Commercial and Pipeline Insight: Hepatitis B

Summary

The global pharmaceutical pricing and reimbursement environment is notoriously complex and continuously changing. Pharma companies must implement strategic pricing assessments across global markets and product lifecycle phases in order to develop effectiv

Fuelled by an increasing disease awareness, the growing use of new, expensive drugs as well as combination therapy, the HBV drugs market, sized at $431m in 2006 across the seven major markets, will nearly triple in size by 2016. Rapid growth until 2011 will slow down in the following years as a result of genericization and the beginning impact of routine HBV vaccination.

Contents

• Chapter 1 Executive Summary
  • Objective Of The Analysis
  • Datamonitor Insight Into The Disease Market
  • Contributing Experts
  • Key Metrics
  • Datamonitor Pipeline Assessment Summary
  • Related Reports
  • Upcoming Related Reports
• Chapter 2 Hepatitis B - Disease Background
  • Summary
  • Epidemiology
  • Virus
  • Structure
  • Lifecycle
  • Transmission
  • Risk Groups
  • Symptoms And Disease Progression
  • Acute Hbv Infection
  • Chronic Hbv Infection
  • Diagnosis
• Chapter 3 Market Definition And Overview
  • Summary
  • Market Definition For This Report
  • Current Market Situation
  • Sales And Volume Use In Hbv Are Increasing Steadily
  • Key Events - Five New Drug Approvals Since 1999 Have Increased Treatment Diversity
  • Country Market Analysis - Us Is Leading The Field, While Market Growth Is Strongest In The Eu5
  • Us: New Antivirals Experience A Good Uptake In A Diverse Market
  • Japan: Lamivudine Takes Over From Interferon Alfa-2b
  • Eu5: Strong Growth Driven By Adefovir
  • Market Drivers And Restrictors - Disease Awareness As The Key Factor
  • Lack Of Awareness Leads To Low Diagnosis And Treatment Rates For Hbv Infections
  • Segmentation Of Hepatitis B
  • Hbv Prevalence Is Highest In Adults Aged >25 Years Of Age
  • Men Represent A Higher Percentage Of Hbv Patients Than Women
  • Sex Between Men Accounts For An Increasing Percentage Of Hbv Cases
  • Immigrants Account For The Vast Majority Of Infections
  • Hiv-Hbv Co-Infected Patients Constitute A Significant Target Population
  • Unmet Needs In Hepatitis B
  • A Cure For Hepatitis B Is The Key Clinical Unmet Need
  • The Increasing Level Of Hbv Drug Resistance Is Creating A Need For Novel Therapeutics
  • Combination Therapy Approaches Are Needed For Second- And Third-Line Therapy
  • Market Forecast
  • The Hbv Market Is Set To Grow To $1.2 Billion By 2012, But Will Stagnate Afterwards
  • Genericization Will Start In 2010, But Its Impact Will Remain Limited
  • The Us Will Remain Leader In Sales, Whereas Japan Will Show High Growth In Volume Use
• Chapter 4 Prevention And Treatment
  • Summary
  • Vaccines
  • Hbv Vaccination Is Recommended In More And More Countries
  • Plasma-Derived Vaccines Have Been Replaced By Safer, Recombinant Products
  • Currently Available Vaccines Provide Strong Protection
  • Hbv Vaccination Is Widely Regarded As Safe
  • Coverage In Most Of The 7mm Is High
  • Currently Marketed Hep B Vaccines Include Single-Antigen As Well As Combination Vaccines
  • Hbv Pharmacotherapy
  • Serum Levels Of Alt And Hbv Dna Are The Key Factors For Treatment Initiation
  • Suppression Of Hbv Replication Is The Key Endpoint In Chronic Hepatitis B (Chb) Therapy
  • Currently Marketed Drugs Are Split Into Interferons And Antivirals
  • Choice Of First-Line Treatment Depends On Multiple Factors
  • Interferons
  • Antivirals
• Chapter 5 Key Players In The Hepatitis B Market
  • Summary
  • Gilead And Bristol-Myers Squibb Will Dominate The Hbv Market, Whereas Gsk And Schering-Plough Will Lose Share
  • Gsk - Vaccines As Future Revenue Drivers?
