ BHQ880

6.2.2.9 Cell Genesys’ GVAX

6.2.2.10 Oncovir’s Hiltonol

6.2.3 Candidates in Phase I Development

6.2.3.1 Genentech’s DFRF4539A

6.2.3.2 ImmunoGen’s Lorvotuzumab Mertansine

6.2.3.3 Eli Lilly’s Tabalumab

6.2.3.4 Genentech’s MFGR1877S

6.2.3.5 Oncolytics’ Reolysin

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Contents 6.3 Future Epigenetics-Based Treatments

7.1 The Leading Companies in 2012

7.2 Celgene Corporation is the Market Leader

7.3 Johnson & Johnson: Proteasome and MAb Leader

7.4 Takeda: A Strong Portfolio Through Subsidiary Millennium Pharmaceuticals

7.5 Novartis: A Small Market Share in 2012, But a Well-Stocked Pipeline

7.6 Bristol-Myers Squibb: Poised for Market Entry

7.7 Onyx Pharmaceuticals: Now Part of Amgen

8.1 Strengths and Weaknesses of the Multiple Myeloma Drug Treatment Market, 2013

8.1.1 Proven Commercial Viability of the Multiple Myeloma Drug Treatment Market

8.1.2 Use of Combination Therapies Mean the Market Can Sustain a High Number of

Products

8.1.3 As a Result, The R&D Pipeline is Well Stocked

8.1.4 Governmental Incentives are Helping to Drive this R&D Effort

8.1.5 But Multiple Myeloma Remains an Incurable Disease

8.1.6 Few Products Dominating that Market: a Weakness?

8.2 Opportunities and Threats Facing the Multiple Myeloma Drug Treatment Market,

2013-2023

8.2.1 Oncology is a Growth Area for Investment, Creating Opportunities in the Market

8.2.2 Will Oncology Remain a Strong Investment for Pharma?

8. Qualitative Analysis of the Multiple Myeloma Drug Treatment Market

7. The Leading Companies of the Multiple Myeloma Drug Treatment Market, 2013

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Contents 8.3 Social, Technological, Economic and Political (STEP) Forces Influencing the Multiple

Myeloma Drug Industry and Market, 2013-2023

8.3.1 Social: Adherence, Support and Education are Crucial

8.3.2 Technological: Increasing Understanding of Cancer Biology

8.3.3 Economic: Stretched Healthcare Budgets Will Affect that Drug Industry

8.3.4 Political: Broadening and Narrowing of Governmental Healthcare Spending

9.1 Interview with Dr Paul Richardson, MD, R.J. Corman Professor of Medicine at Harvard

Medical School and Clinical Director of the Jerome Lipper Center for Multiple Myeloma at the

Dana-Farber Cancer Institute

9.1.1 On the Current State of the Multiple Myeloma Drug Market

9.1.2 On the Potential of the Novel Treatments, Pomalidomide and Carfilzomib

9.1.3 On the Future of Multiple Myeloma Treatment

9.2 Interview with an External Authority in the Field (Views Given Anonymously)

9.2.1 Recent Research: Obesity is a Strong Risk Factor for Multiple Myeloma

9.2.2 Multiple Myeloma Treatment: Proactive versus Reactive

9.2.3 Treatment Options for Obese Patients

9.2.4 Multiple Myeloma Incidence Will Increase Owing to Obesity

10.1 The World Multiple Myeloma Drug Treatment Market, 2013-2023

10.2 The Leading National Markets for Multiple Myeloma Drug Treatments, 2013-2023

10.3 The Leading Products in the Multiple Myeloma Drug Treatment Market, 2013-2023

10.4 Trends in the Industry and Market

10.4.1 Multiple Myeloma Treatment is a Thriving Market That Will Continue to Expand

10. Conclusions from Our Research and Analysis

9. Research Interviews from Our Survey

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Contents 10.4.2 The R&D Pipeline is Large and Diverse

