Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Diseases pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the HIV market
- Contributing experts
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Current market situation
- Overview of antiretroviral classes
- Nucleoside reverse transcriptase inhibitors
- Cross-class fixed dose combination - Atripla
- Non-nucleoside reverse transcriptase inhibitors
- Protease inhibitors
- Entry Inhibitors
- Strategic scoping and focus
- Emerging markets
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Summary of environmental issues affecting HIV market size
- Six major market opportunities and threats
- Epidemiology: Increase in the HIV population
- Increase in diagnosis rates
- Increase in life expectancy
- Increase in risk behavior
- Increased immigration from areas of high HIV prevalence
- Continuing rise in development of resistance
- Acceleration and harmonization of approval procedures
- Threats
- Generic incursion
- Pricing pressure imposed by governments
- Parallel trade
- Preventative measures
- Vaccine/microbicide development
- US: opportunities and threats
- HIV market overview
- Opportunities
- Increased government funding for treatment of HIV
- Direct to Consumer Advertising
- Branded products achieve high prices as a result of the free pricing
system
- Threats
- Introduction of Medicare Part D has resulted in difficulties in
accessing treatment for HIV
- Waiting lists and other cost-containment measures implemented by
several ADAPs due to underfunding
- Opposition to the rising prices of antiretrovirals
- Genericization
- Parallel trade currently illegal in the US
- France: opportunities and threats
- HIV market overview
- Opportunities
- Critical attitude towards MRP slows down generic approvals
- Creation of HAS facilitates P&R approval
- High volume of prescription
- Reimbursement system favors use of innovative drugs
- Threats
- Cost-containment policies aim at reducing expenditure on
prescription drugs
- Genericization set to increase and be further supported
- Germany: opportunities and threats
- HIV market overview
- Opportunities
- Legalization of mail order
- Free pricing system in Germany facilitates novel drug development
- Threats
- Jumbo reference pricing
- Genericization
- Italy: opportunities and threats
- HIV market overview
- Opportunities
- Lack of confidence in generics may limit their uptake
- Reimbursement based on negotiations
- Threats
- Unpredictability of regulations hampers reliable strategic planning
- Reference pricing may result in downward price trends
- Changes in reimbursement rules for lipid-lowering drugs pose a
significant threat to the protease inhibitor market
- Spain: opportunities and threats
- HIV market overview
- Opportunities
- Supportive legislation and reimbursement schemes for innovative drugs
- Decentralized system provides localized opportunities
- Threats
- Cost containment measures proposed by Spanish authorities
- The use of generics is being promoted by the Spanish government
- UK: opportunities and threats
- HIV market overview
- Opportunities
- A less stringent pricing and reimbursement system makes the UK
attractive
- The UK has one of highest new infection rates in Europe
- Threats
- Improper management of HIV drugs budgets may lead to tighter
restrictions on prescription of antiretrovirals
- Prevention programmes
- NICE: the pre-guidance and post-guidance effect
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- Events not included
- Six major market events
- Increase in the population of HIV-infected patients
- New product launches
- Product-specific events
- New product launches in the NRTI class to have relatively small
impact
- Atripla to take market share away from NRTI FDCs
- Tibotec' s compounds will be valuable additions to the NNRTI class
- Kaletra and Reyataz challenged by Prezista
- Novel classes to enter the EIs & others
- Antiretroviral patent expiries
- Retrovir patent expiry
- Hivid patent expiry
- Zerit patent expiry
- Videx patent expiry
- Ziagen patent expiry
- Epivir patent expiry
- Emtriva patent expiry
- Invirase patent expiry
- Crixivan patent expiry
- Viramune patent expiry
- Combivir patent expiry
- Sustiva patent expiry
- Agenerase patent expiry
- Norvir patent expiry
- Fuzeon patent expiry
- Viracept patent expiry
- Kaletra patent expiry
- Data definitions, limitations and assumptions
- Derivation of sales forecasts and pricing trends
