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Diabetes Assays - Medical Devices Pipeline Assessment, 2018

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  • Details
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  • Licence Rights
  • Section Purchase
  • Products and Companies

Details

Diabetes Assays-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Diabetes Assays-Medical Devices Pipeline Assessment, 2018" provides an overview of Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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.

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 6

2 Introduction 7

2.1 Diabetes Assays Overview 7

3 Products under Development 8

3.1 Diabetes Assays-Pipeline Products by Stage of Development 8

3.2 Diabetes Assays-Pipeline Products by Segment 9

3.3 Diabetes Assays-Pipeline Products by Territory 10

3.4 Diabetes Assays-Pipeline Products by Regulatory Path 11

3.5 Diabetes Assays-Pipeline Products by Estimated Approval Date 12

4 Diabetes Assays-Pipeline Products under Development by Companies 13

4.1 Diabetes Assays Companies-Pipeline Products by Stage of Development 13

4.2 Diabetes Assays-Pipeline Products by Stage of Development 15

5 Diabetes Assays Companies and Product Overview 17

5.1 Abcodia Ltd Company Overview 17

5.2 Abionic SA Company Overview 18

5.3 Achira Labs Pvt Ltd Company Overview 19

5.4 Adaptive Biotechnologies Corp Company Overview 20

5.5 Alfa Wassermann Inc Company Overview 21

5.6 Aura Biotechnologies Pvt Ltd Company Overview 22

5.7 Beckman Coulter Inc Company Overview 24

5.8 Biocrates Life Sciences AG Company Overview 29

5.9 Caprion Biosciences Inc Company Overview 31

5.10 Drexel University Company Overview 33

5.11 ELITechGroup Inc Company Overview 34

5.12 Enable Biosciences Inc Company Overview 36

5.13 Fujirebio Diagnostics Inc Company Overview 37

5.14 Genalyte Inc Company Overview 38

5.15 Helmholtz Centre for Infection Research Company Overview 39

5.16 ImmusanT Inc Company Overview 40

5.17 Janssen Pharmaceuticals Inc Company Overview 41

5.18 Johns Hopkins University Company Overview 42

5.19 Mellitus, LLC Company Overview 43

5.20 Mindray Medical International Ltd Company Overview 44

5.21 Numares AG Company Overview 46

5.22 Ortho-Clinical Diagnostics Inc Company Overview 47

5.23 PeriRx Inc Company Overview 52

5.24 PortaScience Inc Company Overview 53

5.25 Protagen AG Company Overview 54

5.26 Queen Mary University of London Company Overview 55

5.27 QuickCheck Health Inc Company Overview 56

5.28 Singulex Inc Company Overview 57

5.29 The Forsyth Institute Company Overview 58

5.30 University of Canterbury Company Overview 59

5.31 University of Colorado Company Overview 60

5.32 University of Florida Company Overview 62

5.33 University of South Florida Company Overview 63

5.34 Xhale Inc Company Overview 64

5.35 Yaathum Biotech Pvt Ltd Company Overview 65

6 Diabetes Assays- Recent Developments 66

6.1 Jun 01, 2018: ISBT Satellite Symposium Co-hosted by Ortho Clinical Diagnostics and Quotient Discusses Responding to the Challenges of Resource Constraints in Transfusion Diagnostics 66

6.2 May 08, 2018: Ortho Clinical Diagnostics Holds Summit to Help Asia-Pacific Lab Leaders Envision the Lab of the Future 67

6.3 Jan 25, 2018: Proteomics International Laboratories: Quarterly Business Update 67

6.4 Nov 22, 2017: Proteomics International strengthens Board and Business Development team 69

6.5 Oct 20, 2017: Asahi Kasei Pharma received 510(k) clearance from the FDA for Lucica Glycated Albumin-L 70

6.6 Oct 05, 2017: Mercodia Akurio Multiplex Used in a Recently Published Article 71

6.7 Aug 29, 2017: New technology could predict the risk of type 2 diabetes 71

6.8 Aug 16, 2017: HealPros and BioIQ Collaborate to Deliver a Comprehensive Diabetes Care Gap Closure Solution to Help Health Plans Improve Quality Ratings 72

