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Hepatitis C Virus And Therapeutics - A Global Strategic Business Report

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USD $3,950.00
ISBN/SKU #:
GIA-MCP1858
Research Group:
Global Industry Analysts
Date of Publication:
April 2009
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Summary

This report analyzes the worldwide markets for Hepatitis C Virus And Therapeutics in US$ Millions. Annual forecasts are provided for each region for the period of 2006 through 2015. The report profiles 123 companies including many key and niche players such as Abbott Diagnostics, Achillion Pharmaceuticals, Inc., Anadys Pharmaceuticals, Inc., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc, Hayashibara Biochemical Labs, Inc., HemispheRx Biopharma, Inc., Human Genome Sciences, Idenix Pharmaceuticals, Inc., Innogenetics NV, InterMune, Inc., Intarcia Therapeutics, Inc., Medivir AB, Merck & Co., Inc., Novartis AG, Chiron Corporation, Pfizer, Inc., Schering-Plough Corporation, Tibotec Pharmaceuticals Ltd., Tripep AB, Toray Industries, Inc., Valeant Pharmaceuticals International, and Vertex Pharmaceuticals, 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

HEPATITIS C VIRUS AND THERAPEUTICS
A GLOBAL STRATEGIC BUSINESS REPORT						MCP-1858


                                           CONTENTS


  I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

      Study Reliability and Reporting Limitations                       I-1
      Disclaimers                                                       I-2
      Data Interpretation & Reporting Level                             I-2
      Product Definition and Scope of Study                             I-3
       Hepatitis C Virus                                                I-3


 II. EXECUTIVE SUMMARY

  1. Industry Overview                                                  II-1
      Market Outlook                                                    II-1
       Table 1: World Recent Past, Current and Future Analysis for
       Hepatitis C Virus Therapeutics Market – Annual Sales Figures
       in US$ Million for the Years 2006 through 2015 (includes
       corresponding Graph/Chart)                                       II-1
      Market Overview                                                   II-2
       Pegylated Alpha Interferon Plus Ribavirin – The Standard Therapy II-2
        Approved Drugs for HCV Combination Therapy                      II-2
         Table 2: HCV Treatment Market in the US (2007-2010): Number
         of Patients Undergoing Treatment with PEG-IFN and Ribavirin
         Drugs (includes corresponding Graph/Chart)                     II-2
       Alpha Interferons and Ribavirin are Here to Stay                 II-3
        Interferon-based Drugs in Pipeline by Company and
         Development Stage                                              II-3
         Table 3: HCV Treatment Market in Europe (2007): Percentage
         of Patients Treated with Interferon Drugs in Select
         Countries (includes corresponding Graph/Chart)                 II-3
        Albuferon – Rising Above the Standards                          II-4
        Viramidine – Next-Generation Ribavirin Drug                     II-4
       High Mutation Rates Keep HCV Elusive                             II-4
       Genotype I – Least Responsive and Most Common Variant of HCV     II-4
        Table 4: Distribution of Genotypes: As a Percentage of Total
        Infected Population in Select Pharmaceutical Markets - USA,
        France, Germany, Italy, Spain, and Global (includes
        corresponding Graph/Chart)                                      II-5
       Protease Inhibitors (PIs) - Way Above Others                     II-5
        Protease Inhibitor Drugs in Pipeline by Company and
         Development Stage                                              II-6
        SCH 900518 – Schering’s Next-Generation Protease Inhibitor      II-6
        Telaprevir (VX-950) – The Most Promising Pipeline HCV
         Protease Inhibitor                                             II-6
        Boceprevir – Schering’s PI Class Lead Candidate                 II-7
        Comparison Between Telaprevir and Boceprevir                    II-7
         Telaprevir and Boceprevir – A Comparison                       II-8
       Polymerase Inhibitors (PLIs) – Adding More Teeth to HCV Pipeline II-8
        Viral Polymerases                                               II-8
         Polymerase Inhibitor Drugs in Pipeline by Company,
          Category, and Development Stage                               II-9
         Comparison of Antiviral Properties in Select Polymerase
          Inhibitor Drugs                                               II-9
        R7128 – A Promising PLI Class Drug                              II-10
        Development of PLIs Remains a Challenge for HCV Researchers     II-10
       Industry in Search of Novel STAT-C Drugs                         II-10
        Specific Antiviral Activity of Select HCV Drug Classes          II-10
        Select NS5A Inhibitors, Entry Inhibitors, and Thiazolides in
         Pipeline by Company and Development Stage                      II-11
       Researchers Show Continued Appetite for Immunomodulators and
        Other Classes                                                   II-11
        Immunomodulators in Pipeline by Company, and Development Stage  II-11
       Adjuvant Therapies to Compete with Mainline Therapies            II-12
        Cyclophilin Analogs and Fibrosis/Inflammation Inhibitors in
         Pipeline by Company                                            II-12
       Vaccine Development Remains at Low Scale                         II-12
        HCV Vaccines in Pipeline by Company, and Development Stage      II-12
       Decisive Factors For Success of New HCV Therapeutics             II-13
       HCV Treatment Costs to Escalate                                  II-13
        Table 5: HCV Treatment Market: Cost Structure for Years 2007
        through 2016 and Beyond (includes corresponding Graph/Chart)    II-13
       Roche & Schering – Dominant Players in HCV Therapeutics Market   II-14
        HCV Drugs from Roche & Schering                                 II-14
       Partnerships in R&D Become Order of the Day                      II-14
        Select Partnership Deals in HCV Drug Development Programs       II-15
      Market Drivers/Constraints                                        II-16
       Treatment-Experienced Patients – A Potential Opportunity for
        Developers                                                      II-16
       Education Campaigns to Magnify Patient Diagnosis Rates           II-16
       Stigmatization and Discrimination – Major Hurdles for HCV
        Treatment                                                       II-16
       Treatment with Current Therapies Plagued by Side Effects         II-16
        Side Effects Associated with HCV Treatment Therapies            II-17
        Hemolytic Anemia – A Key Side Effect with Ribavirin             II-18
      Epidemiology                                                      II-18
       Quick Facts about HCV Infection                                  II-18
        Table 6: Recent Estimates for HCV Infected Population in
        Millions By Region – Far East Asia, South East Asia, East
        Mediterranean, West Europe, Africa, South America, USA,
        Canada, and Australia                                           II-18

