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Commercial Insight: HIV - From the Naïve to the Complex

Published by: Datamonitor

Published: Sep. 2, 2004 - 184 Pages


Table of Contents


TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 3

Objective of the analysis 3

Datamonitor insight into the HIV market 3

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 11

Market definition for this report 11

Current market situation 11

Class overview 13

Nucleoside reverse transcriptase inhibitors 14

Non-nucleoside reverse transcriptase inhibitors 16

Protease inhibitors 17

Entry inhibitors 18

Strategic scoping and focus 19

The emerging markets 21

CHAPTER 3 COUNTRY MARKET ASSESSMENTS 24

Current and future opportunities and threats in the HIV market 24

Global opportunities and threats 24

Opportunities 24

Threats 34

US: opportunities and threats 40

Market overview 40

Opportunities 42

Threats 45

Japan: opportunities and threats 49

Market overview 49

Opportunities 51

Threats 55

France: opportunities and threats 59

Market overview 59

Opportunities 62

Threats 62

Germany: opportunities and threats 64

Market overview 64

Opportunities 66

Threats 67

Italy: opportunities and threats 69

Market overview 69

Opportunities 71

Threats 73

Spain: opportunities and threats 74

Market overview 74

Opportunities 76

Threats 78

UK: opportunities and threats 79

Market overview 79

Opportunities 81

Threats 84

Summary of environmental issues affecting the antiretroviral market size 87

CHAPTER 4 FORECAST ANALYSIS 88

Assumptions and events 88

Events not included 88

Global events 88

Increase in the number of patients receiving antiretroviral therapy 88

Pricing adjustments 89

Product-specific events 90

AHF request for Trizivir to be restricted due to new efficacy data 90

Reyataz labeling expanded to include use with low-dose ritonavir in treatment-experienced patients 90

Launch of new combination drugs - tenofovir/emtricitabine (Truvada) and lamivudine/abacavir (Epzicom) 91

Approval of reformulated versions of Kaletra and Invirase 93

Antiretroviral patent expiries 95

Launch of new drugs with activity against resistant strains of HIV 105

Launch of new entry inhibitors and mABs 108

Country-specific events 111

Increased uptake of Fuzeon in the US 111

Norvir price increase in the US 111

Limitations of data 112

Standard units 112

Japanese market data 112

Regional launch dates for new products 113

Forecasts 113

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 114

Introduction 114

Case studies 115

Lifecycle management 115

Managing the pill burden 115

Fixed-dose combinations 119

Targeting niche markets 123

Co-infection 123

Antiretroviral use in pregnancy 127

Double-boosting 131

Product positioning 133

Journal advertisements 133

Websites 134

Treatment guidelines 136

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 139

Global HIV market data 139

NRTI market data 140

PI market data 151

NNRTI market data 160

Others market data 163

APPENDIX B 164

Journal articles and conference abstracts 164

Press releases 170

General 170

EU 171

France 171

Italy 172

Japan 172

Spain 173

UK 174

US 174

Conferences 177

Websites 178

Organizations 179

Miscellaneous 179

Report methodology 181

About Datamonitor 182

About Datamonitor Healthcare 182

About the Infectious Disease analysis team 183

Disclaimer 184





Abstract

Introduction
As HIV therapy reaches a more mature phase, the antiretroviral market is also entering a new cycle. Companies involved will have to employ new portfolio management strategies to ensure they are optimally positioned to defend against sales erosion. Product positioning and promotional activity will become increasingly important to the successful launch and sales maintenance of new drugs.

Scope
The HIV market is analyzed in detail on a country basis (including the US, EU5 and Japan), with historic and forecast sales from 1999 to 2014 provided
An analysis of key top level opportunities and threats for each of the seven markets is provided
A quantification of various key events expected to impact the HIV market and individual drugs is provided, along with a qualitative analysis
Various lifecycle management strategies are analyzed, using case studies, and their applicability for the future is determined
Highlights
Although expected to witness continued growth to 2014, there will be a number of challenges facing those involved in the HIV market, including generic incursion, the launch of new, second generation products and increasing disease complexity. Companies will have to adopt new strategies to maintain their HIV presence in the face of such challenges.

Although the US will remain the dominant market, accounting for two thirds of total sales, the Japanese market will experience the fastest growth. Alliances with local companies, taking advantage of their domestic knowledge and presence, will enhance the prospects for benefiting from this growth.

Early lifecycle management, such as fixed dose combinations and once-daily reformulation, is recommended to protect against sales erosion from generics and new pipeline products. For some products, establishing a position as the drug of choice in niche markets, such as hepatitis, is a more prudent strategy to ensure maintenance of HIV sales.

Reasons to Purchase
Understand key drivers in the antiretroviral market and predict the future performance of key compounds
Quantify the future size and scope of the HIV market and the potential for new products
Evaluate a range of lifecycle-management strategies to combat the threat of generic incursion and quantify the impact of key patent expiries


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