10.4.3 The Small Patient Population Generates Uncertainty

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Contents

Table 1.1 Currency Exchange Rates,

Table 2.1 Drugs Indicated for the Treatment of Multiple Myeloma: Brand Name, Generic Name

and Therapeutic Class, 2013

Table 3.1 The World Multiple Myeloma Drug Market by Therapeutic Class: Revenue ($m) and

Market Share (%), 2012

Table 3.2 World Multiple Myeloma Drug Market: Overall Revenue Forecast ($m), 2013-2023

Table 3.3 The Multiple Myeloma Drug Market by Therapeutic Class: Comparison of Revenue

($m) and Market Share (%), 2018 and 2023

Table 3.4 Multiple Myeloma Drug Market by Therapeutic Subclass: Group Revenue ($m) and

Market Share (%) Forecasts, 2013-2023

Table 3.5 Immunomodulators for Multiple Myeloma: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 3.6 Proteasome Inhibitors for Multiple Myeloma: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 3.7 Monoclonal Antibodies for Multiple Myeloma: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 3.8 Kinase Inhibitors for Multiple Myeloma: Revenue ($m) and Market Share (%) Forecast,

2013-2023

Table 4.1 The Leading National Markets: Revenue ($m) and Market Share (%), 2012

Table 4.2 The Leading National Markets: Comparison of Revenue ($m) and Market Share (%),

2018 and 2023

Table 4.3 The Leading National Markets: Grouped Revenue Forecasts ($m), 2013-2023

Table 4.4 The US Multiple Myeloma Drug Treatment Market: Revenue ($m) and Market Share

(%) Forecast, 2013-2023

Table 4.5 The EU5 Multiple Myeloma Market by Country: Revenue ($m) and Market Share (%)

Forecasts, 2013-2023

Table 4.6 The German Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

List of Tables

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Contents Table 4.7 The French Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.8 The Italian Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.9 The UK Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.10 The Spanish Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.11 The Japanese Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.12 The Chinese Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.13 The Brazilian Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.14 The Russian Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 4.15 The Indian Multiple Myeloma Drug Market: Revenue ($m) and Market Share (%)

Forecast, 2013-2023

Table 5.1 The Leading Drugs for Multiple Myeloma: Revenue ($m) and Market Share (%), 2012

Table 5.2 Leading Drugs for MM: Comparison of Revenue ($m) and Market Share (%), 2018 and

2023

Table 5.3 Leading MM Drugs: Grouped Revenue Forecasts ($m), 2013-2023

Table 5.4 Revlimid: Key Facts

Table 5.5 Revlimid: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.6 Velcade: Key Facts

Table 5.7 Velcade: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.8 Thalomid: Key Facts

Table 5.9 Thalomid: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.10 Zometa: Key Facts

Table 5.11 Zometa: Revenue ($m) and Market Share (%) Forecast, 2013-2023

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Contents Table 5.12 Kyprolis: Key Facts

Table 5.13 Kyprolis: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.14 Pomalyst: Key Facts

Table 5.15 Pomalyst: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.16 Elotuzumab: Key Facts

Table 5.17 Elotuzumab: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.18 MLN9708: Key Facts

Table 5.19 MLN9708: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.20 Panobinostat: Key Facts

Table 5.21 Panobinostat: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 5.22 Aplidin: Key Facts

Table 5.23 Aplidin: Revenue ($m) and Market Share (%) Forecast, 2013-2023

Table 6.1 Small Molecule Candidates in Phase III Development For MM, 2013

Table 6.2 Small Molecule Candidates in Phase II Development for MM, 2013

Table 6.3 Small Molecule Candidates in Phase I Development for MM, 2013

Table 6.4 Biologic Candidates in Phase III Development for MM, 2013

Table 6.5 Biologic Candidates in Phase II Development for MM, 2013

Table 6.6 Biologic Candidates in Phase I Development for MM, 2013

Table 7.1 The Leading Companies in the MM Drug Market: Revenue ($m) and Market Share

