Printer Friendly Printed from http://www.researchandmarkets.com/reports/367677 Commercial Insight: HIV - Change of Guard Description: The HIV market generated $7.4 billion of sales in 2005 and experienced a CAGR of 13.3% from 2001-2005, making it one of the fastest growing infectious diseases sub sectors. Despite the antiretroviral markets relative immaturity, many older flagship products such as Combivir are expected to lose patent protection before 2015. Scope of this title: - In-depth analysis of the current HIV market across the major Western markets (US, France, Germany, Italy, Spain, UK) - Thorough assessment of underlying commercial and clinical influencing factors shaping the antiretroviral market - Detailed sales forecasts for the three major antiretroviral classes, molecules and brands in each of the six major markets - Case study analysis of the competitive environment and critical success factors in the Protease Inhibitor class Highlights of this title: - By 2015 the global antibacterial market is forecast to be valued at more than $10 billion with a modest CAGR of 4.1%. The main contributor to growth will be the new drug classes such as integrase- and entry inhibitors. - Since the advent of HAART, HIV has turned into a chronic disease with an average life expectancy similar to that of Type 2 diabetes, emphasizing the importance of side effect profiles associated with long-term use. - The launch of several new products from new classes such as integrase inhibitors, CCR5 inhibitors from 2007, and recently launched PIs, will cause the salvage market to decline. Despite proven synergy between Fuzeon and the new drugs, use of the former is predicted to decline. Reasons to order your copy: - Understand the constantly evolving market dynamics of antiretroviral (ARV) drugs - Explore the impact of pending patent expiries and generic incursion on the ARV market, including product-specific case studies - Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline ARVs from 2005 to 2015. Contents: Chapter 1. Executive summary 3 Objective of the analysis 3 Our insight into the HIV market 3 Contributing experts 5 Chapter 2. Market definition and overview 13 Market definition for this report 13 Current market situation 13 Overview of antiretroviral classes 17 Nucleoside reverse transcriptase inhibitors 17 Non nucleoside reverse transcriptase inhibitors 21 Protease inhibitors 23 Entry Inhibitors 27 Strategic scoping and focus 29 Emerging markets 30 Chapter 3. Country market assessments 34 Global opportunities and threats 34 Opportunities 34 Epidemiology: HIV population growth driven by increased diagnosis rates, new infections and rising life expectancy 34 Acceleration and harmonization of approval procedures 38 Threats 39 Regulatory pathways for generics get streamlined across the globe 41 Governments impose pricing pressure on drug manufacturers in response to cost containment needs 43 Parallel trade – illegal in the US, encouraged in Europe 44 New preventative measures 46 US: opportunities and threats 47 HIV market overview 47 Opportunities 49 Direct-to-consumer advertising 49 Branded products achieve high prices as a result of the free pricing system 50 Threats 50 Initiatives by public and private health providers aim to encourage cost containment 50 Further genericization is encouraged by legislation and public programs 52 Although still illegal, parallel trade is likely to be legalized in the medium term 53 France: opportunities and threats 54 HIV market overview 54 Opportunities 55 Critical attitude towards MRP slows down generic penetration 55 High prescription volume boosts drug revenues 56 The creation of HAS facilitates P&R approval 56 Reimbursement system favors use of innovative drugs 57 Threats 58 Cost containment policies aim at reducing the expenditure for prescription drugs 58 Genericization has increased recently and is further supported 59 Germany: opportunities and threats 60 HIV market overview 60 Opportunities 62 Legalization of mail order provides new distribution channels 62 Free pricing system and culture of innovation encourages novel drug development 63 Fewer cost containment restrictions make the hospital sector a valuable opportunity 63 Threats 64 Jumbo Reference Pricing is threatening drug revenue growth 64 Increasing genericization is strongly supported by the government 64 Italy: opportunities and threats 66 HIV market overview 66 Opportunities 68 Low levels of generic penetration as a result of lack of confidence 68 Reimbursement levels are determined by negotiations rather than regulations 69 Threats 69 Unpredictability of regulations hampers reliable strategic planning 69 Reference pricing might result in downward price spirals and support genericization 71 Spain: opportunities and threats 71 HIV market overview 71 Opportunities 73 Legislation and reimbursement schemes support innovation 73 Decentralization of the healthcare system provides localized opportunities 74 Threats 74 Cost containment measurements restrict manufacturer’s profit margins 74 Government encourages generic use 75 UK: opportunities and threats 76 HIV market overview 76 Opportunities 78 Decreasing incentives for pharmacists to prescribe generics as a result of new DoH initiative 78 Threats 78 Price reduction for branded products after PPRS change in 2004 78 Complex structures for P&R negotiations elongate time to market 79 High generic penetration is a large challenge for brand manufacturers 81 Summary of environmental issues affecting the antiretroviral country markets 82 Chapter 4. Forecast analysis 83 Assumptions and events 83 Events not included 83 Global events 83 Increase in the number of patients receiving antiretroviral therapy 83 Product-specific events 84 Launch of Atripla 84 Truvada and Epzicom 86 Aptivus and Prezista 87 Major Clinical Trials 89 Three class strategies versus two class strategies evaluated in the FIRST trial 89 Antiretroviral patent expiries 91 Retrovir patent expiry 92 Hivid patent expiry 92 Zerit patent expiry 93 Videx patent expiry 93 Ziagen patent expiry 94 Epivir patent expiry 94 Emtriva patent expiry 94 Invirase patent expiry 95 Crixivan patent expiry 95 Viramune patent expiry 95 Combivir patent expiry 96 Sustiva patent expiry 96 Agenerase patent expiry 97 Norvir patent expiry 97 Fuzeon patent expiry 97 Viracept patent expiry 98 Kaletra patent expiry 98 New product launches 99 Launch of NNRTIs with novel resistance profiles 99 Launch of new classes of drugs, CCR5 inhibitors, integrase inhibitors, etc. 100 Data definitions, limitations and assumptions 103 Standard Units 103 Derivation of Sales Forecasts and Pricing Trends 103 Forecasts 103 Forecast methodology 103 Chapter 5. Commercial impact and lifecycle management: case studies 104 Introduction 104 Case studies 104 Tibotec – the emergence of a new kind of HIV competitor 105 The path to market 105 R&D approach focused on HIV 107 Market conditioning and competitive positioning 109 Positive market opinion 112 Conclusions 113 Kaletra versus Reyataz – lifecycle management battles for PI dominance 114 PI market evolution, 2003-05 114 Efficacy versus safety versus convenience 117 Kaletra versus Reyataz 118 Conclusions 123 APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 125 Summary HIV market data 125 Nucleoside reverse transcriptase inhibitors (NRTI) market data 126 Protease Inhibitor market data 137 Non-nucleoside reverse transcriptase inhibitor (NNRTI) market data 146 Entry Inhibitors (EIs) and others market data 148 BIBLIOGRAPHY 149 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/367677 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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