Commercial Insight: Select herpes viruses and human papilloma virus - Non-biologic interventions for oral and genital herpes, cytomegalovirus infection, herpes zoster and genital warts

Published by: Datamonitor

Published: Aug. 26, 2008 - 270 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION

Market definition for this report

Pathogens and disease indications

Herpes simplex viruses

Primitive herpes simplex virus (HSV) prophylaxis

Reducing the frequency of recurrence

Reducing the impact of recurrence

Varicella zoster virus

The vaccination paradox

Ambiguous early signs - a major barrier to necessary early treatment

Continued reliance on alleviating symptoms does not solve the problem of post-herpetic neuralgia

Vaccination - an advance, but by no means a complete solution

Preventing the damage - new antiviral trials emphasize prevention of post-herpetic neuralgia

Zoster complications as a non-infectious disease sector

Human papillomavirus

Barriers to vaccine uptake - universal adoption is not a given

Continued demand for non-vaccine interventions

Cytomegalovirus

Congenital cytomegalovirus

Acquired cytomegalovirus infection

CHAPTER 3 PATIENT ACQUISITION PROCESS

Introduction

Herpes simplex virus type 1 and 2 patient care pathways

Self-diagnosis and treatment of herpes

Initial presentation

Managing transmission risk

Varicella zoster virus patient care pathways

Pediatric illness - the curse of the industry dollar

A bitter pill for pediatric vaccines

General education - leave it to the [medical] professionals

Adult illness

Decision making and decision makers in advanced age

High presentation rates, but early enough?

Human papillomavirus patient care path

Cytomegalovirus patient care path

CHAPTER 4 MARKET OVERVIEW

Market Overview

Seven major markets versus rest of world

Seven major markets drive market value despite high volume growth in rest of market

Seven major market HSV/VZV sectors dominate the market, but interesting signs of growth elsewhere

Relative shelter from generic incursion in the seven major markets and further afield

Seven major markets

Key market events and characteristics

Current market assessment

US commands highest value sales but Japan is pushing volume sales

Herpes simplex virus and varicella zoster virus sectors dominate, and newer treatments drive value growth

Branded sales volumes take a small but important generic hit

Very high concentration around leading brands in each sector

Future market assessment

US to take the biggest hit as growth rates start to falter

Major, but sector-specific genericization is imminent

Generic domination threatens the likelihood of new blood and new solutions

Few survivors of the generic tidal wave

Opportunities and threats

Still no cures

Respite from the looming threat of vaccines?

The curse of aciclovir

Genital warts and beyond

The vaccine-antiviral combination approach

Reducing toxicity in patients least able to tolerate it

US

Key event summary

Current market assessment

The US HSV/VZV sector is the defining sector of the seven major markets

Strong generic growth bested by brands taking new and switch prescriptions?

Valtrex drives three-quarters of US growth

Future market assessment

Brand expansion of patient populations fuels future growth - in all sectors but human papillomavirus

From a heavily branded sector to a generic haven in less than 10 years

Valtrex patent expiry: side effects may include portfolio headaches

Japan

Key market events

Current market assessment

High growth market, even in traditionally miniscule sectors

Japan goes generic

Japan shows a preference for budget products

Future market assessment

CMV - the resilient sector

The big slowdown - brands first

Less about Valtrex, more about Valcyte

5EU

Key market events

Current market assessment

Higher emphasis on CMV and HPV

Not the cheapest brands, and higher generic costs, but much smaller margin between the two

More even distribution of revenues

Future market assessment

Cytomegalovirus sector growth offsets losses elsewhere

Brand versus generic

Key brands

CHAPTER 5 BRAND DYNAMICS

Herpes simplex virus and varicella zoster virus

Overview of competitive landscape

Key issues in brand preference

Genital herpes

Oral herpes

Varicella zoster

Herpes zoster

US formulary status for leading brands

Pipeline profile

Valtrex - the current gold standard

Drug profile

Product positioning

Brand forecast to 2017

Strategic recommendations

Cytomegalovirus

Valcyte's capture of the cytomegalovirus market

Limited options drive brand choice

Cause or effect: necessity drives US formulary status

Practical information has greater impact than brand positioning?

Maribavir - filling the gaps in transplant indications

Brand forecast to 2017

Strategic recommendations

Human papillomavirus

Overview of competitive landscape

Drivers of brand choice

US formulary status for leading brands

Pipeline profile

Brand forecasts to 2017

Strategic recommendations

BIBLIOGRAPHY

Journal papers

Websites

Articles

Books

Datamonitor reports

Other

APPENDIX A - MARKET ASSUMPTION

Background 5EU Sales data

New product launches

Patent expiries

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Other points of note

Distribution of specialist products and sales data collection methodologies.