6.9 Jul 18, 2017: Australian-first at-home blood test helping researchers delay and prevent onset of type 2 diabetes 73

6.10 Jul 18, 2017: Oramed Pharmaceuticals appoints vice president of medical affairs 74

6.11 Jul 17, 2017: EKF publish new diabetes and HbA1c testing guide 74

7 Appendix 76

7.1 Methodology 76

7.2 About GlobalData 79

7.3 Contact Us 79

7.4 Disclaimer 79


List Of Figure

1.2 List of Figures

Figure 1: Diabetes Assays-Pipeline Products by Stage of Development 8

Figure 2: Diabetes Assays-Pipeline Products by Segment 9

Figure 3: Diabetes Assays-Pipeline Products by Territory 10

Figure 4: Diabetes Assays-Pipeline Products by Regulatory Path 11

Figure 5: Diabetes Assays-Pipeline Products by Estimated Approval Date 12


List Of Table

1.1 List of Tables

Table 1: Diabetes Assays-Pipeline Products by Stage of Development 8

Table 2: Diabetes Assays-Pipeline Products by Segment 9

Table 3: Diabetes Assays-Pipeline Products by Territory 10

Table 4: Diabetes Assays-Pipeline Products by Regulatory Path 11

Table 5: Diabetes Assays-Pipeline Products by Estimated Approval Date 12

Table 6: Diabetes Assays Companies-Pipeline Products by Stage of Development 13

Table 7: Diabetes Assays-Pipeline Products by Stage of Development 15

Table 8: Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 17

Table 9: Molecular Biomarker-Diabetes-Product Status 17

Table 10: Molecular Biomarker-Diabetes-Product Description 17

Table 11: Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 18

Table 12: IVD CAPSULE-Diabetes Test-Product Status 18

Table 13: IVD CAPSULE-Diabetes Test-Product Description 18

Table 14: Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

Table 15: Diabetes Panel-Product Status 19

Table 16: Diabetes Panel-Product Description 19

Table 17: Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 20

Table 18: Pre-Symptomatic Biomarker-Type 1 Diabetes-Product Status 20

Table 19: Pre-Symptomatic Biomarker-Type 1 Diabetes-Product Description 20

Table 20: Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 21: ACE Alera Clinical Chemistry System-Direct A1c Assay-Product Status 21

Table 22: ACE Alera Clinical Chemistry System-Direct A1c Assay-Product Description 21

Table 23: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

Table 24: AURA Quant Glargine ELISA Kit-Product Status 22

Table 25: AURA Quant Glargine ELISA Kit-Product Description 22

Table 26: AURA Quant Human C-peptide Kit-Product Status 23

Table 27: AURA Quant Human C-peptide Kit-Product Description 23

Table 28: AURA Quant Human Insulin ELISA Kit-Product Status 23

Table 29: AURA Quant Human Insulin ELISA Kit-Product Description 23

Table 30: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 31: AU480 Clinical System-Next Generation HbA1c Assay-Product Status 24

Table 32: AU480 Clinical System-Next Generation HbA1c Assay-Product Description 25

Table 33: AU5810 Clinical System-Next-generation HbA1c Assay-Product Status 25

Table 34: AU5810 Clinical System-Next-generation HbA1c Assay-Product Description 25

Table 35: AU5820 Clinical System-Next-generation HbA1c Assay-Product Status 26

Table 36: AU5820 Clinical System-Next-generation HbA1c Assay-Product Description 26

Table 37: AU5830 Clinical System-Next-generation HbA1c Assay-Product Status 26

Table 38: AU5830 Clinical System-Next-generation HbA1c Assay-Product Description 27

Table 39: AU5840 Clinical System-Next-generation HbA1c Assay-Product Status 27

Table 40: AU5840 Clinical System-Next-generation HbA1c Assay-Product Description 27

Table 41: AU680 Clinical System-Next-generation HbA1c Assay-Product Status 28

Table 42: AU680 Clinical System-Next-generation HbA1c Assay-Product Description 28

Table 43: Biocrates Life Sciences AG Pipeline Products & Ongoing Clinical Trials Overview 29

Table 44: Diagnostic Assay-Type 2 Diabetes-Product Status 29

Table 45: Diagnostic Assay-Type 2 Diabetes-Product Description 29

Table 46: Metabolomic Biomarker Assay-Diabetes-Product Status 30

Table 47: Metabolomic Biomarker Assay-Diabetes-Product Description 30

Table 48: Caprion Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 49: Diagnostic Assay-Gestational Diabetes Progression-Product Status 31

Table 50: Diagnostic Assay-Gestational Diabetes Progression-Product Description 31

