Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Disease and Respiratory pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the HIV market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Related reports
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- HIV pipeline overview
- Growth in the HIV market will be driven by launch of new compounds and
classes from 2007 onwards
- Key companies involved in the HIV pipeline
- GSK set to lose significant market share
- Gilead' s fixed dose combinations dominating initial therapy
- Merck' s promising pipeline will strengthen its presence in HIV
- Tibotec positioning compounds across all lines of therapy
- Key R&D company strategies
- Major players in HIV are also developing their drugs for HBV as a
secondary indication
- CHAPTER 3 HIV - MARKET POTENTIAL
- Definition of disease HIV
- Segmentation of HIV
- Treatment-naïve patients
- Treatment-experienced patients
- Epidemiology of HIV
- HIV prevalence in US and Western Europe increasing
- MSM remains the predominant transmission group in the US
- Immigration from areas of high prevalence driving the increase in
number of HIV-infected patients in Western Europe
- Prolonged life expectancy from HAART
- Awareness campaigns increasing diagnosis rates in the US but not
enough emphasis on testing in Western Europe
- Unmet needs in HIV
- Efficacy is generally not an issue for most classes
- Resistance remains a key unmet need for the NRTIs and NNRTIs
- Side effects are particularly problematic for PIs
- Issue of pill burden eliminated by availability of simplified
treatments
- PIs are more commonly associated with drug-drug interactions
- Cost is currently not an issue but likely to be problem in the future
- CHAPTER 4 R&D APPROACH
- Antiretroviral drug classes
- NRTIs are the oldest class of drugs and form the backbone of HAART
regimens
- NNRTIs are generally used in first-line but are prone to resistance
- Despite the availability of several PIs, two members dominate this
class
- Selzentry and Isentress are latest additions to the entry inhibitors
and others class
- Entry inhibitors
- Integrase inhibitors
- First cross class combination - Atripla
- Clinical trials in HIV
- Clinical trial endpoints
- Early trials were based on ' hard' clinical endpoints, such as
progression to AIDS or death
- The availability of HIV viral load diagnostics enabled trials to
measure the direct effect on the virus, use ' soft' clinical endpoints
and reduced the length of trials
- Reduction in viral load
- CD4 elevation
- Efficacy equivalence
- With improved understanding of HIV and the advent of HAART therapy,
endpoints have changed significantly
- Activity against resistant virus - a must for most of the HIV
pipeline
- Quality of life considerations
- CHAPTER 5 NUCLEOSIDE REVERSE TRANSCRIPTASE INHBITORS LATE-STAGE DRUG
ANALYSIS & FORECASTS
- Overview for NRTIs
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- NRTI gold standard - Truvada
- Apricitabine
- Drug overview
- Clinical trial data
- Satisfaction of unmet needs
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Elvucitabine
- Drug overview
- Clinical trial data
- Satisfaction of unmet needs
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment study
- Racivir
- Drug overview
- Clinical trial data
- Satisfaction of unmet needs
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment study
- Other drugs in the NRTI class
- CHAPTER 6 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS LATE-STAGE DRUG
ANALYSIS AND FORECASTS
- Overview for the NNRTI class
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- NNRTI ' gold-standard' : Sustiva
- Etravirine
- Drug overview
- Clinical trial data
- Satisfaction of unmet needs
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment study
- Rilpivirine
- Drug overview
- Clinical trial data
- Satisfaction of unmet needs
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment study
- Other drugs in development from the NNRTI class
- UK 453,061
- RDEA806
- IDX-899
- CHAPTER 7 PROTEASE INHIBITORS LATE STAGE DRUG ANALYSIS AND FORECASTS
- Overview for the PI class
- Pipeline summary
- Definition of current comparator therapy
- PI gold-standard Kaletra
- Competitive pressure from Reyataz and Prezista
- PIs in early stage development
- Late-stage development compounds recently discontinued
- CHAPTER 8 EIS AND OTHERS LATE STAGE DRUG ANALYSIS AND FORECASTS
- Overview for the EI & others class
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Fuzeon
- Selzentry/Celsentri
- Drug assessment study for entry inhibitors
- Isentress
- Compounds in late-stage development
- Elvitegravir
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Vicriviroc
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Drug assessment study
- Bevirimat
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Other drugs in the EI and others class
- PRO-140
- Ibalizumab (TNX-355)
- INCB9471
- MK-2048
- Vivecon (MPC-9055)
- APPENDIX A
- Bibliography
- Journal articles and conference abstracts
- Websites
