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Commercial Insight: HIV in the USA - Increasing Choice, Flexibility and Competition

Published by: Datamonitor

Published: Jun. 13, 2003 - 174 Pages


Table of Contents


CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the US HIV market

Despite predicted slow down in overall growth and key obstacles with regard to efficacy, diagnosis, resistance and compliance, Datamonitor predicts that the US HIV market will more than double by 2011 providing an additional $4.2 billion in revenue. During this timeframe, an influx of new products and competitors will fragment the current market challenging the dominant oligopoly.

The NRTI class will continue to dominate the HIV treatments market through its inclusion as a ‘backbone’ to global treatment regimens. Most inter-class competition will occur between NNRTI and PI based products. Their penetration as adjuncts or alternatives to existing NRTI backbones will depend on official recommendation, superior efficacy and improved resistance profile.

The HIV treatments market currently is more driven by product life-cycle management than ‘radical’ new product development. Datamonitor believes that enhanced dosing as a source of product differentiation will be effective in the short term, but will soon become commonplace. A focus on portfolio balance, minimizing exposure to NRTI patent expiry and shifting treatment regimes will be key to success.

Datamonitor believes the search for commercial value in the HIV treatments market will become increasingly complex. Product development should focus on targeting wider patient groups, taking into context commitments to corporate social responsibility, brand awareness and improved capture/diagnosis. Larger players should remain vigilant with regard to smaller, more agile competitors.

Summary

Key metrics

Key market events during 2002/2003

AIDS Healthcare Foundation Sues GSK

VaxGen’s AIDSVAX Shows Disappointing Endpoints

Gilead Acquires Triangle Pharmaceuticals

Fuzeon Receives FDA Approval

CHAPTER 2 MARKET SEGMENTATION & DEFINITION

2.1 Strategic scoping and focus

2.2 Market definition

Nucleoside reverse transcriptase inhibitors

Non-nucleoside reverse transcriptase inhibitors

Protease inhibitors

Entry inhibitors/fusion inhibitors

2.3 Definition of gold-standard drugs/classes

2.4 Associated pharmaceutical markets

CHAPTER 3 US MARKET ANALYSIS

3.1 US market analysis

Forecast scenario analysis

3.2 NRTI analysis

3.3 NRTI brand analysis

Combivir analysis

Epivir analysis

Trizivir analysis

Viread analysis

Zerit analysis

Ziagen analysis

Other drugs in the NRTI class

R&D drugs in the NRTI drug class

3.4 NNRTI brand analysis

Sustiva analysis

Viramune analysis

Rescriptor analysis

R&D drugs in the NNRTI drug class

3.5 PI brand analysis

Kaletra analysis

Viracept analysis

Other drugs in the PI class

R&D drugs in the PI drug class

3.6 Fusion inhibitor brand analysis

Fuzeon analysis

R&D drugs in the FI drug class

CHAPTER 4 LIFE-CYCLE AND PORTFOLIO MANAGEMENT

4.1 Strategic portfolio analysis

Introduction

Global pharmaceutical performance for key HIV market players

US pharmaceutical and HIV portfolio performance

Therapy area attractiveness matrix

Portfolio gap analysis

4.2 Life-cycle management overview

GSK’s Retrovir lifecycle characteristics

Life-cycle comparisons to GSK’s other HIV drugs

4.3 Launch strategy/market penetration analysis

Kaletra development and launch strategy: lessons from Norvir

Benchmarks and case studies

4.4 Optimizing peak sales

Benchmarks and case studies

4.5 Revenue protection strategies

Generic penetration analysis across classes

CHAPTER 5 STRATEGIC PRODUCT POSITIONING

5.1 Pricing and reimbursement

Health economic considerations

Pricing data for key products in the US

Patient cost analysis by line of therapy

Case studies

Role of patient advocacy

What do companies need to do to justify setting high price points?

