Table of Contents
CHAPTER 1: Executive Summary
Market Potential
Epidemiology
Technology
Screening and Diagnosis
Level 1: Screening for HIV Infection
Level 2: Confirmatory Testing for HIV Infection
Level 3: Diagnosis
Level 4: Monitoring Treatment and Prognosis
Therapeutics
Binding
Reverse Transcription
Transcription
Translation
Viral Assembly and Maturation
Other Areas
Scope and Methodology
CHAPTER 2: HIV/AIDS: Nature and Epidemiology
HIV/AIDS Basics
HIV/AIDS Complications
Pneumocystis carinii pneumonia
Tuberculosis
Toxoplasmosis
Cytomegalovirus (CMV)
Mycobacterium avium complex
Kaposi’s sarcoma
Non-Hodgkin’s Lymphoma
Primary CNS Lymphoma
Hodgkin’s Disease
Cervical Cancer
Anal Cancer
Coinfection with Hepatitis C
HIV/AIDS Epidemiology
HIV/AIDS in the United States
HIV/AIDS in Western Europe
HIV/AIDS in Central Europe, Eastern Europe and Central Asia
HIV/AIDS in Africa
HIV/AIDS in Latin America and the Caribbean
HIV/AIDS in India, China and South/Southeast Asia
India
China
South and Southeast Asia
HIV/AIDS in North Africa and the Middle East
CHAPTER 3: Screening and Diagnosis
Level 1: Screening
Level 2: Confirmatory Testing
Level 3: Diagnosis
Level 4: Monitoring Treatment and Prognosis
CHAPTER 4: HIV/AIDS: Therapeutics
Drug Therapy
Binding
AMD070 (AnorMED, Inc.)
BMS-488043 (Bristol-Myers Squibb)
GSK-873,140 [aplaviroc] (GlaxoSmithKline)
Peptide T (Advanced Immuni T, Inc.)
PRO-542 (Progenics Pharmaceuticals, Inc.)
SCH-C (Schering Plough Corp.)
SCH-D [vicriviroc] (Schering Plough Corp.)
TNX-355 (Tanox, Inc.)
UK-427,857 [maraviroc] (Pfizer Inc.)
Reverse Transcription
Alovudine (Boehringer Ingelheim GmbH)
Amdoxovir [DAPD] (Gilead Sciences Inc.)
AVX754 (Avexa Limited)
DPC 817 [Reverset] (Pharmasset, Inc.)
Elvucitabine (Achillion Pharmaceuticals)
KP-1461 [SN1461, SN1212, KP-1212, KP1212/1461] (Koronis Pharmaceuticals)
Racivir (Pharmasset, Inc.)
Calanolide A (Sarawak MediChem Pharmaceuticals, Inc.)
Capravirine (Pfizer, Inc,)
TMC125 (Tibotec)
Integration
L-000870810 (Merck & Co., Inc.)
Transcription
Translation
Viral Assembly and Maturation
Microbicides
C31G (Cellegy Pharmaceuticals, Inc.)
Carbopol 974P [BufferGel] (ReProtect LLC)
Carrageenan [Carraguard] (FMC Biopolymer; Population Council)
Cellulose Sulfate [Ushercell] (Polydex Pharmaceuticals Ltd.)
Cyanovirin-N (Cellegy Pharmaceuticals, Inc.)
Dextran sulfate (Ueno Fine Chemicals Industry Ltd)
PRO 2000 (Indevus Pharmaceuticals, Inc.)
UC-781 (Cellegy Pharmaceuticals, Inc.)
Chemokine Therapeutics
Genes and HIV/AIDS
HIV/AIDS Vaccines
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)
CHAPTER 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
CHAPTER 2: HIV/AIDS: Nature and Epidemiology
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
CHAPTER 3: Screening and Diagnosis
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
CHAPTER 4: HIV/AIDS: Therapeutics
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)
CHAPTER 5: Strategic Assessment of HIV/AIDS
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
