Global Multiple Myeloma Therapeutics Industry

  • October 2011
  • -
  • Global Industry Analysts

This report analyzes the worldwide markets for Multiple Myeloma Therapeutics in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. A six-year historic analysis is also provided for these markets. The report profiles 75 companies including many key and niche players such as Amgen Inc., Bristol-Myers Squibb Company, Celgene Corporation, F. Hoffmann-La Roche Ltd, Genentech, Inc., Janssen Biotech, Inc., Millennium Pharmaceuticals, Seattle Genetics, and Ziopharm Oncology, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

Table Of Contents





1. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation and Reporting Level 3
Quantitative Techniques and Analytics 3
Product Definitions and Scope of Study 3

2. INDUSTRY OVERVIEW 5
Robust Growth Ahead for Myeloma Therapeutics Market 5
Multiple Myeloma: A Second Most Common Hematological Cancer 5
Table 1: Global Multiple Myeloma Disease Statistics: 2010
(includes corresponding Graph/Chart) 6
Table 2: Global Multiple Myeloma Patient Population in
Thousands under Treatment by Treatment Stage: 2010 (includes
corresponding Graph/Chart) 6

Table 3: Leading Companies in the Global Oncology Therapy
Market (2010): Percentage Market Share Breakdown of Revenues
for Roche, Novartis, Amgen, AstraZeneca, sanofi-aventis,
Celgene, and Others (includes corresponding Graph/Chart) 7
US Remains the Largest Market; Rest of World to Spearhead Growth 7

3. MULTIPLE MYELOMA DRUGS MARKET - AN OVERVIEW 8
The Myeloma Drug Domain 8
Table 4: Annual Revenues of Select Multiple Myeloma Drugs
Worldwide: 2008 and 2009 (In US$ Million) (includes
corresponding Graph/Chart) 8
Revlimid Outshines Other Leading Drugs 8
Velcade - Still the Most Superior in terms of Survival Rate 9
Table 5: Sales of Velcade in the US and Rest of World: 2008 and
2009 (In US$ Million) (includes corresponding Graph/Chart) 9
Subcutaneous Infusion - A Refuge for Velcade from Nueropathy? 9
Unmet Needs Drive Further Innovation in the Therapeutic Area 10
Promising Drugs on the Anvil, Potential Market Remains Uncertain 10
Revlimid - A Key Revenue Generator for Celgene 10
Table 6: Sales of Revlimid in the US and Rest of World: 2009 and
2010 (In US$ Million) (includes corresponding Graph/Chart) 11

Table 7: Sales of Thalomid in the US and Rest of World: 2009 and
2010 (In US$ Million) (includes corresponding Graph/Chart) 11
Doxil Regains Sales Momentum 12
Treatment Therapies: Move Up the Learning Curve 12
Risk-Adapted Therapy: The New Norm of Future Treatment 12
New Generation Drugs in the Arsenal Against Multiple Myeloma 13
Revlimid® (lenalidomide) 13
Velcade® (bortezomib) 13
Thalomid® (thalidomide) 13
Doxil (liposomal doxorubicin) 14
Alkeran (melphalan) 14
Trisenox® (arsenic trioxide) 14
Select Promising Pipeline Drugs 14
Carfilzomib (Onyx Pharmaceuticals) 14
Phase II Results of Carfilzomib 15
Pomalidomide (Celgene) 15
Noteworthy Issues Related to Major Drugs: An Evaluation of
Pros and Cons 16
Revlimid Overtakes Thalomid: Why? 16
How Effective Will Thalomid Be in the 3rd Line Setting?
Skepticism Overflows 16
Revlimid Impedes Stem Cell Harvesting!!: What’s the Truth? 17
Other Trends and Issues 17
Approval of New Generation Drugs Push the Market Into the
Bulge Bracket 17
Growth Fundamentals Get Stronger 17
Multidrug Resistance: A Challenge to Reckon With 17
Gene Therapy Exudes Hope 18

