単純ヘルペスウイルス診断検査:医療機器パイプライン分析2017

調査会社GlobalData社が発行したリサーチレポート(データ管理コード:GDME0424EPD)
◆英語タイトル:Herpes Simplex Virus Diagnostic Tests - Medical Devices Pipeline Assessment, 2017
◆発行会社/調査会社:GlobalData
◆商品コード:GDME0424EPD
◆発行日:2017年9月1日
◆調査対象地域:グローバル
◆産業分野:医療機器
◆ページ数:143
◆レポート言語:英語
◆レポート形式:PDF
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*** レポート概要(サマリー)***

Herpes Simplex Virus Diagnostic Tests – Medical Devices Pipeline Assessment, 2017
Summary

GlobalData’s Medical Devices sector report, “Herpes Simplex Virus Diagnostic Tests – Medical Devices Pipeline Assessment, 2017″ provides an overview of Herpes Simplex Virus Diagnostic Tests currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Herpes Simplex Virus Diagnostic Tests pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData’s team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Herpes Simplex Virus Diagnostic Tests under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Herpes Simplex Virus Diagnostic Tests and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons to buy

The report enables you to –
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Herpes Simplex Virus Diagnostic Tests under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date

*** レポート目次(コンテンツ)***

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Herpes Simplex Virus Diagnostic Tests Overview 7
3 Products under Development 8
3.1 Herpes Simplex Virus Diagnostic Tests – Pipeline Products by Stage of Development 8
3.2 Herpes Simplex Virus Diagnostic Tests – Pipeline Products by Territory 9
3.3 Herpes Simplex Virus Diagnostic Tests – Pipeline Products by Regulatory Path 10
3.4 Herpes Simplex Virus Diagnostic Tests – Pipeline Products by Estimated Approval Date 11
4 Herpes Simplex Virus Diagnostic Tests – Pipeline Products under Development by Companies 12
4.1 Herpes Simplex Virus Diagnostic Tests Companies – Pipeline Products by Stage of Development 12
4.2 Herpes Simplex Virus Diagnostic Tests – Pipeline Products by Stage of Development 13
5 Herpes Simplex Virus Diagnostic Tests Companies and Product Overview 14
5.1 Adaltis S.r.l. Company Overview 14
5.1.1 Adaltis S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 14
5.2 Becton Dickinson and Co Company Overview 15
5.2.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 15
5.3 Biokit SA Company Overview 16
5.3.1 Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 16
5.4 Cepheid Company Overview 17
5.4.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 17
5.5 Da An Gene Co Ltd Company Overview 19
5.5.1 Da An Gene Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19
5.6 DiaSorin S.p.A Company Overview 20
5.6.1 DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 20
5.7 GeneProof AS Company Overview 21
5.7.1 GeneProof AS Pipeline Products & Ongoing Clinical Trials Overview 21
5.8 Genera Biosystems Ltd Company Overview 23
5.8.1 Genera Biosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
5.9 Hologic Inc Company Overview 24
5.9.1 Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 24
5.10 Infopia Co Ltd Company Overview 26
5.10.1 Infopia Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
5.11 OPKO Health Inc Company Overview 27
5.11.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 27
5.12 Paramedical Srl Company Overview 28
5.12.1 Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 28
5.13 Qiagen NV Company Overview 32
5.13.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 32
5.14 Roche Diagnostics International Ltd Company Overview 33
5.14.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
5.15 Sansure Biotech Inc Company Overview 36
5.15.1 Sansure Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 36
5.16 Siemens Healthcare GmbH Company Overview 37