  • Current Position
  • Strategic Development
  • Outlook
  • Gilead - New Hope In Tenofovir
  • Current Position
  • Strategic Development
  • Outlook
  • Bristol-Myers Squibb - The One-Product Franchise
  • Current Position
  • Strategic Development
  • Outlook
  • Novartis - A New Entrant With Ambitions
  • Current Position
  • Strategic Development
  • Outlook
  • Roche - Flying On The Wings Of Pegasys
  • Current Position
  • Strategic Development
  • Outlook
  • Schering-Plough - Gloomy Prospects
  • Current Position
  • Strategic Development
  • Outlook
• Chapter 6 Forecasting Analysis
  • New Product Launches
  • Patent Expiries
  • Data Definitions, Limitations And Assumptions
  • Standard Units
  • Japanese Market Data
  • Forecasts
  • Forecast Methodology
• Chapter 7 Hbv Pipeline: Class Overview And R&D Approach
  • Summary
  • Pipeline Overview: The Immune System Is The Key Target For Future Hbv Drugs
  • Clinical Trial Design In Hepatitis B
  • Vaccines
  • Therapeutics
• Chapter 8 Hbv Vaccines: Late-Stage Pipeline Analysis
  • Summary
  • Overview For Prophylactic Hbv Vaccines
  • Pipeline Summary
  • Definition Of Current Comparator Therapy
  • Engerix-B
  • Key Improvement Opportunities
  • Heplisav
  • Vaccine Overview
  • Clinical Trial Data
  • Patient Potential
  • Marketing Factors
  • Satisfaction Of Unmet Needs
  • Datamonitor Vaccine Assessment Summary
  • Other Late-Stage Hbv Vaccine Candidates
  • Sci-B-Vac (Scigen)
  • Supervax (Dynavax)
  • Overview For Therapeutic Hbv Vaccines
  • Pipeline Overview
  • Hepatitis B Therapeutic Vaccine (Emergent Biosolutions)
  • Hi-8 Hepatitis B Vaccine (Oxford Biomedica)
• Chapter 9 Hbv Therapeutics: Late-Stage Pipeline Analysis And Forecast
  • Summary
  • Overview For Hbv Therapeutics
  • Pipeline Summary
  • Assessment Of Clinical And Commercial Attractiveness
  • Comparative Forecasts
  • Definition Of Current Comparator Therapy
  • Tenofovir/Emtricitabine
  • Drug Overview
  • Clinical Trial Data
  • Trials Investigating Tenofovir As Monotherapy In Chb Patients
  • Trials Investigating Tenofovir In Combination With Emtricitabine In Chb Patients
  • Trials Investigating Tenofovir With And Without Emtricitabine In Hiv-Hbv Co-Infected Patients
  • Patient Potential
  • Marketing Factors
  • Satisfaction Of Unmet Needs
  • Forecasts To 2016
  • Datamonitor Drug Assessment Summary
  • Clevudine
  • Drug Overview
  • Clinical Trial Data
  • The Korean Phase Iii Trials - More Data Needed On Long-Term Efficacy
  • Patient Potential
  • Marketing Factors
  • Satisfaction Of Unmet Needs
  • Forecasts To 2016
  • Datamonitor Drug Assessment Summary
  • Other Hbv Therapeutics In Late-Stage Development
  • Valtorcitabine (Novartis/Idenix)
  • Eht899 (Enzo Biochem Inc)
  • Nitazoxanide (Romark Laboratories Lc)
  • Elvucitabine (Achillion Pharmaceuticals)
  • Immunitin/He2000 (Hollis-Eden Pharmaceuticals)
  • Late-Stage Development Compounds Recently Discontinued
  • Pradefovir (Metabasis Therapeutics/Valeant/Schering-Plough)
• Chapter 10 Combination Therapies
  • Summary
  • Combination Therapy Would Prove A Valuable Alternative In Resistant Patients And Potentially Increase The Chance Of Eradicating The Virus
  • Combinations Between Two Antivirals
  • Lamivudine Plus Adefovir Dipivoxil - No Benefits In Efficacy, But In Decelerating Resistance Development
  • Combinations With Telbivudine - Potential Benefits With Tenofovir, Adefovir Or Valtorcitabine?