Table 51: Diagnostic Assay-Islet Cell Health-Product Status 32

Table 52: Diagnostic Assay-Islet Cell Health-Product Description 32

Table 53: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 33

Table 54: Diagnostic Assay-Diabetic Ulcers-Product Status 33

Table 55: Diagnostic Assay-Diabetic Ulcers-Product Description 33

Table 56: ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 57: Eon 100 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Status 34

Table 58: Eon 100 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Description 34

Table 59: Eon 300 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Status 35

Table 60: Eon 300 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Description 35

Table 61: Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 62: ADAP Type1 Diabetes Assay-Product Status 36

Table 63: ADAP Type1 Diabetes Assay-Product Description 36

Table 64: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 65: Lumipulse G C-Peptide Assay Kit-Product Status 37

Table 66: Lumipulse G C-Peptide Assay Kit-Product Description 37

Table 67: Genalyte Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 68: Maverick Type 1 Diabetes (T1D) Assay Kit-Product Status 38

Table 69: Maverick Type 1 Diabetes (T1D) Assay Kit-Product Description 38

Table 70: Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 39

Table 71: Diagnostic Biomarker -Type 2 Diabetes-Product Status 39

Table 72: Diagnostic Biomarker -Type 2 Diabetes-Product Description 39

Table 73: ImmusanT Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 74: Diagnostic Test-Type 1 Diabetes-Product Status 40

Table 75: Diagnostic Test-Type 1 Diabetes-Product Description 40

Table 76: Janssen Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 77: Diagnostic Biomarker-Beta-cell Function-Product Status 41

Table 78: Diagnostic Biomarker-Beta-cell Function-Product Description 41

Table 79: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 42

Table 80: Screening Test-Gestational Diabetes-Product Status 42

Table 81: Screening Test-Gestational Diabetes-Product Description 42

Table 82: Mellitus, LLC Pipeline Products & Ongoing Clinical Trials Overview 43

Table 83: Blood Test-Gestational Diabetes-Product Status 43

Table 84: Blood Test-Gestational Diabetes-Product Description 43

Table 85: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 86: CL-2000i-C-peptide Test-Product Status 44

Table 87: CL-2000i-C-peptide Test-Product Description 44

Table 88: CL-2000i-Insulin Test-Product Status 45

Table 89: CL-2000i-Insulin Test-Product Description 45

Table 90: Numares AG Pipeline Products & Ongoing Clinical Trials Overview 46

Table 91: Diagnostic Test-Diabetes-Product Status 46

Table 92: Diagnostic Test-Diabetes-Product Description 46

Table 93: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 94: VITROS 3600-Insulin Assay-Product Status 47

Table 95: VITROS 3600-Insulin Assay-Product Description 48

Table 96: Vitros 4600/5,1 FS Chemistry System-Beta Hydroxybutrate Assay-Product Status 48

Table 97: Vitros 4600/5,1 FS Chemistry System-Beta Hydroxybutrate Assay-Product Description 48

Table 98: Vitros 5600 Integrated System-Beta Hydroxybutrate Assay-Product Status 49

Table 99: Vitros 5600 Integrated System-Beta Hydroxybutrate Assay-Product Description 49

Table 100: Vitros ECi-C-Peptide Assay-Product Status 49

Table 101: Vitros ECi-C-Peptide Assay-Product Description 49

Table 102: Vitros ECi-Insulin Assay-Product Status 50

Table 103: Vitros ECi-Insulin Assay-Product Description 50

Table 104: Vitros Insulin Assay-Product Status 50

Table 105: Vitros Insulin Assay-Product Description 51

Table 106: PeriRx Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 107: SaliMark D2-Product Status 52

Table 108: SaliMark D2-Product Description 52

Table 109: PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 110: HbA1c Blood Test-Product Status 53

Licence Rights

Single User License:
Report can be used by individual purchaser only

Site License:
Report can be shared by unlimited users within one corporate location, e.g. a regional office

Corporate User License: 
Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Section Purchase

To know more information on Purchase by Section, please send a mail to support@kenresearch.com

