Commercial Insight: HIV - Reshaping Treatment Paradigms

Publication Date	July 2007
Publisher	Datamonitor
Product Type	Report
Pages	194
ISBN Number	not applicable
Product Code	DAT05973

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Summary

Introduction

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.

Content

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 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