Forecast methodology

APPENDIX B

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Infectious Disease analysis team

Disclaimer

List of Tables

Table 1: Herpes, varicella, cytomegalovirus and human papillomavirus antivirals analyzed and forecast in this report, 2008

Table 2: Infectious agents and indications covered in this report

Table 3: Human herpes virus subfamilies and their constituent members

Table 4: Trends in herpes simplex virus type 1 and type 2 sero-prevalence in the US, 1988-1994 and 1999--2004

Table 5: Threshold for sustainable transmission and transmission probability per partnership for key sexually transmitted infections, 2008

Table 6: Herpes zoster incidence in the US and EU

Table 7: Zostavax efficacy in preventing herpes zoster and post-herpetic neuralgia (PHN) in patients developing herpes zoster post-vaccination

Table 8: Non-antiviral interventions for post-herpetic neuralgia

Table 9: Human papillomavirus: comparative analysis of Gardasil and Cervarix

Table 10: Herpes simplex virus (HSV), varicella zoster virus (VZV), human papillomavirus (HPV) and cytomegalovirus (CMV): key factors influencing patient flow through the healthcare system

Table 11: Key* antiviral market sales by value, seven major markets (7MM) versus rest of world (ROW), indexed (2003-07) and actual (2007)

Table 12: Key* antiviral market sales by volume, seven major markets (7MM) versus rest of world (ROW), indexed (2003-07) and actual (2007)

Table 13: Seven major market (7MM) and rest of world (ROW) antiviral sales by volume and sector, 2007

Table 14: Seven major market (7MM) and rest of world (ROW) antiviral sales by value and sector, 2007

Table 15: Seven major market (7MM) and rest of world (ROW) antiviral brand and generic value sales (2007) and key dynamics (volume and value growth rates, 2003-07)

Table 16: Indexed antiviral sector sales by value in the seven major markets by region, 2003-07

Table 17: Indexed antiviral sector sales by volume in the seven major markets by region, 2003-07

Table 18: Indexed antiviral value sales by sector in the seven major markets, 2003-07

Table 19: Indexed antiviral volume sales by sector in the seven major markets, 2003-07

Table 20: Indexed generic versus branded antiviral value sales in the seven major markets, 2003-07

Table 21: Indexed generic versus branded antiviral volume sales in the seven major markets, 2003-07

Table 22: Indexed value sales for key antiviral brands in the seven major markets, 2003-07

Table 23: Indexed volume sales for key antiviral brands in the seven major markets, 2003-07

Table 24: Seven major market performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets by region, 2007 and 2017

Table 25: Seven major market sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Table 26: Seven major market sector performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Table 27: Seven major market herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 28: Herpes simplex and varicella zoster, cytomegalovirus and human papillomavirus virus all-sector scenario assessment - finding a curative or suppressive therapy

Table 29: Herpes simplex and varicella zoster, cytomegalovirus and human papillomavirus virus all-sector scenario assessment - vaccines do not displace need for antiviral therapies

Table 30: Herpes simplex and varicella zoster virus scenario assessment - aciclovir sets the bar too high

Table 31: Herpes simplex and varicella zoster virus scenario assessment - lowering the price of generic valaciclovir to compete with branded oral aciclovir

Table 32: Varicella zoster virus scenario assessment - upfront investment to improve understanding of viral involvement in post-herpetic neuralgia

Table 33: Human papillomavirus scenario assessment - leveraging new genital warts treatments into much broader applications

Table 34: Human papillomavirus scenario assessment - using an HPV antiviral to increase the potential market for HPV vaccines

Table 35: Cytomegalovirus scenario assessment - providing a less toxic alternative for cytomegalovirus

Table 36: Cytomegalovirus scenario assessment - improvement in the management of acquired and induced immunosuppression

Table 37: US herpes simplex and varicella zoster virus sector timeline, 1977-2015

Table 38: US human papillomavirus sector timeline, 1991-2013

Table 39: US cytomegalovirus sector timeline, 1988-2015

Table 40: Indexed US antiviral value sales by sector in the US, 2003-07

Table 41: Indexed US antiviral volume sales by sector in the US, 2003-07

Table 42: Indexed US antivirals brand versus generic value sales, 2003-07

Table 43: Indexed US antivirals brand versus generic volume sales, 2003-07

Table 44: Indexed value sales, CAGR (2003-07) and actual sales (2007) for key antiviral brands

Table 45: Indexed US volume sales, CAGR (2003-07) and actual sales (2007) for key antiviral brands

Table 46: US sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Table 47: US performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Table 48: Indexed US value sales for key antiviral brands, 2007-2017

