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Published by: Datamonitor
Published: Jul. 11, 2007 - 194 Pages
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
AbstractIntroduction
Detailed analysis of the antiretroviral therapy market. 10 year sales forecast for marketed drugs and key pipeline compounds, factoring in clinical trial results, new product launches and patent expiries.
Scope
In-depth analysis of the current HIV market across the major US and EU markets Thorough assessment of underlying commercial and clinical factors shaping the antiretroviral market Detailed sales forecasts for the three major antiretroviral classes, molecules and brands in each of the six major markets Case study analysis of the entry inhibitor class focusing on the competitive environment and critical success factors
Highlights
By 2016 the HIV market is forecasted to grow to $11.5 billion. This growth will be driven mainly by the increase in numbers of patients accessing treatments as well as the launch of several new drugs and drug classes The availability of several simple, once-daily treatments such as fixed dose combinations and once daily protease inhibitors has intensified the competition within the respective classes. Adherence to therapy is consequently expected to improve leading to a decline in the number of patients entering late-stage therapy. The anticipated launches of pipeline antiretrovirals such as CCR5 inhibitors, integrase inhibitors and others, which demonstrate novel activity and efficacy against resistant mutants, will not only offer more variety to patients but will increase the overall value of the market.
Reasons to Purchase
Understand the constantly evolving market dynamics of antiretroviral drugs Understand the impact of pending patent expiries and generic incursion on the ARV market, including product-specific case studies Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2006 to 2016.
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