        Table 7: Global HCV Market (2006): Prevalence and Incidence
        Rate of HCV Infected Population by Select Country –
        Australia, Canada, China, New Zealand, and Switzerland
        (includes corresponding Graph/Chart)                            II-19
       Low-Treatment Rates vis-ŕ-vis Patient Population                 II-19
        Table 8: HCV Epidemiology in Major Pharmaceutical Markets:
        Patients in Thousands Collectively in the US, France,
        Germany, Italy, Spain and the UK (includes corresponding
        Graph/Chart)                                                    II-19

        Table 9: HCV Prevalence in Europe (2006): Number of Total,
        Reported and Un-diagnosed Cases of HCV Infection in Select
        Countries (includes corresponding Graph/Chart)                  II-20
       Factors Influencing HCV Treatment Market                         II-20
        Drivers                                                         II-20
        Bottle Necks                                                    II-20

  2. HCV Medication - Approved & Pipeline Drugs                         II-21
      Approved Drugs for HCV Treatment                                  II-21
       Interferons – The Backbone of HCV Treatment                      II-21
        FDA Approval of Interferons for Use as Monotherapy in
         Chronic Hepatitis C Treatment                                  II-22
       Ribavirin – Antiviral Drug for HCV Treatment                     II-22
        Table 10: Global HCV Therapeutics Market: Annual Sales of
        Select Interferons & Ribavirins offered by Major Players -
        Roche and Schering for the Years 2003 through 2008 (In US$
        Million) (includes corresponding Graph/Chart)                   II-23
      Drugs in Pipeline for HCV Treatment                               II-23
       Select HCV Drugs Under Pipeline (Phase III/Phase II) by Company  II-23
       Select HCV Drugs Under Pipeline (Phase I) by Company             II-24
       Select HCV Drugs in Pre-Clinical/Research Stage by Company       II-25
       Select HCV Drugs with Cancelled Clinical Studies by Company      II-26

