• Therapeutic Vaccines
  
  • Phase I - Safety/Immunogenicity of Immunizations of ALVAC-DC-SC Vs ALVAC-SC (NIAID: NCT00026624)
    
  • Phase II - Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients (NIAID: NCT00080106)
    
  • Phase III - Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy (NIAID: NCT00107549)
    
  • Phase I - Study of the HIV gp120/NefTat/AS02A Vaccine to Treat Individuals With Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART) (GlaxoSmithKline: NCT00117429)
    
  • Phase I/Phase II - Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection (NIAID: NCT00125099
    
  • Phase II - Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection (NIAID: NCT00183261)
    
  • Phase I/Phase II - Safety and Tolerability of and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving Anti-HIV Treatment (NIAID: NCT00270205)
  
  
  
• Preventive Vaccines
  
  • No Phase - A Study to Prepare for Future HIV Vaccine Studies (NIAID: NCT00029744)
    
  • No Phase - Screening Protocol for HIV Vaccine Studies (NIAID: NCT00031304)
    
  • Phase I - Development of a New HIV Vaccine (NIAID: NCT00051922)
    
  • Phase I - Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults (NIAID: NCT 00083603)
    
  • Phase I - Safety of an Oral Vaccine in HIV Uninfected Volunteers (NIAID: NCT00062530)
    
  • Phase I - Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults (NIAID: NCT00097838)
    
  • Phase I - Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers (NIAID, NICHD, NIDA, NIMH: NCT00098163)
    
  • Phase I - Study of HIV Preventive Vaccines Given With or Without an Adjuvant in HIV Uninfected Adults (NIAID: NCT00111605)
    
  • Phase I - Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 3 Different Booster Vaccinations in HIV Uninfected Adults (NIAID: NCT00115960)
    
  • Phase I - Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults (NIAID: NCT00119873)
    
  • Phase I/Phase II - Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults (NIAID, DOD: NCT00123968)
    
  • Phase I - Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults (NIAID: NCT00124007)
    
  • Phase II - Safety of and Immune Response to a DNA HIV Vaccine Followed By an Adenoviral Vector HIV Vaccine in Healthy Adults (NIAID: NCT00125970)
    
  • Phase I - Safety of and Immune Response to Two Experimental Preventive HIV Vaccines (EP HIV-1090 and EP-1043) Given Alone or in Combination in Healthy, HIV-1 Uninfected Adults (NIAID: NCT00141024)
    
  • Phase I - Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults (International AIDS Vaccine Initiative, Aaron Diamond AIDS Research Center, University of Rochester: NCT00252148)

CHAPTE R 5: Strategic Assessment of HIV/AIDS

• Market Potential
  
• Epidemiology
  
  • The “Next Wave” Countries
    
  • Nigeria
    
  • Ethiopia
    
  • Russia
    
  • India
    
  • China
  
  
  
• Existing Epidemics—Africa
  
• Technology

Appendix A: Glossary

Appendix B: Companies Active in HIV/AIDS Therapeutics and Diagnostics

List of Exhibits

CHAPTER 1: Executive Summary

• Table 1-1: Estimated Theoretical Global Market Potentials for HIV/AIDS Diagnostics and Therapeutics by Region (10 regions) 2005
  
• Table 1-2: Estimated Realistic Global Market Potentials for HIV/AIDS Diagnostics and Therapeutics by Region (10 regions) 2005
  
• Table 1-3: Global Epidemiology View of HIV/AIDS Incidence, Prevalence, Adult Prevalence, and Deaths by Region 2005

• Table 2-1: Global Summary of HIV/AIDS Populations Average and Range of Prevalance, Incidence, Deaths 2005
  
• Table 2-2: Regional HIV/AIDS Statistic and Features: 2005
  
• Table 2-3: Estimated Number of Cases of HIV/AIDS in the United States by
  Year of Diagnosis, Race/Ethnicity, and Transmission Category
  2001-2004
  
• Table 2-4: Estimated Number of AIDS Cases in the United States by Age at Diagnosis, Race/Ethnicity, Transmission Category, and Region
  2000-2004
  
• Table 2-5: Estimated Number of People Living with HIV/AIDS in the U.S. by
  Age at Diagnosis, Race/Ethnicity, and Transmission Category
  2001-2004
  
• Table 2-6: Estimated Number of Persons Living with AIDS in the United
  States by Year, Race/Ethnicity, Transmission Category, and
  Region 2000-2004
  
• Table 2-7: HIV Diagnoses in Western Europe by Country (22 counties)
  Number of Diagnoses 2004 or 2003, Rate per Million, and
  Cumulative Total
  
• Table 2-8: Estimated Number of People Living with HIV in Western Europe by Country (26 countries) 2001 and 2003
  
• Table 2-9: HIV Diagnoses in Central and Eastern Europe and in Central
  Asia by Country: Number of Diagnoses 2004 or 2003, Rate per
  Million, and Cumulative Total
  
