World HIV/AIDS Testing Market

World HIV/AIDS Testing Market

This report analyzes the worldwide markets for HIV/AIDS Testing in Millions of US$. The Product segments analyzed include HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World. Annual forecasts are provided for each region for the period of 2000 through 2015. The report profiles 63 companies including many key and niche players worldwide such as Abbott Laboratories Inc., Abbott Molecular Inc., Adaltis Inc., Siemens Healthcare Diagnostics Inc., Biomérieux SA, Bio-Rad Laboratories Inc., Calypte Biomedical Corporation, Celera Group, Gen-Probe, Inc., Innogenetics NV, MedMira Laboratories, Inc., Medical Services International Inc., OraSure Technologies Inc., Ortho-Clinical Diagnostics Inc., and Roche Diagnostics. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

HIV/AIDS TESTING MCP-3401
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Product Definitions and Scope of Study I-3
Definitions I-3
HIV/AIDS Screening Tests I-3
HIV/AIDS Confirmatory Tests I-3
HIV/AIDS Monitoring Tests I-3


II. EXECUTIVE SUMMARY

1. Industry Overview II-1
Worldwide HIV/AIDS Testing Market – An Analysis II-1
Regional Analysis II-1
The US II-1
Asia Pacific II-1
Europe II-1
Majority of HIV Infections Seen in Developing Countries II-2
Segment Analysis II-2
HIV/AIDS Screening II-2
Confirmatory Test Market II-2
HIV/AIDS Monitoring Market II-3
Growth Drivers II-3
Rapid Testing- Displays High Potential II-3
Molecular Diagnostics Register Strong Growth in Blood
Screening Markets II-4
Ultra-Rapid HIV-screening Tests- A Strong Fight against HIV-
Epidemic II-4
Emergency Room Testing to Help HIV Diagnosis II-4
OTC HIV Tests to See The Light? II-4
Leading Players II-5
FDA Approved Rapid HIV Tests II-5
HIV/AIDs Diagnostics Market Participants – Product Matrix II-5

2. Aids: A Global Epidemic II-7
Facts & Figures II-7
Table 1: HIV/AIDS Statistics Worldwide: End-2007 II-7
Table 2: Worldwide Living Population Infected withHIV/ AIDS
(2007-End) (includes corresponding Graph/Chart) II-8

Table 3: Worldwide HIV & AIDS Incidences (End-2007): A
Regional Breakdown for Living and Newly Infected Cases
(includes corresponding Graph/Chart) II-8

Table 4: HIV/AIDS Cases (Living & New Infections) in Adults
and Children Worldwide: Breakdown by Region- End 2007
(includes corresponding Graph/Chart) II-9

Table 5: Worldwide Deaths Due to AIDS (2007-End) (includes
corresponding Graph/Chart) II-9

Table 6: HIV/AIDS Cases in Adults and Children Worldwide:
Breakdown by Region-End 2007 II-10

Table 7: Countries With the Highest Number of People Living
with HIV: 2003 (includes corresponding Graph/Chart) II-11
AIDS : A Serious Threat II-11
Catching them Young II-11
Estimated Number of New HIV Infections in Young People II-11
Anti-AIDS Therapeutics: A Blessing in Disguise in Developed
Countries II-12

3. Understanding the Disease II-13
Mechanism of Action II-13
Symptoms II-14
Full-Blown AIDS II-15
Transmission of HIV II-15
On the Brighter Side II-16
HIV Therapy II-16
The Search Continues II-16
Infection Process - Targets for HIV Therapy II-17

4. Diagnosis of HIV/Aids II-18
Testing: The Basis for AIDS Prevention and Treatment II-18
Blood Processing II-18
The Earliest Time to Detect Infection II-18
Testing Plagued by Problems Such As II-19
Major Drawbacks of Laboratory Diagnosis of HIV Infections II-19
Rapid Tests - Suitable for Developing Countries II-19

