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Published by: Global Industry Analysts
Published: Apr. 1, 2009 - 466 Pages
Table of Contents
- I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
- Study Reliability and Reporting Limitations
- Disclaimers
- Data Interpretation & Reporting Level
- Product Definition and Scope of Study
- Hepatitis C Virus
- II. EXECUTIVE SUMMARY
- 1.Industry Overview
- Market Outlook
- Table 1: World Recent Past, Current and Future Analysisfor Hepatitis C Virus Therapeutics Market - AnnualSales Figures in US$ Million for the Years 2006through 2015 (includes corresponding Graph/Chart)
- Market Overview
- Pegylated Alpha Interferon Plus Ribavirin -The Standard Therapy
- Approved Drugs for HCV Combination Therapy
- Table 2: HCV Treatment Market in the US(2007-2010): Number of Patients UndergoingTreatment with PEG-IFN and Ribavirin Drugs(includes corresponding Graph/Chart)
- Alpha Interferons and Ribavirin are Here to Stay
- Interferon-based Drugs in Pipeline by Companyand Development Stage
- Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients Treated with InterferonDrugs in Select Countries (includescorresponding Graph/Chart)
- Albuferon - Rising Above the Standards
- Viramidine - Next-Generation Ribavirin Drug
- High Mutation Rates Keep HCV Elusive
- Genotype I - Least Responsive and Most CommonVariant of HCV
- Table 4: Distribution of Genotypes: As a Percentage of Total Infected Population in Select PharmaceuticalMarkets - USA, France, Germany, Italy, Spain, andGlobal (includes corresponding Graph/Chart)
- Protease Inhibitors (PIs) - Way Above Others
- Protease Inhibitor Drugs in Pipeline by Companyand Development Stage
- SCH 900518 - Schering’s Next-GenerationProtease Inhibitor
- Telaprevir (VX-950) - The Most PromisingPipeline HCV Protease Inhibitor
- Boceprevir - Schering’s PI Class Lead Candidate
- Comparison Between Telaprevir and Boceprevir
- Telaprevir and Boceprevir - A Comparison
- Polymerase Inhibitors (PLIs) - Adding More Teethto HCV Pipeline
- Viral Polymerases
- Polymerase Inhibitor Drugs in Pipeline by Company,Category, and Development Stage
- Comparison of Antiviral Properties in SelectPolymerase Inhibitor Drugs
- R7128 - A Promising PLI Class Drug
- Development of PLIs Remains a Challenge forHCV Researchers
- Industry in Search of Novel STAT-C Drugs
- Specific Antiviral Activity of Select HCV DrugClasses
- Select NS5A Inhibitors, Entry Inhibitors, andThiazolides in Pipeline by Company andDevelopment Stage
- Researchers Show Continued Appetite forImmunomodulators and Other Classes
- Immunomodulators in Pipeline by Company,and Development Stage
- Adjuvant Therapies to Compete with MainlineTherapies
- Cyclophilin Analogs and Fibrosis/InflammationInhibitors in Pipeline by Company
- Vaccine Development Remains at Low Scale
- HCV Vaccines in Pipeline by Company, andDevelopment Stage
- Decisive Factors For Success of New HCVTherapeutics
- HCV Treatment Costs to Escalate
- Table 5: HCV Treatment Market: Cost Structurefor Years 2007 through 2016 and Beyond(includes corresponding Graph/Chart)
- Roche & Schering - Dominant Players in HCVTherapeutics Market
- HCV Drugs from Roche & Schering
- Partnerships in R&D Become Order of the Day
- Select Partnership Deals in HCV Drug DevelopmentPrograms
- Market Drivers/Constraints
- Treatment-Experienced Patients - A PotentialOpportunity for Developers
- Education Campaigns to Magnify PatientDiagnosis Rates
