The Global Antivirals Market - R&D Pipelines, Market Analysis and Competitive Landscape

Table of Contents

1 EXECUTIVE SUMMARY

2 INTRODUCTION TO INFECTIOUS DISEASES

• 2.1 Cytomegalovirus (CMV)
• 2.2 Hepatitis B virus (HBV)
• 2.3 Hepatitis C Virus (HCV)
• 2.4 Herpes Simplex Virus (HSV)
• 2.5 Human Immunodeficiency Virus (HIV)
• 2.6 Influenza (Flu)
• 2.7 Respiratory Syncytial Virus (RSV)

3 PATIENT DEMOGRAPHICS

• 3.1 Cytomegalovirus Patient Statistics
• 3.2 Hepatitis B Patient Statistics
• 3.3 Hepatitis C Patient Statistics
• 3.4 Herpes Simplex Patient Statistics
• 3.5 Human Immunodeficiency Patient Statistics
• 3.6 Influenza Patient Statistics
• 3.7 Respiratory Syncytial Patient Statistics

4 KEY DRIVERS

• 4.1 Drug Resistance
• 4.2 Cross-Resistance
• 4.3 New treatments
• 4.4 Combination therapy
• 4.5 Improvements in diagnosis
• 4.6 Vaccines
• 4.7 Potential for clinical success
• 4.8 Indirect cost associated with infectious diseases

5 KEY RESISTORS

• 5.1 Cost-benefit of prophylactic therapy or antiviral therapy
• 5.2 Treatment availability
• 5.3 Patient demographics
• 5.4 Generics
• 5.5 Curative Therapies and Vaccines
• 5.6 Diagnosis

6 THE MARKET

• 6.1 The Global Anti-Infective Market
• 6.2 Market Segments
• 6.3 Global Anti-Viral Market
  • 6.3.1 Antiretroviral Agents
  • 6.3.2 Hepatitis Antiviral Agents
  • 6.3.3 Other Antiviral Agents
• 6.4 The Major Players
  • 6.4.1 Antiviral Major Players in 2006
  • 6.4.2 Antiviral Major Players in 2012
• 6.5 Market Trends
  • 6.5.1 Antiretroviral Agents by 2012
  • 6.5.2 Hepatitis Agents by 2012
  • 6.5.3 Other Antiviral Agents by 2012

7 LEADING DRUG CLASSES

• 7.1 Antisense
• 7.2 DNA Polymerase Inhibitors
• 7.3 Interferons
• 7.4 Fusion Inhibitors
• 7.5 Neuraminidase Inhibitors
• 7.6 Reverse Transcriptase Inhibitors
• 7.7 RNA Polymerase Inhibitors
• 7.8 Protease Inhibitors
• 7.9 Uncoating Inhibitors

8 LEADING BRANDS

• 8.1 Antisense
  • 8.1.1 Vitravene (Novartis/[ISIS Pharmaceuticals])
  • 8.1.2 Antisense Sales Forecasts
• 8.2 DNA Polymerase Inhibitors
  • 8.2.1 DNA Polymerase Inhibitors Forecasts
• 8.3 RNA Polymerase Inhibitors
  • 8.3.1 RNA Polymerase Inhibitors Forecasts
• 8.4 Fusion Inhibitors
  • 8.4.1 Fuzeon (Roche/Trimeris)
    • 8.4.1.1 Fuzeon' s tolerability profile
    • 8.4.1.2 Fuzeon' s Needle-Free Device
  • 8.4.2 Fusion Inhibitor Sales Forecasts
• 8.5 Inteferons
  • 8.5.1 Interferon Sales Forecasts
• 8.6 Monoclonal Antibodies
  • 8.6.1 Synagis (MedImmune)
  • 8.6.2 Monoclonal Antibody Sales Forecasts
• 8.7 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
  • 8.7.1 NNRTI Sales Forecasts
• 8.8 Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
  • 8.8.1 NRTIs Combination Franchises
  • 8.8.2 NRTI Sales Forecasts
• 8.9 Nucleotide Reverse Transcriptase Inhibitors (NtRTIs)
  • 8.9.1 NtRTI Sales Forecasts
• 8.10 Protease Inhibitors
  • 8.10.1 PI Sales Forecasts
• 8.11 Neuraminidase Inhibitors (NIs)
  • 8.11.1 Neuraminidase Inhibitors Sales Forecasts
• 8.12 Global Anti-Viral Sales Forecasts

