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

Published by: Arrowhead Publishers

Published: May. 17, 2007 - 186 Pages

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

Abstract

The global anti-infective market is currently valued at US$66.5 billion with antiviral agents accounting for 24% of sales (excluding vaccines which target viral infectious diseases).

According to Arrowhead Publishers’ new report The Antivirals Market: R&D Pipelines, Markey Analysis and Competitive Landscape, the anti-viral market will be driven by the uptake of newer anti-retroviral agents in combination therapy and the launch of ten new products for the treatment of HIV and hepatitis which will address the need of treatment-resistant patients. This will help to stem the tide of this prevalent and often lethal killer in our society today.

Pharmaceutical companies continue to develop a new generation of antiretroviral agents to overcome the issue of drug and cross-resistance. Meanwhile new drug classes are under evaluation that increases the virologists armory against these endemic and often deadly infectious diseases.

This report examines each of the antiviral classes in turn, assessing the market potential and encompassing the major infectious diseases to which they are applicable.

The following product classes are analyzed in this report:

• antisense
• attachment, entry and fusion inhibitors
• DNA polymerase inhibitors
• integrase inhibitors
• interferons
• maturation inhibitors
• monoclonal antibodies
• neuraminidase inhibitors
• NS3 protease inhibitors
• nucleoside reverse transcriptase inhibitors
• nucleotide reverse transcriptase inhibitors
• protease inhibitors
• reverse transcriptase inhibitors
• RNA polymerase inhibitors

The report assesses the overall antiviral market, key classes, the drivers and resistors influencing their prescription. The report provides an overview of key products in each category, summarizing their clinical efficacy and marketing position. The overview of the current market is given in terms of segmentation by category and by leading players, therapies and their products and analyzes market trends.

The report examines promising pipeline products and their potential impact on the prescription of current and new antiviral agents and the future antiviral market.

Key features of this report:

• Overview of the antiviral market, including main infectious agents, therapeutic drug classes and key players.
• In-depth analysis of different classes of antiviral agents, including key antiretroviral and antiviral agents and compares drugs within each class.
• Comprehensive facts and figures for the antiviral market, including main players and therapeutic break-downs.
• Future trends in the antiviral marketplace, driven by drug resistance, cross-resistance and patient demographics.
• Outlook for the antiviral market, including the emergence of novel therapies, new combination therapies and the impact of generics.

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