Abstract
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
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 Analysis for Hepatitis C
Virus Therapeutics Market - Annual Sales Figures in US$ Million for the Years
2006 through 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
Undergoing Treatment with PEG-IFN and Ribavirin Drugs (includes corresponding
Graph/Chart)
- Alpha Interferons and Ribavirin are Here to Stay
- Interferon-based Drugs in Pipeline by Company and Development Stage
- Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients
Treated with Interferon Drugs in Select Countries (includes corresponding
Graph/Chart)
- Albuferon - Rising Above the Standards
- Viramidine - Next-Generation Ribavirin Drug
- High Mutation Rates Keep HCV Elusive
- Genotype I - Least Responsive and Most Common Variant of HCV
- 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)
- Protease Inhibitors (PIs) - Way Above Others
- Protease Inhibitor Drugs in Pipeline by Company and Development Stage
- SCH 900518 - Schering' s Next-Generation Protease Inhibitor
- Telaprevir (VX-950) - The Most Promising Pipeline 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 Teeth to HCV Pipeline
- Viral Polymerases
- Polymerase Inhibitor Drugs in Pipeline by Company, Category, and
Development Stage
- Comparison of Antiviral Properties in Select Polymerase Inhibitor Drugs
- R7128 - A Promising PLI Class Drug
- Development of PLIs Remains a Challenge for HCV Researchers
- Industry in Search of Novel STAT-C Drugs
- Specific Antiviral Activity of Select HCV Drug Classes
- Select NS5A Inhibitors, Entry Inhibitors, and Thiazolides in Pipeline by
Company and Development Stage
- Researchers Show Continued Appetite for Immunomodulators and Other Classes
- Immunomodulators in Pipeline by Company, and Development Stage
- Adjuvant Therapies to Compete with Mainline Therapies
- Cyclophilin Analogs and Fibrosis/Inflammation Inhibitors in Pipeline by
Company
- Vaccine Development Remains at Low Scale
- HCV Vaccines in Pipeline by Company, and Development Stage
- Decisive Factors For Success of New HCV Therapeutics
- HCV Treatment Costs to Escalate
- Table 5: HCV Treatment Market: Cost Structure for Years 2007 through 2016
and Beyond (includes corresponding Graph/Chart)
- Roche & Schering - Dominant Players in HCV Therapeutics Market
- HCV Drugs from Roche & Schering
- Partnerships in R&D Become Order of the Day
- Select Partnership Deals in HCV Drug Development Programs
- Market Drivers/Constraints
- Treatment-Experienced Patients - A Potential Opportunity for Developers
- Education Campaigns to Magnify Patient Diagnosis Rates
- Stigmatization and Discrimination - Major Hurdles for HCV Treatment
- Treatment with Current Therapies Plagued by Side Effects
- Side Effects Associated with HCV Treatment Therapies
- Hemolytic Anemia - A Key Side Effect with Ribavirin
- Epidemiology
- Quick Facts about HCV Infection
- 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
- 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)
- Low-Treatment Rates vis-a-vis Patient Population
- 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)
- 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)
- 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 as Monotherapy in Chronic Hepatitis C
Treatment
- Ribavirin - Antiviral Drug for HCV Treatment
- 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)
- 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 Stage by Company
- Select HCV Drugs with Cancelled Clinical Studies by 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 Select Geographic Regions
- Table 11: Percentage Breakdown of Viral Load Levels (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 Chronic HCV 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 for Monotherapy Treatment
- Comparison of Response of Interferon Based Drugs in Chronic Hepatitis C
Treatment
- Combination Therapy
- Table 12: Major Side Effects Associated with HCV Treatment with Pegasys +
Copegus Combination Therapy and Pegasys Monotherapy (includes corresponding
Graph/Chart)
- Table 13: Comparison Between PEG-Intron and Pegasys in Monotherapy and
Combination Therapy in HCV Treatment (includes corresponding Graph/Chart)
- Table 14: Data for 20-Year Risks and Other Related Aspects in Treatment
Given and Untreated 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 Infected People 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- Injection Drugs, 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 (includes corresponding 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 US for the Years 1996
through 2007 (includes corresponding Graph/Chart)
- Table 20: US HCV Market (2006): Incidence of Acute Hepatitis C by Age
Group and Gender (includes corresponding Graph/Chart)
- Canada
- Australia
- Table 21: Modes of HCV Infection Transmission in Australia (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 Groups in 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 of HIV Patients infected with HCV in Select CEE Countries (includes
corresponding Graph/Chart)
- Testing and Counseling Structure Poorly Developed
- Depleted Testing Schemes for Prisoners
- Scarcity Prevails at Health Care Providers and Governments As Well
- Practical Availability of PEG-IFN Remains Limited
- Dearth in Political Commitment
- HCV Diagnostic Tests and Treatment in Select CEE Countries
- Bulgaria
- Czech Republic
- Hungary
- Romania
- Russia
- Ukraine
- Availability of Testing Protocols for HCV in Select CEE Countries
5. Drug Approvals & Clinical Trials
- Vertex to Initiate Phase III Trial of Telaprevir
- Amarillo and CytoPharm to Initiate Phase II Study of Novel Oral Interferon
- Biolex Releases Locteron(r) Phase IIa Trial Results
- Schering-Plough Releases Details of Boceprevir Phase 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 Results for ChronVac-C(r)
- InterMune Starts Clinical Study of ITMN-191
- Roche and Associates Commence Clinical Trial of All-Oral Dual-Antiviral
Therapy
- GlobeImmune Announces Phase II Clinical Trials with GI-5005
- Human Genome Gets Encouraging Interim Results with Albuferon
- Intarcia Releases Study Results of Omega Interferon
- Nautilus Biotech Commences Phase I Study for Belerofon(r)
- Migenix Announces Phase II Proof-of-Concept Study Results of Celgosivir
- Pharmasset Begins Multiple Dose-Escalating Study of R7128
- Transgene Commences Phase I Trial of TG4040
- Debiopharm Releases Phase Ib Results of Debio 025
- Nabi Biopharmaceuticals Starts Proof-Of-Concept Trial for Civacir
- Peregrine Announces Positive Results for Bavituximab
- Jenken to Commence Phase II Trial of JBK-122
- Pevion Biotech Initiates Phase I Study of Hepatitis C Vaccine
- Intercell Releases Phase II Findings of IC41
6. Recent Industry Activity
- Three Rivers Acquires Infergen(r)
- 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' Stake in Locteron(r)
- OraSure and Schering-Plough Form Global Alliance
- Tacere and Oncolys Sign Licensing Agreement
- Beckman Wins HCV Diagnostics Rights from Siemens Healthcare
- Anadys Secures FDA Fast Track Designation for its Lead Drug Candidate
- Roche Bags European Commission Approval for Combination Therapy
- Roche Receives European Commission Approval for Shortened Hepatitis C
Therapy
- iTherX Establishes Advisory Board for Hepatitis C Advanced Therapeutics
- SciClone Terminates Zadaxin(r)
- 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 of Pennsylvania
- Presidio Wins Exclusive License to Novel HCV Technology
- Roche Inks Licensing Deal with Novartis and Ortho-Clinical
- Peregrine Opens Subsidiary in China
- InterMune Completes Production Milestone
- Arrow Expands Hepatitis C Pipeline
- Roche Wins Japanese Approval for Combination Therapy
- Schering-Plough Bags European Commission Approval 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 Approval for HCV Diagnostic Kit
- Tibotec Applies to European Regulator to Initiate Phase I Trials
- Roche Submits Application for Novel Hepatitis C to 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)
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