• Table 2-10: Estimated Number of People Living with HIV in Central and
  Eastern Europe and Central Asia by Country (29 Countries)
  2001 and 2003
  
• Table 2-11: Estimated Number of People Living with HIV in Sub-Saharan
  Africa by Country (44 Countries) 2001 and 2003
  
• Table 2-12: Estimated Number of People Living with HIV in Latin America by Country (20 Countries) 2001 and 2003
  
• Table 2-13: Estimated Number of People Living with HIV in the Caribbean by Country (7 Countries) 2001 and 2003
  
• Table 2-14: Estimated Number of People Living with HIV in India, China and South/Southeast Asia by Country (20 Countries Total)
  2001 and 2003
  
• Table 2-15: Estimated Number of People Living with HIV in North Africa
  and the Middle East by Country (20 Countries) 2001 and 2003

• Table 3-1: HIV Screening and Confirmatory Testing Products Approved for
  Use in the United States as of January 9, 2006
  
• Table 3-2: Conditions Attributable to or Complicated by HIV
  
• Table 3-3: AIDS: Indicator Conditions

• Table 4-1: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Approved by the FDA for Use in HIV/AIDS Treatment (Brand Name, Generic Name, Manufacturer, Approval Date, Time to Approval)
  
• Table 4-2: Non-Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Approved by the FDA for Use in HIV/AIDS Treatment (Brand Name, Generic Name, Manufacturer, Approval Date, Time to Approval)
  
• Table 4-3: Protease Inhibitors (PIs) Approved by the FDA for Use in HIV/AIDS Treatment (Brand Name, Generic Name, Manufacturer, Approval
  Date, Time to Approval)
  
• Table 4-4: Generic Drugs Used in the Treatment of HIV Infection (Generic
  Name, Manufacturer, Approval Date, Time to Approval)
  
• Table 4-5: Drugs Approved by the FDA for Use in Pediatric HIV/AIDS Treatment (Generic Name, Manufacturer, Adult Approval Date, Pediatric
  Approval Date)
  
• Table 4-6: Drugs Approved by the FDA for Use in the Treatment of HIV/AIDS Complications (Brand Name, Generic Name[s], Use, Manufacturer,
  Approval Date)

• Figure 5-1: Theoretical Distribution of Global HIV/AIDS Diagnostics and Therapeutics Markets: 2005
  
• Table 5-1: Estimated Theoretical Global Market Potentials for HIV/AIDS Diagnostics and Therapeutics by Region (10 regions) 2005
  
• Table 5-2: Estimated Realistic Global Market Potentials for HIV/AIDS
  Diagnostics and Therapeutics by Region (10 regions) 2005
  
• Figure 5-2: Realistic Distribution of Global HIV/AIDS Diagnostics and
  Therapeutics Markets: 2005
  
• Figure 5-3: High and Low Estimates of Current and Future HIV/AIDS-Infected Adults in the “Next-Wave” Countries: 2002 and 2010
  
• Table 5-3: High and Low Estimates of Current and Future HIV/AIDS-Infected Adults in the “Next-Wave” Countries 2002 and 2010

Abstract

For the development of a coherent strategy in this therapeutic area, companies must clearly focus on three primary areas, the first of which is strongly influenced by the latter two:

• market potential,
• epidemiology (including HIV/AIDS patient trends) and
• the current and emerging technologies in both diagnostics and therapeutics.

This in-depth strategic analysis of the worldwide HIV/AIDS market discusses the technologies available and emerging and discusses realistic and theoretical market potential and detailed epidimiological assessments for various geographic regions (many to the national level), including:

• Sub-Saharan Africa
• North Africa/Middle East
• South/Southeast Asia
• East Asia
• Latin America
• Caribbean
• Eastern Europe/Central Asia
• Western/Central Europe
• North America
• Oceania

The report focuses on the policy aspects of HIV/AIDS, the options presented, the factors associated with strategic market development of HIV/AIDS diagnostics and therapeutics, and prospects for the future. The major strategic market effects of epidemiology, medical technology, and market potential analyses are discussed in detail. The trends in epidemiology and social/political attitudes towards HIV/AIDS, as well as their impacts on developing markets, are selected in conjunction with the growing interest in HIV/AIDS preventive medicine. These are presented to provide the most informative picture of potential market advances in this field.

Market analysis for this report is limited in the sense of projections, market shares, etc. Instead, it considers the various aspects of broad market development and estimates throughout the world. It looks at regions of the globe in terms of their existing theoretic and realist market potential. This is tempered by discussions of where and how these markets may develop and the factors influencing them. This report does not discuss in detail the individual products that may be marketed in each of these countries. Some mention is made of specific product types by way of example, but greater emphasis is placed on the product classes, in their generic sense, and their application to HIV/AIDS per se and its complications. The focus of the report is on the strategic factors associated with existing and future market potentials to provide pharmaceutical and diagnostics companies wishing to enter the field with a “field general’s” perspective.

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