【レポートの概要（一部）】
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 9
2.1 What Is This Report About? 9
3 Definitions of Markets/Categories Covered 10
3.1 In Vitro Diagnostics 10
3.1.1 Infectious Immunology 10
4 Company Snapshot 11
4.1 Key Facts 11
4.2 Company Overview 11
4.3 Financial Performance 11
4.4 SWOT Snapshot 11
4.5 Business Overview 12
4.6 Major Products and Services 13
4.6.1 Overview 13
5 History 14
6 SWOT Analysis 16
6.1 Overview 16
6.2 OraSure Technologies, Inc. Strengths 16
6.2.1 Increase in Current Asset Turnover 16
6.2.2 Broad Product Portfolio 16
6.2.3 Focused Research & Development Activities 17
6.3 OraSure Technologies, Inc. Weaknesses 17
6.3.1 High Dependency on the US Market 17
6.3.2 Low Debt to Equity Ratio 17
6.4 OraSure Technologies, Inc. Opportunities 18
6.4.1 Growing In Vitro Diagnostics Market 18
6.4.2 Strong Pipeline Products 18
6.4.3 Acquisition of DNA Genotek (DNAG) 18
6.5 OraSure Technologies, Inc. Threats 19
6.5.1 Regulatory Environment 19
6.5.2 Industry Consolidation Challenges 19
6.5.3 Intense Competition 19
7 Competitors 20
8 Competative Landscape 21
8.1 In Vitro Diagnostics (Infectious Immunology), Global, Market Share (%), 2011 21
8.2 OraSure Technologies, Inc., In Vitro Diagnostics (Infectious Immunology), by Region, Market Share (2011) 23
8.3 OraSure Technologies, Inc., In Vitro Diagnostics (Infectious Immunology), by Country, Market Share (2011) 25
9 Key Employees 27
10 Key Employee Biographies 28
11 Company Statement 29
12 Locations And Subsidiaries 32
12.1 Head Office 32
12.2 Other Locations & Subsidiaries 32
13 Financial Deals Landscape 33
13.1 OraSure Technologies, Inc., Deals Volume Summary, 2007 to YTD 2012 33
13.2 Partnerships 35
13.2.1 OraSure Technologies Signs Licensing Agreement With Inverness Medical Innovations 35
13.2.2 DNA Genotek Enters Into Distribution Agreement With Abyntek Biopharma 36
13.2.3 OraSure Technologies Enters Into An Agreement With Roche Diagnostics 37
13.2.4 OraSure Technologies Expands Agreement With Schering-Plough 38
13.2.5 OraSure Technologies Enters Into Agreement With Schering-Plough 39
13.3 Equity Offering 40
13.3.1 Orasure Technologies Files Shelf Registration Statement For Public Offering Of Securities For $200 Million 40
13.3.2 OraSure Technologies Completes Public Offering Of Common Stock For $75 Million 41
13.4 Acquisition 43
13.4.1 OraSure Technologies Completes Acquisition Of DNA Genotek 43
14 Recent Developments 45
14.1 Strategy And Business Planning 45
14.1.1 Aug 19, 2010: Amerinet Partners With St. Barnabas-Bronx And OraSure Technologies To Implement Efficient HIV Testing Procedures 45
14.2 Financial Announcements 45
14.2.1 Nov 07, 2012: OraSure Technologies Reports Revenue Of $22.1m In Q3 2012 45
14.2.2 Aug 07, 2012: OraSure Technologies Reports Revenue Of $22.6m In Q2 2012 47
14.2.3 May 02, 2012: OraSure Technologies Reports Revenue Of $20.9m In Q1 2012 47
14.2.4 Feb 08, 2012: OraSure Technologies Reports Revenue Of $81.9m In 2011 48
14.2.5 Nov 02, 2011: OraSure Technologies Reports Revenues Of $21.7m In Q3 2011 49
14.2.6 Aug 03, 2011: OraSure Technologies Reports Revenues Of $19.1m In Q2 2011 51
14.2.7 May 04, 2011: OraSure Technologies Reports Revenues Of $17.4m In Q1 2011 52
14.2.8 Feb 09, 2011: OraSure Technologies Reports Revenues Of $75.01m In 2010 52
14.2.9 Nov 09, 2010: OraSure Reports Net Revenues Of $19.03 Million For Q3 2010 53
14.2.10 Aug 04, 2010: OraSure Reports Net Loss Of $0.5 Million For Q2 2010 54
14.2.11 May 05, 2010: OraSure Technologies Reports Revenues Of $17.9 Million In Q1 2010 55
14.2.12 Feb 10, 2010: OraSure Technologies Reports Revenues Of $77 Million In 2009 55
14.2.13 Nov 04, 2009: OraSure Reports Net Income Of $1.8 Million In Q3 2009 57