4. CLINICAL TRIALS FOR MULTIPLE MYELOMA 19
Focus on Select Mid- and Late-Stage Clinical Trials in
Multiple Myeloma 19
Lenalidomide versus Placebo Maintenance Treatment post Single
AHSCT for Myeloma 19
Lenalidomide Maintenance Therapy Post Stem Cell
Transplantation for Myeloma 19
Doxorubicin + Bortezomib + Dexamethasone versus VAD Ensued by
High-Dose Melphalan and Maintenance with Thalidomide/
Bortezomib in Newly Diagnosed MM Patients . 20
Weekly Bortezomib Maintenance Therapy Following Bortezomib-
based Induction Therapy in Recently Diagnosed, Aged MM
Sufferers .. 20
Lenalidomide in Combination with Prednisone and Melphalan in
Recently Diagnosed Patients Above 65 years of Age . 21
Bortezomib + Prednisone + Melphalan, and Thalidomide Ensued
by Thalidomide + Bortezomib Maintenance for Preliminary
Treatment of Aged MM Patients 21
Lenalidomide + Dexamethasone + Carfilzomib in Recently
Diagnosed Multiple Myeloma 21
Carfilzomib in Refractory and Relapsed MM Setting 22
Carfilzomib as Standalone Therapy in Relapsed or Refractory MM 22
Combination of Vorinostat and Lenalidomide + Bortezomib in
Relapsed/Refractory Multiple Myeloma 23
Carfilzomib in Refractory/Relapsed MM Patients (for Long-Term
Tolerability and Treatment) 23
Multiple Myeloma Drugs In Pipeline in the Us As of the Year 2008 24
Phase III Drugs in Pipeline 24
Phase II Drugs in Pipeline 25
Phase I Drugs in Pipeline 31

5. HEMATOLOGICAL CANCERS - AN OVERVIEW and THERAPIES 36
Hematological Cancer Therapies: A Prelude 36
Treatment Regimes: The Golden Rule 36
Challenges Encountered in Clinical Trials 37
FDA’s Antidotes 38

6. DISEASE and TREATMENT OVERVIEW 39
Cancer: A Definition 39
Hematological Cancers 39
Types of Hematological Cancer 39
Multiple Myeloma 39
Multiple Myeloma Stages 40
Stage I 40
Stage II/III 40
Treatment Procedures 40
Diagnosis 40
Treatment 41
Initial Treatment Regimen 41
Induction Therapy for SCT Candidates 41
Induction Therapy for Non-SCT Candidates 42
Therapy for Relapsed or Refractory Myeloma 42
Maintenance Therapy for Relapsed or Refractory Myeloma 42
Treatment Pros and Cons 42
Other Types of Hematological Cancers 43
Leukemia 43
Acute Lymphocytic Leukemia 44
Chronic Lymphocytic Leukemia 44
Acute Myeloid Leukemia 44
Chronic Myeloid Leukemia 44
Lymphoma 45
Non-Hodgkin’s Lymphoma 45
Hodgkin’s Lymphoma 45
Myelodysplastic Syndromes 46
Hematological Cancer Therapies 46
Chemotherapy 46
Radiation Therapy 46
Stem Cell Transplants 47
Biological Therapy 47
Targeted Therapy 47
Gene Therapy 48
Immunotherapy 48
Monoclonal Antibody Treatment 48
Vaccines 49
Donor Lymphocyte Infusion 49
Hematological Cancer Drug Classes 49
Hypomethylating Agents and Antimetabolites 49
Bisphosphonates 49
Alkylating Agents and DNA-Damaging Agents 49
DNA-Repair Enzyme Inhibitors 50
Histone Deacetylase Inhibitor 50
Immunomodulators 50
Proteasome Inhibitor 50
Tyrosine Kinase Inhibitors 50

