HIV/AIDS Testing

Published by: Global Industry Analysts

Published: Aug. 1, 2006 - 323 Pages

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability And Reporting Limitations

Disclaimers

Data Interpretation & Reporting Level

Product Definitions and Scope of Study

Definitions

HIV/AIDS Screening Tests

HIV/AIDS Confirmatory Tests

HIV/AIDS Monitoring Tests

II. EXECUTIVE SUMMARY

1. Industry Overview

Worldwide HIV/AIDS Testing Market - An Analysis

Regional Analysis

The US

Europe

Majority of HIV Infections Seen in Developing Countries

Segment Analysis

HIV/AIDS Screening

Confirmatory Test Market

HIV/AIDS Monitoring Market

Growth Drivers

Rapid Testing- Displays High Potential

FDA Approved Rapid HIV Tests in US

WHO’s “3 by 5” Initiative -Boosts Testing Market

Molecular Diagnostics Register Strong Growth in Blood Screening Markets

Ultra-Rapid HIV-screening Tests- A Strong Fight against HIV-Epidemic

Emergency Room Testing to Help HIV Diagnosis

Leading Players

HIV/AIDs Diagnostics Market Participants - Product Matrix

2. Aids: A Global Epidemic

Facts & Figures

Table 1: HIV/AIDS Statistics Worldwide: End-2005

Table 2: Worldwide Living Population Infected with HIV/AIDS (2005-End) (includes corresponding Graph/Chart)

Table 3: Worldwide HIV & AIDS Incidences (End-2005): A Regional Breakdown for Living and Newly Infected Cases(includes corresponding Graph/Chart)

Table 4: HIV/AIDS Cases (Living & New Infections) in Adults and Children Worldwide: Breakdown by Region- End 2005(includes corresponding Graph/Chart)

Table 5: Worldwide Deaths Due to AIDS (2005-End) (includes corresponding Graph/Chart)

HIV/AIDS Cases in Adults and Children Worldwide: Breakdown by Region-End 2004

Table 6: Deaths Due to AIDS Worldwide: Breakdown by Region- 2004 (in Million)

Table 7: Countries With the Highest Number of People Living with HIV: 2003 (includes corresponding Graph/Chart)

AIDS : A Serious Threat to Development

Catching them Young

Estimated Number of New HIV Infections in Young People

Anti-AIDS Therapeutics: A Blessing in Disguise in Developed Countries

3. Understanding the Disease

Mechanism of Action

Symptoms

Full-Blown AIDS

Transmission of HIV

On the Brighter Side

HIV Therapy

The Search Continues

Infection Process - Targets for HIV Therapy

4. Diagnosis of HIV/Aids

Testing: The Basis for AIDS Prevention and Treatment

Blood Processing

The Earliest Time to Detect Infection

Testing Plagued by Problems Such As

Major Drawbacks of Laboratory Diagnosis of HIV Infections

Rapid Tests - Suitable for Developing Countries

5. HIV Tests

Testing Subject to Strict Rules

Diagnostic Tests

I. Antibody Tests

A. HIV-1 Screening Tests

Test Methodology

a. Enzyme-linked Immunosorbent Assays/Enzyme Immunoassays (ELISA/EIA)

b. Home AccessHIV-1 test system/Dried Blood Spot

c. Rapid Tests

Generic Assay Formats in Rapid Test

The Dot Blot Rapid Test

Agglutination Tests

Solid Phase Test

Immunochromatographic strip (ICS) Tests

Rapid Serological Tests Vs. ELISA Tests

B. HIV-1 Antibody Confirmatory Tests

a. The Western Blot Test

Commonly Used in Developed Countries

Interpretation of Results

Modified Western Blots

b. Indirect Immunofluorescent Antibody Assay (IFA)

c. Line Immunoassay

d. Radioimmunoprecipitation Assay (RIPA)