5.16.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 37
5.17 Theranos Inc Company Overview 40
5.17.1 Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 40
5.18 University of Texas Medical Branch at Galveston Company Overview 41
5.18.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 41
5.19 VEGA Ltd Company Overview 42
5.19.1 VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
6 Herpes Simplex Virus Diagnostic Tests – Recent Developments 43
6.1 Aug 18, 2017: District Court Issues Final Judgment – Retractable Technologies v. Becton, Dickinson 43
6.2 Aug 17, 2017: Victoria Laughman Named Executive Vice President of Sales for OPKO’s BioReference Laboratories 43
6.3 Aug 15, 2017: NIH herpesvirus study in mice leads to discovery of potential broad-spectrum antiviral 44
6.4 Aug 08, 2017: OPKO Health Reports Second Quarter 2017 Business and Financial Results 44
6.5 Aug 08, 2017: Meridian Bioscience Elects John Rice to the Board of Directors 46
6.6 Aug 07, 2017: Luminex Reports Second Quarter 2017 Financial Results 46
6.7 Aug 03, 2017: BD Announces Results For 2017 Third Fiscal Quarter 47
6.8 Aug 03, 2017: Bio-Rad Reports Second-Quarter 2017 Financial Results 49
6.9 Aug 03, 2017: Diasorin Group Reports Strong Growth in Revenues and Profitability in Q2 2017 50
6.10 Aug 02, 2017: Hologic Announces Financial Results for Third Quarter of Fiscal 2017 53
6.11 Aug 01, 2017: Theranos Reaches Settlement with Walgreens 55
6.12 Jul 27, 2017: QIAGEN Reports Results for Second Quarter and First Half of 2017 55
6.13 Jul 27, 2017: Meridian Bioscience Reports Third Fiscal Quarter 2017 Operating Results 58
6.14 Jul 26, 2017: Quidel Reports Second Quarter 2017 Financial Results 62
6.15 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 63
6.16 Jul 20, 2017: Trinity Biotech Announces Results for Q2, 2017 65
6.17 Jul 20, 2017: Meridian Announces Wholly Foreign Owned Enterprise Office in Beijing, China 67
6.18 Jul 13, 2017: Meridian Bioscience Comments on Recent FDA Press Statement 68
6.19 Jun 20, 2017: Hologic Announces FDA Clearance of Aptima Assay to Detect Herpes Simplex Virus 1 & 2 68
6.20 Jun 06, 2017: BD Releases 2016 Sustainability Report 69
6.21 May 17, 2017: Theranos Names Former Abbott Diagnostics Executive Cass Grandone as Head of Product Development 69
6.22 May 16, 2017: Charles J. Dockendorff Elected to Hologic Board of Directors 70
6.23 May 10, 2017: Hologic Announces Financial Results for Second Quarter of Fiscal 2017 70
6.24 May 10, 2017: Meridian Bioscience Engages Korn Ferry to Conduct CEO Search as John A. Kraeutler Announces Plans to Retire 71
6.25 May 09, 2017: OPKO Health Reports 2016 Financial and Operating Results 72
6.26 May 04, 2017: Bio-Rad Reports First-Quarter 2017 Financial Results 73
6.27 May 02, 2017: BD Announces Results For 2017 Second Fiscal Quarter 74
6.28 May 02, 2017: QIAGEN reports results for first quarter 2017 76
6.29 May 01, 2017: Luminex Reports Record First Quarter 2017 Financial Results; Raises 2017 Financial Guidance 79
6.30 May 01, 2017: Theranos Reaches Settlement with Partner Fund Management 79
6.31 Apr 27, 2017: Trinity Biotech Announces Results for Q1, 2017 80
6.32 Apr 27, 2017: Meridian Bioscience Reports Second Quarter 2017 Operating Results 81
6.33 Apr 24, 2017: Quidel Reports First Quarter 2017 Financial Results 83
6.34 Apr 23, 2017: BD Announces Appointment Of Tom Polen As President 84
6.35 Apr 19, 2017: Abbott Reports First-Quarter 2017 Results 85
6.36 Mar 28, 2017: BD Announces Success of Helping Build Healthy Communities Program, Launches New Effort Focused on Medication Therapy Management 87
6.37 Mar 21, 2017: Retractable Technologies Announces Litigation Updates 88
6.38 Mar 14, 2017: Trinity Biotech announces Quarter 4 and Fiscal Year 2016 Financial Results 88
