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Commercial Insight: HIV - Simplicity and Survival
Datamonitor - 8/3/2005 - 218 Pages - ID: DFMN1152509
URL: http://www.marketresearch.com/product/display.asp?productid=1152509

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Abstract

Introduction
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
 
 

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