Fujirebio Diagnostics Inc - Product Pipeline Analysis, 2018 Update

Fujirebio Diagnostics Inc - Product Pipeline Analysis, 2018 Update


  • Products Id :- GDME2171PD
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  • Pages: 78
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Executive Summary

Summary

Fujirebio Diagnostics Inc (FDI), a subsidiary of Fujirebio Inc is a healthcare diagnostic company that manufactures, markets and develops biomarker assays and in-vitro diagnostic products. The company's products include OEM custom solutions, manual kits, serum products, multi-constituent controls, EIA kits, and other test kits, among others. Its serum products comprise enzyme conjugate stabilizer, glycated human hemoglobin animal serums, and nonglycated human haemoglobin, among others. FDI also provides reagents and controls, and manual assay products, among others. The company offers elisa antibody and antigen kits. It has its operations through its offices located in the US, Italy and Russia. FDI is headquartered in Malvern, Pennsylvania, the US.

This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

Scope:

- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments

- The report analyzes all pipeline products in development for the company Fujirebio Diagnostics Inc

- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)

- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date

- The report provides detailed description of products in development, technical specification and functions

- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.

Reasons to Buy:

- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape

- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio

- To formulate effective Research & Development strategies

- Develop market-entry and market expansion strategies

- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return

- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

- Develop competition strategies by identifying the status and likely launch of the competitors' pipeline products through review of the clinical trials, stage and of development, etc

- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio

Note: Some sections may be missing if data is unavailable for the company



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Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 7

Fujirebio Diagnostics Inc Company Overview 8

Fujirebio Diagnostics Inc Company Snapshot 8

Fujirebio Diagnostics Inc Pipeline Products and Ongoing Clinical Trials Overview 8

