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Multiple Myeloma Therapeutics - U.S. Market Report

Price:
USD $3,950.00
ISBN/SKU #:
GIA-MCP1857
Research Group:
Global Industry Analysts
Date of Publication:
April 2009
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Summary

This report analyzes the US market for Multiple Myeloma Therapeutics in Millions of US$. The market for multiple myeloma therapeutics is analyzed by the following Drugs: Thalomid, Revlimid, Velcade, and Others. The market for multiple myeloma therapeutics is also analyzed by the Lines of Treatment - Induction Therapy for SCT Candidates, Induction Therapy for Non-SCT Candidates, and Therapy for Relapsed or Refractory Myeloma.  Annual forecasts are provided for the period of 2006 through 2015. The report profiles 98 companies including many key and niche players such as Amgen Inc., Avalon Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Kosan Biosciences, Inc., Celgene Corporation, F. Hoffmann-La Roche Ltd, Genentech, Inc., Genta Incorporated, Millennium Pharmaceuticals, Ortho Biotech Products, LP, 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

MULTIPLE MYELOMA THERAPEUTICS
A US MARKET REPORT								MCP-1857


                                           CONTENTS


  I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

      Study Reliability and Reporting Limitations                       I-1
      Disclaimers                                                       I-2
      Data Interpretation & Reporting Level                             I-2
       Quantitative Techniques & Analytics                              I-3
      Product Definitions and Scope of Study                            I-3


 II. A US MARKET REPORT

  1. Industry Overview                                                  II-1
      Hematological Cancer Therapies: A Prelude                         II-1
       Treatment Regimes: The Golden Rule                               II-1
      Multiple Myeloma: A Second Most Common Hematological Cancer       II-2
       Table 1: Hematological Malignancies in the US (2007): Number
       of Incidences and 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), and Myelodysplastic Syndromes
       (MDS) (includes corresponding Graph/Chart)                       II-3

       Table 2: Blood Cancer Statistics in the US (2008E):
       Percentage Breakdown of Hematological Cancer Cases by Type:
       Lymphoma, Myeloma, and Leukemia (includes corresponding
       Graph/Chart)                                                     II-3

       Table 3: Multiple Myeloma Statistics in the US (2008E):
       Number of Persons Undergoing Initial Diagnosis and Monitoring
       (includes corresponding Graph/Chart)                             II-4
       Treatment Therapies: Move Up the Learning Curve                  II-4
        Risk-Adapted Therapy: The New Norm of Future Treatment          II-5
        New Generation Drugs in the Arsenal Against Multiple Myeloma    II-5
         Velcade® (Bortezomib)                                          II-5
         Thalomid® (Thalidomide)                                        II-5
         Revlimid® (Lenalidomide)                                       II-6
         Alkeran (Melphalan)                                            II-6
         Doxil (Liposomal Doxorubicin)                                  II-6
         Trisenox® (Arsenic trioxide)                                   II-6
        Noteworthy Issues Related to Major Drugs: An Evaluation of
         Pros and Cons                                                  II-7
         Revlimid Overtakes Thalomid: Why?                              II-7
         How Effective Will Thalomid Be in the 3rd Line Setting?
          Skepticism Overflows                                          II-7
         Revlimid Impedes Stem Cell Harvesting!!: What’s the Truth?     II-7
         1st & 2nd Generation Geldanamycin Analog to Do Wonders for
          Myeloma Treatment                                             II-8
       Other Trends & Issues                                            II-8
        Approval of New Generation Drugs Push the Market Into the
         Bulge Bracket                                                  II-8
        Growth Fundamentals Get Stronger                                II-8
         Table 4: 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)                                                   II-9
        Multidrug Resistance: A Challenge to Reckon With                II-9
        Gene Therapy Exudes Hope                                        II-9
        Challenges Encountered in Clinical Trials                       II-10
        FDA’s Antidotes                                                 II-10
        Europe Lagging Behind in Drug Approvals                         II-11
         Table 5: Multiple Myeloma Market in Europe (2006):
         Percentage Breakdown of Drugs Used in First Line Treatment -
         Melphalan, Thalidomide, Velcade, Doxorubicin, and Others
         (includes corresponding Graph/Chart)                           II-11

         Table 6: Multiple Myeloma Market in Europe (2006):
         Percentage Breakdown of Drugs Used in Second Line Treatment -
         Melphalan, Thalidomide, Velcade, and Doxorubicin
         (includes corresponding Graph/Chart)                           II-11

