Immunohaematology Diagnostic Tests - Medical Devices Pipeline Assessment, 2017

2017-08-04
Price :
Published : Aug-2017
No. of Pages : 105
Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 6
2.1 Immunohaematology Diagnostic Tests Overview 6
3 Products under Development 7
3.1 Immunohaematology Diagnostic Tests - Pipeline Products by Stage of Development 7
3.2 Immunohaematology Diagnostic Tests - Pipeline Products by Segment 8
3.3 Immunohaematology Diagnostic Tests - Pipeline Products by Territory 9
3.4 Immunohaematology Diagnostic Tests - Pipeline Products by Regulatory Path 10
3.5 Immunohaematology Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
4 Immunohaematology Diagnostic Tests - Pipeline Products under Development by Companies 12
4.1 Immunohaematology Diagnostic Tests Companies - Pipeline Products by Stage of Development 12
4.2 Immunohaematology Diagnostic Tests - Pipeline Products by Stage of Development 13
5 Immunohaematology Diagnostic Tests Companies and Product Overview 15
5.1 AbSorber AB Company Overview 15
5.1.1 AbSorber AB Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Amity University Company Overview 16
5.2.1 Amity University Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 Arizona State University Company Overview 17
5.3.1 Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 Haemonetics Corp Company Overview 18
5.4.1 Haemonetics Corp Pipeline Products & Ongoing Clinical Trials Overview 18
5.5 Immucor, Inc. Company Overview 19
5.5.1 Immucor, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
5.6 Ortho-Clinical Diagnostics Inc Company Overview 20
5.6.1 Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 20
5.7 Quotient Limited Company Overview 22
5.7.1 Quotient Limited Pipeline Products & Ongoing Clinical Trials Overview 22
5.8 TBG Diagnostics Ltd Company Overview 28
5.8.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28
5.9 TheraDiag SA Company Overview 31
5.9.1 TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 31
5.10 Transfusion & Transplantation Technologies (Inactive) Company Overview 39
5.10.1 Transfusion & Transplantation Technologies (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39
6 Immunohaematology Diagnostic Tests - Recent Developments 45
6.1 Jul 28, 2017: Grifols increases its revenues by 12.3% to EUR 2,192 million driven by growth of its main divisions 45
6.2 Jul 25, 2017: Theradiag: Further Strong Sales Growth in the First Half of 2017: +9% 51
6.3 Jun 22, 2017: Haemonetics Announces Formation of Scientific Advisory Council 52
6.4 May 22, 2017: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Fourth Quarter and Fiscal Year 2017 Financial Results 52
6.5 May 08, 2017: Haemonetics Reports 4th Quarter and Fiscal Year 2017 Results and Provides Fiscal 2018 Guidance 54
6.6 May 04, 2017: Bio-Rad Reports First-Quarter 2017 Financial Results 56
6.7 May 03, 2017: Bioscience Division sales increase 15% to drive Grifols' revenue growth by 11% to Euros 1,062 million 57
6.8 Apr 27, 2017: THERADIAG Announces First-quarter 2017 Revenues 62
6.9 Apr 27, 2017: Theradiag: First-Quarter 2017 Revenues 62
6.10 Apr 03, 2017: U.S. District Judge Grants AllCells Motion for Preliminary Injunction in Lawsuit Against Cepheus Biosciences 62
6.11 Mar 13, 2017: Bio-Rad Intends to Propose Three New Independent Directors 63
6.12 Mar 13, 2017: Bio-Rad Initiates Long Term Financial Guidance; Commits to Defining Long Term Capital Allocation Targets and Hosting an Annual Investor Day 64
6.13 Mar 01, 2017: Appointment of Dominique Costantini and Dominique Takizawa to Theradiag's Board of Directors 65
6.14 Mar 01, 2017: THERADIAG: Full-year 2016 results 66
6.15 Feb 28, 2017: Grifols' revenues exceed Euros 4,000 million, driven by +6.5% growth of the Bioscience Division 68
6.16 Feb 23, 2017: VBio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 78
6.17 Feb 23, 2017: Bio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 80
6.18 Feb 09, 2017: Quotient Announces Appointment of Christopher Lindop as Chief Financial Officer 82