Table 49: US herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 50: Japanese herpes simplex and varicella zoster virus sector timeline, 1984-2015

Table 51: Japanese human papillomavirus sector timeline, 2004-2013

Table 52: Japanese cytomegalovirus sector timeline, 1988-2016

Table 53: Indexed Japanese antiviral value sales by sector, 2003-07

Table 54: Indexed Japanese antiviral volume sales by sector, 2003-07

Table 55: Indexed Japanese antiviral brand versus generic value sales, 2003-07

Table 56: Indexed Japanese antiviral brand versus generic volume sales, 2003-07

Table 57: Indexed Japanese value sales for key antiviral brands, 2003-07

Table 58: Indexed Japanesevolume sales for key antiviral brands, 2003-07

Table 59: Japanese sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Table 60: Japanese performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Table 61: Japanese herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 62: 5EU herpes simplex and varicella zoster virus sector timeline, 2007-2016

Table 63: 5EU human papillomavirus sector timeline, 2009

Table 64: 5EU cytomegalovirus sector timeline, 2007-2016

Table 65: Indexed 5EU antiviral value sales by sector, 2003-07

Table 66: Indexed antiviral volume sales by sector in the 5EU, 2003-07

Table 67: Indexed 5EU antiviral brand versus generic value sales, 2003-07

Table 68: Indexed 5EU antiviral brand versus generic volume sales, 2003-07

Table 69: Indexed 5EU value sales for key antiviral brands, 2003-07

Table 70: Indexed 5EU volume sales for key antiviral brands, 2003-07

Table 71: 5EU sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Table 72: 5EU performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Table 73: 5EU herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 74: Leading branded drug sales ($m) for herpes simplex and varicella zoster virus, 2007-17

Table 75: Relative dosing and unit cost for Zovirax, Famvir and Valtrex

Table 76: Current formulary status for leading brands in the herpes simplex and varicella zoster virus sector

Table 77: Pipeline products in clinical development for herpes simplex virus and varicella zoster virus, 2007

Table 78: Valtrex - key facts, 2008

Table 79: Seven major market sales forecast ($m) for Valtrex, 2007-17

Table 80: Impacting factors on valaciclovir revenues, 2007-2017

Table 81: Leading branded drug sales ($m) for cytomegalovirus, 2007-2017

Table 82: Current formulary status for leading brands in cytomegalovirus sector for selected US healthcare plans

Table 83: Pipeline products in clinical development for herpes simplex virus and varicella zoster virus, 2007

Table 84: Timeline for maribavir clinical development, 2006-2011

Table 85: Seven major market sales forecast ($m) for Valcyte, 2007-17

Table 86: Leading branded drug sales ($m) for human papillomavirus, 2007-2017

Table 87: Current formulary status for leading brands in the human papillomavirus sector for selected US healthcare plans, 2008

Table 88: Pipeline products in clinical development for human papillomavirus, 2008

Table 89: Seven major market sales forecast ($m) for Aldara, 2007-2017

Table 90: Impacting factors on imiquimod revenues, 2007-2017

Table 91: France herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 92: Germany herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 93: Italy herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 94: Spain herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 95: UK herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus antiviral sales ($m) forecasts, 2007-2017

Table 96: Datamonitor projected launch dates for herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus sectors in the seven major markets, 2008

Table 97: Patent expiry dates used in forecasting herpes simplex virus, varicella zoster virus, cytomegalovirus and human papillomavirus sectors market, 2007-2017

List of Figures

Figure 1: Herpes simplex virus lifecycle

Figure 2: Varicella zoster disease progression

Figure 3: Zostavax efficacy in preventing herpes zoster and post-herpetic neuralgia in patients developing herpes zoster post-vaccination

Figure 4: Genital herpes patient care path

Figure 5: Oral herpes patient care path

Figure 6: Varicella zoster virus patient care path

Figure 7: Human papillomavirus patient care path

Figure 8: Cytomegalovirus patient care path

Figure 9: Key antiviral market sales by value - seven major markets (7MM) versus rest of world, indexed (2003-07) and actual (2007)

Figure 10: Key antiviral market sales by volume, seven major markets (7MM) versus rest of world (ROW), indexed (2003-07) and actual (2007)

Figure 11: Seven major market (7MM) and rest of world (ROW) antiviral sector value sales (2007) and key dynamics (volume and value growth rates, 2003-07)

Figure 12: Seven major market and rest of world antiviral brand and generic value sales (2007) and key dynamics (volume and value growth rates, 2003-07)

Figure 13: Key events by sector - herpes simplex and varicella zoster virus, cytomegalovirus and human papillomavirus, 1981-2016

Figure 14: Indexed antiviral sector sales by value in the US, 5EU and Japan, 2003-07