C. HIV-2 Diagnostic Tests and HIV Group “O

Testing Protocols

Types of Antibody Tests Based on Sample

i. Traditional Blood Antibody Tests

ii. Dried Blood Spot (DBS) Sampling

Technique

Blood Tests Are Highly Expensive

iii. Other Alternatives in Samples

Oral Testing for HIV

Urine Tests

II. Viral Identification Assays

A. p24 Antigen Test

B. Qualitative PCR Tests

C. Viral Culture

Monitoring Tests

A. Lymphocyte Analysis

B. Viral Load Tests

Levels of CD4 and Viral Load in AIDS

C. Drug Resistance Tests

Main Types

i. Genotyping Tests

ii. Phenotyping Tests

Molecular Diagnostics and Gene Detection

Products

DNA Probe-Based Products

Direct Assays

Amplification

Amplification Methodologies

6. Technology Review

PCR: A Promising Development in HIV/AIDS Monitoring Market

DNA Probes are Highly Specific and Sensitive

OCA-particles Based Detection System-Offers Increased Accuracy

Home HIV Tests: Unfolding a New Era of Testing

Yet Nascent

Not Without Share of Objections

Home Access: Monopolizing the Home HIV Test Kit Market

Drawbacks of Blood-Based Tests

7. Regulations

Overview

UN’s Testing Policies in Peacekeeping Force

Anonymous Versus Confidential Diagnostic Testing for HIV infection in US

Regulatory Approval for Rapid HIV Test Kits in US

HIV Testing - Mandatory in US Blood Banks

8. New Product Approvals & Launches

Shanghai Kehua Develops New HIV/AIDS Test Kit for Faster Diagnosis

INSTI™ HIV Test Kit from bioLytical™ Receives European CE Mark

Rockeby Biomed Gains Approval from MOH to Sell OraQuick across Singapore

FDA Approves Chembio’s Rapid HIV Tests for Sale in the US

MiraWell Whole Blood Rapid HIV Test Receives Approval from China SFDA

MiraCare Rapid HIV Antibody Test Receives CE Mark

Calypte Receives Approval for Marketing Aware Rapid HIV Tests in Kenya

FDA Approves Bayer’s Automated HIV Antibody Test Product

SA Government Approves Marketing of Calypte’s Aware OMT HIV Test Product

Calypte Introduces OTC Version of Aware HIV Test in UAE

Roche Obtains European Union’s CE Mark for its cobas TaqScreen MPX Test

MedMira Registers Rapid HIV/ADIS Test Products for Latin American Market

bioLytical Gains Health Canada’s Approval for Marketing INSTI HIV Test Kit

Calypte’s Aware BSP HIV 1/2 Test Product Receives Malaysian Government’s Clearance

FDA Approves Upgrades to Reveal G2 Rapid HIV Test

MedMira Introduces OTC Version of MiraCare in Select Asian Markets

Calypte Includes Dried Blood Specimen-Based Testing Capability into HIV-1 BED Incidence EIA Test