7. DRUG APPROVALS/LAUNCHES 51
Celgene Launches Revlimid and Lenadex Drugs in Japan 51
Millennium Receives FDA Approval for Supplemental NDA of VELCADE 51
Intas Introduces Bortezomib Injection for Treating Multiple
Myeloma in India 51
NICE Grants Approval for Use of Revlimid® 51
SWOG Announces Closure of Phase III Trial (S0232) for Paitents
with Multiple Myeloma 52
Fujimoto Pharmaceutical Receives Approval to Market Thalidomide 52
Celgene Obtains Health Canada Approval for Revlimid Oral
Cancer Drug 52
FDA Grants Orphan-Drug Designation to Melphalan 52
Merck Commences Phase b and Phase III Clinical Trial of
Zolinza 53
Clavis Initiates Phase II Trial of Elacytarabine 53
Gilead Sciences Commences GS 9219 Phase I Clinical Trial 53
AstraZeneca Carries Out AZD 0530 Phase II trial 53
European Commission Grants Approval of Thalidomide for
Multiple Myeloma 54
EMEA Issues Positive Opinion for Thalidomide Use in Multiple
Myeloma 54
Global Regulatory Developments for the Use of Revlimid® in
Multiple Myeloma 54
Takeda Gains FDA Approval to Promote Velcade 55
Health Canada Approves VELCADE 55
Genzyme Receives FDA Certification for Mozobil 55
Celgene’s Thalidomide Pharmion Receives Marketing Authorization 56
Ziopharm Commences Phase II Clinical Trial of ZIO-101 56
FDA Approves Pluristem’s Pre-IND Application of PLX-I 56
Merck Pharmaceuticals Commences Phase I Study for R763 Kinase
Inhibitor 56
Swissmedic Approves Celgene’s REVLIMID Oral Cancer Drug 57
Celgene’s REVLIMID Receives EU’s Marketing Authorization 57
FDA Approves Application of Piramal’s IND-P276 Multiple
Myeloma Drug 57
Millennium Pharmaceuticals and Johnson and Johnson Initiate
Velcade® Phase II Trial 57
FDA to Consider the New Drug Application Filed for Use of
Doxil® Combined with Velcade® in Patients with Multiple
Myeloma 58
Ortho Biotech Files Application with FDA for Approval of
Combination Drug DOXIL® and VELCADE® 58
Caraco’s Allopurinol Receives FDA Approval 58
FDA Approves Thalomid® as Combination Therapy for Multiple
Myeloma 58
Revlimid® Obtains Regulatory Approval for the Treatment of
Multiple Myeloma 59
LymphoSign Inc. Announces Successful Completion of LS104
Drug’s Pre-Clinical Testing 59
Seattle Genetics Commences SGN-40 Phase I Clinical Trial 59
FDA Approves Use of Revlimid® for Multiple Myeloma 59
US FDA Approves Use of Thalidomide for Multiple Myeloma 59
Ziopharm Oncology Receives Approval to Commence ZIO-101 and
ZIO-201 Trial 59
FDA Grants Approval for Use of VELCADE® for Patients with
Mantle Cell Lymphoma 60

8. RECENT INDUSTRY ACTIVITY 61
Onyx Files NDA for Carfilzomib in Myeloma Treatment 61
XTL Gains Orphan Drug Designation for rHuEPO 61
Signal Genetics Enters into a Commercialization Agreement with
NeoGenomics Laboratories 61
The Leukemia and Lymphoma Society Forms Alliance with Acetylon
Pharmaceuticals 62
Onyx Pharmaceuticals Gains FDA Fast Track Designation for
Carfilzomib 62
MMRF Enters into Collaboration with Astellas Pharma 62
Takeda and Millennium Submit Two sNDA to FDA for Bortezomib 62
Astex Enters into Definitive Merger Agreement with SuperGen 63
Yakult Honsha Enters into an Agreement with Aeterna Zentaris 63
Celgene Submits MAA for REVLIMID in Europe 63
BMS Halts Tanespimycin Development 64
Acetylon Releases Pre-Clinical Data for ACY-1215 in Multiple
Myeloma 64
Intellikine and MMRC Initiate Phase I Clinical Trial of INK128 64
Celgene Gains MHLW Approval for REVLIMID in Japan 64
XTL Acquires Bio-Gal 65
Compugen Discovers New Drug Target for Treating Multiple Myeloma 65
Boehringer Ingelheim Enters into a Collaboration Agreement
with Micromet 65
Abbott Acquires Facet Biotech 66
Mannkind Enters Into a Research Agreement with MMRF 66
Genentech Terminates Collaboration Agreement with Seattle for
SGN-40 66
Keryx Gains Fast Track Designation for Perifosine from FDA 67
FDA Clears Perifosine for Phase III Clinical Trials in
Multiple Myeloma 67
CyDex Receives FDA Approval for Clinical Evaluation of CDX-353 67
Onyx Acquires Proteolix 68
Johnson and Johnson to Acquire Cougar 68
Janssen and Takeda Ink Co-Promotion Agreement 68
Eisai Establishes Subsidiary in Canada 69
Roche Group and ImmunoCellular Therapeutics Ink Licensing
Agreement 69
CytRx Acquires Innovive 69
Launch of Epoetin alfa Hexal 70
PDL and Bristol-Myers Signs Agreement 70
MNKD and LLS Conclude Joint Research Agreement 70
MorphoSys and DSM Enter into Agreement 70
StemCyte Enters into Joint Venture with Cadila and Apollo
Hospitals in India 71
ImmunoCellular Acquires Molecular Antibody Technology 71
US House of Representatives Sanction the Hematological Cancer
Research Investment and Education Act 71
Bayer and Cell Therapeutics Enter into Mutual Agreement 71
Bristol-Myers Takes Over Kosan Biosciences 72
Bristol and PDL BioPharma Enter into Agreement 72
Gamida Cell Enters Into a Agreement with Amgen 72
Circadian Acquires Complete Stake in Vegenics 72
Takeda Acquires Millennium Pharmaceuticals 73
Access Pharmaceuticals Acquires Somanta 73
Celgene Acquires Pharmion 73
GlaxoSmithKline Forms Alliance with OncoMed for Developing
Cancer Therapeutics 74
Cyclacel Acquires ALIGN Pharmaceuticals 74
Biogen and Genentech to Jointly Develop and Commercialize New
Blood Cancer Drug 75
Aegera Therapeutics Acquires LymphoSign Inc 75
Velcade Gains Subsidy 75
Inex Pharmaceuticals Spins Off Biotechnology Business into
Tekmira Pharmaceuticals 75
MilleGen Enters into Collaboration with LFB 76
TopoTarget Acquires Apoxis SA 76
Genentech Inks Exclusive Global Licensing Agreement with
Seattle Genetics 76
PerkinElmer Takes Over ViaCell 76
Favrille Announces Acquisition of Monoclonal Antibody Range
from Diversa 77
Johnson and Johnson Secures Contract worth US$112 Million 77
Bioniche Pharma Acquires Branded Pharmaceutical from Nabi
Biopharmaceuticals 77
Takara Bio's RetroNect Used for Clinical Trials of Gene
Therapy in Australia 77
MDS Pharma Services Becomes Recommended CRO for Multiple
Myeloma Drug RandD 78
Celgene Certifies McKesson Specialty to Launch Revlimid 78
Medarex and PacMab to Co-Develop Blood Cancer Therapies 78
Gamida Cell and Teva to Co-Develop Therapy for Hematological
Malignancies 78
GlaxoSmithKline Takes Over Praecis Pharmaceuticals 79
Biotest Acquires ImmunoGen Anticancer Technology Rights 79
Hana Signs Licensing Agreement with Inex 79
Cephalon Acquires Zeneus 79