- Forecasts
- Forecast methodology
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Case studies
- Pfizer' s maraviroc, close to approval, despite hurdles along the way
- CCR5 inhibitors, a novel class of antiretrovirals
- Collaboration with Monogram to make tropism assay globally available
with Maraviroc
- Setbacks suffered by GSK and Schering-Plough damage class reputation
- Clinical trials demonstrate good safety and efficacy profiles
- Maraviroc' s place in therapy
- Needle-free Fuzeon (enfuvirtide, T-20)
- Slow uptake of Fuzeon due to high cost and mode of administration
- Roche and Trimeris aim to develop needle-free format of Fuzeon
- Impact of a needle-free version
- Commercial outlook for Roche HIV portfolio
- BIBLIOGRAPHY
- Journal papers and news articles
- Press releases
- Websites
- Datamonitor reports
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary HIV market data
- NRTI market data
- NNRTI market data
- PI market data
- EI and others market data
- APPENDIX B - MARKET FORECAST DATA
- Six major market
- M5EU
- US
- France
- Germany
- Italy
- Spain
- UK
- APPENDIX C
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Infectious Diseases and Respiratory analysis team
- Disclaimer
- List of Tables
- Table 1: Overview of the NRTIs, 2007
- Table 2: Overview of the NNRTIs, 2007
- Table 3: Overview of currently marketed PIs, 2007
- Table 4: Overview of sales and market share of antiretrovirals by
company, 2006
- Table 5: Methods for HIV prevention in clinical development, 2007
- Table 6: Overview of vaccines in development, 2007
- Table 7: Total funding for Ryan White Care Act, 2006
- Table 8: Summary HIV Market Data
- Table 9: Key facts: Combivir
- Table 10: Key facts: Viread
- Table 11: Key facts: Trizivir
- Table 12: Key facts: Epivir
- Table 13: Key facts: Zerit
- Table 14: Key facts: Abacavir
- Table 15: Key facts: Videx
- Table 16: Key facts: Retrovir
- Table 17: Truvada
- Table 18: Key facts: Emtriva
- Table 19: Key facts: Epzicom
- Table 20: Key facts: Hivid
- Table 21: Key facts: Atripla
- Table 22: Key facts: Sustiva
- Table 23: Key facts: Viramune
- Table 24: Key facts: Kaletra
- Table 25: Key facts: Reyataz
- Table 26: Key facts: Viracept
- Table 27: Key facts: Norvir
- Table 28: Key facts: Crixivan
- Table 29: Key facts: Lexiva
- Table 30: Key facts: Invirase
- Table 31: Key facts: Agenerase
- Table 32: Key facts: Prezista
- Table 33: Key facts: Aptivus
- Table 34: Key facts: Fuzeon
- Table 35: Six major markets
- Table 36: M5EU
- Table 37: US
- Table 38: France
- Table 39: Germany
- Table 40: Italy
- Table 41: Spain
- Table 42: UK
- List of Figures
- Figure 1: Pharmaceutical sales across the seven major markets, 2002-06
- Figure 2: Overview of sales of HIV treatments by class, 2002-06
- Figure 3: Overview of 10 best-selling antiretrovirals and market
share, 2007
- Figure 4: Timeline of the development of the HIV market, 1985-2015
- Figure 5: HIV market share by company, 2003-06
- Figure 6: Regional HIV and AIDS overview, 2005
- Figure 7: UK HIV diagnoses by the two main routes of transmission, 2005
- Figure 8: HIV infections in the UK by the region they were acquired
from
- Figure 9: US sales by class, 2003-06
- Figure 10: Total funding for the Ryan White Care act, 1991-2006
- Figure 11: France sales by class, 2002-06
- Figure 12: Germany sales by class, 2003-06
- Figure 13: Italy sales by class, 2003-06
- Figure 14: Spanish sales by class 2003-06
- Figure 15: UK sales by class, 2003-06
- Figure 16: New HIV cases across Europe, 2006
- Figure 17: Summary of opportunities and threats
- Figure 18: Sales forecasts for antiretrovirals across six major
markets 2006-2016
- Figure 19: Sales forecasts for Atripla, Truvada and Sustiva 2006-2016
- Figure 20: Sales forecasts for the NNRTI class 2006-2016
- Figure 21: Sales forecasts Reyataz, Kaletra and Prezista 2006-2016
- Figure 22: Sales forecasts Fuzeon, raltegravir and maraviroc
- Figure 23: Sales forecasts of marketed drugs 2006-2016 with key patent
expiries
- Figure 24: HIV mechanism of entry into host cell
- Figure 25: Percentage of CCR5 tropic patients
- Figure 26: MOTIVATE trial design
- Figure 27: Mean change in CD4+ count in patients failing treatment
- Figure 28: Sales forecast for maraviroc 2006-2016
- Figure 29: Overview of sales of Fuzeon in the US and Canada, 2003-06
- Figure 30: SWOT analysis for Fuzeon
- Figure 31: Sales forecasts for Fuzeon 2006-2016
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