  • Tenofovir Plus Emtricitabine - Extending Truvada's Success In Hiv?
  • Others - Focus On Entecavir Plus Nucleotides
  • Combinations Between One Interferon And One Antiviral
  • Combinations With Peginterferon Alfa-2a - Building On The Success In Hcv Treatment?
  • Combinations With Interferon Alfa-2b - No Added Value In Efficacy Shown For Lamivudine And Ribavirin
• Bibliography
  • Literature
• Appendix A - Market Forecast Data
  • Seven Major Markets
  • Eu5
  • Us
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • Uk
• Appendix B
  • Methodology
  • Datamonitor Forecast Methodology
  • Epidemiology Forecasts
  • Product Forecasts
  • Definition Of A Standard Unit
  • Datamonitor Drug Assessment Summary
  • Datamonitor Healthcare's Therapy Area Capabilities
  • About The Infectious Diseases Analysis Team
  • Key Therapy Team Members
  • Holger Rovini, Head Of Respiratory And Infectious Diseases
  • Hedwig Kresse, Analyst, Infectious Diseases
  • Disclaimer
• List Of Tables
  • Table 1: Key Parameters Of Hepatitis B For The Seven Major Markets, 2006-2016
  • Table 2: Forecast Key Products In Hepatitis B; 7mm, 2006-2016 ($M)
  • Table 3: Hbv Nomenclature - Viral And Host-Derived Serum Markers
  • Table 4: Hbv Serology - Diagnosis Results
  • Table 5: Hbv - Prevalence, Diagnosis And Treatment Rates Across The 7mm, 2004
  • Table 6: Hep B Vaccines - Key Products, 2007
  • Table 7: Currently Marketed Hbv Drugs
  • Table 8: Factors Influencing The Choice Of First-Line Therapy For Hbv
  • Table 9: Hbv Treatment Options - Comparison Of Resistances, Mode Of Administration, Safety Profile And Duration Of Treatment
  • Table 10: Hbv Therapy With Interferons - Factors Indicating The Likelihood Of Response
  • Table 11: Intron A: Product Profile
  • Table 12: Events Impacting Sales Forecast For Intron-A, 2006-2016
  • Table 13: Pegasys: Product Profile
  • Table 14: Events Impacting Sales Forecast For Pegasys, 2006-2016
  • Table 15: Mechanism Of Currently Marketed Antivirals, 2007
  • Table 16: Zeffix: Product Profile
  • Table 17: Events Impacting Sales Forecast For Zeffix; 2006-2016
  • Table 18: Hepsera: Product Profile
  • Table 19: Events Impacting Sales Forecast For Hepsera; 2006-2016
  • Table 20: Baraclude: Product Profile
  • Table 21: Events Impacting Sales Forecast For Baraclude 2006-2016
  • Table 22: Tyzeka: Product Profile
  • Table 23: Events Impacting Sales Forecast For Tyzeka, 2006-2016
  • Table 24: Key Players In The Hepatitis B Market, 2007
  • Table 25: Datamonitor's Launch Dates For Hbv Therapeutics In The 7mm, 2007-2016
  • Table 26: Patent Expiry Dates For Hbv Therapeutics In The 7mm, 2007-2016
  • Table 27: Number Of Key Hepatitis B Pipeline Candidates By Class And Phase Of Development, September 2007
  • Table 28: Hbv Prophylactic Vaccines Pipeline - Overview, September 2007
  • Table 29: Engerix-B - Vaccine Profile
  • Table 30: Heplisav - Vaccine Profile
  • Table 31: Heplisav - Key Phase Iii Clinical Trials, 2007
  • Table 32: Heplisav - Key Phase Ii Clinical Trials, 2007
  • Table 33: Hbv Therapeutic Vaccines Pipeline - Overview, September 2007
  • Table 34: Hbv Therapy - Clinical Pipeline Overview, 2007
  • Table 35: Hbv Therapy - Preclinical Pipeline Overview, 2007
  • Table 36: Entecavir - Comparative Profile
  • Table 37: Tenofovir - Product Profile
