Individual and Specified Hormones - Medical Devices Pipeline Assessment, 2018

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 Individual and Specified Hormones Overview 7

3 Products under Development 8

3.1 Individual and Specified Hormones-Pipeline Products by Stage of Development 8

3.2 Individual and Specified Hormones-Pipeline Products by Segment 9

3.3 Individual and Specified Hormones-Pipeline Products by Territory 10

3.4 Individual and Specified Hormones-Pipeline Products by Regulatory Path 11

3.5 Individual and Specified Hormones-Pipeline Products by Estimated Approval Date 12

4 Individual and Specified Hormones-Pipeline Products under Development by Companies 13

4.1 Individual and Specified Hormones Companies-Pipeline Products by Stage of Development 13

4.2 Individual and Specified Hormones-Pipeline Products by Stage of Development 14

5 Individual and Specified Hormones Companies and Product Overview 16

5.1 Alere Inc Company Overview 16

5.2 AMS Diagnostics LLC Company Overview 17

5.3 Beckman Coulter Inc Company Overview 19

5.4 Carolina Liquid Chemistries Corp Company Overview 20

5.5 Ceres Nanosciences Inc Company Overview 22

5.6 Columbia University Company Overview 23

5.7 DiaSorin SpA Company Overview 24

5.8 DIAsource ImmunoAssays SA Company Overview 27

5.9 Fujirebio Diagnostics Inc Company Overview 29

5.10 Immunodiagnostic Systems Holdings plc Company Overview 30

5.11 Mindray Medical International Ltd Company Overview 33

5.12 Novartis AG Company Overview 39

5.13 OJ-Bio Ltd Company Overview 40

5.14 Roche Diagnostics International Ltd Company Overview 41

5.15 Sendera Discovery Company Overview 51

5.16 Siemens Healthcare GmbH Company Overview 52

5.17 Thermo Fisher Scientific Inc Company Overview 59

5.18 Tosoh Bioscience Inc Company Overview 60

6 Individual and Specified Hormones- Recent Developments 61

6.1 Jun 20, 2018: Immunodiagnostic Systems: Final Results for year ended 31 March 2018 61

6.2 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 65

6.3 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

6.4 May 08, 2018: The Diasorin Group Reports Growth in Revenues and Profitability in the First Quarter 2018 67

6.5 May 08, 2018: Ortho Clinical Diagnostics Holds Summit to Help Asia-Pacific Lab Leaders Envision the Lab of the Future 69

6.6 May 07, 2018: Luminex Announces First Quarter 2018 Financial Results 70

6.7 May 03, 2018: Siemens Healthineers fully on track to meet the targets 70

6.8 Apr 23, 2018: Science Start-Ups Gain Strong Momentum at the Prince William Science Accelerator 71

6.9 Apr 18, 2018: Abbott Reports First-Quarter 2018 Results 72

6.10 Mar 26, 2018: New Study Highlights the Use of MR-proADM in Assessing Disease Severity and Treatment Response in Patients with Sepsis and Septic Shock 75

6.11 Mar 21, 2018: Immunodiagnostic Systems Holdings: Directorate Change 2018 75

6.12 Feb 12, 2018: Luminex Reports Fourth Quarter and Full-Year 2017 Financial Results 76

6.13 Jan 30, 2018: Siemens Healthineers Names Deepak Nath Head of Laboratory Diagnostics 76

6.14 Jan 24, 2018: Abbott Reports Fourth-Quarter 2017 Results 77

6.15 Jan 22, 2018: FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers 79

6.16 Nov 29, 2017: Siemens plans to list Siemens Healthineers on Frankfurt Stock Exchange 80

6.17 Nov 24, 2017: Immunodiagnostic Systems Holdings: Unaudited Interim Results for the six month period ended 30 September 2017 80

6.18 Nov 09, 2017: Growth In Revenues And Net Profit In Q3 2017. Strong Free Cash Flow Generation. 2017 Guidance Confirmed 87

6.19 Oct 31, 2017: Immunodiagnostic Systems Holdings: Directorate Change 88

6.20 Oct 30, 2017: Luminex Reports Third Quarter 2017 Financial Results 89

6.21 Oct 20, 2017: Immunodiagnostic Systems Holdings: H1 Trading Update 2017 90

6.22 Oct 18, 2017: Abbott Reports Third-Quarter 2017 Results 91

6.23 Sep 22, 2017: Abbott and the Abbott Fund Provide USD2 Million in Additional Relief to Help Families Affected by Hurricane Maria and the Earthquake in Central Mexico 94

6.24 Sep 18, 2017: Abbott and the Abbott Fund Expand Support for Hurricane Relief With USD1 Million to Help Families Affected by Hurricane Irma 95

6.25 Sep 07, 2017: Abbott Named Industry Leader for Responsible and Sustainable Business for Five Consecutive Years on the Dow Jones Sustainability Index 95

