Table of Contents

Commercial Insight: HIV in the USA - Increasing Choice, Flexibility and Competition - Focus on commercial aspects of HIV treatments market in the US with predictive insights to 2011

Product Code: dmhc1894

Publication Date: 13-Jun-2003

---

Overview

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

---

Table of Contents

---

CHAPTER 1 EXECUTIVE SUMMARY	3
Scope of the analysis	3
Datamonitor insight into the US HIV market	3
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.	4
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.	5
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.	6
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.	7
Summary	8
Key metrics	8
Key market events during 2002/2003	10
AIDS Healthcare Foundation Sues GSK	10
VaxGen’s AIDSVAX Shows Disappointing Endpoints	10
Gilead Acquires Triangle Pharmaceuticals	10
Fuzeon Receives FDA Approval	10
CHAPTER 2 MARKET SEGMENTATION & DEFINITION	12
2.1 Strategic scoping and focus	13
2.2 Market definition	15
Nucleoside reverse transcriptase inhibitors	15
Non-nucleoside reverse transcriptase inhibitors	16
Protease inhibitors	18
Entry inhibitors/fusion inhibitors	19
2.3 Definition of gold-standard drugs/classes	20
2.4 Associated pharmaceutical markets	21
CHAPTER 3 US MARKET ANALYSIS	22
3.1 US market analysis	23
Forecast scenario analysis	24
3.2 NRTI analysis	26
3.3 NRTI brand analysis	27
Combivir analysis	27
Epivir analysis	30
Trizivir analysis	32
Viread analysis	34
Zerit analysis	37
Ziagen analysis	40
Other drugs in the NRTI class	42
R&D drugs in the NRTI drug class	43
3.4 NNRTI brand analysis	44
Sustiva analysis	44
Viramune analysis	47
Rescriptor analysis	50
R&D drugs in the NNRTI drug class	51
3.5 PI brand analysis	51
Kaletra analysis	51
Viracept analysis	55
Other drugs in the PI class	57
R&D drugs in the PI drug class	58
3.6 Fusion inhibitor brand analysis	59
Fuzeon analysis	59
R&D drugs in the FI drug class	61
CHAPTER 4 LIFE-CYCLE AND PORTFOLIO MANAGEMENT	62
4.1 Strategic portfolio analysis	63
Introduction	63
Global pharmaceutical performance for key HIV market players	63
US pharmaceutical and HIV portfolio performance	84
Therapy area attractiveness matrix	88
Portfolio gap analysis	93
4.2 Life-cycle management overview	95
GSK’s Retrovir lifecycle characteristics	95
Life-cycle comparisons to GSK’s other HIV drugs	98
4.3 Launch strategy/market penetration analysis	100
Kaletra development and launch strategy: lessons from Norvir	100
Benchmarks and case studies	105
4.4 Optimizing peak sales	108
Benchmarks and case studies	110
4.5 Revenue protection strategies	114
Generic penetration analysis across classes	114
CHAPTER 5 STRATEGIC PRODUCT POSITIONING	119
5.1 Pricing and reimbursement	120
Health economic considerations	120
Pricing data for key products in the US	124
Patient cost analysis by line of therapy	127
Case studies	131
Role of patient advocacy	133
What do companies need to do to justify setting high price points?	135
Physician focused product positioning	136
Specialists in HIV Medicine	137
Physician targeting strategies	139
5.2 Patient targeting and influence	144
Patient sub-group positioning analysis	144
Brand eImaging	146
Patient advocacy and community initiatives	148
US HIV market data	150
Forecasting methodology	152
List of tables	153
List of figures	153
Bibliography	153
About Datamonitor	154
About Datamonitor Healthcare	154
Datamonitor Healthcare’s research and analysis methodologies	155
Datamonitor Healthcare’s therapy area capabilities	155
About Disease analysis team	156
Datamonitor Healthcare’s Consulting expertise	156
Datamonitor’s Therapeutic Consulting expertise	157
Key therapy team members	158
Simon Hemsworth, Director of Therapy Area Analysis	158
John Savopoulos, Lead analyst, Infectious Diseases	159
David Abramson, Therapeutic Lead Consultant	160
Dheeraj Khiytani, Senior Infectious Diseases Analyst	160
Disclaimer	161
List of Tables
Table 1: Key parameters of the US HIV market to 2011	9
Table 2: US forecasts of key currently marketed products in HIV, 2003–11	9
Figure 2: Timeline: the development of HIV therapy, 1987–2003	15
Table 3: Gold standard comparison by indication and class, 2003	21
Table 4: US HIV drug sales ($m), 2001–11	23
Figure 3: Top 10 drug contribution to market growth, 2001–11	24
Figure 4: Key NRTI contribution to US market growth, 2001–11	26
Table 5: Combivir: key facts	27
Table 6: US Combivir sales forecasts, 2003–11	29
Table 7: Epivir: key facts	30
Table 8: US Epivir sales forecasts, 2003–11	31
Table 9: Trizivir: key facts	32
Table 10: US Trizivir sales forecasts, 2003–11	33
Table 11: Viread: key facts	34
Table 12: US Viread sales forecasts, 2003–11	37
Table 13: Zerit: key facts	37
Table 14: US Zerit sales forecasts, 2003–11	39
Table 15: Ziagen: key facts	40
Table 16: US Ziagen sales forecasts, 2003–11	42
Table 17: Other NRTI drugs: key facts	42
Table 18: R&D included in NRTI forecast, 2003–11	43
Table 19: Sustiva: key facts	44
Table 20: US Sustiva sales forecasts, 2003–11	47
Table 21: Viramune: key facts	47
Table 22: US Viramune sales forecasts, 2003–11	50
Table 23: Rescriptor: key facts	50
Table 24: R&D included in NNRTI forecast, 2003–11	51
