Hematology Tests Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Published: November 21, 2023 Report Code: GDME1649EPD-ST

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Hematology Tests Pipeline Market Report Overview

Hematology tests include various blood tests that help diagnose and monitor various conditions. The Hematology Tests pipeline market research report provides comprehensive information about the Hematology tests pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Segments ·        Hemoglobin Point of Care (POC) Tests

·        Other Hematology Rapid Tests & POC

·        Platelets Point of Care (POC) Tests

·        Rapid Haematology Tests (Point-Of-Care/Near Patient)

·        White Blood Count Point of Care (POC) Tests

·        Complete Blood Count (CBC) Tests

·        Hemoglobin Laboratory Tests
Key Territories ·        The US

·        Europe

·        South Korea

·        India

·        Mexico
Key Regulatory Paths ·        510(k)

·        CE-IVD

·        MDITAC

·        ICAC

·        INVIMA

·        ANVISA
Leading Companies ·        Aptitude Medical Systems Inc

·        Biochip Labs Inc

·        BioMedomics Inc

·        Biosurfit, SA

·        DxDiscovery Inc

·        Dynasil Corporation of America

·        Epimune GmbH
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Hematology Tests Pipeline Market by Segments

Some of the key segments in the hematology tests pipeline market are Hemoglobin Point of Care (POC) Tests, Other Hematology Rapid Tests & POC, Platelets Point of Care (POC) Tests, Rapid Haematology Tests (Point-Of-Care/Near Patient), and White Blood Count Point of Care (POC) Tests, among others. As of November 2023, Hemoglobin Point of Care (POC) tests have the highest number of pipeline products.

Hemoglobin POC evaluates the hemoglobin content of blood as part of a general health check-up. It is also used to screen for and help diagnose conditions that affect red blood cells (RBCs). In patients suffering from anemia or polycythemia, hemoglobin POC is used to assess the severity of these conditions and to monitor response to treatment.

Hematology Tests Pipeline Market Analysis by Segments, 2023 (%)

Hematology Tests Pipeline Market Analysis by Segments, 2023 (%)

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Hematology Tests Pipeline Market Segmentation by Territories

Some of the key territories in the hematology tests market are the US, Europe, South Korea, India, and Mexico. As of November 2023, the US has the highest number of pipeline products.

Hematology Tests Pipeline Market Analysis by Territories, 2023 (%)

Hematology Tests Pipeline Market Analysis by Territories, 2023 (%)

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Hematology Tests Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the hematology tests pipeline market are 510(k), CE-IVD, MDITAC, ICAC, INVIMA, and ANVISA. As of November 2023, 510(k) is the most followed pathway for pipeline products in the market.

Hematology Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Hematology Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Hematology Tests Pipeline Market – Competitive Landscape

Some of the key companies in the hematology tests pipeline market are Aptitude Medical Systems Inc, Biochip Labs Inc, BioMedomics Inc, Biosurfit, SA, DxDiscovery Inc, Dynasil Corporation of America, and Epimune GmbH.

Aptitude Medical Systems Inc: It operates as a developer of dynamic proteins, peptides, toxins, glycans, metabolites, and small epitopes. Aptitude Medical’s products are used for the detection and manipulation of proteins for cancer, diabetes, autoimmune, heart disease, and personalized drug response. The company works in collaboration with the life science, clinical diagnostic, and therapeutic companies. Aptitude Medical is headquartered in Santa Barbara, California, the US.

BioMedomics Inc: It is a point-of-care diagnostics company that develops and markets immunologically based disease-specific tests and advanced highly sensitive quantitative platforms. The company provides technologies such as time-resolved lateral flow immunoassay and nanotube-based POC platform. BioMedomics is headquartered in Morrisville, North Carolina, the US.

Hematology Tests Pipeline Market Analysis by Companies, 2023

Hematology Tests Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Hematology Tests Pipeline Market Segments Outlook

  • Hemoglobin Point of Care (POC) Tests
  • Other Hematology Rapid Tests & POC
  • Platelets Point of Care (POC) Tests
  • Rapid Haematology Tests (Point-Of-Care/Near Patient)
  • White Blood Count Point of Care (POC) Tests
  • Complete Blood Count (CBC) Tests
  • Hemoglobin Laboratory Tests

Hematology Tests Pipeline Market Territories Outlook

  • The US
  • Europe
  • South Korea
  • India
  • Mexico

Hematology Tests Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE-IVD
  • MDITAC
  • ICAC
  • INVIMA
  • ANVISA

Scope

This report provides:

  • Extensive coverage of the Hematology Tests under development.