- Stigmatization and Discrimination - Major Hurdlesfor HCV Treatment
- Treatment with Current Therapies Plagued bySide Effects
- Side Effects Associated with HCV TreatmentTherapies
- Hemolytic Anemia - A Key Side Effect withRibavirin
- Epidemiology
- Quick Facts about HCV Infection
- Table 6: Recent Estimates for HCV Infected Populationin Millions By Region - Far East Asia, South East Asia,East Mediterranean, West Europe, Africa,South America, USA, Canada, and Australia
- Table 7: Global HCV Market (2006): Prevalenceand Incidence Rate of HCV Infected Populationby Select Country - Australia, Canada, China,New Zealand, and Switzerland (includescorresponding Graph/Chart)
- Low-Treatment Rates vis-à-vis Patient Population
- Table 8: HCV Epidemiology in Major Pharmaceutical Markets: Patients in Thousands Collectively inthe US, France, Germany, Italy, Spain andthe UK (includes corresponding Graph/Chart)
- Table 9: HCV Prevalence in Europe (2006): Numberof Total, Reported and Un-diagnosed Cases ofHCV Infection in Select Countries (includescorresponding Graph/Chart)
- Factors Influencing HCV Treatment Market
- Drivers
- Bottle Necks
- 2.HCV Medication - Approved & Pipeline Drugs
- Approved Drugs for HCV Treatment
- Interferons - The Backbone of HCV Treatment
- FDA Approval of Interferons for Use asMonotherapy in Chronic Hepatitis C Treatment
- Ribavirin - Antiviral Drug for HCV Treatment
- Table 10: Global HCV Therapeutics Market: AnnualSales of Select Interferons & Ribavirins offered byMajor Players - Roche and Schering forthe Years 2003 through 2008 (In US$ Million)(includes corresponding Graph/Chart)
- Drugs in Pipeline for HCV Treatment
- Select HCV Drugs Under Pipeline (Phase III/Phase II)by Company
- Select HCV Drugs Under Pipeline (Phase I)by Company
- Select HCV Drugs in Pre-Clinical/Research Stageby Company
- Select HCV Drugs with Cancelled Clinical Studiesby Company
- 3.Hepatitis C Virus - An Overview
- Hepatitis A Virus
- Hepatitis B Virus
- Hepatitis C Virus
- History
- Structure
- Components of HCV Genome
- Life Cycle
- Genotypes
- Prevalence of HCV Genotypes in SelectGeographic Regions
- Table 11: Percentage Breakdown of Viral LoadLevels (High and Low) in Common Genotypes
- Physicochemical and Morphology Properties
- Transmission of HCV
- Injection Drugs
- Sexual Contact
- Tattoos and Body Piercing
- Contaminated Medical Equipment
- Occupational Risks
- Personal Care Goods
- Mother-to-Baby
- Blood and Blood Products
- Transmission of Hepatitis Virus
- HCV Risk Groups
- Types of Infection
- Chart: HCV Infection Outcome
- Acute Hepatitis C
- Figure: Natural History of Hepatitis C
- Chronic Hepatitis C
- Stages and Symptoms
- Stages in Chronic HCV Condition
- Symptoms of Liver Disease in ChronicHCV Condition
- Complications Due to Chronic HCV Infection
- Diagnosis
- Tests to Confirm HCV Presence
- HCV IgG Antibody Test
- HCV RNA Test
- HCV Core Antigen EIA
- Genotype Tests
- Liver Biopsy
- Treatment for HCV Infection
- Monotherapy
- Brief Description of Approved Drugs forMonotherapy Treatment
- Comparison of Response of Interferon BasedDrugs in Chronic Hepatitis C Treatment
- Combination Therapy
- Table 12: Major Side Effects Associated withHCV Treatment with Pegasys + CopegusCombination Therapy and Pegasys Monotherapy (includes corresponding Graph/Chart)
- Table 13: Comparison Between PEG-Intron andPegasys in Monotherapy and CombinationTherapy in HCV Treatment (includes corresponding Graph/Chart)
