World Hepatitis C Virus And Therapeutics Market

World Hepatitis C Virus And Therapeutics Market

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.

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-à-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