Physician focused product positioning

Specialists in HIV Medicine

Physician targeting strategies

5.2 Patient targeting and influence

Patient sub-group positioning analysis

Brand eImaging

Patient advocacy and community initiatives

US HIV market data

Forecasting methodology

List of tables

List of figures

Bibliography

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare’s research and analysis methodologies

Datamonitor Healthcare’s therapy area capabilities

About Disease analysis team

Datamonitor Healthcare’s Consulting expertise

Datamonitor’s Therapeutic Consulting expertise

Key therapy team members

Simon Hemsworth, Director of Therapy Area Analysis

John Savopoulos, Lead analyst, Infectious Diseases

David Abramson, Therapeutic Lead Consultant

Dheeraj Khiytani, Senior Infectious Diseases Analyst

Disclaimer

List of Tables

Table 1: Key parameters of the US HIV market to 2011

Table 2: US forecasts of key currently marketed products in HIV, 2003-11

Figure 2: Timeline: the development of HIV therapy, 1987-2003

Table 3: Gold standard comparison by indication and class, 2003

Table 4: US HIV drug sales ($m), 2001-11

Figure 3: Top 10 drug contribution to market growth, 2001-11

Figure 4: Key NRTI contribution to US market growth, 2001-11

Table 5: Combivir: key facts

Table 6: US Combivir sales forecasts, 2003-11

Table 7: Epivir: key facts

Table 8: US Epivir sales forecasts, 2003-11

Table 9: Trizivir: key facts

Table 10: US Trizivir sales forecasts, 2003-11

Table 11: Viread: key facts

Table 12: US Viread sales forecasts, 2003-11

Table 13: Zerit: key facts

Table 14: US Zerit sales forecasts, 2003-11

Table 15: Ziagen: key facts

Table 16: US Ziagen sales forecasts, 2003-11

Table 17: Other NRTI drugs: key facts

Table 18: R&D included in NRTI forecast, 2003-11

Table 19: Sustiva: key facts

Table 20: US Sustiva sales forecasts, 2003-11

Table 21: Viramune: key facts

Table 22: US Ziagen sales forecasts, 2003-11

Table 23: Rescriptor: key facts

Table 24: R&D included in NNRTI forecast, 2003-11

Table 25: Kaletra: key facts

Table 26: US Kaletra sales forecasts, 2003-11

Table 27: Viracept: key facts

Table 28: US Viracept sales forecasts, 2003-11

Table 29: Other PI drugs: key facts

Table 30: R&D drugs included in PI forecast, 2003-11

Table 31: Fuzeon: key facts

Table 32: Analyst estimates of Fuzeon sales ($m), 2003-04

Table 33: R&D in FI drug class

Table 34: Global pharmaceutical sales for HIV drug manufacturers, 2000-02

Table 35: Global sales of infectious disease products for HIV drug manufacturers, 2000-02

Table 36: Global HIV product sales for HIV drug manufacturers, 2000-02

Table 37: Proportion of global pharmaceutical revenues generated by infectious disease franchises and HIV franchises, 2002

Table 38: Proportion of infectious disease revenues generated by HIV portfolio, 2002

Table 39: Comparison of global pharmaceutical, infectious disease and HIV CAGRs for HIV drug manufacturers, 2000-02

Table 40: US pharmaceutical, infectious disease and HIV product sales for HIV drug manufacturers, 2002

Table 41: Comparison of sales share of global and US HIV markets for HIV drug manufacturers (%), 2002

Table 42: Global HIV market comparison to other infectious disease areas ($m), 2003-10

Table 43: Comparison of HIV market leader global revenue dynamics to peer products in other infectious disease areas ($m), 2002

Table 44: Criteria for determining therapy attractiveness

Table 45: HIV market leader portfolio composition, 2002

Figure 26: Global sales of Retrovir, 1987-2002

Table 46: Annual US prices for currently marketed antiretrovirals, 2003

Table 47: Cost comparison for commonly used HIV drug regimens in the US, 2003

Figure 46: Viread patient product positioning

Table 48: US sales data for the top 10 selling HIV drugs by quarter ($m), 2001-02

