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Published by: Datamonitor
Published: Aug. 3, 2005 - 218 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Disease pharmaceutical analysis team
- 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 -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
- MARKET FORECAST DATA
- Forecasts for the HIV market in the US to 2014
- Forecasts for the HIV market in Japan to 2014
- Forecasts for the HIV market in France to 2014
- Forecasts for the HIV market in Germany to 2014
- Forecasts for the HIV market in Italy to 2014
- Forecasts for the HIV market in Spain to 2014
- Forecasts for the HIV market in the UK to 2014
- M5EU forecasts for the HIV market to 2014
- Global forecasts for the HIV market to 2014
- 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
- Table 50: Forecasts for the HIV market in the US to 2014
- Table 51: Forecasts for the HIV market in Japan to 2014
- Table 52: Forecasts for the HIV market in France to 2014
- Table 53: Forecasts for the HIV market in Germany to 2014
- Table 54: Forecasts for the HIV market in Italy to 2014
- Table 55: Forecasts for the HIV market in Spain to 2014
- Table 56: Forecasts for the HIV market in the UK to 2014
- Table 57: M5EU forecasts for the HIV market to 2014
- Table 58: Global forecasts for the HIV market to 2014
- List of Figures
- Figure 1: Pharmaceutical market, 2004
- Figure 2: Infectious disease markets, seven major markets, 2000-04
- Figure 3: Timeline of the development of the HIV market
- Figure 4: Relative contribution of the leading products to total HIV sales, seven markets, 2000-04
- Figure 5: Combivir and Viread sales in the first four years following launch
- Figure 6: Kaletra quarterly sales in the seven major markets, 2000-04
- Figure 7: Reyataz and Kaletra initial post-launch uptake
- Figure 8: HIV market share by company, seven major markets, 2000-04
- Figure 9: Annual HIV incidence, US, Germany and UK, 1995-2003
- Figure 10: Total AIDS cases per year, seven major markets, 1991-2004
- Figure 11: Persons living with HIV/AIDS in 30 areas* in the US by age group, 2000 & 2003
- Figure 12: US HIV market shares, top brands by value ($m) and by volume (SU millions), 2004
- Figure 13: Pacific Rim HIV market shares, top 10 brands by value, 2004
- Figure 14: France HIV market shares, top six brands by value, 2004
- Figure 15: The number of new cases of AIDS in women according to their nationality
- Figure 16: German HIV market shares, top five brands by value, 2004
- Figure 17: Italian HIV market shares, top 10 brands by value, 2004
- Figure 18: Spanish HIV market shares, top brands by value ($m) and by volume (SU million), 2004
- Figure 19: Most important sexual health concerns in Spain
- Figure 20: UK HIV market shares, top 10 brands by value, 2004
- Figure 21: Probable route of infection and ethnic group of diagnosed HIV patients in the UK, 2003
- Figure 22: An overview of the key opportunities and threats in the HIV market, 2005
- Figure 23: Truvada and Epzicom forecast sales, 2005 - 2015
- Figure 24: Expected antiretroviral patent expiries, 2005-15
- Figure 25: The NRTI pill burden has been significantly reduced following the introduction of the FDCs
- Figure 26: Sales of the components of the FDCs have either stalled or fallen since the launches of Epzicom and Truvada
- Figure 27: Combivir and Trizivir are likely to lose share as uptake of Truvada and Epzicom increases
- Figure 28: Combivir is still the highest selling NRTI FDC in terms of value and volume in the seven major markets, 2004
- Figure 29: Price comparison of FDCs and their components in US
- Figure 30: Price comparison of FDCs and their components in UK
- Figure 31: PI sales by product, seven major markets, 2000-04
- Figure 32: Total pill burden associated with each antiretroviral drug
- Figure 33: Crixivan and Agenerase sales in the seven major markets, 2000-04
- Figure 34: Overview of the tipranavir clinical development program
- Figure 35: Country-specific sales of Aptivus, 2005 - 2015
- Figure 36: Videx/Videx EC sales following generic didanosine approval
- Figure 37: Sales of older antiretrovirals have fallen since 2000
- Figure 38: Viread, Sustiva, Epivir and Kaletra forecast sales, seven major markets, 2005-15
AbstractIntroduction
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 naïve patients a battleground where simplicity wins. Even older flagship products such as Combivir are now under threat.
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
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.
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 2015
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