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AIDS & HIV |
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Commercial Insight: HIV
Simplicity and Survival
Publication Date August 2005
Publisher Datamonitor
Product Type Report
Pages 218
ISBN Number not applicable
Product Code DAT339
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Summary
Despite accounting for only 1% of global pharmaceutical sales, HIV antiretrovirals have experienced rapid growth between 2000-2004, accounting for $6.6 billion in global sales. Enthusiasm for new once daily FDCs and PIs such as Reyataz has rendered the market for first-line nave patients a battleground where simplicity wins. Even older flagship products such as Combivir are now under threat.
Highlights
- Datamonitor opinion leader research has revealed that in the majority of Western markets the major route of HIV transmission is changing. Most reported increased presentation of individuals believed to have been infected by heterosexual contact. In countries such as France, immigrants from Sub-Saharan Africa continue to dominate new diagnoses.
- In 2004, the global market for HIV antiretrovirals was valued at $6.6 billion with the US accounting for around 70% of value. In Europe, France is the largest market valued at around $600m. Despite an increase in commercial value, most markets apart from the UK have experienced a decline in standard unit volume driven by uptake of FDC products.
- Boehringer Ingelheim's FDA approval for Aptivus (tipranavir) raises the PI class to nine members. Despite challenges during clinical development, testing in a highly experienced population and 24-weeks data using a surrogate for efficacy, tipranavir's approval signals a high need for additional agents to Fuzeon (enfuvirtide) in this patient group.
Scope
- Examination of drivers and resistors to prescription of new FDCs - pricing analysis and opinion leader perception of short and long term toxicities
- Coverage of FDA approval of Boehringer Ingelheim's Aptivus (tipranavir) - future lessons for clinical studies in highly treatment experienced patients
- Assessment of the impact of generic antiretrovirals - case analysis of generic didanosine, FDA tentative approval of NNRTIs, efavirenz and nevirapine
- In-depth regional sales forecasts of marketed and pipeline drugs from 2005 to 2015 with full event analysis
Reasons to Purchase
- Assess the value and volume dynamics of HIV antiretrovirals on a regional level with a 5 year retrospective view
- Understand the pending impact of patent expiries and generic incursion on the antiretrovirals market, including product-specific case studies
- Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2005 to 2015h3>
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Content
- Chapter 1 Executive Summary
- Objective of the analysis
- Datamonitor insight into the HIV market
- Chapter 2 Market Definition And Overview
- Market definition for this report
- Current market situation
- Class overview
- Nucleoside reverse transcriptase inhibitors
- Non-nucleoside reverse transcriptase inhibitors
- Protease inhibitors
- Entry inhibitors
- Strategic scoping and focus
- The emerging markets
- Chapter 3 Country Market Assessments
- Current and future opportunities and threats in the HIV market
- Global opportunities and threats
- Opportunities
- Threats
- US: opportunities and threats
- Market overview
- Opportunities
- Threats
- Japan: opportunities and threats
- Market overview
- Opportunities
- Threats
- France: opportunities and threats
- Market overview
- Opportunities
- Threats
- Germany: opportunities and threats
- Market overview
- Opportunities
- Threats
- Italy: opportunities and threats
- Market overview
- Opportunities
- Threats
- Spain: opportunities and threats
- Market overview
- Opportunities
- Threats
- UK: opportunities and threats
- Market overview
- Opportunities
- Threats
- Summary of environmental issues affecting the antiretroviral market size
- Chapter 4 Forecast Analysis
- Assumptions and events
- Events not included
- Global events
- Increase in the number of patients receiving antiretroviral therapy
- Pricing adjustments
- Product-specific events
- Launch of new combination drugs - tenofovir/emtricitabine (Truvada) and lamivudine/abacavir (Epzicom)
- Antiretroviral patent expiries
- Launch of new drugs with activity against resistant strains of HIV
- Launch of new entry inhibitors and mABs
- Limitations of data
- Standard units
- Japanese market data
- Regional launch dates for new products
- Forecasts
- Chapter 5 Commercial Impact And Lifecycle Management: Case Studies
- Introduction
- Fixed-dose combinations - the future of NRTI therapy?
