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HEPATITIS C VIRUS AND THERAPEUTICS - A GLOBAL MARKET REPORT   

Research Abstract

This report analyzes the global market for Hepatitis C Virus And Therapeutics in US$ Millions. Annual estimates and forecasts are provided for each region for the period 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.

Code : MCP-1858
Price : $3950
Companies : 123
Pages : 466
Date : April 2009
Market Data Tables : 209

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 TABLE OF CONTENTS

  HEPATITIS C VIRUS AND THERAPEUTICS (Complete Report) Pages : 466   | $3950
 
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS3$100
   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 SUMMARY95$3000
  1. Industry Overview.....II-122 $2200  
   Outlook .....II-1
Table 1: World Recent Past, Current and Future Analysis for Hepatitis C Virus Therapeutics Market - Annual Sales Figures in US$ Million for the Years 2006 through 2015 (includes corresponding Graph/Chart).....II-1
1$300
   Pegylated Alpha Interferon Plus Ribavirin – The Standard Therapy for HCV.....II-2
Table 2: HCV Treatment Market in the US (2007, 2008): Number of Patients Undergoing Treatment with PEG-IFN and Ribavirin Drugs.....II-2
Protease Inhibitors (PIs) - Way Above Others in HCV Pipeline.....II-2
Protease Inhibitor Drugs in Pipeline by Company and Development Stage.....II-2
1$300
   SCH 900518 – Schering’s Next-Generation Protease Inhibitor.....II-3
Telaprevir (VX-950) – The Most Promising Pipeline HCV Protease Inhibitor.....II-3
1$100
   Telaprevir, in Combination with Ribavirin and Pegylated Interferon, Shortens
  Therapy Duration.....II-4
Boceprevir – Schering’s PI Class Lead Candidate.....II-4
Comparison Between VX-950 and SCH 503034.....II-4
1$100
   Telaprevir and Boceprevir – A Comparison.....II-5
Polymerase Inhibitors (PLIs) – Adding More Teeth to HCV Pipeline.....II-5
Viral Polymerases.....II-5
1$100
   Polymerase Inhibitor Drugs in Pipeline by Company, Category, and Development
  Stage.....II-6
1$100
   Comparison of Antiviral Properties in Select Polymerase Inhibitor Drugs.....II-7
R7128 – A Promising PLI Class Drug.....II-7
Development of PLIs Remains a Challenge for HCV Researchers.....II-7
Industry in Search of Novel STAT-C Drugs.....II-7
1$100
   Non-Interferon Combination Therapies Gain Traction.....II-8
Specific Antiviral Activity of Select HCV Drug Classes.....II-8
Select NS5A Inhibitors, Entry Inhibitors, and Thiazolides in Pipeline by Company and
  Development Stage.....II-8
1$100
   Researchers Show Continuous Appetite for Immunomodulators and Other Classes.....II-9
Oral Interferon Makes Treatment Easier.....II-9
Immunomodulators in Pipeline by Company, and Development Stage.....II-9
Alpha Interferons and Ribavirin – Continue to Stay in HCV Market.....II-9
1$100
   Interferon-based Drugs in Pipeline by Company and Development Stage.....II-10
Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients Treated with Interferon Drugs in Select Countries (includes corresponding Graph/Chart).....II-10
Albuferon – Rising Above the Standards.....II-10
1$300
   Viramidine – Next-Generation Ribavirin Drug.....II-11
PEG-Interferon ? (lambda): A Type III Interferon.....II-11
Adjuvant Therapies to Compete with Mainline Therapies.....II-11
1$100
   Cyclophilin Analogs and Fibrosis/Inflammation Inhibitors in Pipeline by
  Company.....II-12
Vaccine Development Remains at Low Scale.....II-12
HCV Therapeutic Vaccines in Pipeline by Company, and Development Stage.....II-12
High Mutation Rates Keep HCV Elusive.....II-12
1$100
   Genotype I – Least Responsive and Most Common Variant of HCV.....II-13
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-13
1$300
   Decisive Factors For Success of New HCV Therapeutics.....II-14
Novel HCV Therapies: Challenges Ahead.....II-14
HCV Treatment Costs to Escalate.....II-14
1$300
   Table 5: HCV Treatment Market: Cost Structure for Years 2007 through 2016 and Beyond (includes corresponding Graph/Chart).....II-15
Roche & Schering – Dominant Players in HCV Therapeutics Market.....II-15
HCV Drugs from Roche & Schering.....II-15
1$100
   Partnerships in R&D Become Order of the Day.....II-16
Select Partnership Deals in HCV Drug Development Programs.....II-16
1$100
   Market Drivers/Constraints.....II-17
Treatment-Experienced Patients – A Potential Opportunity for Developers.....II-17
Education Campaigns to Magnify Patient Diagnosis Rates.....II-17
Stigmatization and Discrimination – Major Hurdles for HCV Treatment.....II-17
1$100
   Treatment with Current Therapies Plagued by Side Effects.....II-18
Side Effects Associated with HCV Treatment Therapies.....II-18
1$100
   Hemolytic Anemia – A Key Side Effect with Ribavirin.....II-19
Epidemiology.....II-19
Quick Facts about HCV Infection.....II-19
1$300
   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-20