9. FOCUS ON SELECT PLAYERS 80
Amgen, Inc. (USA) 80
Bristol-Myers Squibb Company (USA) 80
Celgene Corporation (USA) 80
F. Hoffmann-La Roche Ltd (Switzerland) 80
Genentech, Inc. (USA) 81
Janssen Biotech, Inc. (USA) 81
Millennium Pharmaceuticals (USA) 81
Seattle Genetics (USA) 81
Ziopharm Oncology, Inc. (USA) 82

10. GLOBAL MARKET PERSPECTIVE 83
Table 8: World Recent Past, Current and Future Analysis for
Multiple Myeloma Therapeutics by Geographic Region - US,
Japan, Europe and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) 83

Table 9: World Historic Review for Multiple Myeloma
Therapeutics by Geographic Region - US, Japan, Europe, and
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 84

Table 10: World 15-Year Perspective for Multiple Myeloma
Therapeutics by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Japan, Europe and Rest of World Markets
for Years 2003, 2010 and 2017 (includes corresponding
Graph/Chart) 85

11. THE UNITED STATES 86
A.Market Analysis 86
Current and Future Analysis 86
US Myeloma Statistics 86
Table 11: Multiple Myeloma Disease Statistics in the US:
2010 (includes corresponding Graph/Chart) 86

Table 12: Addressable Multiple Myeloma Patient Population
in the US by Treatment Stage: 2010 (includes corresponding
Graph/Chart) 86

Table 13: Hematological Malignancies in the US (2009):
Number of Incidences by Type of Cancer - Lymphoma
(Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma), Multiple
Myeloma, Leukemia (Acute Lymphocytic Leukemia, Chronic
Lymphocytic Leukemia, Acute Myeloid Leukemia, Chronic
Myeloid Leukemia, and Other Leukemia) (includes
corresponding Graph/Chart) 87

Table 14: Hematological Malignancies in the US (2009):
Number of Deaths by Type of Cancer - Lymphoma (Hodgkin's
Lymphoma and Non-Hodgkin's Lymphoma), Multiple Myeloma,
Leukemia (Acute Lymphocytic Leukemia, Chronic Lymphocytic
Leukemia, Acute Myeloid Leukemia, Chronic Myeloid
Leukemia, and Other Leukemia) (includes corresponding
Graph/Chart) 88