  3. Hepatitis C Virus - An Overview                                    II-27
      Hepatitis A Virus                                                 II-27
      Hepatitis B Virus                                                 II-27
      Hepatitis C Virus                                                 II-27
       History                                                          II-27
       Structure                                                        II-27
      Components of HCV Genome                                          II-28
       Life Cycle                                                       II-28
       Genotypes                                                        II-28
        Prevalence of HCV Genotypes in Select Geographic Regions        II-29
         Table 11: Percentage Breakdown of Viral Load Levels (High
         and Low) in Common Genotypes                                   II-29
       Physicochemical and Morphology Properties                        II-29
       Transmission of HCV                                              II-30
        Injection Drugs                                                 II-30
        Sexual Contact                                                  II-30
        Tattoos and Body Piercing                                       II-30
        Contaminated Medical Equipment                                  II-30
        Occupational Risks                                              II-30
        Personal Care Goods                                             II-30
        Mother-to-Baby                                                  II-30
        Blood and Blood Products                                        II-30
         Transmission of Hepatitis Virus                                II-31
       HCV Risk Groups                                                  II-31
       Types of Infection                                               II-32
        Chart: HCV Infection Outcome                                    II-32
        Acute Hepatitis C                                               II-32
         Figure: Natural History of Hepatitis C                         II-32
        Chronic Hepatitis C                                             II-33
         Stages and Symptoms                                            II-33
          Stages in Chronic HCV Condition                               II-33
          Symptoms of Liver Disease in Chronic HCV Condition            II-34
          Complications Due to Chronic HCV Infection                    II-34
       Diagnosis                                                        II-34
        Tests to Confirm HCV Presence                                   II-35
         HCV IgG Antibody Test                                          II-35
          HCV RNA Test                                                  II-35
          HCV Core Antigen EIA                                          II-36
          Genotype Tests                                                II-36
          Liver Biopsy                                                  II-36
       Treatment for HCV Infection                                      II-36
        Monotherapy                                                     II-36
         Brief Description of Approved Drugs for Monotherapy Treatment  II-37
         Comparison of Response of Interferon Based Drugs in Chronic
          Hepatitis C Treatment                                         II-37
        Combination Therapy                                             II-37
         Table 12: Major Side Effects Associated with HCV Treatment
         with Pegasys + Copegus Combination Therapy and Pegasys
         Monotherapy (includes corresponding Graph/Chart)               II-38

         Table 13: Comparison Between PEG-Intron and Pegasys in
         Monotherapy and Combination Therapy in HCV Treatment
         (includes  corresponding Graph/Chart)                          II-38

         Table 14: Data for 20-Year Risks and Other Related Aspects
         in Treatment Given and Untreated HCV Patients                  II-39
        Alternative Therapies                                           II-39
        Vaccine                                                         II-39
        Liver Transplantation                                           II-39
       Treatment Costs                                                  II-40
       Types of Treatment Responses                                     II-40
        Sustained Response                                              II-40
        Relapsing (Transient) Response                                  II-40
        Breakthrough Response                                           II-40
        Null Response                                                   II-40
       Monitoring Tests                                                 II-41
        Laboratory tests                                                II-41
        Medical Examinations                                            II-41
       Prevention                                                       II-41

  4. Regional Perspective                                               II-42
      United States                                                     II-42
       Table 15: HCV Infection in the US: Number of Infected People
       for the Years 2006, 2007 and 2008 (in '000s) (includes
       corresponding Graph/Chart)                                       II-42

       Table 16: HCV Infection in the US (2007): Percentage
       Breakdown of Infection Sources by Medium- Injection Drugs,
       Sexual Contact, Transfusions, Occupation - Related Exposure,
       and Others and Unknown (includes corresponding Graph/Chart)      II-42
       HCV Infection – Ethnicity                                        II-43
        Table 17: HCV Prevalence in the US (1999-2002): Prevalence
        Rate by Age and Race (includes corresponding Graph/Chart)       II-43
        African-Americans React Poorly to Treatment                     II-43
       Genotype 1 – The Most Prevalent HCV Strain                       II-44
        Table 18: HCV Prevalence in the US (2005): Prevalence by
        Genotype (In %)                                                 II-44
       Falling HCV Incidences in the US                                 II-44
        Table 19: Acute HCV Infection Incidences in the US for the
        Years 1996 through 2007 (includes corresponding Graph/Chart)    II-44