Products and Companies

Products

Abcodia Ltd, Molecular Biomarker - Diabetes; Abionic SA, IVD CAPSULE - Diabetes Test; Achira Labs Pvt Ltd, Diabetes Panel; Adaptive Biotechnologies Corp, Pre - Symptomatic Biomarker - Type 1 Diabetes; Alfa Wassermann Inc, ACE Alera Clinical Chemistry System - Direct A1c Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Glargine ELISA Kit; Aura Biotechnologies Pvt Ltd, AURA Quant Human C-peptide Kit; Aura Biotechnologies Pvt Ltd, AURA Quant Human Insulin ELISA Kit; Beckman Coulter Inc, AU480 Clinical System - Next Generation HbA1c Assay; Beckman Coulter Inc, AU5810 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5820 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5830 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5840 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU680 Clinical System - Next-generation HbA1c Assay; Biocrates Life Sciences AG, Diagnostic Assay - Type 2 Diabetes; Biocrates Life Sciences AG, Metabolomic Biomarker Assay - Diabetes; Caprion Biosciences Inc, Diagnostic Assay - Gestational Diabetes Progression; Caprion Biosciences Inc, Diagnostic Assay - Islet Cell Health; Drexel University, Diagnostic Assay - Diabetic Ulcers; ELITechGroup Inc, Eon 100 Automated Chemistry Analyzer - Hemoglobin A1c Assay; ELITechGroup Inc, Eon 300 Automated Chemistry Analyzer - Hemoglobin A1c Assay; Enable Biosciences Inc, ADAP Type1 Diabetes Assay; Fujirebio Diagnostics Inc, Lumipulse G C-Peptide Assay Kit; Genalyte Inc, Maverick Type 1 Diabetes (T1D) Assay Kit; Helmholtz Centre for Infection Research, Diagnostic Biomarker -Type 2 Diabetes; ImmusanT Inc, Diagnostic Test - Type 1 Diabetes; Janssen Pharmaceuticals Inc, Diagnostic Biomarker - Beta-cell Function; Johns Hopkins University, Screening Test - Gestational Diabetes; Mellitus, LLC, Blood Test - Gestational Diabetes; Mindray Medical International Ltd, CL-2000i - C-peptide Test; Mindray Medical International Ltd, CL-2000i - Insulin Test; Numares AG, Diagnostic Test - Diabetes; Ortho-Clinical Diagnostics Inc, VITROS 3600 - Insulin Assay; Ortho-Clinical Diagnostics Inc, Vitros 4600/5,1 FS Chemistry System - Beta Hydroxybutrate Assay; Ortho-Clinical Diagnostics Inc, Vitros 5600 Integrated System - Beta Hydroxybutrate Assay; Ortho-Clinical Diagnostics Inc, Vitros ECi - C-Peptide Assay; Ortho-Clinical Diagnostics Inc, Vitros ECi - Insulin Assay; Ortho-Clinical Diagnostics Inc, Vitros Insulin Assay; PeriRx Inc, SaliMark D2; PortaScience Inc, HbA1c Blood Test; Protagen AG, Diagnostic Assay - Type 1 Diabetes; Queen Mary University of London, Biomarker Assay - Type I Diabetes; QuickCheck Health Inc, Diagnostic Test - A1c; Singulex Inc, SMC Adiponectin Test; The Forsyth Institute, Saliva Based Diagnostic Assay - Metabolic Syndrome; University of Canterbury, Low Intensity Model Based Test - Insulin Resistance; University of Colorado, Diagnostic Test - Type 1 Diabetes; University of Colorado, IGRP Autoantibody Based Assay - Type-1 Diabetes; University of Florida, Diagnostic Assay - Diabetes; University of South Florida, Saliva Based Biomarker Assay - Diabetes; Xhale Inc, Oral Glucose Tolerance Test; Yaathum Biotech Pvt Ltd, Screening-Diagnostic-Prognostic Test - Diabetes


Companies

Abcodia Ltd

Abionic SA

Achira Labs Pvt Ltd

Adaptive Biotechnologies Corp

Alfa Wassermann Inc

Aura Biotechnologies Pvt Ltd

Beckman Coulter Inc

Biocrates Life Sciences AG

Caprion Biosciences Inc

Drexel University

ELITechGroup Inc

Enable Biosciences Inc

Fujirebio Diagnostics Inc

Genalyte Inc

Helmholtz Centre for Infection Research

ImmusanT Inc

Janssen Pharmaceuticals Inc

Johns Hopkins University

Mellitus, LLC

Mindray Medical International Ltd

Numares AG

Ortho-Clinical Diagnostics Inc

PeriRx Inc

PortaScience Inc

Protagen AG

Queen Mary University of London

QuickCheck Health Inc

Singulex Inc

The Forsyth Institute

University of Canterbury

University of Colorado

University of Florida

University of South Florida

Xhale Inc

Yaathum Biotech Pvt Ltd

Diabetes Assays-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Diabetes Assays-Medical Devices Pipeline Assessment, 2018" provides an overview of Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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 Diabetes Assays 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.

