Specific Proteins Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Published: October 27, 2022 Report Code: GDME1464EPD-ST

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Specific Proteins are reagents and test kits that are used to quantify and detect protein molecules from bodily fluids. The Specific Proteins pipeline market research report provides comprehensive information about the Specific Proteins pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Specific Proteins Pipeline Products Market Segmentation by Territories

Some of the key territories with products in the pipeline are the US, India, China, and Europe. As of October 2022, the US has the highest number of products in the pipeline out of them all.

Specific Proteins Pipeline Products Market Analysis, by Territories, 2022 (%)

Specific Proteins Pipeline Products Market Analysis, by Territories

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Specific Proteins Pipeline Products Market Segmentation by Regulatory Paths

The key regulatory paths followed by the Specific Proteins pipeline products market are 510(k), CE-IVD, ICAC, and NMPA. Most of the products follow the 510(k) pathway to enter the market.

Specific Proteins Pipeline Products Market Analysis, by Regulatory Paths, 2022 (%)

Specific Proteins Pipeline Products Market Analysis, by Regulatory Paths

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Competitive Landscape

Some of the key companies in the Specific Proteins pipeline products market are Alfa Wassermann Diagnostic Technologies, LLC, Amerimmune LLC, Beckman Coulter Inc, China Medical Technologies Inc (Inactive), Colorado State University, Fujirebio Diagnostics Inc, Genesis Detection Systems, Inc., Guanine Inc, Hologic Inc, and Isoformix Inc.

Amerimmune LLC: It is a pharmaceutical and healthcare company that identifies and develops tests within the clinic’s in-office lab. The company also offers solutions that include product development, quality assurance, diagnostic, real-world data solution, and consulting. It also develops the laboratory manual, basic tests, pipeline tests, and all necessary validation that ranges in CAP and CLIA-approved laboratories. Amerimmune is headquartered in Fairfax, Virginia, the US.

Beckman Coulter Inc: It is a manufacturer of biomedical testing instrument systems that develops, manufactures, and markets biomedical laboratory instruments, software, and other things that simplify and automate complex biomedical tests. The company also provides scientific solutions for laboratory customers such as universities, biotechnology and pharmaceutical companies, government, hospitals, and commercial laboratories. Beckman is headquartered in Brea, California, the US. 

China Medical Technologies Inc: It is engaged in the development, manufacture, and marketing of in-vitro diagnostics (IVD) products for the treatment of solid cancers and benign tumors. The company focuses on research and development activities to develop new applications and improve the product designs of its existing immunodiagnostic systems and molecular diagnostic systems. China Medical is headquartered in Beijing, China.

Specific Proteins Pipeline Products Market Report Overview

Key Territories The US, India, China, and Europe
Key Regulatory Paths 510(k), CE-IVD, ICAC, and NMPA
Key Companies Alfa Wassermann Diagnostic Technologies, LLC, Amerimmune LLC, Beckman Coulter Inc, China Medical Technologies Inc (Inactive), Colorado State University, Fujirebio Diagnostics Inc, Genesis Detection Systems, Inc., Guanine Inc, Hologic Inc, and Isoformix Inc

Segments Covered in the Report

Specific Proteins Pipeline Products Market Territories Outlook

  • The US
  • India
  • China
  • Europe

Specific Proteins Pipeline Products Market Regulatory Paths Outlook

  • 510(k)
  • CE-IVD
  • ICAC
  • NMPA

Scope

This report provides:

  • Extensive coverage of the Specific Proteins under development.

  • Details of major pipeline products which include product description, licensing, collaboration details, and other developmental activities.

  • Reviews of major players involved in the development of Specific Proteins and lists all their pipeline projects.

  • The coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.

  • 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 a potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.

  • Identify and understand important and diverse types of Specific Proteins 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.