Calypte’s Aware™ HIV-1/2 BSP Approved for Marketing in Zimbabwe

FDA Approves Rockville Facility for Manufacturing HIV-1 Urine EIA Screening Test

OraSure Introduces OraQuick ADVANCE Rapid HIV Test in Mexico

Adaltis Develops Advanced Detect-HIV™ Test for Early Detection of HIV Infection

Xenomics Develops HIV DNA Detection Technology

Abbott and Celera Diagnostics Receive CE Certification

Bio-Rad Receives FDA Approval for HIV-1& HIV 2 Rapid Test

FDA Approval for MedMira’s Enhanced Rapid HIV Test

Roche Receives CE Mark Certification for Virology Tests

Roche Receives FDA Approval for COBAS AmpliScreen Test

Chembio Diagnostics Launches HIV Stat-Pak Dipstick

Medical Services Develops Next Generation HIV Test Kits

Bio-Rad’s Multispot HIV-1/HIV-2 rapid test Approved by FDA

Abbott Receives CE Mark Certification for PCR Test

Bayer Receives CE Mark Certification for TRUGENE® HIV-1

MedMira Receives Health Canada Approval for Rapid HIV Test

OraSure Receives FDA Approval for Oral Fluids and Plasma

Roche Receives FDA Approval for Diagnostic Test

Trinity Receives FDA Waiver for Uni-Gold

bioMérieux Unveils VIDAS® HIV Duo Ultra and Duo Quick HIV Tests

OraQuick® Rapid HIV-1/2 Antibody Assay Approved by the FDA

MedMira Launches Reveal™ G2

OraSure Launches OraQuick® ADVANCE Rapid HIV Test

Celera Diagnostics Obtains FDA Clearance for Enhanced ViroSeq™

Calypte Unveils HIV-1/2 Oral Fluid Rapid Tests

Bio-Rad’s HIV-1/HIV-2 PLUS O EIA Assay Approved by the FDA

OraQuick HIV-1 Test Approved by FDA for Use with Venuous Whole Blood

Bio-Rad Receives FDA Approval for HIV-1/HIV- 2 PLUS O Test

Calypte Introduces Urine Based HIV-1 Assay in Africa

China Develops Novel HIV Testing Reagent

Calypte Receives FDA Approval for Western Blot Supplemetary Test

Year 2002 in Review

Year 2001 in Review

Year 2000 in Review

9. Recent Industry Activity

Calypte and Mineseeker to Supply Aware™ AIDS Test Kit Across Africa

Pharmaceutical Companies Agree to Cut Costs of AIDS Tests and Drugs

OraSure Bags US$6 Million Order to Deliver HIV Test Kits

Trinity Biotech Enters into Agreement to Deliver Uni- Gold HIV Test Kits to PPFA

Trinity Biotech Delivers Uni-Gold™ Rapid HIV Test to 340B Prime Vendor Program

MedMira Bags Order from Exportrade for MiraWell Rapid HIV Tests

OraSure Receives Bulk Order for Rapid HIV Tests from CDC

MedMira Bags Order from Spree Trading for MiraWell Rapid HIV Tests

IRIS Acquires Leucadia with Plans to Introduce HIV & Cancer Testing Products

Clindia to Distribute MiraCare Rapid HIV Test in the Netherlands

MedMira Bags Order from Goodman Medical

bioMérieux Bags Contract to Provide Equipment for HIV Viral Load Measurement

Bayer to Divest Diagnostic Division of Bayer Healthcare to Siemens

Novartis Acquires Chiron to Create a New Diagnostics & Vaccines Division

Abbott Enters into Agreement with Novation for Supplying OraQuick® ADVANCE™ HIV Tests

Roche Diagnostics Enters into Three-Year Agreement with Premier to Deliver Molecular Products

MedMira Bags Order to Deliver MiraCare™ HIV Tests Across Europe

BD Partners with KEMRI to Provide Modern HIV/AIDS Testing Skills

KEMRI Sets Up Facility to Mass Produce AIDS Test Kit for African Market

MSI Bags Iranian Order for its Rapid VScan HIV/AIDS Test Kits

MSI Inks Contract to Deliver VScan HIV Test Kits Across China

MSI Inks Deals for Delivery of VScan HIV 1 & 2 Test Kits to Eastern Europe and Taiwan

Abbott and OraSure Enter into Agreement

ViroLogic Offers License to GlaxoSmithKline

Bio-Rad Sublicenses HIV-2 Rapid Test Patent to OraSure

Biotech Cogstate Strikes a Deal with CDC

Calypte Receives CDC License for HIV Incidence Test

Calypte Biomedical Licences Rapid Test HIV-2 Patent from Bio-Rad

Calypte Licenses Immunodiagnostic Technology from Adaltis

OraSure Receives Purchase Order from SAMHSA

Roche Signs Agreement with Pasteur Institute and Bio-Rad

Roche Enters into Agreement with Korean Red Cross

Roche, Dade Behring and Chiron Enters into Licensing Agreement

Hedley and BioLytical Sign Pact

Abbott and Boehringer Announce Agreement

Year 2002 in Review

Year 2001 in Review

10. Focus on Select Global Players

Abbott Laboratories (USA)

Adaltis Inc. (Canada)

Bayer Diagnostics (USA)

Biomérieux (France)

Bio-Rad Laboratories (USA)

Calypte Biomedical Corporation (USA)

Chiron Corp. (USA)

Gen-Probe Inc. (USA)

Innogenetics NV (Belgium)

MedMira Laboratories, Inc. (Canada)

Medical Services International Inc. (Canada)

OraSure Technologies Inc. (USA)

Ortho-Clinical Diagnostics (USA)

Roche Diagnostics (Switzerland)