Fujirebio Diagnostics Inc - Pipeline Analysis Overview 11

Fujirebio Diagnostics Inc - Key Facts 11

Fujirebio Diagnostics Inc - Major Products and Services 12

Fujirebio Diagnostics Inc Pipeline Products by Development Stage 13

Fujirebio Diagnostics Inc Pipeline Products Overview 16

Lumipulse G - AFP Assay 16

Lumipulse G - AFP Assay Product Overview 16

Lumipulse G - ApoB48 Assay Kit 17

Lumipulse G - ApoB48 Assay Kit Product Overview 17

Lumipulse G - CA15-3 Assay Kit 18

Lumipulse G - CA15-3 Assay Kit Product Overview 18

Lumipulse G - CA19-9 Assay 19

Lumipulse G - CA19-9 Assay Product Overview 19

Lumipulse G - CEA Assay 20

Lumipulse G - CEA Assay Product Overview 20

Lumipulse G - CYFRA Assay 21

Lumipulse G - CYFRA Assay Product Overview 21

Lumipulse G - Free PSA Assay 22

Lumipulse G - Free PSA Assay Product Overview 22

Lumipulse G - FT3 Assay 23

Lumipulse G - FT3 Assay Product Overview 23

Lumipulse G - FT4 Assay 24

Lumipulse G - FT4 Assay Product Overview 24

Lumipulse G - HAVAb Assay Kit 25

Lumipulse G - HAVAb Assay Kit Product Overview 25

Lumipulse G - HAVIgM Assay Kit 26

Lumipulse G - HAVIgM Assay Kit Product Overview 26

Lumipulse G - HBcIgM Assay Kit 27

Lumipulse G - HBcIgM Assay Kit Product Overview 27

Lumipulse G - HBcrAg Assay Kit 28

Lumipulse G - HBcrAg Assay Kit Product Overview 28

Lumipulse G - HbeAg Assay Kit 29

Lumipulse G - HbeAg Assay Kit Product Overview 29

Lumipulse G - HBsAb Assay Kit 30

Lumipulse G - HBsAb Assay Kit Product Overview 30

Lumipulse G - HBsAg-Qualitative Assay Kit 31

Lumipulse G - HBsAg-Qualitative Assay Kit Product Overview 31

Lumipulse G - HBsAg-Qualitative Confirmation Assay 32

Lumipulse G - HBsAg-Qualitative Confirmation Assay Product Overview 32

Lumipulse G - HBsAg-Quant Assay Kit 33

Lumipulse G - HBsAg-Quant Assay Kit Product Overview 33

Lumipulse G - HBsAg-Quant Confirmation Assay Kit 34

Lumipulse G - HBsAg-Quant Confirmation Assay Kit Product Overview 34

Lumipulse G - HCV Ab Assay Kit 35

Lumipulse G - HCV Ab Assay Kit Product Overview 35

Lumipulse G - HCV Ag Assay Kit 36

Lumipulse G - HCV Ag Assay Kit Product Overview 36

Lumipulse G - HIV 1/2 Assay Kit 37

Lumipulse G - HIV 1/2 Assay Kit Product Overview 37

Lumipulse G - HIV-1p24 Assay Kit 38

Lumipulse G - HIV-1p24 Assay Kit Product Overview 38

Lumipulse G - HIVAg/Ab Assay Kit 39

Lumipulse G - HIVAg/Ab Assay Kit Product Overview 39

Lumipulse G - HTLV-l Assay Kit 40

Lumipulse G - HTLV-l Assay Kit Product Overview 40

Lumipulse G - IL-6 Assay 41

Lumipulse G - IL-6 Assay Product Overview 41

Lumipulse G - L- FABP Assay 42

Lumipulse G - L- FABP Assay Product Overview 42

Lumipulse G - NCC-ST439 Assay 43

Lumipulse G - NCC-ST439 Assay Product Overview 43

Lumipulse G - PIVKA-II Assay 44

Lumipulse G - PIVKA-II Assay Product Overview 44

Lumipulse G - PLAP Assay Kit 45

Lumipulse G - PLAP Assay Kit Product Overview 45

Lumipulse G - PSA Assay Kit 46

Lumipulse G - PSA Assay Kit Product Overview 46

Lumipulse G - 2M (S) Assay 47

Lumipulse G - 2M (S) Assay Product Overview 47

Lumipulse G - 2M (U) Assay 48

Lumipulse G - 2M (U) Assay Product Overview 48

Lumipulse G - T3 Assay 49

Lumipulse G - T3 Assay Product Overview 49

Lumipulse G - T4 Assay 50

Lumipulse G - T4 Assay Product Overview 50

Lumipulse G - TgAb Assay 51

Lumipulse G - TgAb Assay Product Overview 51

Lumipulse G - TP Assay 52

Lumipulse G - TP Assay Product Overview 52

Lumipulse G - TPOAb Assay 53

Lumipulse G - TPOAb Assay Product Overview 53

Lumipulse G C-Peptide Assay Kit 54

Lumipulse G C-Peptide Assay Kit Product Overview 54

Lumipulse G1200 - AMH 55

Lumipulse G1200 - AMH Product Overview 55

Lumipulse G1200 - Estradiol Assay 56

Lumipulse G1200 - Estradiol Assay Product Overview 56

Lumipulse G1200 - FSH Test 57

Lumipulse G1200 - FSH Test Product Overview 57

Lumipulse G1200 - HTLV I/II Test 58

Lumipulse G1200 - HTLV I/II Test Product Overview 58

Lumipulse G1200 - Myoglobin 59

Lumipulse G1200 - Myoglobin Product Overview 59

Lumipulse G1200 - Progestrone Test 60

Lumipulse G1200 - Progestrone Test Product Overview 60

Lumipulse G1200 - pTAU 61

Lumipulse G1200 - pTAU Product Overview 61

Lumipulse G1200 - -amyloid 1-42 62

Lumipulse G1200 - -amyloid 1-42 Product Overview 62

Lumipulse G1200 - Testosterone Assay 63

Lumipulse G1200 - Testosterone Assay Product Overview 63

Lumipulse G1200 - Total -HCG Assay 64

Lumipulse G1200 - Total -HCG Assay Product Overview 64

Lumipulse G1200 - Troponin I 65

Lumipulse G1200 - Troponin I Product Overview 65

Lumipulse G1200 - Whole PTH 66

Lumipulse G1200 - Whole PTH Product Overview 66

Fujirebio Diagnostics Inc - Key Competitors 67

Fujirebio Diagnostics Inc - Key Employees 68

Fujirebio Diagnostics Inc - Locations And Subsidiaries 69

Head Office 69

Other Locations & Subsidiaries 69

Recent Developments 70

Fujirebio Diagnostics Inc, Recent Developments 70

Jun 12, 2018: Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G BRAHMS PCT Assay 70

Jun 18, 2015: Fujirebio Europe Releases The Lumipulse G He4 Assay Dedicated To Ovarian Cancer Therapy Monitoring And Conservative Management Of Women With Pelvic Mass 70

Sep 06, 2011: Fujirebio Receives FDA 510 (k) Clearance For ROMA (HE4 EIA + ARCHITECT CA 125 II) Test To Monitor Ovarian Cancer 70