Table 25: Kaletra: key facts	51
Table 26: US Kaletra sales forecasts, 2003–11	54
Table 27: Viracept: key facts	55
Table 28: US Viracept sales forecasts, 2003–11	57
Table 29: Other PI drugs: key facts	57
Table 30: R&D drugs included in PI forecast, 2003–11	58
Table 31: Fuzeon: key facts	59
Table 32: Analyst estimates of Fuzeon sales ($m), 2003–04	61
Table 33: R&D in FI drug class	61
Table 34: Global pharmaceutical sales for HIV drug manufacturers, 2000–02	63
Table 35: Global sales of infectious disease products for HIV drug manufacturers, 2000–02	64
Table 36: Global HIV product sales for HIV drug manufacturers, 2000–02	64
Table 37: Proportion of global pharmaceutical revenues generated by infectious disease franchises and HIV franchises, 2002	66
Table 38: Proportion of infectious disease revenues generated by HIV portfolio, 2002	66
Table 39: Comparison of global pharmaceutical, infectious disease and HIV CAGRs for HIV drug manufacturers, 2000–02	68
Table 40: US pharmaceutical, infectious disease and HIV product sales for HIV drug manufacturers, 2002	84
Table 41: Comparison of sales share of global and US HIV markets for HIV drug manufacturers (%), 2002	86
Table 42: Global HIV market comparison to other infectious disease areas ($m), 2003–10	88
Table 43: Comparison of HIV market leader global revenue dynamics to peer products in other infectious disease areas ($m), 2002	90
Table 44: Criteria for determining therapy attractiveness	91
Table 45: HIV market leader portfolio composition, 2002	94
Figure 26: Global sales of Retrovir, 1987–2002	96
Table 46: Annual US prices for currently marketed antiretrovirals, 2003	126
Table 47: Cost comparison for commonly used HIV drug regimens in the US, 2003	128
Figure 46: Viread patient product positioning	147
Table 48: US sales data for the top 10 selling HIV drugs by quarter ($m), 2001–02	150
Table 49: Forecast US sales for the top selling NRTIs ($m), 2001–11	151
Table 50: Forecast US sales for the top selling NNRTIs ($m), 2001–11	151
Table 51: Forecast US sales for the top selling PIs ($m), 2001–11	152
List of Figures
Figure 1: Key NRTI contribution to US market growth, 2001-2011	8
Figure 5: Key factors in the market dynamics of Combivir, 2003	29
Figure 6: Key factors in the market dynamics of Epivir, 2003	31
Figure 7: Key factors in the market dynamics of Trizivir, 2003	33
Figure 8: Key factors in the market dynamics of Viread, 2003	36
Figure 9: Key factors in the market dynamics of Zerit, 2003	39
Figure 10: Key factors in the market dynamics of Ziagen, 2003	41
Figure 11: Key factors in the market dynamics of Sustiva, 2003	46
Figure 12: Key factors in the market dynamics of Viramune, 2003	49
Figure 13: Key factors in the market dynamics of Kaletra, 2003	54
Figure 14: Key factors in the market dynamics of Viracept, 2003	56
Figure 15: Key factors in the market dynamics of Fuzeon, 2003	60
Figure 16: SWOT analysis of GSK’s portfolio strategy, 2003	69
Figure 17: GSK’s therapeutic strategy to 2007	72
Figure 18: SWOT analysis of BMS’s portfolio strategy, 2003	74
Figure 19: BMS’s therapeutic strategy to 2007	77
Figure 20: SWOT analysis of Abbott’s portfolio strategy, 2003	79
Figure 21: Average global company pharmaceutical, infectious disease and HIV product share by market, 2000–02	83
Figure 22: Comparison of US pharmaceutical, infectious disease and HIV sales dominance by rank, 2002	85
Figure 23: Comparison of sales share of the global and US HIV markets by HIV drug manufacturer, 2002	87
Figure 24: Global HIV market comparison to other infectious disease areas ($m), 2003–10	89
Figure 25: Therapeutic attractiveness matrix for selected infectious disease areas, 2003–07	92
Figure 27: Retrovir’s global sales life cycle characteristics, 1987–2002	97
Figure 28: Global sales lifecycle curves for GSK’s antiretrovirals, 1987–2002	98
Figure 29: Kaletra positioning summary, 2001	102
Figure 30: Kaletra pre-launch strategy, 1996–2000	103
Figure 31: Kaletra positioning strategy	105
Figure 32: Comparison of US Kaletra and Trizivir sales growth, 2000–02	106
Figure 33: Comparison of US Sustiva and Ziagen sales growth, 2000–02	107
Figure 34: Sales of Kaletra and Viracept following Kaletra launch, 2000–02	112
Figure 35: Viread and Zerit US sales by quarter preceding and following Viread launch, 2000–02	113
Figure 36: Lifecycle of a drug, and the potential effect of reformulation	118
Figure 37: Factors affecting company intervention in issues of public interest, 2003	123
Figure 38: Methodology for calculating average annual drug cost	127
Figure 39: Comparison of average vs. total cost for key combination regimens used in the US, 2003	129
Figure 40: Comparison of price points charged by GSK and BMS for their HIV portfolios in the US, 2003	131
Figure 41: Comparison of Trizivir and Combivir pricing in the US, 2003	132
Figure 42: AAHIVM segmentation of HIV-treating physicians by specialty, 2003	137
Figure 43: Patient segmentation by treating physicians	138
Figure 44: Strategies involved in physician detailing	141
Figure 45: Maximizing promotional effectiveness	145
Figure 47: Datamonitor’s Healthcare Consultancy	157
Figure 48: Datamonitor Healthcare’s Therapeutic Consulting capabilities	158

---