6.19 Feb 06, 2017: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Third Quarter Fiscal 2017 Financial Results 82
6.20 Jan 05, 2017: Quotient Reports Positive MosaiQ Results From Performance Evaluation Study for Blood Grouping 84
6.21 Nov 08, 2016: Sales of the Bioscience Division grow by +6.5%, increasing Grifols' revenues to EUR 2,952 million 85
6.22 Nov 02, 2016: Quotient Announces CFO Transition 90
6.23 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 90
6.24 Oct 31, 2016: Quotient Second Quarter Fiscal 2017 Financial Results 91
6.25 Oct 31, 2016: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Second Quarter Fiscal 2017 Financial Results 93
6.26 Oct 27, 2016: Catherine M. Burzik Joins Haemonetics Board of Directors 95
6.27 Oct 24, 2016: Immucor Announces CE Mark in Europe for NEO Iris; Next Generation, Fully Automated Instrument for Transfusion Medicine 96
6.28 Oct 20, 2016: AllCells Announces New Vice President, Manufacturing Operations 97
6.29 Oct 13, 2016: THERADIAG: Very strong revenue growth at end-September 2016: +31% 97
6.30 Sep 14, 2016: THERADIAG: First-half 2016 Revenues and Results 98
6.31 Aug 08, 2016: Quotient Reports Further Progress on the Commercial Scale-up of MosaiQ and First Quarter Fiscal 2017 Financial Results 99
7 Appendix 102
7.1 Methodology 102
7.2 About GlobalData 105
7.3 Contact Us 105
7.4 Disclaimer 105

1.1 List of Tables
Table 1: Immunohaematology Diagnostic Tests - Pipeline Products by Stage of Development 7
Table 2: Immunohaematology Diagnostic Tests - Pipeline Products by Segment 8
Table 3: Immunohaematology Diagnostic Tests - Pipeline Products by Territory 9
Table 4: Immunohaematology Diagnostic Tests - Pipeline Products by Regulatory Path 10
Table 5: Immunohaematology Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
Table 6: Immunohaematology Diagnostic Tests Companies - Pipeline Products by Stage of Development 12
Table 7: Immunohaematology Diagnostic Tests - Pipeline Products by Stage of Development 13
Table 8: AbSorber AB Pipeline Products & Ongoing Clinical Trials Overview 15
Table 9: ABO Diagnostic Test - Product Status 15
Table 10: ABO Diagnostic Test - Product Description 15
Table 11: Amity University Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: Blood Group Testing Kit - Product Status 16
Table 13: Blood Group Testing Kit - Product Description 16
Table 14: Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: Blood Screening Immunosignaturing - Product Status 17
Table 16: Blood Screening Immunosignaturing - Product Description 17
Table 17: Haemonetics Corp Pipeline Products & Ongoing Clinical Trials Overview 18
Table 18: Blood Typing System - Product Status 18
Table 19: Blood Typing System - Product Description 18
Table 20: Immucor, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
Table 21: NEO Iris - Product Status 19
Table 22: NEO Iris - Product Description 19
Table 23: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 20
Table 24: ORTHO AutoVue - Rare Sera Assay - Product Status 20
Table 25: ORTHO AutoVue - Rare Sera Assay - Product Description 20
Table 26: ORTHO BioVue - Rare Sera Assay - Product Status 21
Table 27: ORTHO BioVue - Rare Sera Assay - Product Description 21
Table 28: Quotient Limited Pipeline Products & Ongoing Clinical Trials Overview 22
Table 29: ALBAclone Anti-C beta Reagent - Product Status 22
Table 30: ALBAclone Anti-C beta Reagent - Product Description 23
Table 31: ALBAclone Anti-e beta Reagent - Product Status 23
Table 32: ALBAclone Anti-e beta Reagent - Product Description 23
Table 33: ALBAclone Anti-H Reagent - Product Status 23
Table 34: ALBAclone Anti-H Reagent - Product Description 24
Table 35: ALBAcyte O Adult i Cell Reagent - Product Status 24
Table 36: ALBAcyte O Adult i Cell Reagent - Product Description 24
Table 37: ALBAcyte O RhD VI Reagent Cells - Product Status 24
Table 38: ALBAcyte O RhD VI Reagent Cells - Product Description 25
Table 39: Eluate Kit - Product Status 25
Table 40: Eluate Kit - Product Description 25
Table 41: MosaiQ IH Microarray - Product Status 25