Table 49: Forecast US sales for the top selling NRTIs ($m), 2001-11

Table 50: Forecast US sales for the top selling NNRTIs ($m), 2001-11

Table 51: Forecast US sales for the top selling PIs ($m), 2001-11

List of Figures

Figure 1: Key NRTI contribution to US market growth, 2001-2011

Figure 5: Key factors in the market dynamics of Combivir, 2003

Figure 6: Key factors in the market dynamics of Epivir, 2003

Figure 7: Key factors in the market dynamics of Trizivir, 2003

Figure 8: Key factors in the market dynamics of Viread, 2003

Figure 9: Key factors in the market dynamics of Zerit, 2003

Figure 10: Key factors in the market dynamics of Ziagen, 2003

Figure 11: Key factors in the market dynamics of Sustiva, 2003

Figure 12: Key factors in the market dynamics of Viramune, 2003

Figure 13: Key factors in the market dynamics of Kaletra, 2003

Figure 14: Key factors in the market dynamics of Viracept, 2003

Figure 15: Key factors in the market dynamics of Fuzeon, 2003

Figure 16: SWOT analysis of GSK’s portfolio strategy, 2003

Figure 17: GSK’s therapeutic strategy to 2007

Figure 18: SWOT analysis of BMS’s portfolio strategy, 2003

Figure 19: BMS’s therapeutic strategy to 2007

Figure 20: SWOT analysis of Abbott’s portfolio strategy, 2003

Figure 21: Average global company pharmaceutical, infectious disease and HIV product share by market, 2000-02

Figure 22: Comparison of US pharmaceutical, infectious disease and HIV sales dominance by rank, 2002

Figure 23: Comparison of sales share of the global and US HIV markets by HIV drug manufacturer, 2002

Figure 24: Global HIV market comparison to other infectious disease areas ($m), 2003-10

Figure 25: Therapeutic attractiveness matrix for selected infectious disease areas, 2003-07

Figure 27: Retrovir’s global sales life cycle characteristics, 1987-2002

Figure 28: Global sales lifecycle curves for GSK’s antiretrovirals, 1987-2002

Figure 29: Kaletra positioning summary, 2001

Figure 30: Kaletra pre-launch strategy, 1996-2000

Figure 31: Kaletra positioning strategy

Figure 32: Comparison of US Kaletra and Trizivir sales growth, 2000-02

Figure 33: Comparison of US Sustiva and Ziagen sales growth, 2000-02

Figure 34: Sales of Kaletra and Viracept following Kaletra launch, 2000-02

Figure 35: Viread and Zerit US sales by quarter preceding and following Viread launch, 2000-02

Figure 36: Lifecycle of a drug, and the potential effect of reformulation

Figure 37: Factors affecting company intervention in issues of public interest, 2003

Figure 38: Methodology for calculating average annual drug cost

Figure 39: Comparison of average vs. total cost for key combination regimens used in the US, 2003

Figure 40: Comparison of price points charged by GSK and BMS for their HIV portfolios in the US, 2003

Figure 41: Comparison of Trizivir and Combivir pricing in the US, 2003

Figure 42: AAHIVM segmentation of HIV-treating physicians by specialty, 2003

Figure 43: Patient segmentation by treating physicians

Figure 44: Strategies involved in physician detailing

Figure 45: Maximizing promotional effectiveness

Figure 47: Datamonitor’s Healthcare Consultancy

Figure 48: Datamonitor Healthcare’s Therapeutic Consulting capabilities

Abstract

Introduction:
With a focus on the commercial environment within the HIV sector in the USA, this Analysis investigates key market characteristics and the strategies required to improve market conditions. Analysis of company portfolio strategies and product positioning provides the reader with knowledge of how company strategies result in varying levels of commercial returns.

Scope:
* Detailed case studies featuring company portfolio, product development and launch strategies

* US sales data for the top 10 HIV products along with forecasts to 2011 for the top 10 selling HIV drugs and classes

* SWOT analyses of key HIV drugs are provided, along with 12-month event screens - providing detailed knowledge of events specific to each product

Report Highlights:
Despite a predicted slow down in overall growth and key obstacles with regard to efficacy, diagnosis, resistance and compliance, Datamonitor predicts that the US HIV market will more than double by 2011 providing an additional $4.2 bn in revenue.

The approval of Roche’s novel fusion inhibitor Fuzeon will change treatment strategies for late stage patients. The key barrier to use is its delivery method (subcutaneous) and high price.

With the launch of BMS’ Reyataz and BI’s tipranavir, the PI drug class will be as large as the NRTI drug class in terms of number of therapeutics. This will shift the usage of HAART towards NRTI-sparing regimens.

Reasons to Purchase:
* Understand the relationship between company product positioning strategies and HIV market characteristics

* Gain insight to HIV portfolio strategies and factors that drive successful drug development and launch



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