5. HIV Tests II-20
Testing Subject to Strict Rules II-20
Diagnostic Tests II-20
I. Antibody Tests II-20
A. HIV-1 Screening Tests II-20
Test Methodology II-21
a. Enzyme-linked Immunosorbent Assays/Enzyme Immunoassays
(ELISA/EIA) II-21
b. Home AccessHIV-1 test system/Dried Blood Spot II-22
c. Rapid Tests II-22
Generic Assay Formats in Rapid Test II-23
The Dot Blot Rapid Test II-23
Agglutination Tests II-23
Solid Phase Test II-24
Immunochromatographic strip (ICS) Tests II-24
Rapid Serological Tests Vs. ELISA Tests II-24
B. HIV-1 Antibody Confirmatory Tests II-24
a. The Western Blot Test II-24
Commonly Used in Developed Countries II-25
Interpretation of Results II-25
Modified Western Blots II-26
b. Indirect Immunofluorescent Antibody Assay (IFA) II-26
c. Line Immunoassay II-26
d. Radioimmunoprecipitation Assay (RIPA) II-26
C. HIV-2 Diagnostic Tests and HIV Group “O II-26
Testing Protocols II-27
Types of Antibody Tests Based on Sample II-27
i. Traditional Blood Antibody Tests II-27
ii. Dried Blood Spot (DBS) Sampling Technique II-28
Blood Tests Are Highly Expensive II-28
iii. Other Alternatives in Samples.. II-28
Oral Testing for HIV II-28
Urine Tests II-28
II. Viral Identification Assays II-29
A. p24 Antigen Test II-29
B. Qualitative PCR Tests II-29
C. Viral Culture II-29
Monitoring Tests II-30
A. Lymphocyte Analysis II-30
B. Viral Load Tests II-31
Levels of CD4 and Viral Load in AIDS II-31
C. Drug Resistance Tests II-31
Main Types II-32
i. Genotyping Tests II-32
ii. Phenotyping Tests II-32
Molecular Diagnostics and Gene Detection Products II-32
DNA Probe-Based Products II-32
Direct Assays II-33
Amplification II-33
Amplification Methodologies II-33

6. Technology Review II-34
PCR: A Promising Development in HIV/AIDS Monitoring Market II-34
DNA Probes are Highly Specific and Sensitive II-34
OCA-particles Based Detection System-Offers Increased Accuracy II-34
Home HIV Tests: Unfolding a New Era of Testing II-34
Yet Nascent II-34
Not Without Share of Objections II-35
Home Access: Monopolizing the Home HIV Test Kit Market II-35
Drawbacks of Blood-Based Tests II-35

7. Regulations II-36
Overview II-36
UN’s Testing Policies in Peacekeeping Force II-36
Anonymous Versus Confidential Diagnostic Testing for HIV
infection in US II-36
Regulatory Approval for Rapid HIV Test Kits in US II-36
HIV Testing - Mandatory in US Blood Banks II-37