  • Table 38: Tenofovir - Clinical Trials For Monotherapy, 2007
  • Table 39: Tenofovir - Trials For Hbv Therapy With Tenofovir Plus Emtricitabine (Truvada)
  • Table 40: Tenofovir - Trials For Hiv/Hbv Co-Infection
  • Table 41: Impacting Factors On The Revenues Of Tenofovir, 2006-2016
  • Table 42: Clevudine - Drug Profile
  • Table 43: Clevudine - Terminated Clinical Trials In Korea
  • Table 44: Clevudine - Ongoing Clinical Trials
  • Table 45: Impacting Factors On The Revenues Of Clevudine, 2006-2016
  • Table 46: Recently Discontinued Hbv Therapeutics, 2007
  • Table 47: Combination Therapies - Clinical Trials For Lamivudine + Adefovir Dipivoxil
  • Table 48: Combination Therapies - Clinical Trials For Combinations Involving Telbivudine
  • Table 49: Combination Therapies - Other Clinical Trials
  • Table 50: Combination Therapies - Clinical Trials Based On Peginterferon Alfa-2a
  • Table 51: Combination Therapies - Clinical Trials Based On Interferon Alfa-2b
  • Table 52: Seven Major Market Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 53: Eu5 Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 54: Us Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 55: Japan Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 56: France Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 57: Germany Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 58: Italy Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 59: Spain Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 60: Uk Hepatitis B Drug Sales ($000s) Forecasts, 2006-2016
  • Table 61: Datamonitor Drug Assessment Parameters
• List Of Figures
  • Figure 1: Datamonitor Drug Assessment Summary Of Pipeline Drugs In Development For Chronic Hepatitis B, 2007
  • Figure 2: Global Hbv Prevalence, 2005
  • Figure 3: Hbv - Prevalence And Mortality, 2004
  • Figure 4: Hbv - Impact Of Vaccination On Case Numbers, Us, 1978-2006
  • Figure 5: Hbv - Key Structural Elements
  • Figure 6: Hbv - Lifecycle
  • Figure 7: Hbv - Routes Of Transmission
  • Figure 8: Hbv - Major Routes Of Transmission Across The Seven Major Markets, 2004
  • Figure 9: Hepatitis B - Course Of Disease
  • Figure 10: Hbv - Risk Of Chronic Hbv Carriage By Age Of Infection
  • Figure 11: Hbv Disease Progression - Factors Triggering Development Of Cirrhosis
  • Figure 12: Hbv Serology - Development Of Alt And Hbv Dna Levels Over The Course Of Hbv Infection
  • Figure 13: Hbv Therapeutics Market Sales Value Across The 7mm By Class And Molecule, 2003-06
  • Figure 14: Hbv Therapeutics Market Volume Across The 7mm By Class And Molecule, 2003-06
  • Figure 15: Key Events Impacting The Hbv Therapeutics Market, 1999-2006
  • Figure 16: Performance Of The Us, Eu5 And Japan Hbv Therapeutics Markets, 2006
  • Figure 17: Us Hbv Market - Overview Of Sales And Volume Use, 2003-06
  • Figure 18: Japanese Hbv Market - Overview Of Sales And Volume Use; 2003-06
  • Figure 19: Eu5 Hbv Market - Overview Of Sales And Volume Use, 2003-06
  • Figure 20: Hbv Market - Drivers And Restrictors, 2007
  • Figure 21: Key Target Groups For Hbv Therapy
  • Figure 22: Incidence Of Acute Hepatitis B By Age Group, Us, 1990-2005
  • Figure 23: Incidence Of Acute Hbv Infection By Sex, Us, 2005
  • Figure 24: Trends In Selected Epidemiologic Characteristics In Patients With Acute Hbv Infection, Us 1999-2005