- Table 14: Data for 20-Year Risks and OtherRelated Aspects in Treatment Given andUntreated HCV Patients
- Alternative Therapies
- Vaccine
- Liver Transplantation
- Treatment Costs
- Types of Treatment Responses
- Sustained Response
- Relapsing (Transient) Response
- Breakthrough Response
- Null Response
- Monitoring Tests
- Laboratory tests
- Medical Examinations
- Prevention
- 4.Regional Perspective
- United States
- Table 15: HCV Infection in the US: Number of InfectedPeople for the Years 2006, 2007 and 2008 (in '000s)(includes corresponding Graph/Chart)
- Table 16: HCV Infection in the US (2007): Percentage Breakdown of Infection Sources by Medium- InjectionDrugs, Sexual Contact, Transfusions, Occupation -Related Exposure, and Others and Unknown(includes corresponding Graph/Chart)
- HCV Infection - Ethnicity
- Table 17: HCV Prevalence in the US (1999-2002): Prevalence Rate by Age and Race (includescorresponding Graph/Chart)
- African-Americans React Poorly to Treatment
- Genotype 1 - The Most Prevalent HCV Strain
- Table 18: HCV Prevalence in the US (2005):Prevalence by Genotype (In %)
- Falling HCV Incidences in the US
- Table 19: Acute HCV Infection Incidences in the USfor the Years 1996 through 2007 (includescorresponding Graph/Chart)
- Table 20: US HCV Market (2006): Incidence ofAcute Hepatitis C by Age Group and Gender(includes corresponding Graph/Chart)
- Canada
- Australia
- Table 21: Modes of HCV Infection Transmission inAustralia (includes corresponding Graph/Chart)
- Table 22: Hepatitis C Infection in Australia (2000):Rate of Incidence by Age Group and Gender(includes corresponding Graph/Chart)
- India
- Egypt
- France
- The Netherlands
- Table 23: HCV Infection Prevalence in Risk Groupsin the Netherlands
- Central and Eastern Europe
- HCV Prevalence Rate Higher in Injection Drug Users
- Alarming Rates of HIV/HCV Co-Infection
- Table 24: HIV/HCV Co-Infection in CEE (2005):Number of HIV Patients and Percentage ofHIV Patients infected with HCV inSelect CEE Countries (includescorresponding Graph/Chart)
- Testing and Counseling Structure Poorly Developed
- Depleted Testing Schemes for Prisoners
- Scarcity Prevails at Health Care Providers andGovernments As Well
- Practical Availability of PEG-IFN Remains Limited
- Dearth in Political Commitment
- HCV Diagnostic Tests and Treatment in SelectCEE Countries
- Bulgaria
- Czech Republic
- Hungary
- Romania
- Russia
- Ukraine
- Availability of Testing Protocols for HCV inSelect CEE Countries
- 5.Drug Approvals & Clinical Trials
- Vertex to Initiate Phase III Trial of Telaprevir
- Amarillo and CytoPharm to Initiate Phase II Studyof Novel Oral Interferon
- Biolex Releases Locteron® Phase IIa Trial Results
- Schering-Plough Releases Details of BoceprevirPhase II Study
- Progenics Releases Pre-Clinical Results of PRO 206
- ZymoGenetics Reveals Phase Ib Results of IL-29
- Phenomix Begins Phase Ia Study of PHX1766
- Inovio and Tripep Release Additional Interim Resultsfor ChronVac-C®
- InterMune Starts Clinical Study of ITMN-191
- Roche and Associates Commence Clinical Trialof All-Oral Dual-Antiviral Therapy
- GlobeImmune Announces Phase II Clinical Trialswith GI-5005
- Human Genome Gets Encouraging Interim Resultswith Albuferon
- Intarcia Releases Study Results of Omega Interferon
- Nautilus Biotech Commences Phase I Study forBelerofon®
- Migenix Announces Phase II Proof-of-ConceptStudy Results of Celgosivir
- Pharmasset Begins Multiple Dose-Escalating Studyof R7128
- Transgene Commences Phase I Trial of TG4040