6.39 Mar 13, 2017: Bio-Rad Intends to Propose Three New Independent Directors 90
6.40 Mar 13, 2017: Bio-Rad Initiates Long Term Financial Guidance; Commits to Defining Long Term Capital Allocation Targets and Hosting an Annual Investor Day 91
6.41 Mar 03, 2017: OPKO Health Appoints Dr. Akhtar Ashfaq as Renal Division Senior Vice President, Clinical Research and Development 92
6.42 Mar 01, 2017: OPKO Health Reports 2016 Financial and Operating Results 92
6.43 Feb 23, 2017: VBio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 94
6.44 Feb 23, 2017: Bio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 96
6.45 Feb 08, 2017: Quidel Reports Fourth Quarter and Full Year 2016 Financial Results 98
6.46 Feb 06, 2017: Luminex Reports Fourth Quarter And Full Year 2016 Results 99
6.47 Feb 02, 2017: BD Announces Results For 2017 First Fiscal Quarter 100
6.48 Feb 01, 2017: QIAGEN Reports Results for Fourth Quarter and Full-year 2016 102
6.49 Feb 01, 2017: Hologic Announces Financial Results for First Quarter of Fiscal 2017 106
6.50 Jan 23, 2017: Quidel Announces Modification of Revenue Reporting Categories 107
6.51 Jan 17, 2017: Theranos Announces Engineering Experts Join Company’s New Technology Advisory Board 108
6.52 Jan 09, 2017: Luminex Announces Preliminary Revenue for Fourth Quarter 2016 and Issues 2017 Revenue Guidance 109
6.53 Jan 06, 2017: Quidel Announces Preliminary Revenue for Fourth Quarter 2016 110
6.54 Jan 04, 2017: Hologic Appoints President of EMEA and Canada, Completing International Leadership Team 110
6.55 Dec 19, 2016: OPKO Health to be Added to the NASDAQ Biotechnology Index 111
6.56 Dec 16, 2016: Amy Wendell Elected to Hologic Board of Directors 111
6.57 Dec 12, 2016: Theranos Enhances Executive Ranks 112
6.58 Dec 01, 2016: Theranos appoints new board member 112
6.59 Nov 29, 2016: Quidel Receives FDA Clearance for Its New Solana(R) Molecular Assay for the Detection of Herpes Simplex Virus 1+2 and Varicella Zoster Virus 113
6.60 Nov 15, 2016: Hologic Obtains European CE Mark for Aptima Assay to Detect Herpes Simplex Virus 1 & 2 114
6.61 Nov 10, 2016: Meridian Bioscience Reports Fourth Quarter and Full-Year Operating Results 115
6.62 Nov 10, 2016: Diasorin Group Reports Continued Growth In Revenues And Profitability In The Third Quarter 2016 117
6.63 Nov 07, 2016: OPKO Health Reports Third Quarter Financial and Operating Results 118
6.64 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 119
6.65 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 121
6.66 Nov 02, 2016: Hologic Announces Financial Results for Fourth Quarter of Fiscal 2016 124
6.67 Nov 02, 2016: QIAGEN launches restructuring initiatives, revises outlook for 2016 earnings and provides initial net sales and adjusted earnings guidance for 2017 126
6.68 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 126
6.69 Oct 31, 2016: Luminex Reports Third Quarter 2016 Results; Raises Full Year Guidance 127
6.70 Oct 26, 2016: Quidel Reports Third Quarter 2016 Financial Results 128
6.71 Oct 25, 2016: Trinity Biotech announces Quarter 3 Financial Results 129
6.72 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 132
6.73 Oct 18, 2016: Meridian Bioscience Comments on Preliminary Fiscal 2016 Operating Results and Provides Fiscal 2017 Revenue and Earnings Guidance 134
6.74 Oct 05, 2016: An Open Letter From Elizabeth Holmes 136
6.75 Oct 03, 2016: Bioline is Certified to the ISO 13485 Quality Standard 136
6.76 Oct 03, 2016: Genera Biosystems: 2016 Annual Report Highlights 137
6.77 Sep 13, 2016: OPKO Health Appoints Jane Pine Wood as Chief Legal and Compliance Officer of BioReference Laboratories 138
7 Appendix 140
7.1 Methodology 140
7.2 About GlobalData 143
7.3 Contact Us 143
7.4 Disclaimer 143