11. Global Market Perspective

Unit Analytics

Table 8: World Recent Past, Current & Future Analysis for HIV/AIDS Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 9: World 10-Year Perspective for HIV/AIDS Testing by Geographic Region - Percentage Breakdown of Unit Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 10: World Recent Past, Current & Future Analysis for HIV/AIDS Screening Tests by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 11: World 10-Year Perspective for HIV/AIDS Screening Tests by Geographic Region - Percentage Breakdown of Unit Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 12: World Recent Past, Current & Future Analysis for HIV/AIDS Confirmatory Tests by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 13: World 10-Year Perspective for HIV/AIDS Confirmatory Tests by Geographic Region - Percentage Breakdown of Unit Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Dollar Analysis

Table 14: World Recent Past, Current & Future Analysis for HIV/AIDS Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 15: World 10-Year Perspective for HIV/AIDS Testing by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 16: World Recent Past, Current & Future Analysis for HIV/AIDS Screening Tests by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 17: World 10-Year Perspective for HIV/AIDS Screening Tests by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 18: World Recent Past, Current & Future Analysis for HIV/AIDS Confirmatory Tests by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 19: World 10-Year Perspective for HIV/AIDS Confirmatory Tests by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 20: World Recent Past, Current & Future Analysis for HIV/AIDS Monitoring Tests by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 21: World 10-Year Perspective for HIV/AIDS Monitoring Tests by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

III. MARKET

1. The United States

A. Market Analysis

Market Overview

Dollar Analysis

Unit Analysis

Competitive Structure

Table 22: Leading Players in HIV Viral Load Testing Market in the US (2004- 2005E): Percentage Share Breakdown of Value Sales for Roche, Bayer, and Others (includes corresponding Graph/Chart)

Table 23: Leading Players in HIV Viral Load Testing Market in the US (2004- 2005E): Percentage Share Breakdown of Value Sales Roche, Bayer, and Others (includes corresponding Graph/Chart)

Rapid HIV Tests Display Rapid Growth

Leading Players

FDA Approved Rapid HIV Tests in US

NAT Tests Score High in Blood Banks

HIV/AIDS Stats

Table 24: Percentage of HIV/AIDS Cases in the US, by Gender: 1993-2029 (includes corresponding Graph/Chart)

Table 25: AIDS Diagnoses in the US (2004): Breakdown by Ethnic Groups/Race(includes corresponding Graph/Chart)

Table 26: HIV Infected Persons in US (2003): Percentage Breakup by Ethnic Groups (includes corresponding Graph/Chart)

Table 27: AIDS Cases by Exposure Category in the US: 2003 (includes corresponding Graph/Chart)

New Cases on the Decline

Major End-Users of HIV/AIDS Tests

HIV Testing Made Mandatory in Blood Banks

Physician and Public Health Clinical Market

Home HIV Tests

Efforts by Organizations

FDA Approved HIV/AIDS Tests in the US market (1998-2004)

Product Launches

Strategic Corporate Developments

Key Players

Abbott Laboratories

Bayer Diagnostics

Bio-Rad Laboratories

Calypte Biomedical

Celera Diagnostics

Chiron Corp

Gen-Probe Inc

OraSure Technologies Inc

Ortho-Clinical Diagnostics

B. Market Analytics

Table 28: US Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 29: US 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 30: US Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 31: US 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

2. Canada

A. Market Analysis

Market Overview

AIDS/HIV: Some Facts & Figures

Table 32: AIDS Cases in Canada by Ethnic Status: 2001 - 2005 (includes corresponding Graph/Chart)

Table 33: AIDS Statistics for Canada by Exposure Category: End-2005

HIV Statistics

Table 34: AIDS/ HIV Diagnosis Trend in Canada: 1995-2005

Table 35: AIDS and Positive HIV Cases in Canada by Age Group: 2005-End

HIV Incidence Among Women on the Rise

Historical Stats- Late 1990s

Product Launches/Approvals

Strategic Developments

Key Players

Adaltis Inc

MedMira Laboratories, Inc.

