Hepatitis C Virus And Therapeutics: Market Research Report

April 2009 | 466 pages | ID: HE647B66E29EN
Global Industry Analysts, Inc

Abstracts

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.

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® 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®
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®
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®
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®
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®
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)

III. COMPETITIVE LANDSCAPE