Abstract
The strategic interplay of of HIV/AIDS diagnostics and therapeutics is one of
the most complex that the healthcare industry has ever seen. In order to cope
with the challenges and opportunities of HIV/AIDS, companies must think on a
global basis, and in addition to the basic pathology and complications of
HIV/AIDS, there are societal and ethical pressures, geopolitical factors, and
evolving marketplace disruptions.
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.
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)
CHAPTE R 5: Strategic Assessment of HIV/AIDS
- Market Potential
- Epidemiology
- The "Next Wave" Countries
- Nigeria
- Ethiopia
- Russia
- India
- China
- Existing Epidemics--Africa
- Technology
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
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