Medical Services International Inc

B. Market Analytics

Table 36: Canadian Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 37: Canadian 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 38: Canadian Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 39: Canadian 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

3. Japan

A. Market Analysis

Market Overview

HIV on Rise

B. Market Analytics

Table 40: Japanese Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 41: Japanese 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 42: Japanese Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 43: Japanese 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4. Europe

A. Market Analysis

Market Overview

Regional Analysis

Segment Analysis

Market Drivers

AIDs/HIV Stats - A Review

Western Europe

Table 44: HIV Diagnosis in Western Europe: Facts and Figures by Country(2003)

Central Europe

Table 45: HIV Diagnosis in Central Europe: Facts and Figures by Country(2003) (includes corresponding Graph/Chart)

Eastern Europe

Table 46: HIV Diagnosis in Eastern Europe: Facts and Figures by Country (2003)

Regulations

Antenatal HIV Testing in Europe

Denmark

Finland

Germany

Luxembourg

Netherlands

Portugal

Spain

Sweden

Product Approvals/Launches

Strategic Developments

B. Market Analytics

Unit Analytics

Table 47: European Recent Past, Current & Future Analysis for HIV/AIDS Testing by Geographic Region - France, Germany, Italy, UK, Spain, & Rest of Europe Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 48: European 10-Year Perspective for HIV/AIDS Testing by Geographic Region - Percentage Breakdown of Unit Sales for France, Germany, Italy, UK, Spain, & Rest of Europe Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 49: European Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 50: European 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Dollar Analytics

Table 51: European Recent Past, Current & Future Analysis for HIV/AIDS Testing by Geographic Region - France, Germany, Italy, UK, Spain, & Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 52: European Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 53: European 10-Year Perspective for HIV/AIDS Testing by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, & Rest of Europe Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart)

Table 54: European 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4a. France

A. Market Analysis

Market Overview

Key Player

bioMérieux

Strategic Corporate Developments

B. Market Analytics

Table 55: French Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 56: French 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 57: French Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 58: French 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4b. Germany

A. Market Analysis

Market Overview

Few Facts

Strategic Corporate Developments

B. Market Analytics

Table 59: German Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 60: German 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 61: German Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 62: German 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4c. Italy

A. Market Analysis

Market Overview

Few Facts

Table 63: HIV/ AIDS Prevalence and Mortality Rates by Age Group in Italy: End of 2003

B. Market Analytics

Table 64: Italian Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 65: Italian 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 66: Italian Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 67: Italian 10-Year Perspective for HIV/AIDS esting by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4d. The United Kingdom

A. Market Analysis

Market Overview

Trends in HIV and AIDS Statistics

At Risk Groups - A Review

Table 68: HIV and AIDS Cases in the UK: Breakdown by Age Group and Gender: Till March 2006 (includes corresponding Graph/Chart)

Table 69: AIDS Statistics for the UK by Exposure Category: Till March 2006 (includes corresponding Graph/Chart)

Regulation

Historic Product Launches

B. Market Analytics

Table 70: UK Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 71: UK 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit ales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 72: UK Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 73: UK 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4e. Spain

A. Market Analysis

Market Overview

HIV Prevalence Rate

B. Market Analytics

Table 74: Spanish Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in 000’ Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 75: Spanish 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 76: Spanish Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment -HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 77: Spanish 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

4f. Rest of Europe

A. Market Analysis

Market Overview

AIDS Review

Austria

Russia

Provision of Antiretroviral Treatment

Ukraine

Other European Countries

Key Players

Innogenetics NV (Belgium)

Roche Diagnostics (Switzerland)

Strategic Developments

Historic Developments

B. Market Analytics

Table 78: Rest of Europe Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 79: Rest of Europe 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table80: Rest of Europe Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 81: Rest of Europe 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

5. Asia Pacific

A. Market Analysis

Market Overview

The Next Epicenter for the AIDS Epidemic

China and India: The Worst Affected

Review of Select Asian Countries

Australia

Table 82: Number of HIV and AIDs Cases in Australia: Mid1990s to 2003

Table 83: Estimated Living Population in India with HIV/ AIDS Infection (2005-End): Breakdown by Group (In Million) (includes corresponding Graph/Chart)

Strategic Development

China

AIDs/HIV- A Review

Historical Note

Efforts to Combat HIV/ AIDs

Strategic Corporate Developments

India- Rapid Increase in HIV

Table 84: HIV/AIDS Cases in India (2005): Percentage Breakup by Age Group (includes corresponding Graph/Chart)