Jun 06, 2011: Fujirebio Reports New Publication Validates Use Of HE4 In Evaluating Risk Of Ovarian Cancer 71

May 31, 2011: Fujirebio Receives FDA 510 (k) Clearance For CYFRA 21-1 EIA Assay To Monitor Lung Cancer 72

Mar 23, 2009: Fujirebio Diagnostics Appoints Grady Barnes As CSO 72

Feb 11, 2009: Fujirebio Diagnostics` Risk Of Ovarian Malignancy Algorithm(ROMA) In Combination With Biomarker Demonstrates Accuracy In Detecting Ovarian Cancer 72

Jan 26, 2009: Fujirebo Diagnostics Reports Published Pivotal Data For First Biomarker Combination Test 73

Sep 16, 2008: Quest Diagnostics And Fujirebio Diagnostics Announce Availability Of New FDA-Cleared Blood-Based Test For Ovarian Cancer 73

Jun 19, 2008: Fujirebio Diagnostics Receives FDA Clearance For The HE4 EIA Assay For The Monitoring Of patients With Ovarian Cancer 74

Appendix 75

Methodology 75

About GlobalData 78

Contact Us 78

Disclaimer 78

List of Figures

Fujirebio Diagnostics Inc Pipeline Products by Equipment Type 9

Fujirebio Diagnostics Inc Pipeline Products by Development Stage 13

List of Tables

Fujirebio Diagnostics Inc Pipeline Products and Ongoing Clinical Trials Overview 8