Alfa Wassermann Diagnostic Technologies, LLC
Amerimmune LLC
Beckman Coulter Inc
China Medical Technologies Inc (Inactive)
Colorado State University
Fujirebio Diagnostics Inc
Genesis Detection Systems, Inc.
Guanine Inc
Hologic Inc
Isoformix Inc
Numares AG
Ortho Clinical Diagnostics Holdings Plc
Ottawa Hospital Research Institute
Roche Diagnostics International Ltd
Sebia SA
Siemens Healthcare Diagnostics Inc
SomaLogic Inc
Umea University
University of California

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 5

|1.2 List of Figures 8

2 Introduction 9

2.1 Specific Proteins Overview 9

3 Products under Development 10

3.1 Specific Proteins – Pipeline Products by Stage of Development 10

3.2 Specific Proteins – Pipeline Products by Territory 11

3.3 Specific Proteins – Pipeline Products by Regulatory Path 12

3.4 Specific Proteins – Pipeline Products by Estimated Approval Date 13

3.5 Specific Proteins – Ongoing Clinical Trials 14

4 Specific Proteins – Pipeline Products under Development by Companies 15

4.1 Specific Proteins Companies – Pipeline Products by Stage of Development 15

4.2 Specific Proteins – Pipeline Products by Stage of Development 16

5 Specific Proteins Companies and Product Overview 18

5.1 Alfa Wassermann Diagnostic Technologies, LLC Company Overview 18

5.1.1 Alfa Wassermann Diagnostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Amerimmune LLC Company Overview 20

5.2.1 Amerimmune LLC Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 Beckman Coulter Inc Company Overview 22

5.3.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.4 China Medical Technologies Inc (Inactive) Company Overview 30

5.4.1 China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

5.5 Colorado State University Company Overview 31

5.5.1 Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Fujirebio Diagnostics Inc Company Overview 32

5.6.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.7 Genesis Detection Systems, Inc. Company Overview 33

5.7.1 Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.8 Guanine Inc Company Overview 34

5.8.1 Guanine Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Hologic Inc Company Overview 35

5.9.1 Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Isoformix Inc Company Overview 36

5.10.1 Isoformix Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 Numares AG Company Overview 37

5.11.1 Numares AG Pipeline Products & Ongoing Clinical Trials Overview 37

5.12 Ortho Clinical Diagnostics Holdings Plc Company Overview 38

5.12.1 Ortho Clinical Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 38

5.13 Ottawa Hospital Research Institute Company Overview 40

5.13.1 Ottawa Hospital Research Institute Pipeline Products & Ongoing Clinical Trials Overview 40

5.14 Roche Diagnostics International Ltd Company Overview 41

5.14.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

5.15 Sebia SA Company Overview 48

5.15.1 Sebia SA Pipeline Products & Ongoing Clinical Trials Overview 48

5.16 Siemens Healthcare Diagnostics Inc Company Overview 49

5.16.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.17 SomaLogic Inc Company Overview 53

5.17.1 SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.18 Umea University Company Overview 57

5.18.1 Umea University Pipeline Products & Ongoing Clinical Trials Overview 57

5.19 University of California Company Overview 58

5.19.1 University of California Pipeline Products & Ongoing Clinical Trials Overview 58

6 Specific Proteins- Recent Developments 59

6.1 Oct 05, 2022: DiaSorin Gets $31M BARDA Funding for Point-of-Care Instrument 59

6.2 Aug 19, 2022: Bio-Works Sweden announce first half Jan – Jun 2022 results 59

6.3 Aug 01, 2022: PerkinElmer Announces Financial Results for the Second Quarter of 2022 61

6.4 Jul 25, 2022: Beckman Coulter partners with Mass General and BARDA to identify severe pediatric infections in emergency departments 62

6.5 Jul 20, 2022: Abbott Reports Second-Quarter 2022 Results and Raises Full-Year EPS Guidance 63

6.6 May 04, 2022: Ortho Clinical Diagnostics Reports First Quarter 2022 Results 64

6.7 May 03, 2022: PerkinElmer Announces Financial Results for the First Quarter of 2022 65

6.8 Apr 26, 2022: Study of more than 18,000 patients finds exome sequencing delivers higher diagnostic rates for autism spectrum disorders 66

6.9 Apr 20, 2022: Ortho Clinical Diagnostics to Report First Quarter 2022 Results on May 4, 2022 67

6.10 Apr 12, 2022: BIO-TECHNE and Cygnus Technologies, part of Maravai LifeSciences, introduce new simple plex HEK 293 HCP 3G immunoassay 67

