HIV: A Strategic Analysis of Therapeutic and Testing Markets

Published by: Kalorama Information

Published: Mar. 1, 2006 - 200 Pages

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

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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