8. New Product Approvals & Launches II-38
Calypte Launches Aware Messenger™ II-38
Abbott Launches Advanced Viral Load Test II-38
MedMira Launches MiraCare™ Rapid Tests with Extended Shelf Life II-38
University Researcher Develops Novel HIV/AIDs Antibody Test Kit II-38
bioMérieux Introduces VIKIA® HIV 1 / 2 Rapid HIV Test II-38
Dr Lal Pathlabs Develops Inexpensive HIV Monitoring Test II-39
MedMira to Launch Multiplo™ Rapid HIV/HCV Antibody Test II-39
Shanghai Kehua Develops New HIV/AIDS Test Kit for Faster
Diagnosis II-39
INSTI™ HIV Test Kit from bioLytical™ Receives European CE Mark II-39
Rockeby Biomed Gains Approval from MOH to Sell OraQuick across
Singapore II-39
FDA Approves Chembio’s Rapid HIV Tests for Sale in the US II-40
MiraWell Whole Blood Rapid HIV Test Receives Approval from
China SFDA II-40
MiraCare Rapid HIV Antibody Test Receives CE Mark II-40
Calypte Receives Approval for Marketing Aware Rapid HIV Tests
in Kenya II-40
FDA Approves Bayer’s Automated HIV Antibody Test Product II-41
SA Government Approves Marketing of Calypte’s Aware OMT HIV
Test Product II-41
Calypte Introduces OTC Version of Aware HIV Test in UAE II-41
Roche Obtains European Union’s CE Mark for its cobas TaqScreen
MPX Test II-41
MedMira Registers Rapid HIV/ADIS Test Products for Latin
American Market II-42
bioLytical Gains Health Canada’s Approval for Marketing INSTI
HIV Test Kit II-42
Calypte’s Aware BSP HIV 1/2 Test Product Receives Malaysian
Government’s Clearance II-42
FDA Approves Upgrades to Reveal G2 Rapid HIV Test II-42
MedMira Introduces OTC Version of MiraCare in Select Asian
Markets II-42
Calypte Includes Dried Blood Specimen-Based Testing Capability
into HIV-1 BED Incidence EIA Test II-43
Calypte’s Aware™ HIV-1/2 BSP Approved for Marketing in Zimbabwe II-43
FDA Approves Rockville Facility for Manufacturing HIV-1 Urine
EIA Screening Test II-43
OraSure Introduces OraQuick ADVANCE Rapid HIV Test in Mexico II-43
Adaltis Develops Advanced Detect-HIV™ Test for Early
Detection of HIV Infection II-44
Xenomics Develops HIV DNA Detection Technology II-44
Abbott and Celera Diagnostics Receive CE Certification II-44
Bio-Rad Receives FDA Approval for HIV-1& HIV 2 Rapid Test II-44
FDA Approval for MedMira’s Enhanced Rapid HIV Test II-45
Roche Receives CE Mark Certification for Virology Tests II-45
Roche Receives FDA Approval for COBAS AmpliScreen Test II-45
Chembio Diagnostics Launches HIV Stat-Pak Dipstick II-45
Medical Services Develops Next Generation HIV Test Kits II-45
Bio-Rad’s Multispot HIV-1/HIV-2 rapid test Approved by FDA II-46
Abbott Receives CE Mark Certification for PCR Test II-46
Bayer Receives CE Mark Certification for TRUGENE® HIV-1 II-47
MedMira Receives Health Canada Approval for Rapid HIV Test II-47
OraSure Receives FDA Approval for Oral Fluids and Plasma II-47
Roche Receives FDA Approval for Diagnostic Test II-47
Trinity Receives FDA Waiver for Uni-Gold II-47
bioMérieux Unveils VIDAS® HIV Duo Ultra and Duo Quick HIV Tests II-47
OraQuick® Rapid HIV-1/2 Antibody Assay Approved by the FDA II-48
MedMira Launches Reveal™ G2 II-48
OraSure Launches OraQuick® ADVANCE Rapid HIV Test II-48
Celera Diagnostics Obtains FDA Clearance for Enhanced ViroSeq™ II-48
Calypte Unveils HIV-1/2 Oral Fluid Rapid Tests II-49
Bio-Rad’s HIV-1/HIV-2 PLUS O EIA Assay Approved by the FDA II-49
OraQuick HIV-1 Test Approved by FDA for Use with Venuous Whole
Blood II-49
Bio-Rad Receives FDA Approval for HIV-1/HIV- 2 PLUS O Test II-49
Calypte Introduces Urine Based HIV-1 Assay in Africa II-49
China Develops Novel HIV Testing Reagent II-50
Calypte Receives FDA Approval for Western Blot Supplemetary Test II-50