6.11 Apr 11, 2022: Aviva Systems Biology Launches AvivaBlot ECL Reagents for Western Blot 68

6.12 Apr 11, 2022: Aviva Systems Biology announces the launch of high throughput antibody characterization services 68

6.13 Mar 28, 2022: New order of WorkBeads – the next generation of protein purification – to Spanish CDMO 3P Biopharmaceuticals 68

6.14 Mar 18, 2022: Researchers study how gene expression changes in the brain in Alzheimer’s disease 69

6.15 Mar 16, 2022: GeneDx announces discovery of 200 new and expanded genetic conditions 70

6.16 Mar 02, 2022: Opthea Expands Leadership Team with the Appointment of Joel Naor, M.D., M.Sc., MBA as Chief Medical Officer 70

6.17 Feb 16, 2022: Ortho Clinical Diagnostics Reports Fourth Quarter and Fiscal Year 2021 Results 71

6.18 Feb 10, 2022: PerkinElmer to Present at Citi’s 2022 Virtual Healthcare Conference 72

6.19 Feb 01, 2022: PerkinElmer Announces Financial Results for the Fourth Quarter and Full Year of 2021 72

6.20 Jan 06, 2022: SomaLogic partners with Illumina to develop proteomic solutions 74

6.21 Jan 03, 2022: Ortho Clinical Diagnostics to Participate in the 40th Annual JP Morgan Healthcare Conference 75

6.22 Jan 02, 2022: Ortho Clinical Diagnostics Announces Preliminary Financial Results for Fourth Quarter and Fiscal Year 2021 75

6.23 Nov 16, 2021: PerkinElmer to Present at Evercore ISI HealthCONx Conference 2021 76

6.24 Nov 16, 2021: Artificial intelligence successfully predicts protein interactions 76

6.25 Oct 26, 2021: Bionova Scientific unveils new commercial-ready GMP biologics manufacturing facility at grand opening event 77

7 Appendix 79

7.1 Methodology 79

7.2 About GlobalData 82

7.3 Contact Us 82

7.4 Disclaimer 82

Table

Specific Proteins – Pipeline Products by Stage of Development 10

Specific Proteins – Pipeline Products by Territory 11

Specific Proteins – Pipeline Products by Regulatory Path 12

Specific Proteins – Pipeline Products by Estimated Approval Date 13

Specific Proteins – Ongoing Clinical Trials 14

Specific Proteins Companies – Pipeline Products by Stage of Development 15

Specific Proteins – Pipeline Products by Stage of Development 16

Alfa Wassermann Diagnostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 18

ACE Axcel System – Microalbumin Assay – Product Status 18

ACE Axcel System – Microalbumin Assay – Product Description 18

ACE Axcel System – Transferrin Assay – Product Status 19

ACE Axcel System – Transferrin Assay – Product Description 19

Amerimmune LLC Pipeline Products & Ongoing Clinical Trials Overview 20

FoxP3 Protein Expression Assay – Product Status 20

FoxP3 Protein Expression Assay – Product Description 20

Wiscott-Aldrich Protein Expression Assay – Product Status 21

Wiscott-Aldrich Protein Expression Assay – Product Description 21

Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Access – sFlt-1 Assay – Product Status 23

Access – sFlt-1 Assay – Product Description 23

UniCel DxC 680i Synchron Access Clinical System – PlGF Assay – Product Status 23

UniCel DxC 680i Synchron Access Clinical System – PlGF Assay – Product Description 23

UniCel DxC 680i Synchron Access Clinical System – sFlt-1 Assay – Product Status 24

UniCel DxC 680i Synchron Access Clinical System – sFlt-1 Assay – Product Description 24

UniCel DxC 860i Synchron Access Clinical System – PlGF Assay – Product Status 24

UniCel DxC 860i Synchron Access Clinical System – PlGF Assay – Product Description 24

UniCel DxC 860i Synchron Access Clinical System – sFlt-1 Assay – Product Status 25

UniCel DxC 860i Synchron Access Clinical System – sFlt-1 Assay – Product Description 25