(%), 2012

Table 7.2 Celgene: Multiple Myeloma Product Portfolio, 2013

Table 7.3 Johnson & Johnson: Multiple Myeloma Product Portfolio, 2013

Table 7.4 Takeda: Multiple Myeloma Product Portfolio, 2013

Table 7.5 Novartis: Multiple Myeloma Product Portfolio, 2013

Table 7.6 Bristol-Myers Squibb: Multiple Myeloma Product Portfolio, 2013

Table 7.7 Amgen: Multiple Myeloma Product Portfolio, 2013

Table 8.1 Strengths and Weaknesses of the Multiple Myeloma Drug Treatment Market, 2013

Table 8.2 Opportunities and Threats Facing the Multiple Myeloma Drug Treatment Market,

2013-2023

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Contents Table 8.3 The Social, Technological, Economic and Political Factors Influencing the MM Drug

Treatment Market, 2013-2023

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Contents

Figure 2.1 The Incidence Rate of Multiple Myeloma (per 100,000) by World Region, 2008

Figure 3.1 The World Multiple Myeloma Drug Market by Therapeutic Class: Market Share (%),

2012

Figure 3.2 The World Multiple Myeloma Drug Treatment Market: Revenue Forecast ($m), 2013-

2023

Figure 3.3 The Multiple Myeloma Drug Market by Therapeutic Class: Market Share (%), 2018

Figure 3.4 The Multiple Myeloma Drug Market by Therapeutic Class: Market Share (%), 2023

Figure 3.5 The Multiple Myeloma Drug Market by Therapeutic Class: Revenue Forecasts ($m),

2013-2023

Figure 3.6 Immunomodulators for Multiple Myeloma: Revenue Forecast ($m), 2013-2023

Figure 3.7 Proteasome Inhibitors for Multiple Myeloma: Revenue Forecast ($m), 2013-2023

Figure 3.8 Monoclonal Antibodies for Multiple Myeloma: Revenue Forecast ($m), 2013-2023

Figure 3.9 Kinase Inhibitors for Multiple Myeloma: Revenue Forecast ($m), 2013-2023

Figure 3.10 The Multiple Myeloma Drug Treatment Market: Driving and Restraining Factors,

2013

Figure 4.1 The Leading National Markets: Market Shares (%), 2012

Figure 4.2 The Leading National Markets for Multiple Myeloma: Market Share (%), 2018

Figure 4.3 The Leading National Markets for Multiple Myeloma: Market Share (%), 2023

Figure 4.4 The US Multiple Myeloma Drug Treatment Market: Revenue Forecast ($m), 2013-

2023

Figure 4.5 US: Multiple Myeloma Drug Market Penetration – Usage of Revlimid, Velcade and

Thalomid in Early Stage of Disease (%), 2011

Figure 4.6 US: Multiple Myeloma Drug Market Penetration – Usage of Revlimid, Velcade and

Thalomid in Late Stages of Disease (%), 2011

Figure 4.7 The EU5 Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.8 The German Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.9 The French Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.10 The Italian Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

List of Figures

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Contents Figure 4.11 The UK Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.12 The Spanish Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.13 The Japanese Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.14 The Chinese Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.15 The Brazilian Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.16 The Russian Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 4.17 The Indian Multiple Myeloma Drug Market: Revenue Forecast ($m), 2013-2023