Figure 15: Indexed antiviral sector sales by volume seven major markets by region, 5EU and Japan, 2003-07

Figure 16: Indexed antiviral value sales by sector in the seven major markets, 2003-07

Figure 17: Indexed antiviral volume sales by sector in the seven major markets, 2003-07

Figure 18: Indexed generic versus branded antiviral value sales in the seven major markets, 2003-07

Figure 19: Indexed generic versus branded antiviral volume sales in the seven major markets, 2003-07

Figure 20: Key antiviral brand dynamics, 2008

Figure 21: Impact of key events on the herpes simplex and varicella zoster virus, cytomegalovirus and human papillomavirus antivirals market, 2007-2017

Figure 22: Seven major market performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets by region, 2007 and 2017

Figure 23: Seven major market sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Figure 24: Seven major market sector performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Figure 25: Seven major market sector performance of herpes simplex and varicella zoster virus, cytomegalovirus and human papillomavirus key brands, other branded drugs and generics, 2007 and 2017

Figure 26: Seven major market sector performance of herpes simplex and varicella zoster virus, cytomegalovirus and human papillomavirus key brands, other branded drugs and generics, 2007 2017

Figure 27: Milestones in organ transplant, 1950s-2000s

Figure 28: Indexed US antiviral value sales by sector in the US, 2003-07

Figure 29: Indexed US antiviral volume sales by sector in the US, 2003-07

Figure 30: Indexed US antivirals brand versus generic value sales, 2003-07

Figure 31: Indexed US antivirals brand versus generic volume sales, 2003-07

Figure 32: Indexed US value sales for key antiviral brands, 2003-07

Figure 33: Indexed US volume sales for key antiviral brands, 2003-07

Figure 34: US sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Figure 35: US performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Figure 36: Indexed US value sales for key antiviral brands, 2007-2017

Figure 37: Indexed Japanese antiviral value sales by sector, 2003-07

Figure 38: Indexed Japanese antiviral volume sales by sector, 2003-07

Figure 39: Indexed Japanese antiviral brand versus generic value sales, 2003-07

Figure 40: Indexed Japanese antiviral brand versus generic volume sales, 2003-07

Figure 41: Indexed Japanese value sales for key antiviral brands, 2003-07

Figure 42: Indexed Japanese volume sales for key antiviral brands, 2003-07

Figure 43: Japanese sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Figure 44: Japanese performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Figure 45: Indexed Japanese value sales for key antiviral brands, 2007-2017

Figure 46: Indexed 5EU antiviral value sales by sector, 2003-07

Figure 47: Indexed antiviral volume sales by sector in the 5EU, 2003-07

Figure 48: Indexed 5EU antiviral brand versus generic value sales, 2003-07

Figure 49: Indexed 5EU antiviral brand versus generic volume sales, 2003-07

Figure 50: Indexed 5EU value sales for key antiviral brands, 2003-07

Figure 51: Indexed 5EU volume sales for key antiviral brands, 2003-07

Figure 52: 5EU sector performance of the herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, 2007 and 2017

Figure 53: 5EU performance of herpes simplex virus and varicella zoster virus, cytomegalovirus and human papilloma markets, branded versus generic sales, 2007 and 2017

Figure 54: Indexed 5EU value sales for key antiviral brands, 2007-2017

Figure 55: Seven major market sector performance of herpes simplex virus and varicella zoster virus key brands, other branded drugs and generics, 2007 and 2017

Figure 56: Seven major market sales forecast ($m) for Valtrex, 2007-2017

Figure 57: The effect of patent expiry on Valtrex sales ($m) (valaciclovir) in the seven major markets, 2007-2017

Figure 58: Seven major market sector performance of cytomegalovirus key brands, other branded drugs and generics, 2007 and 2017

Figure 59: Seven major market sales forecast ($m) for Valcyte, 2007-2017

Figure 60: The effect of patent expiry on Valcyte (valganciclovir) sales in the seven major markets, 2007-2017

Figure 61: Seven major market sector performance of human papillomavirus key brands, other branded drugs and generics, 2007 and 2017

Figure 62: Seven major market sales forecast ($m) for Aldara, 2007-2017

Figure 63: The effect of patent expiry on Aldara (imiquimod) sales ($m) in the seven major markets, 2007-2017

Abstract

• Market overview of available treatments for four viral pathogens
• Assessment of brand dynamics for major players
• Comparative assessment of strengths and weaknesses in current and future competitive environment
• Ten year sales volume and value forecast for the 7 Major Markets by brand, molecule and region

• Identify key opportunities and threats that will impact the use and uptake of branded and generic products
• Select effective lifecycle management strategies through analysis of key brand strategies
• Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

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