6.26 Aug 29, 2017: Abbott and the Abbott Fund Donate USD1 Million to Support Hurricane Harvey Relief Efforts 96

6.27 Aug 07, 2017: Luminex Reports Second Quarter 2017 Financial Results 96

6.28 Aug 03, 2017: Diasorin Group Reports Strong Growth in Revenues and Profitability in Q2 2017 97

6.29 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 100

7 Appendix 103

7.1 Methodology 103

7.2 About GlobalData 106

7.3 Contact Us 106

7.4 Disclaimer 106

List Of Figure

1.2 List of Figures

Figure 1: Individual and Specified Hormones-Pipeline Products by Stage of Development 8

Figure 2: Individual and Specified Hormones-Pipeline Products by Segment 9

Figure 3: Individual and Specified Hormones-Pipeline Products by Territory 10

Figure 4: Individual and Specified Hormones-Pipeline Products by Regulatory Path 11

Figure 5: Individual and Specified Hormones-Pipeline Products by Estimated Approval Date 12

List Of Table

1.1 List of Tables

Table 1: Individual and Specified Hormones-Pipeline Products by Stage of Development 8

Table 2: Individual and Specified Hormones-Pipeline Products by Segment 9

Table 3: Individual and Specified Hormones-Pipeline Products by Territory 10

Table 4: Individual and Specified Hormones-Pipeline Products by Regulatory Path 11

Table 5: Individual and Specified Hormones-Pipeline Products by Estimated Approval Date 12

Table 6: Individual and Specified Hormones Companies-Pipeline Products by Stage of Development 13

Table 7: Individual and Specified Hormones-Pipeline Products by Stage of Development 14

Table 8: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 16

Table 9: Vitamin D Assay-Product Status 16

Table 10: Vitamin D Assay-Product Description 16

Table 11: AMS Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 17

Table 12: LIASYS 330-Vitamin D Assay-Product Status 17

Table 13: LIASYS 330-Vitamin D Assay-Product Description 17

Table 14: Liasys 450-Vitamin D Assay-Product Status 17

Table 15: Liasys 450-Vitamin D Assay-Product Description 18

Table 16: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 17: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Status 19

Table 18: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Description 19

Table 19: Carolina Liquid Chemistries Corp Pipeline Products & Ongoing Clinical Trials Overview 20

Table 20: CLC 480 Analyzer-Vitamin D Assay-Product Status 20

Table 21: CLC 480 Analyzer-Vitamin D Assay-Product Description 20

Table 22: CLC 720i Analyzer-Vitamin D Assay-Product Status 21

Table 23: CLC 720i Analyzer-Vitamin D Assay-Product Description 21

Table 24: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Table 25: Nanotrap Human Growth Hormone Test-Product Status 22

Table 26: Nanotrap Human Growth Hormone Test-Product Description 22

Table 27: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 23

Table 28: Diagnostic Test-Menopause-Product Status 23

Table 29: Diagnostic Test-Menopause-Product Description 23

Table 30: DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 24

Table 31: LIAISON-High Sclerostin Assay-Product Status 24

Table 32: LIAISON-High Sclerostin Assay-Product Description 25

Table 33: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Status 25

Table 34: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Description 25

Table 35: LIAISON XL-Sclerostin Assay-Product Status 26

Table 36: LIAISON XL-Sclerostin Assay-Product Description 26

Table 37: DIAsource ImmunoAssays SA Pipeline Products & Ongoing Clinical Trials Overview 27

Table 38: 25-OH Vitamin D Total ELISA Test-Product Status 27

Table 39: 25-OH Vitamin D Total ELISA Test-Product Description 28

Table 40: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 41: Lumipulse G1200-Whole PTH-Product Status 29

Table 42: Lumipulse G1200-Whole PTH-Product Description 29

Table 43: Immunodiagnostic Systems Holdings plc Pipeline Products & Ongoing Clinical Trials Overview 30

Table 44: IDS-iSYS Cortisol Assay-Product Status 30

Table 45: IDS-iSYS Cortisol Assay-Product Description 30

Table 46: IDS-iSYS Intact PINP Assay-Product Status 31

Table 47: IDS-iSYS Intact PINP Assay-Product Description 31

Table 48: IDS-iSYS MGP Assay-Product Status 31

Table 49: IDS-iSYS MGP Assay-Product Description 32

Table 50: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Table 51: CL-1000i-Calcitonin Test-Product Status 33