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-20
Low-Treatment Rates vis-à-vis Patient Population.....II-20
1$300
   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-21

Table 9: HCV Prevalence in Europe (2006): Number of Reported and Un-diagnosed Cases of HCV Infection in Select Countries (includes corresponding Graph/Chart).....II-21
1$300
   The Effect of Race Factor.....II-22
Factors Influencing HCV Treatment Market.....II-22
Drivers.....II-22
Bottle Necks.....II-22
1$100
  2. HCV Medication - Approved & Pipeline Drugs.....II-2310 $1000  
   Approved Drugs for HCV Treatment.....II-23
Interferons – The Backbone of HCV Treatment.....II-23
Intron® A.....II-23
Roferon A.....II-23
Infergen.....II-23
PEG-Intron®.....II-23
Pegasys.....II-23
1$100
   FDA Approval of Interferons for Use as Monotherapy in Chronic Hepatitis C
  Treatment.....II-24
Ribavirin – Antiviral Drug for HCV Treatment.....II-24
Rebetol®.....II-24
Copegus.....II-24
1$300
   Table 10: Global HCV Therapeutics Market: Annual Sales of Select Interferons & Ribavirins offered by Major Players - Roche and Schering for the Years 2003 through 2008 (In US$ Million) (includes corresponding Graph/Chart).....II-25
Drugs in Pipeline for HCV Treatment.....II-25
BI-201335 – A Protease Inhibitor.....II-25
ITMN-191 (R7227) - An Oral HCV NS3/4A Protease Inhibitor.....II-25
1$100
   IDX184 – A Polymerase Inhibitor.....II-26
PSI-7851 – An Analog Polymerase Inhibitor.....II-26
A-831 & A-832: NS5A Inhibitors in Pipeline.....II-26
ITX5061 - HCV Entry Inhibitor.....II-26
1$100
   Debio 025 – A Cyclophilin Inhibitor.....II-27
ANA773 - A TLR9 Agonist.....II-27
SPC3649 (LNA-antimiRTM-122): microRNA in Pipeline.....II-27
1$100
   Bavituximab – A Potent Anti-Phospholipid Antibody.....II-28
Celgosivir (MX- 3253) - A Glucosidase I Inhibitor.....II-28
PF-03491390 – A Caspase Inhibitor.....II-28
1$100
   Taribavirin - A Nucleoside Analogue Inhibitor.....II-29
Select HCV Drugs Under Pipeline (Phase III/Phase II) by Company.....II-29
1$100
   Select HCV Drugs Under Pipeline (Phase I) by Company.....II-301$100
   Select HCV Drugs in Pre-Clinical/Research Stage by Company.....II-311$100
   Select HCV Drugs with Cancelled Clinical Studies by Company.....II-32
1$100
  3. Hepatitis C Virus - An Overview.....II-3320 $2000  
   Hepatitis A Virus.....II-33
Hepatitis B Virus.....II-33
Hepatitis C Virus.....II-33
History.....II-33
Structure.....II-33
1$100
   Components of HCV Genome.....II-34
NS4B – A Hydrophobic Protein.....II-34
Life Cycle.....II-34
1$100
   Genotypes.....II-35
Prevalence of HCV Genotypes in Select Geographic Regions.....II-35
Table 11: Percentage Breakdown of Viral Load Levels (High and Low) in Common Genotypes.....II-35
Physicochemical and Morphology Properties.....II-35
1$300
   Transmission of HCV.....II-36
Injection Drugs.....II-36
Sexual Contact.....II-36
Tattoos and Body Piercing.....II-36
Contaminated Medical Equipment.....II-36
1$100
   Occupational Risks.....II-37
Personal Care Goods.....II-37
Mother-to-Baby.....II-37
Blood and Blood Products.....II-37
Transmission of Hepatitis Virus.....II-37
1$100
   HCV Risk Groups.....II-38
Types of Infection.....II-38
Chart: HCV Infection Outcome.....II-38
Acute Hepatitis C.....II-38
1$100
   Figure: Natural History of Hepatitis C.....II-39
Chronic Hepatitis C.....II-39
Damage to Liver.....II-39
1$100
   Stages and Symptoms.....II-40
Stages in Chronic HCV Condition.....II-40
1$100
   Symptoms of Liver Disease in Chronic HCV Condition.....II-41
Common Symptoms.....II-41
Uncommon Symptoms (Indications of Severe Liver Disease).....II-41
Complications Due to Chronic HCV Infection.....II-41
1$100
   HCV Intensifies Risk of Lymphoma.....II-42
Diagnosis.....II-42
Tests to Confirm HCV Presence.....II-42
Antibody Tests.....II-42
1$100
   ELISA.....II-43
RIBA.....II-43
HCV RNA Test.....II-43
1$100
   Other Test Types.....II-44
ALT Tests.....II-44
Genotype Tests.....II-44
Liver Biopsy.....II-44
Treatment for HCV Infection.....II-44
Monotherapy.....II-44
1$100
   Brief Description of Approved Drugs for Monotherapy Treatment.....II-45
Comparison of Response of Interferon Based Drugs in Chronic Hepatitis C
  Treatment.....II-45
Interferons – An Overview.....II-45
1$100
   Interferons Working Mechanism.....II-46
Interferon Types.....II-46
1$100
   Combination Therapy.....II-47
Table 12: Approved Drugs for HCV Combination Therapy.....II-47
1$300
   Table 13: Major Side Effects Associated with Pegasys + Copegus, and Pegasys (includes corresponding Graph/Chart).....II-48