1.1 List of Tables
Table 1: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Stage of Development 8
Table 2: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Territory 9
Table 3: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Regulatory Path 10
Table 4: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
Table 5: Herpes Simplex Virus Diagnostic Tests Companies - Pipeline Products by Stage of Development 12
Table 6: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Stage of Development 13
Table 7: Adaltis S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 14
Table 8: MOLgen DNA HSV - 1,2 Set 1 Kit - Product Status 14
Table 9: MOLgen DNA HSV - 1,2 Set 1 Kit - Product Description 14
Table 10: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 15
Table 11: BD Viper LT HSV 1/2 Assay - Product Status 15
Table 12: BD Viper LT HSV 1/2 Assay - Product Description 15
Table 13: Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 16
Table 14: BIO-FLASH HSV 1+2 IgM Assay - Product Status 16
Table 15: BIO-FLASH HSV 1+2 IgM Assay - Product Description 16
Table 16: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 17
Table 17: Xpert HSV 1 And 2 Test - Product Status 17
Table 18: Xpert HSV 1 And 2 Test - Product Description 17
Table 19: Xpert HSV CSF Assay - Product Status 18
Table 20: Xpert HSV CSF Assay - Product Description 18
Table 21: Da An Gene Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19
Table 22: Real Time PCR Kit - HSV General Type - Product Status 19
Table 23: Real Time PCR Kit - HSV General Type - Product Description 19
Table 24: DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 20
Table 25: Diagnostic Assay - HSV M + cntr - Product Status 20
Table 26: Diagnostic Assay - HSV M + cntr - Product Description 20
Table 27: GeneProof AS Pipeline Products & Ongoing Clinical Trials Overview 21
Table 28: Human Herpes Virus 6/7 PCR Kit - Product Status 21
Table 29: Human Herpes Virus 6/7 PCR Kit - Product Description 21
Table 30: Human Herpes Virus 8 PCR Kit - Product Status 22
Table 31: Human Herpes Virus 8 PCR Kit - Product Description 22
Table 32: Genera Biosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
Table 33: Diagnostic Test- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Status 23
Table 34: Diagnostic Test- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Description 23
Table 35: Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 36: Panther Fusion - HSV 1 & 2 Assay - Product Status 24
Table 37: Panther Fusion - HSV 1 & 2 Assay - Product Description 24
Table 38: Panther System - HSV-2 Assay - Product Status 25
Table 39: Panther System - HSV-2 Assay - Product Description 25
Table 40: Infopia Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 41: GeneFinder STDIII (HSV1/2/UP) Real Amp Kit - Product Status 26
Table 42: GeneFinder STDIII (HSV1/2/UP) Real Amp Kit - Product Description 26
Table 43: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 27
Table 44: mChip - Herpes - Product Status 27
Table 45: mChip - Herpes - Product Description 27
Table 46: Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 28
Table 47: PKL PPC - Torch - ANTI HSV1 IGG - Product Status 28
Table 48: PKL PPC - Torch - ANTI HSV1 IGG - Product Description 28
Table 49: PKL PPC - Torch - ANTI HSV1 IGM - Product Status 29
Table 50: PKL PPC - Torch - ANTI HSV1 IGM - Product Description 29
Table 51: PKL PPC - Torch - ANTI HSV1+2 IGM - Product Status 29
Table 52: PKL PPC - Torch - ANTI HSV1+2 IGM - Product Description 30
Table 53: PKL PPC - Torch - ANTI HSV2 IGG - Product Status 30
Table 54: PKL PPC - Torch - ANTI HSV2 IGG - Product Description 30
Table 55: PKL PPC - Torch - ANTI HSV2 IGM - Product Status 31
Table 56: PKL PPC - Torch - ANTI HSV2 IGM - Product Description 31
Table 57: Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 32
Table 58: QIAensemble 400 - Herpes Simplex Virus 1 and 2 - Product Status 32
Table 59: QIAensemble 400 - Herpes Simplex Virus 1 and 2 - Product Description 32
Table 60: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
Table 61: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Test - Product Status 33
Table 62: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Test - Product Description 33
Table 63: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Test - Product Status 34
Table 64: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Test - Product Description 34
Table 65: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II Assay - Product Status 34
Table 66: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II Assay - Product Description 34
Table 67: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II Assay - Product Status 35
Table 68: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II Assay - Product Description 35
Table 69: Sansure Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 36
Table 70: Herpes Simplex Virus (1/2) DNA Fluorescence Diagnostic Kit - Product Status 36
Table 71: Herpes Simplex Virus (1/2) DNA Fluorescence Diagnostic Kit - Product Description 36
Table 72: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 37
Table 73: ADVIA Centaur CP Immunoassay System - Herpes I Assay - Product Status 37
Table 74: ADVIA Centaur CP Immunoassay System - Herpes I Assay - Product Description 37
Table 75: ADVIA Centaur CP Immunoassay System - Herpes II Assay - Product Status 38
Table 76: ADVIA Centaur CP Immunoassay System - Herpes II Assay - Product Description 38
Table 77: ADVIA Centaur XP Immunoassay System - Herpes I Assay - Product Status 38
Table 78: ADVIA Centaur XP Immunoassay System - Herpes I Assay - Product Description 38
Table 79: ADVIA Centaur XP Immunoassay System - Herpes II Assay - Product Status 39
Table 80: ADVIA Centaur XP Immunoassay System - Herpes II Assay - Product Description 39
Table 81: Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 40
Table 82: HSV-1 IgG Test - Venous/Capillary - Product Status 40
Table 83: HSV-1 IgG Test - Venous/Capillary - Product Description 40
Table 84: University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 41
Table 85: Diagnostic Assay - HSV - Product Status 41
Table 86: Diagnostic Assay - HSV - Product Description 41
Table 87: VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
Table 88: Enzyme Immunoassay - HSV2 - Product Status 42
Table 89: Enzyme Immunoassay - HSV2 - Product Description 42
Table 90: Glossary 142

1.2 List of Figures
Figure 1: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Stage of Development 8
Figure 2: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Territory 9
Figure 3: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Regulatory Path 10
Figure 4: Herpes Simplex Virus Diagnostic Tests - Pipeline Products by Estimated Approval Date 11

*** 掲載企業 ***

Adaltis S.r.l.
Becton Dickinson and Co
Biokit SA
Cepheid
Da An Gene Co Ltd
DiaSorin S.p.A
GeneProof AS
Genera Biosystems Ltd
Hologic Inc
Infopia Co Ltd
OPKO Health Inc
Paramedical Srl
Qiagen NV
Roche Diagnostics International Ltd
Sansure Biotech Inc
Siemens Healthcare GmbH
Theranos Inc
University of Texas Medical Branch at Galveston
VEGA Ltd

*** 免責事項 ***
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