9. Recent Industry Activity II-51
MedMira Bags Supply Contract from PAHO II-51
MedMira Seeks Patent for Latest Rapid Test Platform II-51
Abbott Attains Supplemental FDA Approval for RealTime HIV- 1
Viral Load Test II-51
USCDC Awards Federal Grant to District of Columbia for HIV
Testing II-51
Premier Includes Roche COBAS HIV-1 Monitoring Test in Contract II-52
MedMira Receives USAID Approval for Reveal G3 Rapid HIV Test II-52
Calypte Biomedical Inks Agreement with Fusion Capital II-52
Roche Inks Agreement with Clinton Foundation II-52
Ortho-Clinical Attains FDA Approval for HIV Test II-53
Geneart Awarded Patent for HIV Vaccine II-53
Crucell’s Adenovirus Vector Enters Phase I Clinical Studies II-53
MedMira to Expand Operations in Eastern Europe II-53
Calypte Initiates Sale of Aware™ HIV-1/2 OMT Oral Fluid Test
in India II-54
Calypte Receives Approval for Aware HIV-1/2 OMT Test II-54
Bundi Opts for SurgiLance Safety Lancet II-54
Chembio Diagnostics Receives Sublicense for HIV-2 Patent II-54
Calypte Receives USAID Approval II-55
Roche’s Latest HIV-1 Test Receives FDA Approval II-55
Beckman Coulter Receives Grant II-55
Oregon Medical Adopts Roche Diagnostics' HIV Test II-55
OraSure Inks Agreement with Supply Chain Management System II-56
Bio-Rad Enters into Multi-Year Agreements with Quest Diagnostics II-56
CytoDyn Pockets Advanced Genetic Technologies II-56
Aethlon Partners with ImQuest II-56
Quest Diagnostics Receives License from Pathway II-57
OraSure Inks Agreement with Constella Group II-57
LabCorp to Offer Fully Automated Real-Time HIV Test of Roche
Diagnostics II-57
Abbott Receives FDA Approval for RealTime HIV-1 Test II-57
Abbott Receives Health Canada Approval II-58
Novartis Receives Health Canada Approval II-58
Medical Services Completes Trials of VScan Hepatitis C and HIV
Test Kit II-58
Health Canada Approves Versant 440 Molecular Systems II-58
OraSure Receives CE Mark for OraQuick ADVANCE HIV Test II-58
MedMira Receives Approval for Multiplo HBV/HIV/HCV II-59
Roche Diagnostics Partners with ARK Diagnostics II-59
Roche’ HIV Viral Load Test Used In Clinical Trials II-59
Innogenetics and Bio-Rad Ink Licensing Agreement II-59
OraSure Bags Contract From Madagascar Government II-59
Calypte Receives Approval for Aware(TM) HIV-1/2 OMT Rapid Test II-59
Siemens Acquires Bayer Diagnostics II-59
Gen-Probe’s HIV Test Receives FDA Approval II-60
Bayer Receives FDA Approval for Automated HIV Test II-60
Inverness Receives Marketing Rights for Rapid HIV Test II-60
Clinton Foundation Inks Agreement with Guava Technologies II-60
MedMira Inks Distribution Agreement with Voden II-60
Roche Bags CE Mark certification II-60
Chembio Diagnostics Bags Major Contract II-61
Calypte Receives Approval for HIV Test II-61
Medical Services Expands Distribution Channel in South Africa II-61
Rockeby Receives Approval from Singaporean Ministry of Health II-61
MedMira Receives SFDA Approval II-61
Roche Adopts Primagen’s DFS Technology II-61
Calypte and Mineseeker to Supply Aware™ AIDS Test Kit Across
Africa II-61
OraSure Bags US$6 Million Order to Deliver HIV Test Kits II-62
Trinity Biotech Enters into Agreement to Deliver Uni- Gold HIV
Test Kits to PPFA II-62
Trinity Biotech Delivers Uni-Gold™ Rapid HIV Test to 340B
Prime Vendor Program II-62
MedMira Bags Order from Exportrade for MiraWell Rapid HIV Tests II-63
OraSure Receives Bulk Order for Rapid HIV Tests from CDC II-63
MedMira Bags Order from Spree Trading for MiraWell Rapid HIV
Tests II-63
IRIS Acquires Leucadia with Plans to Introduce HIV & Cancer
Testing Products II-63
Clindia to Distribute MiraCare Rapid HIV Test in the Netherlands II-64
MedMira Bags Order from Goodman Medical II-64
bioMérieux Bags Contract to Provide Equipment for HIV Viral
Load Measurement II-64
Bayer to Divest Diagnostic Division of Bayer Healthcare to
Siemens II-64
Novartis Acquires Chiron to Create a New Diagnostics &
Vaccines Division II-64
Abbott Enters into Agreement with Novation for Supplying
OraQuick® ADVANCE™ HIV Tests II-64
Roche Diagnostics Enters into Three-Year Agreement with
Premier to Deliver Molecular Products II-65
MedMira Bags Order to Deliver MiraCare™ HIV Tests Across Europe II-65
BD Partners with KEMRI to Provide Modern HIV/AIDS Testing Skills II-65
KEMRI Sets Up Facility to Mass Produce AIDS Test Kit for
African Market II-65
MSI Bags Iranian Order for its Rapid VScan HIV/AIDS Test Kits II-66
MSI Inks Contract to Deliver VScan HIV Test Kits Across China II-66
MSI Inks Deals for Delivery of VScan HIV 1 & 2 Test Kits to
Eastern Europe and Taiwan II-66
Abbott and OraSure Enter into Agreement II-66
ViroLogic Offers License to GlaxoSmithKline II-66
Bio-Rad Sublicenses HIV-2 Rapid Test Patent to OraSure II-67
Biotech Cogstate Strikes a Deal with CDC II-67
Calypte Receives CDC License for HIV Incidence Test II-67
Calypte Biomedical Licences Rapid Test HIV-2 Patent from Bio-Rad II-67
OraSure Receives Purchase Order from SAMHSA II-67
Roche Signs Agreement with Pasteur Institute and Bio-Rad II-68
Roche Enters into Agreement with Korean Red Cross II-68
Roche, Dade Behring and Chiron Enters into Licensing Agreement II-68
Hedley and BioLytical Sign Pact II-68

