カテゴリ： GlobalData, アメリカ, 企業調査

Fujirebio Diagnostics Inc：企業の製品パイプライン分析2018

◆英語タイトル：Fujirebio Diagnostics Inc - Product Pipeline Analysis, 2018 Update
◆商品コード：DATA904C2872
◆発行会社（調査会社）：GlobalData
◆発行日：2018年8月
◆ページ数：78
◆レポート言語：英語
◆レポート形式：PDF
◆納品方法：Eメール
◆対象地域：アメリカ
◆産業分野：医療機器
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【レポートの概要】

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

【レポートの目次】

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 – ß2M (S) Assay 47
Lumipulse G – ß2M (S) Assay Product Overview 47
Lumipulse G – ß2M (U) Assay 48
Lumipulse G – ß2M (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 – ß-amyloid 1-42 62
Lumipulse G1200 – ß-amyloid 1-42 Product Overview 62
Lumipulse G1200 – Testosterone Assay 63
Lumipulse G1200 – Testosterone Assay Product Overview 63
Lumipulse G1200 – Total ß-HCG Assay 64
Lumipulse G1200 – Total ß-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 B•R•A•H•M•S 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 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 - ß2M (S) Assay - Product Status 47
Lumipulse G - ß2M (S) Assay - Product Description 47
Lumipulse G - ß2M (U) Assay - Product Status 48
Lumipulse G - ß2M (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 - ß-amyloid 1-42 - Product Status 62
Lumipulse G1200 - ß-amyloid 1-42 - Product Description 62
Lumipulse G1200 - Testosterone Assay - Product Status 63
Lumipulse G1200 - Testosterone Assay - Product Description 63
Lumipulse G1200 - Total ß-HCG Assay - Product Status 64
Lumipulse G1200 - Total ß-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

List of Figures
Fujirebio Diagnostics Inc Pipeline Products by Equipment Type 9
Fujirebio Diagnostics Inc Pipeline Products by Development Stage 13

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