Global HIV/AIDS Testing Industry

• Publication date: October 2010

This report analyzes the worldwide markets for HIV/AIDS Testing in US$ Million by the following product segments: 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 estimates and forecasts are provided for the period 2007 through 2015. A seven-year historic analysis is al...

This report analyzes the worldwide markets for HIV/AIDS Testing in US$ Million by the following product segments: 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 estimates and forecasts are provided for the period 2007 through 2015. A seven-year historic analysis is also provided for these markets.The report profiles 63 companies including many key and niche players such as Abbott Laboratories Inc., Abbott Molecular Inc., Adaltis S.r.l., 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., Roche Diagnostics, and Siemens Healthcare Diagnostics, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

Global Diagnostics Industry

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


CONTENTS


1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation & Reporting Level 2
Quantitative Techniques & Analytics 3
Product Definitions and Scope of Study 3
Definitions 3
HIV/AIDS Screening Tests 3
HIV/AIDS Confirmatory Tests 3
HIV/AIDS Monitoring Tests 4

2. INDUSTRY OVERVIEW 5
Recession & Healthcare Industry 5
Impact on Testing Market 5
IVD Market: Growth Despite Recession 5
AIDS Testing, Treatment and Services - An Insight 6
Worldwide HIV/AIDS Testing Market - An Analysis 6
Regional Analysis 7
Segment Analysis 7
HIV/AIDS Screening 7
Confirmatory Test Market 8
HIV/AIDS Monitoring Market 8
Growth Drivers 8
Rapid HIV Tests - Vast Growth Potential 9
New HIV Assays to Fuel Growth 9
Home Testing to Gain Strength 10
Molecular Diagnostics Register Strong Growth in Blood
Screening Markets 10
Ultra-Rapid HIV-screening Tests- A Strong Fight against HIV-
Epidemic 10
Emergency Room Testing to Help HIV Diagnosis 10
OTC HIV Tests to See The Light? 11
Leading Players 11
FDA Approved Rapid Test Kits 12
HIV/AIDs Diagnostics Market Participants - Product Matrix 12

3. AIDS: A GLOBAL EPIDEMIC 14
AIDS - A Serious Threat 14
Facts & Figures 14
Table 1: HIV/AIDS Statistics Worldwide: End-2008 (includes
corresponding Graph/Chart) 15

Table 2: Worldwide Living Population Infected with HIV/AIDS
(2008-End) (includes corresponding Graph/Chart) 15

Table 3: Worldwide HIV & AIDS Incidences (End-2008):
Percentage Share Breakdown of Living and Newly Infected
Cases by Region (includes corresponding Graph/Chart) 16
Table 4: Worldwide Deaths Due to AIDS (2008-End) (includes
corresponding Graph/Chart) 16
Table 5: HIV/AIDS Cases in Adults and Children Worldwide:
Breakdown by Region-End 2008 17
Table 6: HIV Prevalence (%) in Adults (15-49 years) (
includes corresponding Graph/Chart) 17
New HIV Infections in Young People 18
Anti-AIDS Therapeutics: A Blessing in Disguise in Developed
Countries 18

4. UNDERSTANDING THE DISEASE 19
Mechanism of Action 19
Symptoms 20
Full-Blown AIDS 21
Transmission of HIV 22
On the Brighter Side 22
HIV Therapy 22
The Search Continues 23
Infection Process - Targets for HIV Therapy 23

5. DIAGNOSIS OF HIV/AIDS 24
Testing: The Basis for AIDS Prevention and Treatment 24
Blood Processing 24
The Earliest Time to Detect Infection 24
Testing Plagued by Problems Such As 25
Major Drawbacks of Laboratory Diagnosis of HIV Infections 25
Rapid Tests - Suitable for Developing Countries 25