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

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

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

  • Provides key clinical trial data of ongoing clinical 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 a competitive advantage.

  • Identify and understand important and diverse types of Hematology Tests 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.

Aptitude Medical Systems Inc
Biochip Labs Inc
BioMedomics Inc
Biosurfit, SA
DxDiscovery Inc
Dynasil Corporation of America
Epimune GmbH
Flobio LLC
genedrive plc
Group K Diagnostics
hemCheck Sweden AB
Hemex Health Inc
McMaster University
MiCo BioMed Co Ltd
Ohio State University
Optolane Technologies Inc
PortaScience Inc
Retham Technologies LLC
rHealth
Sanguina LLC
ShanMukha Innovations Pvt Ltd
Siemens Healthcare Diagnostics Inc
Silver Lake Research Corporation
T2 Biosystems Inc
University of Florida
University of Melbourne
VitaMe Technologies Inc

Table of Contents

  • 1 Table of Contents

    • 1.1 List of Tables

    • 1.2 List of Figures

  • 2 Introduction

    • 2.1 Hematology Tests Overview

  • 3 Products under Development

    • 3.1 Hematology Tests – Pipeline Products by Stage of Development

    • 3.2 Hematology Tests – Pipeline Products by Segment

    • 3.3 Hematology Tests – Pipeline Products by Territory

    • 3.4 Hematology Tests – Pipeline Products by Regulatory Path

    • 3.5 Hematology Tests – Pipeline Products by Estimated Approval Date

  • 4 Hematology Tests – Pipeline Products under Development by Companies

    • 4.1 Hematology Tests Companies – Pipeline Products by Stage of Development

    • 4.2 Hematology Tests – Pipeline Products by Stage of Development

  • 5 Hematology Tests Companies and Product Overview

    • 5.1 Aptitude Medical Systems Inc Company Overview

      • 5.1.1 Aptitude Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.2 Biochip Labs Inc Company Overview

      • 5.2.1 Biochip Labs Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.3 BioMedomics Inc Company Overview

      • 5.3.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.4 Biosurfit, SA Company Overview

      • 5.4.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview

    • 5.5 DxDiscovery Inc Company Overview

      • 5.5.1 DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.6 Dynasil Corporation of America Company Overview

      • 5.6.1 Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview

    • 5.7 Epimune GmbH Company Overview

      • 5.7.1 Epimune GmbH Pipeline Products & Ongoing Clinical Trials Overview

    • 5.8 Flobio LLC Company Overview

      • 5.8.1 Flobio LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.9 genedrive plc Company Overview

      • 5.9.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.10 Group K Diagnostics Company Overview

      • 5.10.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview

    • 5.11 hemCheck Sweden AB Company Overview

      • 5.11.1 hemCheck Sweden AB Pipeline Products & Ongoing Clinical Trials Overview

    • 5.12 Hemex Health Inc Company Overview

      • 5.12.1 Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.13 McMaster University Company Overview

      • 5.13.1 McMaster University Pipeline Products & Ongoing Clinical Trials Overview

    • 5.14 MiCo BioMed Co Ltd Company Overview

      • 5.14.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.15 Ohio State University Company Overview

      • 5.15.1 Ohio State University Pipeline Products & Ongoing Clinical Trials Overview

    • 5.16 Optolane Technologies Inc Company Overview

      • 5.16.1 Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.17 PortaScience Inc Company Overview

      • 5.17.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.18 Retham Technologies LLC Company Overview

      • 5.18.1 Retham Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.19 rHealth Company Overview

      • 5.19.1 rHealth Pipeline Products & Ongoing Clinical Trials Overview

    • 5.20 Sanguina LLC Company Overview

      • 5.20.1 Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview

    • 5.21 ShanMukha Innovations Pvt Ltd Company Overview

      • 5.21.1 ShanMukha Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.22 Siemens Healthcare Diagnostics Inc Company Overview

      • 5.22.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.23 Silver Lake Research Corporation Company Overview