         Table 7: Multiple Myeloma Market in Europe (2006):
         Percentage Breakdown of Drugs Used in Third Line Treatment -
         Melphalan, Thalidomide, Velcade, Doxorubicin, and Others
         (includes corresponding Graph/Chart)                           II-12
       Market Share Statistics                                          II-12
        Present Batting Order                                           II-12
         Table 8: US Market for Multiple Myeloma Therapeutics
         (2006): Percentage Breakdown of Revenues by Company -
         Celgene Corporation, Millennium Pharmaceuticals,
         Ortho-Biotech, and Others (includes corresponding
         Graph/Chart)                                                   II-12
        Looking Through the Crystal Ball: Year 2013                     II-12
         Table 9: US Market for Multiple Myeloma Therapeutics
         (2013P): Percentage Breakdown of Revenues by Company -
         Celgene Corporation, Millennium Pharmaceuticals Inc, Kosan
         Biosciences, Ortho Biotech, Ziopharm Oncology Inc and
         Others (includes corresponding Graph/Chart)                    II-12
        Oncology and Hematology Market                                  II-13
         Table 10: Leading Players in the Oncology and Hematology
         Market in the US (2008E): Percentage Breakdown of Value
         Sales by Company - Amgen, Roche, Novartis, DNA,
         AstraZeneca, and Others (includes corresponding
         Graph/Chart)                                                   II-13
       Drugs Approved & In Pipeline: A Review                           II-13
        Multiple Myeloma Drugs Approved by the FDA As of the Year 2008  II-13
        Multiple Myeloma Drugs in Pipeline in the US As of the Year
         2008                                                           II-14
         Phase III Drugs in Pipeline                                    II-14
         Phase II Drugs in Pipeline                                     II-15
         Phase I Drugs in Pipeline                                      II-21
       Key Non-Profit Organizations in the US                           II-25
        Multiple Myeloma Research Foundation (MMRF)                     II-25
        National Coalition for Cancer Survivorship (NCCS)               II-25
        National Marrow Donor Program (NMDP)                            II-25
        Oregon Health and Science University Cancer Institute           II-25

  2. Disease & Treatment Overview                                       II-26
      Cancer: A Definition                                              II-26
      Hematological Cancers                                             II-26
       Types of Hematological Cancer                                    II-26
        Multiple Myeloma                                                II-26
         Multiple Myeloma Stages                                        II-27
          Stage I                                                       II-27
          Stage II/III                                                  II-27
         Treatment Procedures                                           II-27
          Diagnosis                                                     II-27
          Treatment                                                     II-28
           Initial Treatment Regimen                                    II-28
           Induction Therapy for SCT Candidates                         II-28
           Induction Therapy for Non-SCT Candidates                     II-29
           Therapy for Relapsed or Refractory Myeloma                   II-29
           Maintenance Therapy for Relapsed or Refractory Myeloma       II-29
           Treatment Pros & Cons                                        II-29
        Others Types of Hematological Cancers                           II-30
         Leukemia                                                       II-30
          Acute Lymphocytic Leukemia                                    II-30
          Chronic Lymphocytic Leukemia                                  II-31
          Acute Myeloid Leukemia                                        II-31
          Chronic Myeloid Leukemia                                      II-31
         Lymphoma                                                       II-31
          Non-Hodgkin’s Lymphoma                                        II-32
          Hodgkin’s Lymphoma                                            II-32
         Myelodysplastic Syndromes                                      II-32
      Hematological Cancer Therapies                                    II-33
       Chemotherapy                                                     II-33
       Radiation Therapy                                                II-33
       Stem Cell Transplants                                            II-33
       Biological Therapy                                               II-34
       Targeted Therapy                                                 II-34
       Gene Therapy                                                     II-34
       Immunotherapy                                                    II-34
       Monoclonal Antibody Treatment                                    II-35
       Vaccines                                                         II-35
       Donor Lymphocyte Infusion                                        II-35
      Hematological Cancer Drug Classes                                 II-35
       Hypomethylating Agents & Antimetabolites                         II-35
       Bisphosphonates                                                  II-36
       Alkylating Agents and DNA-Damaging Agents                        II-36
       DNA-Repair Enzyme Inhibitors                                     II-36
       Histone Deacetylase Inhibitor                                    II-36
       Immunomodulators                                                 II-36
       Proteasome Inhibitor                                             II-36
       Tyrosine Kinase Inhibitors                                       II-36