6. HIV TESTS 26
Testing Subject to Strict Rules 26
Diagnostic Tests 26
I. Antibody Tests 26
A. HIV-1 Screening Tests 26
Test Methodology 27
a. Enzyme-linked Immunosorbent Assays/Enzyme Immunoassays
(ELISA/EIA) 27
b. Home AccessHIV-1 test system/Dried Blood Spot 28
c. Rapid Tests 29
Generic Assay Formats in Rapid Test 29
The Dot Blot Rapid Test 29
Agglutination Tests 30
Solid Phase Test 30
Immunochromatographic strip (ICS) Tests 30
Rapid Serological Tests Vs. ELISA Tests 30
B. HIV-1 Antibody Confirmatory Tests 31
a. The Western Blot Test 31
Commonly Used in Developed Countries 31
Interpretation of Results 32
Modified Western Blots 32
b. Indirect Immunofluorescent Antibody Assay (IFA) 32
c. Line Immunoassay 33
d. Radioimmunoprecipitation Assay (RIPA) 33
C. HIV-2 Diagnostic Tests and HIV Group “O 33
Testing Protocols 34
Types of Antibody Tests Based on Sample 34
i. Traditional Blood Antibody Tests 34
ii. Dried Blood Spot (DBS) Sampling Technique 34
Blood Tests Are Highly Expensive 34
iii. Other Alternatives in Samples 35
Oral Testing for HIV 35
Urine Tests 35
II. Viral Identification Assays 35
A. p24 Antigen Test 35
B. Qualitative PCR Tests 36
C. Viral Culture 36
Monitoring Tests 36
A. Lymphocyte Analysis 37
B. Viral Load Tests 37
Indicator of Successful Therapy 38
Levels of CD4 and Viral Load in AIDS 38
C. Drug Resistance Tests 38
Main Types 38
i. Genotyping Tests 39
ii. Phenotyping Tests 39
Molecular Diagnostics and Gene Detection Products 39
DNA Probe-Based Products 39
Direct Assays 39
Amplification 40
Amplification Methodologies 40

7. TECHNOLOGY REVIEW 41
PCR: A Promising Development in HIV/AIDS Monitoring Market 41
DNA Probes are Highly Specific and Sensitive 41
OCA-particles Based Detection System-Offers Increased Accuracy 41
Home HIV Tests: Unfolding a New Era of Testing 41
Yet Nascent 41
Not Without Share of Objections 42
Home Access: Monopolizing the Home HIV Test Kit Market 42
Drawbacks of Blood-Based Tests 42

8. REGULATIONS 43
Overview 43
UN’s Testing Policies in Peacekeeping Force 43
Anonymous Versus Confidential Diagnostic Testing for HIV
infection in US 43
Regulatory Approval for Rapid HIV Test Kits in US 43
HIV Testing - Mandatory in US Blood Banks 44

9. NEW PRODUCT APPROVALS & LAUNCHES 45
BioMérieux Launches New HIV Test 45
Quest Diagnostics Releases HIV-1 Coreceptor Tropism Test 45
Avioq Wins FDA Clearance for HIV-1 Microelisa System 46
FDA Approves Ortho Clinical Diagnostics’ Diagnostic Assay 46
FDA Approves Abbott’s HIV Virus Screening Test 47

10. PRODUCT INTRODUCTIONS/INNOVATIONS IN RECENT PAST -
A PERSPECTIVE BUILDER 48
MedMira Secures Approval for Multiplo Triple Test 48
Calypte Launches Aware Messenger™ 48
Abbott Launches Advanced Viral Load Test 48
MedMira Launches MiraCare™ Rapid Tests with Extended Shelf Life 48
University Researcher Develops Novel HIV/AIDs Antibody Test Kit 49
bioMérieux Introduces VIKIA® HIV 1 / 2 Rapid HIV Test 49
Dr Lal Pathlabs Develops Inexpensive HIV Monitoring Test 49
MedMira to Launch Multiplo™ Rapid HIV/HCV Antibody Test 49
Shanghai Kehua Develops New HIV/AIDS Test Kit for Faster
Diagnosis 49
INSTI™ HIV Test Kit from bioLytical™ Receives European CE Mark 50
Rockeby Biomed Gains Approval from MOH to Sell OraQuick across
Singapore 50
FDA Approves Chembio’s Rapid HIV Tests for Sale in the US 50
MiraWell Whole Blood Rapid HIV Test Receives Approval from
China SFDA 50
MiraCare Rapid HIV Antibody Test Receives CE Mark 51
Calypte Receives Approval for Marketing Aware Rapid HIV Tests
in Kenya 51
FDA Approves Bayer’s Automated HIV Antibody Test Product 51
SA Government Approves Marketing of Calypte’s Aware OMT HIV
Test Product 52
Calypte Introduces OTC Version of Aware HIV Test in UAE 52
Roche Obtains European Union’s CE Mark for its cobas TaqScreen
MPX Test 52