  • Figure 25: Unmet Needs In Hepatitis B
  • Figure 26: Hbv Market - Sales And Volume Use Forecast Across The, 7mm By Molecule, 2006-2016
  • Figure 27: Impact Of Genericization On Sales And Volume Use Of Hbv Drugs, 7mm, 2006-2016
  • Figure 28: Hbv Therapeutics - Sales And Volume Use Forecast By Country, 7mm, 2006-2016
  • Figure 29: Hepatitis B Vaccination - Geographical Spread Of Vaccination Introduction And Coverage, 2005
  • Figure 30: Hepatitis B Vaccination - Recommendations Across The 7mm, 2007
  • Figure 31: Hbv Vaccination - Coverage Rates, 2007
  • Figure 32: Chronic Hbv - Treatment Algorithms
  • Figure 33: Hbv Treatment Options - Comparison Of Efficacy In Hbeag+ And Hbeag- Patients, 2007
  • Figure 34: Hbv - Cost Of Treatment In The Us, 2006
  • Figure 35: Interferon Therapy - Swot Analysis, 2007
  • Figure 36: Intron-A (Interferon Alfa 2b) Sales In The 7mm For Hbv, 2003-06
  • Figure 37: Intron-A: Sales Forecast For Hbv, 7mm, 2006-2016
  • Figure 38: Pegasys (Peginterferon Alfa 2a) - 7mm Hbv Sales 2003-06
  • Figure 39: Pegasys - Sales Forecast In Hbv, 7mm, 2006-2016
  • Figure 40: Antiviral Therapy - Swot Analysis, 2007
  • Figure 41: Zeffix (Lamivudine) - 7mm Sales 2003-06
  • Figure 42: Zeffix - Sales Forecast In Hbv, 7mm, 2006-2016
  • Figure 43: Hepsera (Adefovir Dipivoxil) - 7mm Sales In Hbv, 2003-06
  • Figure 44: Hepsera - Sales Forecast In Hbv, 7mm, 2006-2016
  • Figure 45: Baraclude (Entecavir) - 7mm Sales In Hbv, 2003-06
  • Figure 46: Baraclude - Sales Forecast, 7mm, 2006-2016
  • Figure 47: Tyzeka (Telbivudine) - 7mm Sales, 2003-06
  • Figure 48: Tyzeka - Sales Forecast, 7mm, 2006-2016
  • Figure 49: Hbv Drugmakers - Portfolio Focus
  • Figure 50: Sales Forecast For The Hbv Drugs Market By Company - 7mm, 2006-2016
  • Figure 51: Hbv Drugs Market By Company Market Share, 2006, 2011 And 2016
  • Figure 52: Gsk - Hbv Antiviral Revenues By Country, 7mm, 2003-07
  • Figure 53: Gsk - Hbv Vaccines Portfolio, 2007
  • Figure 54: Gsk - Timeline Of Hbv Product Approvals, 1993-2007
  • Figure 55: Gilead - Strategic Development Of Hbv Portfolio, 2007
  • Figure 56: Bristol-Myers Squibb - Strategic Development Of Baraclude (Entecavir)
  • Figure 57: Novartis - Strategic Development Of Hbv Portfolio, 2007
  • Figure 58: Hbv Pipeline - Key Focal Points Of Development, 2007
  • Figure 59: Engerix-B - Efficacy In Different Age Groups
  • Figure 60: Heplisav - Results Of Phase Iii Trial, (Asia, 2005-07)
  • Figure 61: Heplisav - Results Of Phase Ii/Iii Trial (Singapore, 2005)
  • Figure 62: Heplisav - Strategic Assessment
  • Figure 63: Datamonitor Drug Assessment Summary Of Hbv Therapeutics Late-Stage Pipeline, 2007
  • Figure 64: Sales Forecasts For Hbv Therapeutics Pipeline, 7mm, 2006-2016
  • Figure 65: Tenofovir (Hbv) - Sales Forecast In 7mm By Country, 2006-2016
  • Figure 66: Datamonitor's Competitive Positioning Analysis Of Tenofovir, 2007
  • Figure 67: Clevudine - Hbv Dna Reduction In Phase Iii Trial In Hbeag+ Patients
  • Figure 68: Clevudine - Hbv Dna Reduction In Phase Iii Trial In Hbeag- Patients
  • Figure 69: Clevudine - Sales Forecast In Hbv For The 7mm By Country, 2006-2016
  • Figure 70: Clevudine - Impact Of Genericization, 7mm, 2006-2016
  • Figure 71: Datamonitor's Competitive Positioning Analysis Of Clevudine, 2007