Table 52: CL-1000i-Calcitonin Test-Product Description 33

Table 53: CL-1000i-Intact PTH Test-Product Status 34

Table 54: CL-1000i-Intact PTH Test-Product Description 34

Table 55: CL-1000i-Vitamin D Total Test-Product Status 34

Table 56: CL-1000i-Vitamin D Total Test-Product Description 35

Table 57: CL-2000i-ACTH Test-Product Status 35

Table 58: CL-2000i-ACTH Test-Product Description 35

Table 59: CL-2000i-Calcitonin Test-Product Status 36

Table 60: CL-2000i-Calcitonin Test-Product Description 36

Table 61: CL-2000i-Cortisol Test-Product Status 36

Table 62: CL-2000i-Cortisol Test-Product Description 37

Table 63: CL-2000i-PTH Test-Product Status 37

Table 64: CL-2000i-PTH Test-Product Description 37

Table 65: CL-2000i-Vitamin D Total Test-Product Status 38

Table 66: CL-2000i-Vitamin D Total Test-Product Description 38

Table 67: Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 39

Table 68: Rapid Diagnostic Test-Vitamin D-Product Status 39

Table 69: Rapid Diagnostic Test-Vitamin D-Product Description 39

Table 70: OJ-Bio Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

Table 71: Parathyroid Hormone Assay-Product Status 40

Table 72: Parathyroid Hormone Assay-Product Description 40

Table 73: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

Table 74: Cobas 4000 Analyzer Series With e 411 Module-IGF-1 Assay-Product Status 42

Table 75: Cobas 4000 Analyzer Series With e 411 Module-IGF-1 Assay-Product Description 42

Table 76: Cobas 6000 Analyzer Series With c 501 Module-IGF BP3 Assay-Product Status 42

Table 77: Cobas 6000 Analyzer Series With c 501 Module-IGF BP3 Assay-Product Description 43

Table 78: Cobas 6000 Analyzer Series With c 501 Module-IGF-1 Assay-Product Status 43

Table 79: Cobas 6000 Analyzer Series With c 501 Module-IGF-1 Assay-Product Description 43

Table 80: Cobas 6000 Analyzer Series With e 601 Module-IGF BP3 Assay-Product Status 43

Table 81: Cobas 6000 Analyzer Series With e 601 Module-IGF BP3 Assay-Product Description 44

Table 82: Cobas 6000 Analyzer Series With e 601 Module-IGF-1 Assay-Product Status 44

Table 83: Cobas 6000 Analyzer Series With e 601 Module-IGF-1 Assay-Product Description 44

Table 84: Cobas 8000 Analyzer Series With c 502 Module-IGF BP3 Assay-Product Status 45

Table 85: Cobas 8000 Analyzer Series With c 502 Module-IGF BP3 Assay-Product Description 45

Table 86: Cobas 8000 Analyzer Series With c 502 Module-IGF-1 Assay-Product Status 45

Table 87: Cobas 8000 Analyzer Series With c 502 Module-IGF-1 Assay-Product Description 46

Table 88: Cobas 8000 Analyzer Series With c 701 Module-IGF BP3 Assay-Product Status 46

Table 89: Cobas 8000 Analyzer Series With c 701 Module-IGF BP3 Assay-Product Description 46

Table 90: Cobas 8000 Analyzer Series With c 701 Module-IGF-1-Product Status 47

Table 91: Cobas 8000 Analyzer Series With c 701 Module-IGF-1-Product Description 47

Table 92: Cobas 8000 Analyzer Series With c 702 Module-IGF-1 Assay-Product Status 47

Table 93: Cobas 8000 Analyzer Series With c 702 Module-IGF-1 Assay-Product Description 48

Table 94: Cobas 8000 Analyzer Series With e 602 Module-IGF BP3 Assay-Product Status 48

Table 95: Cobas 8000 Analyzer Series With e 602 Module-IGF BP3 Assay-Product Description 48

Table 96: Cobas 8000 Analyzer Series With e 602 Module-IGF-1 Assay-Product Status 49

Table 97: Cobas 8000 Analyzer Series With e 602 Module-IGF-1 Assay-Product Description 49

Table 98: Cobas 8000 Analyzer Series With e 801 Module-IGF BP3 Assay-Product Status 49

Table 99: Cobas 8000 Analyzer Series With e 801 Module-IGF BP3 Assay-Product Description 50

Table 100: Cobas 8000 Analyzer Series With e 801 Module-IGF-1 Assay-Product Status 50

Table 101: Cobas 8000 Analyzer Series With e 801 Module-IGF-1 Assay-Product Description 50

Table 102: Sendera Discovery Pipeline Products & Ongoing Clinical Trials Overview 51

Table 103: In-Vitro Diagnostic Kit-Androgen Replacement Therapy-Product Status 51

Table 104: In-Vitro Diagnostic Kit-Androgen Replacement Therapy-Product Description 51

Table 105: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 52

Table 106: ADVIA Centaur CP Immunoassay System-Vitamin D Assay-Product Status 52

Table 107: ADVIA Centaur CP Immunoassay System-Vitamin D Assay-Product Description 53

Table 108: Dimension EXL 200 Integrated Chemistry System-LOCI IPTH-Product Status 53

Table 109: Dimension EXL 200 Integrated Chemistry System-LOCI IPTH-Product Description 53

Table 110: Dimension EXL 200 Integrated Chemistry System-Vitamin D Assay-Product Status 54

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