14.2.14 Aug 05, 2009: OraSure Technologies Posts Net Loss Of $5.2 Million In Q2 2009 58
14.2.15 May 06, 2009: OraSure Technologies Posts Net Loss Of $1.6 Million In Q1 2009 58
14.2.16 Feb 11, 2009: OraSure Technologies Reports 2008 Results 59
14.2.17 Nov 05, 2008: OraSure Technologies Reports 3Q 2008 Results 61
14.2.18 Aug 05, 2008: OraSure Technologies Reports 2Q 2008 Results 62
14.2.19 May 06, 2008: OraSure Technologies Declares Q1 2008 Results 62
14.2.20 Feb 12, 2008: OraSure Technologies Declares Q4 2007 Results 63
14.2.21 Oct 30, 2007: OraSure Technologies Declares Q3 2007 Results 65
14.2.22 Jul 31, 2007: OraSure Technologies Reports Q2 2007 Results 66
14.2.23 May 08, 2007: OraSure Technologies Reports Q1 2007 Results 66
14.2.24 Feb 13, 2007: OraSure Technologies Reports 2006 Results 67
14.2.25 Nov 01, 2006: OraSure Technologies Reports Q3 2006 Results 68
14.2.26 Aug 08, 2006: OraSure Technologies Reports Q2 2006 Results 69
14.3 Corporate Communications 70
14.3.1 Nov 10, 2011: OraSure Technologies Appoints Gerald M Ostrov To Board 70
14.3.2 Apr 07, 2011: OraSure Appoints Stephen Tang To Board Of Directors 71
14.3.3 Jan 04, 2011: OraSure Appoints Tony Zezzo As New Executive Vice President, Marketing And Sales 71
14.3.4 May 13, 2010: OraSure Technologies Eliminates 18 Positions At Its Bethlehem Plants 72
14.3.5 Sep 10, 2009: OraSure Technologies Appoints Robert Gregg As VP, Regulatory Affairs And Quality Assurance 72
14.3.6 Nov 17, 2008: OraSure Technologies CEO To Present At Lazard Conference 73
14.3.7 Sep 10, 2008: OraSure Technologies Appoints Vice President, International Sales 73
14.3.8 Jan 02, 2008: OraSure Appoints VP, Government And External Affairs 73
14.3.9 Oct 05, 2006: OraSure Technologies Elects New Board Members 74
14.3.10 May 22, 2006: OraSure Technologies Appoints New Board Member 74
14.4 Legal and Regulatory 74
14.4.1 Nov 19, 2009: OraSure Technologies Settles Patent Lawsuit With Inverness Medical And Church & Dwight 74
14.5 Government and Public Interest 75
14.5.1 Nov 21, 2012: OraSure Supports New Routine HIV Screening Recommendations By US Preventive Services Task Force 75
14.5.2 Nov 01, 2011: OraSure Supports AAP Updated Recommendations For Routine HIV Screening For Adolescents 76
14.6 Product News 77
14.6.1 Oct 09, 2012: OraSure Announces Availability Of OraQuick In-Home HIV Test To Consumers Across US 77
14.6.2 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 77
14.6.3 Jun 27, 2012: OraSure Supports Rapid HIV Testing Initiatives In Recognition Of 18th Annual National HIV Testing Day 78
14.6.4 May 18, 2012: OraSure Technologies Issues Statement On CDC Proposed Draft Guidelines For Testing Of Baby Boomers For Hepatitis C 79
14.6.5 May 15, 2012: OraSure’s OraQuick In-Home HIV Test Receives Unanimous Positive Recommendation From FDA Advisory Committee 79
14.6.6 Apr 04, 2012: FDA Sets Date For Advisory Committee On Review Of OraQuick Rapid HIV-1/2 Test 80
14.6.7 Jan 03, 2012: OraSure Makes Final FDA Submission For Approval Of OTC Rapid HIV Test 80
14.6.8 Nov 29, 2011: OraSure Technologies Receives CLIA Waiver For OraQuick HCV Rapid Test 81
14.6.9 Nov 29, 2011: OraSure Technologies Receives CLIA Waiver For OraQuick HCV Rapid Test For Use With Fingerstick Whole Blood And Venous Whole Blood Specimens 82
14.6.10 Aug 09, 2011: OraSure Closes Enrollment In Final Clinical Study For OraQuick Rapid HIV Over-The-Counter Test 82
14.6.11 Mar 23, 2011: OraSure Technologies Submits CLIA Waiver Application For OraQuick HCV Rapid Test 83
14.6.12 Feb 22, 2011: OraSure Technologies Receives FDA Approval For OraQuick HCV Rapid Test Using Fingerstick Whole Blood 83
