Home > Back to Publisher > Report Information

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

Datamonitor
August 26, 2008
270 Pages - SKU: DFMN1898216

Abstract Table of Contents Related Reports

Introduction

Despite high unmet need, the market for the small molecules used to manage conditions such as genital and oral herpes, genital warts, cytomegalovirus retinitis and pneumonia or shingles has been neglected compared with the successfully promoted immunizations for varicella in children, zoster in adults, or human papilloma virus in adolescents.

Scope

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

Highlights

Current formulary reimbursement restrictions on valaciclovir could be overturned if generic rivals to Valtrex were launched at a dramatic discount rather than the commonly applied practice of charging highest achievable price , replacing acyclovir as the most popular drug in the process.

The level of unmet need in all four disease markets is still substantial, opening up substantial opportunities for true innovations in an otherwise highly genericised competitive environment characterized by high volume, low value offerings. The few existing late-stage development pipeline compounds will not be able to benefit.

While the seven Major Markets currently dominate the commercial landscape, the ROW offers huge scope for market expansion. While pricing levels are far lower, commodity products such as antivirals and antibacterials are an ideal platform for branded Pharma to increase their presence in Emerging Markets.

Reasons to Purchase

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

Please note: This is delivered as a Zip file.

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

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

Share this report

Other tasks

Research Assistance

Related Markets

Infectious Diseases Reports

Free Alert Me service