      • 5.23.1 Silver Lake Research Corporation Pipeline Products & Ongoing Clinical Trials Overview

    • 5.24 T2 Biosystems Inc Company Overview

      • 5.24.1 T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.25 University of Florida Company Overview

      • 5.25.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview

    • 5.26 University of Melbourne Company Overview

      • 5.26.1 University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview

    • 5.27 VitaMe Technologies Inc Company Overview

      • 5.27.1 VitaMe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview

  • 6 Hematology Tests- Recent Developments

    • 6.1 Sep 11, 2023: Capitainer-backed initiative in personalized medicine and diagnostics secures a SEK 12 million boost from KK-stiftelsen

    • 6.2 Aug 28, 2023: Bio-Rad to Participate in Fireside Chat During Wells Fargo’s 2023 Healthcare Conference

    • 6.3 Aug 09, 2023: Biohit Group Announces Half Year Financial Report 2023

    • 6.4 Aug 09, 2023: Halo Collective Releases Q4 2022, Q1 2023 Financial Results

    • 6.5 Jun 14, 2023: Biohit Announces Decisions of the Annual General Meeting

    • 6.6 Jun 14, 2023: Biohit Decisions of the Annual General Meeting

    • 6.7 May 03, 2023: Halo Collective Announces Change to Board of Directors

    • 6.8 Apr 04, 2023: Capitainer Launches Fully Automated Sample Handler

    • 6.9 Mar 28, 2023: EKF Diagnostics Holdings Announces its final results for the year ended 31 December 2022

    • 6.10 Mar 22, 2023: Biohit Announces Annual Report 2022

    • 6.11 Feb 16, 2023: Terumo Blood and Cell Technologies’ IMUGARD platelet pooling set cleared by FDA

    • 6.12 Feb 15, 2023: Biohit Announces Group Financial Statements Release

    • 6.13 Jan 27, 2023: Halo Collective Reports Q4 Revenue Increase For its Budega(TM) Retail Stores in California

    • 6.14 Jan 27, 2023: New test could detect Alzheimer’s disease

      3.5 years before clinical diagnosis

    • 6.15 Jan 10, 2023: Molecular You launches a new preventive solution shown to improve health outcomes over 100 days

    • 6.16 Jan 06, 2023: Bio-Rad to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, February 16, 2023

    • 6.17 Dec 15, 2022: Biohit Announces Change of R&D Director

    • 6.18 Dec 13, 2022: Capitainer launches a new product for a larger blood volume in self-sampling

    • 6.19 Nov 30, 2022: Biohit Oyj’s Financial Reporting and Annual General Meeting in 2023

  • 7 Appendix

    • 7.1 Methodology

    • 7.2 About GlobalData

    • 7.3 Contact Us

    • 7.4 Disclaimer

Table

Hematology Tests – Pipeline Products by Stage of Development 10

Hematology Tests – Pipeline Products by Segment 11

Hematology Tests – Pipeline Products by Territory 12

Hematology Tests – Pipeline Products by Regulatory Path 13

Hematology Tests – Pipeline Products by Estimated Approval Date 14

Hematology Tests Companies – Pipeline Products by Stage of Development 15

Hematology Tests – Pipeline Products by Stage of Development 17

Aptitude Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 18

POC Test – Trauma Coagulopathy – Product Status 18

POC Test – Trauma Coagulopathy – Product Description 18

Biochip Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Endothelium-on-a-Chip Assay – Product Status 19

Endothelium-on-a-Chip Assay – Product Description 19

BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Fetomaternal Hemorrhage Test – Product Status 20

Fetomaternal Hemorrhage Test – Product Description 20

Hemo SCAN – Product Status 21

Hemo SCAN – Product Description 21

Hemo SCAN S – Product Status 21

Hemo SCAN S – Product Description 22

Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test – Product Status 22

Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test – Product Description 22

Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 23

Spinit Device – Blood Quantitation Anemia Assay – Product Status 23

Spinit Device – Blood Quantitation Anemia Assay – Product Description 23

Spinit Device – Thrombocytopenia Assay – Product Status 24

Spinit Device – Thrombocytopenia Assay – Product Description 24

DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Diagnostic Assay – Sickle Cell Disease – Product Status 25