Table 15: Blood Cancer Statistics in the US (2010):
Percentage Breakdown of Hematological Cancer Cases by
Type: Lymphoma, Myeloma, and Leukemia (includes
corresponding Graph/Chart) 88
Trends in Myeloma Therapeutics in the US 88
Doctors Shift to Continuous Therapy in Myeloma Treatment 88
Table 16: Key Drug Regimens in the US Multiple Myeloma
Market (2006): Breakdown of Typical Length of Treatment
Cycle and Cost per Cycle (In US$) (includes corresponding
Graph/Chart) 89
Market Share Statistics 90
Table 17: Market Share Breakdown of Major Multiple Myeloma
Drug Regimens in the US in First Line Setting by Number of
Patients on Treatment: 2010 (includes corresponding
Graph/Chart) 90

Table 18: Market Share Breakdown of Major Multiple Myeloma
Drug Regimens in the US in Relapsed/ Refractory Setting by
Number of Patients on Treatment: 2010 (includes
corresponding Graph/Chart) 90

Table 19: US Market for Multiple Myeloma Therapeutics
(2010): Percentage Market Share Breakdown of Revenues by
Company - Celgene Corporation, Millennium Pharmaceuticals
and Others (includes corresponding Graph/Chart) 90
Key Non-Profit Organizations in the US 90
Multiple Myeloma Research Foundation (MMRF) 91
National Coalition for Cancer Survivorship (NCCS) 91
National Marrow Donor Program (NMDP) 91
Oregon Health and Science University Cancer Institute 91
Drug Approvals 91
Strategic Corporate Developments 92
Focus on Select Key Players 98
B.Market Analytics 100
Table 20: The US Recent Past, Current and Future Analysis for
Multiple Myeloma Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) 100

Table 21: US Historic Review for Multiple Myeloma
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 101

12. JAPAN 102
A.Market Analysis 102
Current and Future Analysis 102
Myeloma in Japan 102
Table 22: Multiple Myeloma Disease Statistics in Japan:
2010 (includes corresponding Graph/Chart) 102
Table 23: Addressable Multiple Myeloma Patient Population
in Japan by Treatment Stage: 2010 (includes corresponding
Graph/Chart) 102
Drug Launches 102
Strategic Corporate Developments 103
B.Market Analytics 104
Table 24: Japanese Recent Past, Current and Future Analysis
for Multiple Myeloma Therapeutics Market Analyzed with
Annual Sales Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) 104

Table 25: Japanese Historic Review for Multiple Myeloma
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 105

13. EUROPE 106
A.Market Analysis 106
Current and Future Analysis 106
Myeloma in the EU - A Statistical Review 106
Table 26: Multiple Myeloma Disease Statistics in the EU:
2010 (includes corresponding Graph/Chart) 106

Table 27: Addressable Multiple Myeloma Patient Population
in the EU by Treatment Stage: 2010 (includes corresponding
Graph/Chart) 106

Table 28: Market Share Breakdown of Major Multiple Myeloma
Drug Regimens in the EU in First Line Setting by Number of
Patients on Treatment: 2010 (includes corresponding
Graph/Chart) 106

Table 29: Market Share Breakdown of Major Multiple Myeloma
Drug Regimens in the EU in Relapsed/ Refractory Setting by
Number of Patients on Treatment: 2010 (includes
corresponding Graph/Chart) 107
Europe Lagging Behind in Drug Approvals 107
Thalidomide Takes Rebirth in the UK NHS 107
Strategic Corporate Developments 107
F. Hoffmann-La Roche Ltd (Switzerland) - A Key Player 108
B.Market Analytics 109
Table 30: European Recent Past, Current and Future Analysis
for Multiple Myeloma Therapeutics Market Analyzed with
Annual Sales Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) 109

Table 31: European Historic Review for Multiple Myeloma
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 110

14. REST OF WORLD 111
A.Market Analysis 111
Current and Future Analysis 111
Strategic Corporate Developments 111
Drug Launch 112
B.Market Analytics 113
Table 32: Rest of World Recent Past, Current and Future
Analysis for Multiple Myeloma Therapeutics Market Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) 113

Table 33: Rest of World Historic Review for Multiple Myeloma
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 114


COMPETITIVE LANDSCAPE

Total Companies Profiled: 75 (including Divisions/Subsidiaries - 80)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 56
Canada 1
Japan 6
Europe 13
Germany 5
The United Kingdom 1
Italy 1
Spain 1
Rest of Europe 5
Asia-Pacific (Excluding Japan) 3
Middle-East 1
------------------------------------------

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