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 6

2 Introduction 7

2.1 Diabetes Assays Overview 7

3 Products under Development 8

3.1 Diabetes Assays-Pipeline Products by Stage of Development 8

3.2 Diabetes Assays-Pipeline Products by Segment 9

3.3 Diabetes Assays-Pipeline Products by Territory 10

3.4 Diabetes Assays-Pipeline Products by Regulatory Path 11

3.5 Diabetes Assays-Pipeline Products by Estimated Approval Date 12

4 Diabetes Assays-Pipeline Products under Development by Companies 13

4.1 Diabetes Assays Companies-Pipeline Products by Stage of Development 13

4.2 Diabetes Assays-Pipeline Products by Stage of Development 15

5 Diabetes Assays Companies and Product Overview 17

5.1 Abcodia Ltd Company Overview 17

5.2 Abionic SA Company Overview 18

5.3 Achira Labs Pvt Ltd Company Overview 19

5.4 Adaptive Biotechnologies Corp Company Overview 20

5.5 Alfa Wassermann Inc Company Overview 21

5.6 Aura Biotechnologies Pvt Ltd Company Overview 22

5.7 Beckman Coulter Inc Company Overview 24

5.8 Biocrates Life Sciences AG Company Overview 29

5.9 Caprion Biosciences Inc Company Overview 31

5.10 Drexel University Company Overview 33

5.11 ELITechGroup Inc Company Overview 34

5.12 Enable Biosciences Inc Company Overview 36

5.13 Fujirebio Diagnostics Inc Company Overview 37

5.14 Genalyte Inc Company Overview 38

5.15 Helmholtz Centre for Infection Research Company Overview 39

5.16 ImmusanT Inc Company Overview 40

5.17 Janssen Pharmaceuticals Inc Company Overview 41

5.18 Johns Hopkins University Company Overview 42

5.19 Mellitus, LLC Company Overview 43

5.20 Mindray Medical International Ltd Company Overview 44

5.21 Numares AG Company Overview 46

5.22 Ortho-Clinical Diagnostics Inc Company Overview 47

5.23 PeriRx Inc Company Overview 52

5.24 PortaScience Inc Company Overview 53

5.25 Protagen AG Company Overview 54

5.26 Queen Mary University of London Company Overview 55

5.27 QuickCheck Health Inc Company Overview 56

5.28 Singulex Inc Company Overview 57

5.29 The Forsyth Institute Company Overview 58

5.30 University of Canterbury Company Overview 59

5.31 University of Colorado Company Overview 60

5.32 University of Florida Company Overview 62

5.33 University of South Florida Company Overview 63

5.34 Xhale Inc Company Overview 64

5.35 Yaathum Biotech Pvt Ltd Company Overview 65

6 Diabetes Assays- Recent Developments 66

6.1 Jun 01, 2018: ISBT Satellite Symposium Co-hosted by Ortho Clinical Diagnostics and Quotient Discusses Responding to the Challenges of Resource Constraints in Transfusion Diagnostics 66

6.2 May 08, 2018: Ortho Clinical Diagnostics Holds Summit to Help Asia-Pacific Lab Leaders Envision the Lab of the Future 67

6.3 Jan 25, 2018: Proteomics International Laboratories: Quarterly Business Update 67

6.4 Nov 22, 2017: Proteomics International strengthens Board and Business Development team 69

6.5 Oct 20, 2017: Asahi Kasei Pharma received 510(k) clearance from the FDA for Lucica Glycated Albumin-L 70

6.6 Oct 05, 2017: Mercodia Akurio Multiplex Used in a Recently Published Article 71

6.7 Aug 29, 2017: New technology could predict the risk of type 2 diabetes 71

6.8 Aug 16, 2017: HealPros and BioIQ Collaborate to Deliver a Comprehensive Diabetes Care Gap Closure Solution to Help Health Plans Improve Quality Ratings 72