UniCel DxC 880i Synchron Access Clinical System – PlGF Assay – Product Status 25

UniCel DxC 880i Synchron Access Clinical System – PlGF Assay – Product Description 25

UniCel DxC 880i Synchron Access Clinical System – sFlt-1 Assay – Product Status 26

UniCel DxC 880i Synchron Access Clinical System – sFlt-1 Assay – Product Description 26

UniCel DxI 600 Access Immunoassay System – PlGF Assay – Product Status 26

UniCel DxI 600 Access Immunoassay System – PlGF Assay – Product Description 26

UniCel DxI 600 Access Immunoassay System – sFlt-1 Assay – Product Status 27

UniCel DxI 600 Access Immunoassay System – sFlt-1 Assay – Product Description 27

UniCel DxI 660i Synchron Access Clinical System – sFlt-1 Assay – Product Status 27

UniCel DxI 660i Synchron Access Clinical System – sFlt-1 Assay – Product Description 27

UniCel DxI 800 Access Immunoassay System – PlGF Assay – Product Status 28

UniCel DxI 800 Access Immunoassay System – PlGF Assay – Product Description 28

UniCel DxI 800 Access Immunoassay System – sFlt-1 Assay – Product Status 28

UniCel DxI 800 Access Immunoassay System – sFlt-1 Assay – Product Description 28

UniCel DxI 860i Synchron Access Clinical System – PlGF Assay – Product Status 29

UniCel DxI 860i Synchron Access Clinical System – PlGF Assay – Product Description 29

UniCel sFlt-1 Assay – Product Status 29

UniCel sFlt-1 Assay – Product Description 29

China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

Diagnostic Assay – Protein 24 – Product Status 30

Diagnostic Assay – Protein 24 – Product Description 30

Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 31

Unconjugated Ubiquitin Assay – Product Status 31

Unconjugated Ubiquitin Assay – Product Description 31

Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Lumipulse G – ApoB48 Assay Kit – Product Status 32

Lumipulse G – ApoB48 Assay Kit – Product Description 32

Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Rapid Home Test – Albumin – Product Status 33

Rapid Home Test – Albumin – Product Description 33

Guanine Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Guanine Amplified Assay Kit – Proteins – Product Status 34

Guanine Amplified Assay Kit – Proteins – Product Description 34

Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Quant. fFN Test – Product Status 35

Quant. fFN Test – Product Description 35

Isoformix Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Mass Spectrometry – Protein Clinical Test – Product Status 36

Mass Spectrometry – Protein Clinical Test – Product Description 36

Numares AG Pipeline Products & Ongoing Clinical Trials Overview 37

Axinon LDL-P Test – Product Status 37

Axinon LDL-P Test – Product Description 37

Ortho Clinical Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 38

VITROS XT 7600 Integrated System – Alpha-1 Acid Glycoprotein Assay – Product Status 38

VITROS XT 7600 Integrated System – Alpha-1 Acid Glycoprotein Assay – Product Description 38

VITROS XT 7600 Integrated System – Alpha-2 Macroglobulin Assay – Product Status 39

VITROS XT 7600 Integrated System – Alpha-2 Macroglobulin Assay – Product Description 39

Ottawa Hospital Research Institute Pipeline Products & Ongoing Clinical Trials Overview 40

IGFBP-4 Blood Test – Product Status 40

IGFBP-4 Blood Test – Product Description 40

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

Cobas 6000 Analyzer Series With e 601 Module – PIGF Assay – Product Status 41

Cobas 6000 Analyzer Series With e 601 Module – PIGF Assay – Product Description 42

Cobas 6000 Analyzer Series With e 601 Module – sFlt-1 Assay – Product Status 42

Cobas 6000 Analyzer Series With e 601 Module – sFlt-1 Assay – Product Description 42

Cobas 8000 Analyzer Series With c 701 Module – Alpha 2 Microglobulin Assay – Product Status 43

Cobas 8000 Analyzer Series With c 701 Module – Alpha 2 Microglobulin Assay – Product Description 43

Cobas 8000 Analyzer Series With c 702 Module – Alpha 2 Microglobulin Assay – Product Status 43