- Debiopharm Releases Phase Ib Results of Debio 025
- Nabi Biopharmaceuticals Starts Proof-Of-Concept Trialfor Civacir
- Peregrine Announces Positive Results for Bavituximab
- Jenken to Commence Phase II Trial of JBK-122
- Pevion Biotech Initiates Phase I Study ofHepatitis C Vaccine
- Intercell Releases Phase II Findings of IC41
- 6.Recent Industry Activity
- Three Rivers Acquires Infergen®
- International Consolidated Cos Takes Over China Gene
- Hologic Signs Definitive Deal to Acquire Third Wave
- GlaxoSmithKline Inks Deal to Take Over Genelabs
- Biolex Signs Deal to Purchase OctoPlus’ Stakein Locteron®
- OraSure and Schering-Plough Form Global Alliance
- Tacere and Oncolys Sign Licensing Agreement
- Beckman Wins HCV Diagnostics Rights fromSiemens Healthcare
- Anadys Secures FDA Fast Track Designation forits Lead Drug Candidate
- Roche Bags European Commission Approval forCombination Therapy
- Roche Receives European Commission Approvalfor Shortened Hepatitis C Therapy
- iTherX Establishes Advisory Board for Hepatitis CAdvanced Therapeutics
- SciClone Terminates Zadaxin®
- AstraZeneca Acquires Arrow Therapeutics
- Cubist Takes Over Illumigen
- China Medical to Take Over Beijing Bio-Ekon
- Schering-Plough Collaborates with OraSure
- Pro-Pharmaceuticals to Collaborate with Digna Biotech
- Medivir and Tibotec Establish Collaboration Deal
- VGX Extends Collaboration with University ofPennsylvania
- Presidio Wins Exclusive License to NovelHCV Technology
- Roche Inks Licensing Deal with Novartis andOrtho-Clinical
- Peregrine Opens Subsidiary in China
- InterMune Completes Production Milestone
- Arrow Expands Hepatitis C Pipeline
- Roche Wins Japanese Approval for CombinationTherapy
- Schering-Plough Bags European CommissionApproval for Combination Therapy
- Abbott Bags FDA Approval for Screening Test
- Abbott Bags Canadian Approval for Viral Load Tests
- Phynova Bags FDA Approval for IND Application
- Worldwide Biotech Bags Chinese FDA Approvalfor HCV Diagnostic Kit
- Tibotec Applies to European Regulator to InitiatePhase I Trials
- Roche Submits Application for Novel Hepatitis Cto with FDA
- Anadys Discontinues ANA975
- Cerus Bags NIH Funding for HCV Vaccine Program
- 7.Focus on Select Global Players
- Abbott Diagnostics (USA)
- Achillion Pharmaceuticals, Inc. (USA)
- Anadys Pharmaceuticals, Inc. (USA)
- Boehringer Ingelheim GmbH (Germany)
- Bristol-Myers Squibb Company (USA)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- GlaxoSmithKline plc (UK)
- Hayashibara Biochemical Labs, Inc. (Japan)
- HemispheRx Biopharma, Inc. (USA)
- Human Genome Sciences (USA)
- Idenix Pharmaceuticals, Inc. (USA)
- Innogenetics NV (Belgium)
- InterMune, Inc. (USA)
- Intarcia Therapeutics, Inc. (USA)
- Medivir AB (Sweden)
- Merck & Co., Inc. (USA)
- Novartis AG (Switzerland)
- Chiron Corporation (USA)
- Pfizer, Inc. (USA)
- Schering-Plough Corporation (USA)
- Tibotec Pharmaceuticals Ltd. (Ireland)
- Tripep AB (Sweden)
- Toray Industries, Inc. (Japan)
- Valeant Pharmaceuticals International (USA)
- Vertex Pharmaceuticals, Inc. (USA)
- III. COMPETITIVE LANDSCAPE
- Total Companies Profiled: 123 (including Divisions/Subsidiaries - 127 )
- Region/Country Players
- The United States
- Canada
- Japan
- Europe
- France
- Germany
- The United Kingdom
- Italy
- Spain
- Rest of Europe
- Asia-Pacific (Excluding Japan)
- Middle East
AbstractThis 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.
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