9 FUTURE BRANDS

• 9.1 Attachment, Entry and Fusion Inhibitors
  • 9.1.1 AMD070 (AnorMed/Genzyme)
  • 9.1.2 BMS-488043 (Bristol-Myers Squibb)
  • 9.1.3 FP-21399 (EMD Lexigen)
  • 9.1.4 HIV Fusion Inhibitor (Panacos)
  • 9.1.5 Maraviroc (Pfizer)
• 9.1. Ongoing pivotal Phase II/III Maraviroc trails
  • 9.1.6 PRO 140 (Progenics)
  • 9.1.7 SP01A (Samaritan Pharmaceuticals)
  • 9.1.8 TNX-355 (Tanox/Biogen Idec)
  • 9.1.9 T-1249 / TRI-1144/TRI-999 (Roche/Trimeris)
  • 9.1.10 Vicriviroc (Schering-Plough)
• 9.1. Safety Profile of Vicriviroc
• 9.2 Integrase Inhibitors
  • 9.2.1 GS 9137 (Gilead Sciences/[Japan Tobacco])
  • 9.2.2 MK-0518 (Merck & Co)
    • 9.2.2.1 Safety Profile of MK-0518
• 9.3 Interferons
  • 9.3.1 Albuferon (Novartis/Human Genome Sciences)
    • 9.3.1.1 Pivotal ACHIEVE Trial results
• 9.4 Maturation Inhibitors
  • 9.4.1 Bevirimat (Panacos)
    • 9.4.1.1 Mixed Phase II results with Bevirimat
• 9.5 Non-Nucleoside Reverse Transcriptase Inhibitors
  • 9.5.1 BILR 355 BS (Boehringer Ingelheim)
  • 9.5.2 Calanolide A (Advanced Life Sciences)
  • 9.5.3 Etravirine (Johnson & Johnson/[Tibotec])
    • 9.5.3.1 Etravirine discontinued in treatment-naïve patients
    • 9.5.3.2 Etravirines safety profile
    • 9.5.3.3 Ongoing pivotal etravine trials
  • 9.5.4 UK-453,061 (Pfizer)
• 9.6 Nucleoside Reverse Transcriptase Inhibitors
  • 9.6.1 Alovudine & Fosalvudine (Medivir)
  • 9.6.2 Apricitabine (Avexa/Shire Pharmaceuticals)
    • 9.6.2.1 Ongoing Pivotal Apricitabine Trials
  • 9.6.3 Dexelvutabine (Pharmasset)
  • 9.6.4 Elvucitabine (Achillion Pharmaceuticals)
  • 9.6.5 Racivir (Pharmasset Inc)
    • 9.6.5.1 Racivir' s mutation profile
• 9.7 Protease Inhibitors
  • 9.7.1 PPL-100 (Ambrilla Biopharma/Merck & Co.)
• 9.8 NS3 Protease Inhibitors
  • 9.8.1 SCH 503034 (Schering-Plough)
    • 9.8.1.1 SCH 503034 safety profile
    • 9.8.1.2 Ongoing pivotal SCH 503034 trials
  • 9.8.2 Telaprevir (Vertex/ Johnson & Johnson/Mitsubishi)
    • 9.8.2.1 Telaprevir' s Tolerability Profile
    • 9.8.2.2 Ongoing Pivotal Telaprevir Trials
• 9.9 Polymerase Inhibitors
  • 9.9.1 R1626 (Roche)
  • 9.9.2 R7128 (Roche/[Pharmasset])
  • 9.9.3 Valopicitabine (Idenix Pharmaceuticals/Novartis)
  • 9.9.4 Valtorcitabine (Index Pharmaceuticals)
• 9.10 Global Sales Forecasts for New Anti-Viral Agents
• 9.11 The Future of the Antiviral Market

10 APPENDIX 1 - PHARMACEUTICAL COMPANIES

• Abbott Laboratories
• AstraZeneca AB
• Boehringer Ingelheim Corporation
• Bristol-Myers Squibb Company
• GlaxoSmithKline plc
• Johnson & Johnson,
• Merck & Co Inc
• Novartis International AG
• Pfizer Inc
• Roche

11 APPENDIX 2 - BIOTECHNOLOGY AND BIOPHARMACEUTICAL COMPANY PROFILES

• 11.1 Achillon Pharmaceuticals
• 11.2 Agouron Pharmaceuticals (A Pfizer subsidiary)
• 11.2 Genzyme
• 11.3 ISIS Pharmaceuticals
• 11.4 MEDIVIR AB
• 11.5 Panacos
• 11.6 Pharmasset, Inc.
• 11.7 Progenics Pharmaceuticals, Inc.
• 11.8 Tanox
• 11.9 Tibotec
• 11.10 Trimeris, Inc.
• 11.11 Vertex Pharmaceuticals