Cobas 8000 Analyzer Series With c 702 Module – Alpha 2 Microglobulin Assay – Product Description 43

Cobas 8000 Analyzer Series With e 602 Module – Alpha 2 Microglobulin Assay – Product Status 44

Cobas 8000 Analyzer Series With e 602 Module – Alpha 2 Microglobulin Assay – Product Description 44

Cobas 8000 Analyzer Series With e 602 Module – PIGF Assay – Product Status 44

Cobas 8000 Analyzer Series With e 602 Module – PIGF Assay – Product Description 45

Cobas 8000 Analyzer Series With e 801 Module – Alpha 2 Microglobulin Assay – Product Status 45

Cobas 8000 Analyzer Series With e 801 Module – Alpha 2 Microglobulin Assay – Product Description 45

Cobas 8000 Analyzer Series With e 801 Module – PIGF Assay – Product Status 46

Cobas 8000 Analyzer Series With e 801 Module – PIGF Assay – Product Description 46

Cobas 8000 Analyzer Series With e 801 Module – sFlt-1 Assay – Product Status 46

Cobas 8000 Analyzer Series With e 801 Module – sFlt-1 Assay – Product Description 47

Cobas Alpha 2 Microglobulin Assay – Product Status 47

Cobas Alpha 2 Microglobulin Assay – Product Description 47

Sebia SA Pipeline Products & Ongoing Clinical Trials Overview 48

Capillarys 3 Tera Assay – Protein HR – Product Status 48

Capillarys 3 Tera Assay – Protein HR – Product Description 48

Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

ADVIA 1800 Chemistry System – Soluble Transferrin Receptor (sTfR) Assay – Product Status 49

ADVIA 1800 Chemistry System – Soluble Transferrin Receptor (sTfR) Assay – Product Description 49

ADVIA Chemistry XPT System – Soluble Transferrin Receptor (sTfR) Assay – Product Status 50

ADVIA Chemistry XPT System – Soluble Transferrin Receptor (sTfR) Assay – Product Description 50

ADVIA Soluble Transferrin Receptor (sTfR) Assay – Product Status 50

ADVIA Soluble Transferrin Receptor (sTfR) Assay – Product Description 50

Atellica Solution – PIGF – Product Status 51

Atellica Solution – PIGF – Product Description 51

PIGF Biomarker-Based Preeclampsia Diagnostic Assay – Product Status 51

PIGF Biomarker-Based Preeclampsia Diagnostic Assay – Product Description 51

SFLT-1 Biomarker-Based Preeclampsia Diagnostic Assay – Product Status 52

SFLT-1 Biomarker-Based Preeclampsia Diagnostic Assay – Product Description 52

SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Next-Generation SOMAscan Assay – Product Status 53

Next-Generation SOMAscan Assay – Product Description 53

SOMAscan Assay – Product Status 54

SOMAscan Assay – Product Description 54

SomaLogic Inc – Ongoing Clinical Trials Overview 55

SOMAscan Assay – Cerebrospinal Fluid-biomarkers-based Diagnostic and Prognostic Models for Multiple Sclerosis 56

SOMAscan Assay – Multi-Ethnic Study of Atherosclerosis (MESA) 56

SOMAscan Assay – Triangular Phenotyping and Response Assessment in Small Bowel Crohn’s Disease Using Magnetic Resonance Enterography (MRE) and Novel Proteomic Biomarkers 56

Umea University Pipeline Products & Ongoing Clinical Trials Overview 57

Immunoglobulin Measurement Test – Zika Infection – Product Status 57

Immunoglobulin Measurement Test – Zika Infection – Product Description 57

University of California Pipeline Products & Ongoing Clinical Trials Overview 58

Serologic Assay – Brain Ischemia – Product Status 58

Serologic Assay – Brain Ischemia – Product Description 58

Glossary 81

Figures

Specific Proteins – Pipeline Products by Stage of Development 9

Specific Proteins – Pipeline Products by Territory 10

Specific Proteins – Pipeline Products by Regulatory Path 11

Specific Proteins – Pipeline Products by Estimated Approval Date 12

Specific Proteins – Ongoing Clinical Trials 13

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