Table 85: HIV/AIDS Cases in India in 2005: Percentage Breakup by Mode of Transmission (includes corresponding Graph/Chart)

Table 86: Number of Live Persons Infection with HIV in Thailand: 2005-End (includes corresponding Graph/Chart)

Strategic Development

Historic Developments

Singapore

Thailand

HIV Cases on Decline

Table 87: Number of Live Persons Infection with HIV in Thailand: 2005-End (includes corresponding Graph/Chart)

Strategic Developments

Philippines

2004: Hedley Receives Approval for INSTI(R) HIV-1/HIV-2 Antibody Tests

Korea

2004: Roche to Supply COBAS AmpliScreen HIV-1 to Korean RedCross

Vietnam

Product Launches/Approval

B. Market Analytics

Table 88: Asia Pacific Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 89: Asia Pacific 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 90: Asia Pacific Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 91: Asia Pacific 10-Year Perspective for HIV/ AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

6. Latin America

A. Market Analysis

Market Overview

Epidemics of HIV in Latin America

Table 92: People Living with HIV Infection in Latin America by Country:2004 (in thousands) (includes corresponding Graph/Chart)

Trends and Transmission Modes

Table 93: HIV/AIDS Prevalence in Latin America: 2002-2004 (in Millions)

Table 94: HIV/ AIDS Prevalence and Mortality Rates by Region till End of 2003

Trends in Antiretroviral Treatment

Product Launches/Approvals

Strategic Corporate Developments

B. Market Analytics

Table 95: Latin America Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/ AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 96: Latin America 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 97: Latin America Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/ AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 98: Latin America 10-Year Perspective for HIV/ AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

7. Rest of World

A. Market Analysis

Market Overview

Africa

Facing the Brunt of the Disease

Mortality Rates on Rise

Table 99: HIV/AIDS Cases in Africa as of End 2003: Breakdown By Top 20 Countries

Table 100: Adults & Children Deaths Due to AIDS in Africa (2003): Breakdown by Top 10 Countries (includes corresponding Graph/Chart)

Uganda - A Review

Product Launches/Approvals

Strategic Developments

Caribbean Nations

Table 101: HIV/AIDS Prevalence & Mortality Rates in Caribbean Nations Till End of 2003

Strategic Developments

Iran

Table 102: HIV infection in Iran: % Breakdown by Exposure Category (includes corresponding Graph/Chart)

B. Market Analytics

Table 103: Rest of World Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets Independently Analyzed with Annual Sales Figures in ‘000 Units for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 104: Rest of World 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Unit Sales for HIV/AIDS Screening Tests and HIV/AIDS Confirmatory Tests Markets for 2000, 2005 & 2010

Table 105: Rest of World Recent Past, Current & Future Analysis for HIV/AIDS Testing by Product Segment - HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets Independently Analyzed with Annual Sales Figures in US$ Millions for Years 2000 through 2010 (includes corresponding Graph/Chart)

Table 106: Rest of World 10-Year Perspective for HIV/AIDS Testing by Product Segment - Percentage Breakdown of Dollar Sales for HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, HIV/AIDS Monitoring Tests Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart)

IV. COMPETITION

1. Abbott Laboratories (USA)

Table 107: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ billion)

Table 108: Annual Sales Analysis by Segment: 2004-2005 (In US$ billion)

Abbott Diagnostics (USA)

2. Adaltis, Inc, (Canada)

3. Advanced Biotechnologies, Inc. (USA)

4. AGEN Biomedical Ltd. (Australia)

5. Akers Biosciences, Inc. (USA)

6. Avant Immunotherapeutics, Inc. (USA)

Table 109: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 110: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

7. Bayer Diagnostics (USA)

8. Beacon Diagnostics, Inc. (USA)

9. Beckman Coulter, Inc. (USA)

Table 111: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 112: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 113: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

10. Becton Dickinson and Company (USA)

Table 114: Half Yearly Sales Analysis by Quarters: 2005-2006 (H1) (In US$ million)

Table 115: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million)

Table 116: Quarterly Sales Analysis: 2004-2005 (In US$ million)

Table 117: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million)

Table 118: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

11. bioLytical™ Laboratories, Inc. (Canada)

