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Commercial Insight: HIV - Simplicity and Survival

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

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


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