10. Focus on Select Global Players II-69
Abbott Laboratories Inc. (USA) II-69
Abbott Molecular Inc. (USA) II-69
Adaltis Inc. (Canada) II-69
Siemens Healthcare Diagnostics Inc. (USA) II-69
Biomérieux SA (France) II-70
Bio-Rad Laboratories Inc. (USA) II-70
Calypte Biomedical Corporation (USA) II-70
Celera Group (LLC) II-71
Gen-Probe Inc. (USA) II-71
Innogenetics NV (Belgium) II-71
MedMira Laboratories, Inc. (Canada) II-72
Medical Services International Inc. (Canada) II-72
OraSure Technologies Inc. (USA) II-72
Ortho-Clinical Diagnostics Inc. (USA) II-72
Roche Diagnostics (Switzerland) II-73

11. Global Market Perspective II-74
Unit Analytics II-74
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) II-74

Table 9: World Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) II-75

Table 10: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-76

Table 11: 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) II-77

Table 12: World Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) II-78

Table 13: 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
2003, 2008 & 201 (includes corresponding Graph/Chart) II-79

Table 14: 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) II-80

Table 15: World Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) II-81

Table 16: 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
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-82
Dollar Analysis II-83
Table 17: 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) II-83

Table 18: World Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) II-84

Table 19: 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) II-85

Table 20: 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) II-86

Table 21: World Long-term Projections for HIV/AIDS Screening
Tests by Geographic Region – US, Canada,Japan, Europe,
Asia-Pacific (excluding Japan), Latin America & Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Millions for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-87

Table 22: 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
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-88

Table 23: 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) II-89

Table 24: World Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) II-90

Table 25: 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
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-91

Table 26: 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) II-92

Table 27: World Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) II-93

Table 28: 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
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-94


III. MARKET

1. The United States III-1
A.Market Analysis III-1
Market Overview III-1
Dollar Analysis III-1
Unit Analysis III-1
Competitive Structure III-1
Table 29: 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) III-2

Table 30: 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) III-2
Rapid HIV Tests Display Rapid Growth III-3
Leading Players III-3
FDA Approved Rapid Test Kits III-3
NAT Tests Score High in Blood Banks III-3
HIV/AIDS Stats III-4
Table 31: Percentage of HIV/AIDS Cases in the US, by
Gender: 1993-2029 (includes corresponding Graph/Chart) III-4

Table 32: AIDS Diagnoses in the US (2005): Breakdown by
Ethnic Groups/Race (includes corresponding Graph/Chart) III-5

Table 33: HIV Infected Persons in US (2005): Percentage
Breakup by Ethnic Groups (includes corresponding
Graph/Chart) III-5

Table 34: AIDS Cases by Exposure Category in the US: 2005
(includes corresponding Graph/Chart) III-6
Major End-Users of HIV/AIDS Tests III-6
HIV Testing Made Mandatory in Blood Banks III-6
Physician and Public Health Clinical Market III-7
Home HIV Tests III-7
Efforts by Organizations III-7
Vermont Department of Health Suggests HIV Screening for
Pregnant Women III-8
FDA Approved HIV/AIDS Tests in the US market (1998-2004) III-8
Product Launches III-10
Strategic Corporate Developments III-16
Key Players III-25
Abbott Laboratories Inc. III-25
Abbott Molecular Inc. III-26
Bio-Rad Laboratories Inc. III-26
Calypte Biomedical Corporation III-26
Celera Group III-27
Gen-Probe Inc. III-27
OraSure Technologies Inc. III-27
Ortho-Clinical Diagnostics Inc. III-28
Siemens Healthcare Diagnostics Inc. (USA) III-28
B.Market Analytics III-29
Table 35: 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) III-29

Table 36: US Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-29

Table 37: 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 2003, 2008 & 2012 III-30

Table 38: 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) III-31

Table 39: US Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) III-31

Table 40: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-32

2. Canada III-33
A.Market Analysis III-33
Market Overview III-33
AIDS/HIV: Some Facts & Figures III-33
Table 41: AIDS Cases in Canada by Ethnic Status: 2002 –
2006 (includes corresponding Graph/Chart) III-34
Table 42: AIDS Statistics for Canada by Exposure Category
Till June 2007 III-34
HIV Statistics III-35
Table 43: AIDS/ HIV Diagnosis Trend in Canada: 1996-2006
(includes corresponding Graph/Chart) III-35