  3. Clinical Trials and Drug Approvals                                 II-37
      NICE Grants Approval for Use of Revlimid®                         II-37
      SWOG Announces Closure of Phase III Trial (S0232) for Paitents
       with Multiple Myeloma                                            II-37
      Fujimoto Pharmaceutical Receives Approval to Market Thalidomide   II-37
      Celgene Obtains Health Canada Approval for Revlimid Oral
       Cancer Drug                                                      II-37
      FDA Grants Orphan-Drug Designation to Melphalan                   II-38
      Merck Commences Phase II-b and Phase III Clinical Trial of
       Zolinza                                                          II-38
      Clavis Initiates Phase II Trial of Elacytarabine                  II-38
      Gilead Sciences Commences GS 9219 Phase I Clinical Trial          II-38
      AstraZeneca Carries Out AZD 0530 Phase II trial                   II-39
      European Commission Grants Approval of Thalidomide for
       Multiple Myeloma                                                 II-39
      EMEA Issues Positive Opinion for Thalidomide Use in Multiple
       Myeloma                                                          II-39
      Global Regulatory Developments for the Use of Revlimid® in
       Multiple Myeloma                                                 II-39
      Takeda Gains FDA Approval to Promote Velcade                      II-40
      Health Canada Approves VELCADE                                    II-40
      Genzyme Receives FDA Certification for Mozobil                    II-40
      Celgene’s Thalidomide Pharmion Receives Marketing Authorization   II-41
      Ziopharm Commences Phase II Clinical Trial of ZIO-101             II-41
      FDA Approves Pluristem’s Pre-IND Application of PLX-I             II-41
      Merck Pharmaceuticals Commences Phase I Study for R763 Kinase
       Inhibitor                                                        II-41
      Swissmedic Approves Celgene’s REVLIMID Oral Cancer Drug           II-42
      Celgene’s REVLIMID Receives EU’s Marketing Authorization          II-42
      FDA Approves Application of Piramal’s IND-P276 Multiple
       Myeloma Drug                                                     II-42
      Millennium Pharmaceuticals and Johnson & Johnson Initiate
       Velcade® Phase II Trial                                          II-42
      FDA to Consider the New Drug Application Filed for Use of
       Doxil® Combined with Velcade® in Patients with Multiple
        Myeloma                                                         II-42
      Ortho Biotech Files Application with FDA for Approval of
       Combination Drug DOXIL® and VELCADE®                             II-43
      Caraco’s Allopurinol Receives FDA Approval                        II-43
      FDA Approves Thalomid® as Combination Therapy for Multiple
       Myeloma                                                          II-43
      Revlimid® Obtains Regulatory Approval for the Treatment of
       Multiple Myeloma                                                 II-43
      LymphoSign Inc. Announces Successful Completion of LS104
       Drug’s Pre-Clinical Testing                                      II-43
      Seattle Genetics Commences SGN-40 Phase I Clinical Trial          II-44
      FDA Approves Use of Revlimid® for Multiple Myeloma                II-44
      US FDA Approves Use of Thalidomide for Multiple Myeloma           II-44
      Ziopharm Oncology Receives Approval to Commence ZIO-101 and
       ZIO-201 Trial                                                    II-44
      FDA Grants Approval for Use of VELCADE® for Patients with
       Mantle Cell Lymphoma                                             II-44