Figure 5.1 The Leading Drugs for MM: Market Share (%), 2012

Figure 5.2 Leading Drugs for MM: Market Share (%), 2018

Figure 5.3 Leading MM Drugs: Market Share (%), 2023

Figure 5.4 Revlimid: Drivers and Restraints, 2013-2023

Figure 5.5 Revlimid: Revenue Forecast ($m), 2013-2023

Figure 5.6 Velcade: Driving and Restraining Forces, 2013-2023

Figure 5.7 Velcade: Revenue Forecast ($m), 2013-2023

Figure 5.8 Thalomid: Driving and Restraining Forces, 2013-2023

Figure 5.9 Thalomid: Revenue Forecast ($m), 2013-2023

Figure 5.10 Zometa: Driving and Restraining Forces, 2013-2023

Figure 5.11 Zometa: Revenue Forecast ($m), 2013-2023

Figure 5.12 Kyprolis: Driving and Restraining Factors, 2013-2023

Figure 5.13 Kyprolis: Revenue Forecast ($m), 2013-2023

Figure 5.14 Pomalyst: Driving and Restraining Forces, 2013-2023

Figure 5.15 Pomalyst: Revenue Forecast ($m), 2013-2023

Figure 5.16 Elotuzumab: Driving and Restraining Forces, 2013-2023

Figure 5.17 Elotuzumab: Revenue Forecast ($m), 2013-2023

Figure 5.18 MLN9708: Driving and Restraining Factors, 2013-2023

Figure 5.19 MLN9708: Revenue Forecast ($m), 2013-2023

Figure 5.20 Panobinostat: Driving and Restraining Forces, 2013-2023

Figure 5.21 Panobinostat: Revenue Forecast ($m), 2013-2023

Figure 5.22 Aplidin: Driving and Restraining Forces, 2013-2023

Figure 5.23 Aplidin: Revenue Forecast ($m), 2013-2023

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Contents Figure 6.1 Breakdown of Small Molecule Drug Pipeline by Development Phase (%), 2013

Figure 6.2 Breakdown of Biologic Drug Pipeline by Development Phase (%), 2013

Figure 7.1 Leading Companies in the MM Drug Market: Market Share (%), 2012

Figure 10.1 The World MM Drug Treatment Market: Breakdown of Revenue ($m) by Therapeutic

Class, 2012

Figure 10.2 The MM Drug Treatment Market: Revenue ($m) by Country, 2012, 2018 and 2023

Figure 10.3 Leading Drugs of the Multiple Myeloma Market: Comparison of Revenue ($m),

2012, 2018 and 2023

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Contents

AB Science

Abbott Laboratories

AbbVie

Abramsom Cancer Centre

Abraxis

Actavis

Allos Therapeutics

Amgen

Anthrogenesis

Arno Therapeutics

Array Biopharma

Astellas

Astex Pharmaceuticals

AstraZeneca

Bayer

Biogen Idec

Biotest Pharmaceuticals

Bristol-Myers Squibb

Broad Institute

Cancer Research UK

Celanese

Celgene

Cell Genesys

Celldex Therapeutics

Cephalon

Constellation Pharmaceuticals

Cougar Biotechnology

Dana-Farber Cancer Institute

Companies and Organisations Mentioned in the Report

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Contents Dr. Reddy’s Laboratories

Eli Lilly

Emcure Pharmaceuticals

Entremed

EntreMed

Epizyme

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

Galapagos

Genentech

Genmab

Geron Corporation

GlaxoSmithKline (GSK)

Gliknik

Gloucester Pharmaceuticals

Harvard Medical School

Hospira

Human Genome Sciences

Immune System Therapeutics

ImmunoGen

Immunomedics

Janssen Biotech

Jerome Lipper Centre for Multiple Myeloma

Johnson & Johnson

Karyopharm Therapeutics

Kyowa Hakko Kirin Pharma

Kyowa Hakko Kirin Pharma

Leukosite

Lipomed

MD Anderson Cancer Centre

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Contents Merck & Co.

Millennium Pharmaceuticals

MorphoSys

Multiple Myeloma Research Consortium

Multiple Myeloma Research Foundation

Mylan

Myogenics/ ProScript

Natco Pharma

National Institute for Health and Care Excellence (NICE)

Nereus Pharmaceuticals

Novartis

Oncolytics

OncoPep

Oncopeptides

Oncovir

Onyx Pharmaceuticals

Otsuka America Pharmaceutical

PDL BioPharma

Pfizer

Pharmaceutical Research and Manufacturers of America (PhRMA)