Table 44: AIDS and Positive HIV Cases in Canada by Age
Group: 2006-End (includes corresponding Graph/Chart) III-36
HIV Incidence Among Women.. III-36
Historical Stats- Late 1990s III-37
Product Launches/Approvals III-37
Strategic Developments III-38
Key Players III-39
Adaltis Inc. III-39
MedMira Laboratories, Inc. III-39
Medical Services International Inc. III-40
B.Market Analytics III-40
Table 45: 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) III-40

Table 46: Canadian Long-term Projections 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 2011
through 2015 (includes corresponding Graph/Chart) III-41

Table 47: 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 2003, 2008 & 2012 III-41

Table 48: 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) III-42

Table 49: Canadian Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) III-42

Table 50: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-43

3. Japan III-44
A.Market Analysis III-44
Market Overview III-44
HIV in Japan III-44
B.Market Analytics III-44
Table 51: 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) III-44

Table 52: Japanese Long-term Projections 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 2011
through 2015 (includes corresponding Graph/Chart) III-45

Table 53: 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 2003, 2008 & 2012 III-45

Table 54: 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) III-46

Table 55: Japanese Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) III-46

Table 56: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-47

4. Europe III-48
A.Market Analysis III-48
Market Overview III-48
Regional Analysis III-48
Segment Analysis III-48
AIDs/HIV Stats – A Review III-48
Western Europe III-49
Table 57: HIV Diagnosis in Western Europe: Facts and
Figures by Country(2006) (includes corresponding
Graph/Chart) III-49
Central Europe III-50
Table 58: HIV Diagnosis in Central Europe: Facts and
Figures by Country(2006) (includes corresponding
Graph/Chart) III-50
Eastern Europe III-51
Table 59: HIV Diagnosis in Eastern Europe: Facts and
Figures by Country (2006) (includes corresponding
Graph/Chart) III-51
Regulations III-52
Antenatal HIV Testing in Europe III-52
Finland III-52
Germany III-52
Luxembourg III-52
Sweden III-52
Product Approvals/Launches III-52
Strategic Developments III-53
B.Market Analytics III-55
Unit Analytics III-55
Table 60: 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) III-55

Table 61: European Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-56

Table 62: 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 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-56

Table 63: 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) III-57

Table 64: European Long-term Projections 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 2011
through 2015 (includes corresponding Graph/Chart) III-57

Table 65: 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 2003, 2008 & 2012 III-58
Dollar Analytics III-59
Table 66: 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) III-59

Table 67: European Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-60

Table 68: 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 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-61

Table 69: 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) III-62

Table 70: European Long-term Projections 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 2011 through 2015 (includes
corresponding Graph/Chart) III-62

Table 71: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-63

4a. France III-64
A.Market Analysis III-64
Market Overview III-64
Key Player III-64
BioMérieux SA III-64
Product Launches III-64
Strategic Corporate Developments III-65
B.Market Analytics III-65
Table 72: 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) III-65

Table 73: French Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-66

Table 74: 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 2003, 2008 & 2012 III-66

Table 75: 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) III-67

Table 76: French Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) III-67

Table 77: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-68

4b. Germany III-69
A.Market Analysis III-69
Market Overview III-69
Few Facts III-69
Strategic Corporate Developments III-69
B.Market Analytics III-70
Table 78: 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) III-70

Table 79: German Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-71

Table 80: 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 2003, 2008 & 2012 III-71

Table 81: 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) III-72

Table 82: German Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) III-72

Table 83: 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) III-73

4c. Italy III-74
A.Market Analysis III-74
Market Overview III-74
Few Facts III-74
Table 84: HIV/ AIDS Prevalence and Mortality Rates by Age
Group in Italy: End of 2003 III-74
Strategic Developments III-75
B.Market Analytics III-75
Table 85: 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) III-75

Table 86: Italian Long-term Projections 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 2011 through
2015 (includes corresponding Graph/Chart) III-76

Table 87: 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 2003, 2008 & 2012 III-76

Table 88: 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) III-77

Table 89: Italian Long-term Projections 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 2011 through 2015 (includes corresponding
Graph/Chart) III-77

Table 90: 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 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-78

4d. The United Kingdom III-79
A.Market Analysis III-79
Market Overview III-79
Trends in HIV and AIDS Statistics III-79
At Risk Groups – A Review III-80
Table 91: HIV and AIDS Cases in the UK: Breakdown by Age
Group and Gender: Till March 2006 (includes corresponding
Graph/Chart) III-80
Table 92: AIDS Statistics for the UK by Exposure Category:
Till June 2007 (includes corresponding Graph/Chart) III-80
B.Market Analytics III-81
Table 93: 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) III-81