        Table 20: US HCV Market (2006): Incidence of Acute Hepatitis
        C by Age Group and Gender (includes corresponding
        Graph/Chart)                                                    II-45
      Canada                                                            II-45
      Australia                                                         II-46
       Table 21: Modes of HCV Infection Transmission in Australia
       (includes corresponding Graph/Chart)                             II-46

       Table 22: Hepatitis C Infection in Australia (2000): Rate of
       Incidence by Age Group and Gender (includes corresponding
       Graph/Chart)                                                     II-47
      India                                                             II-47
      Egypt                                                             II-47
      France                                                            II-48
      The Netherlands                                                   II-48
       Table 23: HCV Infection Prevalence in Risk Groups in the
       Netherlands                                                      II-49
      Central and Eastern Europe                                        II-49
       HCV Prevalence Rate Higher in Injection Drug Users               II-49
       Alarming Rates of HIV/HCV Co-Infection                           II-49
        Table 24: HIV/HCV Co-Infection in CEE (2005): Number of HIV
        Patients and Percentage of HIV Patients infected with HCV in
        Select CEE Countries (includes corresponding Graph/Chart)       II-50
       Testing and Counseling Structure Poorly Developed                II-50
       Depleted Testing Schemes for Prisoners                           II-51
       Scarcity Prevails at Health Care Providers and Governments As
        Well                                                            II-51
       Practical Availability of PEG-IFN Remains Limited                II-51
       Dearth in Political Commitment                                   II-51
       HCV Diagnostic Tests and Treatment in Select CEE Countries       II-52
        Bulgaria                                                        II-52
        Czech Republic                                                  II-52
        Hungary                                                         II-52
        Romania                                                         II-52
        Russia                                                          II-52
        Ukraine                                                         II-53
         Availability of Testing Protocols for HCV in Select CEE
          Countries                                                     II-53

  5. Drug Approvals & Clinical Trials                                   II-54
      Vertex to Initiate Phase III Trial of Telaprevir                  II-54
      Amarillo and CytoPharm to Initiate Phase II Study of Novel
       Oral Interferon                                                  II-54
      Biolex Releases Locteron® Phase IIa Trial Results                 II-54
      Schering-Plough Releases Details of Boceprevir Phase II Study     II-54
      Progenics Releases Pre-Clinical Results of PRO 206                II-55
      ZymoGenetics Reveals Phase Ib Results of IL-29                    II-55
      Phenomix Begins Phase Ia Study of PHX1766                         II-56
      Inovio and Tripep Release Additional Interim Results for
       ChronVac-C®                                                      II-56
      InterMune Starts Clinical Study of ITMN-191                       II-57
      Roche and Associates Commence Clinical Trial of All-Oral Dual
       -Antiviral Therapy                                               II-57
      GlobeImmune Announces Phase II Clinical Trials with GI-5005       II-57
      Human Genome Gets Encouraging Interim Results with Albuferon      II-58
      Intarcia Releases Study Results of Omega Interferon               II-58
      Nautilus Biotech Commences Phase I Study for Belerofon®           II-58
      Migenix Announces Phase II Proof-of-Concept Study Results of
       Celgosivir                                                       II-59
      Pharmasset Begins Multiple Dose-Escalating Study of R7128         II-59
      Transgene Commences Phase I Trial of TG4040                       II-59
      Debiopharm Releases Phase Ib Results of Debio 025                 II-59
      Nabi Biopharmaceuticals Starts Proof-Of-Concept Trial for Civacir II-60
      Peregrine Announces Positive Results for Bavituximab              II-60
      Jenken to Commence Phase II Trial of JBK-122                      II-60
      Pevion Biotech Initiates Phase I Study of Hepatitis C Vaccine     II-61
      Intercell Releases Phase II Findings of IC41                      II-61