11. RECENT INDUSTRY ACTIVITY 53
Spartan Collaborates with Cooperative Diagnostics for PCR
Testing for HIV/AIDS 53
MedMira Inks Private Label Deal with Swiss Partner 53
MedMira Expands Deal with AHD and Forays into Southeast Asian
Markets 54
MedMira Bags Supply Contract from PAHO 54
MedMira Seeks Patent for Latest Rapid Test Platform 54
Abbott Attains Supplemental FDA Approval for RealTime HIV- 1
Viral Load Test 54
USCDC Awards Federal Grant to District of Columbia for HIV
Testing 54
Premier Includes Roche COBAS HIV-1 Monitoring Test in Contract 55
MedMira Receives USAID Approval for Reveal G3 Rapid HIV Test 55
Calypte Biomedical Inks Agreement with Fusion Capital 55
Roche Inks Agreement with Clinton Foundation 56
Ortho-Clinical Attains FDA Approval for HIV Test 56
Geneart Awarded Patent for HIV Vaccine 56
Crucell’s Adenovirus Vector Enters Phase I Clinical Studies 56
MedMira to Expand Operations in Eastern Europe 57
Calypte Initiates Sale of Aware™ HIV-1/2 OMT Oral Fluid Test
in India 57
Calypte Receives Approval for Aware HIV-1/2 OMT Test 57
Bundi Opts for SurgiLance Safety Lancet 58
Chembio Diagnostics Receives Sublicense for HIV-2 Patent 58

12. CORPORATE ACTIVITY IN RECENT PAST - A PERSPECTIVE BUILDER 59
Calypte Receives USAID Approval 59
Roche’s Latest HIV-1 Test Receives FDA Approval 59
OraQuick ADVANCE Becomes Preferred HIV Test kit in Philadelphia 59
Beckman Coulter Receives Grant 59
Oregon Medical Adopts Roche Diagnostics' HIV Test 60
OraSure Inks Agreement with Supply Chain Management System 60
Bio-Rad Enters into Multi-Year Agreements with Quest Diagnostics 60
CytoDyn Pockets Advanced Genetic Technologies 60
Aethlon Partners with ImQuest 61
Quest Diagnostics Receives License from Pathway 61
OraSure Inks Agreement with Constella Group 61
LabCorp to Offer Fully Automated Real-Time HIV Test of Roche
Diagnostics 61
Abbott Receives FDA Approval for RealTime HIV-1 Test 62
Abbott Receives Health Canada Approval 62
Novartis Receives Health Canada Approval 62
Medical Services Completes Trials of VScan Hepatitis C and HIV
Test Kit 62
Health Canada Approves Versant 440 Molecular Systems 62
OraSure Receives CE Mark for OraQuick ADVANCE HIV Test 63
MedMira Receives Approval for Multiplo HBV/HIV/HCV 63
Roche Diagnostics Partners with ARK Diagnostics 63
Roche’ HIV Viral Load Test Used In Clinical Trials 63
Innogenetics and Bio-Rad Ink Licensing Agreement 63
OraSure Bags Contract From Madagascar Government 63
Calypte Receives Approval for Aware(TM) HIV-1/2 OMT Rapid Test 64
Siemens Acquires Bayer Diagnostics 64
Gen-Probe’s HIV Test Receives FDA Approval 64
Bayer Receives FDA Approval for Automated HIV Test 64
Inverness Receives Marketing Rights for Rapid HIV Test 64
Clinton Foundation Inks Agreement with Guava Technologies 64
MedMira Inks Distribution Agreement with Voden 65
Roche Bags CE Mark certification 65
Chembio Diagnostics Bags Major Contract 65
Calypte Receives Approval for HIV Test 65
Medical Services Expands Distribution Channel in South Africa 65
Rockeby Receives Approval from Singaporean Ministry of Health 66
MedMira Receives SFDA Approval 66
Roche Adopts Primagen’s DFS Technology 66
Calypte and Mineseeker to Supply Aware™ AIDS Test Kit Across
Africa 66
OraSure Bags US$6 Million Order to Deliver HIV Test Kits 66
Trinity Biotech Enters into Agreement to Deliver Uni- Gold HIV
Test Kits to PPFA 67
Trinity Biotech Delivers Uni-Gold™ Rapid HIV Test to 340B
Prime Vendor Program 67
MedMira Bags Order from Exportrade for MiraWell Rapid HIV Tests 67
OraSure Receives Bulk Order for Rapid HIV Tests from CDC 68
MedMira Bags Order from Spree Trading for MiraWell Rapid HIV
Tests 68
IRIS Acquires Leucadia with Plans to Introduce HIV & Cancer
Testing Products 68
Clindia to Distribute MiraCare Rapid HIV Test in the Netherlands 68
MedMira Bags Order from Goodman Medical 69
bioMérieux Bags Contract to Provide Equipment for HIV Viral
Load Measurement 69
Novartis Acquires Chiron to Create a New Diagnostics &
Vaccines Division 69
Abbott Enters into Agreement with Novation for Supplying
OraQuick® ADVANCE™ HIV Tests 69
Roche Diagnostics Enters into Three-Year Agreement with
Premier to Deliver Molecular Products 70
MedMira Bags Order to Deliver MiraCare™ HIV Tests Across Europe 70