12 APPENDIX 3

• 12.1 Bibliography

TABLES

• Table 2.1: Infectious Disease Leading Worldwide Health Burden
• Table 3.1: Worldwide Prevalence of HCV
• Table 4.1. Potential for clinical success
• Table 6.1: Historical Sales of 30 Leading Anti-infective Brands US$ million (2001-2005)
• Table 8.1. Infectious Agent Treatment Options
• Table 8.2: Sales Forecasts of Antisense Products US$m 2005A - 2012E
• Table 8.3: Comparison of the Leading DNA Polymerase Inhibitor Brands for the Treatment of CMV
• Table 8.4: Comparison of the Leading DNA Polymerase Inhibitor Brands for the Treatment of HSV
• Table 8.5: Sales Forecasts of DNA Polymerase Inhibitors (US$m) 2005A - 2012E
• Table 8.6: Sales Forecasts of RNA Polymerase Inhibitors 2005A - 2012E
• Table 8.7: Sales Forecasts of Fusion Inhibitors (US$m) 2005A - 2012E
• Table 8.8: Comparison of the Leading Interferon Monotherapies Approved for Hepatitis
• Table 8.9: Comparison of the Leading Interferon Combination Therapies Approved for Hepatitis
• Table 8.10: Sales Forecasts of Interferons (US$m) 2005A - 2012E
• Table 8.11: Sales Forecasts of Monoclonal Antibodies (US$m) 2005A - 2012E
• Table 8.12: Comparison of the Leading NNRTIs
• Table 8.13: Sales Forecasts of NNRTIs (US$m) 2005A - 2012E
• Table 8.14: Comparison of the Leading NRTI Approved for HBV
• Table 8.15: Comparison of the Leading NRTIs Approved for HIV Monotherapy
• Table 8.16: Comparison of the Leading NRTI Combination Therapies Approved for HIV
• Table 8.17: Sales Forecasts of NRTIs (US$m) 2005A - 2012E
• Table 8.18: Comparison of the Leading NtRTIs Brands
• Table 8.19: Sales Forecasts of NtRTIs (US$m) 2005A - 2012E
• Table 8.20: Comparison of the Leading PI Brands - Single Agents
• Table 8.21: The Leading Combination PI Brand
• Table 8.22: Sales Forecasts of PIs (US$m) 2005A - 2012E
• Table 8.23: Leading NIs Approved for Influenza
• Table 8.24: Sales Forecasts of NIs (US$m) 2005A - 2012E
• Table 8.25: Sales Summary of Antiviral Agents (US$m) 2005A - 2012E
• Table 9.1 Reduction of Viral Load Following Treatment with GS 0137
• Table 9.2: Reduction of Viral Load Following Treatment with TNC125
• Table 9.3: Sales Summary of New AntiViral Agents (US$m) 2005A - 2012E
• Table 9.4 Sales Summary of New Antiviral Agents (US$m) 2005A - 2012E

FIGURES

• Figure 2.1 Schematic of influenza virus
• Figure 3.1 Geographic Distribution of Chronic HBV Infection
• Figure 6.1 Global Anti-Infective Market US$66.5 bn (2006)
• Figure 6.2 Global Anti-Infective Market US$100 bn (2015)
• Figure 6.3 Antiretroviral Agents US$9.7 bn - Drug Class Split (2006)
• Figure 6.4 Hepatitis Antiviral Agents US$3.8 bn - Drug Class Split (2006)
• Figure 6.5 Other Antiviral Agents US$6.4 bn - Therapy Class Split (2006)
• Figure 6.6 The Major Players (2006)
• Figure 6.7 The Major Players (2012)
• Figure 6.8 The Global Antiviral Market (2012)
• Figure 6.9 Antiretroviral Agents US$12.6 bn - Drug Class Split (2012)
• Figure 6.10 Antiviral Agents US$5.5 bn - Drug Class Split (2012)
• Figure 6.11 Other Antiviral Agents US$5.6 bn - Therapy Class Split (2012)
• Figure 7.1 Site of Action of Leading Antiviral Agents
• Figure 8.1 Clinical Efficacy in TORO 1 & 2 Studies
• Figure 8.2 Global HCV Therapy
• Figure 9.1 Structure of Maraviroc
• Figure 9.2 Clinical Efficacy of TNX-355
• Figure 9.3 Virologic Response to TNX-355
• Figure 9.4 Pharmacokinetics of TRI-1144 in Rat Models
• Figure 9.5 Pharmokinetics of TRI-999 formulations in Rat Models
• Figure 9.6 Clinical Efficacy of Vicriviroc
• Figure 9.7 Clinical Efficacy of Vicriviroc in Sub Populations
• Figure 9.8 Clinical Efficacy of MK0518
• Figure 9.9 Schematic of Albuferon' s Structure
• Figure 9.10 Phase II Pharmacokinetic Profile of Albuferon
• Figure 9.11 (+)-Calanolide A Structure
• Figure 9.12 Clinical Efficacy of Racivir
• Figure 9.13 Clinical Efficacy of Racivir
• Figure 9.14 Phase I Clinical Efficacy of Racivir
• Figure 9.15 Clinical Efficacy of Valopicitabine
• Figure 9.16 Clinical Efficacy of Valopicitabine
• Figure 11.1 Medivir AB Pipeline
• Figure 11.2 Pharmassett Pipeline
• Figure 11.3 Progenics Pipeline
• Figure 11.4 Tanox Pipeline
• Figure 11.5 Vertex Pipeline