Table 42: MosaiQ IH Microarray - Product Description 26
Table 43: Polyagglutionation Kit - Product Status 26
Table 44: Polyagglutionation Kit - Product Description 26
Table 45: Sensitivity Kit Anti-S, K, e, C - Product Status 26
Table 46: Sensitivity Kit Anti-S, K, e, C - Product Description 27
Table 47: TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28
Table 48: HLAssure SE A Locus SBT Kit - Product Status 28
Table 49: HLAssure SE A Locus SBT Kit - Product Description 28
Table 50: HLAssure SE B Locus SBT Kit - Product Status 29
Table 51: HLAssure SE B Locus SBT Kit - Product Description 29
Table 52: HLAssure SE C Locus SBT Kit - Product Status 29
Table 53: HLAssure SE C Locus SBT Kit - Product Description 29
Table 54: HLAssure SE DQB Locus SBT Kit - Product Status 30
Table 55: HLAssure SE DQB Locus SBT Kit - Product Description 30
Table 56: HLAssure SE DRB-EX Locus SBT Kit - Product Status 30
Table 57: HLAssure SE DRB-EX Locus SBT Kit - Product Description 30
Table 58: TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 31
Table 59: LTA003 LISA-TRACKER Anti-Adalimumab - Product Status 32
Table 60: LTA003 LISA-TRACKER Anti-Adalimumab - Product Description 32
Table 61: LTC003 LISA-TRACKER Anti-Certolizumab - Product Status 33
Table 62: LTC003 LISA-TRACKER Anti-Certolizumab - Product Description 33
Table 63: LTE003 LISA-TRACKER Anti-Etanercept - Product Status 33
Table 64: LTE003 LISA-TRACKER Anti-Etanercept - Product Description 34
Table 65: LTG003 LISA-TRACKER Anti-Golimumab - Product Status 34
Table 66: LTG003 LISA-TRACKER Anti-Golimumab - Product Description 34
Table 67: LTI003 LISA-TRACKER Anti-Infliximab Assay - Product Status 35
Table 68: LTI003 LISA-TRACKER Anti-Infliximab Assay - Product Description 35
Table 69: LTR003 LISA-TRACKER Anti-Rituximab Assay - Product Status 35
Table 70: LTR003 LISA-TRACKER Anti-Rituximab Assay - Product Description 36
Table 71: LTT003 LISA TRACKER Anti-Tocilizumab Assay - Product Status 36
Table 72: LTT003 LISA TRACKER Anti-Tocilizumab Assay - Product Description 36
Table 73: LTTR003 LISA-TRACKER Anti-Trastuzumab Assay - Product Status 37
Table 74: LTTR003 LISA-TRACKER Anti-Trastuzumab Assay - Product Description 37
Table 75: LTU003 LISA-TRACKER Anti-Ustekinumab Assay - Product Status 37
Table 76: LTU003 LISA-TRACKER Anti-Ustekinumab Assay - Product Description 38
Table 77: Transfusion & Transplantation Technologies (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39
Table 78: Aegis - Blood Grouping Assay - Product Status 39
Table 79: Aegis - Blood Grouping Assay - Product Description 39
Table 80: Aegis - Anti-A Quantitation In Group O Platelets - Product Status 40
Table 81: Aegis - Anti-A Quantitation In Group O Platelets - Product Description 40
Table 82: Aegis - Antibody Screening And Identification Assay - Product Status 40
Table 83: Aegis - Antibody Screening And Identification Assay - Product Description 41
Table 84: Aegis - Feto-maternal Hemorrhage Assay - Product Status 41
Table 85: Aegis - Feto-maternal Hemorrhage Assay - Product Description 41
Table 86: Aegis - Platelet Cross-match Assay - Product Status 42
Table 87: Aegis - Platelet Cross-match Assay - Product Description 42
Table 88: Aegis - Residual A Quantitation Assay - Product Status 42
Table 89: Aegis - Residual A Quantitation Assay - Product Description 43
Table 90: Aegis - rWBC Quantitation Assay - Product Status 43
Table 91: Aegis - rWBC Quantitation Assay - Product Description 43
Table 92: AEGIS System - Product Status 44
Table 93: AEGIS System - Product Description 44
Table 94: Glossary 104

1.2 List of Figures
Figure 1: Immunohaematology Diagnostic Tests - Pipeline Products by Stage of Development 7
Figure 2: Immunohaematology Diagnostic Tests - Pipeline Products by Segment 8
Figure 3: Immunohaematology Diagnostic Tests - Pipeline Products by Territory 9
Figure 4: Immunohaematology Diagnostic Tests - Pipeline Products by Regulatory Path 10
Figure 5: Immunohaematology Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
Filed in: Medical Device
Publisher : GlobalData