  4. Recent Industry Activity                                           II-45
      CytRx to Acquire Innovive                                         II-45
      Launch of Epoetin alfa Hexal                                      II-45
      PDL and Bristol-Myers Signs Agreement                             II-45
      MNKD and LLS Conclude Joint Research Agreement                    II-45
      MorphoSys and DSM Enter into Agreement                            II-46
      StemCyte Enters into Joint Venture with Cadila and Apollo
       Hospitals in India                                               II-46
      ImmunoCellular Acquires Molecular Antibody Technology             II-46
      US House of Representatives Sanction the Hematological Cancer
       Research Investment and Education Act                            II-46
      Bayer and Cell Therapeutics Enter into Mutual Agreement           II-47
      Bristol-Myers to Take Over Kosan Biosciences                      II-47
      Bristol and PDL BioPharma Enter into Agreement                    II-47
      Gamida Cell Enters Into a Agreement with Amgen                    II-47
      Circadian Acquires Complete Stake in Vegenics                     II-48
      Takeda Acquires Millennium Pharmaceuticals                        II-48
      GlaxoSmithKline Forms Alliance with OncoMed for Developing
       Cancer Therapeutics                                              II-48
      Cyclacel Signs Agreement to Acquire ALIGN Pharmaceuticals         II-49
      Biogen and Genentech to Jointly Develop and Commercialize New
       Blood Cancer Drug                                                II-49
      Aegera Therapeutics Acquires LymphoSign Inc                       II-49
      Velcade Gains Subsidy                                             II-50
      Inex Pharmaceuticals Spins Off Biotechnology Business into
       Tekmira Pharmaceuticals                                          II-50
      MilleGen Enters into Collaboration with LFB                       II-50
      Access Pharmaceuticals to Acquire Somanta                         II-50
      TopoTarget to Acquire Apoxis SA                                   II-51
      Genentech Inks Exclusive Global Licensing Agreement with
       Seattle Genetics                                                 II-51
      Celgene Agrees to Acquisition of Pharmion                         II-51
      PerkinElmer Plans Acquisition of ViaCell                          II-51
      Favrille Announces Acquisition of Monoclonal Antibody Range
       from Diversa                                                     II-52
      Johnson & Johnson Secures Contract worth US$112 Million           II-52
      Bioniche Pharma to Acquire Branded Pharmaceutical from Nabi
       Biopharmaceuticals                                               II-52
      Takara Bio's RetroNect Used for Clinical Trials of Gene
       Therapy in Australia                                             II-52
      Millennium Pharmaceuticals to Take Over AnorMED                   II-53
      MDS Pharma Services Becomes Recommended CRO for Multiple
       Myeloma Drug R&D                                                 II-53
      Celgene Certifies McKesson Specialty to Launch Revlimid           II-53
      Medarex and PacMab to Co-Develop Blood Cancer Therapies           II-53
      Gamida Cell and Teva to Co-Develop Therapy for Hematological
       Malignancies                                                     II-54
      GlaxoSmithKline to Take Over Praecis Pharmaceuticals              II-54
      Biotest Acquires ImmunoGen Anticancer Technology Rights           II-54
      Hana Signs Licensing Agreement with Inex                          II-54
      Cephalon Acquires Zeneus                                          II-54

  5. Focus on Select Players                                            II-55
      Amgen Inc (USA)                                                   II-55
      Avalon Pharmaceuticals, Inc. (USA)                                II-55
      Bristol-Myers Squibb Company (USA)                                II-55
       Kosan Biosciences, Inc. (USA)                                    II-55
      Celgene Corporation (USA)                                         II-56
      F. Hoffmann-La Roche Ltd (Switzerland)                            II-56
      Genentech, Inc. (USA)                                             II-56
      Genta Incorporated (USA)                                          II-56
      Millennium Pharmaceuticals (USA)                                  II-57
      Ortho Biotech Products, LP (USA)                                  II-57
      Seattle Genetics (USA)                                            II-57
      Ziopharm Oncology, Inc. (USA)                                     II-57

  6. Market Perspective                                                 II-59
      Table 11: US Recent Past, Current & Future Analysis for
      Multiple Myeloma Therapeutics by Drug - Thalomid, Revlimid,
      Velcade, and Others Independently Analyzed with Annual Sales
      Figures in US$ Million for Years 2006 through 2015 (includes
      corresponding Graph/Chart)                                        II-59

      Table 12: US 10-Year Perspective for Multiple Myeloma
      Therapeutics by Drug - Percentage Breakdown of Dollar Sales
      for Thalomid, Revlimid, Velcade, and Others for Years 2006,
      2009 & 2015 (includes corresponding Graph/Chart)                  II-59

      Table 13: US Recent Past, Current & Future Analysis for
      Multiple Myeloma Therapeutics by Line of Treatment - Induction
      Therapy for SCT Candidates, Induction Therapy for Non-SCT
      Candidates, and Therapy for Relapsed or Refractory Myeloma
      Independently Analyzed with Annual Sales Figures in US$
      Million  for Years 2006 through 2015 (includes  corresponding
      Graph/Chart)                                                      II-60

      Table 14: US 10-Year Perspective for Multiple Myeloma
      Therapeutics by Line of Treatment - Percentage Breakdown of
      Dollar Sales for Induction Therapy for SCT Candidates,
      Induction Therapy for Non-SCT Candidates, and Therapy for
      Relapsed or Refractory Myeloma for Years 2006, 2009 & 2015
      (includes corresponding Graph/Chart)                              II-60


III. COMPETITIVE LANDSCAPE


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Number of Pages: 493

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