Table 14: Effectiveness of PEG-Intron, Pegasys, and PEG-Intron + Ribavirin in HCV Treatment Therapy (includes corresponding Graph/Chart).....II-48
1$300
   Table 15: Data for 20-Year Risks and Other Related Aspects in HCV Patients (Treated and Untreated Patients).....II-49
Alternative Therapies.....II-49
Vaccine.....II-49
Liver Transplantation.....II-49
1$100
   Treatment Costs.....II-50
Types of Treatment Responses.....II-50
Sustained Response.....II-50
Relapsing (Transient) Response.....II-50
Breakthrough Response.....II-50
Null Response.....II-50
1$100
   Monitoring Tests.....II-51
Laboratory tests.....II-51
Medical Examinations.....II-51
Prevention.....II-51
1$100
   HBV-HCV Coinfection.....II-52
Treatment Options for HBV-HCV Coinfected Patients.....II-52
1$100
  4. Regional Perspective.....II-5314 $1400  
   United States.....II-53
Table 16: HCV Infection in the US: Number of Infected People for the Years 2006, 2007 and 2008 (in '000s) (includes corresponding Graph/Chart).....II-53

Table 17: 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-53
1$300
   HCV Infection – Ethnicity.....II-54
Table 18: HCV Prevalence in the US (1999-2002): Prevalence Rate by Age and Race (includes corresponding Graph/Chart).....II-54
African-Americans React Poorly to Treatment.....II-54
1$300
   Genotype 1 – The Most Prevalent HCV Strain.....II-55
Table 19: HCV Prevalence in the US (2005): Prevalence by Genotype (In %).....II-55
Falling HCV Incidences in the US.....II-55
Table 20: Acute HCV Infection Incidences in the US for the Years 1996 through 2007 (includes corresponding Graph/Chart).....II-55
1$300
   Table 21: US HCV Market (2006): Incidence of Acute Hepatitis C by Age Group and Gender (includes corresponding Graph/Chart).....II-56
HCV in Children.....II-56
1$100
   Unresolved Factors.....II-57
Treatment Options.....II-57
US Scientists Develop Monoclonal Antibody to Neutralize HCV.....II-57
Canada.....II-57
1$100
   Australia.....II-58
Table 22: Modes of HCV Infection Transmission in Australia (includes corresponding Graph/Chart).....II-58
1$300
   Table 23: Hepatitis C Infection in Australia (2000): Rate of Incidence by Age Group and Gender (includes corresponding Graph/Chart).....II-59
China.....II-59
1$100
   India.....II-60
Egypt.....II-60
1$100
   France.....II-61
The Netherlands.....II-61
Table 24: HCV Infection Prevalence in Risk Groups in the Netherlands.....II-61
Brazil.....II-61
Sportspersons Expose to HCV Risks.....II-61
1$300
   Central and Eastern Europe.....II-62
HCV Prevalence Rate Higher in Injection Drug Users.....II-62
Alarming Rates of HIV/HCV Co-Infection.....II-62
1$300
   Table 25: 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-63
Testing and Counseling Structure Poorly Developed.....II-63
1$100
   Depleted Testing Schemes for Prisoners.....II-64
Scarcity Prevails at Health Care Providers and Governments As Well.....II-64
Practical Availability of PEG-IFN Remains Limited.....II-64
Dearth in Political Commitment.....II-64
1$100
   HCV Diagnostic Tests and Treatment in Select CEE Countries.....II-65
Bulgaria.....II-65
Czech Republic.....II-65
Hungary.....II-65
Romania.....II-65
Russia.....II-65
1$100
   Ukraine.....II-66
Availability of Testing Protocols for HCV in Select CEE Countries.....II-66
1$100
  5. Drug Approvals & Clinical Trials.....II-679 $900  
   Pharmasset Initiates Phase Ib Clinical Study of PSI-7851 in Chronic HCV
  Patients.....II-67
