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Drugs of Tomorrow: HIV - Managing Portfolio Growth During Sector SlowdownPublished by: Datamonitor Published: Mar. 14, 2003 - 244 Pages Table of ContentsCHAPTER 1 Executive Summary 1.1 Scope 1.2 Datamonitor insight into the HIV market 1.3 Key metrics CHAPTER 2 Patient potential 2.1 Overall HIV/AIDS population HIV and AIDS Commercial Imperative Definition of AIDS Commercial utilization of demographic data Seven Major Market Prevalence of HIV/AIDS Strategic considerations for non-treated patients CHAPTER 3 Diagnosis 3.1 Diagnosis, treatment and compliance rates Overall HIV and AIDS diagnosed patient populations Epidemiology by mode of transmission Implications for the pharmaceutical industry US epidemiology by race/ethnicity Segmentation of the HIV/AIDS population by associated co-morbidity Impact of comorbidities on patient management Commercial Implications 3.2 Future trends in the incidence and prevalence of HIV 3.3 Unmet needs in HIV Ranking of unmet needs Unmet needs by class NRTIs NNRTIs PIs Case Study 1: Two or more drugs in one pill - the GSK strategy Case Study 2: BMS - Once Daily Dosing, reducing pill burden Case Study 3: Abbott - PI boosting, reducing toxicity Case Study 4: Novel pipeline therapeutics - The fusion inhibitors Analysis of all commercial strategies and unmet need CHAPTER 4 R&D Approach 4.1 Classification of pipeline products Nucleoside reverse transcriptase inhibitors (NRTIs) Non-nucleoside reverse transcriptase inhbitors (NNRTIs) Protease inhibitors (PIs) Nucleotide reverse transcriptase inhibitors Immune based therapies Fusion inhbitors Vaccines 4.2 Clinical trials endpoints in HIV Endpoint 1 HIV RNA Endpoint 2 Immunological status Target population dependent endpoints HIV therapies and Drug to Drug Interactions Additional Endpoints 4.3 Clinical trial design in HIV Inclusion/Exclusion Criteria Use of Placebos Trial Size Duration of Trial Randomization and Blindness CHAPTER 5 HIV Pipeline Analysis 5.1 Pipeline overview 5.2 Key companies involved in the disease pipeline Current Market Performance of traditional HIV market leaders Portfolio Composition Class composition of pipeline Origination and Licensing of Pipeline products Level of Portfolio Advance 5.3 R&D company strategy 101 Key drug delivery strategies in HIV Once daily dosing Combination products IV administration Key niche population strategies in HIV Mother to Child Transmission - MTCT Post Exposure Prophylaxis - PEP Developed and Developing World Markets Key Ethnic Groups Specific Co-morbidities Specific Resistance Patterns Key line of therapy strategies in HIV CHAPTER 6 HIV Pipeline Analysis By Class 6.1 NRTI Product Pipeline Coactinon Performance relative to comparator Coviracil Performance relative to comparator Ziagen / Epivir Combination Performance relative to comparator DAPD Performance relative to comparator ACH-126443 MIV-310 Performance relative to comparator 6.2 NNRTI Product Pipeline Calanolide A Capravirine Performance relative to comparator DPC-083 Performance relative to comparator TMC-125 Performance relative to comparator 6.3 PI Product Pipeline Zrivada Performance relative to comparator Amprenavir pro-drug Performance relative to comparator Tipranavir Performance relative to comparator TMC114 Performance relative to comparator 6.4 Entry Inhibitor Product Pipeline Fuzeon Performance relative to comparator FP-21399 Performance relative to comparator PRO-542 Performance relative to comparator S1360 Performance relative to comparator Viraldon Performance relative to comparator T-1249 Performance relative to comparators Cytolin 6.5 Immunotherapeutic Product Pipeline Proleukin WF10 HE2000 Performance relative to comparator Reticulose 6.6 Biologics Product Pipeline Remune AIDSVAX B/E & B/B MVA-BN HIV NEF HGTV-43 VIR201 L.E.A.P.S. with HGP-30 hNM01 6.7 Other Products in Pipeline Ampligen Memantine 6.8 Recently discontinued Developmental Compounds DMP-450 AMD3100 CHAPTER 7 Late Stage Drug Analysis & Forecasts 7.1 Late Stage Drug Market Forecasts Commercial attractiveness by class 7.2 Late Stage Drug Forecasts by Class NRTI New Entrants, 2003-2010 NNRTI New Entrants, 2003-2010 PI New Entrants, 2003-2010 Other New Entrants CHAPTER 8 Innovative Early Stage Projects 8.1 Early Stage NNRTI Pipeline 8.2 Early Stage NRTI Pipeline 8.3 Early Stage PI Portfolio 8.4 Early Stage Entry Inhibitor Pipeline 8.5 Early Stage Immunotherapeutic Pipeline 8.6 Early Stage Biologics Pipeline CHAPTER 9 Appendix A 9.1 List of tables 9.2 List of figures 9.3 Bibliography 9.4 Datamonitor Opinion Leader Panel Antonio Antela - HIV/AIDS Richard Pollard - HIV/AIDS Professor Christine Katlama Dr Graeme Moyle Professor Brian Gazzard Professor Andrew Phillips Professor Jay Levy Dr Giuseppe Pantaleo Mr Jorma Koskinen Dr Nicola Mackie 9.5 Pipeline analysis 9.6 Market forecasts 9.7 R&D research methodology Introduction Hypothesis formulation Hypothesis testing Ongoing information update Product specific primary research Data verification and quality control Quantification of data reliability Date of research completion Confidence ratings 9.8 Forecast methodology Current drug forecast methodology Methodology Market events Validation Pipeline drug forecast methodology Predicting initial market share Forecasting future growth Influencing factors CHAPTER 10 Appendix B: About Datamonitor 10.1 About Datamonitor About Datamonitor Healthcare Datamonitor Healthcare’s research and analysis methodologies 10.2 Datamonitor Healthcare’s therapy area capabilities About Disease analysis team Datamonitor Healthcare’s Consulting expertise Datamonitor’s Therapeutic Consulting expertise Key therapy team members Simon Hemsworth, Director of TherapyArea Analysis Steve Birch, Director Infectious Disease David Abramson, Therapeutic Lead Consultant Disclaimer AbstractIntroduction:The HIV sector is experiencing a slowdown following high growth rates during its early years, but the R&D pipeline is set to deliver products onto the market to 2010 with the potential to fundamentally alter the competitive dynamics of the current market. This Pipeline Analysis provides in-depth knowledge of potential future market leaders and the strategies adopted by the product developers. Scope: * Analysis of the R&D pipeline for HIV, covering sales forecasts for late phase II & III stage products through to 2010. * Analysis of strategic aspects of trial design in HIV, launch strategies and company portfolio composition. Report Highlights: Current market leaders are reappraising their positioning within the HIV market, with direct impacts on the level and composition of investment in pipeline portfolios. The HIV sector is experiencing a slowdown following high growth rates during its formative years, leading to negative growth rates for three of the seven HIV portfolios currently on the market New market entrant in the HIV sector is faced with a major choice between usurping existing market share by substituting a current HAART component, or attempting to create additional market potential. Reasons to Purchase: * What can the pharmaceutical industry do to improve the capture of non-diagnosed patients? * Understand the factors involved in the development of a compound that yield the best potential for subsequent commercial success * Analyze the commercial impact of the approval of late stage pipeline products on the HIV market Get Full Details About This Report >> |
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