13. FOCUS ON SELECT GLOBAL PLAYERS 71
Abbott Laboratories, Inc. (USA) 71
Abbott Molecular, Inc. (USA) 71
Adaltis S.r.l. (Italy) 71
Biomérieux SA (France) 71
Bio-Rad Laboratories, Inc. (USA) 72
Calypte Biomedical Corporation (USA) 72
Celera Group (USA) 72
Gen-Probe, Inc. (USA) 73
Innogenetics NV (Belgium) 73
MedMira Laboratories, Inc. (Canada) 73
Medical Services International Inc. (Canada) 74
OraSure Technologies, Inc. (USA) 74
Ortho-Clinical Diagnostics, Inc. (USA) 74
Roche Diagnostics (Switzerland) 75
Siemens Healthcare Diagnostics, Inc. (USA) 75

14. GLOBAL MARKET PERSPECTIVE 76
Unit Analytics 76
Table 7: 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 2007 through 2015
(includes corresponding Graph/Chart) 76

Table 8: World Historic Review 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 2006 (includes corresponding
Graph/Chart) 77

Table 9: World 11-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 2005, 2010 &
2015 (includes corresponding Graph/Chart) 78

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 2007 through 2015
(includes corresponding Graph/Chart) 79

Table 11: World Historic Review 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 2006 (includes
corresponding Graph/Chart) 80

Table 12: World 11-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
2005, 2010 & 2015 (includes corresponding Graph/Chart) 81

Table 13: 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 2007
through 2015 (includes corresponding Graph/Chart) 82

Table 14: World Historic Review 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 2006 (includes
corresponding Graph/Chart) 83

Table 15: World 11-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
2005, 2010 & 2015 (includes corresponding Graph/Chart) 84
Dollar Analytics 85
Table 16: 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 2007 through 2015
(includes corresponding Graph/Chart) 85

Table 17: World Historic Review 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 2006 (includes corresponding
Graph/Chart) 86

Table 18: World 11-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 2005, 2010 &
2015 (includes corresponding Graph/Chart) 87

Table 19: World Recent Past, Current & Future Analysis 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 2007 through 2015
(includes corresponding Graph/Chart) 88

Table 20: World Historic Review 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 2000 through 2006 (includes
corresponding Graph/Chart) 89

Table 21: World 11-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
2005, 2010 & 2015 (includes corresponding Graph/Chart) 90

Table 22: 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 2007
through 2015 (includes corresponding Graph/Chart) 91

Table 23: World Historic Review 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 2006 (includes
corresponding Graph/Chart) 92

Table 24: World 11-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
2005, 2010 & 2015 (includes corresponding Graph/Chart) 93

Table 25: 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 2007 through 2015
(includes corresponding Graph/Chart) 94

Table 26: World Historic Review 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 2006 (includes
corresponding Graph/Chart) 95

Table 27: World 11-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
2005, 2010 & 2015 (includes corresponding Graph/Chart) 96

15. THE UNITED STATES 97
A.Market Analysis 97
Outlook 97
Rapid HIV Tests Display Rapid Growth 97
FDA Approved Rapid Test Kits 98
NAT Tests Score High in Blood Banks 98
HIV/AIDS Stats 98
Table 28: Percentage of HIV/AIDS Cases in the US, by
Gender: 1993-2029 (includes corresponding Graph/Chart) 99

Table 29: AIDS Diagnoses in the US (2005): Breakdown by
Ethnic Groups/Race (includes corresponding Graph/Chart) 99
Major End-Users of HIV/AIDS Tests 100
HIV Testing Made Mandatory in Blood Banks 100
Home HIV Tests 100
Efforts by Organizations 101
FDA Approved HIV/AIDS Tests in the US Market (2006-2009) 101
FDA Approved HIV/AIDS Tests in the US market (1998-2004) 102
Competitive Structure 104
Historic Market Share Data 105
Table 30: Leading Players in the HIV Diagnostics Market in
the US (2005): Percentage Share Breakdown of Value Sales
for Abbott Laboratories, Bio-Rad, BioMerieux, Ortho
Clinical Diagnostics and Others (includes corresponding
Graph/Chart) 105