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Definition of a standard unit (only use if ForeSight model used to
forecast)
- Contributing experts
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Key therapy team members
- Holger Rovini, Lead Analyst, Infectious Disease and Respiratory
- Disclaimer
- List of Tables
- Table 1: Key parameters of HIV for the sixmajor markets
- Table 2: HIV pipeline overview, 2007
- Table 3: Overview of GSK' s HIV portfolio, 2007
- Table 4: Overview of Gilead' s HIV portfolio, 2007
- Table 5: Overview of the NRTIs, 2007
- Table 6: Overview of the NNRTIs, 2007
- Table 7: Overview of currently marketed PIs, 2007
- Table 8: Key NRTI products in late-stage R&D pipeline for HIV, 2007
- Table 9: Sales forecasts for pipeline NRTIs across the six major
markets, 2006 -2015
- Table 10: Gilead' s Truvada
- Table 11: Key NNRTI products in late-stage R&D pipeline for HIV,
2007
- Table 12: Sales forecasts for pipeline NNRTIs across the six major
markets, 2007-2015
- Table 13: BMS' s Sustiva
- Table 14: Key PI products in early-stage R&D pipeline for HIV, 2007
- Table 15: Abbott' s Kaletra
- Table 16: Key EI and others products in late-stage R&D pipeline
for HIV, 2007
- Table 17: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Datamonitor drug assessment summary of pipeline drugs in
late stage development for HIV, 2007
- Figure 2: Number of compounds in late-stage development for HIV by
class, 2007
- Figure 3: Antiretroviral sales forecasts, six major markets, 2006-2016
- Figure 4: HIV market share by company, 2003-06
- Figure 5: Sales forecasts for Gilead products, six major markets,
2006-2016
- Figure 6: Gilead HIV market share, 2006 and 2016
- Figure 7: Sales forecasts for Prezista, etravirine and rilpivirine,
six major markets, 2006-2016
- Figure 8: Adults and children estimated to be living with HIV, 2007
- Figure 9: Estimated number of people living with HIV globally,
1990-2007
- Figure 10: Estimated number of people newly infected with HIV
globally, 1990-2007
- Figure 11: HIV diagnoses by exposure category, United Kingdom:
1981-2005
- Figure 12: Number of newly diagnosed cases of HIV infection by
transmission group and year of report in Western Europe (13 countries),
1999-2006
- Figure 13: UK HIV diagnoses by the two main routes of transmission,
1997 -2004
- Figure 14: HIV infections in the UK by the region they were acquired
from, 2006
- Figure 15: HIV lifecycle
- Figure 16: Unmet needs for HIV drugs by class
- Figure 17: Overview of sales of HIV treatments by drug class, 2002-06
- Figure 18: HIV mechanism of entry into host cell
- Figure 19: Datamonitor drug assessment summary of pipeline NRTIs
- Figure 20: Sales forecasts for pipeline NRTIs across the six major
markets, 2006-2016
- Figure 21: Sales of Truvada. Epzicom and Combivir 2002-2006
- Figure 22: Sales forecasts for apricitabine across the six major
markets to 2016
- Figure 23: Datamonitor' s competitive positioning analysis of
apricitabine, 2007
- Figure 24: Sales forecasts for elvucitabine across the six major
markets to 2016
- Figure 25: Datamonitor' s competitive positioning analysis of
elvucitabine, 2007
- Figure 26: Sales forecasts for racivir across the six major markets to
2016
- Figure 27: Datamonitor' s competitive positioning analysis of racivir,
2007
- Figure 28: Datamonitor drug assessment summary of pipeline NNRTIs
- Figure 29: Sales forecasts for pipeline NNRTIs across the six major
markets, 2006-2016
- Figure 30: Sales of Sustiva Viramune and Rescriptor 2002-2006
- Figure 31: DUET studies
- Figure 32: Sales forecasts for etravirine across the six major markets
to 2016
- Figure 33: Datamonitor' s competitive positioning analysis of
etravirine, 2007
- Figure 34: Phase II program for rilpivirine
- Figure 35: Sales forecasts for rilpivirine across the six major
markets to 2016
- Figure 36: Datamonitor' s competitive positioning analysis of
rilpivirine, 2007
- Figure 37: Sales of PIs 2002-2006
- Figure 38: Sales forecasts for developmental and recently introduced
EIs and others drugs, 6MM, 2006-2016
- Figure 39: Overview of sales of Fuzeon in the US and Canada, 2003-06
- Figure 40: MOTIVATE trials
- Figure 41: MOTIVATE trial results
- Figure 42: MERIT study
- Figure 43: Sales forecasts for Selzentry across the six major markets
to 2016
- Figure 44: Datamonitor drug assessment summary of pipeline entry
inhibitors
- Figure 45: BENCHMARK trials
- Figure 46: TRIO study
- Figure 47: Sales forecasts for Isentress across the six major markets
to 2016
- Figure 48: Sales forecasts for elvitegravir across the six major
markets to 2016
- Figure 49: Sales forecasts for vicriviroc across the six major markets
to 2016
- Figure 50: Datamonitor' s competitive positioning analysis of
rilpivirine, 2007
- Figure 51: Sales forecasts for bevirimat across the six major markets
to 2016
- Figure 52: Datamonitor drug assessment summary of pipeline molecular
targeted therapies in development for hematological malignancies, 2007
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