6.9 Jul 18, 2017: Australian-first at-home blood test helping researchers delay and prevent onset of type 2 diabetes 73

6.10 Jul 18, 2017: Oramed Pharmaceuticals appoints vice president of medical affairs 74

6.11 Jul 17, 2017: EKF publish new diabetes and HbA1c testing guide 74

7 Appendix 76

7.1 Methodology 76

7.2 About GlobalData 79

7.3 Contact Us 79

7.4 Disclaimer 79


List Of Figure

1.2 List of Figures

Figure 1: Diabetes Assays-Pipeline Products by Stage of Development 8

Figure 2: Diabetes Assays-Pipeline Products by Segment 9

Figure 3: Diabetes Assays-Pipeline Products by Territory 10

Figure 4: Diabetes Assays-Pipeline Products by Regulatory Path 11

Figure 5: Diabetes Assays-Pipeline Products by Estimated Approval Date 12


List Of Table

1.1 List of Tables

Table 1: Diabetes Assays-Pipeline Products by Stage of Development 8

Table 2: Diabetes Assays-Pipeline Products by Segment 9

Table 3: Diabetes Assays-Pipeline Products by Territory 10

Table 4: Diabetes Assays-Pipeline Products by Regulatory Path 11

Table 5: Diabetes Assays-Pipeline Products by Estimated Approval Date 12

Table 6: Diabetes Assays Companies-Pipeline Products by Stage of Development 13

Table 7: Diabetes Assays-Pipeline Products by Stage of Development 15

Table 8: Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 17

Table 9: Molecular Biomarker-Diabetes-Product Status 17

Table 10: Molecular Biomarker-Diabetes-Product Description 17

Table 11: Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 18

Table 12: IVD CAPSULE-Diabetes Test-Product Status 18

Table 13: IVD CAPSULE-Diabetes Test-Product Description 18

Table 14: Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

Table 15: Diabetes Panel-Product Status 19

Table 16: Diabetes Panel-Product Description 19

Table 17: Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 20

Table 18: Pre-Symptomatic Biomarker-Type 1 Diabetes-Product Status 20

Table 19: Pre-Symptomatic Biomarker-Type 1 Diabetes-Product Description 20

Table 20: Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 21: ACE Alera Clinical Chemistry System-Direct A1c Assay-Product Status 21

Table 22: ACE Alera Clinical Chemistry System-Direct A1c Assay-Product Description 21

Table 23: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

Table 24: AURA Quant Glargine ELISA Kit-Product Status 22

Table 25: AURA Quant Glargine ELISA Kit-Product Description 22

Table 26: AURA Quant Human C-peptide Kit-Product Status 23

Table 27: AURA Quant Human C-peptide Kit-Product Description 23

Table 28: AURA Quant Human Insulin ELISA Kit-Product Status 23

Table 29: AURA Quant Human Insulin ELISA Kit-Product Description 23

Table 30: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 31: AU480 Clinical System-Next Generation HbA1c Assay-Product Status 24

Table 32: AU480 Clinical System-Next Generation HbA1c Assay-Product Description 25

Table 33: AU5810 Clinical System-Next-generation HbA1c Assay-Product Status 25

Table 34: AU5810 Clinical System-Next-generation HbA1c Assay-Product Description 25

Table 35: AU5820 Clinical System-Next-generation HbA1c Assay-Product Status 26

Table 36: AU5820 Clinical System-Next-generation HbA1c Assay-Product Description 26

Table 37: AU5830 Clinical System-Next-generation HbA1c Assay-Product Status 26

Table 38: AU5830 Clinical System-Next-generation HbA1c Assay-Product Description 27

Table 39: AU5840 Clinical System-Next-generation HbA1c Assay-Product Status 27

Table 40: AU5840 Clinical System-Next-generation HbA1c Assay-Product Description 27

Table 41: AU680 Clinical System-Next-generation HbA1c Assay-Product Status 28

Table 42: AU680 Clinical System-Next-generation HbA1c Assay-Product Description 28

Table 43: Biocrates Life Sciences AG Pipeline Products & Ongoing Clinical Trials Overview 29

Table 44: Diagnostic Assay-Type 2 Diabetes-Product Status 29

Table 45: Diagnostic Assay-Type 2 Diabetes-Product Description 29

Table 46: Metabolomic Biomarker Assay-Diabetes-Product Status 30

Table 47: Metabolomic Biomarker Assay-Diabetes-Product Description 30

Table 48: Caprion Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 49: Diagnostic Assay-Gestational Diabetes Progression-Product Status 31

Table 50: Diagnostic Assay-Gestational Diabetes Progression-Product Description 31