Table 31: Leading Players in HIV Viral Load Testing Market
in the US (2005): Percentage Share Breakdown of Value
Sales Roche, Bayer, and Others (includes corresponding
Graph/Chart) 105
B.Market Analytics 106
Table 32: 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
2007 through 2015 (includes corresponding Graph/Chart) 106

Table 33: US Historic Review 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 2006 (includes
corresponding Graph/Chart) 107

Table 34: US 11-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 2005, 2010 & 2015 107

Table 35: 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 2007 through 2015
(includes corresponding Graph/Chart) 108

Table 36: US Historic Review 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 2006 (includes corresponding Graph/Chart) 109

Table 37: US 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 109

16. CANADA 110
A.Market Analysis 110
Outlook 110
AIDS/HIV: Some Facts & Figures 110
Table 38: AIDS Cases in Canada by Ethnic Status: 2002 -
2006 (includes corresponding Graph/Chart) 111
HIV Statistics 111
Table 39: HIV Statistics for Canada by Exposure Category:
2008 (includes corresponding Graph/Chart) 112

Table 40: AIDs and Positive HIV Cases in Canada by Age
Group: 2006-End (includes corresponding Graph/Chart) 113
HIV Incidence Among Women 113
B.Market Analytics 114
Table 41: 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
2007 through 2015 (includes corresponding Graph/Chart) 114

Table 42: Canadian Historic Review 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
2006 (includes corresponding Graph/Chart) 115

Table 43: Canadian 11-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 2005, 2010 & 2015 115

Table 44: 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 2007 through 2015
(includes corresponding Graph/Chart) 116

Table 45: Canadian Historic Review 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 2006 (includes corresponding
Graph/Chart) 117

Table 46: Canadian 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 117

17. JAPAN 118
Market Analysis 118
Table 47: 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
2007 through 2015 (includes corresponding Graph/Chart) 118

Table 48: Japanese Historic Review 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
2006 (includes corresponding Graph/Chart) 119

Table 49: Japanese 11-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 2005, 2010 & 2015 119

Table 50: 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 2007 through 2015
(includes corresponding Graph/Chart) 120

Table 51: Japanese Historic Review 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 2006 (includes corresponding
Graph/Chart) 121

Table 52: Japanese 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 121

18. EUROPE 122
A.Market Analysis 122
Outlook 122
Regional Analysis 122
Segment Analysis 122
AIDs/HIV Stats - A Review 122
Western Europe 123
Table 53: HIV/AIDS Prevalence in Western Europe: Facts and
Figures by Country (2007) (includes corresponding Graph/
Chart) 123
Central Europe 123
Table 54: HIV/AIDS Prevalence in Central Europe: Facts and
Figures by Country (2007) 124
Table 55: HIV Diagnosis in Central Europe: Facts and
Figures by Country(2006) (includes corresponding
Graph/Chart) 124
E astern Europe 125
Table 56: HIV/AIDS Prevalence in Eastern Europe: Facts and
Figures by Country (2007) 125
Table 57: HIV Diagnosis in Eastern Europe: Facts and
Figures by Country (2006) (includes corresponding
Graph/Chart) 126
Regulations 127
Antenatal HIV Testing in Europe 127
Finland 127
Germany 127
Luxembourg 127
Sweden 127
B.Market Analytics 128
Unit Analytics 128
Table 58: 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 2007 through 2015 (includes corresponding
Graph/Chart) 128

Table 59: European Historic Review 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 2006
(includes corresponding Graph/Chart) 129

Table 60: European 11-Year Perspective for HIV/AIDS Testing
by Geographic Region - Percentage Breakdown of Unit Sales
for France, Germany, Italy, UK, Spain, and Rest of Europe
Markets for Years 2005, 2010 & 2015 (includes corresponding
Graph/Chart) 130

Table 61: 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
2007 through 2015 (includes corresponding Graph/Chart) 131

Table 62: European Historic Review 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
2006 (includes corresponding Graph/Chart) 131