Pharmacyclics

PharmaMar

Pharmion

Pharmion

Roche

Rockefeller University

Seattle Genetics

Senesco Technologies

Signal Pharmaceuticals

Sun Pharma Global

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Contents Synta Pharmaceuticals

Takeda

Teva Pharmaceuticals

The World Health Organization (WHO)

Threshold Pharmaceuticals

Translational Genomics Research Institute

University of Arkansas

University of Illinois

US National Comprehensive Cancer Network

Watson Pharmaceuticals

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Multiple Myeloma Treatments: World Drug Industry and Market 2013-2023

thalidomide, and supplies patients with educational materials relating to the product and required to

sign an informed consent form. Women are required to use at least two methods of contraception

and undergo periodic pregnancy tests when using the product, owing to reported teratogenicity.

Following these measures would erode the profit margins for any company manufacturing generic

thalidomide.

5.6.2 Thalomid: Revenue Forecast, 2013-2023 Thalomid will see negative annual growth throughout the forecast period, with revenue steadily

contracting over the next 10 years. This will result from competition from the next generation

immunomodulators Revlimid and Velcade, and increasing off-label use of competitor compounds in

1st line treatment for MM. Between 2013 and 2018, revenue will contract at a CAGR of -13.2%. It is

likely that Thalomid will see generic competition during the forecast period, with European patents

for the drug set to expire in 2019. This generic competition will drive revenue contraction in the

second half of the forecast period. The rate of contraction will slow in the latter half of the forecast

period with revenue contracting at a CAGR of -10.8% between 2018 and 2023. In 2023, sales of

Thalomid for the treatment of MM will generate revenue of $70m, accounting for 0.49% of the total

market.

Drivers •Generic challenge is disincentivised by the necessity of running a drug monitoring program.

•The drug is used as a 1st line treatment, whereas Revlimid and Pomalyst are approved as 2nd and 3rd line treatments, respectively.

• It is less expensive than the follow-on Celgene products and may thus be used in the emerging markets.

Restraints •Revlimid is an improved version of Thalomid, limiting the commercial scope for the older product.

•The recent approval of the next immunomodulator, Pomalyst, will further reduce demand for Thalomid.

•Generic versions of the product are an option for a company who sees it as commercially viable.

Source: visiongain 2013

Figure 5.8 Thalomid: Driving and Restraining Forces, 2013-2023

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Multiple Myeloma Treatments: World Drug Industry and Market 2013-2023

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023Market Share (%) 4.69 3.68 2.81 2.06 1.49 1.22 1.03 0.85 0.74 0.64 0.56 0.49Revenue ($m) 287 253 220 191 164 141 124 109 99 88 79 70AGR (%) -12 -13 -13 -14 -14 -12 -12 -10 -11 -10 -11CAGR (%) -13.20 -10.80

5.7 Zometa: Facing Generic Competition Zometa (zoledronic acid) is a bisphosphonate which reduces the turnover of bone. It is used in

oncology to reduce or delay skeletal-related events (bone pain or fractures as a result of

weakening) in patients with bone metastases from solid tumours, such as breast or prostate

cancer, and multiple myeloma. In addition, it is used to treat hypercalcaemia of malignancy (HCM),

a condition in which blood calcium levels are raised due to cancer. Therefore, Zometa is used in

the treatment regimen for many cancers. Launched on the EU market in 2001 and the US in 2003,

Zometa is marketed by Novartis. The company has reported previously that indications of MM

account for approximately 21% of the drugs total revenue. This is the figure that visiongain has

used to determine revenue in 2012, our base year. In 2012, revenue generated by Zometa

declined as a result of competition.

0

50

100

150

200

250

300

350

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Reve

nue

($m

)

Year

Source: visiongain 2013; estimate of revenue from indications of MM only

Figure 5.9 Thalomid: Revenue Forecast ($m), 2013-2023

Source: visiongain 2013; estimate of revenue from indications of MM only

Table 5.9 Thalomid: Revenue ($m) and Market Share (%) Forecast, 2013-2023