Table 51: Diagnostic Assay-Islet Cell Health-Product Status 32

Table 52: Diagnostic Assay-Islet Cell Health-Product Description 32

Table 53: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 33

Table 54: Diagnostic Assay-Diabetic Ulcers-Product Status 33

Table 55: Diagnostic Assay-Diabetic Ulcers-Product Description 33

Table 56: ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 57: Eon 100 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Status 34

Table 58: Eon 100 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Description 34

Table 59: Eon 300 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Status 35

Table 60: Eon 300 Automated Chemistry Analyzer-Hemoglobin A1c Assay-Product Description 35

Table 61: Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 62: ADAP Type1 Diabetes Assay-Product Status 36

Table 63: ADAP Type1 Diabetes Assay-Product Description 36

Table 64: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 65: Lumipulse G C-Peptide Assay Kit-Product Status 37

Table 66: Lumipulse G C-Peptide Assay Kit-Product Description 37

Table 67: Genalyte Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 68: Maverick Type 1 Diabetes (T1D) Assay Kit-Product Status 38

Table 69: Maverick Type 1 Diabetes (T1D) Assay Kit-Product Description 38

Table 70: Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 39

Table 71: Diagnostic Biomarker -Type 2 Diabetes-Product Status 39

Table 72: Diagnostic Biomarker -Type 2 Diabetes-Product Description 39

Table 73: ImmusanT Inc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 74: Diagnostic Test-Type 1 Diabetes-Product Status 40

Table 75: Diagnostic Test-Type 1 Diabetes-Product Description 40

Table 76: Janssen Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 77: Diagnostic Biomarker-Beta-cell Function-Product Status 41

Table 78: Diagnostic Biomarker-Beta-cell Function-Product Description 41

Table 79: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 42

Table 80: Screening Test-Gestational Diabetes-Product Status 42

Table 81: Screening Test-Gestational Diabetes-Product Description 42

Table 82: Mellitus, LLC Pipeline Products & Ongoing Clinical Trials Overview 43

Table 83: Blood Test-Gestational Diabetes-Product Status 43

Table 84: Blood Test-Gestational Diabetes-Product Description 43

Table 85: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 86: CL-2000i-C-peptide Test-Product Status 44

Table 87: CL-2000i-C-peptide Test-Product Description 44

Table 88: CL-2000i-Insulin Test-Product Status 45

Table 89: CL-2000i-Insulin Test-Product Description 45

Table 90: Numares AG Pipeline Products & Ongoing Clinical Trials Overview 46

Table 91: Diagnostic Test-Diabetes-Product Status 46

Table 92: Diagnostic Test-Diabetes-Product Description 46

Table 93: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 94: VITROS 3600-Insulin Assay-Product Status 47

Table 95: VITROS 3600-Insulin Assay-Product Description 48

Table 96: Vitros 4600/5,1 FS Chemistry System-Beta Hydroxybutrate Assay-Product Status 48

Table 97: Vitros 4600/5,1 FS Chemistry System-Beta Hydroxybutrate Assay-Product Description 48

Table 98: Vitros 5600 Integrated System-Beta Hydroxybutrate Assay-Product Status 49

Table 99: Vitros 5600 Integrated System-Beta Hydroxybutrate Assay-Product Description 49

Table 100: Vitros ECi-C-Peptide Assay-Product Status 49

Table 101: Vitros ECi-C-Peptide Assay-Product Description 49

Table 102: Vitros ECi-Insulin Assay-Product Status 50

Table 103: Vitros ECi-Insulin Assay-Product Description 50

Table 104: Vitros Insulin Assay-Product Status 50

Table 105: Vitros Insulin Assay-Product Description 51

Table 106: PeriRx Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 107: SaliMark D2-Product Status 52

Table 108: SaliMark D2-Product Description 52

Table 109: PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 110: HbA1c Blood Test-Product Status 53