14.6.13 Jan 11, 2011: OraSure Technologies To Launch OraSure QuickFlu Rapid Flu A+B Test 84
14.6.14 Dec 13, 2010: OraSure Initiates Enrollment In Final Clinical Study For OraQuick Rapid HIV Over-The-Counter Test 84
14.6.15 Nov 22, 2010: OraSure Technologies Receives FDA Approval To Conduct Final Phase Of Clinical Studies For OraQuick OTC HIV Test 85
14.6.16 Aug 04, 2010: OraSure Delays FDA Filing Of Oral Version Of OraQuick HCV Test 85
14.6.17 Jun 25, 2010: OraSure Technologies Receives FDA Approval For OraQuick HCV Rapid Test 85
14.6.18 Jan 07, 2010: OraSure Submits Additional Data For PMA Approval Of OraQuick Rapid HCV Test 86
14.6.19 Dec 15, 2009: OraSure Gains CE Mark Approval For OraQuick Rapid HCV Antibody Test 86
14.6.20 Sep 24, 2009: OraSure Technologies Supplies OraQuick ADVANCE Rapid HIV-1/2 Antibody Test For 36-Months To Premier Purchasing Partners 87
14.6.21 Jan 28, 2009: OraSure Technologies Announces US FDA Approval For OraQuick ADVANCE 12-Month Shelf Life Dating 87
14.6.22 Nov 05, 2008: OraSure Technologies To Sell OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Directly To US Hospitals 88
14.6.23 Nov 04, 2008: OraSure’s Intercept Oral Fluid Drug Test Results Comparable To Urine Drug Screening According To Landmark Five-Year Analysis 88
14.6.24 Oct 28, 2008: OraSure Technologies Files For FDA Approval Of OraQuick Rapid Hepatitis C Test 88
14.6.25 Oct 13, 2008: OraSure Technologies Helps Expand Access To Rapid HIV Testing In Recognition Of National Latino AIDS Awareness Day 89
14.6.26 Feb 11, 2008: Schering-Plough and OraSure Technologies Sign International Collaboration For Rapid Point-of-Care Oral Hepatitis C Test 89
14.6.27 Oct 26, 2005: FDA To Consider Quick HIV Self Test 89
14.7 Product Approvals 90
14.7.1 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 90
14.7.2 Nov 29, 2011: OraSure Technologies Receives CLIA Waiver For OraQuick HCV Rapid Test For Use With Fingerstick Whole Blood And Venous Whole Blood Specimens 90
14.7.3 Feb 22, 2011: OraSure Technologies Receives FDA Approval For OraQuick HCV Rapid Test Using Fingerstick Whole Blood 91
14.7.4 Jun 25, 2010: OraSure Technologies Receives FDA Approval For OraQuick HCV Rapid Test 91
14.7.5 Jan 28, 2009: OraSure Technologies Announces US FDA Approval For OraQuick ADVANCE 12-Month Shelf Life Dating 92
14.8 Clinical Trials 92
14.8.1 Aug 09, 2011: OraSure Closes Enrollment In Final Clinical Study For OraQuick Rapid HIV Over-The-Counter Test 92
14.8.2 Dec 13, 2010: OraSure Initiates Enrollment In Final Clinical Study For OraQuick Rapid HIV Over-The-Counter Test 93
14.8.3 Nov 22, 2010: OraSure Technologies Receives FDA Approval To Conduct Final Phase Of Clinical Studies For OraQuick OTC HIV Test 93
14.8.4 Nov 04, 2008: OraSure’s Intercept Oral Fluid Drug Test Results Comparable To Urine Drug Screening According To Landmark Five-Year Analysis 94
14.9 Other Significant Developments 94
14.9.1 Oct 30, 2012: Hospitals, Healthcare Providers To Benefit From New Premier Agreements For Rapid Diagnostic Test Kits 94
14.9.2 Sep 22, 2009: Meridian Bioscience, OraSure Technologies Sign Agreement With Premier 94
14.9.3 Nov 17, 2008: OraSure Technologies CEO To Present At Lazard Conference 94
15 Appendix 95
15.1 Research Methodology 96
15.2 Secondary Research 96
15.3 Primary Research 96
15.4 Models 97
15.5 Forecasts 97
15.6 Expert Panels 97
15.7 GlobalData Consulting 97
15.8 Currency Conversion 98
15.9 Contact Us 99
15.10 Disclaimer 99
【レポート販売概要】
■ タイトル：OraSure Technologies, Inc.：市場シェア分析■ 英文：OraSure Technologies, Inc. Market Share Analysis
■ 発行日：2013年2月15日
■ 調査会社：GlobalData
■ 商品コード：GDATA403160400
■ 調査対象地域：グローバル
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