Diagnostic Assay – Sickle Cell Disease – Product Description 25

Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 26

Diagnostic Test – Hemophilia – Product Status 26

Diagnostic Test – Hemophilia – Product Description 26

Epimune GmbH Pipeline Products & Ongoing Clinical Trials Overview 27

i.Mune Tbnk Test – Product Status 27

i.Mune Tbnk Test – Product Description 27

Flobio LLC Pipeline Products & Ongoing Clinical Trials Overview 28

DOAC Diagnostic Assay – Product Status 28

DOAC Diagnostic Assay – Product Description 28

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 29

Genedrive – Factor V Leiden – Product Status 29

Genedrive – Factor V Leiden – Product Description 29

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 30

KromaHealth Kit – Complete Blood Count – Product Status 30

KromaHealth Kit – Complete Blood Count – Product Description 30

hemCheck Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 31

v-Test – Serum Tubes – Product Status 31

v-Test – Serum Tubes – Product Description 31

Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Gazelle Hb Variant Test – Product Status 32

Gazelle Hb Variant Test – Product Description 32

McMaster University Pipeline Products & Ongoing Clinical Trials Overview 33

aFXa DOAC Assay – Product Status 33

aFXa DOAC Assay – Product Description 33

MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 34

Labchip Based Test – Hemoglobin – Product Status 34

Labchip Based Test – Hemoglobin – Product Description 34

Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 35

Diagnostic Assay – Thrombotic Thrombocytopenic Purpura – Product Status 35

Diagnostic Assay – Thrombotic Thrombocytopenic Purpura – Product Description 35

Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Molecular Dx – Thrombosis Panel – Product Status 36

Molecular Dx – Thrombosis Panel – Product Description 36

PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 37

PortaWBC – Product Status 37

PortaWBC – Product Description 37

Retham Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 38

HITDx – Product Status 38

HITDx – Product Description 38

rHealth Pipeline Products & Ongoing Clinical Trials Overview 39

Diagnostic Test – Thrombocytopenia – Product Status 39

Diagnostic Test – Thrombocytopenia – Product Description 39

Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview 40

AnemoCheck Home – Product Status 40

AnemoCheck Home – Product Description 40

ShanMukha Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

SickleFind – Product Status 41

SickleFind – Product Description 41

Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 42

ADVIA 120 Hematology System – IRF Test – Product Status 42

ADVIA 120 Hematology System – IRF Test – Product Description 42

ADVIA 120 Hematology System – MPC Test – Product Status 43

ADVIA 120 Hematology System – MPC Test – Product Description 43

ADVIA 120 Hematology System – MPM Test – Product Status 43

ADVIA 120 Hematology System – MPM Test – Product Description 43

ADVIA 2120 Hematology System – MPC Test – Product Status 44

ADVIA 2120 Hematology System – MPC Test – Product Description 44

ADVIA 2120 Hematology System – MPM Test – Product Status 44

ADVIA 2120 Hematology System – MPM Test – Product Description 45

ADVIA 2120i Hematology System – MPC Test – Product Status 45

ADVIA 2120i Hematology System – MPC Test – Product Description 45

ADVIA 2120i Hematology System – MPM Test – Product Status 46

ADVIA 2120i Hematology System – MPM Test – Product Description 46

Silver Lake Research Corporation Pipeline Products & Ongoing Clinical Trials Overview 47

HemoTypeBT – Product Status 47

HemoTypeBT – Product Description 47

T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 48

T2HemoStat – Product Status 48

T2HemoStat – Product Description 48

T2MR Assay – Platelet Function Testing – Product Status 49

T2MR Assay – Platelet Function Testing – Product Description 49

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 50

Hemoglobin Measurement Device – Product Status 50

Hemoglobin Measurement Device – Product Description 50

University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 51

Thrombin Generation Assay – Product Status 51

Thrombin Generation Assay – Product Description 51

VitaMe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Iron.Scan – Product Status 52

Iron.Scan – Product Description 52

Glossary 90

Figures

Hematology Tests – Pipeline Products by Stage of Development 9_x000D_

Hematology Tests – Pipeline Products by Segment 10_x000D_

Hematology Tests – Pipeline Products by Territory 11_x000D_

Hematology Tests – Pipeline Products by Regulatory Path 12_x000D_

Hematology Tests – Pipeline Products by Estimated Approval Date 13_x000D_

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