Chugai Initiates Phase I Trial for NA 808 HCV Drug.....II-67
Aethlon Medical Releases Positive Clinical Data with Aethlon Hemopurifier®.....II-67
Schering-Plough Receives FDA Approval for HCV Drug in Children.....II-67
1$100
   Human Genome Reveals Data on Phase III Clinical Trial on Albuferon.....II-68
Canopus Initiates Phase II Clinical Trial for Hepatitis C Drug - CB5300.....II-68
Vertex to Initiate Phase III Trial of Telaprevir.....II-68
Amarillo and CytoPharm to Initiate Phase II Study of Novel Oral Interferon.....II-68
Biolex Releases Locteron® Phase IIa Trial Results.....II-68
1$100
   Schering-Plough Releases Details of Boceprevir Phase II Study.....II-69
Progenics Focuses on HCV Entry Inhibitors.....II-69
1$100
   ZymoGenetics Reveals Phase Ib Results of IL-29.....II-70
Phenomix Begins Phase Ia Study of PHX1766.....II-70
Inovio and Tripep Release Additional Interim Results for ChronVac-C®.....II-70
1$100
   InterMune Starts Clinical Study of ITMN-191.....II-71
Roche and Associates Commence Clinical Trial of All-Oral Dual-Antiviral
  Therapy.....II-71
GlobeImmune Announces Phase II Clinical Trials with GI-5005.....II-71
1$100
   Human Genome Gets Encouraging Interim Results with Albuferon.....II-72
Intarcia Releases Study Results of Omega Interferon.....II-72
Nautilus Biotech Commences Phase I Study for Belerofon®.....II-72
1$100
   Migenix Announces Phase II Proof-of-Concept Study Results of Celgosivir.....II-73
Pharmasset Begins Multiple Dose-Escalating Study of R7128.....II-73
Transgene Commences Phase I Trial of TG4040.....II-73
Debiopharm Releases Phase Ib Results of Debio 025.....II-73
1$100
   Nabi Biopharmaceuticals Starts Proof-Of-Concept Trial for Civacir.....II-74
Peregrine Announces Positive Results for Bavituximab.....II-74
Jenken to Commence Phase II Trial of JBK-122.....II-74
1$100
   Pevion Biotech Initiates Phase I Study of Hepatitis C Vaccine.....II-75
Intercell Releases Phase II Findings of IC41.....II-75
1$100
  6. Recent Industry Activity.....II-7610 $1000  
   Roche Acquires Genentech.....II-76
Schering-Plough to Merge with Merck.....II-76
Valeant Enters into Agreement with Schering-Plough for HCV Drug – Taribavirin.....II-76
ImQuest and Arisyn Receive Grant for Developing Novel HCV Therapeutic Agent.....II-76
1$100
   Virco Signs an Agreement with Siemens Healthcare.....II-77
Indian Government Issues Patent to Roche’s HCV Drug – Pegasys.....II-77
Vertex Takes Over HCV and HIV Drug Development Company, ViroChem.....II-77
InterMune Wins US Patent for HCV Drug - ITMN-191.....II-77
BMS Collaborates with ZymoGenetics for Developing HCV Drug.....II-77
Quest Diagnostics Develops New Quantitative Test for HCV.....II-77
1$100
   Three Rivers Acquires Infergen®.....II-78
International Consolidated Cos Takes Over China Gene.....II-78
Hologic Signs Definitive Deal to Acquire Third Wave.....II-78
1$100
   GlaxoSmithKline Inks Deal to Take Over Genelabs.....II-79
Biolex Signs Deal to Purchase OctoPlus’ Stake in Locteron®.....II-79
OraSure and Schering-Plough Form Global Alliance.....II-79
Tacere and Oncolys Sign Licensing Agreement.....II-79
1$100
   Beckman Wins HCV Diagnostics Rights from Siemens Healthcare.....II-80
Anadys Secures FDA Fast Track Designation for its Lead Drug Candidate.....II-80
Roche Bags European Commission Approval for Combination Therapy.....II-80
Roche Receives European Commission Approval for Shortened Hepatitis C Therapy.....II-80
