Commercial Insight: HIV - Change of guard

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