- Fixed-dose combinations - an overview
- Convenience and simplicity drive FDC uptake
- FDC prescription practices
- NRTI FDC clinical trials - the three go head-to-head
- The need for data - is bioequivalence enough?
- Generic incursion - are FDCs adequate protection?
- The cost of FDCs - what price for convenience?
- FDCs - the future of antiretroviral therapy?
- NRTIs - will the backbone be fixed?
- PI fixed dose combinations - generic ritonavir may open the way for new FDCs
- Cross class fixed-dose combinations - could HAART be reduced to a single pill?
- Once-daily dosing
- Once-daily dosing - a double-edged sword for HIV therapy?
- Few products now require more than twice daily dosing
- Aptivus (tipranavir, TPV) - Boehringer pulls it through
- Open label trial design leads to differences in analyses
- Safety concerns and required follow-up
- Lessons for HIV trials in "heavily treatment experienced patients"
- Commercial outlook for BI's HIV portfolio
- Guideline changes for nevirapine
- Aptivus - a Fuzeon-like product?
- Generics and patent expiries
- Generic impact is likely to vary considerably
- Older products are not expected to raise generic interest
- Those hardest hit will be the most widely prescribed products - Epivir, Viread, Sustiva and Kaletra
- Appendix A - Market Data And Major Brand Key Facts
- NRTI market data
- PI market data
- NNRTI market data
- Others market data
- Appendix B
- Bibliography
- Journal articles and conference abstracts
- Press releases
- General
- EU
- France
- Italy
- Japan
- Spain
- UK
- US
- Conferences
- Websites
- Organizations
- Miscellaneous
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Infectious Disease analysis team
- Disclaimer
- List Of Tables
- Table 1: Overview of the NRTIs
- Table 2: Overview of the NNRTIs
- Table 3: Overview of the PIs
- Table 4: HIV/AIDS prevalence, incidence and death rates by region, 2004
- Table 5: HIV/AIDS prevalence and diagnosis rates in the seven major markets, 2004*
- Table 6: Exposure category of HIV infections diagnosed in the US and UK, 1999 to 2003
- Table 7: Patent expiries of antiretrovirals, 2005-15
- Table 8: US antiretroviral market, 2000-04
- Table 9: Pacific Rim antiretroviral market, 2000-04
- Table 10: French antiretroviral market, 2000-04
- Table 11: German antiretroviral market, 2000-04
- Table 12: Italian antiretroviral market, 2000-04
- Table 13: Spanish antiretroviral market, 2000-04
- Table 14: UK antiretroviral market, 2000-04
- Table 15: An overview of selected pipeline products included in the HIV market forecasts
- Table 16: Comparison of Combivir, Epzicom & Truvada
- Table 17: Key products in late-stage R&D pipeline for NRTIs
- Table 18: Boosted PI regimes
- Table 19: Key antiretroviral combinations, not currently available in the seven major markets, 2005
- Table 20: Once-daily ARVs currently available (in US)
- Table 21: Patient populations for the tipranavir RESIST trials
- Table 22: Tipranavir post-marketing studies, as requested by the FDA
- Table 23: Patent expiries of antiretrovirals, 2005-15
- Table 24: Combivir: key facts
- Table 25: Viread: key facts
- Table 26: Trizivir: key facts
- Table 27: Epivir: key facts
- Table 28: Zerit: key facts
- Table 29: Ziagen: key facts
- Table 30: Videx EC: key facts
- Table 31: Videx: key facts
- Table 32: Retrovir: key facts
- Table 33: Truvada: key facts
- Table 34: Emtriva: key facts
- Table 35: Epzicom: key facts
- Table 36: Hivid: key facts
- Table 37: Kaletra: key facts
- Table 38: Reyataz: key facts
- Table 39: Viracept: key facts
- Table 40: Norvir: key facts
- Table 41: Crixivan: key facts
- Table 42: Lexiva: key facts
- Table 43: Invirase: key facts
- Table 44: Fortovase: key facts
- Table 45: Agenerase: key facts
- Table 46: Sustiva: key facts
- Table 47: Viramune: key facts
- Table 48: Rescriptor: key facts
- Table 49: Fuzeon: key facts
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