  6. Recent Industry Activity                                           II-62
      Three Rivers Acquires Infergen®                                   II-62
      International Consolidated Cos Takes Over China Gene              II-62
      Hologic Signs Definitive Deal to Acquire Third Wave               II-62
      GlaxoSmithKline Inks Deal to Take Over Genelabs                   II-62
      Biolex Signs Deal to Purchase OctoPlus’ Stake in Locteron®        II-63
      OraSure and Schering-Plough Form Global Alliance                  II-63
      Tacere and Oncolys Sign Licensing Agreement                       II-63
      Beckman Wins HCV Diagnostics Rights from Siemens Healthcare       II-63
      Anadys Secures FDA Fast Track Designation for its Lead Drug
       Candidate                                                        II-64
      Roche Bags European Commission Approval for Combination Therapy   II-64
      Roche Receives European Commission Approval for Shortened
       Hepatitis C Therapy                                              II-64
      iTherX Establishes Advisory Board for Hepatitis C Advanced
       Therapeutics                                                     II-64
      SciClone Terminates Zadaxin®                                      II-64
      AstraZeneca Acquires Arrow Therapeutics                           II-65
      Cubist Takes Over Illumigen                                       II-65
      China Medical to Take Over Beijing Bio-Ekon                       II-65
      Schering-Plough Collaborates with OraSure                         II-65
      Pro-Pharmaceuticals to Collaborate with Digna Biotech             II-65
      Medivir and Tibotec Establish Collaboration Deal                  II-66
      VGX Extends Collaboration with University of Pennsylvania         II-66
      Presidio Wins Exclusive License to Novel HCV Technology           II-66
      Roche Inks Licensing Deal with Novartis and Ortho-Clinical        II-66
      Peregrine Opens Subsidiary in China                               II-66
      InterMune Completes Production Milestone                          II-66
      Arrow Expands Hepatitis C Pipeline                                II-67
      Roche Wins Japanese Approval for Combination Therapy              II-67
      Schering-Plough Bags European Commission Approval for
       Combination Therapy                                              II-67
      Abbott Bags FDA Approval for Screening Test                       II-67
      Abbott Bags Canadian Approval for Viral Load Tests                II-67
      Phynova Bags FDA Approval for IND Application                     II-67
      Worldwide Biotech Bags Chinese FDA Approval for HCV Diagnostic
       Kit                                                              II-68
      Tibotec Applies to European Regulator to Initiate Phase I Trials  II-68
      Roche Submits Application for Novel Hepatitis C to with FDA       II-68
      Anadys Discontinues ANA975                                        II-68
      Cerus Bags NIH Funding for HCV Vaccine Program                    II-68

  7. Focus on Select Global Players                                     II-69
      Abbott Diagnostics (USA)                                          II-69
      Achillion Pharmaceuticals, Inc. (USA)                             II-69
      Anadys Pharmaceuticals, Inc. (USA)                                II-69
      Boehringer Ingelheim GmbH (Germany)                               II-69
      Bristol-Myers Squibb Company (USA)                                II-70
      F. Hoffmann-La Roche Ltd. (Switzerland)                           II-70
      GlaxoSmithKline plc (UK)                                          II-71
      Hayashibara Biochemical Labs, Inc. (Japan)                        II-72
      HemispheRx Biopharma, Inc. (USA)                                  II-72
      Human Genome Sciences (USA)                                       II-72
      Idenix Pharmaceuticals, Inc. (USA)                                II-73
      Innogenetics NV (Belgium)                                         II-73
      InterMune, Inc. (USA)                                             II-73
      Intarcia Therapeutics, Inc. (USA)                                 II-74
      Medivir AB (Sweden)                                               II-74
      Merck & Co., Inc. (USA)                                           II-75
      Novartis AG (Switzerland)                                         II-75
       Chiron Corporation (USA)                                         II-75
      Pfizer, Inc. (USA)                                                II-76
      Schering-Plough Corporation (USA)                                 II-76
      Tibotec Pharmaceuticals Ltd. (Ireland)                            II-77
      Tripep AB (Sweden)                                                II-77
      Toray Industries, Inc. (Japan)                                    II-77
      Valeant Pharmaceuticals International (USA)                       II-78
      Vertex Pharmaceuticals, Inc. (USA)                                II-78


III. COMPETITIVE LANDSCAPE

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Number of Pages: 466

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