12. Biomerica, Inc. (USA)

Table 119: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million):

Table 120: Half Yearly Sales Analysis by Business Segment: 2005-2006 (In US$ million)

Table 121: Half yearly Sales Analysis by Geographic Region: 2005-2006 (In US$ million)

Table 122: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million)

Table 123: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

13. bioMerieux SA (France)

Biomerieux Vitek, Inc. (USA)

14. Bionor AS (Norway)

15. Bio-Rad Laboratories, Inc. (USA)

Table 124: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)

Table 125: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 126: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 127: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

16. Biotest AG (Germany)

Biotest Diagnostics Corporation (USA)

17. Calypte Biomedical Corporation (USA)

Table 128: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million)

18. Capricorn Products, Inc. (USA)

19. Celera Diagnostics (USA)

20. Cell Sciences, Inc. (USA)

21. CEL-SCI Corporation (USA)

Table 129: Nine Months Sales Analysis by Quarter: 2005-2006 (Nine Months ended, June) (In US$ thousand)

22. Chembio Diagnostics, Inc. (USA)

23. Cliniqa Corporation (USA)

24. Dade Behring, Inc. / Dade Behring Holdings, Inc. (USA)

Table 130: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million)

Table 131: Half Yearly Sales Analysis by Geographic Region: 2005-2006 (H1) (In US$ million)

Table 132: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 133: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 134: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

25. Digene Corporation (USA)

Table 135: Nine Months Sales Analysis: 2005-2006 (Nine Months Ended March) (In US$ million)

Table 136: Annually Sales Analysis by Quarter: 2004-2005 (In US$ million)

26. Exonix, Inc. (USA)

27. Exportrade Corporation (USA)

28. Genelabs Technologies, Inc. (USA)

Table 137: Half-Year Sales Analysis: 2005-2006 (H1) (In US$ thousands)

Table 138: Quarterly Sales Analysis: 2004-2005 (In US$ thousands)

29. Gen-Probe, Inc. (USA)

Table 139: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million)

Table 140: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 141: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

30. Hemagen Diagnostics, Inc. (USA)

Table 142: Half Yearly Sales Analysis by Geographic Region: 2005-2006 (H1) (In US$ million)

Table 143: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

31. Immuno Concepts NA, Ltd. (USA)

32. Innogenetics NV (Belgium)

33. Invitrogen Corporation (USA)

Table 144: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million)

Table 145: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 146: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

34. LabNow, Inc. (USA)

35. Medical Services International (Canada)

36. MedMira Laboratories, Inc. (Canada)

37. Monogram Biosciences, Inc. (USA)

Table 147: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 148: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

38. Novartis Vaccines & Diagnostics (USA)

39. Orasure Technologies, Inc. (USA)

Table 149: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million)

Table 150: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million)

Table 151: Half Yearly Sales Analysis by Geographic Region: 2005-2006 (H1) (In US$ million)

Table 152: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 153: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 154: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

40. Orgenics Ltd. (Israel)

41. Ortho-Clinical Diagnostics (USA)

42. Roche Diagnostics (Schweiz) AG (Switzerland)

Roche Diagnostics Corporation (USA)

43. Rockeby Biomed (Singapore) Pte., Ltd. (Singapore)

44. Saliva Diagnostic Systems, Inc. (USA)

45. Scimedx Corporation (USA)

46. SeraCare Life Sciences, Inc. (USA)

47. Shanghai Kehua Bio-Engineering Co.,Ltd. (China)

48. Tecan Trading AG (Switzerland)

49. Tecan US, Inc. (USA)

50. The Binding Site Ltd. (UK)

51. Theratechnologies, Inc. (Canada)

52. Trinity Biotech Plc (Ireland)

Table 155: First Quarter Sales Analysis by Product Line: 2005-2006 (In US$ million)

Table 156: First Quarter Sales Analysis by Geographic Region: 2005-2006 (In US$ million)

Table 157: Annual Sales Analysis by Product Line: 2004-2005 (In US$ million)

Table 158: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

53. Tulip Group - Qualpro Diagnostics (India)

54. United Biomedical, Inc. (USA)

55. ZeptoMetrix Corporation (USA)

56. Zeus Scientific, Inc. (USA)

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