Table 63: European 11-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 2005, 2010 & 2015 132
Dollar Analytics 133
Table 64: 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 2007 through 2015 (includes
corresponding Graph/Chart) 133

Table 65: European Historic Review 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 2006
(includes corresponding Graph/Chart) 134

Table 66: European 11-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 2005, 2010 & 2015 (includes corresponding
Graph/Chart) 135

Table 67: 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 2007 through 2015
(includes corresponding Graph/Chart) 136

Table 68: European Historic Review 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$
Million for Years 2000 through 2006 (includes corresponding
Graph/Chart) 137

Table 69: European 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 137

18a. FRANCE 138
Market Analysis 138
Table 70: 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
2007 through 2015 (includes corresponding Graph/Chart) 138

Table 71: French Historic Review 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
2006 (includes corresponding Graph/Chart) 139

Table 72: French 11-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 2005, 2010 & 2015 139

Table 73: 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 2007 through 2015
(includes corresponding Graph/Chart) 140

Table 74: French Historic Review 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 2006 (includes corresponding
Graph/Chart) 141

Table 75: French 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 141

18b. GERMANY 142
Market Analysis 142
Table 76: 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
2007 through 2015 (includes corresponding Graph/Chart) 142

Table 77: German Historic Review 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
2006 (includes corresponding Graph/Chart) 143

Table 78: German 11-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 2005, 2010 & 2015 143

Table 79: 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 2007 through 2015
(includes corresponding Graph/Chart) 144

Table 80: German Historic Review 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 2006 (includes corresponding
Graph/Chart) 145

Table 81: German 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 145

18c. ITALY 146
A.Market Analysis 146
Outlook 146
Few Facts 146
Table 82: HIV/AIDS Prevalence Rates by Age Group in Italy:
End of 2007 (includes corresponding Graph/Chart) 146
B.Market Analytics 147
Table 83: 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
2007 through 2015 (includes corresponding Graph/Chart) 147

Table 84: Italian Historic Review 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
2006 (includes corresponding Graph/Chart) 148

Table 85: Italian 11-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 2005, 2010 & 2015 148

Table 86: 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 2007 through 2015
(includes corresponding Graph/Chart) 149

Table 87: Italian Historic Review 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 2006 (includes corresponding
Graph/Chart) 150

Table 88: Italian 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 150

18d. THE UNITED KINGDOM 151
A.Market Analysis 151
Outlook 151
Trends in HIV and AIDS Statistics 151
Table 89: HIV Diagnoses in the UK by Exposure Category:
1995 Till June 2007 (includes corresponding Graph/Chart) 152

Table 90: HIV Cases in the UK: Breakdown by Age Group Till
June 2009 (includes corresponding Graph/Chart) 152
B.Market Analytics 153
Table 91: 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
2007 through 2015 (includes corresponding Graph/Chart) 153

Table 92: UK Historic Review 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 2006 (includes
corresponding Graph/Chart) 154

Table 93: UK 11-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 2005, 2010 & 2015 154

Table 94: 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 2007 through 2015
(includes corresponding Graph/Chart) 155

Table 95: UK Historic Review 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 2006 (includes corresponding Graph/Chart) 156

Table 96: UK 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 156

18e. SPAIN 157
Market Analysis 157
Table 97: 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
2007 through 2015 (includes corresponding Graph/Chart) 157

Table 98: Spanish Historic Review 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
2006 (includes corresponding Graph/Chart) 158

Table 99: Spanish 11-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 2005, 2010 & 2015 158

Table 100: 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 2007 through 2015
(includes corresponding Graph/Chart) 159

Table 101: Spanish Historic Review 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 2006 (includes corresponding
Graph/Chart) 160

Table 102: Spanish 11-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 2005, 2010 & 2015
(includes corresponding Graph/Chart) 160

18f. REST OF EUROPE 161
A.Market Analysis 161
Outlook 161
AIDS Review 161
Austria 161
Russia 162
Ukraine 162
Other European Countries 162
B.Market Analytics 163
Table 103: 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 2007 through 2015 (includes corresponding
Graph/Chart) 163

Table 104: Rest of Europe Historic Review 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 2006 (includes corresponding Graph/Chart) 164

Table 105: Rest of Europe 11-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 2005, 2010 & 2015 164

Table 106: 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 2007 through 2015
(includes corresponding Graph/Chart) 165

Table 107: Rest of Europe Historic Review 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 2006 (includes
corresponding Graph/Chart) 166

Table 108: Rest of Europe 11-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 2005, 2010 &
2