iTherX Establishes Advisory Board for Hepatitis C Advanced Therapeutics.....II-80
1$100
   SciClone Terminates Zadaxin®.....II-81
Tacere Therapeutics Signs Agreement with Pfizer for RNAi Hepatitis C Drug.....II-81
OraSure Technologies Files PMA Application for OraQuickÒ HCV Test.....II-81
GENOVAC Develops New Therapy for HCV.....II-81
AstraZeneca Acquires Arrow Therapeutics.....II-81
1$100
   Cubist Takes Over Illumigen.....II-82
China Medical to Take Over Beijing Bio-Ekon.....II-82
Schering-Plough Collaborates with OraSure.....II-82
Pro-Pharmaceuticals to Collaborate with Digna Biotech.....II-82
1$100
   Medivir and Tibotec Establish Collaboration Deal.....II-83
VGX Extends Collaboration with University of Pennsylvania.....II-83
Presidio Wins Exclusive License to Novel HCV Technology.....II-83
Roche Inks Licensing Deal with Novartis and Ortho-Clinical.....II-83
Peregrine Opens Subsidiary in China.....II-83
InterMune Completes Production Milestone.....II-83
1$100
   Arrow Expands Hepatitis C Pipeline.....II-84
Roche Wins Japanese Approval for Combination Therapy.....II-84
Schering-Plough Bags European Commission Approval for Combination Therapy.....II-84
Abbott Bags FDA Approval for Screening Test.....II-84
Abbott Bags Canadian Approval for Viral Load Tests.....II-84
Worldwide Biotech Bags Chinese FDA Approval for HCV Diagnostic Kit.....II-84
1$100
   Tibotec Applies to European Regulator to Initiate Phase I Trials.....II-85
Roche Submits Application for Novel Hepatitis C to with FDA.....II-85
Anadys Discontinues ANA975.....II-85
Cerus Bags NIH Funding for HCV Vaccine Program.....II-85
1$100
  7. Focus on Select Global Players.....II-8610 $1000  
   Abbott Diagnostics (USA).....II-86
Achillion Pharmaceuticals, Inc. (USA).....II-86
Anadys Pharmaceuticals, Inc. (USA).....II-86
Boehringer Ingelheim GmbH (Germany).....II-86
1$100
   Bristol-Myers Squibb Company (USA).....II-87
F. Hoffmann-La Roche Ltd. (Switzerland).....II-87
1$100
   GlaxoSmithKline plc (UK).....II-881$100
   Hayashibara Biochemical Labs, Inc. (Japan).....II-89
HemispheRx Biopharma, Inc. (USA).....II-89
Human Genome Sciences (USA).....II-89
1$100
   Idenix Pharmaceuticals, Inc. (USA).....II-90
Innogenetics NV (Belgium).....II-90
InterMune, Inc. (USA).....II-90
1$100
   Intarcia Therapeutics, Inc. (USA).....II-91
Medivir AB (Sweden).....II-91
1$100
   Merck & Co., Inc. (USA).....II-92
Novartis AG (Switzerland).....II-92
Chiron Corporation (USA).....II-92
1$100
   Pfizer, Inc. (USA).....II-93
Schering-Plough Corporation (USA).....II-93
1$100
   Tibotec Pharmaceuticals Ltd. (Ireland).....II-94
Tripep AB (Sweden).....II-94
Toray Industries, Inc. (Japan).....II-94
1$100
   Valeant Pharmaceuticals International (USA).....II-95
Vertex Pharmaceuticals, Inc. (USA).....II-95
1$100
III. COMPETITIVE LANDSCAPE 371$995
  
Total Companies Profiled: 123 (including Divisions/Subsidiaries - 127 )

Region/Country                 Players


The United States                77
Canada                            4
Japan                             5
Europe                           27 
     France                       3  
     Germany                      2
     The United Kingdom           4
     Italy                        1
     Spain                        1
     Rest of Europe              16
Asia-Pacific (Excluding Japan)   12
Middle East                       2
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