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

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Contents
1.
1.1 1.2 1.3 1.4

Executive Summary
What This Report Covers Multiple Myeloma: World Drug Market Overview 2013-2023 Chapter Outlines Research and Analysis Methods

2. Introduction to Multiple Myeloma and its Treatment


2.1 2.2 2.3 2.4 2.5 2.6 What is Multiple Myeloma? What Are Plasma Cells? What Causes Multiple Myeloma? Signs and Symptoms of the Disease Demographic Risk Variation in Multiple Myeloma 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. The World Multiple Myeloma Drug Treatment Market, 2013-2023


3.1 3.2 3.3 The World Multiple Myeloma Drug Treatment Market in 2012 Multiple Myeloma Drug Treatment: Overarching Market Forecast 2013-2023 World Multiple Myeloma Drug Treatment Market by Therapeutic Subclass:

Comparison of Revenue and Market Share, 2018 and 2023

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


4.1 4.2 2023 4.3 The Leading National Markets for Multiple Myeloma Drug Treatment: Grouped The Leading National Markets in 2012 The Leading National Markets: Comparison of Revenue and Market Share, 2018 and

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

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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 4.7 4.8 4.9 4.10 Japan: Delays in Regulatory Approval China: Pursuing Domestic Oncology R&D Brazil: Governmental Healthcare Investments Support Growth Russia: Poor Treatment Outcomes Mean Demand for More-Effective Therapy is High India: A Strong Domestic Drug Industry Limits Market Share

5. The Leading Drugs of the World Multiple Myeloma Market, 20132023


5.1 5.2 and 2023 5.3 5.4 Leading Multiple Myeloma Drugs: Grouped Revenue Forecasts, 2013-2023 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 Immunomodulators and Proteasome Inhibitors Dominate the Market in 2012 Leading Multiple Myeloma Drugs: Comparison of Revenue and Market Share, 2018

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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: Celgenes 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 Elotuzumab: The 1st Monoclonal Antibody For MM? Elotuzumab: Driving and Restraining Forces Elotuzumab: Revenue Forecast, 2013-2023

5.10.1

5.10.1.1 5.10.1.2 5.10.2

MLN9708: A Game Changing Proteasome Inhibitor? MLN9708: Driving and Restraining Factors MLN9708: Revenue Forecast, 2013-2023

5.10.2.1 5.10.2.2 5.10.3

Panobinostat: A First-in-Class Therapy Panobinostat: Driving and Restraining Factors Panobinostat: Revenue Forecast, 2013-2023

5.10.3.1 5.10.3.2 5.10.4

Aplidin: A Marine-Derived Compound for the Treatment of Multiple Myeloma Aplidin: Driving and Restraining Factors Aplidin: Revenue Forecast, 2013-2023

5.10.4.1 5.10.4.2 5.11

Late-Stage Product Candidates

6. Multiple Myeloma: R&D Pipeline, 2013


6.1 The Small-Molecule Drug Pipeline 6.1.1 Five Candidates in Phase III Development

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6.1.1.1 6.1.1.2 6.1.1.3 6.1.1.4 6.1.1.5 Novartis Panobinostat AB Sciences Masitinib Millennium Pharmaceuticals MLN9708 (ixazomib) PharmaMars Aplidin Otsuka America Pharmaceuticals Busulfex

6.1.2 Candidates in Phase II Development: An Abundance of Kinase Inhibitors 6.1.2.1 6.1.2.2 6.1.2.3 6.1.2.4 6.1.2.5 6.1.2.6 6.1.2.7 6.1.2.8 6.1.2.9 6.1.2.10 6.1.2.11 6.1.2.12 Oncopeptides Melflufen Mercks Dinaciclib Astra Zenecas Selumetinib Pharmacyclics Ibrutinib Geron Corporations Imetelstat Celgenes Istodax Bristol-Myers Squibbs Dasatinib Cephalons Treanda Pfizers Torisel Novartis Everolimus Millennium Pharmaceuticals MLN8237 Bayer and Onyx Pharmaceuticals Nexavar

6.1.3 Candidates in Phase I Development 6.1.3.1 GlaxoSmithKlines GSK2110183 (afuresertib): Development Apparently

Suspended 6.1.3.2 6.1.3.3 6.1.3.4 6.1.3.5 Array BioPharmas Arry-520 Arno Therapeutics AR-42 EntreMeds ENMD-2076 Genentechs Erivedge