Fujirebio Diagnostics Inc Pipeline Products by Equipment Type 9

Fujirebio Diagnostics Inc Pipeline Products by Indication 10

Fujirebio Diagnostics Inc, Key Facts 11

Fujirebio Diagnostics Inc, Major Products and Services 12

Fujirebio Diagnostics Inc Number of Pipeline Products by Development Stage 13

Fujirebio Diagnostics Inc Pipeline Products Summary by Development Stage 14

Lumipulse G - AFP Assay - Product Status 16

Lumipulse G - AFP Assay - Product Description 16

Lumipulse G - ApoB48 Assay Kit - Product Status 17

Lumipulse G - ApoB48 Assay Kit - Product Description 17

Lumipulse G - CA15-3 Assay Kit - Product Status 18

Lumipulse G - CA15-3 Assay Kit - Product Description 18

Lumipulse G - CA19-9 Assay - Product Status 19

Lumipulse G - CA19-9 Assay - Product Description 19

Lumipulse G - CEA Assay - Product Status 20

Lumipulse G - CEA Assay - Product Description 20

Lumipulse G - CYFRA Assay - Product Status 21

Lumipulse G - CYFRA Assay - Product Description 21

Lumipulse G - Free PSA Assay - Product Status 22

Lumipulse G - Free PSA Assay - Product Description 22

Lumipulse G - FT3 Assay - Product Status 23

Lumipulse G - FT3 Assay - Product Description 23

Lumipulse G - FT4 Assay - Product Status 24

Lumipulse G - FT4 Assay - Product Description 24

Lumipulse G - HAVAb Assay Kit - Product Status 25

Lumipulse G - HAVAb Assay Kit - Product Description 25

Lumipulse G - HAVIgM Assay Kit - Product Status 26

Lumipulse G - HAVIgM Assay Kit - Product Description 26

Lumipulse G - HBcIgM Assay Kit - Product Status 27

Lumipulse G - HBcIgM Assay Kit - Product Description 27

Lumipulse G - HBcrAg Assay Kit - Product Status 28

Lumipulse G - HBcrAg Assay Kit - Product Description 28

Lumipulse G - HbeAg Assay Kit - Product Status 29

Lumipulse G - HbeAg Assay Kit - Product Description 29

Lumipulse G - HBsAb Assay Kit - Product Status 30

Lumipulse G - HBsAb Assay Kit - Product Description 30

Lumipulse G - HBsAg-Qualitative Assay Kit - Product Status 31

Lumipulse G - HBsAg-Qualitative Assay Kit - Product Description 31

Lumipulse G - HBsAg-Qualitative Confirmation Assay - Product Status 32

Lumipulse G - HBsAg-Qualitative Confirmation Assay - Product Description 32

Lumipulse G - HBsAg-Quant Assay Kit - Product Status 33

Lumipulse G - HBsAg-Quant Assay Kit - Product Description 33

Lumipulse G - HBsAg-Quant Confirmation Assay Kit - Product Status 34

Lumipulse G - HBsAg-Quant Confirmation Assay Kit - Product Description 34

Lumipulse G - HCV Ab Assay Kit - Product Status 35

Lumipulse G - HCV Ab Assay Kit - Product Description 35

Lumipulse G - HCV Ag Assay Kit - Product Status 36

Lumipulse G - HCV Ag Assay Kit - Product Description 36

Lumipulse G - HIV 1/2 Assay Kit - Product Status 37

Lumipulse G - HIV 1/2 Assay Kit - Product Description 37

Lumipulse G - HIV-1p24 Assay Kit - Product Status 38

Lumipulse G - HIV-1p24 Assay Kit - Product Description 38

Lumipulse G - HIVAg/Ab Assay Kit - Product Status 39

Lumipulse G - HIVAg/Ab Assay Kit - Product Description 39

Lumipulse G - HTLV-l Assay Kit - Product Status 40

Lumipulse G - HTLV-l Assay Kit - Product Description 40

Lumipulse G - IL-6 Assay - Product Status 41

Lumipulse G - IL-6 Assay - Product Description 41

Lumipulse G - L- FABP Assay - Product Status 42

Lumipulse G - L- FABP Assay - Product Description 42

Lumipulse G - NCC-ST439 Assay - Product Status 43

Lumipulse G - NCC-ST439 Assay - Product Description 43

Lumipulse G - PIVKA-II Assay - Product Status 44

Lumipulse G - PIVKA-II Assay - Product Description 44

Lumipulse G - PLAP Assay Kit - Product Status 45

Lumipulse G - PLAP Assay Kit - Product Description 45

Lumipulse G - PSA Assay Kit - Product Status 46

Lumipulse G - PSA Assay Kit - Product Description 46

Lumipulse G - 2M (S) Assay - Product Status 47

Lumipulse G - 2M (S) Assay - Product Description 47

Lumipulse G - 2M (U) Assay - Product Status 48

Lumipulse G - 2M (U) Assay - Product Description 48

Lumipulse G - T3 Assay - Product Status 49

Lumipulse G - T3 Assay - Product Description 49

Lumipulse G - T4 Assay - Product Status 50

Lumipulse G - T4 Assay - Product Description 50

Lumipulse G - TgAb Assay - Product Status 51

Lumipulse G - TgAb Assay - Product Description 51

Lumipulse G - TP Assay - Product Status 52

Lumipulse G - TP Assay - Product Description 52

Lumipulse G - TPOAb Assay - Product Status 53

Lumipulse G - TPOAb Assay - Product Description 53

Lumipulse G C-Peptide Assay Kit - Product Status 54

Lumipulse G C-Peptide Assay Kit - Product Description 54

Lumipulse G1200 - AMH - Product Status 55

Lumipulse G1200 - AMH - Product Description 55

Lumipulse G1200 - Estradiol Assay - Product Status 56

Lumipulse G1200 - Estradiol Assay - Product Description 56

Lumipulse G1200 - FSH Test - Product Status 57

Lumipulse G1200 - FSH Test - Product Description 57

Lumipulse G1200 - HTLV I/II Test - Product Status 58

Lumipulse G1200 - HTLV I/II Test - Product Description 58

Lumipulse G1200 - Myoglobin - Product Status 59

Lumipulse G1200 - Myoglobin - Product Description 59

Lumipulse G1200 - Progestrone Test - Product Status 60

Lumipulse G1200 - Progestrone Test - Product Description 60

Lumipulse G1200 - pTAU - Product Status 61

Lumipulse G1200 - pTAU - Product Description 61

Lumipulse G1200 - -amyloid 1-42 - Product Status 62

Lumipulse G1200 - -amyloid 1-42 - Product Description 62

Lumipulse G1200 - Testosterone Assay - Product Status 63

Lumipulse G1200 - Testosterone Assay - Product Description 63

Lumipulse G1200 - Total -HCG Assay - Product Status 64

Lumipulse G1200 - Total -HCG Assay - Product Description 64

Lumipulse G1200 - Troponin I - Product Status 65

Lumipulse G1200 - Troponin I - Product Description 65

Lumipulse G1200 - Whole PTH - Product Status 66

Lumipulse G1200 - Whole PTH - Product Description 66

Fujirebio Diagnostics Inc, Key Employees 68

Fujirebio Diagnostics Inc, Subsidiaries 69

Glossary 77

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