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Commercial Insight: HIV - Change of guardPublished by: Datamonitor Published: Dec. 22, 2006 - 157 Pages Table of ContentsCHAPTER 1 EXECUTIVE SUMMARY Objective of the analysis Datamonitor insight into the HIV market Contributing experts CHAPTER 2 MARKET DEFINITION AND OVERVIEW Market definition for this report Current market situation Overview of antiretroviral classes Nucleoside reverse transcriptase inhibitors Non nucleoside reverse transcriptase inhibitors Protease inhibitors Entry Inhibitors Strategic scoping and focus Emerging markets CHAPTER 3 COUNTRY MARKET ASSESSMENTS Global opportunities and threats Opportunities Epidemiology: HIV population growth driven by increased diagnosis rates, new infections and rising life expectancy Acceleration and harmonization of approval procedures Threats Regulatory pathways for generics get streamlined across the globe Governments impose pricing pressure on drug manufacturers in response to cost containment needs Parallel trade - illegal in the US, encouraged in Europe New preventative measures US: opportunities and threats HIV market overview Opportunities Direct-to-consumer advertising Branded products achieve high prices as a result of the free pricing system Threats Initiatives by public and private health providers aim to encourage cost containment Further genericization is encouraged by legislation and public programs Although still illegal, parallel trade is likely to be legalized in the medium term France: opportunities and threats HIV market overview Opportunities Critical attitude towards MRP slows down generic penetration High prescription volume boosts drug revenues The creation of HAS facilitates P&R approval Reimbursement system favors use of innovative drugs Threats Cost containment policies aim at reducing the expenditure for prescription drugs Genericization has increased recently and is further supported Germany: opportunities and threats HIV market overview Opportunities Legalization of mail order provides new distribution channels Free pricing system and culture of innovation encourages novel drug development Fewer cost containment restrictions make the hospital sector a valuable opportunity Threats Jumbo Reference Pricing is threatening drug revenue growth Increasing genericization is strongly supported by the government Italy: opportunities and threats HIV market overview Opportunities Low levels of generic penetration as a result of lack of confidence Reimbursement levels are determined by negotiations rather than regulations Threats Unpredictability of regulations hampers reliable strategic planning Reference pricing might result in downward price spirals and support genericization Spain: opportunities and threats HIV market overview Opportunities Legislation and reimbursement schemes support innovation Decentralization of the healthcare system provides localized opportunities Threats Cost containment measurements restrict manufacturer’s profit margins Government encourages generic use UK: opportunities and threats HIV market overview Opportunities Decreasing incentives for pharmacists to prescribe generics as a result of new DoH initiative Threats Price reduction for branded products after PPRS change in 2004 Complex structures for P&R negotiations elongate time to market High generic penetration is a large challenge for brand manufacturers Summary of environmental issues affecting the antiretroviral country markets CHAPTER 4 FORECAST ANALYSIS Assumptions and events Events not included Global events Increase in the number of patients receiving antiretroviral therapy Product-specific events Launch of Atripla Truvada and Epzicom Aptivus and Prezista Major Clinical Trials Three class strategies versus two class strategies evaluated in the FIRST trial Antiretroviral patent expiries Retrovir patent expiry Hivid patent expiry Zerit patent expiry Videx patent expiry Ziagen patent expiry Epivir patent expiry Emtriva patent expiry Invirase patent expiry Crixivan patent expiry Viramune patent expiry Combivir patent expiry Sustiva patent expiry Agenerase patent expiry Norvir patent expiry Fuzeon patent expiry Viracept patent expiry Kaletra patent expiry New product launches Launch of NNRTIs with novel resistance profiles Launch of new classes of drugs, CCR5 inhibitors, integrase inhibitors, etc. Data definitions, limitations and assumptions Standard Units Derivation of Sales Forecasts and Pricing Trends Forecasts Forecast methodology CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES Introduction Case studies Tibotec - the emergence of a new kind of HIV competitor The path to market R&D approach focused on HIV Market conditioning and competitive positioning Positive market opinion Conclusions Kaletra versus Reyataz - lifecycle management battles for PI dominance PI market evolution, 2003-05 Efficacy versus safety versus convenience Kaletra versus Reyataz Conclusions APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS Summary HIV market data Nucleoside reverse transcriptase inhibitors (NRTI) market data Protease Inhibitor market data Non-nucleoside reverse transcriptase inhibitor (NNRTI) market data Entry Inhibitors (EIs) and others market data BIBLIOGRAPHY General Websites Reports Datamonitor Reports Report methodology ABOUT DATAMONITOR About Datamonitor Healthcare About the Infectious Disease analysis team Key therapy team members Disclaimer AbstractIntroductionThe 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 market's relative immaturity, many older flagship products such as Combivir are expected to lose patent protection before 2015. Scope
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 Purchase
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