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6.1.3.6 6.1.3.7 6.2 Allos Therapeutics Folotyn Synta Pharmaceuticals Ganetespib 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 6.2.1.3 Amgens Xgeva: Could it Supersede Zometa? Janssen Biotech and Genmabs Daratumumab

6.2.2 Candidates in Phase II Development 6.2.2.1 6.2.2.2 6.2.2.3 6.2.2.4 6.2.2.5 6.2.2.6 6.2.2.7 6.2.2.8 6.2.2.9 6.2.2.10 Novartis HCD122 (Lucatumumab): Development Appears to Have Stalled Senesco Technologies SNS01-T Glikniks GL-0817 Celldex Therapeutics CDX-1401 Janssens Siltuximab Roches Avastin GlaxoSmithKlines Bexxar Novartis BHQ880 Cell Genesys GVAX Oncovirs Hiltonol

6.2.3 Candidates in Phase I Development 6.2.3.1 6.2.3.2 6.2.3.3 6.2.3.4 6.2.3.5 Genentechs DFRF4539A ImmunoGens Lorvotuzumab Mertansine Eli Lillys Tabalumab Genentechs MFGR1877S Oncolytics Reolysin

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Contents
6.3 Future Epigenetics-Based Treatments

7. The Leading Companies of the Multiple Myeloma Drug Treatment Market, 2013
7.1 7.2 7.3 7.4 7.5 7.6 7.7 The Leading Companies in 2012 Celgene Corporation is the Market Leader Johnson & Johnson: Proteasome and MAb Leader Takeda: A Strong Portfolio Through Subsidiary Millennium Pharmaceuticals Novartis: A Small Market Share in 2012, But a Well-Stocked Pipeline Bristol-Myers Squibb: Poised for Market Entry Onyx Pharmaceuticals: Now Part of Amgen

8. Qualitative Analysis of the Multiple Myeloma Drug Treatment Market


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?

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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. Research Interviews from Our Survey


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. Conclusions from Our Research and Analysis


10.1 10.2 10.3 10.4 The World Multiple Myeloma Drug Treatment Market, 2013-2023 The Leading National Markets for Multiple Myeloma Drug Treatments, 2013-2023 The Leading Products in the Multiple Myeloma Drug Treatment Market, 2013-2023 Trends in the Industry and Market Multiple Myeloma Treatment is a Thriving Market That Will Continue to Expand

10.4.1

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10.4.2 10.4.3 The R&D Pipeline is Large and Diverse The Small Patient Population Generates Uncertainty

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List of Tables
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

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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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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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Table 8.3 The Social, Technological, Economic and Political Factors Influencing the MM Drug Treatment Market, 2013-2023

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List of Figures
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 ($m), 20132023 Figure 3.3 The Multiple Myeloma Drug Market by Therapeutic Class: Market Share (%), 2018 Figure 3.4 The Multiple Myeloma Drug Market by Therapeutic Class: Market Share (%), 2023 Figure 3.5 The Multiple Myeloma Drug Market by Therapeutic Class: Revenue Forecasts ($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 ($m), 20132023 Figure 4.5 US: Multiple Myeloma Drug Market Penetration Usage of Revlimid, Velcade and Thalomid in Early Stage of Disease (%), 2011 Figure 4.6 US: Multiple Myeloma Drug Market Penetration Usage of Revlimid, Velcade and Thalomid in Late Stages of Disease (%), 2011 Figure 4.7 The EU5 Multiple Myeloma Drug Market: Revenue Forecast ($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

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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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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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Companies and Organisations Mentioned in the Report
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

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Dr. Reddys 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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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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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.

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

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 1 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.
st

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


Table 5.9 Thalomid: Revenue ($m) and Market Share (%) Forecast, 2013-2023
2012 Market Share (%) 4.69 Revenue ($m) 287 AGR (%) CAGR (%) 2013 3.68 253 -12 2014 2.81 220 -13 2015 2.06 191 -13 2016 1.49 164 -14 2017 2018 1.22 1.03 141 124 -14 -12 -13.20 2019 2020 2021 2022 2023 0.85 0.74 0.64 0.56 0.49 109 99 88 79 70 -12 -10 -11 -10 -11 -10.80

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

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


350 300 250 Revenue ($m) 200 150 100 50 0 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

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

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.

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