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Products

Abcodia Ltd, Molecular Biomarker - Diabetes; Abionic SA, IVD CAPSULE - Diabetes Test; Achira Labs Pvt Ltd, Diabetes Panel; Adaptive Biotechnologies Corp, Pre - Symptomatic Biomarker - Type 1 Diabetes; Alfa Wassermann Inc, ACE Alera Clinical Chemistry System - Direct A1c Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Glargine ELISA Kit; Aura Biotechnologies Pvt Ltd, AURA Quant Human C-peptide Kit; Aura Biotechnologies Pvt Ltd, AURA Quant Human Insulin ELISA Kit; Beckman Coulter Inc, AU480 Clinical System - Next Generation HbA1c Assay; Beckman Coulter Inc, AU5810 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5820 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5830 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU5840 Clinical System - Next-generation HbA1c Assay; Beckman Coulter Inc, AU680 Clinical System - Next-generation HbA1c Assay; Biocrates Life Sciences AG, Diagnostic Assay - Type 2 Diabetes; Biocrates Life Sciences AG, Metabolomic Biomarker Assay - Diabetes; Caprion Biosciences Inc, Diagnostic Assay - Gestational Diabetes Progression; Caprion Biosciences Inc, Diagnostic Assay - Islet Cell Health; Drexel University, Diagnostic Assay - Diabetic Ulcers; ELITechGroup Inc, Eon 100 Automated Chemistry Analyzer - Hemoglobin A1c Assay; ELITechGroup Inc, Eon 300 Automated Chemistry Analyzer - Hemoglobin A1c Assay; Enable Biosciences Inc, ADAP Type1 Diabetes Assay; Fujirebio Diagnostics Inc, Lumipulse G C-Peptide Assay Kit; Genalyte Inc, Maverick Type 1 Diabetes (T1D) Assay Kit; Helmholtz Centre for Infection Research, Diagnostic Biomarker -Type 2 Diabetes; ImmusanT Inc, Diagnostic Test - Type 1 Diabetes; Janssen Pharmaceuticals Inc, Diagnostic Biomarker - Beta-cell Function; Johns Hopkins University, Screening Test - Gestational Diabetes; Mellitus, LLC, Blood Test - Gestational Diabetes; Mindray Medical International Ltd, CL-2000i - C-peptide Test; Mindray Medical International Ltd, CL-2000i - Insulin Test; Numares AG, Diagnostic Test - Diabetes; Ortho-Clinical Diagnostics Inc, VITROS 3600 - Insulin Assay; Ortho-Clinical Diagnostics Inc, Vitros 4600/5,1 FS Chemistry System - Beta Hydroxybutrate Assay; Ortho-Clinical Diagnostics Inc, Vitros 5600 Integrated System - Beta Hydroxybutrate Assay; Ortho-Clinical Diagnostics Inc, Vitros ECi - C-Peptide Assay; Ortho-Clinical Diagnostics Inc, Vitros ECi - Insulin Assay; Ortho-Clinical Diagnostics Inc, Vitros Insulin Assay; PeriRx Inc, SaliMark D2; PortaScience Inc, HbA1c Blood Test; Protagen AG, Diagnostic Assay - Type 1 Diabetes; Queen Mary University of London, Biomarker Assay - Type I Diabetes; QuickCheck Health Inc, Diagnostic Test - A1c; Singulex Inc, SMC Adiponectin Test; The Forsyth Institute, Saliva Based Diagnostic Assay - Metabolic Syndrome; University of Canterbury, Low Intensity Model Based Test - Insulin Resistance; University of Colorado, Diagnostic Test - Type 1 Diabetes; University of Colorado, IGRP Autoantibody Based Assay - Type-1 Diabetes; University of Florida, Diagnostic Assay - Diabetes; University of South Florida, Saliva Based Biomarker Assay - Diabetes; Xhale Inc, Oral Glucose Tolerance Test; Yaathum Biotech Pvt Ltd, Screening-Diagnostic-Prognostic Test - Diabetes


Companies

Abcodia Ltd

Abionic SA

Achira Labs Pvt Ltd

Adaptive Biotechnologies Corp

Alfa Wassermann Inc

Aura Biotechnologies Pvt Ltd

Beckman Coulter Inc

Biocrates Life Sciences AG

Caprion Biosciences Inc

Drexel University

ELITechGroup Inc

Enable Biosciences Inc

Fujirebio Diagnostics Inc

Genalyte Inc

Helmholtz Centre for Infection Research

ImmusanT Inc

Janssen Pharmaceuticals Inc

Johns Hopkins University

Mellitus, LLC

Mindray Medical International Ltd

Numares AG

Ortho-Clinical Diagnostics Inc

PeriRx Inc

PortaScience Inc

Protagen AG

Queen Mary University of London

QuickCheck Health Inc

Singulex Inc

The Forsyth Institute

University of Canterbury

University of Colorado

University of Florida

University of South Florida

Xhale Inc

Yaathum Biotech Pvt Ltd