HIV市場動向

Abstract

Overview

Introduction

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 market' s relative immaturity, many older flagship products such as Combivir are expected to lose patent protection before 2015.

Scope

• 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

Report Highlights

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

• 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.

Table of Contents

• ABOUT HEALTHCARE
  • About the Infectious Diseases & Respiratory pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
  • 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
  • List of Tables
    • Table 1: Overview of the NRTI drug class, 2006
    • Table 2: Overview of marketed NNRTIs, 2002-05
    • Table 3: Overview of marketed PIs, 2002-05
    • Table 4: Regional HIV and AIDS overview, 2005
    • Table 5: Patent expiry dates of antiretroviral drugs in the US and EU5
    • Table 6: Methods for HIV prevention in clinical development
    • Table 7: HIV vaccines in clinical development, 2006
    • Table 8: Prezista versus Aptivus trial data
    • Table 9: Pill burden for leading PIs, 2006
    • Table 10: Kaletra versus Reyataz trial data
    • Table 11: Summary: HIV market data in the six major markets, 2005
    • Table 12: Combivir: key facts
    • Table 13: Viread: key facts
    • Table 14: Trizivir: key facts
    • Table 15: Epivir: key facts
    • Table 16: Zerit: key facts
    • Table 17: Ziagen: key facts
    • Table 18: Videx: key facts
    • Table 19: Retrovir: key facts
    • Table 20: Truvada: key facts
    • Table 21: Emtriva: key facts
    • Table 22: Hivid: key facts
    • Table 23: Kaletra: key facts
    • Table 24: Reyataz: key facts
    • Table 25: Viracept: key facts
    • Table 26: Norvir: key facts
    • Table 27: Crixivan: key facts
    • Table 28: Lexiva: key facts
    • Table 29: Invirase: key facts
    • Table 30: Fortovase: key facts
    • Table 31: Agenerase: key facts
    • Table 32: Sustiva: key facts
    • Table 33: Viramune: key facts
    • Table 34: Fuzeon: key facts
  • List of Figures
    • Figure 1: Pharmaceutical market, 2001-2005
    • Figure 2: Infectious disease markets, 2001-05
    • Figure 3: Timeline of the development of the HIV market, 1985-2015
    • Figure 4: Quarterly sales of currently marketed NRTIs ($m), Q12002-Q42005
    • Figure 5: Quarterly sales of key PIs 2002-2006
    • Figure 6: HIV host cell entry mechanism
    • Figure 7: HIV market share by company, six major markets, 2002-05
    • Figure 8: Source of new HIV infections in Western Europe, 1993-2005
    • Figure 9: Transmission categories of adults and adolescents with HIV/AIDS diagnosed in the US during 2004
    • Figure 10: Effect of advances in ART on HIV survival
    • Figure 11: US sales by class
    • Figure 12: US sales - top 10 products 2005
    • Figure 13: France Sales by class
    • Figure 14: France sales - Top 10 products 2005
    • Figure 15: Germany Sales by class
    • Figure 16: Germany sales - Top 10 products 2005
    • Figure 17: Italy Sales by class
    • Figure 18: Italy sales - Top 10 products 2005
    • Figure 19: Spain, Sales by class 2002-2005
    • Figure 20: Spain sales - Top 10 products 2005
    • Figure 21: UK sales by class
    • Figure 22: UK sales - Top 10 products 2005
    • Figure 23: A range of bodies having an impact on drug prescription in the UK
    • Figure 24: Overview of Opportunities and Threats
    • Figure 25: Sales forecasts for antiretrovirals across six major markets, 2005-2015
    • Figure 26: Forecast sales for Atripla ($m), 2005-2015
    • Figure 27: Forecast sales for Aptivus and Prezista, 2002-2015
    • Figure 28: Design of the FIRST trial
    • Figure 29: Tibotec historical timeline
    • Figure 30: Tibotec portfolio product positioning
    • Figure 31: Evolution of US PI market by sales and standard unit doses, 2003-2005
    • Figure 32: US promotional data for Kaletra and Reyataz, 2003-2005